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Testing the viability of an injectable medical sensor by first strapping it to a bee’s back like a tiny bee backpack may not initially make the most sense. But are you really going to question researchers’ motives for something that looks so cute?

As detailed in a paper published earlier this week in Science, a team at Philips Research in Hamburg, Germany recently designed a 1-millimeter-wide sensor employing two opposing magneto-mechanical resonators (MMRs) within a cylindrical casing. They then attached the sensor to a honeybee just above its wings, and released the insect into a small enclosure featuring a variety of flowers to hop between.

Researchers wirelessly checked the sensor’s conditions by remotely stimulating the MMRs with pulses of current from electromagnetic coils. How much the magnets oscillated, the distance between them, as well as how much they contracted and expanded subsequently helped the team measure its location, pressure, and temperature. MMRs are generally far more sensitive than other, similar radiofrequency trackers, and are thus also capable of three-dimensional spatial tracking. As such, researchers could track the bee’s flight patterns, as well as its positioning as it walked upside down across the case’s ceiling.

[Related: Neuralink human brain-computer implant trials finally get FDA approval.]

The sensor didn’t only stay strapped to its bee test subject—researchers also experimented with using their device to three-dimensionally chart its path through a lengthy, twisting tube simulating a gastrointestinal tract. And if that weren’t enough, the sensor also helped navigate a biopsy needle in a simulated environment, as well as recorded the paths of a writing marker tracing continents’ outlines on a globe.

Although the team estimates their device is still between 5 and 8 years away from becoming available to the public, they believe that the sensor could prove extremely useful in a variety of medical settings. For example, such a sensor could one day be implanted directly in a patient’s heart to measure arterial blood pressure, or within tumors to observe their progress or eradication. A safe, ingestible pill to assess GI tract health is also easily foreseeable for such a small sensor.

That’s all well and good, but would all be worth it alone to see more bees buzzing around gardens with miniature fanny packs.

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A phase 3 trial found that a new meningococcal disease vaccine is safe and effective and also induces a strong immune response across five strains of meningococcal bacteria. The results were published May 24 in the New England Journal of Medicine. The vaccine could be a useful tool in eliminating meningitis in African countries including parts of Senegal, Mali, and Ethiopia.

[Related: A once-forgotten antibiotic could be a new weapon against drug-resistant infections.]

Meningococcal disease is a cause of meningitis and blood poisoning. According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019. While vaccines are readily available in wealthier countries, vaccinating the more vulnerable regions has been a challenge, largely due to cost. Developing affordable vaccines that provide broad coverage against meningococcal disease strains is a key part of the World Health Organization’s Defeating Meningitis by 2030 Global Roadmap.

The trial compared the immune response generated by a new pentavalent, or 5-in-1, vaccine  called NmCV-5 against that of the licensed quadrivalent, or 4-in-1, MenACWY-D vaccine. The participants included 1,800 healthy two to 29-year-olds in Mali and The Gambia in western Africa. The vaccinations occurred in June 2021, and the trial didn’t find any safety concerns with NmCV-5. 

After 28 days, the immune responses generated by one dose of NmCV-5 were generally higher than those generated by the 4-in-1 vaccine across all age groups. The 5-in-1 vaccine also induced a strong immune response across meningococcal bacteria strains A, C, W, and Y and the emerging X strain. Currently, there is no licensed vaccine against the X strain, which may be the cause of meningitis epidemics in sub-Saharan Africa.

“Meningitis is a deadly disease with the ability to spread like wildfire in the event of an outbreak, this affects all ages most especially within the meningitis belt region,” study co-author Ama Umesi said in a statement. Umesi is a clinical trial coordinator and clinician from the Medical Research Council’s Unit The Gambia at the London School of Hygiene & Tropical Medicine. 

“Epidemic preparedness is the way forward in providing available, affordable and accessible vaccines relevant to regions prone to meningitis outbreaks. Having meningitis vaccines should be a public health priority to prevent catastrophic outcomes during an outbreak and would be a game changer in the fight against meningitis,” Umensi said.

Issues with supply and affordability have limited the use of 4-in-1 meningococcal vaccines across a portion of sub-Saharan Africa called the meningitis belt. This region is at high-risk of epidemics of both meningococcal and pneumococcal meningitis. The NmCV-5 vaccine was developed by the Serum Institute of India and PATH, the global division of the Bill & Melinda Gates foundation. It follows the successful Meningitis Vaccine Project that developed an effective meningococcal A vaccine called MenAfriVac.

[Related: Ghana is the first country to approve Oxford’s malaria vaccine.]

According to the study, the new NmCV-5 vaccine can be made available at lower cost than existing 4-in-1 vaccines with more cost-effective production methods. The trial was designed to provide the World Health Organization with the evidence it needs to license the new vaccine for future epidemic control.

“As a researcher in the continent, I am hopeful that relevant vaccines for the common strains within the meningitis belt region will be readily available for timely interventions due to the collaboration and teamwork of multicentre trials like ours,” Umesi said. “Together we can defeat meningitis,” Umesi said. 

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Joel Cramer was at the pool with his kids when another dad, competing in a big splash contest, got up onto the diving board. He bounced up once, and when he landed on the board for the second time, his quadriceps muscle tore. “It rolled up his leg and balled up near the top of his thigh,” says Cramer, a professor of exercise physiology at the University of Nebraska. “[It was] like rolling up a window shade.”

That’s an extreme (and extremely rare) example of a muscle strain, a common injury that happens to high school soccer stars, recreational runners, and middle-aged racquetball players alike. “Strain” is the medical term for the condition, though it’s colloquially known as a pulled muscle. The term is a catch-all that covers everything from a small twinge to a full-on rupture.

What we call a “tear” and what we coin a “pull or strain” all boil down to the same type of injury: A rip to some part of the muscle. But some are worse than others. A mild or “grade one” strain—what many people call a “pulled muscle”—happens when you tear about 5 percent of the fibers in a particular muscle. This typically feels like an uncomfortable twinge that may force you off the court for a few weeks. A moderate sprain involves a higher percentage of fibers, and might sideline you for a month or more. A full rupture severs the muscle entirely, and usually requires surgery to repair.

[Related: Why do my muscles ache the day after a big workout?]

Okay, but how exactly do these tears occur? And why do some instances result in more muscle fiber damage than others? Cramer says three major factors contribute to this muscle busting. Muscles that cover two joints, like the hamstring which extends across the hip and knee joints, are at the highest risk. That’s because having both joints moving and stretching the muscle simultaneously adds tension, which can lead to strains.

Muscles are also more likely to strain while they are contracting. At this point, muscles are shortening and lengthening at the same time. During a dumbbell curl, for example, raising the weight up towards the shoulder compresses the bicep, and lowering it back down stretches it back out again. The muscle can create and sustain much more force during the lengthening portion of the activity, says Cramer, which makes it easier for it to strain.

Finally, muscles that have a higher proportion of fast-twitch to slow-twitch fibers strain more readily. Fast-twitch fibers contract quickly and generate more power, says Cramer. For that reason, they are the ones recruited for explosive tasks like sprinting. “It’s relatively uncommon for slow twitch [muscles] to strain,” he says. “They’re used to being active all the time.”

Technically, Cramer says, it’s possible to strain any of the skeletal muscles in your body. “For some, it’s not physiologically impossible, just very highly unlikely,” he says. “You’re probably not going to strain deep muscles with very specific functions.” The muscles in the finger, for example, are probably not going to cause much trouble, since they only have one task and don’t do much heavy lifting.

[Related: How to get muscle gains: A beginner’s guide to becoming buff]

Low flexibility and range of motion are major factors at risk for muscle strain, says Cramer. Despite the popular belief that larger muscles are tighter, Cramer says greater muscle mass is actually associated with greater give. “There’s evidence to suggest that weight training done with a good range of motion increases flexibility,” he says. And even though it may not seem like it when you’re struggling to touch your toes, Cramer says most people can teach their body to be springy enough to do the splits. So, to help keep your muscle fibers intact—pick up the weights and don’t skip your stretching routine, no matter how tedious it is.

How does a pulled muscle heal?

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Everyone has different perceptions of pain. Some can sit for hours getting tattooed for an arm sleeve, while others squirm at having their finger pricked. Because pain is subjective, doctors have a hard time evaluating and treating patients who are dealing with it chronically.

Now, neurologists have successfully used a person’s brain signals to predict how much pain they were feeling. The small but unprecedented study, published today in the journal Nature Neuroscience, identified hard clues in brainwaves that could objectively measure the intensity of chronic pain versus acute pain. 

The findings are part of a larger clinical trial aimed at creating a personalized brain stimulation therapy that could bring relief to the 51.6 million Americans living with chronic pain. Another recent study in the journal JAMA Network Open reported that the rate of chronic pain in the US was as high as other common health issues like diabetes, depression, and high blood pressure. 

“For the first time, the authors were able to understand and visualize the differences between the acute and chronic pain experience on a neural level,” says Akanksha Sharma, a neurologist at the Pacific Neuroscience Institute in California who was not involved in the research. “This is novel and important, learning how and where our brain perceives and processes acute and chronic pain and understanding how the individual brain rewires in response to chronic pain.”

[Related: Medical startup put useless plastic implants in chronic pain patients, says FBI]

The study authors invited four people with uncontrollable long-term pain—three recovering from strokes and one with phantom limb syndrome—to get implants that tracked neural activity. The patients had exhausted all their treatment options. “They tried medications, injections, and nothing was working. Brain surgery was the last resort,” says lead author Prasad Shirvalkar, a neurologist and pain medicine specialist at the University of California, San Francisco. 

Each participant underwent deep brain stimulation, a medical procedure that acts like a pacemaker for the cerebrum. The medical team implanted electrodes in specific areas to detect and record electrical activity from two brain regions associated with pain: the anterior cingulate cortex and the orbitofrontal cortex. The technique is commonly used for neurological conditions such as epilepsy and Parkinson’s, but has never been tested with chronic pain. 

For three to six months, the participants answered surveys about the severity and quality of their pain. Immediately after, they pressed a remote to let the electrode implants take a snapshot of their brain activity. A computer then used the recordings and survey responses to build models that calculated a pain severity score for each patient. Changes in the orbitofrontal cortex helped inform the personalized neural signatures more than any other brain region.

“This information can help drive more customized treatment options for patients,” Sharma says. “If we can objectively “see” the pain experience of a patient, then we can potentially modulate those areas of the brain with new interventions to alleviate or change the perception of pain.”

Brain activity recordings also showed a difference between chronic and acute pain. Signs of chronic pain were more strongly associated with changes in how neurons in the orbitofrontal cortex fired. According to Shirvalkar, this brain region is understudied in its role in shaping the pain experience. The anterior cingulate cortex, on the other hand, is better known for its role in perceiving and processing pain across the body. This brain region was found to be more associated with acute pain.

The team learned that they couldn’t apply the same kinds of brain activity used to chart acute pain in therapeutic research to chronic pain in the real world. “Chronic pain is not a more enduring version of acute pain—it’s fundamentally different in the brain with different circuits,” Shirvalkar explains.

Understanding the differences in how patients are neurologically wired for acute versus chronic pain can help further personalized brain stimulation therapies for the most severe forms of discomfort. Medhat Mikhael, a pain management specialist at the MemorialCare Orange Coast Medical Center in California who did not contribute to the research, says this would help treat the most difficult of chronic pain cases, especially those stemming from a stroke and traumatic brain injury.

[Related: The slow, but promising progress of electrode therapy for paralysis]

While Sharma finds the work fascinating, she warns people to exercise caution in interpreting the data and generalizing it to all neuropathic pain conditions, given that there were only four people in the trial. The study authors say their next goal is to recruit six patients and then move on to a phase two trial where the sample size would increase to 20 or 30 patients. There’s also a risk of life-altering complications with surgical implants in the brain. At the moment, Shirvalkar says noninvasive methods such as electroencephalography and functional MRIs would not be able to record for long periods of time. However, he hopes that one day tech companies can make small wearable devices that track brainwaves. 

“Treating pain relies on subjective reporting, or on how the person with pain communicates their pain to their provider. Not everyone’s pain is believed or treated equally,” Kate Nicholson, the executive director and founder of the National Pain Advocacy Center, wrote in an email to PopSci. “For these reasons, the search for phenotypes and objective measures for pain is the search for a holy grail in pain management. Objective measures [like the ones found through this study], if valid and validated, hold promise to transform pain’s assessment and treatment.”

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Doctors may have a new tool to protect patients against multi-drug resistant bacterial infections. But the new defense against increasingly difficult-to-treat bacteria isn’t a brand new development—it is an 80 year-old antibiotic. A study published May 16 in the open access journal PLOS Biology looked at a natural product made in soil called nourseothricin that was discovered in 1942.

[Related: Kids all over the US are getting strep, but antibiotics are hard to come by.]

The rise of antibiotic-resistant bacterial infections has encouraged a search for new antibiotics. Antibiotic resistance is a very serious and growing medical problem—according to the Centers for Disease Control and Prevention, antimicrobial resistance killed at least 1.27 million people worldwide and was associated with close to 5 million deaths in 2019. In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, and over 35,000 people die as a result.

Nourseothricin contains multiple forms of a complex molecule called streptothricin. There were high hopes that the streptothricin inside would be a powerful agent against bacteria called gram-negative bacteria. These bacteria, such as E.coli., have a thick outer protective layer and are particularly hard for antibiotics to kill. 

Unfortunately, nourseothricin was toxic to kidneys according to the results of an unpublished limited human trial sometime in the 1940’s and its development was dropped. The team in this study decided to go back and take a second look at nourseothricin.

“We started searching around for drugs that we could use, and it turns out these super resistant bugs were highly susceptible to streptothricin, so we were able to use it as a selection agent to do these experiments,” study co-author and pathologist at Harvard Medical School James Kirby said in a statement. “What scientists were isolating in 1942 was not as pure as what we are working with today. In fact, what was then called streptothricin is actually a mixture of several streptothricin variants. The natural mixture of different types of streptothricins is now referred to as nourseothricin.”

Kirby is also the director of the Clinical Microbiology Laboratory at Beth Israel Deaconess Medical Center.

In the earlier studies on the antibiotic, nourseothricin suffered from incomplete purification of  streptothricin which was likely causing the toxicity. A study published in 2022 showed that multiple forms of streptothricin actually have different toxicities. 

One called streptothricin-F was significantly less toxic while also working against present day pathogens that are resistant to multiple drugs. 

[Related: Raw dog food can harbor antibiotic-resistant bacteria.]

In this study, the team looked closely at streptothricin-F and also streptothricin- D. Streptothricin-D strain was also highly selective for the gram-negative bacteria and was even more powerful than streptothricin-F against drug-resistant Enterobacterales and other bacterial species. However, it caused renal toxicity at a lower dose. 

The team used cryo-electron microscopy to show that streptothricin-F bound extensively to a subunit of the bacterial ribosome. This binding causes translation errors in the bacteria, which helps antibiotics inhibit the spread of a bacterial infection.  

“It works by inhibiting the ability of the organism to produce proteins in a very sneaky way. When a cell makes proteins, they make them off a blueprint or message that tells the cell what amino acids to link together to build the protein. Our studies help explain how this antibiotic confuses the machinery so that the message is read incorrectly, and it starts to put together gibberish. Essentially the cell gets poisoned because it’s producing all this junk,” said Kirby.

The team is still trying to figure out the mechanism behind how nourseothricin works, but found that it acts differently than other antibiotics. Kirby will continue studying nourseothricin with collaborators at Northwestern University and Case Western Reserve University Medical Center to dive deeper and understand how it actually works.

“We have great collaborators that have allowed us to pursue a project that crosses multiple fields. This work is an example of collaborative science really at its best,” said Kirby. 

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This article was originally featured on KFF Health News.

What use could health care have for someone who makes things up, can’t keep a secret, doesn’t really know anything, and, when speaking, simply fills in the next word based on what’s come before? Lots, if that individual is the newest form of artificial intelligence, according to some of the biggest companies out there.

Companies pushing the latest AI technology — known as “generative AI” — are piling on: Google and Microsoft want to bring types of so-called large language models to health care. Big firms that are familiar to folks in white coats — but maybe less so to your average Joe and Jane — are equally enthusiastic: Electronic medical records giants Epic and Oracle Cerner aren’t far behind. The space is crowded with startups, too.

The companies want their AI to take notes for physicians and give them second opinions — assuming they can keep the intelligence from “hallucinating” or, for that matter, divulging patients’ private information.

“There’s something afoot that’s pretty exciting,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “Its capabilities will ultimately have a big impact.” Topol, like many other observers, wonders how many problems it might cause — like leaking patient data — and how often. “We’re going to find out.”

The specter of such problems inspired more than 1,000 technology leaders to sign an open letter in March urging that companies pause development on advanced AI systems until “we are confident that their effects will be positive and their risks will be manageable.” Even so, some of them are sinking more money into AI ventures.

The underlying technology relies on synthesizing huge chunks of text or other data — for example, some medical models rely on 2 million intensive care unit notes from Beth Israel Deaconess Medical Center in Boston — to predict text that would follow a given query. The idea has been around for years, but the gold rush, and the marketing and media mania surrounding it, are more recent.

The frenzy was kicked off in December 2022 by Microsoft-backed OpenAI and its flagship product, ChatGPT, which answers questions with authority and style. It can explain genetics in a sonnet, for example.

OpenAI, started as a research venture seeded by Silicon Valley elites like Sam Altman, Elon Musk, and Reid Hoffman, has ridden the enthusiasm to investors’ pockets. The venture has a complex, hybrid for- and nonprofit structure. But a new $10 billion round of funding from Microsoft has pushed the value of OpenAI to $29 billion, The Wall Street Journal reported. Right now, the company is licensing its technology to companies like Microsoft and selling subscriptions to consumers. Other startups are considering selling AI transcription or other products to hospital systems or directly to patients.

Hyperbolic quotes are everywhere. Former Treasury Secretary Larry Summers tweeted recently: “It’s going to replace what doctors do — hearing symptoms and making diagnoses — before it changes what nurses do — helping patients get up and handle themselves in the hospital.”

But just weeks after OpenAI took another huge cash infusion, even Altman, its CEO, is wary of the fanfare. “The hype over these systems — even if everything we hope for is right long term — is totally out of control for the short term,” he said for a March article in The New York Times.

Few in health care believe this latest form of AI is about to take their jobs (though some companies are experimenting — controversially — with chatbots that act as therapists or guides to care). Still, those who are bullish on the tech think it’ll make some parts of their work much easier.

Eric Arzubi, a psychiatrist in Billings, Montana, used to manage fellow psychiatrists for a hospital system. Time and again, he’d get a list of providers who hadn’t yet finished their notes — their summaries of a patient’s condition and a plan for treatment.

Writing these notes is one of the big stressors in the health system: In the aggregate, it’s an administrative burden. But it’s necessary to develop a record for future providers and, of course, insurers.

“When people are way behind in documentation, that creates problems,” Arzubi said. “What happens if the patient comes into the hospital and there’s a note that hasn’t been completed and we don’t know what’s been going on?”

The new technology might help lighten those burdens. Arzubi is testing a service, called Nabla Copilot, that sits in on his part of virtual patient visits and then automatically summarizes them, organizing into a standard note format the complaint, the history of illness, and a treatment plan.

Results are solid after about 50 patients, he said: “It’s 90% of the way there.” Copilot produces serviceable summaries that Arzubi typically edits. The summaries don’t necessarily pick up on nonverbal cues or thoughts Arzubi might not want to vocalize. Still, he said, the gains are significant: He doesn’t have to worry about taking notes and can instead focus on speaking with patients. And he saves time.

“If I have a full patient day, where I might see 15 patients, I would say this saves me a good hour at the end of the day,” he said. (If the technology is adopted widely, he hopes hospitals won’t take advantage of the saved time by simply scheduling more patients. “That’s not fair,” he said.)

Nabla Copilot isn’t the only such service; Microsoft is trying out the same concept. At April’s conference of the Healthcare Information and Management Systems Society — an industry confab where health techies swap ideas, make announcements, and sell their wares — investment analysts from Evercore highlighted reducing administrative burden as a top possibility for the new technologies.

But overall? They heard mixed reviews. And that view is common: Many technologists and doctors are ambivalent.

For example, if you’re stumped about a diagnosis, feeding patient data into one of these programs “can provide a second opinion, no question,” Topol said. “I’m sure clinicians are doing it.” However, that runs into the current limitations of the technology.

Joshua Tamayo-Sarver, a clinician and executive with the startup Inflect Health, fed fictionalized patient scenarios based on his own practice in an emergency department into one system to see how it would perform. It missed life-threatening conditions, he said. “That seems problematic.”

The technology also tends to “hallucinate” — that is, make up information that sounds convincing. Formal studies have found a wide range of performance. One preliminary research paper examining ChatGPT and Google products using open-ended board examination questions from neurosurgery found a hallucination rate of 2%. A study by Stanford researchers, examining the quality of AI responses to 64 clinical scenarios, found fabricated or hallucinated citations 6% of the time, co-author Nigam Shah told KFF Health News. Another preliminary paper found, in complex cardiology cases, ChatGPT agreed with expert opinion half the time.

Privacy is another concern. It’s unclear whether the information fed into this type of AI-based system will stay inside. Enterprising users of ChatGPT, for example, have managed to get the technology to tell them the recipe for napalm, which can be used to make chemical bombs.

In theory, the system has guardrails preventing private information from escaping. For example, when KFF Health News asked ChatGPT its email address, the system refused to divulge that private information. But when told to role-play as a character, and asked about the email address of the author of this article, it happily gave up the information. (It was indeed the author’s correct email address in 2021, when ChatGPT’s archive ends.)

“I would not put patient data in,” said Shah, chief data scientist at Stanford Health Care. “We don’t understand what happens with these data once they hit OpenAI servers.”

Tina Sui, a spokesperson for OpenAI, told KFF Health News that one “should never use our models to provide diagnostic or treatment services for serious medical conditions.” They are “not fine-tuned to provide medical information,” she said.

With the explosion of new research, Topol said, “I don’t think the medical community has a really good clue about what’s about to happen.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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COVID-19 is no longer a public health emergency in the US. The Biden administration’s deadline follows the World Health Organization’s announcement last week that removed COVID’s status as a global health crisis.

Infectious disease experts tell Popular Science that it’s an encouraging step and a sign that we are in a very different place than where we were in 2020. And while the recent decisions in no way mean the virus is gone—it’s expected to be endemic like the flu—access to COVID testing, treatments such as Paxlovid, and the vaccines have put the US in a position to coexist with it.

That said, managing your safety will come at a higher cost now. In one of the biggest changes from ending the federal emergency response, insurances are no longer required to cover the costs of COVID testing or reimburse people if they bought an over-the-counter home COVID-19 test. The federal government is also ending its free COVID-test program over the mail. 

As the financial burden of testing shifts to families and individuals, knowing where and when to get tested will keep you protected as the country transitions into this new stage of the pandemic. “We’re still seeing up to 1,000 deaths a week in the US from COVID for people that are older and at risk,” warns Del DeHart, a medical director of the infectious diseases department at the University of Michigan Health-West. “For those people, COVID is still not over and so testing for early treatment is going to be critical.”

Where to get COVID tests

There are still options for getting free COVID tests around the US The last day to order four free at-home COVID tests from the government is May 31, but local community clinics can give away free COVID tests or at a lower cost until supplies run out. 

Access to free testing might also depend on where you live. David Souleles, the director of the COVID-Response Team at the University of California, Irvine, says some state governments are taking measures to avoid financial barriers with COVID testing. California, for example, issued a mandate for health insurances to continue providing reimbursement for eight monthly at-home tests. Check your state government’s website to see what policies are in place following the end of the public health emergency.

If you are uninsured, the US government will continue to provide access to swabs through the Increasing Community Access to Testing Program. This government program partners with specific healthcare sites such as Walgreens and Quest Diagnostics to provide no-cost COVID tests with priority for people with a known exposure to the virus or who are showing symptoms.

[Related: An at-home test for both COVID-19 and the flu gains approval]

At-home rapid tests and PCR laboratory testing will still be available at your local pharmacies and doctor’s office, but it’s up to your insurance company if they want to bear the cost or require a copayment. What’s more, insurance companies may charge different prices for COVID tests; if they cover the cost, they may set limits on how many tests they will cover per individual. 

Prices for COVID test kits in stores like CVS range from $9.99 to $28.99, meaning testing can quickly get expensive. DeHart is concerned that the prices will create a financial barrier that will deter people from getting tested. If affordability becomes a question, it’s important to make every COVID test you take count.

When it’s still important to get tested for COVID

While most COVID mandates have lifted around the country, some employers and places might require you to get tested. For instance, healthcare workers employed in facilities like nursing homes will likely continue routine COVID testing. And as of now, many hospitals still require routine COVID testing for admitted patients, though it remains unclear whether the hospitals will cover the cost or if the test will be added to a person’s medical bill.

For voluntary testing, it’s important to evaluate your risk of having a severe COVID infection. DeHart says individuals above the age of 65 and those with immunosuppressive conditions should get tested regularly, along with loved ones in close contact with those that fall under this category. Souleles also recommends taking a test before visiting a relative in assisted living or anyone who is considered at high-risk of exposure. 

Other scenarios may apply, too, Souleles adds. “We would still encourage people to test before and after travel and before and after gatherings if they have the ability to do so. Anytime that you have the ability to test before you’re going to be around lots of people is great, and anytime you have the ability to test three to five days after being around a lot of people, that’s also a good thing.”

[Related: Long COVID recovery is finally getting the attention it deserves in the US]

If you have COVID-like symptoms, get tested before going out in public, even if the side effects seem mild. Testing early will give you more chances to get Paxlovid, which is most effective when taken within the first five days of seeing symptoms, and potentially avoid life-threatening complications. 

If you need to purchase a COVID test, treat it like you would any other over-the-counter goods. This includes checking the expiration dates to avoid a false positive or false negative result. You will also want to throw out any recalled COVID tests. If purchased for a later date, keep COVID tests at room temperature and away from the hands of pets and young children.

What to do if you test positive for COVID

If the test comes out positive, follow the Centers for Disease Control and Prevention’s (CDC) guidelines. Stay home and isolate yourself from others in the household for five days. People experiencing moderate symptoms like difficulty breathing should isolate for 10 days. Monitor your condition and go to the hospital if there are any severe or life-threatening complications. 

If you must go outside, wear a high-quality mask and avoid going to places where you would have to take it off. Also contact your doctor to see if you are eligible for any COVID-19 treatments and start those as soon as possible.

You can stop isolating after five days if you have no symptoms. If you continue to show symptoms, the CDC says you should stay put until your symptoms improve or you are fever-free for 24 hours without using medication.

[Related: Getting COVID more than once might be even worse than we thought]

Keep in mind that COVID tests are only one of the many tools available to reduce your risk of severe infection and death. Both DeHart and Souleles strongly urge people to get vaccinated and get their booster shot when eligible. Insurers will still be expected to cover the bivalent COVID vaccine as a routine immunization, and the Biden administration’s Bridge Access Program for COVID-19 Vaccines and Treatments will continue to provide vaccines free-of-charge to the uninsured.

“Stay up to date with your vaccines,” says Souleles. “It’s still the most important tool that we have right now.”

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After being approached by a neurosurgeon seeking a less invasive method to treat conditions that require a brain implant, a team of researchers at Switzerland’s Ecole Polytechnique Fédérale de Lausanne led by neurotechnology expert Stephanie Lacour started working. They took inspiration from soft robots to create a large cortical electrode array that can squeeze through a tiny hole in the skull. They published their findings in Science on May 10. 

A cortical electrode array stimulates, records, or monitors electrical activity in the brain for patients who suffer with conditions like epilepsy. Epilepsy is relatively common, and affects around 1.2 percent of the US’s population. The disorder is known to cause seizures, which are electrical activity bursts in the brain and may cause uncontrollable shaking, sudden stiffness, collapsing, and other symptoms. 

While microelectrode arrays were first invented decades ago, the use of these arrays for deep brain stimulation in epilepsy patients has only became FDA approved in the past handful of years. Even so, current devices often have certain trade offs, be it electrode resolution, cortical surface coverage, or even aesthetics, the authors write in their paper.

The researchers created a superthin flower-shaped device that can be folded small enough to fit a 2 centimeter hole in the skull, where it can rest in between the skull and the surface of the brain—a tiny, delicate area that only measures around a millimeter in width. Once deployed, the flexible electrode releases each of its six spiraled arms one by one to extend across a region of the brain around 4 centimeters in diameter. Other devices may require a hole in the skull the same size as the diameter of the electrode array. 

 “The beauty of the eversion mechanism is that we can deploy an arbitrary size of electrode with a constant and minimal compression on the brain,” Sukho Song, lead author of the study, said in an EPFL statement. “The soft robotics community has been very much interested in this eversion mechanism because it has been bio-inspired. This eversion mechanism can emulate the growth of tree roots, and there are no limitations in terms of how much tree roots can grow.”

The device, however, isn’t exactly ready for human brains yet—the team has only tested it in a mini-pig—but will continue to be developed by a spinoff of EPFL Laboratory for Soft Bioelectronic Interfaces called Neurosoft Bioelectronics. 

“Minimally invasive neurotechnologies are essential approaches to offer efficient, patient-tailored therapies,” Lacour said in the EPFL statement.

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When the Human Genome Project launched in 1990, it was hailed as one of the greatest scientific endeavors of all time. The 13-year project identified about 20,000 genes and gave researchers a genetic blueprint to transform modern medicine. Doctors can now use genetic information to better diagnose diseases and debilitating conditions, such as linking a rare case of leg pain to a single mutation. The research also ushered in hope for an age of precision medicine, where every treatment would be tailored to the individual. There was only one problem—the work wasn’t really finished.

That’s because humans are 99.9 percent identical. But the 0.1 percent in genetic differences explains our uniqueness, and can also account for why some people are more susceptible to disease. Having one map of a single genome, which the 90s-era project produced, does not adequately represent the breadth of the human population.

An international study published today in Nature is filling in these gaps by analyzing a much more diverse set of genetic sequences. “We’re retooling the foundation of genomics to create a diverse and inclusive representation of human variation as the fundamental reference structure,” says senior study author Benedict Paten, an associate director at the University of California, Santa Cruz Genomics Institute. 

[Related: The benchmark for human diversity is based on one man’s genome. A new tool could change that.]

By eliminating bias and analyzing more inclusive genomic data, geneticists will have a better understanding of how mutations affect a person’s genes and move us closer to a future with equitable healthcare. 

What is a pangenome?

The research focused on creating a pangenome—a collection of DNA sequences within a single species. Past work focused on a reference genome, built from a few individuals, that was supposed to represent a broader set of genes. A pangenome, on the other hand, is created from multiple people worldwide to more accurately reflect our genetic diversity. 

It’s not as though past geneticists did not want to sequence more genetic variations—they just couldn’t. Erich Jarvis, a genetic professor at Rockefeller University Howard Hughes Medical Institute and a co-author of the study, says technology in the 90s and early 2000s did not allow researchers to see large variations between haplotypes—groups of genes inherited together from a single parent—within and across individuals. 

The focus of a pangenome is to study the genetic differences among individuals from across the world. Jarvis says knowing about genomic variations is important, because some mutations are associated with different traits and diseases. For example, the lipoprotein (a) gene has a complex structure that has not been sequenced in humans. But variations in the gene are known to be associated with an increased risk of heart disease among Black people. By sequencing the entire gene and understanding its variations, doctors may be able to revisit and treat previously unexplained cases of coronary heart disease.

“This paper helps us to understand that DNA [is] more than a sequence of letters; DNA is structurally organized, and human variation that structure is important for genomic function and trait diversity,” says Sarah Fong, a postdoctoral scholar studying human population variation at the University of California, San Francisco who was not involved in the study.

What does the first draft reveal?

The authors collected data on 47 genetically diverse individuals. About half came from Africa, with the others representing four other continents (excluding Australia and Antarctica). The genomic information added information on 119 million base pairs and 1,115 duplications—mutations where a portion of DNA on a gene is repeated. As expected, more than 99 percent of the genetic sequences were similar across individuals. But by including the less than one percent of variations in this new pangenome draft, the authors found that structural changes to genes explained 90 million of the identified base pairs. 

[Related: What we might learn about embryos and evolution from the most complete human genome map yet]

“By moving beyond a single, arbitrary, and linear representation of the genome, the work by the Pangenome Reference Consortium more accurately describes the diversity that exists in our species,” says Rajiv McCoy, an assistant professor of biology at Johns Hopkins University who was not involved in the current study but was recently involved in the first complete sequencing of the human genome.

With the latest pangenome model, it may become easier for geneticists to detect and characterize hard-to-find genetic mutations. When the authors analyzed a separate set of genetic information using the pangenome draft as a reference, they detected 104 percent more structural variants. They also improved the accuracy of the comparison sequence, reducing the  variant error rate by 34 percent.

Still a work in progress

Creating the first draft of the pangenome is only phase one of this two-part project. The second phase will take a couple of years, as the authors build collaborations among other international researchers and perform community outreach in areas where there is less genomic data, such as including members of indigenous cultures.

It might take decades before we see the drafts finalized into a complete picture of the human genome. There are several challenges to address, Fong says, such as the development of an efficient strategy to compare multiple human genomes and a concrete plan for testing for genetic variations in the medical field.

Still, Fong says the benefits will be worth the effort. Having complete, diverse human genomes will advance the way genetics is studied, and create a future where people’s genes are more fully considered when treating diseases.

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After 60 years of trial and error, the Food and Drug Administration (FDA) approved the first vaccine to prevent respiratory syncytial virus (RSV) on May 3. More preventative shots for the respiratory virus are on the way.

[Related: How our pandemic toolkit fought the many viruses of 2022.]

The FDA approved Arexvy from pharmaceutical company GSK. The vaccine is designed to protect those over 60 in a single dose. A vaccine from Pfizer is currently under consideration for older adults and pregnant people as a maternal vaccination to protect newborn babies. Sanofi and AstraZeneca’s monoclonal antibody treatment for babies that offers vaccine-like protection during RSV season is also under consideration by the FDA. Additionally, a late-stage trial of an RSV vaccine that uses mRNA technology from Moderna showed promise in late-stage trials. 

The vaccine could be available as soon as this fall, pending a recommendation for its use from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which will meet in June. GSK says it has “millions of doses ready to be shipped,” according to a recent earnings presentation.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

RSV can affect all age groups, but it is particularly worrisome in babies and older adults. It is a highly contagious virus that causes infections of the lungs and breathing passages. According to the Centers for Disease Control and Prevention (CDC), RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older every year. It is also a common cause of lower respiratory tract disease in older adults. This disease affects the lungs and can cause life-threatening pneumonia and bronchiolitis.

The virus circulates seasonally, usually beginning in the fall and peaking in the winter. The 2022-2023 RSV season started particularly early and flooded hospitals and pediatric wards across the United States, leading pharmacies to limit the sales of children’s medicines.

According to the results of a clinical trial of close to 25,000 older adults, the GSK vaccine was 83 percent effective at preventing lower respiratory tract disease by the virus. It was 94 percent effective at preventing severe disease in seniors. In the trial, severe disease was defined as the need for supplemental oxygen or a mechanical help to breathe. The results were published in the New England Journal of Medicine in February. 

[Related: Fighting RSV in babies starts with a mother’s antibodies.]

The vaccine works by using a small piece of the virus called a fusion protein, or F-protein. The F-protein sticks out on the virus’ surface and helps it latch onto cells in the upper airway and infect them. The F-proteins were made in a lab with specially programmed cells. 

In 2013, researchers at the National Institutes of Health discovered how to freeze the normally wiggly and shape-shifting F-protein in the shape that it takes before it fuses onto a cell. When it’s in this shape, the body can produce antibodies against it. The GSK vaccine uses this pre-fusion form of the F-protein and an ingredient called an adjuvant that can boost immune activity.

The search for a vaccine to RSV began in the 1960s, but has been mired by tragedy. Two toddlers died after receiving an experimental shot in the 60’s after it unexpectedly caused them to contract a very serious version of the virus. Many of the safety measures currently in place during vaccine trials were put in place after the failures of the RSV vaccine.

Barney Graham, a vaccine scientist at Morehouse School of Medicine worked alongside Jason McLellan, a structural biologist at the University of Texas at Austin, and Peter Kwong, a vaccine scientist at the National Institutes of Health, to jump-start the RSV vaccine field after decades of failure.

“This is my life’s work, so it’s kind of amazing to see it come to this point,” Graham told The Washington Post.  “It’s exciting for me to see this happening because of all the other people who’ve come before me working on RSV, some of whom are no longer with us. I wish they could see this is happening. It’s been a long struggle.”

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Deep beneath the Pacific Ocean, the edge of one tectonic plate was being jammed beneath the tectonic plate that held Japan. This wasn’t news. It had been happening at a rate of three inches a year since long before humans had invented the concept of news. But that March, it became news in the biggest possible way, when a chunk of the underlying plate suddenly gave way, causing the seafloor to pop up by about 15 feet and the plate holding parts of Japan to suddenly drop by about three feet. The magnitude 9 Tohoku earthquake was so big it shunted Japan eight feet to the east. It was so big it shifted the Earth six inches on its axis. It was so big it sped up the rotation of the planet
(only by 1.8 microseconds a day, but still—your days are now just a tiny bit shorter. Thanks Obama!). The earthquake and resultant tsunami also wreaked havoc on human systems—transportation systems, energy systems, water systems, telecommunication systems, and that most important of all human systems, the biological system that allows us to slobber, reproduce, and contemplate the irrationality of high baby-formula prices (usually in that order).

The tsunami killed more than twenty thousand people and caused multiple nuclear meltdowns, a disastrous toll for everyone except sellers of supplements, who pivoted to prey on the baseless fears of Americans living thousands of miles away from the radiation. Toby McAdam, still selling his RisingSun products, told the local newspaper that he doubted the radiation would drift to Montana—“but it could.” He recommended that his “Lugol’s Iodine solution” be applied to the skin daily as “an ounce of prevention.” Though public health officials said people self-treating with iodide supplements were more likely to harm than help themselves, orders spiked so sharply that Toby’s website crashed.

The multifaceted nature of the tsunami-caused chaos makes it perhaps appropriate that the event also marked the beginning of the United States’ descent into a full-blown zombie apocalypse.

The June following the earthquake, the CDC began a conversation about emergency preparedness on Twitter that led to a handful of people jokingly tweeting that they would like the CDC to weigh in on a catastrophic zombie attack.

This led to the predictable wave of lols, rofls, and laughy-face emoticons, but it also sparked an idea for Dave Daigle (a CDC communications administrator) and Dr. Ali S. Khan (a CDC expert in disaster preparedness).

With Daigle’s input, Khan wrote a piece for the CDC website explaining how to prepare for a zombie apocalypse. This neatly demonstrated the humanity of the person on the other side of the icy-cold stethoscope even as it leveraged the innate appeal of zombies to teach real-life strategies to cope with actual disasters.

It turned out people were hungry for messaging about people hungry for brains. The CDC zombie apocalypse preparedness plan was an instant hit, racking up so many views that the CDC server froze up, overwhelmed by all the traffic.

This bit of fun was so successful that a team of researchers from the University of California, Irvine, published a congratulatory paper in the journal Emerging Infectious Diseases urging other public health officials to follow suit. It argued that zombies were an opportunity “to capitalize on the benefits of spreading public health awareness through the use of relatable popular culture tools and scientific explanations for fictional phenomena.” They proposed that the medical establishment build o those efforts to stimulate the conversation and do better public education on a variety of health topics.

Suddenly, zombies were everywhere in public health and safety. The CDC, the Department of Homeland Security, and the Federal Emergency Management Agency all published in-depth zombie-related literature. Finally, public officials were seizing the initiative and taking back the cul tural space they had inadvertently ceded to promoters of One True Cures.

Also in 2011, a Harvard Medical School physician and aspiring nov elist named Steven Schlozman appeared on the radio show Coast to Coast AM, which spun tales of conspiracy and paranormal phenomena to a large and credulous national audience from 2 a.m. to 4 a.m., seven days a week. Because Coast to Coast AM was the most popular late-night radio show in the country, with ten million listeners, it was a great opportunity for Schlozman, who was there to promote his latest work, The Zombie Autopsies: Secret Notebooks from the Apocalypse. In the book, Schlozman drew on his medical knowledge to describe “Ataxic Neurodegenerative Satiety Deficiency syndrome” as the medical cause
of zombies (it was of course a fictional work of fictitious fiction). The format of the show required that Schlozman spend the opening stretch talking about the events of his novel as if they were real, before shifting to an acknowledgment that it was all pure fantasy.

Daigle, Khan, and Schlozman were helping people learn a bit of science in a fun way.

But their efforts quickly ran up against a problem: there is more than one way to view a zombie apocalypse.

One fact that the CDC and its fellow agencies failed to fully appreciate was that, in zombie properties like 2009’s feature film Zombieland and 2010’s hit television series The Walking Dead, very little
screen time is given to public health concepts like water sanitation. The action takes place after most health authorities have had their faces eaten, leaving individual survivors to run around attacking infected people with baseball bats, crossbows, and shotguns as a means of self-preservation.

That’s why other groups were quickly lining up to enlist the hot new cultural craze into their own, very different agendas. Zombies became the centerpiece in gun advertisements and were a major part of the NRA’s annual conventions, where shooting at the undead carried none of the moral baggage that came with shooting at human targets.

“Because the zombie canon focuses so squarely on the apocalypse, its spread into popular culture can erode faith in the resiliency of civilization,” wrote Daniel Drezner, the Tufts University professor and zombie expert. “The zombie narrative, as it is traditionally presented, socially constructs the very narrative that agencies like the CDC and FEMA are trying to prevent.”

Drezner documented the way that zombie references became a sort of dog whistle for gun rights—those on the outside glossed over a quirky head-scratcher while targeted audiences became fired up, even though they would clearly never need to shoot a zombie in real life.

Until some Americans began to ask, Will I need to shoot a zombie in real life?

Toby McAdam had told me about the 2012 Miami incident in which a man bit the face off a homeless man and then was himself described by authorities as slow to die after being shot. But Toby was not the only person fascinated by that attack. It let the undead cat out of the bag.

Soon after the news broke, a self-described Bitcoin evangelist and promoter of alternative-health supplements doctored a Huffington Post article about the incident so that it attributed the cause of the face eating to “LQP-79,” a virus that destroys internal organs and makes the host hungry for human flesh.

The fake article went viral, blitzing digital media feeds so thoroughly that LQP-79 was soon the third-most-searched term on the CDC website, forcing the agency to officially deny the existence of a zombie virus.

Around then, communities of zombie-themed survivalists and militias sprang up all across America. One was an offshoot of the well-established Michigan Militia, while others had names like the Kansas Anti Zombie Militia, the Anti Zombie Unified Resistance Effort (AZURE), Zombie-Fighting Rednecks, the Zombie Eradication and Survival Team, Postmortem Assault Squadron, and the US Department of Zombie Defense.

One, a loosely affiliated national group called the US Zombie Outbreak Response Team (ZORT), popularized a strange mishmash of survivalism and cosplay. Its website features pictures of preppers in tactical gear and tinted sunglasses using stickers and goofy accessories to trick out their trucks as zombie-fighting vehicles that would be equally at home in Ghostbusters or Mad Max universes. It was in some ways good fun. But they also carried real firearms. And engaged in real postapocalyptic survival exercises.

“A Zombie could be anything from a person infected by a pandemic outbreak to a crazy nut job, criminal or gangster who wants to hurt your family and steal your food and preps,” reads ZORT’s promotional material.

Though ZORT purports to be simply providing tongue-in-cheek cover for legit training that would be helpful in a natural disaster, of course the real difference between zombies and hurricane survivors is that one must be shot in the head and the other should be given a hot toddy and a shower.

Did any of these folks actually believe in zombies?

Probably not. But there was potential.

Drezner cited research showing that when considering paranormal ideas, people look less to the logical evidence and more to whether other people believe in the ideas. This means that even if no one believes in zombies, if some people believe that other people believe in zombies, then some people will believe in zombies. The gaslighting became so effective that the gaslit then gaslighted others, until fear of actual zombies took on an undead life of its own—call it masslighting.

And really, the online picture was becoming quite blurry. At the CDC, Daigle and Khan began getting inquiries about their Zombie Preparedness Plan from concerned citizens who wanted to know what sort of firearm was recommended to repel undead invaders. Meanwhile, after his Coast to Coast AM appearance, Schlozman got emails from listeners who wanted to know what medicines could stave off a zombie infection, and whether he had recommendations for how to protect one’s home. China’s state media had to formally debunk a robust rumor that Ebola victims were rising from the dead as zombies. And in 2014 in the Florida statehouse, a representative formally proposed “An Act Relating to the Zombie Apocalypse” as the name of a bill that would allow citizens to carry firearms without a permit in an emergency.

Shockingly, a 2015 survey showed that 2 percent of American adults thought the most likely apocalyptic scenario would be one caused by zombies.

And zombie references kept popping up in unexpected places. People downloaded audio fitness tracks in which joggers were kept motivated by imaginary zombie antagonists that pursued them as they ran.

A man named Vermin Supreme, who sought the 2016 Libertarian Party nomination for president, added a platform plank on “zombie apocalypse awareness.” He also advocated using zombies for renewable energy. Even Big Tech was in on it. Buried in Amazon’s user agreement for a game-development engine, clause 57.10—a gag, probably?—read that the software should not be used in life-and-death situations, such as in medical equipment, nuclear facilities, spacecraft, or military combat operations. “However, this restriction will not apply in the event of the occurrence (certified by the United States Centers for Disease Control or successor body) of a widespread viral infection transmitted via bites or contact with bodily fluids that causes human corpses to reanimate and seek to consume living human flesh, blood, brain or nerve tissue and is likely to result in the fall of organized civilization.”

With zombie stories saturating popular culture, the lore in TV and film began to expand beyond the simple trope of shambling brain eaters. There were zombie rom-coms and zombie mockumentaries. On the CW Television Network, a show called iZombie tells the story of a Seattle morgue worker infected by a zombie virus. In this world, zombies retain their personality and capacity for reason, as long as they are well fed (on brains). During the third season, which aired in 2017, a militant group of zombies releases a deadly flu virus in Seattle; local public health officials announce a mandatory flu vaccination, only to find that the zombies have tainted the vaccines with a substance that will turn the vaccinated into zombies.

Vaccines that zombified ordinary citizens?

Luckily for public health, no one would believe that in real life.

Buy If It Sounds Like a Quack by Matthew Hongoltz-Hetling here.

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Researchers at the University of California San Diego have invented an adhesive, elastic patch capable of performing ultrasounds—but don’t expect any baby pictures just yet. Even without the social media fodder, the new wearable technology could soon provide an extremely useful tool for a wide array of medical monitoring procedures.

As detailed in a paper published on Monday in Nature Biomedical Engineering, a team led by nanoengineering professor Sheng Xu has developed a tiny, wearable device capable of measuring tissue stiffness up to 4 centimeters underneath the skin with a spatial resolution of 0.5 millimeters. In a statement, study coauthor and postdoctoral researcher Hongjie Hu explained that the group “integrated an array of ultrasound elements into a soft elastomer matrix and used wavy serpentine stretchable electrodes to connect these elements,” thus creating a conformable patch for portable medical monitoring.

According to the team’s paper, the device is composed of a 16-by-16 array of transducer elements connected via a seven-layer electrode. This is all protected by a waterproof and biocompatible silicone elastomer. A backing layer made from a composite of silver-epoxy helps absorb excessive vibrations to broaden bandwidth capabilities and improve resolution.

[Related: Wearable liquid pumps could one day regulate body temperature.]

All together, the patch comfortably conforms and “acoustically couples” to a patient’s skin to take repeated, three-dimensional images of underlying tissue. Compared with traditional ultrasound technology, the new patch can take the monitoring outside of hospital settings and eliminates the need for staff assistance. “This allows patients to continuously monitor their health status anytime, anywhere,” added Hu.

One significant challenge the team initially encountered involved the actual manufacturing of the patch. Traditional fabrication methods often require high-temperature bonding procedures that thermally damage the device’s sensitivity. To solve this problem, Xu’s team replaced their patch’s soldering paste with a conductive epoxy that bonded at room temperature, thus avoiding any burn-related problems.

Already, the team’s patch shows promise across a number of medical areas and research. Among the potential usages: monitoring the progression of cancerous cells, which often stiffen as they spread; assessing sports injuries affecting tendons, ligaments, and muscles; and analyzing the efficacy of treatments for liver and cardiovascular diseases alongside chemotherapy results. According to UC San Diego’s announcement, the ability to continuously monitor these health issues could aid in avoiding misdiagnosis and fatalities while also reducing costs via the new, non-invasive alternative to traditional hospital procedures.

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A new sound wave technique can help treat a deadly brain cancer called glioblastoma in only four minutes. The breakthrough report was published May 2 in the journal The Lancet Oncology and demonstrates the results of a phase 1 in-human clinical trial with 17 patients.

In the trial, the patients underwent surgery for resection, or removal, of their tumors and had an ultrasound device implanted. The device inside the skull opens the blood-brain barrier, repeatedly using sound waves to permeate the barrier and reach the brain tumor. IV chemotherapy is then able to reach the neurological tissues where the cancer can grow.

Treating this type of brain tumor, which has a 6.8 percent survival rate within the first five years of diagnosis, with the most potent types of chemotherapy is difficult. The strongest cancer medicines are typically unable to permeate the blood-brain barrier. The blood-brain barrier acts as a line of defense, making an extra wall around the brain to keep toxins and pathogens from getting into such a crucial area of the body. However, the repertoire of drugs that can be used to treat brain diseases is very limited. In 2014, scientists first found that sound waves could be used to permeate the blood-brain barrier and this study builds on that discovery.

[Related: Understanding glioblastoma, the most common—and lethal—form of brain cancer.]

“This is potentially a huge advance for glioblastoma patients,” co-author and Northwestern University neurosurgeon Adam Sonabend said in a statement. 

The study reports that using a novel skull-implantable grid of nine ultrasound emitters made by French biotech company Carthera can open the blood-brain barrier in a volume of the brain nine times larger than the small single-ultrasound emitter implants originally used. This importantly helps treat a large region of the brain next to the cavity that remains after glioblastoma tumors are removed.  

This is also the first study that shows how quickly the blood-brain barrier closes after being opened by the ultrasound. It closes in the first 30 to 60 minutes after the communication. and this will help scientists optimize what order to deliver the drugs to allow for better penetration of the brain. The procedure to open the blood-brain barrier only takes four minutes and is performed while the patient is awake. The new results show that the treatment is safe, well-tolerated, and some patients received up to six cycles of treatment. 

[Related: Scientists used Zika to kill aggressive brain cancer cells in mice.]

Opening up the blood-brain barrier led to a roughly four- to six-fold increase in the drug concentrations in the human brain. The team observed this increase with two chemotherapy drugs called paclitaxel and carboplatin. These drugs are typically not used to treat glioblastoma patients, because they typically do not cross the blood brain barrier in normal circumstances. 

According to Sonobend, the current chemotherapy used for glioblastoma (Temozolomide) does cross the blood-brain barrier, but is weak. Sonabend also said that previous studies that injected paclitaxel directly into the brains of patients with these tumors had promising signs of efficacy, but the direct injection was associated with toxicity such as brain irritation and meningitis.

A phase 2 clinical trial is already underway. “While we have focused on brain cancer (for which there are approximately 30,000 gliomas in the U.S.), this opens the door to investigate novel drug-based treatments for millions of patients who suffer from various brain diseases,” said Sonabend.

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This article was originally featured on The Conversation.

Many adults take prescription drugs, and usage rates are continually increasing. With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug events each year, patient education is becoming increasingly important.

All prescription drugs come with instructions on how to safely and effectively use them. Depending on the medication, there may be several types of information included: the patient package insert, medication guide and instructions for use. One or more of these documents could be folded up in the box or attached as a printed page provided by your pharmacist.

I am a scientist who studies how drugs and other chemicals affect human health. While they may look intimidating, package inserts – and particularly the prescribing information – can help patients better understand the science inside the pill bottle and blister pack, among others.

What can I learn from package inserts?

An often overlooked part of the package insert is the prescribing information. Though written primarily for health care professionals, it contains a wealth of information regarding the ways in which the medication interacts with the body.

If the prescribing information was not included with your prescription, you can often find a copy on the National Institutes of Health’s DailyMed website or other drug information websites.

As an example, let’s consider one of the most widely prescribed medications in the U.S., atorvastatin (Lipitor). Among other effects, it reduces elevated levels of cholesterol overall as well as levels of low-density lipoprotein cholesterol – LDL, or “bad” cholesterol.

Reading the insert can answer a few important questions about the drug. If you’d like to follow along, a copy of the prescription information for Lipitor can be found here.

How does the drug work?

To answer this question, you can refer to the “Mechanism of Action” and “Pharmacodynamics” subsections of the prescription insert.

The mechanism of action and pharmacodynamics are related concepts. The mechanism of action describes the chemical and molecular interactions that cause a drug’s therapeutic or toxic effects. Pharmacodynamics refers to “what the drug does to the body,” which includes the mechanism of action as well as how other factors like drug concentration influences its effects.

Often the mechanism of action of a drug is related to how it interacts with cell receptors and enzymes involved in mediating specific signals and biochemical reactions in the body.

In the case of Lipitor, the prescribing information tells us three important things about how the drug works. First, the liver is the primary site that produces cholesterol in the body and the area the drug is meant to target. Second, the drug works by inhibiting an enzyme involved in cholesterol production called HMG-CoA reductase. And third, the drug increases the number of LDL cholesterol receptors on cell surfaces, ultimately increasing the catabolism, or metabolic breakdown, of LDL cholesterol.

Where does the drug go in my body?

Before we answer this question, let’s start with some background information in the “Pharmacokinetics” subsection.

Pharmacokinetics can be thought of as “what the body does to the drug.” It focuses on four major processes the body undergoes in response to the chemical: absorption, or how the drug gets into the body; distribution, or how the drug is dispersed throughout the body; metabolism, or how the drug is converted into other chemical forms; and excretion, or how the drug is eliminated from the body.

The pharmacokinetics of a drug are determined by factors related to the chemical itself and the person taking the medication. For instance, disease state, age, sex and genetic makeup can all cause the same medication to work differently in different people.

Now, let’s look at the “Distribution” subsection.

For Lipitor, the prescription insert does not specifically say where the drug goes in the body, but it does note that the volume of distribution is 381 liters. The volume of distribution is the ratio of the amount of the drug in the body overall to its concentration in the blood. A value greater than about 30 liters suggests that the drug has entered body tissues and is not confined to the bloodstream. For reference, the drug warfarin, which prevents blood clots, is tightly bound to proteins in the blood and has a volume of distribution of only 8 liters. On the other hand, chloroquine, an antimalarial drug that enters body fat, has a value of 15,000 liters.

Does the drug cause the effects or its byproducts?

Though the therapeutic effects of most drugs come from the chemical compound it’s made of, many break down into active metabolites in the body that also have some relevant biological effects.

Some medications are administered in an inactive form called a prodrug that the body converts into metabolites with the desired therapeutic effects. Drugmakers generally use prodrugs because they have better pharmacokinetics – such as improved absorption and distribution in the body – than the active form of the drug.

In the case of Lipitor, the “Metabolism” subsection under “Pharmacokinetics” tells us that the drug is broken down into several products and that these metabolites contribute significantly to its therapeutic effect.

How long will the drug be in my system?

A key drug property to consider in this case is its half-life, which is the length of time required for the concentration of the drug to decrease to half of its initial amount in the body. Information about a drug’s half-life is found in the “Excretion” subsection under “Pharmacokinetics.”

The half-life for Lipitor is approximately 14 hours. If you were to stop taking the medication, 97% of the drug would be gone from your blood after about three days, or five half-lives.

The prescription insert provides another interesting piece of information: because Lipitor’s active metabolites have a longer half-life than the drug itself, the half-life for its cholesterol enzyme inhibiting effects is 20 to 30 hours. This means that the drug’s effects may last even after the drug itself is out of your system.

Why do I need to take medications with food or at certain times?

Eating food can change the amount and rate at which a drug is absorbed into the body in several ways, including changing the acidity of the digestive system, altering the release of bile and increasing blood flow to the gut.

For Lipitor specifically, the answer to this question can be found in the “Absorption” subsection under “Pharmacokinetics.” Food decreases the rate and extent of Lipitor’s absorption but doesn’t significantly affect LDL cholesterol reduction.

Interestingly, the insert also states that the blood concentration of the drug is significantly lower when taken in the evening than in the morning, but reduction in LDL cholesterol levels is the same regardless of when the drug is taken.

The upshot of all of this is written on the drug label on the outside of the package: Lipitor can be taken with or without food. Morning or evening is not specified, but the recommendation is to take it at the same time every day.

Why does my doctor ask about other drugs I’m taking?

Drugs can interact with one another in ways that affect their safety and efficacy. For instance, two drugs may rely on the same enzyme system in the body to break them down. Taking them at the same time can ultimately lead to higher-than-anticipated levels of either or both drugs in the body.

Information to answer this question can be found in the “Drug Interactions” section.

One of the drug categories of concern for Lipitor are “strong inhibitors of CYP 3A4,” an enzyme that plays a key role in metabolizing many drugs. Because Lipitor itself is broken down by this enzyme, taking it alongside drugs that inhibit CYP 3A4, such as the antibiotic clarithromycin or the fungal infection drug itraconazole, can lead to its increased concentration in the blood and potentially result in adverse effects.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Three years ago, Nancy Klimas sat in an auditorium waiting to discuss her latest research progress. The audience was made up of the usual suspects at a scientific conference: doctors, scientists, and other academic colleagues. But this group was a bit different. The room was also packed to the brim with retired US veterans, all waiting to hear about any new developments over a “moonshot” idea that could be the closest attempt to a cure for Gulf War illness. 

Klimas, who serves as the director for the Institute for Neuro-Immune Medicine at Nova Southeastern University in Florida, has been studying this debilitating condition for three decades. The strange sickness affects 175,000 to 250,000 soldiers who were deployed in the 1990-1991 Persian Gulf War. For those veterans, nearly half of who are pushing 50 or above, life has been an uphill battle. There is currently no cure for Gulf War illness, and because it involves a cluster of symptoms—fatigue, joint pain, diarrhea, memory loss—attempts to treat it have come up short. “These people served our country and put themselves in harm’s way,” says Klimas. “Now they’re sick with a chronic illness that ruined their quality of life and ability to work for more than 30 years.” Exhausting her options, Klimas came up with a rather unconventional idea: use a well-established abortion drug to reset the body’s overwhelming response to chronic illness.

[Related: The PACT Act will take the burden of proof off US veterans exposed to burn pits]

Mifepristone, more widely known as the abortion pill, is capable of treating multiple illnesses. At low doses and when paired with another pill, misoprostol, the synthetic steroid binds to a protein in the uterus and stops the release of progesterone and other hormones needed to sustain pregnancy. But the drug has another effect, which Klimas is looking to tap. When taken at higher doses, mifepristone also blocks hormone receptors in the adrenal gland, which regulates the body’s stress response. The drug has already proven capable of doing this, and is currently approved as a treatment for the metabolic disorder Cushing’s syndrome. 

Based on that evidence, Klimas wondered if the medication could temporarily block the adrenal gland and rebalance the hormone signals that are blunted with Gulf War illness. Repurposing the FDA-approved drug would also save the 10 to 15 years it would take to develop and test a brand-new drug. Klimas is halfway through her phase 1 trial testing the safety of the drug at different dosages on veterans, and is making plans for the second phase of the study. 

The recent legal mess surrounding mifepristone access threw a wrench in Klimas’s plans, along with those of other researchers using mifepristone in their work. In early April, a federal circuit judge in Texas overturned the FDA’s 23-year-long approval of mifepristone, citing claims that the drug is unsafe for public use because abortion is now illegal in some states. And while the Supreme Court blocked the ruling that would have suspended mifepristone access across clinics, pharmacies, and mail orders, the future of the treatment remains uncertain in the US. “Obviously, we’re very concerned,” says Klimas, adding that mifepristone was already hard to get for research purposes. “Attempts to limit access to this drug has already had a splashback on the veteran population in these trials, as we’re delayed in rolling things out. How long will they have to wait for an effective therapy?”

Further constraints on mifepristone could impact medical progress on many other diseases and conditions as well. The medication is being studied as a potential treatment for diabetes in people without Cushing’s syndrome. It has also shown some potential in preventing weight gain caused by antipsychotic medication. Some ongoing clinical trials have found that mifepristone can be effective in slowing down the spread of breast cancer: The drug blocks progesterone receptors from releasing the hormone, which would normally stimulate tumor cell growth. And at different dosages, the pill can improve the quality of life of people dealing with painful uterine growths.

[Related: Abortion bans are impeding access to ulcer, arthritis, and cancer medications]

Banning mifepristone goes beyond stalling research—it puts any FDA-approved treatment at risk of being recalled. “You have a medication with an excellent track record of safety, efficacy, and high patient satisfaction,” says Carrie Cwiak, an OB-GYN at Emory Healthcare in Georgia. “The idea that the entire process for approving medication can be overturned [in court] is earth-shattering.” She says that restricting mifepristone opens a dangerous door to having people with legal power make treatment decisions based on their opinion and ideology rather than medical evidence. 

If the courts decide to bar or limit mifepristone use down the line, it would discourage pharmaceutical companies from spending money on producing new drugs that appear controversial. That could include contraceptives, hormone blockers, or treatments completely unrelated to reproductive issues. “If you were a pharmaceutical company and it was going to cost you $20 million to move a pipeline drug all the way up through phase three [clinical trials], would you want to invest the money for it if it’s possible the bench could reverse the authority of the FDA?” Klimas asks. 

Despite the setbacks on mifepristone access and potential legal battles, Klimas is optimistic that the research she is doing will help give veterans their long and overdue treatment. Her team is hoping to start their phase 2 trial soon and get as many results before politics interferes in science again. 

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Your stomach is extremely moody—at any given time, a complex interplay of factors such as hormone production and various neurological signals can leave you feeling hungry, overstuffed, excited, or nauseous. These experiences stem directly from the enteric nervous system (ENS), which controls gastrointestinal tract functions along a path known as the gut-brain axis. The ENS is so complex, in fact, that it is often referred to as your “second brain.”

Because of this, there are a number of ways for things to go sideways, resulting in issues such as suppressed appetites and slow digestion. Recently, however, researchers developed a first-of-its-kind treatment to help spur hunger via stimulating hormone levels in the gut—an “electroceutical” ingestible capsule inspired by a “water wicking” reptile.

In a new paper published by a team of scientists at NYU Abu Dhabi working alongside experts at MIT, the team explored a novel way to “significantly and repeatedly” induce the production of ghrelin, a hormone that triggers hunger. To accomplish this, they looked to the Australian thorny devil lizard, whose spiky skin is evolved to transport any water it touches towards the reptile’s mouth. Similarly, the research team’s ingestible device features a grooved, hydrophilic exterior designed to defer fluids away from the stomach’s inner lining. When this occurs, the pill-shaped tool’s electrodes come into direct contact with the tissue to produce a tiny current stimulating ghrelin production.

[Related: Doctors need to change the way they treat obesity.]

Dan Azagury, an associate professor and Chief of Minimally Invasive and Bariatric Surgery at Stanford University who was not involved in the study, admired the new device, and said they found the findings “really intriguing.”

“I love the creativity of the device, the idea, and how they found a way to get around the fluid constraints,” Azagury said via email, but cautioned that “even if that works, the path for this to show clinical efficacy in a disease as complex as obesity, is very, very challenging.”

Azagury points towards experts’ still relatively poor understanding of gut hormones and the gut-brain axis, which are “more complex than we think, and likely underutilized.” As an example, he offered that the “new blockbuster drugs” used to treat obesity are based on gut hormones only discovered in the 1980s, far after doctors had begun performing weight loss surgeries.

Although Azagury estimates there is a “long road ahead” before the device is commercially used to treat diseases, its creators are more optimistic. “It’s a relatively simple device,” Giovanni Traverso, an associate professor of mechanical engineering at MIT and gastroenterologist at Brigham and Women’s Hospital, and the senior author of the study, argued in a statement for MIT. “So we believe it’s something that we can get into humans on a relatively quick time scale.”

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This article was originally published on Undark.

When a dentist told Corrine Rivera that her 7-year-old daughter needed a baby root canal at her routine checkup, Rivera didn’t understand that “baby” was describing the tooth, not the size of the procedure. She imagined it was like a baby ice cream cone — less than what an adult gets, just a little bit of a root canal. Rivera’s daughter had yet to have any dental interventions other than cleanings, so Rivera didn’t realize what she was in for.

The dentist, Rivera recalled, proceeded with the root canal right then and there. It was painful for her daughter, who had to endure large tools in her mouth for the unexpected hour-and-a-half long procedure, and distressing for Rivera. “I just wanted what was best for my daughter’s teeth at the time,” she said about that 2017 experience at Pediatric Dentistry of Albany, in New York state. “Unfortunately,” she added, “having the procedure led to a hell of a lot more problems.”

A few months later, Rivera said her daughter developed an infection, and a new dentist at a different practice explained to her that a baby root canal, or pulpotomy, is a root canal on a baby tooth, not a “mini” procedure.

Rivera remains skeptical that her daughter needed a root canal in the first place, and state and federal prosecutors, it turns out, later responded to allegations that other pulpotomy cases in that same dental practice had been medically unnecessary. In October 2022, Pediatric Dentistry of Albany and 12 affiliated clinics — all operated by pediatric dentist Barry L. Jacobson and his company, HQRC Management Services, LLC — reached a settlement of more than $750,000 with the New York State Attorney General’s Medicaid Fraud Control Unit and the United States Attorney’s Office for the District of New Jersey.

The state and federal investigation was spurred by a 2017 whistleblower lawsuit filed by a former manager of five of Jacobson’s upstate New York locations. The former employee alleged that staff at the clinics performed unnessary procedures, and were pressured to increase the number of patients and procedures in order to meet a $180,000-per-month revenue goal.

A spokesperson for HQRC declined to comment on specific claims from the complaint, but insisted that the settlement did not suggest that dental care provided by the company’s practitioners was inappropriate; rather, that the recordkeeping needed to support a limited number of specific procedures was lacking. “HQRC has steadfastly denied these allegations,” the spokesperson stated, adding that the company has “cooperated fully with the five-year government investigation that followed, and ultimately settled over record keeping and billing issues that occurred at a few of its offices several years ago that have long ago been addressed and corrected.”  

According to the settlement agreement, Jacobson and his company admitted that “in some instances, between 2011 and 2018, some dentists affiliated with HQRC performed and billed Medicaid for therapeutic pulpotomies not supported by the medical records maintained at the respective HQRC affiliated dental practices.”

New York state officials have not revealed the exact number of investigated procedures performed under the HQRC umbrella, and the experience of Rivera and her daughter was not, at least to Rivera’s knowledge, scrutinized as part of the lawsuit and subsequent settlement. This could mean that despite their experience, this particular “baby root canal” was medically necessary.

And according to experts who spoke to Undark, while some patients are likely to get more treatment than others, the main goal of pediatric dentistry is to promote oral hygiene, mediate pain, and keep baby teeth healthy until the adult teeth come in, said Donald Chi, a pediatric dentist and professor of oral health sciences at the University of Washington.

Still, deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance, compared to other medical research. Dentistry research is far smaller in scope and often plagued by funding biases. And while there’s good evidence that less invasive alternatives to fillings work well in kids, those alternatives haven’t been as widely adopted. Several dental experts also stressed to Undark that not every case is not the same — what might work well for one child may not work for another.

Worsening the problem, experts say there’s a strong economic incentive to focus on interventions, especially at practices that serve Medicaid or the Children’s Health Insurance Program, also called CHIP, which have exceptionally low reimbursement rates in many states. This may lead some practices to turn to private equity firms, which gives investment companies a hand in the operations of medical practice and may incentivize unnecessary treatments. (A private equity firm invested in HQRC Management. According to the plaintiff’s complaint, the practices’ revenue was mainly from Medicaid.)

This persistently murky tableau of incomplete science and financial incentivizing, alongside worrying lawsuits, can cast a shadow on a whole profession, some experts say. And it leaves patients like Rivera to wonder and worry whether their own children’s dental interventions were rooted in good-faith medical decision making, or something else entirely.

Baby teeth are, of course, temporary. And anyone who has ever tried to brush a reluctant toddler’s teeth knows firsthand that those tiny molars don’t always get high-quality home care. But their impermanence doesn’t mean that care isn’t important — if those teeth get ignored, it’s likely to cause problems with adult teeth later on.

As a specialty, pediatric dentistry is a little more than a century old. In 1909, about 70 years after the first U.S. dentistry college opened, a dentist named Minnie Evangeline Jordon established the first practice just for children. A few years later, she wrote that her male colleagues were glad to be rid of their pediatric patients “so that they could settle down to the serious work of dentistry — the making of bridges and plates.”

Today, although any dentist can treat kids, there is a thriving subspecialty of practices specializing in pediatric dentistry. There are more than 200,000 dentists in the country, about 8,000 of whom are pediatric specialists — a full-fledged discipline, with specialized training, a national professional organization, and journals like Pediatric Dentistry Journal and Journal of Clinical Pediatric Dentistry, where dentists publish their research into best practices into the field. Some of that research has bolstered longstanding claims: Regular brushing with fluoride toothpaste helps prevent cavities, early dental visits (before age four) reduce the amount of treatment needed later, and fluoride treatments such as gels, varnish, and mouth rinses may be valuable.

These measures are engaged in a sustained battle with the bacteria that create acids that corrode teeth. By physically removing stuck food that feeds the bacteria, and by strengthening the enamel with fluoride, these measures can prevent cavities and the proliferation of the decay-causing bacteria that can linger in a child’s mouth far past when their baby teeth fall out.

But, some experts say, it’s difficult for dentists to translate pediatric dentistry research to practice. Review articles, which evaluate a body of research on a particular subject, conclude that findings regarding pediatric dentistry have low certainty. For one thing, much of the relevant research that does exist has a high risk of bias, according to Shaun Sellars, a general dentist in Suffolk in the United Kingdom, because it is paid for by players in the industry, such as manufacturers of dental materials. Dentists “don’t do a lot of practice-based research either,” said Sellars, who is also the ethics columnist for the British Dental Journal. “There’s the funding issue there,” he added. “Because dentists, if they’re not hands in mouth, they’re not making money.”

Still, research on evidence-based practices and technology are advancing, and quickly. In dentistry schools “half of what we teach is out of date in five years,” said David Johnsen, a professor of dentistry at the University of Iowa. This can make it hard for providers to keep up with new findings. According to Sellars, many dentists face barriers to making evidence-based decisions, such as not having enough time to follow new studies or not having access to research articles behind paywalls. And even if dentists do read the literature, Sellars said, “not enough of it is relevant to what we actually do in practice.” Oftentimes, he added, “dentists will find what works for them, or what they believe works for them, and just continue to apply that.”

Recently, research has called into question common procedures used to fight cavities in kids. Evidence shows that fillings aren’t necessarily better than noninvasive alternatives, such as silver diamine fluoride, an inexpensive liquid that can slow decay, or caps that can be pushed onto the tooth (sometimes called the “Hall Technique”). Neither of these alternatives require drilling, filing down a tooth, or using anesthetics, said Nicola Innes, a professor of pediatric dentistry at Cardiff University.

Sellars lamented that there aren’t many resources, such as clinical guidelines, that would help dentists navigate the complex situations they face every day in an evidence-based way.

Dentistry decisions aren’t always straightforward. There are a wide range of approaches over how to treat dental cavities — one of the most common disease treatments in a dental office — in kids, including the kind of baby root canal that Rivera’s daughter received. As Johnsen put it: “If you get 10 really good dentists around a patient or a case and you say, ‘What’s the right treatment plan?’ you may get six or 10 or 11 different opinions.”

When a child comes in to see a dentist with a cavity, deciding how to treat a child’s cavity can be complicated, Chi told Undark. The dentist has to consider: How deep is the cavity? How much has it progressed since the patient’s last visit? Does the child appear to have regular brushing habits? Does the child have a risk factor for tooth decay? Might the tooth fall out soon?

If the cavity is not too deep and the tooth might fall out soon, the dentist might opt to do nothing and check again in six months. Or the dentist might slow the decay by painting on diamine fluoride to halt or slow decay (a downside: the material stains the tooth black).

If a dentist believes the cavity needs more intervention, many may choose fillings. “The problem with fillings is that they don’t do very well in children’s teeth,” said Innes, because baby teeth are small and wet, and kids tend to wiggle. Injecting anesthesia and drilling can also be unpleasant. There’s solid evidence, from her research and others, that fillings aren’t necessarily better than the noninvasive alternatives: silver diamine fluoride or caps.

When a cavity becomes so deep that a tooth’s pulp becomes infected, options include pulling the tooth or performing a root canal. Both have downsides, Innes said. A gap left from a pulled tooth can allow teeth to twist and migrate, which can lead to a need for orthodontia later. For a root canal, a child needs to be able to sit for a long time, first during the root canal and again when the tooth is shaved down and a crown is put on. Baby root canals come with a risk of infection, as Rivera said happened with her daughter in New York state. For instance, the Centers for Disease Control and Prevention recently issued a health advisory because multiple outbreaks of nontuberculous mycobacteria infections have occurred in children who received pulpotomies in pediatric dental clinics where the dental treatment water contained high levels of bacteria.

For many children, extensive dental work such as multiple root canals or fillings may require general anesthesia. But it’s uncomfortable to have a tooth pulled, even when a child is anesthetized and the procedure is painless, Innes said.

Anesthesia is also expensive, and it can have real risks for kids, including, in very rare cases, serious injury and death. More commonly in the short term, “they can have some attachment disorders, some night terrors, bedwetting, things like that,” said Innes. “And in the longer term, there was a very small amount of evidence that it probably doesn’t do them any good neurologically.”

Most dental treatments, several experts stressed to Undark, should be preventative. “I’d much rather spend my time telling people and helping people remain healthy than treating someone for a root canal, said Margherita Fontana, a professor at the University of Michigan School of Dentistry, adding: “They’re not having fun, and I’m not having fun. I mean, it’s not a fun thing to do to something to someone that you know is in pain.”

Unfortunately, Fontana said, there’s little data to indicate which patients are most at risk for dental disease, and how to best prevent it. “We need better prediction tools, in general, for children and for adults,” she added. “Many times, we are reactive to the damage rather than trying to prevent the damage.”

Part of the issue of prioritizing prevention, Fontana and other experts say, is an incentive system that offers few rewards for prevention-centered approaches — and large payouts for interventions.

Fontana’s research focuses on predicting dental health risks and using easy interventions like silver diamine fluoride, but generally requires routine dental visits to keep an eye on whether the cavity is progressing.

“I just have happy kids sitting in the chair. I’m doing things and testing things that I think are going to be super easy, fast, and accessible,” she said. “But then I know that at the time to get translated into practice is going to be difficult, because there’s no good way for people to get reimbursed to do those things.”

When more robust research supports a particular dentistry tool or technique, there may still be financial barriers for widespread use. In many states in the U.S., less invasive treatments and preventative measures, including fluoride varnish and silver diamine fluoride, are reimbursed at a much lower rate than more invasive ones, which may make them less likely to be adopted into practices. And dentists don’t get paid at all for taking time to walk a patient through their potential treatment options. If dentists “don’t physically do something in your mouth, they do not get reimbursed,” said Fontana.

Reimbursement can be particularly difficult for dentists who accept Medicaid or the Children’s Health Insurance Program, which serve more than 41 million kids and tend to have much lower reimbursement rates than private insurance or private pay rates. While overhead costs are increasing due to inflation, data indicate that Medicaid reimbursement rates have failed to keep up. Those problems can be especially acute in practices that are under pressure from owners or investors to make cash.

“You’re fighting a system where the driver is doing something — dentists don’t get paid to prevent disease,” Fontana added. “I don’t think it’s ever going to change if the system doesn’t change.”

With low reimbursement rates for preventative measures like cleanings and fluoride applications, it’s hard to imagine how pediatric dentists earn more than general dentists. But Chi said that a key component of pediatric dentistry “is to provide high quality care as quickly as possible. And the main reason for that is that children have short attention spans.” That also means that a pediatric dentist can potentially book more patients in a day than a general dentist can, which may lead to more income.

Dentists that accept Medicaid or CHIP face other challenges in billing and running a practice. Medicaid is a joint federal-state program, but it varies from state to state, explained Jason Ray, a Texas lawyer with experience in Medicaid dentistry-related lawsuits. In addition to low reimbursement rates, some Medicaid programs also require dentists to do more paperwork than the state’s dental board generally does, such as getting consent for each visit and each procedure, which could add to administrative costs. Medicaid audits can also be time consuming.

Ideally, a dentist would have a mix of patients, some who pay with private insurance, others out-of-pocket, and some Medicaid patients. However, dentists often don’t achieve a good balance. Research shows that dentists who treat more Medicaid patients are more likely to be located in a majority non-White zip code, a rural area, or high-poverty zip code. Because of Medicaid’s low reimbursement rates, Ray pointed out, one way for a dentist to make money is to see a high number of patients and do a large number of procedures.

There’s no doubt that this could lead to incentives to do procedures that may not be necessary, Ray said. An analysis of California’s Medicaid program in 2012 indicated that about 8 percent of dentists reviewed that provided Medicaid services to children met certain thresholds for questionable billing. The average general dentist performs root canals on 5 percent of pediatric patients. In the sample reviewed, the threshold of questionable billing was 18 percent, which about 2 percent of the Medicaid dentists exceeded.

A 2022 analysis of dentists found that about 33 percent treat at least one Medicaid patient. Those that do may also be tempted by the offers of private equity firms, which can lead to big payouts, but might also encourage practices to prioritize profits over evidence-based care. (Firms often don’t pay penalties in cases of fraud.) A 2013 report prepared by a U.S. Senate committee noted that corporate-managed “clinics tend to focus on low-income children eligible for Medicaid. However, these clinics have been cited for conducting unnecessary treatments.”

Whether Rivera’s daughter’s procedure was one of those unnecessary treatments is something that she and her family may never truly know. But she told Undark that the experience has left her rattled — even though she and her daughter, now 13, have found a Medicaid-accepting dental practice that they say they’re generally happy with.

Still, Rivera says that ever since her daughter received that “baby root canal” six years ago, she has deeply hated going to the dentist. “She remembers that day,” Rivera said, “very clearly.”

Christina Szalinski is a freelance science writer with a Ph.D. in cell biology based near Philadelphia.

This article was originally published on Undark. Read the original article.

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On April 26, the Food and Drug Administration approved the first pill for fecal transplants. The pill is made from healthy bacteria found in human waste which can help fight dangerous infections in the gut.

[Related: The FDA approved a fecal transplant treatment for the first time.]

According to the FDA, the pill from Massachusetts-based Seres Therapeutics provides doctors and patients with a simpler, and rigorously tested version of the procedure that has been used for just over a decade. Previously, when a patient experienced a Clostridium difficile infection or CDI, doctors would perform a fecal transplant using the stool from a healthy donor. Donor bacteria can help restore the balance of bacteria in the gut and prevent reinfections.  

The new treatment will be sold under the brand name Vowst as four daily capsules for three consecutive days. Vowst was cleared for adults 18 and older who face risks from repeat infections from C. diff, and have already received antibiotic treatment. A CDI can cause severe nausea, cramping, and diarrhea, and is dangerous when it reoccurs. CDI’s lead to roughly 15,000 to 30,000 deaths per year. 

While C. diff can be killed with antibiotics, the drugs can also destroy the beneficial bacteria that live inside the gut, leaving  it more susceptible to infections in the future. People over age 65 are at an increased risk for contracting an infection, but other risk factors include hospitalization, a weakened immune system, and a previous history of infection. Some patients may get the infection again following recovery, and the risk of additional recurrences increases with each infection. 

The FDA approved Vowst based on a study of 180 patients wherein nearly 88 percent of the patients taking the capsules did not experience a reinfection after eight weeks. About 60 percent of those who received dummy pills did see a reinfection. Some of the common side effects included abdominal swelling, constipation and diarrhea.

According to Seres, via reporting from the Associated Press, manufacturing the pills relies on the same techniques and equipment that is used to purify both blood products and other biologic therapies. It starts with stool from a screened group of donors that is tested for potential infections, viruses, and parasites. The samples are then processed to remove the waste and isolate the healthy bacteria,killing any lingering organisms. 

In the approval announcement, the FDA warned that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens.”

[Related: What to know about fecal transplants in the wake of the first death.]

In late 2022, the FDA approved Rebyota, the first pharmaceutical-grade version of a fecal transplant treatment from Ferring Pharmaceuticals. This product must be delivered via the rectum. 

The approvals of both Rebyota and Vowst are the product of years of pharmaceutical research into the bustling community of fungi, bacteria, and viruses that lives in the gut called the microbiome.

A network of stool banks from hospitals and medical institutions across the US have provided most fecal transplants. However, that growing number of fecal transplant practitioners and stool banks around the US has created a regulatory mess for the FDA, since the agency doesn’t traditionally regulate medical procedures performed by doctors. As long as stool donors are carefully screened for any potential infectious diseases, the FDA has rarely intervened in using the procedure.

In response to these new FDA-approved options, the largest stool bank in the US called OpenBiome said it will keep serving the patients like children and adults with treatment-resistant cases who are not eligible for the new treatments. Since 2013, OpenBiome has supplied more than 65,000 stool samples for CDI patients.

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Roughly 55,000 adult consumers in the United States  take popular chewy melatonin gummies to promote better sleep. But they may be getting a little more of the hormone than the label indicates. A study published April 25 as a letter in the Journal of the American Medical Association (JAMA) found that 88 percent of tested supplements were mislabeled.

The study follows a Centers for Disease Control and Prevention (CDC) report from last year about an alarming surge of excessive pediatric infestations of melatonin over the past 10 years.

[Related: Yes, you can overdose on melatonin. Here’s how to use the sleep supplements safely.]

Melatonin is a hormone naturally produced deep within the brain in the pineal gland. It  is released into the bloodstream to regulate the body’s natural sleep cycles. Melatonin is considered a drug in some countries in the European Union, Japan, Canada, and the United Kingdom, making it only available through a prescription. The US Food and Drug Administration considers melatonin a dietary supplement, but manufacturers are not required to receive FDA approval or provide safety data on melatonin products.

For this study, a team of researchers from Cambridge Health Alliance in Massachusetts and the University of Mississippi tested 25 different supplements. According to the authors, the team selected the first 25 gummy melatonin products that displayed on the National Institutes of Health database for this study. The team dissolved the gummies and then measured the quantity of melatonin, cannabidiol (CBD), and other components in the supplements.

Most of the products tested had 20, 30, or 50 percent more melatonin than the quantity listed on the label. Four has less amounts of the hormone than promised, including one without any detectable levels of melatonin. 

Twenty-two were “inaccurately labeled,” meaning they contained 10 percent more or less than the amount of melatonin on the label. 

Five products listed CBD as an ingredient, but they all had slightly higher levels of CBD than indicated on the label. According to the FDA, “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”

[Related: The science behind our circadian rhythms, and why time changes mess them up.]

“One product contained 347 percent more melatonin than what was actually listed on the label of the gummies,” study co-author and professor of medicine at the Cambridge Health Alliance Pieter Cohen told CNN.

In response to the JAMA letter, Steve Mister, the president and chief executive of the Council for Responsible Nutrition, told The Washington Post that supplement companies are required to have “at least 100 percent of labeled dosage” in their products. “It’s not uncommon for companies to put in a little extra,” he added. “So, for instance, a melatonin product that’s labeled as 3 milligrams might put in 4 milligrams.” 

Melatonin was the most cited substance in calls about children to US poison control centers in 2020. Drowsiness, headaches, agitation, and increased bed-wetting or urination in the evening hours are all potential side effects of melatonin use in children. 

“It’s important, especially in kids, not to use melatonin until you’ve spoken with your pediatrician or your sleep doctor,” M. Adeel Rishi, a pulmonology, sleep medicine, and critical care specialist in Indiana and vice chair of the American Academy of Sleep Medicine Public Safety Committee, told PopSci last July. “The dose recommended in children is significantly lower than what is recommended in adults, and if you take too much of anything you have an overdose. Although it’s come to attention really in the last couple of years, we know that cases of melatonin among children have been on an upswing even before the pandemic.”

Other pediatric sleep experts stress the importance of good sleep hygiene and habits before starting melatonin. The new study’s letter also included a warning to parents that giving the gummies to children could result “in ingestion of unpredictable quantities” of melatonin.

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A common diabetes drug has become trendy because of its use as an off-label weight loss drug. From tech moguls to influencers, this drug has become the latest “celebrity secret” for shedding the pounds. 

Ozempic, and a similar medication called Wegovy, are brand names for an injectable medicine called semaglutide. This drug is the synthetic version of a hormone called glucagon-like peptide-1 (GLP-1), which belongs to a class of medications known as GLP-1 agonists. 

The chemistry explains how Ozempic works and what its main side effects are. GLP-1 is a compound that increases insulin production and lowers blood sugar. After we eat, GLP-1 also signals to the brain a feeling of fullness. Meanwhile, GLP-1 agonists slow down the rate at which food empties out of the stomach, further promoting a feeling of satiety. This prevents cravings and overeating, which can result in weight loss. 

While Ozempic and Wegovy are now lumped together with weight loss fads, these medications are not diet hacks. Instead, they are medications proven to lower weight in certain patient populations. 

Despite this, there is a growing concern that these drugs are misused and overprescribed in individuals who casually use them for aesthetic reasons. There’s concern this type of use is resulting in repercussions like unmanaged side effects and drug shortages. Here are some proven facts and common misconceptions surrounding Ozempic. 

Fact: Ozempic’s side effects include weight loss, but it’s not a weight loss drug

This distinction is important. Ozempic is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes. It is intended to help diabetes patients control their blood sugar. While it is not a weight loss drug, diabetes patients on Ozempic may lose weight as a side effect because of the way the medication works. Losing weight can improve insulin production and, in turn, benefit some individuals. Meanwhile, Wegovy is FDA-approved for chronic weight management in adults with obesity.

[Related: There’s still a lot we don’t know about the new generation of weight loss pills.]

Swetha Bhat, a primary care physician in the California Bay Area, prescribes Ozempic and Wegovy to patients who meet the criteria. She tells PopSci she has denied requests for semaglutide for weight loss because patients don’t qualify. 

“I can’t prescribe medications to someone who doesn’t meet the FDA indication,” Bhat says. “There are med spa clinics run by dermatologists or plastic surgeons who prescribe semaglutide and that is simply out of scope for their practice.”

Fact: Ozempic and Wegovy are the same medication

Ozempic and Wegovy are two names for the same injectable drug manufactured by Novo Nordisk: semaglutide. But they are approved for different conditions and administered at different dosages.

Ozempic first received FDA approval as a treatment for type 2 diabetes in 2017 at a maximum dosage of 1 milligram once weekly, and was approved again in 2022 for a larger maximum dose of 2.0 milligrams. 

Wegovy received FDA approval in 2021 for adults who are obese or overweight with at least one weight-related condition (high blood pressure, type 2 diabetes, or high cholesterol). People taking Wegovy start at a dose of 0.25 milligrams once a week and increase the dose every four weeks until they reach the full dose of 2.4 milligrams.

Despite the recent Wegovy approval, there’s already a new drug on the block, which seemingly packs even more punch. In 2022, Eli Lilly launched its first in-class diabetes drug called Mounjaro (generic name tirzepatide), which activates both GLP-1 and GIP receptors for increased blood glucose control. According to the FDA, the average weight loss on Mounjaro at the maximum dose is 12 pounds more than with semaglutide. 

Fact: Ozempic has other side effects, but they’re not the same for everyone

There are some reports that Ozempic use results in a side effect called “Ozempic face,” in which the face becomes noticeably more gaunt and sunken due to the drastic weight loss. 

[Related: Experts rank the raw food diet as the worst of 2023.]

However, the term “Ozempic face” is misleading. It’s not necessarily a side effect of Ozempic, but a general possible side effect of weight loss. Sometimes a large weight reduction can result in excess skin in the face among other places. But not everyone who uses Ozempic will experience this, and it’s not a clinically proven side effect.

The most common side effects of taking GLP-1 agonists are nausea and diarrhea. Another common side effect is lack of appetite, to the point where some patients need to remind themselves to eat.

Fact: The Ozempic shortage was caused by the weight loss fad—and many other reasons 

There are several reasons for the Ozempic shortage. Novo Nordisk stated the shortage was due to issues with manufacturers coupled with the increase in demand for both on-label and off-label use. Pharmacies also tend to not stock Ozempic as it is expensive with poor cost-benefit. 

Meanwhile, social media increased interest in semaglutide among people who wouldn’t qualify for the drug for FDA-approved reasons. For example, a TikTok of Chelsea Handler went viral after she was unknowingly given Ozempic by her “anti-aging doctor.” This is referred to as “off-label” prescribing—when a doctor uses their best judgment to prescribe a medication for which the drug isn’t FDA approved.

[Related: Weight might not be the best way to detect diabetes early.]

Digital health companies, meanwhile, have made it easy for people who want the drug to access it. This has contributed to drug shortages.

A retail pharmacist in Central California, who did not want their name published, spoke about the opposite end of the experience with PopSci. “At first we were getting an influx of patients who were diabetic and we saw how much it helped. Then all of a sudden there was a surge of non-diabetic patients and we could not get semaglutide for our diabetic patients.”

Now, most practitioners have to provide a diabetes diagnosis when prescribing Ozempic for insurance reasons, they explain. “At the same time, the supply chain was also a major contributor to the shortage. For a while, we couldn’t get the drug at all through McKesson [a drug distributor] and our diabetes patients suffered. We had to switch them to Trulicity [the brand name for the drug dulaglutide] and even that went out of stock for a while.”

Fact: Ozempic is made from lizard lips (kind of)

In a recent episode of the pop culture podcast “Psychobabble,” hosted by Tyler Oakley and Korey Kuhl, the duo giggled in wonderment after reading on Twitter that Ozempic was made from “Gila monster spit.” 

GLP-1 agonists are derived from the venomous saliva of the Gila monster, a giant lizard that lives in US and Mexican deserts. In 1990, an endocrinologist named John Eng researched both the toxic and nontoxic chemicals produced by the species for medicinal use. He discovered that Gila monsters went long periods without eating and slowed down their metabolism while maintaining constant blood sugar levels. 

The peptide that allows them to do this is called Exendin-4 and is strikingly similar in both structure and function to human GLP-1. So Exendin-4 was derived to make the first synthetic GLP-1 drug, called Exenatide.

Fact: Ozempic can be a life-changing medication for the right patients

GLP-1 agonists, including Ozempic, continuously prove to be powerful blood glucose and weight-lowering medicines. They are also one of the few classes of diabetes drugs that have a significant clinical benefit in patients with a cardiovascular disease history and chronic kidney disease, which are risk factors for diabetes. 

With so many headlines and news outlets, the amount of information the average individual has to filter through can be overwhelming, especially when it comes to health. The Ozempic craze is a fantastic example of pop culture amplifying potentially misleading information. It is important to weed out the fact from fodder to avoid an unwarranted bias against a possible life-saving medication for the right candidate.

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This article originally appeared in Knowable Magazine.

The seizures started when Samantha Gundel was just four months old. By her first birthday, she was taking a cocktail of three different anticonvulsant medicines. A vicious cycle of recurrent pneumonia, spurred on by seizure-induced inhalation of regurgitated food, landed the young toddler in and out of the hospital near her Westchester County home in New York State.

Genetic testing soon confirmed her doctors’ suspicions: Samantha, now age 4, has Dravet syndrome, an incurable form of epilepsy. Her brain was misfiring because of a mutation that is unlike those responsible for most genetic diseases; it’s a type that has long eluded the possibility of correction. Available drugs could help alleviate symptoms, but there was nothing that could address the root cause of her disease.

That’s because the mutation at the heart of Dravet creates a phenomenon known as haploinsufficiency, in which a person falls ill if they have only a single working copy of a gene. That lone gene simply can’t produce enough protein to serve its molecular purpose. In the case of Dravet, that means that electrical signaling between nerve cells gets thrown out of whack, leading to the kinds of neuronal shock waves that trigger seizures.

Most genes are not like this. Though the human genome contains two copies of almost every gene, one inherited from each parent, the body can generally do fine with just one.

Not so for genes such as SCN1A, the main culprit behind Dravet. For SCN1A and hundreds of other known genes like it, there’s a delicate balance of molecular activity that is needed to ensure proper function. Too little activity is a problem — and oftentimes, so is too much.

This Goldilocks paradigm partially explains why conventional gene therapy strategies are ill-suited to the task of haploinsufficiency correction. With therapies of this kind — several of which are now available to treat “recessive” genetic diseases such as the blood disorder beta thalassemia and a form of inherited vision loss — the amount of protein made by an introduced gene just needs to cross a minimum threshold to undo the disease process.

In those contexts, it’s not a problem if the added gene is overactive — there’s a floor, but no ceiling, to therapeutic protein levels. That is simply not the case with many dosage-sensitive diseases like Dravet, especially for brain disorders in which too much protein can overexcite neuronal activity, says Gopi Shanker, who served as chief scientific officer of Tevard Biosciences in Cambridge, Massachusetts, until earlier this year. “That’s what makes it more challenging,” he says.

Adding to the challenge: The special types of modified viruses that are used to ferry therapeutic genes into human cells can handle only so much extra DNA — and the genes at the heart of Dravet and many related haploinsufficiency disorders are much too big to fit inside of these delivery vehicles.

Overlooked no more

Faced with these technical and molecular hurdles, the biotechnology industry long ignored haploinsufficiencies. For more than 30 years, companies jostled to get a piece of the drug development action in other areas of rare genetic disease — for cystic fibrosis, say, or for hemophilia — but conditions like Dravet got short shrift. “It’s one of the most neglected classes of disorder,” says Navneet Matharu, cofounder and chief scientific officer of Regel Therapeutics, based in Berkeley, California, and Boston.

Not anymore. Thanks to new therapeutic ideas and a better understanding of disease processes, Regel, Tevard and a group of other biotech startups are taking aim at Dravet, with experimental treatments and technologies that they say should serve as testing grounds for going after haploinsufficiency diseases more broadly.

Currently, there’s little to offer patients with these maladies other than drugs to aid with symptom control, says Kenneth Myers, a pediatric neurologist at Montreal Children’s Hospital who cowrote an article about emerging therapies for Dravet and similar genetic epilepsies in the 2022 issue of the Annual Review of Pharmacology and Toxicology. But thanks to new advances, he says, “there’s a huge reason for optimism.”

Samantha, for one, now seems to have her disease under control because of a drug called STK-001; it is the first ever to be evaluated clinically that addresses the root cause of Dravet.

Between February and April 2022, doctors thrice inserted a long needle into the young girl’s lower spine and injected the investigational therapy, which is designed to bump up levels of the sodium-shuttling protein whose deficiency is responsible for Dravet. It seemed to work. For a time, Samantha lived nearly seizure-free — presumably because the increased protein levels helped correct electrical imbalances in her brain.

She went from epileptic attacks every 7 to 10 days, on average, to nothing for months on end. Her verbal skills improved, as did her physical capabilities. Her gait improved and her tremors disappeared.

Eventually, as the therapy wore off, Samantha began to backslide, with seizures returning every couple of weeks or so. But she started receiving additional doses of STK-001 under a new trial protocol in October 2022, and since then has experienced only two epileptic episodes over the span of six months. “It’s really pretty amazing,” says her mother, Jenni Barnao.

“Is it a cure? No.… But this is absolutely our best shot,” Barnao says. “There’s definitely something with this drug that’s very good. Her brain is just working better.”

Give a boost

The STK-001 treatment relies on the fact that the normal activity of genes is somewhat inefficient and wasteful. When genes get decoded into mRNA, the resulting sequences require further cutting and splicing before they’re mature and ready to serve as guides for making protein. But often, this process is sloppy and doesn’t result in usable product.

Which is where STK-001 comes in.

A kind of “antisense” therapy, STK-001 consists of short, synthetic pieces of RNA that are tailor-made to stick to part of the SCN1A gene transcript and, as a result, make productive cutting and splicing more efficient. The synthetic pieces glom on to mRNA from the one working version of the gene that people with Dravet have and help to ensure that unwanted bits of the mRNA sequence are spliced out, just as a movie editor might cut scenes that detract from a film’s story. As a result, more functional ion channel protein gets made than would otherwise happen.

Protein levels don’t get completely back to normal. According to mouse studies, there’s a 50 percent to 60 percent boost, not a full doubling of the relevant protein in the brain. But that bump seems to be enough to make a real impact on patients’ lives.

Stoke Therapeutics, the company in Bedford, Massachusetts, that is behind STK-001, reported at the American Epilepsy Society’s 2022 Annual Meeting that 20 of the first 27 Dravet patients to receive multiple doses of the therapy in early trials experienced reductions in seizure frequency. The greatest benefits were observed among young children like Samantha whose brains have accumulated less damage from years of debilitating seizures and abnormal cell function. Larger confirmatory trials that could lead to marketing approval are scheduled to begin next year.

Stoke is hardly alone in its quest to fix Dravet and haploinsufficiency disorders more generally. Several other biotech startups are nearing clinical trials with their own technological approaches to enhancing what working gene activity remains. Encoded Therapeutics, for example, will soon begin enrolling participants for a trial of its experimental Dravet therapy, ETX-001; it uses an engineered virus to deliver a protein that ramps up SCN1A gene activity so that many more mRNA copies are made of the single, functional gene.

And if any of these companies succeed in reversing the course of Dravet, their technologies could then be adapted to take on any comparable disease, says Orrin Devinsky, a neurologist at NYU Langone Health who works with several of the firms and is involved in Samantha’s care. “An effective therapy would provide a potential platform to address other haploinsufficiencies,” he says.

New targets, new tactics

Stoke will soon put that idea to the test.

Buoyed by the early promise of its Dravet therapeutic, the company developed a second drug candidate, STK-002, that similarly targets splicing to turn nonproductive gene transcripts into constructive ones. But in this case, it’s designed to tackle an inherited vision disorder known as autosomal dominant optic atrophy, caused by haploinsufficiency of a gene called OPA1. In this disease, a single working copy of OPA1 is not enough to sustain proper nerve signaling from the eyes to the brain.

Clinical evaluation of STK-002 is expected to start next year. Meanwhile, in partnership with Acadia Pharmaceuticals of San Diego, Stoke is also exploring treatments for Rett syndrome and SYNGAP1-related intellectual disability, both severe brain disorders caused by insufficient protein levels.

Stoke’s splice-modulating approach flows naturally from the success of another antisense drug, Spinraza. Developed by Ionis Pharmaceuticals in collaboration with Biogen, Spinraza also works on splicing of mRNA transcripts to promote production of a missing protein. In 2016, it became the first therapy approved for treating a rare neuromuscular disorder called spinal muscular atrophy (SMA).

SMA is somewhat different, though. It isn’t a haploinsufficiency — it occurs when both gene copies are defective, not just one — but it’s an unusual disease from a genetics standpoint. Because of a quirk in the human genome, it turns out that people have a kind of backup gene that doesn’t normally function because its mRNA undergoes faulty splicing. With Spinraza acting as a guide to help the mRNA splice correctly, that backup gene can be made operational and do the job that the damaged gene copies can’t do.

Few diseases are like this. But Stoke’s scientific cofounders, molecular geneticist Adrian Krainer of Cold Spring Harbor Laboratory in New York (who helped to develop Spinraza) and his former postdoctoral researcher Isabel Aznarez, realized that there was a whole world of other ailments — haploinsufficiencies — for which this type of splice modulation could be beneficial.

Spinraza was the prototype. Stoke’s portfolio is full of the next-generation editions. “We brought it to the next level,” says Aznarez, who now serves as head of discovery research at Stoke.

Striking a balance

There was a time when Dravet researchers were more focused on traditional gene replacement therapies. They aimed to insert a working version of the SCN1A gene into the genome of a virus and then introduce the engineered virus into brain cells. The problems proved manifold, though.

For starters, the virus vehicles generally used in gene therapy strategies — adeno-associated viruses (AAVs) — are too small to hold all 6,030 of the DNA letters that constitute the SCN1A gene sequence.

Researchers tried a few potential workarounds. At University College London, for example, gene therapist Rajvinder Karda and her colleagues split the SCN1A gene in half and delivered both parts into mice in different virus carriers. And at the University of Toronto, neuroscientist David Hampson and his group tried introducing a smaller gene that would fit in a single AAV vector and compensate for the SCN1A deficiency in an indirect way.

But none of those efforts advanced past mouse experiments. And while it is technically feasible to deliver the entire SCN1A gene into cells if you use other kinds of viral vectors, as researchers at the University of Navarra in Spain showed in mice, those viruses are generally considered unsafe for use in people.

What is more, even if gene replacement could be made to work, there are many reasons to think it would not be ideal for diseases like Dravet in which the underlying defect is mediated by an imbalance of protein levels. The amount of protein produced by those kinds of gene therapies can be unpredictable, and so are the types of cells that end up manufacturing the proteins.

To get protein levels just right, scientists say, it is best to follow the cell’s own lead, tapping into the ways that it naturally produces the protein of interest only in certain tissues of the body, and then providing a therapeutic nudge to aid the process along.

CAMP4 Therapeutics, for example, is using antisense therapies, like Stoke. But instead of targeting the splicing of gene transcripts, CAMP4’s drugs are directed at regulatory molecules that act like rheostats to control how much of those transcripts are made in the first place. By blocking or stabilizing different regulatory molecules, the company claims it can ramp up the activity of target genes in a precise and tunable way.

“It’s basically teaching the body to do it a little bit better,” says Josh Mandel-Brehm, president and CEO of CAMP4, which is based in Cambridge, Massachusetts.

In theory, the gene-editing technology known as CRISPR could obviate the need for all of these therapeutic approaches. Gene editing allows you to perfectly correct a mistake in a gene — so one could edit a faulty DNA sequence to correct it and render kids with Dravet or some other haploinsufficiency disease as good as new.

But the technology is nowhere near ready for prime time. (Some of the first CRISPR therapies to be tested in children have failed to demonstrate much benefit.) Plus, any gene-correction therapy would have to be tailored to the unique nature of a given patient’s mutations — and there are more than 1,200 Dravet-causing mutations in the SCN1A gene alone.

That’s why Jeff Coller, an RNA biologist at Johns Hopkins University and a scientific cofounder of Tevard, prefers therapeutic strategies that can address all manner of disease-causing alterations in a gene of interest, as most companies are doing now. “Having a mutation-agnostic technology is a way of going after the entire cohort of patients,” he says.

Tevard, whose mission is to “reverse” Dravet syndrome (the company’s name is Dravet spelled backward), is approaching this challenge in various ways. Some involve engineered versions of other RNAs that are key for protein production; known as “transfer” RNAs, they help to ferry amino acid building blocks to the growing protein strands. Others are intended to help bring beneficial regulatory molecules to sites of SCN1A gene activity.

But all of Tevard’s therapeutic candidates remain at least a year away from clinical testing, whereas STK-001 is in human trials today. So the company’s chief executive, Daniel Fischer — who, along with board chair and cofounder Warren Lammert, has a daughter affected by Dravet — is considering enrolling his child, now 13, in the Stoke trial rather than waiting for his own company’s efforts to bear fruit.

“We’re open to any approach that would help our daughters,” Fischer said over lunch last November at the company’s headquarters.

“And help people with Dravet generally,” added Lammert. “We’d love to see many of these things succeed.”

Editor’s note: This article was amended on April 14, 2023, to correct Gopi Shanker’s relationship with Tevard Biosciences. Shanker is Tevard’s former chief scientific officer; he is now chief scientific officer with Beam Therapeutics.

This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.

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Ozone is like Earth’s natural sunscreen, protecting living things from the sun’s harsh UV rays. But this sunscreen is running out. Greenhouse gases are thinning out the ozone layer, and our skin is starting to pay the price. According to the World Health Organization, losing an extra 10 percent of ozone levels will cause an additional 300,000 non-melanoma and 4,500 skin cancer cases.

With skin cancer as the most diagnosed cancer in America, the US Preventative Services Task Force (USPSTF) updated their screening recommendations earlier this month, emphasizing the need for people to get moles and other spots checked early for potential tumors. 

The quicker skin cancer is caught, the better your chances of recovering from it. And recent technological advances in skin cancer research is transforming the way doctors and patients approach this deadly disease. Here are five tech tools to keep an eye on.

Therapeutic skin cancer vaccine

As multiple companies experiment with cancer vaccines, Merck and Moderna are focusing theirs on melanoma. Their phase II clinical trial results, shared last week, showed a 44 percent decrease in risk of death or a melanoma relapse when pairing the vaccine with the immunotherapy Keytruda. Additionally, about 79 percent of people who took the vaccine plus immunotherapy stayed cancer-free for 18 months compared to the 62 percent who just took immunotherapy. The data shows enough promise for the companies to start a Phase 3 trial in adjuvant melanoma this year, and could compel them to rapidly expand the vaccine to other tumor types, including non-small cell lung cancer, Eric Rubin, a senior vice president at Merck, wrote in an email.

[Related: A vaccine trial targeting the most lethal breast cancer just took its next step]

The vaccine isn’t a preventative treatment, but is instead given to melanoma patients early in recovery. The researchers take tumor samples from biopsies and identify which proteins are most likely to be recognized by the human immune system. They then make a personalized mRNA vaccine (adapted from the technology behind Moderna’s COVID jab) using a certain number of these abnormal genes to boost an individual’s adaptive immunity. If the rest of the trials go as planned, the vaccine could be available as soon as 2025 or early 2026, says Eric Whitman, the medical director of Atlantic Health System’s oncology service line.

Genetic tests and personal risk scores

Precision prevention is when doctors use multiple tools to map out a person’s risk of cancer and use that assessment to tailor their treatment and risk-reduction strategy. Instead of following a standard guideline like an annual dermal exam, a person who is considered high-risk (like someone with a history of skin cancer) may need more frequent screenings and extra body imaging, says Meredith McKean, the director of melanoma & skin cancer research at the Sarah Cannon Research Institute in Tennessee. People with very low risk, on the other hand, may be encouraged to learn how to do their own self-checks at home. McKean adds that it’s really helpful “to stratify patients and really help them do the best that we can to prevent another melanoma or skin cancer [case].”

Genetic tests can also be used to identify people with a predisposition to skin cancer. A 2022 study in the journal Cancer Research Communications found that people who were told they had a MC1R mutation, which carries a higher risk for melanoma, made more of an effort to protect themselves against the sun and get regular skin checks. Some doctors even use AI technology to a personalized risk score for individuals based on photos of skin lesions and moles.

Melanoma sticker

The Dermtech SmartSticker is an easy precursor for checking suspicious moles for melanoma. A dermatologist places four skin patches on the potential tumor for less than five seconds, and ships the sample to a Dermtech lab in San Diego, California. The lab then tests for DNA from cancerous cells. If the results come back positive, the dermatologist would follow up with a biopsy. If not, this painful step can be avoided and the doctor would just continue clinically monitoring the patient. 

“It’s a very good test. If it comes up negative, there is a greater than 99-percent reliability that the mole is not melanoma,” says Emily Wood, a dermatologist at Westlake Dermatology & Cosmetic Surgery in Texas. She adds that patients in her clinic favor the stickers over biopsies because they’re painless, cost-effective, and quick. “We’re going to save lives in catching melanoma earlier. I think this will make a dramatic impact for patients long-term.” While the studies are ongoing, there is research suggesting the tool could extend to detecting non-melanoma skin cancer. 

Artificial intelligence apps

Medical researchers are now training computers to recognize patterns and atypical features associated with skin cancer. “AI picks up a lot more subtle changes than the naked eye,” says Trevan Fischer, a surgical oncologist at Providence Saint John’s Health Center. The high accuracy in AI deep learning can help doctors determine whether a mole is malignant and worth biopsying—saving patients from some unneeded discomfort.

The beauty of AI is that you can do a full home skin exam with a press of a few buttons. Popular smartphone apps like MoleMapper lets users upload a picture and have it analyzed for potential skin lesions. They also let you store photos to show your doctor and keep track of any changes to your mole. (Wood warns that a smartphone app is not meant to substitute in-person skin check-ups with your doctor.)

While these apps are useful, there’s always room for improvement. For example, the AI’s accuracy goes down when the view of the mole has shadowing, blurriness, hair, or if the image is rotated. There’s also been research showing that AI databases lack images of darker skin types that would teach the system to better detect skin cancer from people of color. If anything, Wood says the apps can encourage people to submit photos of suspicious moles and start the conversation early with their doctor. 

Millimeter wave imaging 

The same technology used in airport security scanners is getting revamped and used to detect skin tumors. Millimeter wave imaging is a non-invasive method and a low-cost alternative to biopsies that works by scanning a person’s skin for any biochemical and molecular changes related to a disease or disorder. The radio waves reflect differently when looking at benign versus cancerous moles. 

[Related: Everything you need to know about UPF sun protection]

While the approach is not yet available for clinical practice, there is evidence backing up the proof of concept. A 2017 study in IEEE Transactions on Biomedical Engineering found considerable differences when looking back at the scans of healthy skin and those for two common skin cancer types: squamous cell carcinoma and basal cell carcinoma. The study authors could see detailed changes in water molecules, glucose concentrations, and protein levels. A 2018 study in the same journal used ultra-high resolution millimeter wave imaging to identify early-stage skin cancer. Most recently, the diagnostic tool was studied on 136 people suspected of skin cancer. Ultimately, it found malignant tumors from various types of skin cancer on 71 patients, giving the tech a “high diagnostic accuracy.” 

“We’re really trying to leverage all the different ways that advanced technology can help us diagnose and treat skin cancer like melanoma,” Whitman from Atlantic Health Systems says. He emphasizes that most of these strategies weren’t imaginable 10 years ago. Using data to improve on existing AI technology and create new models for personalized medicine, he notes, “can really make a difference for people and their lives.”

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This article was originally published on Undark.

Approximately 300 miles south of New Zealand, the Auckland Islands lie in a belt of winds known as the Roaring Forties. In the late 19th century, sailing ships departing Australasia would catch a ride back to Europe by plunging deep into the Southern Ocean to ride the westerlies home.

But these seas were poorly charted, and weather conditions frequently horrendous.

Sometimes, navigators miscalculated the islands’ position and, too late, found their vessels thrown upon the islands’ rocky ramparts. Ships were torn to pieces and survivors cast ashore on one of the most remote and inhospitable places on the planet. These castaways soon found out they were not alone.

The main land mass in the Auckland archipelago, Auckland Island, was — and still is — home to pigs, initially introduced in the first half of the 19th century by European hunters and explorers, as well as a group of Indigenous New Zealanders fleeing conflict.

The pigs have no natural predators, and over time, they have wrought destruction upon Auckland Island’s flora and fauna. Government conservationists now want them gone — but there’s a twist: These once domesticated farm animals have evolved into ultra-resilient, disease-free pigs that have caught the eye of scientists who study xenotransplantation, a type of medical procedure in which cells, tissues, or organs from one species are transferred into another species.

Last year, for the first time, surgeons transplanted pig hearts and pig kidneys into humans. Such procedures have not yet been tested in clinical trials, and they are not approved by the U.S. Food and Drug Administration or regulatory agencies in New Zealand. But researchers say that xenotransplantation could eventually prove effective at treating a range of conditions and may alleviate the huge global need for donor organs. The Auckland Island pigs, with their unique genetics, may be especially well-suited for this purpose.

Some of the hardy quadrupeds are now housed in a research facility on the New Zealand mainland. Meanwhile, conservation authorities are preparing a massive effort to eradicate those left in the wild.

The first European ship to reach the Auckland Islands (known as Maukahuka or Motu Maha in the Māori language) was the whaler Ocean, in 1806. The ship’s captain returned the following year to drop off a team of seal hunters. During this visit, pigs were first released as a food source. Subsequent introductions continued, and in the late 1800s, with the tales of shipwreck and survival piling up, the New Zealand and Australian governments got involved, releasing additional pigs for the castaways.

The pigs, which were of mostly European and Asian origin, had to learn to live with the persistent cold, rain, and wind — far from ideal conditions for animals bred for sheltered barnyards. But because pigs produce up to two litters each year, they can adapt relatively quickly, said Michael Willis, of the Rare Breeds Conservation Society of New Zealand. Soon, Auckland Island’s pigs formed one unique strain.

In the winter, they survived by eating the island’s endemic plants and scavenging carrion. In the summer, their fortunes changed, and they gorged on plump albatross chicks and protein-filled penguin eggs. Twenty-five species of seabird breed on the Auckland Islands, but after two centuries of pig predation, their numbers have fallen. New Zealand conservationists are increasingly wary of the porcine prowlers.

The archipelago is “an immensely special place,” said Stephen Horn, a project manager at New Zealand’s Department of Conservation. It’s the biggest remaining stronghold of the yellow-eyed penguin, the world’s rarest penguin species, and the Gibson’s wandering albatross, which breeds there exclusively. (Currently, said Horn, seabirds on Auckland Island nest only on the precipitous edges of the land, where even the most tenacious pig won’t venture.)

The pigs have also taken a toll on the spectacular flowering plants known as megaherbs, which are now “almost non-existent” on Auckland Island, Horn said. “They’re absent until you get to the extremely steep cliff areas. Then you can see patches of green that are out of reach” of the pigs.

Horn believes there are between 700 and 1,500 pigs on the island, with the population fluctuating widely. Survival to breeding age, he said, is low. Those that do make it have to be tough and adaptable. “On one hand, super admirable,” he said, “the way they’re able to adapt and survive in those conditions.” And on the other hand, incredibly damaging. “They use the coastline pretty heavily,” he said. “They’ll eat anything that turns up, scavenging things like dead whales and seals or even krill and squid.”

Mindful of the Department of Conservation’s long-held wish to eradicate the pigs, the Rare Breeds Conservation Society sent a team to retrieve some in 1999. Using dogs, they managed to catch 17. “Hunger appeared to be the pigs’ constant companion,” wrote team member Peter Jackson for New Zealand Geographic. “The suckling sows had only two or three teats producing milk, which told how few piglets survived.”

The team loaded the pigs on a boat and brought them back to the southern New Zealand town of Invercargill. There, the animals were put into a quarantine facility, intended to protect the country’s domestic pig herd from potential diseases.

Keeping the pigs in quarantine required money the Society didn’t have, so they prevailed upon Invercargill’s then-mayor, Tim Shadbolt, a colorful former left-wing activist, who dipped into his contingency fund for the approximately 2,300 in today’s New Zealand dollars, or $1,400, needed to feed them.

During the first year of quarantine, the pig population ballooned. “They dined on porridge and swedes and they became raging sexual beasts, producing larger litters than they did on the Auckland Islands,” Shadbolt recalled in a 2008 article in the Otago Daily Times. The pig’s food bill increased tenfold — an expenditure that whipped up a political storm in Invercargill, with councilors and constituents railing against what they characterized as a scandalous waste of public money. Shadbolt was unceremoniously stripped of his contingency fund.

The mayor, though, would be vindicated. These pigs from a previous century soon found an unlikely home in the futuristic world of xenotransplantation.

Globally, the demand for transplant organs is overwhelming. Every year, thousands of people die waiting for a new heart, liver, kidney, or lung that never arrives. In the United States alone, around 17 people on the organ waiting list die every day. For decades, xenotransplantation has been seen as a possibility to bridge this shortfall.

Since the 1960s, surgeons have transplanted chimpanzee and baboon parts into a small number of humans with life-threatening conditions, but these efforts have had little success. The biggest challenge is getting the human body’s immune system to accept the new organ.

The use of non-human primates for biomedical research is controversial, so over time, researchers looked to pigs. “Their organs, their tissues, and their physiology are sufficiently close to humans,” said Paul Tan, founder and CEO of New Zealand xenotransplantation research company NZeno. “Their cells function in a manner that is very close to humans. So their blood sugar levels and our blood sugar levels are pretty close.”

In the late 1980s, New Zealand pediatrician Bob Elliott and colleague David Collinson started a company called Diatranz to investigate whether pig islet cells could be used to treat Type-1 diabetes. For Collinson, the quest was personal. His son suffered from the disease.

Islet cells are found in the pancreas and produce insulin, but in Type-1 diabetes patients, are destroyed by the immune system. Trial transplants of human islet cells had met with mixed results, and in any case, with millions of Type-1 diabetes sufferers globally, there were nowhere near enough human donors to meet demand.

Diatranz aimed to surgically implant pig islet cells, encapsulated in a seaweed-derived polymer that shielded them from the human immune system, into the pancreases of diabetes patients. In the 1990s, though, the work stalled amid fears of disease.

Xenotransplantation, of both cells or organs, carries the risk of bacterial or viral infections crossing from the donor animal into humans. Pigs are not as closely related to humans as apes and baboons, a circumstance that makes transplanted pig parts less likely to spread disease to humans. Still, the risk persists.

While common diseases might be eliminated with medicines, a more serious risk was thought to come from viruses that essentially gatecrash the genetic material of the host animal. These are called retroviruses; they include HIV as well as viruses that cause certain cancers.

Some retroviruses, called endogenous retroviruses, have, in the deep past, even insinuated themselves into the DNA of sperm and egg cells — they are therefore part of the animal’s genetic makeup, replicated in every cell in the body and passed down through generations. There is currently no medication to eliminate retroviruses.

The concern was that pig tissues could secrete infectious particles of a porcine endogenous retrovirus, or PERV, which could then infect human cells to create a new, transmissible human disease. In the worst-case scenario, it was feared, such an event could trigger a global pandemic.

In the late 1990s, a London-based research team confirmed that, in a laboratory setting at least, PERVs could infect human cells.

The discovery, for a time, “killed xenotransplantation,” said Björn Petersen, a xenotransplantation researcher with the Friedrich Loeffler Institute, the German government’s animal-disease research center. “Pharmaceutical companies withdrew their money from the research.”

Around the world, the hunt was on for pigs that were as disease-free as possible.

In 1998, Diatranz partner Olga Garkavenko turned on her radio and got wind of Invercargill’s new arrivals. She decided to investigate.

The company obtained tissue samples from the quarantined pigs for analysis. The islands’ harsh conditions, it seemed, had been tough on disease.

“They remained isolated and therefore they remained free of a lot of common infections that you have in pigs,” said Tan. “The pigs that were weak were probably wiped out. Only the fittest survived.”

The pigs also have an unusually low number of retrovirus copies in their genome. Petersen noted that the population is also completely free of a type of PERV called PERV-C, which may pose the biggest risk to human transplant recipients. This was possible “because they were isolated for a long time and they never had contact with other pigs.”

Joachim Denner, a xenotransplantation researcher from the Free University of Berlin, said the Auckland Island pigs had another major advantage over other pig breeds — their small stature. At around 90 pounds in weight, he said, “they are the right size for transplantation.” A domestic pig weighs 300 to 700 pounds, and its organs, he added, are too large.

In 2004, Elliott, Tan, and others set up a company called Living Cell Technologies, or LCT, which absorbed Diatranz and took over the pigs’ care, building an expensive facility near Invercargill to keep them in medical-grade isolation while they were selectively bred for xenotransplantation.

The animals housed in quarantine were suddenly reputed to be worth hundreds of thousands of dollars each, much to then-Mayor Shadbolt’s barely-concealed glee.

The project brought jobs and millions of dollars of investment to Invercargill. “It has all come to fruition,” Shadbolt said in the 2008 Otago Daily Times article. “I rub it into those people who didn’t support me at every opportunity.”

By the 2010s, concerns around PERVs were lessening, as multiple clinical trials of cell transplants suggested not only that pig cells could be effective in treating diabetes, but also that PERVs weren’t passing to humans. New gene-editing technology also meant that retrovirus genes could be rendered non-functional before an animal was born.

With these advancements, the race to successfully implant pig organs in humans has gathered pace. Groups around the world now breed pigs for this purpose. It’s big business — a recent report estimated the global xenotransplantation market could be worth $24.5 billion by 2029.

In January 2022, a University of Maryland group, using a pig organ from the U.S. company Revivicor, conducted the first successful transplant of a pig heart into a living patient. The patient survived for two months. While the cause of his death is still being examined, evidence of a disease called porcine cytomegalovirus was found during the autopsy. The pig used in the transplant, said Tan, would have been rigorously screened for the virus, which, he added, shows the importance of breeding pigs that are genuinely free from such diseases.

Paul Tan now runs NZeno, which has taken over the breeding and keeping of the Auckland Island pigs. LCT, meanwhile, has switched its focus to Parkinson’s disease and recently began clinical trials of a treatment that involves inserting capsules containing pig brain cells into the human brain to repair nerve damage.

NZeno supplies pig cells to LCT and is also trying to establish itself as a major player in the organ game. “We like to think that our strain of pigs, derived from the Auckland Islands, further developed at Nzeno, would be the ideal pig strain for human organ xenotransplantation,” said Tan. Their cells, he noted, have already been used in humans for years, and have a very good track record of safety. The small number of retrovirus copies in the pigs’ genomes, he said, also require less gene editing compared to other breeds.

NZeno recently provided its pig cells to a team at Ludwig Maximilian University in Munich, which aims to have a genetically-modified pig ready for a pig-human heart transplant by 2025. NZeno is also working with another xenotransplantation group in China that aims to develop kidneys for transplant.

Petersen agreed that there is a solid rationale for minimizing gene editing. “The more genetic modifications you do,” he said, “the more side effects you can maybe expect.” But, he added, there may be cases in which it doesn’t make sense to prioritize the minimization of gene editing. For example, “if you want to have a universal donor” — an animal that can supply a variety of suitable organs or cells for human transplant — “then you need to have a pig with more genetic modifications right from the beginning.”

Denner said the Auckland Island pigs, which he describes as the most disease-free pigs in the world, may yet prove their true worth. But he cautioned against viewing them — or any pig — as a silver bullet. “All these studies have limitations,” he said. “The real effect of PERVs on humans, we will see when we perform the first transplants of organs.”

For now, wild Auckland Island pigs continue to run free in their storm-battered home, but the clock is ticking. Over the last five years, New Zealand’s Department of Conservation has been preparing for eradication.

Stephen Horn leads the team charged with this enormous task. Previous work attached GPS trackers to pigs, trying to learn their movements, and Horn’s team has trialed various methods of killing them. The plan is to wipe out the pigs using a combination of traps, poisoning, and hunters shooting from helicopters and on foot.

“The approach is really high intensity, as quickly as possible,” said Horn, “and try to keep the population as naive as possible.

“You need a suite of tools,” he continued, “because pigs are smart. Not every pig is going to be vulnerable to the same technique.”

Compounding the difficulty is the island’s size and isolation. It is several days’ dangerous sail from the mainland and, aside from a few uninhabitable hut shelters, the islands have no infrastructure to support human life. Once ashore, movement through the dense undergrowth and shoulder-high grasses is extraordinarily difficult.

“It’s rugged, remote, and massive,” said Horn. “It’s pretty overwhelming when you’re looking at it through a lens of animal pest control.”

Not everyone is thrilled at the prospect of the pigs’ demise. The animals are “very much part of our heritage,” said Willis of the Rare Breeds Conservation Society. The organization argues more effort should be made to preserve at least some of them. Perhaps the pigs could be fenced off, so as not to disrupt the entire island, said Willis. Or some could be relocated to another island, where they might not pose as much of a problem. As far as he is aware, however, these options are not being considered.

Paul Tan said he would also jump at the chance to retrieve more pigs.

The Department of Conservation, said Horn, has fielded inquiries about recovering pigs, but the logistics of retrieving them from the Auckland Islands, as well as the enormous costs involved in quarantine, are major hurdles to overcome.

Horn said that while staff are actively discussing options for retrieving pigs, their focus is eradication. With a plan in place, the department just needs to secure enough funding to make it happen, he said, “to undo some of the damage that was done by people, on what is an extremely fragile, but important place.”

Bill Morris is a documentary filmmaker, wildlife cameraman, and science journalist based in Dunedin, New Zealand. He is a regular contributor to New Zealand Geographic magazine and his work has also appeared on the BBC and Animal Planet.

This article was originally published on Undark. Read the original article.

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An early April 2023 decision by a U.S. district judge in Texas to reverse 23 years of approval of the abortion pill mifepristone has sparked explosive debate.

Mifepristone is a medicine that blocks the receptors for the hormone progesterone, which is needed for fetal development. It is part of a two-step medication abortion regimen along with misoprostol, a drug used to prevent stomach ulcers that also causes uterine contractions. Medication abortion with this two-step approach or a slightly less effective misoprostol-only regimen is now used in more than half of all abortions in the U.S.

The Food and Drug Administration approved mifepristone in the year 2000 for use in medication abortion up to seven weeks. Along with the approval, the FDA also required an in-person visit as an additional safety measure. In 2016 the FDA expanded its approval of mifepristone use for up to 10 weeks of pregnancy.

In January 2023, the FDA further modified its rules in light of many studies that show mifepristone is a very safe medication. It decided to not enforce the requirement for an in-person visit, allowing the drug to be offered by certified pharmacies with a prescription.

The Texas judgment by U.S. District Judge Matthew J. Kacsmaryk overturning the FDA’s approval would have taken this medication off the market altogether in the United States. The 5th U.S. Circuit Court of Appeals quickly responded, saying on April 12, 2023, that the plaintiffs could not challenge the original FDA approval of mifepristone because it is too late.

However, the 5th Circuit agreed with the plaintiffs that the FDA’s 2016 approval of mifepristone up to 10 weeks after pregnancy was invalid. In addition, drawing on an 1873 law, the Comstock Act, both the Texas district court and the appeals court said that mifepristone can no longer be sent through the mail.

In order to render these decisions, the Texas judge and the appellate court had to first determine that the groups that brought the case were harmed by the FDA’s original approval and thus had what is called, in legal terms, “standing” to be allowed to sue. The plaintiffs include a coalition of anti-abortion doctors’ associations that brought the lawsuit in Texas so that it would be assigned to this judge, who was an anti-abortion advocate before his judicial appointment.

This case, and another in which a federal judge from Washington made a different decision about mifepristone, are now headed to the Supreme Court. But regardless of how that court rules, we – a legal scholar and an academic obstetrician/gynecologist and complex family planning specialist – see multiple assertions about mifepristone in the decisions with potential ripple effects on reproductive health care and law.

Legal history paved the way

Both decisions stem from decades of judicial rulings that interpret medical science for legal ends. The 2022 Dobbs decision that overturned nearly 50 years of the constitutional right to an abortion opened the door for legal challenges to any and all abortions. Dobbs addressed medical care related to pregnancy and birth, but the case mainly focused on reinterpreting the legal history of abortion to justify overturning precedent.

While some states have further limited access to abortion in the wake of the Dobbs decision, they have not been able to successfully stop the distribution of medications that can induce abortions. In part, this is because both the FDA and the Department of Justice have allowed medication that induces abortion to be mailed from states where there are fewer legal restrictions.

The Texas case illustrates how judges apply their own reading of science to a thorny political question. Kacsmaryk’s reasoning echoes Justice Anthony Kennedy’s approach in a Supreme Court case known as the Carhart decision, which restricted doctors from performing a second-trimester abortion procedure.

In that 2007 case, Kennedy asserted that women experience psychological harms from having an abortion. Yet scientific studies show that the harm of denying an abortion and forcing women to birth are greater and longer lasting, with higher rates of death. Law influences public discourse, and these statements about psychological harms are now commonplace in anti-abortion communications. These arguments were central to the Texas judge’s critique of the FDA’s scientific process.

Assessing harms

Before asserting that the FDA’s scientific determination was inadequate, Kacsmaryk and the 5th Circuit appellate court had to decide whether the plaintiffs have standing to sue. The plaintiff doctors’ first standing argument includes the statement that they are harmed because they may, in the future, have to care for a woman who has an exceedingly rare complication from mifepristone prescribed by another doctor.

Potential harm does not align with long-standing principles related to judicial standing; the plaintiffs must show that the agency rule will harm them.

The decision on standing relies on a highly questionable interpretation of scientific evidence of harm. The 5th Circuit uses statistics about complications from medical abortions since 2000 to suggest that at least one doctor in the plaintiff’s associations, which they claim include approximately 8,200 medical professionals, will see a patient seeking emergency care for using mifepristone. Yet it cites no evidence – because there is none – that mifepristone alone causes complications. Further, it cites no evidence that access to mifepristone through the mail, or up to 10 weeks of pregnancy, increased the rate of complications.

The 5th Circuit that affirmed Kacsmaryk’s decision about standing claims this is a narrow decision about the harm to plaintiffs. The court said these doctors have standing because complications from medical abortion are statistically likely, that the FDA cut doctors out of the process of dispensing mifepristone, and that providing care to women who took mifepristone is emotionally draining for the doctors.

Flawed arguments

The Supreme Court has recently struggled to balance the overall impacts – burdens and benefits – of various regulations, such as student debt relief and immigration policies.

In this case, and using the doctors’ own theory of harm, there are actually numerous benefits that the plaintiff doctors receive from having mifepristone available to pregnant people in Texas. Those who cannot access mifepristone will have to either use less effective medication regimens or will be forced to get surgical abortions at later gestational ages. Delays means the fetus continues to grow, a fact about abortion access restrictions that deeply troubled Justice Kennedy.

All the risks associated with medical abortion – and therefore the time and resources doctors must spend caring for patients – will be higher if pregnant people are compelled to have surgical abortions or to give birth.

Judge Kacsmaryk frames the decision as one designed to protect women and girls, yet mifepristone is a drug that has more benefits than just safe abortion. It has been shown in numerous studies to help women safely treat an incomplete miscarriage and is now used off label for this purpose. Studies have also shown mifepristone to be helpful with labor induction, increasing the safety of the delivery process for someone who does continue with a pregnancy. Ongoing research into other applications for mifepristone may be interrupted by these judges’ decisions that limit the ways the drug can be used.

Finally, it is difficult to see how the FDA’s approvals of other medications are not vulnerable. For example, COVID-19 vaccines do not require an in-person doctor’s visit. Doctors who have been vocally opposed to the COVID-19 vaccine can easily find information to support arguments that they will have to care for vaccine injuries.

Doctors opposed to vaccines and other medications could also claim that it is too emotionally draining to treat patients who need their care – and therefore prevent other doctors who do not find it too emotionally draining from doing that important work for people who need medical care.

The legal and medical implications make clear just how much is at stake in these abortion-related decisions.

Jamie Rowen is an associate professor of legal studies and political science at UMass Amherst. Jamie Rowen receives funding from National Science Foundation and Humanity United. Tami S. Rowen is an associate professor of obstetrics, gynecology and gynecologic surgery at University of California, San Francisco.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Around 3,500 Americans ingest batteries every year, according to the National Capital Poison Center. It’s apparently such a perennial issue that there’s even a specific hotline number to call in the event of such an emergency (1-800-498-8666, just in case). And while it’s unlikely your wristwatch’s power source will ever be safe to eat, that doesn’t mean all batteries will remain inedible—in fact, some are being designed with digestion specifically in mind.

A team of researchers at the Italian Institute of Technology recently unveiled what is being billed as the world’s first fully rechargeable, edible battery. As detailed in a paper published with Advanced Materials, the new device utilizes riboflavin (often found in shiitake mushrooms) as its anode and quercetin (seen in capers) as the cathode. Activated charcoal amplified the electrical conductivity alongside a water-based electrolyte. Nori seaweed—most often seen in sushi—served as the short circuit prevention separator, while beeswax-encased electrodes and food-grade gold foil contacts also contributed to the design.

[Related: MasterChef inspired an edible medical sensor.]

“Edible electronic devices will have major implications for gastrointestinal tract monitoring, therapeutics, as well as rapid food quality monitoring,” reads the paper’s abstract, adding that although recent research proved the feasibility of edible sensors and circuits, “fully edible electronic devices edible power sources are [still] required, of which there have been very few examples.”

According to the team’s findings, their proof-of-concept battery was capable of producing 0.65 volts, which is safely low enough for the human body to handle. The ingestible could provide 48 μA of current for 12 minutes, or alternatively, a few microamps for over an hour. Such a power supply could provide enough energy for small electronics akin to edible pill-shaped modules and other gastrointestinal procedure alternatives. In a statement, researcher coordinator Mario Caironi explained that such a product could help power monitors for both human health conditions and food storage. Additionally, given their safety, more powerful iterations could be utilized within children’s toys, where ingestion risk is higher.

[Related: Watch this metallic material move like the T-1000 from ‘Terminator 2’.]

In the team’s statement, co-author Ivan Ilic also explained that despite the battery’s relatively low power, its digestibility provides a promising example of a battery that doesn’t use any toxic materials. “While our edible batteries won’t power electric cars, they are proof that batteries can be made from safer materials than current Li-ion batteries,” they said, adding that “We believe they will inspire other scientists to build safer batteries for a truly sustainable future.”

Moving forward, the team is already designing future iterations featuring greater capacities at smaller sizes in the hopes of soon powering edible, soft robots for use in medical procedures.

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Ghana is the first country to approve a malaria vaccine for young children, who have the highest risk of death from the disease. Some scientists have called the new vaccine a potential “game-changer” in the fight against the disease that is the leading cause of child death in Africa.

This new vaccine, called R21, has an efficacy rate of 77 percent, according to a September review in the journal The Lancet. One approved Malaria vaccine already exists, called Mosquirix, which has a 30 to 60 percent efficacy rate. 

Late stage testing is still underway in Burkina Faso, Kenya, Mali, and Tanzania. It’s unusual for a country to approve a vaccine before clinical trials are completed, according to WHO guidelines, and the World Health Organization has yet to approve it. 

Oxford researchers shared the mid-stage data with regulatory authorities in Ghana over the past six months and their new data suggests similar performance as in earlier trials, according to Oxford Professor and Chief investigator of the R21/Matrix-M programme, Adrian Hill. The results of R21’s final trials are expected to be published in the coming months. 

[Related: New four-dose malaria vaccine is up to 80 percent effective]

Oxford researchers shared the mid-stage data with regulatory authorities in Ghana over the past six months and their new data suggests similar performance as in earlier trials, according to Oxford Professor and Chief investigator of the R21/Matrix-M programme, Adrian Hill. The results of R21’s final trials are expected to be published in the coming months.

The R21 vaccine is designed to stop disease and death, not prevent transmission, although vaccines that prevent transmission between people are currently in the works at Oxford, Hill said in a press interview.

“The main idea now is to get R21 out there as soon as possible, and then add a transmission blocking vaccine,” Hill said. “That will allow us to use vaccination, not just for disease control, but for initial disease elimination, and then eventually global eradication.”

Ghana’s Food and Drug authority approved its use for children aged five months to three years, but rollout will be delayed until the WHO approves it. Once it is approved, Ghana’s drug regulator has a deal with the Serum Institute of India to produce up to 200 million doses of R21 a year. Each dose is expected to cost a couple dollars, per the BBC.

The mosquito-borne disease kills about 620,000 people globally each year, and 77 percent of those deaths are children. That translates to a death toll of over one thousand children each day, nearly one child lost per minute, according to UNICEF.

Malaria is a parasitic disease transmitted by mosquitoes, most often seen in tropical and subtropical climates. It is preventable and curable. Symptoms range from mild to life-threatening, including tissue inflammation in the brain, kidneys, and lungs. In extreme cases, leading to cerebral malaria, kidney failure, and acute respiratory distress syndrome. Children, pregnant women, and immunocompromised individuals are most at risk.

The parasite responsible for Malaria is the unicellular plasmodium. There are multiple plasmodium species known to cause the disease, each with its own unique characteristics. Unfortunately, the most common species in sub-saharan Africa, Plasmodium falciparum, is also the most deadly. 

Vaccinations are a relatively recent method of treatment for malaria. Since Mosquirix was introduced in 2019, 1.4 million children across Ghana, Kenya, and Malawi were vaccinated, resulting in a 10 percent drop in child mortality. A lack of funding and commercial potential has prevented drugmakers from producing adequate amounts of Mosquirix.

The release of the R21 vaccine “marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most,” Hill said in a statement.

There are multiple reasons why a Malaria vaccine is hard to develop—including the complex life cycles of the parasite and its ability to evade immune responses. 

However, the biggest barrier is not biological, it’s financial. Malaria is most prevalent in sub-saharan Africa, making up 95 percent of all malaria cases and 96 percent of malaria deaths. This region is also home to low-income countries, which have limited resources for research funding and vaccine development. 

[Related: White House invests $5 billion in new COVID vaccines and treatments as national emergency ends]

“Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood,” Adar Poonawalla, CEO of the Serum Institute of India, said in a press release statement. 

“We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” he said.

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This article originally appeared on KFF Health News.

ELKO, Nev. — Anger, devastation, and concern for her patients washed over Dr. Bridget Martinez as she learned that her residency training program in rural northeastern Nevada would be shuttered.

The doctor in training remembered telling one of her patients that, come July of this year, she would no longer be her physician. Martinez had been treating the patient for months at a local health care center for a variety of physical and psychiatric health issues.

“She was like, ‘I don’t know what I’m going to do,’” Martinez said. “It almost set her back, I would say, to square one. That’s so distressing to a patient.”

Martinez and three other resident physicians make up more than a third of the family practice providers at a health clinic in Elko, a city of about 20,000 people in the largely rural 500-mile stretch between Reno, Nevada, and Salt Lake City. Another patient cried and said she was unsure who her provider would be once Martinez returned to Reno to finish training.

Established in 2017, the rural family medicine training program in Elko is shutting down for a variety of reasons, including financial struggles, lack of a united support system, and a historical lack of health care investment in the area. Experts say systemic factors are common barriers to establishing and sustaining training programs for doctors throughout rural America.

More than 100 million people, or nearly one-third of the nation, have trouble accessing primary care, according to a recent study published by the National Association of Community Health Centers. This number has nearly doubled since 2014. The pandemic worsened provider shortages nationwide, but the problem is more acute in rural areas, which have long struggled to recruit and retain doctors and other medical professionals. Researchers say the relative lack of providers is one reason people living in rural areas experience worse health outcomes than people who live in urban areas.

Experts say expanding the number of medical residency training programs in rural areas is key to filling gaps in care because many doctors — including more than half of family medicine physicians — settle within 100 miles of where they train. And while the number of training programs has increased in rural areas during the past few years, research shows 98% of residencies nationwide are in urban areas.

Members of Congress have introduced several bills to address the health provider shortage, but they have not yet advanced.

Meanwhile, rural medical training programs need more state and federal investment to grow and remain sustainable, said Dr. Emily Hawes, associate professor at the University of North Carolina-Chapel Hill School of Medicine and deputy director with the federal Rural Residency Planning and Development Program.

There have been positive milestones, she said, including provisions in the Consolidated Appropriations Act of 2021 that created more flexibility in funding and accreditation for rural hospitals that want to establish residency programs.

Congress also created the Rural Residency Planning and Development Program, which Hawes helps lead. The initiative funded its first cohort in 2019. Since then, the program’s parent agency, the Health Resources and Services Administration, has given more than $43 million to 58 organizations in 32 states to launch rural medical residency programs. As of last fall, the recipients had created 32 accredited training programs in family medicine, internal medicine, psychiatry, and general surgery, and received approval for more than 400 new residency positions in rural areas.

But it’s still not enough, Hawes said.

For starters, the Centers for Medicare & Medicaid Services don’t reimburse rural hospitals for medical residency programs at the same rate they do urban hospitals, despite rural hospitals facing similar or higher costs. Rural hospitals’ lower patient volumes and higher rates of underinsured or uninsured patients affect how much the government pays to fund graduate medical education, or GME.

Hawes and other doctors argued in a research paper that rural hospitals participating in resident physician training should be paid the full cost of hosting residents, which amounts to at least $160,000 each annually.

The challenge of paying residents’ salaries proved to be part of the problem for the program in Elko.

Officials at Northeastern Nevada Regional Hospital decided, when they launched their residency program six years ago, not to use CMS funds to pay salaries and instead to pay those costs out-of-pocket. That amounted to about $500,000 a year, said Dr. Daniel Spogen, a professor in the Family and Community Medicine Department at the University of Nevada-Reno School of Medicine and director of the medical residency training program in Elko.

In retrospect, Spogen said, he wishes he and other faculty had pushed the hospital to pursue CMS funding, because it would have given the program a stronger financial foundation.

In a February press release, hospital officials said the decision to close the medical training program was difficult but necessary, because of rising costs and increased requirements.

In the end, the community and residents suffer the consequences, Spogen said.

Hawes said rural communities and their resident physicians often benefit mutually: Residents experience a more diverse and involved training than they would in a larger hospital, because having fewer residents and doctors means they can take on bigger tasks. Martinez recalled treating a gunshot wound in the emergency room, something she said she probably would not have gotten to do in a Reno hospital.

Closing any rural medical residency program ends a key opportunity to locate physicians in the areas where they’re most needed, said Hawes. Martinez and her husband, who is also finishing his medical training, had planned to stay in Elko. While that’s not off the table, she said, they’re keeping their options open now.

Spogen said people living in Elko will go back to relying on urgent care, which is not a substitute for primary care.

The nearest city with more health care resources, 230 miles away by car, is Salt Lake City. Spogen said the patients he treats through the program don’t have the financial resources to go elsewhere.

Rural medical training programs don’t have to end in struggle, Hawes said. Part of her job with the Rural Residency Planning and Development Program is to ensure faculty, residents, and hospital leaders have the resources, support, and knowledge they need to sustain their programs.

Spogen estimates that a resident physician brings in about $600 a day for the hospital where they train, resulting in roughly $190,000 in revenue per year.

Experts say when programs succeed, they grow quickly, like the Wisconsin Collaborative for Rural Graduate Medical Education, part of the Rural Wisconsin Health Cooperative. When the collaborative was established in 2012, there were 25 rural medical residency training positions in Wisconsin, said Lori Rodefeld, the group’s director of rural GME development and support. Last year, the collaborative supported 51 positions — more than double the number from 11 years ago.

In addition, 65% of residents have remained in rural medical practice, Rodefeld said, which is higher than the national average for physicians who did their residencies in rural areas.

“We’re very, very lucky,” Rodefeld said. “I don’t know of many other states that have this kind of model where they have technical assistance available to multiple existing programs and for those who want to get started.”

Martinez and her husband chose Elko to complete their medical residencies because they knew they could help fill a need.

“It’s almost intoxicating,” Martinez said. “You don’t want to walk away from something like that, especially when you feel so valued.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The national COVID-19 emergency is drawing to a close, which means certain treatments and tests that have previously been available without cost is soon to change. However, working on effective vaccines and therapies for COVID-19 is far from over. The federal government recently announced plans to spend over $5 billion in order to speed up new vaccines and treatments, according to a Department of Health and Human Services (HHS) spokesperson and a Biden administration official.

The plan, called Project NextGen, was first announced in the Washington Post on April 10 and aims to provide better protection from future coronaviruses that could become public health threats. It is the follow-up to the Trump Administration’s Operation Warp Speed, which sped up the production of COVID-19 vaccines in 2020. Project NextGen would take a similar approach by partnering public and private-sector organizations to accelerate development of different vaccines and therapies in an ever changing virus. 

[Related: Biden will end COVID-19 national emergencies in May. Here’s what that means.]

“It’s been very clear to us that the market on this is moving very slowly,” White House coronavirus coordinator Ashish Jha, the White House coronavirus coordinator, told the Post on April 10. “There’s a lot that the government can do, the administration can do, to speed up those tools … for the American people.”

According to Jha, Operation Next Gen will have three main goals: creating long-lasting monoclonal antibodies, speeding up the development of mucosal vaccines to possibly reduce transmission and infection risks, and speeding efforts to develop a universal coronavirus vaccine that protects against COVID-19 and other coronaviruses. 

Medical treatments for COVID-19 have lost effectiveness as the virus has continued to evolve. Even once-hailed “miracle” monoclonal antibodies are no longer effective in the face of the Omicron variant. 

“Our ability to develop … vaccines that generate mucosal immunity will have very large benefits for other respiratory pathogens we deal with all the time, like flu and RSV,” Jha said.

Mucosal vaccinations given in the nose can provide patients “sterilizing immunity” against the virus. Some of these types of vaccines are already in development around the world, with China and India rolling out the nasal vaccines, but it is not clear how well they are working. The ChAdOx1 vaccine failed to induce nasal immunity in a phase 1 trial late last year, but a nasal vaccine in Germany has shown some promise after experiments with hamsters. 

[Related: China approves world’s first nasal COVID-19 vaccine booster.]

Michael Osterholm, an epidemiologist who worked with the administration to develop the new program, told USA Today that the rapidly developed current vaccines are “really good, but they’re not great. There is a substantial amount of work [to be done] to take these good vaccines and hopefully achieve better vaccines,” he added.

Jha did not announce a timeline for when the new products will be available to the general public, but did note that it would be based on factors including drug manufacturer production plans and Food and Drug Administration (FDA) reviews. 

Previous vaccine funding requests have been repeatedly denied by Congress, with Republicans insisting that the Biden Administration use funds left over from previous pandemic aid packages. The White House directed HHS to free up $5 billion for Operation Next Gen and the agency responded by shifting funds from testing and other priorities. 

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A new report from the Centers for Disease Control and Prevention (CDC) reports that cases of infections from A Streptococcus (commonly called strep-a or strep throat) have surged this past winter. During the time period while most COVID-19 mitigations were still in place, cases dropped by about 25 percent, but now cases are above pre-pandemic levels. 

Across the US, the CDC report found that the most severe cases of invasive group A strep infections have been seen in children. Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security, told NPR that in an invasive strep infection, the bacteria has spread to other parts of the body instead of just staying in the throat. It can spread to the bloodstream, cause rashes on the skin, and even infect the body’s organs. 

[Related: Strep throat is figuring out how to beat our go-to antibiotics.]

The recent spike in strep throat cases coincides with a shortage of amoxicillin, an antibiotic commonly used to treat strep throat, especially in children. Rivers also recounted the difficulty her own family and patients have had finding the antibiotics needed to treat strep cases. “We had to visit several pharmacies to find the medication that we needed,” she tells NPR. “It just adds another burden on what’s already been a really difficult winter respiratory season for families.”

Health officials in Illinois warned parents in March to be vigilant, as five pediatric deaths were reported in the state. Illinois Department of Public Health Director Sameer Vohra warned that cases of strep throat infections that lead to severe complications were on the rise in the state “with more cases reported in 2023 than in any of the past five years.”

In October 2022, the Food and Drug Administration (FDA) added amoxicillin products to its list of drug shortages.  Some amoxicillin medications are still not widely available. The shortage is linked to the lack of liquid versions of products  that are easier for children to consume The shortage is affecting multiple generic brands, including Teva and Sandoz.

The current shortage appears to be a demand issue and not a quality issue. “Companies typically look to see what their sales were the prior year. They might make a little bit of an adjustment,” Erin Fox, a national expert on drug shortages at the University of Utah, told NPR. “But with the really severe respiratory season we’ve had this year, it just simply was a mismatch between what people manufactured and what was available.”

[Related: Tik Tokers are taking a diabetes drug to lose weight. Now it’s in short supply.]

Fox also added that while a popular strength of amoxicillin – 400 mg/5mL – isn’t always available, pharmacists have other options, like giving a lower dose at a greater volume. Shortages of many commonly used prescription medications, including adderall and some diabetes drugs, have been common throughout the United States over the past year. Increases in demand and supply chain issues being partially to blame. 

Strep throat cases are typically most common from December through April, however the pandemic has thrown seasonal infection cycles off their usual track. RSV surged especially early and severely in late summer and fall 2022 along with norovirus.

Some of the most common strep throat symptoms include pain, fever, swollen tonsils, and tiny spots at the roof of the mouth called petechiae. Infected patients should see a healthcare provider if the symptoms become serious, get worse, or if they do not go away after two weeks of initial treatment.

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Roughly one in six people (17.5 percent) around the world are affected by infertility, according to a new report from the World Health Organization (WHO). The report is described as a “first of its kind in a decade,” analyzing infertility data from 1990 through 2021. This  includes data from 133 previously published studies on the prevalence of infertility. 

Infertility is defined as not being able to conceive after one year or more of unprotected sex. The WHO called these new numbers “staggering.” Infertility affects both the male and female reproductive system and can cause significant emotional distress and financial hardship, and is still stigmatized and understudied.

[Related: These urologists are setting the record straight about penises and COVID.]

According to the Centers for Disease Control and Prevention (CDC), roughly one in five married women between 15 and 49 years of age experience infertility.

“The report reveals an important truth: infertility does not discriminate,” said WHO Director General Tedros Adhanom Ghebreyesus in a press release. “The sheer proportion of people affected shows the need to widen access to fertility care.”

The report found little variation in fertility rates across income levels in the new report. Higher-income countries experience infertility rates of roughly 18 percent and low- to medium-income countries see rates of close to 17 percent. 

The report, however, did find differences among how much money people are spending on treatments and how accessible they are. Those in the poorest countries spent a significantly larger proportion of their annual income on one single cycle of in vitro fertilization (IVF) or other fertility care compared to those in wealthier countries. IVF is becoming increasingly unaffordable in the US, and just one cycle of IVF can cost between $10,000 and $25,000, according to reporting from The Washington Post,

Additionally, there was limited data available for countries in Africa and across southern Asia, further emphasizing the unequal access to fertility care and the “persistent need” for better data collection methods in those regions.

While there was some regional variation in infertility at the regional level, the WHO said that the differences were either not substantial or conclusive. The highest lifetime prevalence was found in the Western Pacific (23.2 percent) and the lowest was in the Eastern Mediterranean (10.7 percent).  

[Related: Why birth rates are falling, and why it’s no big deal.]

The report did not determine whether the global infertility rate is increasing or decreasing. The WHO also noted that most of the studies used in this report contained estimates based on female respondents, despite infertility being a condition experienced by both sexes. According to the CDC, hormonal disorders, disruptions to ejaculatory or testicular functions, and genetic disorders may result in infertility in males. Lifestyle factors like smoking and excessive alcohol or drug use, age, and body weight can also undermine the ability to conceive in both sexes.

Asima Ahmad, an endocrinologist and fertility expert who serves as chief medical officer and co-founder of Carrot Fertility, told CNN that the new report shows more people need fertility coverage and access to high-quality healthcare, and that inequities need to be addressed.

“These inequities, I’m not surprised that they exist on a global level, because we already see the inequities in the United States domestically, with how infertility impacts different populations and how some populations have limited access. And even with the access that they finally get, they, for example, will have a lower rate of success or even a higher rate of miscarriage,” said Ahmad, who was not involved in the new WHO report.

Ahmad also cited a lack of access to “clinically vetted evidence-based information” about the causes of infertility and how to recognize and treat it and that access to employer-provided fertility benefits is also a significant barrier to care in the United States.

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IN 1989, Albert Wood and Peter Dunn thought they had unlocked a critical chemical door to treating hypertension and recurring chest pain. The two British Pfizer scientists reportedly created a new drug, named sildenafil, that reacts with a specific protein in muscle cells to allow for increased blood flow to the heart. 

But a few years later, human clinical trials revealed the drug was only effective when given multiple times a day and had a poor reaction with other existing cardiac treatments. What’s more, the blood rush was going to unexpected places in the body in addition to the heart. In one study, a nurse observed that most of the male volunteers were lying on their stomachs in embarrassment. The reason? Erections. Wood and Dunn had inadvertently stumbled upon the medicine that became Viagra. The small blue pill treats millions of people each year with erectile dysfunction, and further research suggests it may prove helpful for nonsexual problems such as pulmonary hypertension and altitude sickness.

Sidenafil is one of many prescriptions that treat multiple unrelated illnesses. How a drug becomes a medicinal Swiss Army knife depends on its chemical makeup. Each dose contains compounds that lock onto specific receptors, but that could also have the ability to create or suppress other reactions in the body.

“When somebody takes a medicine, it doesn’t necessarily go to the exact organ they are trying to target,” says Evelyn Huang, an emergency medicine resident physician at Northwestern Memorial Hospital. “The drug circulates through the entire body, so if there are certain receptors found in different parts, it would also affect that organ.” With sidenafil, the drug enlarges blood vessels generally and happens to prep the penis for action specifically. 

Another pill with the potential to tackle multiple conditions is mifepristone. This medicine is approved by the US Food and Drug Administration for medically induced abortions up to 70 days after a person’s last menstrual cycle starts. It works by blocking the effects of progesterone, which is needed to prepare and sustain pregnancy. (An ongoing lawsuit in a US district court in Texas could restrict its availability in pharmacies, doctor’s offices, and more.) Completely tamping down the hormone could also help prevent pancreatic cancer and melanomas, some early research shows. Additionally, at high doses, mifepristone aids in managing a condition called Cushing’s syndrome—characterized by extremely high levels of cortisol—by plugging the receptor that stimulates the production of sex and stress hormones. 

Dosage also matters in producing different drug responses. For example, barbiturates are a type of sedative prescribed in different amounts for a range of conditions from anxiety to seizures. This class of medications enhances the activity of GABA, a neurotransmitter that can slow down brain activity. At smaller doses, barbiturates can make someone feel drowsy and relaxed. But at higher amounts, they can be used as an anesthetic for rapid loss of consciousness. 

Because of the many ways a drug can affect the body, Huang warns against off-label use—taking a prescription for a condition other than the one it’s designed for. In any case, she recommends going over proper dosing, side effects, and other safety precautions with your healthcare provider. With more clinical and real-world research, it’s possible that off-label medications will be approved to target new health issues, producing formulas that pack more than one punch. Sidenafil, with its exciting possibilities, is at the top of that list.

Read more PopSci+ stories.

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On Wednesday, the United States Food and Drug Administration (FDA) approved an over-the-counter version of naloxone, an opioid overdose reversal drug. When administered quickly, naloxone reverses the effects of an opioid overdose by restoring normal breathing. It attaches to opioid receptors to reverse and block the effects of opioids and is most effective when used within minutes of the first signs of an overdose.

The FDA’s approval makes the drug sold under the brand name NARCAN the first opioid overdose reversal drug to be available without a prescription across the United States. The FDA says that it will be sold as a single dose administered as a nasal spray. The timeline for availability and price of this will be determined by the drug’s manufacturer, Emergent BioSolutions. NBC News reported today that the company said it likely won’t be widely available until late summer 2023 and that the over-the-counter (OTC) version will be packaged in a bigger box with detailed instructions and images for easy administration. 

[Related: FDA makes moves to expand life-saving Naloxone access.]

According to FDA officials, the drug could be sold in places like grocery stores, gas stations, online and even in vending machines. Increased availability will help prevent overdose deaths at an individual’s home. The price for a dose of the drug will be set by the manufacturer and has not been announced.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Robert Califf said in a statement. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.” 

The approval came just over a month after an FDA advisory committee unanimously recommended that the regulatory agency allow naloxone to be sold over the counter. Four months ago, the FDA also filed a Federal Register notice on the safety and efficacy of the drug. 

In 2014, an autoinjector containing naloxone was first approved by the FDA (Evzio) and a single-dose nasal spray (NARCAN) was green lit in 2015. A large study found that opioid overdose deaths decreased by 14 percent in states after they enacted naloxone access laws.

Up until now, naloxone has only been available as a prescription drug and, but could be purchased at certain pharmacies without a prescription in all 50 states. This is only because many states have created workarounds that help people get it directly from a pharmacist. One of the methods used is having one state health official write one prescription that can be used by every resident of that state. 

[Related: Walgreens’ and CVS’ roles in the opioid crisis may cost them billions.]

These workarounds can be confusing, and they do not apply to private harm reduction services that buy naloxone in bulk from pharmaceutical companies. Requirements and restrictions are placed on the buyers, such as having a physician sign for the order, but each doctor can only sign for an order for one such group. An address that is not a private home must also be provided. These are easy requirements for hospitals to fill, but not for smaller organizations working to prevent overdose deaths. The FDA’s guidance from September 2022 clarifies that naloxone manufacturers should be able to provide opioid-overdose antidote directly to harm-reduction organizations.

The opioid crisis was declared a public health emergency in 2017 and the Department of Health and Human Services has renewed the declaration every 90 days since. According to data from the Centers for Disease Control and Prevention, drug overdoses are a leading cause of accidental death in the US and killed over 107,000 people in 2021. Opioids were involved in more than 80,000 of those deaths. 

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Following its March meeting, the World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has revised their global COVID-19 vaccination recommendations. The new vaccine guidelines focus on group risk levels and are based on current conditions. These are subject to change as the pandemic and virus evolve. 

For high-risk and high-priority groups, SAGE recommends an additional booster dose of the COVID-19 vaccine six to 12 months after their last dose. This group includes immunocompromised people of any age, those roughly over 60 years-old, front-line health workers, and pregnant people six or 12 months after their last booster.

[Related: The FDA says get used to COVID-19 vaccine boosters.]

For medium risk individuals, like children and adolescents who have health risks, and healthy adults under about age 60, the group recommends the primary vaccination series and first booster doses, but not routine additional boosters.  

For the lowest-risk groups, SAGE recommends that countries vaccinate based on cost-effectiveness and disease burden. This group includes healthy children six months to 17 years-old. 

“The public health impact of vaccinating healthy children and adolescents is comparatively much lower than the established benefits of traditional essential vaccines for children – such as the rotavirus, measles, and pneumococcal conjugate vaccines,” SAGE wrote in a statement.

The new guidelines come as higher income countries are taking different approaches to future vaccinations. The United Kingdom and Canada are currently offering high-risk individuals another dose of bivalent boosters six months after their last dose.

Health officials in the United States are still weighing this option, but the new WHO advice contrasts with the Food and Drug Administration’s proposed plans to treat COVID-19 boosters like annual flu shots. In those plans, new formulas based on dominant circulating strains would be offered to ever fall, possibly regardless of risk status. 

“Countries should consider their specific context in deciding whether to continue vaccinating low risk groups, like healthy children and adolescents, while not compromising the routine vaccines that are so crucial for the health and well-being of this age group,” SAGE Chair Hanna Nohynek said in a statement.

The group also called for urgent global efforts to catch up on routine vaccinations for preventable diseases like measles, mumps, and tuberculosis that have been missed due to the pandemic.

[Related: A good night’s sleep could help vaccines work better.]

“As we all know, the COVID pandemic has taken a heavy toll on immunization programs,” said SAGE Chair Hanna Nohynek said on Tuesday, according to CNN. “It’s been a tremendous effort, and many countries have done very well reaching high coverages, but it is still requiring efforts to reduce the inequities, and we need to reach the high-priority groups, and we need to close the coverage gaps.”

Nohynek cited rising cases of measles in regions that the World Health Organization tracks. Measles is called a “tracer,” or a sign that other vaccine-preventable diseases are present. Polio is also already circulating in several countries, with new samples detected in New York’s wastewater. To combat this, SAGE recommends strengthening vaccine coverage and supplementing with a dose of injectable polio vaccine in places with  “persistent poliovirus circulation.”

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This article was originally featured on KHN.

Some adults who take prescription medication for attention-deficit/hyperactivity disorder are required to have their urine tested for drugs several times a year. Others never are tested.

Such screenings are designed to check if ADHD patients are safely taking their pills, such as Adderall, and not selling them, taking too many, or using other drugs.

Several doctors told KHN there are varying opinions and no national standards on the role of urine testing to monitor adults who take ADHD medication. So patients face dramatically different requirements, depending on their clinics’ and health insurers’ policies.

“There really isn’t much literature to guide you on how to do this,” said Dr. Margaret Chaplin, a Connecticut psychiatrist who treats patients with ADHD, mental illnesses, or substance use disorders.

Chaplin first noticed the lack of testing standards about eight years ago, when she and colleagues proposed ways to prevent stimulant misuse in adult ADHD patients.

Her team recommended urine tests only if patients exhibit “red-flag behavior,” such as appearing intoxicated, repeatedly reporting lost prescriptions, or frequently switching doctors. Some doctors and clinics make testing decisions on a patient-by-patient basis taking into account those red flags or patient history. Others apply universal policies, which may be aimed at preventing discrimination. Some insurance companies and state Medicaid systems also have testing requirements.

ADHD stimulants, opioid pain medications, and some other drugs are classified as controlled substances, which are tightly regulated because they can be addictive or misused.

ADHD patients subjected to frequent drug screens say the tests can be time-consuming and expensive. Some feel stigmatized.

A.C. Shilton felt relieved when she was diagnosed with ADHD in her mid-30s. The farmer and freelance journalist from rural Tennessee said the diagnosis explained why she felt so disorganized and forgetful, and as if her brain were a motor running all day. Shilton said her medication slows that motor down.

The 38-year-old Jamestown resident said her first doctor ordered urine tests once a year. That doctor eventually closed his practice, and Shilton said her next physician made her take a test at nearly every visit.

“You go in to get the standard of care, which is this medicine, and you’re kind of treated like you’re a bad person again; there’s some shame associated with that,” Shilton said.

She was also upset after learning office staffers were incorrect when they told her that urine testing was required by law — something that other ADHD patients posting on social media forums said had happened to them too.

Shilton said few doctors treat adult ADHD patients in her rural community. She now drives more than an hour to a different clinic, which doesn’t require her to take as many drug tests.

Travis Gordon, 47, of Charlotte, North Carolina, has gone to the same ADHD clinic for more than 10 years. Gordon said he wasn’t drug-tested in the first few years. Then, for several years, he had to give a urine sample every three months. During much of the covid-19 pandemic, he wasn’t tested. Now, he’s screened every six months.

“We shouldn’t have to feel like street criminals to get drugs that are needed for our daily success,” Gordon said.

Gordon said it would make sense for doctors to order tests more frequently as they get to know new patients. But he said he doesn’t understand why such testing should continue for people like him, established patients who properly take their medication.

Traci Camper, 50, of northeastern Tennessee, said she has “never even tried a cigarette,” much less used illicit drugs, but her doctor has required urine tests every three months for more than 10 years. Camper said the process can be inconvenient but she’s ultimately OK with the tests, especially since she lives in an area with high rates of drug abuse.

The clinics that Shilton, Gordon, and Camper went to did not respond to KHN’s requests for interviews about their testing policies.

Adults are diagnosed with ADHD if they have multiple, frequent symptoms so severe they interfere with work, relationships, or other aspects of life. Treatments include therapy and medication, most often stimulants.

ADHD patients have been affected by the response to the opioid crisis, which has led to more scrutiny for all controlled medications. Some have reported trouble filling their prescriptions as drug distribution companies limit sales to certain pharmacies. Some patients, especially rural ones, could face obstacles if the federal government reverts to pre-pandemic rules that require at least one in-person appointment to receive controlled drugs via telehealth.

Chaplin said doctors who treat ADHD may feel the need to be extra vigilant with drug testing because of this increased scrutiny, or due to the risk of misuse.

An estimated 3.7 million Americans 12 or older misused prescription stimulants in 2021, and 1.5 million had a prescription stimulant use disorder, according to the National Survey on Drug Use and Health. Americans are more likely to misuse or be addicted to prescription opioids, sedatives, and tranquilizers, the agency said.

Adults with ADHD are more likely to have a substance use disorder than those without the condition, according to the Substance Abuse and Mental Health Services Administration.

Although there aren’t formal standards, several health care organizations and professionals have made recommendations to prevent and detect adult ADHD stimulant misuse. Suggestions include requiring patients to sign prescription-agreement contracts and regularly checking databases that show all controlled medications each patient is buying.

Chaplin said there’s little research into how effective any method is at preventing medication misuse.

A recent survey found that 42% of family physicians and 21% of college health professionals who treat adult ADHD require their patients to submit random urine drug screens.

Gordon, Camper, and some ADHD patients on social media forums said their drug screens have come at predictable intervals, instead of random ones.

Dr. Sidarth Wakhlu, a psychiatrist who specializes in treating substance use disorders at the University of Texas Southwestern Medical Center in Dallas, said some of his patients also have ADHD. He suggests drug-testing most ADHD patients once or twice a year. For “someone who has no addiction history, has no red flags, every three months is an overkill,” he said.

The cost of drug testing is as variable as the frequency.

For example, Dr. Michael Fingerhood at Johns Hopkins University uses urine tests that cost as little as $60 before insurance. Fingerhood makes testing decisions case by case for patients who take controlled substances to treat ADHD, pain, or opioid addiction.

Gordon used to pay $110 for each of his tests when he had insurance his doctor did not accept. Shilton’s insurance was billed $545 for a test. Shilton said she complained to a nurse who said, in the future, she could use a less expensive test.

Shilton said she replied, “Well, why aren’t we doing that to begin with? Why are we doing this extremely fancy drug testing?”

Wakhlu said the more expensive urine tests can identify specific types and quantities of drugs. Such tests are usually used to confirm the results of initial, less pricey tests, according to the Centers for Disease Control and Prevention.

Wakhlu said that when test results show a patient might be misusing stimulants, doctors should initiate a non-accusatory conversation to discuss the results and, if needed, offer help. He also said it’s important to emphasize safety, such as how taking too much ADHD medication or combining it with other stimulants, such as methamphetamine, can be dangerous.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The Health Resources and Services Administration (HRSA) recently announced plans to overhaul the country’s Organ Procurement and Transplantation Network (OPTN). The changes include better and more transparent data,  modernizing the entire system, providing more funding for organ procurement and transplantation, and even breaking up the monopoly power of the United Network for Organ Sharing. The nonprofit organization has run the system for the entire US for 37 years.

The United Network for Organ Sharing has been under contract with the federal government for decades and coordinates matching candidates with donated organs. The nonprofit holds a $6.5 million annual contract with HRSA, and has faced numerous problems such as  discarding or damaging too many organs during transit, as well as using faulty technology.

[Related: Who gets an organ transplant? Waitlist rules are complicated.]

The Biden Administration states that they hope these changes will encourage competition in a system that has effectively operated as a monopoly for decades, thereby improving  outcomes. For years, patients and families have said that the system lacks oversight, efficiency, and discriminates against people of color. Black Americans were four times more likely to have kidney failure than white patients and Latinx Americans were 1.3 times more likely than white peers, according to the results of a public comment period by the Health and Human Services Department. Despite the increased risk, Black and Latinx patients on dialysis are less likely to get on organ donation lists and receive transplants.

Additionally, a 2022 report by the National Academies of Sciences, Engineering, and Medicine called the system “demonstrably inequitable” and found that one in five donated kidneys is not used. 

Federal government data shows that more than 100,000 people in the US are awaiting organ transplants, and about 6,000 Americans per year die while waiting for lifesaving organs. 

“Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network to save the lives of their loved ones who experience organ failure,” HRSA Administrator Carole Johnson said in a press release. “At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less.”

In response, the United Network for Organ Sharing said that it supports HRSA’s plan and that numerous components of the plan also align with the organizations new action agenda published in January 2023. 

[Related: Space might be the perfect place to grow human organs.]

The federal proposal would also change the entire network’s structure,installing a board of directors that is independent of the United Network for Organ Sharing to bring more transparency. 

The Biden administration has committed $67 million (nearly double the current budget) towards modernizing the transplant network in its proposed fiscal budget for 2024.

The overhaul received early bipartisan support from Congress, including Sen. Charles E. Grassley (R-IA) saying and Sen. Elizabeth Warren (D-MA).

Richard Gilroy, a transplant hepatologist and Intermountain Health’s liver transplant medical director, welcomed the new guidelines in an email to PopSci, but stressed that the proposal brought up more questions, namely if a new system can fix issues and immediately manage the complexities of organ donation.

“If appropriately listed for a transplant, patients either get a transplant or they die. For liver transplants, the very sickest patients are the first on the allocation run,” said Gilroy. “But with that, the sickest patients also need to be well enough to survive post-transplant. A lot of people die or are removed from the list before they get a chance at a transplant.”

Gilroy added that the current policy has created waste and diminished efficiency in organ placement and increased costs overall, which harms outcomes across the board. 

“As physicians, we strive to help all patients and want everyone to get a life-saving opportunity. Increasing the number of donors is critical to that goal,” said Gilroy. “However, a process that ensures equity in access to a waiting list is more important (big cities list more people and have advantages over residents of smaller remote towns that list less). Healthcare equity is needed now.”

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This year, the Great Plains, Florida, and the Carolinas are expected to be the worst areas of the US for people with allergies, according to a report by the nonprofit Asthma and Allergy Foundation of America. Outside these regions, Scranton, Pennsylvania, made the list at No. 3, and Rochester, New York, at No. 20. But as anyone with allergies knows—you can suffer anywhere.

Fortunately, there are several kinds of allergy medications that can tame symptoms. But, it’s important to know the differences among the many options to find out when and how long you should take them. Allergy experts have a few tips to keep in mind while bracing for the start of allergy season. 

There are two main categories of antihistamines, says Eric Macy, an allergist-immunologist at Kaiser Permanente in San Diego. In addition to their allergy-fighting effects, “first-generation” antihistamines such as Benadryl can cause drowsiness and coordination problems. They belong to a class of drugs called anticholinergics whose long-term use may increase the risk of dementia.

[Related: Does taking allergy medication make my allergies worse?]

“The first-generation antihistamines have more cognitive or brain-related effects than the second generation do, so it’s not wise to take that every day,” says Sai R. Nimmagadda, an allergist-immunologist at Northwestern University Feinberg School of Medicine and Lurie Children’s Hospital of Chicago. 

Newer “second-generation” antihistamines including Claritin, Zyrtec, and Allegra are generally safe to use regularly. However, Nimmagadda says, some people find that a given antihistamine becomes less effective over time. Rather than increasing the dose, he recommends switching to a different antihistamine. “I tell my patients to alternate the antihistamine therapies every three to six months if they find they have become tolerant to a particular medication,” Nimmagadda says.

Start using nasal spray before the pollen onslaught

Antihistamines are very effective against sneezing, itchy eyes, runny noses, and hives, but they don’t help very much with congestion, Macy says. However, corticosteroid nasal sprays like Flonase treat stuffiness as well as other allergy symptoms. They contain lab-made versions of naturally occuring hormones that calm inflammation.

Corticosteroids can be used daily without losing their edge, Nimmagadda says. “The only thing is that with intranasal steroids it’s important to start them early in the season,” he says. 

If you wait until your immune system goes to work against that dreaded pollen and your symptoms flare up, corticosteroids won’t work as well. Nimmagadda likens it to fighting a blaze before it gets out of hand. “If you have a small fire, it’s easier to put out with a garden hose,” he says. “If you have a large fire, when you try to use a garden hose it’s not going to work very well.”

An even simpler remedy is to use saline (aka salt water) washes to flush mucus and debris from your nasal passages. These solutions can be purchased at the pharmacy or made at home—and using them will likely cut down on the amount of allergy medications you need to keep your symptoms in check, Nimmagadda says.

“The cheapest and best treatment you can do is to wash your nose of all the pollen allergens every morning and night,” he says. “One of the mainstays of my treatment regimens is the saline rinses.” 

[Related: How to tell seasonal allergies from COVID-19 symptoms]

Another thing to keep in mind, Macy says, is that if you’re experiencing congestion and sinus pressure without other symptoms like itching and sneezing, it’s probably not caused by allergies. Other treatable conditions including migraines, infections, and nasal polyps, may actually be to blame. 

Check in with your doctor

If you’re dealing with nasal symptoms year-round, Macy advises, it’s a good idea to visit a doctor and discuss more effective treatment options.

“Basically it comes down to: See an allergist, figure out what the cause of the problem is, and get it dealt with [rather] than taking antihistamines to paint over rust,” he says. 

Immunotherapy treatments—allergy shots and drops—decrease a person’s sensitivity to pollen, dust mites, and other irritants. They work by exposing the immune system to gradually increasing doses of the allergen and can provide long-term relief, Nimmagadda says. 

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Swifties, Jerry Garcia’s Deadheads, and Beyoncé’s BeyHive have nothing on Symphony No. 5 in C Minor composer Ludwig van Beethoven’s fandom. The composer is considered one of the most influential musicians of all time and he defied the onset of deafness in his mid-20s and went on to compose 722 works of music, including 16 string quartets, 35 piano sonatas, and 9 symphonies.

Thanks to locks of hair saved by his devoted fans and collaborators, a team of researchers have analyzed his DNA to learn more about the composer’s ailments, almost 200 years after his death. The research is detailed in a study published this week in the journal Current Biology.

Starting at the end of the 1790s, Beethoven started losing his hearing for unknown reasons. In 1802, 25 years before his death, Beethoven asked that his doctor describe his progressive hearing loss to the world so that “as far as possible at least the world will be reconciled to me after my death.” He was also plagued with gastrointestinal ailments and jaundice. 

[Related: Oldest DNA ever sampled paints a lush portrait of a lost Arctic world.]

Beethoven’s desire for a postmortem description of his illness inspired a team of scientists in Europe to pursue this study. Improvements in DNA analysis enabled them to completely sequence a genome from small quantities of very old hair. 

“Our primary goal was to shed light on Beethoven’s health problems, which famously include progressive hearing loss, beginning in his mid- to late-20s and eventually leading to him being functionally deaf by 1818,” said study co-author Johannes Krause from the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, in a statement. 

Saving locks of hair of the deceased was a common mourning practice in the Nineteenth Century. In 1804, Treasury Secretary Alexander Hamilton was famously killed in a duel with his political rival Aaron Burr and his wife Eliza clipped a lock of her late husband Alexander Hamilton’s hair and kept it in a ring. 

The team on this study first analyzed the locks of hair attributed to Beethoven, soon finding five others that were confirmed to come from the same European male. They deemed that the five locks were “almost certainly authentic” and then sequenced the composer’s Beethoven’s genome.

While the team was unable to find a definitive cause for the musician’s gastrointestinal problems or deafness, they did find evidence of a hepatitis B infection and a number of significant genetic risk factors for liver disease. These factors together with his overconsumption of alcohol likely contributed to his death at the age of 56. Earlier medical biographers had suggested that Beethoven may have had substantial inherited health troubles, but they did not find any evidence of this in his genome. 

[Related: Autopsies are more important than ever. Here’s what they can tell us.]

They also uncovered another surprise locked within the composer’s DNA. Beethoven’s Y chromosome does not match the Y chromosome of any of the five living relatives who share the same last name and common ancestor on Beethoven’s paternal line. There likely was an extramarital “event” on Beethoven’s father’s side.

“This finding suggests an extrapair paternity event in his paternal line between the conception of Hendrik van Beethoven in Kampenhout, Belgium in c.1572 and the conception of Ludwig van Beethoven seven generations later in 1770, in Bonn, Germany,” said study co-author Tristan Begg, now at the University of Cambridge, in a statement. 

The DNA they found in Beethoven’s hair is genetically most similar to that of people living in the present day state of North Rhine-Westphalia, in the western Germany. 

Additional studies of the hair samples may help clarify when Beethoven was infected with hepatitis B. Further studies of his close relatives might also help to clarify his biological relationship to living descendants of the Beethoven family.

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New research from the University of Oxford in the United Kingdom found that while all hormone contraceptives carry a small “excess” risk of breast cancer, the overall risk remains low. 

The study was published March 21 in the journal PLOS Medicine and filled in research gaps on links between breast cancer and progestagen-only contraceptives. Progestagen-only contraceptives include birth control implants, intrauterine devices (IUD), contraceptive injections, and the minipill. Other kinds of hormonal birth control contain a combination of estrogen and progestagen and include the traditional birth control pill and patch. 

[Related: Where is all the hormone-free birth control?]

Importantly, the new study does not say that hormonal contraceptives cause breast cancer. It only investigated any potential links to the disease that affects about 264,000 women and 2,400  men every year. 

“Given that the underlying risk of breast cancer increases with advancing age, the absolute excess risk associated with use of either type of oral contraceptive will be smaller in women who use it at younger rather than at older ages,” the authors wrote in a statement.“These excess risks must, however, be viewed in the context of the well-established benefits of contraceptive use in women’s reproductive years.”

The study included data on roughly 10,000 women in the UK under age 50 who were diagnosed with invasive breast cancer between 1996 and 2017. They also looked at more than 18,000 subjects who did not have breast cancer. 

They found a relative increase of 20 to 30 percent in breast cancer risk with combined birth control (which also contain estrogen in addition to progestagen) and progestagen-only contraceptives. However, after five years of use, the 15-year absolute excess incidence of breast cancer was only 265 cases per 100,000 users at most. Earlier studies show that this excess risk disappears entirely about 10 years after stopping hormonal birth control. 

“These findings suggest that current or recent use of all types of progestagen-only contraceptives is associated with a slight increase in breast cancer risk, similar to that associated with use of combined oral contraceptives,” said co-author and cancer epidemiologist Kirstin Pirie, in a statement. 

The overall risk of breast cancer in hormonal contraceptive uses is low, particularly for younger users. Additionally, the team pointed to a lack of both a complete prescription history and family breast cancer history of the women as some of the limitations in this study.

[Related: Over-the-counter birth control pills could change reproductive care in the US.]

Progestogens, or progestin, are drugs that mimic a natural hormone called progesterone, which is crucial for both menstruation and pregnancy. Progestagen-only birth control options do not contain estrogen the way that combined hormone birth control pills do. They prevent pregnancy by thickening mucus in the cervix, which stops sperm from reaching an egg. It can also completely stop ovulation in some cases.  

According to the Centers for Disease Control and Prevention (CDC), the combined hormone birth control pill is the most popular form of hormonal contraception. More people have been choosing to use the IUD or an implant over the pill for at least a decade.

Claire Knight of Cancer Research UK, who funded this study, told The Guardian that this should not discourage women from taking birth control pills. “Women who are most likely to be using contraception are under the age of 50, where the risk of breast cancer is even lower,” Knight said. “For anyone looking to lower their cancer risk, not smoking, eating a healthy balanced diet, drinking less alcohol, and keeping a healthy weight will have the most impact.”

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We aren’t in an apocalyptic The Last of Us scenario, but there’s still plenty of fungus to be wary of. The Centers for Disease Control and Prevention (CDC) announced on March 20 that a deadly and highly drug resistant fungus is spreading at “an alarming rate” in nursing homes, long-term care hospitals, and other medical facilities that treat very sick patients.

Data from the CDC shows that infections from Candida auris (C. auris) tripled nationally from 476 infections in 2019 to 1,471 in 2021. Additionally, cases where a person carries the fungus but is not infected almost quadrupled from 1,077 in 2019 to 4,040 in 2021. Their early data suggests that these numbers have continued to increase. The CDC’s findings were published in a paper in the Annals of Internal Medicine on March 21. 

[Related: The deadly combination behind the surge of ‘superbug’ fungus outbreaks.]

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” Meghan Lyman, a CDC epidemiologist and co-author of the new paper, said in a press release.

The fungus primarily affects older patients with weakened immune systems. However, the fungus is resistant to some common antifungal medications, making it particularly dangerous.  A 2020 report found that 86 percent of the germ samples tested by the CDC were resistant to a broad class of drugs known as Azoles. Additionally, 1.3 percent of C. auris samples were resistant to echinocandins. These drugs are often the first treatment against the fungus, and if resistance grows as the germ evolves, C. auris could become extremely difficult to treat. 

C. auris was first reported in the United States in 2016 and public health officials hoped that it could be contained (primarily in Illinois and New York) through intensive screening and infection control in healthcare settings.

Now, C. auris can now be found in half of the 50 states, with higher concentrations in California, Texas, Florida, and Nevada. The strain on healthcare systems due to the COVID-19 pandemic may have also worsened the spread of the fungus.

According to the CDC, case counts may have increased due to enhanced screening efforts, including colonization screening. This is a test to see if a patient has the fungus somewhere inside of their body, but does not have the symptoms of infection. Symptoms include chills and fever that intensify without treatment, which are common to other fungal infections. 

While scientists believe that C. auris is not a threat to those with immune systems that can fight it off, it poses a danger to medically fragile individuals, including patients on ventilators, cancer patients on chemotherapy, and nursing home patients. It forms in medical equipment and is estimated to be fatal in between 30 to 70 percent of hospitalized people who develop bloodstream infections.

[Related: A killer fungus could help the US South fight back against insatiable ants.]

Robust cleaning of medical supplies and screening will be needed to help stop the spread since it tends to cling to protective gear like nursing gowns and gloves. These items should be changed frequently, but were reused due to supply shortages brought on by the pandemic. It can also attach to medical equipment like ventilators.

“If [the fungi] get into a hospital, they are very difficult to control and get out.” William Schaffner, a professor of medicine in the infectious diseases division of Vanderbilt University Medical Center, told The Washington Post,“They can persist, smoldering, causing infections for a considerable period of time despite the best efforts of the infection control team and everyone else in the hospital.”

However, it’s not a hopeless situation, Lyman told The New York Times. She cited intensive efforts by Illinois and New York to stop the spread that appear to be effective within health care settings.

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Using microscopes to observe living things has been one of the most powerful ways to understand how biology works, at least since Dutch naturalist Antonie van Leeuwenhoek first zoomed in on bacteria in the 1600s. Today, high-magnification images can help design new medical tools, enrich our understanding of diseases, and explain how embryos develop. And, as shown by the 2023 winners from the MIT Koch Institute Image Awards, they can be works of art, too.

The above image shows Arabidopsis thaliana pollen with proteins removed from their nuclear lamina, a membrane of dense filaments that provides structure to cells. Humans who lack lamina (a mutation seen in some skeletal and muscular conditions) generally cannot survive for more than 20 years, according to the biologists at MIT’s Whitehead Institute and the Koch Institute who took this image. They stuck the grains to carbon tape and imaged them with a Zeiss Crossbeam microscope. Without these proteins, pollen also appear misshapen—underscoring the importance of this meshwork for plants as well.

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Feeling sleepy after getting a flu or COVID-19 vaccine? Go ahead and hit the hay. New research shows that getting a good night’s sleep around the time of your shots could be a boost for immunization. 

A review published in the journal Current Biology on March 13 found that adults who got less than six hours of sleep a night tended to produce fewer antibodies than those who got at least seven hours of sleep. The difference was on par with the decrease in antibodies two months after a brand new COVID jab. The authors didn’t specifically find data for the COVID shots, however—they combined and analyzed seven studies on influenza and hepatitis vaccinations to draw a broader conclusion on how rest benefits people’s immunity. 

[Related: The FDA says get used to COVID-19 vaccine boosters.]

The studies in the review looked at shut-eye in a number of different ways: motion-detecting wristwatches, directly measuring sleep in a lab, or self-reported sleep. The authors only found an association between vaccine strength and sleep in the studies that tracked sleep with devices or in the lab. The duration of self-reported sleep didn’t seem to affect the level of antibodies, probably because survey data is often inaccurate. 

All in all, those who consistently slept for seven or more hours had higher levels of antibodies. There is a big caveat here, though: The effect was only significant in men, and much more variable in women. “We know from immunology studies that sex hormones influence the immune system,” coauthor Karine Spiegel, a research scientist at the French National Institute of Health and Medicine, said in a press release. “In women, immunity is influenced by the state of the menstrual cycle, the use of contraceptives, and by menopause and postmenopausal status, but unfortunately, none of the studies that we summarized had any data about sex hormone levels.”

Additionally, the negative impact of poor sleep on antibodies was mostly prevalent in 18- to 60-year-olds rather. Older populations, however, tend to get less sleep in general. 

[Related: What to know about polio boosters, oral vaccines, and your medical history records.]

“When you see the variability in protection provided by the COVID-19 vaccines—people who have pre-existing conditions are less protected, men are less protected than women, and obese people are less protected than people who don’t have obesity,” Eve Van Cauter, professor emeritus of medicine at UChicago and senior author, said in a press release. “Those are all factors that an individual person has no control over, but you can modify your sleep.

Getting a good night’s sleep is beneficial for many reasons—from cardiac health to maintaining a balanced weight to keeping mental health in check. And unlike many other maladies, it’s something most individuals can change directly. So resting up before and after your next trip to the doctor or vaccine clinic is probably not a bad idea. 

“The link between sleep and vaccine effectiveness could be a major concern for people with irregular work schedules, especially for shift workers who typically have reduced sleep duration,” Van Cauter added. “This is something people should consider planning around, to ensure that they are getting enough sleep in the week before and after their vaccines.”

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A customizable medical implant surgically inserted into patients to alleviate chronic pain was allegedly nothing more than a “dummy component” of inert, useless plastic, according to new legal filings from the FBI.

Medical startup Stimwave touted its StimQ Peripheral Nerve Stimulator (PNS) device as an effective, safe, minimally invasive alternative for patients suffering from chronic pain. In a surgical procedure, doctors implanted the device next to problematic nerve areas near the spinal cord via a cannula, according to past descriptions of the procedure.  A PNS delivered tiny electrical pulses powered by a small wearable patch adhered to a user’s shirt, which supposedly enabled the brain to “remap specific pain signals” as described by the FBI. The implant was approved for use by the FDA in March 2017.

[Related: The Theranos trial exposes issues with FDA review.]

“You know you are making a positive impact on people’s lives when some of these people call you up and say, ‘You know, I was going to kill myself before this,'” Laura Tyler Perryman, Stimwave CEO, co-founder, and co-inventor, told Engadget two months after FDA approval. “We had one the other day, someone who had facial pain for 15 years, was bedridden. This person said their pain was zero after receiving our system.”

Soon after approval, however, the FBI reports some doctors began complaining that the PNS device’s approximately 23-centimeter implantable “Pink Stylet” receiver component could not fit in certain regions of patients’ bodies. According to the agency’s timeline, to maintain financial viability, the company introduced a “White Stylet” variant not long after its initial Pink Stylet approval. This alternative could be cut to a desired length before insertion into the body, but in actuality, cutting the implant would render it useless, the FBI reports.

For years, medical professionals continued to suggest Stimwave’s roughly $16,000 products were a possible solution to their chronic pain. According to the FBI, Perryman herself oversaw training for doctors in which she referred to the White Stylet as a “receiver” for the wearable patches’ electrical charges, despite it containing no conductive component. Stimwave continued charging doctors and medical professionals for the device, according to the FBI, which insurance providers—including Medicare—would then reimburse.

[Related: A little known form of medical pollution is costing Puerto Ricans their health.]

Federal officials are charging Perryman with conspiracy to commit wire fraud and health care fraud. In their statement, the FBI also revealed Stimwave filed for bankruptcy in June 2022, a legal move that remained under seal pending the ongoing federal investigations. Stimwave representatives have admitted to wrongdoing, and are entering into a non-prosecution agreement requiring a $10 million fine. 

“As a result of her illegal actions, not only did patients undergo unnecessary implanting procedures, but Medicare was defrauded of millions of dollars,” FBI Assistant Director Michael J. Driscoll said in their press release. Perryman could face as much as 20 years in prison if convicted.

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For the roughly 94 million Americans with high cholesterol, 90 percent are prescribed a class of drugs called statins. These drugs help lower low-density lipoprotein (LDL)—commonly called the “bad” cholesterol—in the blood, but can trigger muscle pain, increase blood sugar or occurence of type 2 diabetes, and occasionally cause liver damage or neurological issues. An estimated 10 to 30 percent of patients stop taking them due to these unwanted side effects.  

However, a different medication already used around the world might be a solid alternative for those who can’t take statins. A large study published on March 4 in the New England Journal of Medicine found that bempedoic acid can lower LDL levels by 21.7 percent.

[Related: A super-sharp gene editing tool could tackle high cholesterol and other common ailments.]

While statins are considered both safe and effective, they don’t work for everyone. In 2020 the Food and Drug Administration approved bempedoic acid—sold under the brand name Nexletol—to treat patients who can’t or won’t take statins. There was a lack of data from randomized controlled trials on the drug’s effects on heart health, despite studies showing it could lower LDL by 17 to 28 percent. The new research was funded in part by Esperion Therapeutics, the Michigan-based maker of Nexletol.

Bempedoic acid works by drawing cholesterol out of the waxy plaque that can build up in artery walls and interfere with blood flow, the same way that statins do. Too much plaque buildup can lead to strokes and heart attacks. According to the authors, bempedoic acid is activated in the liver and not the muscles, so it is unlikely to cause musculoskeletal pain the way statins can. 

The study included 13,970 patients from 32 countries with an average age of 65 years old. Every participant had experienced musculoskeletal adverse effects from statins, and required alternative treatment. There were roughly the same number of men and women in the trial, but 91 percent were white and 17 percent were Hispanic or Latinx.

The participants were randomized into two groups: one took bempedoic acid and the other was given a placebo. The researchers followed up with the patients for up to five years and found that the drug was well-tolerated and reduced LDL cholesterol by 21.7 percent compared with the placebo. Additionally, the risk of cardiovascular events was 13 percent lower with bempedoic acid over a median of 3.4 years compared with the placebo. By comparison, some statins can lower LDL levels by as much as 50 percent.

According to the authors, the drug worked in patients who’d previously experienced a cardiovascular event or were at risk of a first event. The study also included multiple diabetics, and did not observe any blood-sugar increases from the treatment. There were a few more cases of gout and gallstones in the group that took bempedoic acid than in the placebo group, but one of the authors told CNN that lowering the risk of a heart attack outweighs a possible gout attack.

[Related: Millions of Americans take aspirin to prevent heart disease—but should they?]

In an editorial accompanying the study, John H. Alexander, the director of cardiovascular research at Duke Clinical Research Institute, wrote, “The benefits of bempedoic acid are now clearer. It is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events.”

However, proving that a medication can lower cholesterol does not automatically mean it will improve cardiac health. In 2020, a drug made by Eli Lilly called evacetrapib dramatically lowered LDL cholesterol, but doubled “good” high-density lipoprotein (HDL) and did not prevent heart attacks. The new bempedoic acid study was also not conducted long enough to get a sense of how many deaths it did or did not prevent.

The positive findings are just the first step in getting the statin alternative to be more widely accepted by physicians. The study’s co-author Steven Nissen, the chair of cardiovascular medicine at the Cleveland Clinic, told The Washington Post that unless there is critical “outcome data” showing that bempedoic acid reduces heart attacks, doctors are not as likely to prescribe the treatment and insurers may not cover it. 

“In the current era where we have other cholesterol-lowering drugs, people are not going to use a drug that does not have demonstrated outcome benefits. People want evidence. Everybody has been waiting for this trial,” Nissen said. 

NYU Langone Health cardiologist Howard Weintraub commented that while some will not consider a medication successful unless it reduces mortality, he believes that is short-sighted. “I think there’s more to doing medicine than counting body bags,” he told CNN. Weintraub was not involved in this specific study, but was pleased with the results, especially for those who could benefit from lowering cholesterol but can’t take statin medications. “Preventing things that can be life changing … and certainly change your quality of life forever going forward,” he said, “I think is a good thing.” 

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This article was originally featured on KHN.

For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The U.S. Defense Department issued a memo on Feb. 17, 2023, warning service members to avoid eating poppy seeds because doing so may result in a positive urine test for the opiate codeine. Addiction and pain medicine specialist Gary Reisfield explains what affects the opiate content of poppy seeds and how they could influence drug tests.

What are poppy seeds?

Poppy seeds come from a species of poppy plant called Papaver somniferum. “Somniferum” is Latin for “sleep-bringing,” which hints that it might contain opiates – powerful compounds that depress the central nervous system and can induce drowsiness and sleep.

There are two main uses for the opium poppy. It is a source of the opiates used in painkillers, the most biologically active of which are morphine and codeine. Its seeds are also used for cooking and baking.

Poppy seeds themselves don’t contain opiates. But during harvesting, the seeds can become contaminated with opiates contained in the milky latex of the seed pod covering them.

What affects opiate content in poppy seeds?

Many factors determine the opiate concentrations and ratios of poppies. As with wine grapes, the opiate profile of the poppy plant – and thus its seeds – is affected by its terroir: climate, soil, amount of sunshine, topography and time of harvest.

Another factor is the variety or cultivar of the plant. For example, there are genetically engineered opium poppies that produce no morphine or codeine and others that produce no opium latex at all.

Can you get high from eating poppy seeds?

Practically speaking, you cannot eat enough poppy seeds to get you high. Furthermore, processing dramatically decreases opiate content – for example, by washing or cooking or baking the seeds.

Do poppy seeds affect drug tests?

Poppy seeds don’t have nearly enough opiates to intoxicate you. But because drug tests are exquisitely sensitive, consuming certain poppy seed food products can lead to positive urine drug test results for opiates – specifically for morphine, codeine or both.

Under most circumstances, opiate concentrations in the urine are too low to produce a positive test result. But certain food products – and it’s generally impossible to know which ones, because opiate content does not appear on food labels – contain enough opiates to produce positive test results. Moreover, because of overlap in opiate concentrations and morphine-to-codeine ratios, it can sometimes be challenging to distinguish test results that are due to the consumption of poppy seeds from those that are due to the use of opiate drugs.

This is not a problem with most workplace drug testing. Test results are reviewed by a specially trained physician called a medical review officer. Unless the physician finds evidence of unauthorized opiate use, such as needle marks or signs of opiate intoxication or withdrawal, even relatively high concentrations of opiates in the urine that produce positive test results are generally ruled to be negative.

It turns out, though, that drug testing in the military is different, and poppy seeds pose potential problems. One such problem, as highlighted in recent news reports, concerns service members who test positive for codeine and assert a “poppy seed defense.” They are still regarded as having taken codeine, sometimes with serious consequences, such as a disciplinary action or discharge from the service.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Catheters, stents, and other medical devices are instrumental in saving peoples’ lives, but the methods used to sterilize this equipment could be causing cancer in some parts of the country, most notably in Puerto Rico and the metro areas of Baltimore, Denver, and Richmond, Virginia. A colorless gas called ethylene oxide is used to decontaminate about 20 billion medical devices per year, about half of all medical equipment used annually. This process often happens within buildings that look like ordinary offices, lacking prominent exhaust pipes or billowing clouds often associated with chemical plants. 

The Environmental Protection Agency (EPA) classified ethylene oxide as a carcinogen in 2016, because it can cause lymphoid, breast, and other cancers if inhaled at low doses regularly or infrequently at particularly high levels. The chemical can also damage the brain and nervous system and irritate the eyes, skin, nose, throat and lungs. 

Puerto Rico, a US territory without voting power, has carried a disproportionate load of the country’s burden—both in terms of the number of plants and the effect on local communities. Its facilities tend to receive less legislative action than others, too.  When a sterilizer plant enters a neighborhood, the wealthier and whiter ones are more successful at getting it shut down, according to Adrian Wood, who works on community engagement at the University of Pennsylvania’s Center of Excellence in Environmental Toxicology, and the author of a 2022 research paper analyzing community and government responses to ethylene oxide emissions in the US and Puerto Rico.

Puerto Rico has seven sterilizer plants, including four of the most dangerous facilities, according to a new report from the Union of Concerned Scientists. “Only California and Texas, the two most populous states, have more sterilizers, even though Puerto Rico has roughly one-tenth the population of Texas and 1 percent of its land area,” the report states. The sterilizers are within five miles of more than 413,000 Puerto Ricans (roughly 13 percent of the population) and nearly 300 schools and childcare centers, according to the report.

Because most of Puerto Rico’s sterilizer plants are located in low-income and minority areas, many of the people who get cancer from the toxic fumes might not have access to hospitals with quality treatment. “It is incredibly tragic for people to get cancer and then find themselves being treated with the same materials that caused their cancer,” says Marvin Brown, an attorney for the nonprofit legal advocacy group Earthjustice. 

Accidents at these plants can be frightening. Two explosions at a Steri-Tech plant in Salinas, a small and low-income town in the south of the commonwealth, shook houses late last year and early this year. Residents told the Associated Press that the explosions were worrisome, and one woman said that several of her neighbors who lived nearby had died of cancer.

Then, last year, the EPA took air samples to measure the level of contamination across the island. The agency found extremely high concentrations of ethylene oxide in some areas, with one containing 121 micrograms per cubic meter of air, which is more than 400 times higher than the US national average of 0.3 micrograms. The four plants the EPA said posed the most elevated risks for cancer included Edwards Lifesciences Technology SARL in Añasco, Customed in Fajardo, Steri-Tech in Salinas, and Medtronic in Villalba.

Brown guesses that Puerto Rico might have so many sterilizer plants because of its sizable pharmaceutical industry. Eight percent of US pharmaceuticals are manufactured in Puerto Rico, according to the US Food and Drug Administration.

[Related: Pollution kills 1 in 6 people worldwide]

Sterilizer plants throughout the country are required by the EPA to have emissions controls, which reduce the amount of ethylene oxide diffused into the air above sterilization chambers, aeration room vents, and other parts of the plant. But Brown suspects that most of the ethylene oxide emissions may be produced elsewhere. Ethylene oxide may be released in uncontrolled settings, such as when  product ‘off-gasses,’ or continues to release chemicals, after sterilization.

Under the Clean Air Act, the EPA’s commercial sterilizer regulations must be updated every 8 years. But in 2019, the deadline the agency gave itself for new regulations, the agency failed to produce them. Earthjustice is suing the EPA to issue updated regulations and force the agency to adhere to a court-ordered deadline. The EPA hosted a community meeting on January 24 to address residents’ concerns, though the agency did not respond to request for comment by the time of publication.

Meanwhile, wealthier and whiter communities have used political pressure to shut down facilities that open in their neighborhoods. Wood’s research paper, which analyzed US states and Puerto Rico, found that sterilizer plants located in rich neighborhoods received the most aggressive response from the community, who in turn pushed the government. “The state [came] in quicker and more aggressive with testing and air monitoring, and [got] the facility to shut down in these wealthier suburbs,” she says. 

In two such suburbs, outside Chicago and Atlanta, new sterilizer plants were shut down within a few years. The EPA typically reacts much more slowly, Wood says. “But things did happen in those two areas,” she says. “So why couldn’t they happen in all the other areas, too?”

Researchers are studying other methods for sterilizing equipment. Right now, the Food and Drug Administration has approved three methods for sterilization: heat, steam and ethylene oxide. The problem with heat and steam is that they might melt certain medical equipment. The International Organization for Standardization published standards for hydrogen peroxide, another option for sterilizing these devices, although it hasn’t yet been approved by the FDA. 

[Related: California needs to stop saying everything causes cancer]

“Hydrogen peroxide, for example, appears to be less toxic to workers and the environment,” Darya Minovi, author of the Union of Concerned Scientists report, said in a blog post. “But the status of the FDA’s effort is unclear, and given what we know about ethylene oxide, we hope the agency is considering phasing out its use in medical device sterilization altogether instead of permitting its continued use.”

But the trade association AdvaMed claims the gas can decontaminate tools that other, rougher techniques would destroy. Hospitals and labs rely on ethylene oxide “to sterilize devices and equipment to protect millions of patients from the real risks of infectious diseases caused by bacteria, viruses, and fungi,” the group argues on its website. “For the majority of these products, [ethylene oxide] sterilization is the most effective and efficient—and often the only viable—sterilization technology.” 

Any update to EPA’s ethylene oxide regulations—which Earthjustice is suing for—would affect the commonwealth, too. “Everybody under the Clean Air Act deserves to breathe clean and safe and healthy air,” Brown says. “No part of the country should be a sacrifice zone for the rest of the country.”

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A new era of biodegradable medical sensors may be on the horizon thanks in part to competitive cooks. According to Conor Boland, a materials physics lecturer in the University of Sussex’s School of Mathematical and Physical Sciences, watching contestants on MasterChef utilize seaweed for a vegan gelatin alternative in desserts made him wonder where else those versatile properties could come in handy.

The results, recently published in the journal, ACS Sustainable Chemistry & Engineering, detail how Boland’s team combined graphene with natural materials including rock salt, seaweed, and water to create a new health sensor that is not only biodegradable and edible, but potentially more accurate than existing synthetic options.

[Related: Kombucha may have a surprising new use in tech.]

To make their new, effective monitor material, researchers first created a thin film using a mixture of seaweed—a natural insulator—and electrically conductive graphene. Once soaked in a salt bath, the substance absorbed the water to form a soft, spongy hydrogel akin to the standard synthetic adhesive sensors seen in hospitals. Unlike existing products, however, the new, natural biomedical sensor is so thin and lightweight, the authors described the seaweed mixture as resembling a second skin or temporary tattoo.

Bio-technological hybrid products are increasingly coming to the forefront as cutting edge, sustainable, and innovative advances across a variety of fields—from “brain organoid intelligence” models in computers, to circuit boards built from dried kombucha cultures. Echoing the new seaweed sensors’ conceit, recent developments in biodegradable smart bandages that promise faster healing times. And it’s not seaweed ‘s first tech rodeo—the watery plant serves as a muse for all manner of products and materials lately, including new bioplastics, sustainable farming, and biofuel.

[Related: Why seaweed is a natural fit for replacing certain plastics.]

The medical sensor industry is extremely lucrative—valued at over $6 billion in 2021, with estimates to rise to as much as $10 billion by 2027. Despite advances in technology, the discarded synthetic products still present a huge waste problem. As Boland explains, “The mass production of unsustainable rubber and plastic based health technology could, ironically, pose a risk to human health through microplastics leaching into water sources as they degrade.”

For Boland, recently becoming a parent provided an additional frame for the importance of his team’s work. “As a new parent, I see it as my responsibility to ensure my research enables the realization of a cleaner world for all our children,” he said, although without specifying if the edible sensors are appetizing to toddlers. That said, you can always try your hand at homemade agar-agar jelly.

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There’s no cure, yet, for Alzheimer’s disease. But dozens of programs developed in the past 20 years can improve the lives of both people living with dementia and their caregivers.

Unlike support groups, these programs teach caregivers concrete skills such as how to cope with stress, make home environments safe, communicate effectively with someone who’s confused, or solve problems that arise as this devastating illness progresses.

Some of these programs, known as “comprehensive dementia care,” also employ coaches or navigators who help assess patients’ and caregivers’ needs, develop individualized care plans, connect families to community resources, coordinate medical and social services, and offer ongoing practical and emotional support.

Unfortunately, despite a significant body of research documenting their effectiveness, these programs aren’t broadly available or widely known. Only a small fraction of families coping with dementia participate, even in the face of pervasive unmet care needs. And funding is scant, compared with the amount of money that has flooded into the decades-long, headline-grabbing quest for pharmaceutical therapies.

“It’s distressing that the public conversation about dementia is dominated by drug development, as if all that’s needed were a magic pill,” said Laura Gitlin, a prominent dementia researcher and dean of the College of Nursing and Health Professions at Drexel University in Philadelphia.

“We need a much more comprehensive approach that recognizes the prolonged, degenerative nature of this illness and the fact that dementia is a family affair,” she said.

In the U.S., more than 11 million unpaid and largely untrained family members and friends provide more than 80% of care to people with dementia, supplying assistance worth $272 billion in 2021, according to the Alzheimer’s Association. (This excludes patients living in nursing homes and other institutions.) Research shows these “informal” caretakers devote longer hours to tending to those with dementia and have a higher burden of psychological and physical distress than other caregivers.

Despite those contributions, Medicare expected to spend $146 billion on people with Alzheimer’s disease or other types of dementia in 2022, while Medicaid, which pays for nursing home care for people with low incomes or disabilities, expected to spend about $61 billion.

One might think such enormous spending ensures high-quality medical care and adequate support services. But quite the opposite is true. Medical care for people with Alzheimer’s and other types of dementia in the U.S. — an estimated 7.2 million individuals, most of them seniors — is widely acknowledged to be fragmented, incomplete, poorly coordinated, and insensitive to the essential role that family caregivers play. And support services are few and far between.

“What we offer people, for the most part, is entirely inadequate,” said Carolyn Clevenger, associate dean for transformative clinical practice at Emory University’s Nell Hodgson Woodruff School of Nursing.

Clevenger helped create the Integrated Memory Care program at Emory, a primary care practice run by nurse practitioners with expertise in dementia. Like other comprehensive care programs, they pay considerable attention to caregivers’ as well as patients’ needs. “We spent a great deal of time answering all kinds of questions and coaching,” she told me. This year, Clevenger said, she hopes three additional sites will open across the country.

Expansion is a goal shared by other comprehensive care programs at UCLA (the Alzheimer’s and Dementia Care Program, now available at 18 sites), Eskenazi Health in Indianapolis, the University of California-San Francisco (Care Ecosystem, 26 sites), Johns Hopkins University (Maximizing Independence at Home), and the Benjamin Rose Institute on Aging in Cleveland (BRI Care Consultation, 35 sites).

Over the past decade, a growing body of research has shown these programs improve the quality of life for people with dementia; alleviate troublesome symptoms; help avoid unnecessary emergency room visits or hospitalizations; and delay nursing home placement, while also reducing depression symptoms, physical and emotional strain, and overall stress for caregivers.

In an important development in 2021, an expert panel organized by the National Academies of Sciences, Engineering, and Medicine said there was sufficient evidence of benefit to recommend that comprehensive dementia care programs be broadly implemented.

Now, leaders of these programs and dementia advocates are lobbying Medicare to launch a pilot project to test a new model to pay for comprehensive dementia care. They have been meeting with staff at the Center for Medicare and Medicaid Innovation and “CMMI has expressed a considerable amount of interest in this,” according to Dr. David Reuben, chief of geriatric medicine at UCLA and a leader of its dementia care program.

“I’m very optimistic that something will happen” later this year, said Dr. Malaz Boustani, a professor at Indiana University who helped develop Eskenazi Health’s Aging Brain Care program and who has been part of the discussions with the Centers for Medicare & Medicaid Services.

The Alzheimer’s Association also advocates for a pilot project of this kind, which could be adopted “Medicare-wide” if it’s shown to beneficial and cost-effective, said Matthew Baumgart, the association’s vice president of health policy. Under a model proposed by the association, comprehensive dementia care programs would receive between $175 and $225 per month for each patient in addition to what Medicare pays for other types of care.

A study commissioned by the association estimates that implementing a comprehensive care dementia model could save Medicare and Medicaid $21 billion over 10 years, largely by reducing patients’ use of intensive health care services.

Several challenges await, even if Medicare experiments with ways to support comprehensive dementia care. There aren’t enough health care professionals trained in dementia care, especially in rural areas and low-income urban areas. Moving programs into clinical settings, including primary care practices and medical clinics, may be challenging given the extent of dementia patients’ needs. And training needs for program staff members are significant.

Even if families receive some assistance, they may not be able to afford necessary help in the home or other services such as adult day care. And many families coping with dementia may remain at a loss to find help.

To address that, the Benjamin Rose Institute on Aging later this year plans to publish an online consumer directory of evidence-based programs for dementia caregivers. For the first time, people will be able to search, by ZIP code, for assistance available near them. “We want to get the word out to caregivers that help is available,” said David Bass, a senior vice president at the Benjamin Rose Institute who’s leading that effort.

Generally, programs for dementia caregivers are financed by grants or government funding and free to families. Often, they’re available through Area Agencies on Aging — organizations that families should consult if they’re looking for help. Some examples:

• Savvy Caregiver, delivered over six weeks to small groups in person or over Zoom. Each week, a group leader (often a social worker) gives a mini-lecture, discusses useful strategies, and guides group members through exercises designed to help them manage issues associated with dementia. Now offered in 20 states, Savvy Caregiver recently introduced an online, seven-session version of the program that caregivers can follow on their schedule.
• REACH Community, a streamlined version of a program recommended in the 2021 National Academy of Sciences report. In four hour-long sessions in person or over the phone, a coach teaches caregivers about dementia, problem-solving strategies, and managing symptoms, moods, stress, and safety. A similar program, REACH VA, is available across the country through the Department of Veterans Affairs.
• Tailored Activity Program. In up to eight in-home sessions over four months, an occupational therapist assesses the interests, functional abilities, and home environment of a person living with dementia. Activities that can keep the individual meaningfully engaged are suggested, along with advice on how to carry them out and tips for simplifying the activities as dementia progresses. The program is being rolled out across health care settings in Australia and is being reviewed as a possible component of geriatric home-based care by the VA, Gitlin said.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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On Wednesday, pharmaceutical company Eli Lilly announced a series of price cuts that would lower the price of the most commonly used forms of its insulin by 70 percent. The company will also cap the out-of-pocket cost of insulin at $35 per month for those who have commercial insurance and use participating pharmacies.

The cost cap will come through the expansion of the company’s Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured. 

[Related: From the archives: How a medical ‘outsider’ discovered insulin.]

As of May 1, the company says it will drop the list price of its non branded insulin to $25 a vial from its current list price of $82.41 for a vial. 

Lilly will also lower the list price of Humulin and Humalog, which are its branded injections, during the fourth quarter of 2023. Humalog is the company’s most commonly prescribed insulin and the list price for one vial is currently $274.70 and the new price cuts will drop that down to $66.40. 

This change puts Eli Lilly in line with a provision in the Inflation Reduction Act of 2022 that imposed a $35 monthly cap on the out-of-pocket cost of insulin for senior citizens enrolled in Medicare Part D.

About three in 10 diabetics in the United States rely on insulin made by three companies that control the market–Eli Lilly, Novo Nordisk, and Sanofi.  Eli Lilly was the first company to commercialize insulin 100 years ago and has since become one of the biggest players in the market. 

Insulin manufacturers have faced ongoing criticism for their prices, forcing some patients to ration insulin or reduce their use. Insulin rationing can be life threatening because it can cause dangerous spikes in blood sugar.  Some advocacy groups say that unaffordable insulin may be a human rights abuse. At least 16.5 percent of people in the US have reported rationing insulin due to cost. 

In November 2022, Eli Lilly’s stock price dropped dramatically after a tweet from a fake account  falsely claimed that the company was making insulin free, which renewed focus on the cost of insulin. 

Other manufacturers have created additional programs to help consumers. Sanofi’s Insulin Valyou Savings Program that began in 2019 charges uninsured patients $35 and commercially insured patients up to $15 for a 30-day-supply of insulin, regardless of income. Novo Nordisk created a similar program called My$99Insulin in 2021 and the Danish company also collaborated with retail giant Walmart to sell discounted private-label analog insulin. According to Walmart, ReliOn NovoLog vials and FlexPens save customers 58 to 75 percent off the cash price for branded insulin.

[Related: TikTokers are taking a diabetes drug to lose weight. Now it’s in short supply.]

Insulin is also relatively inexpensive to manufacture. Yet the average price of insulin almost tripled between 2002 and 2013, according to the American Diabetes Association. Research from prescription drug website GoodRx found that that trend has only continued, with the average retail price of insulin increasing 54 percent between 2014 and 2019.

People with diabetes need insulin because their bodies have stopped producing enough of the hormone or aren’t using insulin efficiently to convert food into energy. After eating, the body breaks down food, mostly into sugar. The sugar enters the bloodstream, which signals the pancreas to release insulin. Insulin allows sugar to energize the cells, but if diabetes keeps sugar in the bloodstream too long, it can lead to problems like blindness, nerve damage, kidney disease, and heart disease. 

Diabetes has become the fastest growing chronic disease in the world and has doubled in the United States alone over the past 20 years. Centers for Disease Control and Prevention (CDC) data shows that more than 37.3 million people have the disease, and another 96 million Americans have prediabetes. Prediabetes is a condition where blood sugar levels are higher than normal, but are not high enough to be diagnosed as type 2 diabetes and can lead to the development of the disease.

According to the American Diabetes Association, diabetes was the seventh leading cause of death in the US in 2019.

Correction (March 8, 2023): The prices of insulin under Sanofi’s program have been corrected from $99 to $35 and $15 for uninsured and insured patients, respectively.

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Every four months, pathologist Aaron LeBeau scoops into a net one of the five nurse sharks he keeps in his University of Wisconsin lab. Then he carefully administers a shot to the animal, much like a pediatrician giving a kid a vaccine. The shot will immunize the shark against a human cancer, perhaps, or an infectious disease, such as Covid-19. A couple of weeks later, after the animal’s immune system has had time to react, LeBeau collects a small vial of shark blood.

Halfway across the country, immunologist Hidde Ploegh goes through the same steps, but with alpacas that live on a farm in western Massachusetts. The scientists are after the same thing: tiny antibodies, made only by certain animals, that may have big implications for human health.

Most antibodies — those molecules that course through our blood and tissues patrolling for pathogens — are fairly hefty as proteins go. But the antibodies made by camels and sharks and their close relatives are simpler and smaller. Since their discovery in the late 1980s, researchers have learned that these antibodies pack a big punch: They can latch onto hidden parts of molecules and can penetrate tissues more deeply, enhancing their potential as therapies. 

“They can get into little nooks and crannies of different proteins that human antibodies cannot access,” LeBeau says.

In the last decades, investigations of these diminutive antibodies have surged. Not only can they sneak into small places, they are also easy to work with — sturdier than their ordinary counterparts — and relatively cheap to make in large quantities. All these features make the antibodies promising treatments for a host of diseases, whether clotting disorders or Covid-19. Researchers are also exploring their use for diagnosing conditions such as cancer, and they’re becoming a key tool in other kinds of research, like mapping cells’ insides.

The full promise of these antibodies may still take years to realize, but researchers are very excited about their possibilities. “I think they have potential to save the world,” LeBeau says.

Luck of the blood draw

A group of biology students were the first to discover these unusual antibodies — quite by chance — back in 1989. The students of Free University in Brussels needed some blood for an exam in which they were tasked with separating an antibody into its two main parts: two heavy protein chains, which form a Y shape, and two light protein chains, which flank the prongs at the top of the Y.

Human blood seemed too risky to work with, given concerns at the time about potential HIV exposure, and the students didn’t want to kill a mouse. But the students’ professor, the late Raymond Hamers, happened to be studying sleeping sickness in large animals. He gave the students some blood from a camel, says immunologist Serge Muyldermans, who was then a post-doctoral researcher at the university.

Strangely, the students found only heavy chain proteins in the blood even though antibodies were supposed to also have light chains. As Muyldermans tells it, everyone thought that the camel antibodies had degraded — or that the students had done something wrong — so Hamers went to the Antwerp Zoo to collect fresh camel blood. But the students had not screwed up: Camels make antibodies with only heavy protein chains.

The potential applications of camelids’ small antibodies dawned on Hamers during those early years, says Muyldermans, who details their myriad uses in the 2021  Annual Review of Animal Biosciences. Like antibodies from people or mice, the camelid antibodies could be further pared down into even smaller, yet still effective, fragments — just the tips of the Y. These fragments, called variable domains, are the business end of any antibody — they act as the antibody’s “sensor” and can stick to parts of pathogens or toxins, whatever substance is recognized as foreign and a possible threat.

In standard antibodies (which camels also make), the variable domains come in pairs, one from the heavy chain and one from the light chain. But the variable domains of the camelid’s heavy-chain-only antibodies are singletons. The researchers realized these solitary fragments might be able to grab onto parts of foreign molecules that conventional antibodies were too bulky to reach.

In 1993, the team published the discovery in Nature. The next year, Hamers  patented the production of these camelid antibody fragments (they are also known as VHH antibodies or “nanobodies,” a trademarked term). A few years later, a different group of researchers reported that  sharks also make antibodies with only heavy chains and these have an even smaller tip (these shark end fragments are called variable new antigen receptors, or VNARs).

When the primary patent expired in 2013, research investigating the antibodies really surged, says Ploegh, an immunologist at Boston Children’s Hospital. “That’s sort of when the dam broke and a lot of folks got in on the game.”

Scientists have since learned a lot about the advantages of these mini antibodies. Some is practical: Unlike full-size antibodies, the fragments are stable at room temperature so there’s no need to keep them in a freezer or ship them cold. The mini antibodies of sharks can even be boiled with no effect on their function, LeBeau says. And while full-size antibodies require mammalian cells to be grown in a flask, which can be complicated and expensive to maintain, the fragments can be manufactured in large quantities using bacteria, saving time and money.

These mini antibodies also tend to self-assemble properly, keeping their correct shapes, making them a promising alternative to full-size antibodies, which have more pieces and thus can misfold. Such misfolding may expose parts that are more likely to be recognized by the immune system as foreign molecules, which can provoke a negative immune response in the body, with potentially serious consequences for patient health.

But the standout trait of the mini antibodies is their versatility. All antibodies, whether from human or shark, have variable domains at their tips, but those of sharks and camels have unique traits. They have an especially long, slender finger called a CDR3 loop that can poke into places that human antibodies can’t access. They appear to easily adopt different shapes — LeBeau describes that feature as “molecular yoga.” This means mini antibodies can get into tight spots, whether into tissues of the body or on minuscule parts of individual molecules.

Anti-cancer antibodies

Research into these unusual mini antibodies is now starting to bear fruit. In 2019, the first mini antibody medical treatment to be approved by the US Food and Drug Administration, called Cablivi, came on the market. It treats a rare blood disorder that leads to clots in small blood vessels. The treatment uses nanobodies to bind to a protein in platelets, which stops them from sticking together.

Mini antibodies could become a valuable tool for cancer treatment. Full-size antibodies are already used in immunotherapies to treat certain cancers; in some cases, the antibody tags cancer cells so that the body’s own immune system cells can then recognize and kill the rogue cells; in others, it might bring immune cells closer to the cancer cells so the body can better fight the cancer. The mini antibodies can do the same tasks, but can also be used in other ways, such as targeting proteins to reduce tumor growth or blocking blood vessels from feeding a tumor. And the smaller antibodies also may be less likely to trigger a negative immune response than full-size immunotherapy antibodies, which may lead to dramatic treatment improvements, Ploegh says.

LeBeau, for his part, is focused on developing mini antibodies targeted for prostate and lung cancer. The sharks in his lab, each named for James Bond bad guys — Goldfinger, Hugo Drax, Mr. Stamper, Oddjob and Nick Nack — keep him supplied with antibodies that he uses in lab experiments. His lab recently identified a shark antibody fragment that is specific for a highly aggressive, and currently untreatable, form of lung cancer. He’s hopeful that this new mini antibody could help combat the cancer, and has studies in progress to test it.

The mini antibodies are also helping physicians detect cancers more readily, pinpointing diseased cells with more precision. By attaching radioactive tracer molecules to specific antibodies that seek out cancer cells, physicians can locate cancerous cells on a PET scan, potentially with greater resolution than with standard antibodies because they can penetrate deeper into tissues. One such nanobody-based tracer detected several tumors in mice with  higher specificity than conventional imaging, a team reported in  PNAS in 2019.

Vanquishing viruses

Scientists are also harnessing mini antibodies to fight infectious diseases, including Covid-19. Wai-Hong Tham, an infectious disease researcher at the University of Melbourne and the Walter and Eliza Hall Institute of Medical Research, has been working to generate nanobodies that grab onto part of the spike protein of SARS-CoV-2, to prevent the virus from entering cells in the body.

In a preliminary study, published in PNAS in 2021, Tham and her colleagues identified several nanobodies from alpacas that interfered with the spike proteins’ ability to latch onto the molecular doorknob it uses to get into cells; cocktails of the nanobodies also reduced the amount of virus in experiments with mice. Ideally, Tham says, they could find a nanobody that universally blocks Covid-19 regardless of the coronavirus variant. Other nanobody cocktails also appear promising: Four nanobodies, mixed and matched in various combinations, disabled the spike protein in experiments in cells, a separate team reported in 2021 in  Science.

Mini antibodies might be delivered via mRNA technology so the antibodies assemble inside people’s cells, Tham says. Vaccine-like injections might work against other  infectious diseases, counter toxins such as  botulism, or even deliver therapeutics for cancer or other conditions.

And with a simple pill, mini antibodies could be delivered directly to the gut, which could help to block a number of pathogens, for example rotavirus, that enter the body through the digestive tract. Small microbes — such as yeast, bacteria and algae — can’t efficiently make full-size antibodies because these are too complex. However, researchers have proposed genetically engineering  spirulina (a blue-green alga that’s often sold as a nutritional supplement) or harmless bacteria called  Lactobacilli  or  Lactococcus that could deliver therapeutic nanobodies via a pill, which would be much more cost effective than producing a drug, Tham says.

Sleuthing cell mysteries

The diminutive antibodies are also a boon for scientists who study proteins and investigate interactions between molecules. The size and long finger of these antibodies can help solve protein structures, map proteins  inside cells and show how molecules within cells  interact with each other.

Researchers recently solved the structure of a human protein called ASIC1a, for example — it forms a type of channel that lets sodium into nerve cells and plays an important role in pain perception and several neurodegenerative diseases. Stabilizing the protein with a nanobody allowed the researchers to determine its structure with greater resolution, the team reported in 2021 in  eLife.

Single-domain antibodies “have the potential of mapping interactions that would be very difficult to study otherwise,” says Ploegh, coauthor of an overview of their traits in the 2018  Annual Review of Immunology. Scientists are even investigating their potential use in the brain — a tricky task because the blood-brain barrier likes to keep foreign molecules out. An international team recently reported using nanobodies as  sensors to study whether or not a protein in a mouse brain was activated, and where it was located.

Ploegh says that mini antibodies are exceptionally useful and have significant advantages over full-size antibodies, but they remain somewhat niche because of limited access to the animals that make them — not every researcher has nearby camels, llamas or, in LeBeau’s case, sharks. (“Probably very few people are crazy enough to actually build a shark tank and work with sharks. But we are,” LeBeau says.)

But this is starting to change as interest ramps up. Researchers are also developing new approaches, such as creating synthetic nanobodies and developing mice with “camelized” immune systems for research.

Scientists still don’t know why camelids and cartilaginous fishes, like sharks, are the only animals known to make heavy chain antibodies. Sharks are the most ancient living organisms to rely on antibodies as part of their immune systems, and their antibodies are more stable than those of camelids. Scientists speculate that sharks rely on these antibodies because of the high concentrations of urea in their blood, which would degrade the antibodies of most mammals.

Sharks evolved some 350 million years before camels, yet camelid heavy chain antibodies are also relatively ancient: They are found in both Old World camelids, like camels, and New World camelids, like llamas and alpacas, suggesting that the antibodies may have developed early in the lineage’s evolution. Perhaps “there are certain pathogens that are unique to the camelids that are best fought with these heavy chain antibodies,” Ploegh says.

The heavy chain antibodies of sharks might well be the most ancient immune molecules still in existence — but LeBeau is exuberant about what they could accomplish in the future. “Whenever you work with them, you see something new every day. And that’s really exciting,” he says.

And as for his two-foot-long sharks, when they outgrow their tank, they’ll retire to the local aquarium.

This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.

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For a long time, people have been trying not to get pregnant. In 500-100 CE, European women tied weasel testicles around their legs during sex to prevent pregnancy. Ancient Egyptians stuck a honey and crocodile dung mix up their vaginas to block sperm from entering. And in imperial China, sex workers were encouraged to drink liquid mercury (which might have stopped them from getting pregnant, but often killed them, too). Despite the obviously high demand for contraceptive options, it would take another couple of centuries until humans got their hands on a safe and effective birth control method. 

Nowadays, there are several female contraceptives to choose from, including the widely popular “pill”. But for people who might desire a hormone-free option for medical or religious reasons, the pickings are slim. “Birth control development is a prime symbol of the lack of innovation in women’s health,” says Kelly Culwell, an OB-GYN and head of Research and Development, Women’s Health for Sebela Pharmaceuticals.

With recent research making strides toward hormone-free birth control for men, why do female contraceptives feel so outdated? Here are three reasons.

The effectiveness of hormonal birth control

One of the big reasons why female contraceptives skew toward hormonal drugs is because of their proven effectiveness. Jill Purdie, an OB/GYN and the medical director at Pediatrix Medical Group, says there’s not much motivation for industries to invent a non-hormonal safeguard when they have repeatedly been less protective than hormonal birth control. “When you look at non-hormonal options, they are around the 80 to 89 percent range while your hormonal options are all going to be 95 percent or better.” The one exception is the non-hormonal copper IUD, which is 99 percent effective for up to 12 years after being implanted.

Costs of testing contraceptives

In the 1970s and ‘80s, Culwell says a lot of attention was focused on making lower doses of hormonal birth control pills to lower the risk of severe side effects such as dizziness and vomiting. Doing so was thought to be more cost-effective than starting from scratch. Even in the ‘90s and early 2000s, she says there weren’t many changes to the birth control method. While female birth control was designed in different forms, like rings, IUDs, and patches, Culwell says it still followed the same process of using synthetic versions of estrogen and progesterone hormones to prevent ovulation. “It’s really a capitalistic process for private companies,” she explains. “There’s a lot of research development going on in ‘big money categories’ like in the fields of cancer and neurology. Birth control doesn’t tend to bring the same level of monetary return.”

Sexism in research

Like many corners of innovation, medical research on contraceptives has a deep-seated gender gap problem. In the 1900s women were often excluded from participating in clinical trials or experiments, making it difficult to understand how birth control affected the female body. Culwell says scientists were concerned about enrolling women because there was a risk of getting pregnant, opting to use animal models like rats and rabbits instead. When women were involved in birth control trials, it was through unethical methods such as enrolling individuals hospitalized in mental institutions or recruiting poor Puerto Rican women without telling them what the medications did. It was not until 1994 that the Food and Drug Administration (FDA) made policy changes requiring all drug trials to enroll women in their studies.

Future birth control options

Both experts say there’s been a massive push for more effective non-hormonal contraceptives in the past decade. The overturning of Roe v. Wade has made Americans more vocal in having more options to prevent unwanted pregnancies.

Ironically, research on male contraceptives is helping to widen the field. Culwell says some of the hormonal side effects participants faced during a 2016 trial for shots that lowered sperm counts brought more attention to pursuing non-hormonal contraceptive choices. In response, the National Institute of Health has provided more grants towards research on new types of hormone-free birth control for both sexes, which Culwell says helps to fund innovations pharmaceutical companies initially passed on.

[Related: Everything you need to know about male hormonal birth control]

There are some new non-hormonal options already available and some currently in development. The FDA approved the vaginal gel Phexxi in May 2020. The contraceptive works by changing the pH of the vagina to stop sperm from moving around and reaching an egg. A phase 3 clinical trial with more than 1,300 individuals estimated Phexxi to be 86-percent effective in preventing pregnancy. For comparison, the hormonal pill is 99-percent effective when used properly.

Sebela Pharmaceuticals is also in phase 3 clinical trials of a new version of the copper IUD. It would be smaller, flexible, with half the amount of copper than the current copper IUD on the market. Culwell says that if the FDA approves the product, it could be on the market as early as next year. If so, “it would be the first new non-hormonal IUD in 40 years,” she explains.

While still years away from hitting pharmacy shelves, there is potential for a non-hormonal contraceptive that releases antibodies targeting sperm. Deborah Anderson, a professor of medicine at Boston University who is leading the research on this product, says it’s a topical film that can be inserted in the vagina before intercourse. Seconds after dissolving, it releases antibodies that bind and cause sperm to stick together until they can no longer move. The proteins then trap the bound sperm in the cervical mucus, the gatekeeper standing in the way of the ovaries. With more trials underway and a long FDA-approval process, Anderson gives a rough estimate of 10 years before you see these in the shelves of your local pharmacy.

“The field is getting back in gear as the NIH is putting a lot of money into it and looking for industry engagement again,” says Anderson. “[We] should look forward to more contraceptive productions in the future.”

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This article is excerpted from Sian E. Harding’s book “The Exquisite Machine: The New Science of the Heart.“ It was originally featured on The MIT Press Reader.

Nothing shows more clearly the perfect engineering of the heart than our own failed attempts to imitate it. This history of the total artificial heart is punctuated with both brilliant innovation and continual clinical failure. In 1962, John F. Kennedy challenged the scientific community to land a man on the moon and return him safely to Earth by the end of the decade. In 1964, cardiovascular surgeon Michael DeBakey persuaded President Lyndon B. Johnson to fund a program to develop the first functional self-contained artificial heart, launching a race to successfully make one before the moon landing. In 1969 both aims were apparently achieved, with the Texas Heart Institute implanting the first total artificial heart just three months before the launch of Apollo 11. However, while the moon landings have led to the Space Shuttle, Mars Rover, and International Space Station, and (despite a long lull) the newest aims to develop a moonbase to bring us to Mars, a reliable off-the-shelf total artificial heart is still just out of reach.

At the outset, the artificial heart was aimed to be a lifetime replacement for the failing organ. This was a high bar to reach, since the first design had an external compressor with an air line through the skin into the patient’s body. Compressed air inflated and deflated Dacron pouches or sacs, which collapsed and expanded to displace blood from a surrounding sac. While having the compressor outside the body was useful, since the mechanical parts (which were most susceptible to wear) could be easily replaced, it would make for a bulky piece of equipment to be wheeled about with the patient. It was difficult to see how this could be given to a patient and expect them to live an even partly normal life for many years.

However, the history of the artificial heart is also intertwined with that of the heart transplant. This was again only a hopeful dream in the early 1960s, but by 1967 cardiac surgeon Christian Baarnard in Capetown performed the first successful transplant. Now, the purpose of these first artificial hearts was changed. They did not need to be suitable for a lifetime; their purpose was to keep the patient alive until a transplant donor could be found. As with many highly experimental therapies, the first case was done on a patient who had run out of options. A 47-year-old man was being operated on to repair a huge aneurysm of the left ventricle that had thinned and swollen the heart wall. He was being supported by a heart-lung machine, which bypassed the heart and kept blood flowing through the body. However, he could not be weaned from the machine at the end of the operation as his heart was too weak. He desperately needed a transplant. Denton Cooley, DeBakey’s associate, offered him the new experimental total artificial heart and he accepted. The patient was kept stable with the new device for 64 hours until a matching donor heart was found and then transplanted.

This seemed at first a triumph for the total artificial heart, but tragically the patient died 32 hours later from sepsis. Not only that but the device had damaged both the blood and the kidneys, and the walls of the expandable sacs were coated with blood clots. This heralded a series of problems that would continue to thwart the scientists and engineers wrestling with this procedure. Infections and sepsis are a continual challenge to any device where there is a wire that must permanently cross the skin. Devices that move the blood will alter its composition and the foreign surfaces will cause the blood to clot, resulting in strokes and blood breakdown. The first Jarvik heart, one of the next iterations, was implanted in five patients and one lived for 620 days. But two of the patients had severe strokes, and eventually all died of either sepsis or blood problems.

Heart transplantation also had a shaky start, with Baarnard’s first patient dying after only 18 days. The first patient in the UK, whose transplantation was performed by cardiothoracic surgeon Donald Ross at London’s National Heart Hospital, survived for only 45 days, and the general success rate remained disappointing. The problem here was not the mechanics of the operation or the initial performance of the new heart. It was the mismatch of the immune system of the recipient to that of the donor heart. Even though the donor heart is matched as closely as possible to the patient with the major tissue types, the immune system must be suppressed to stop the heart being rejected. Drugs to suppress the immune system were not very sophisticated in the early days, but the development of ciclosporin in the early 1980s produced a revolution in immunosuppression that dramatically improved the success of heart transplantation. Now, it is a victim of its own success, with many more people in need of a transplant than there are donors. Only about 200 transplants are carried out in the UK each year despite more than 750,000 living with heart failure, and similar figures are seen worldwide. To fill this gap, scientists have been genetically modifying pigs to make their hearts compatible with the human immune system so that they can be transplanted to patients without being rejected. This has proved very complex and challenging, but first clinical transplants started in 2022.

The success of heart transplantation, however, had reinvigorated the search for the total artificial heart, with the more achievable goal of keeping the patient alive until a donor is found, or “bridge to transplant” as it is called. For decades, the artificial heart technologies have improved through changes to more biocompatible materials, better valve design, and more efficient handling of blood flow. Successes have been achieved: one study saw 80 percent of patients on the artificial hearts surviving for over a year, and some for 6 years. The longest time a patient was supported to transplant was 1,373 days. But severe infectious complications were still common, and the goal of a complete “destination” therapy for artificial hearts was still a distant dream.

Meanwhile, the urgent need to bridge to transplant had taken the technology in another direction. Rather than replacing the failing heart completely, the idea was to support it by assisting the blood flow. The ventricular assist device, or VAD, took blood out of the ventricle of the heart by a completely different route and pushed it into the aorta at high pressure. This added to the blood being ejected from the heart and thereby magnified the effective cardiac output. It also solved another problem encountered by the engineers of total artificial hearts — how to balance the right and left heart-blood flow. The amount of blood circulating in the left ventricle/body loop must be very close to that in the right ventricle/lung loop. With 100,000 beats a day, even a teaspoon of difference at each beat would add up to 500 liters of blood in the wrong place. The heart has evolved complex biological mechanisms to make sure this does not happen, but the engineers were having huge battles to try to do the same with feedback systems. For VADs, either the right (or more usually) the left ventricle can be independently supported, taking this problem away.

Left ventricular assist devices, or LVADs, have produced a revolution in care for end-stage heart failure. More than 15,000 LVADs have now been implanted worldwide, and around a third of patients with end-stage heart failure are now supported on LVADs. The intention is usually to bridge the patients to transplant, but in fact the shortage of donor hearts means that patients can often stay on LVAD support for years. Survival rates of over 50 percent are seen at seven years, and there are reports of patients living up to 13 years on these devices. LVADs have therefore become by default a therapy in themselves. Again, technology has progressed, with newer LVADs performing better. A breakthrough idea was to stop imitating the heart, with its pulsing action, and move to constant flow of blood. Rotating paddles (impellers) push the blood along in a continuous motion, creating a smooth unbroken stream. This has the curious side effect of creating a patient without a pulse, which can be disconcerting for the unsuspecting physician as well as producing some unwanted side effects as the body adapts to the new flow. External battery packs are still an inconvenience and a source of infection, but systems are being developed that transfer energy transcutaneously (across the skin) based on induction (like domestic induction stoves). The LVAD units would still need a small, implanted battery in case of a temporary device failure — and it has been known for external battery packs to be snatched from patients by handbag thieves!

The search for a completely implantable total artificial heart continues. Trying to develop external transcutaneous units to fully power the demands of the heart is the biggest barrier. Specifications for a total artificial heart require it to pump eight liters per minute of blood against a blood pressure of 110 mmHg. (The biological power storage molecule adenosine triphosphate [ATP] would be needed in quantities greater than half your body weight per day to power your own heart to do that, if ATP were not continually renewed in cells.) Compressors have been miniaturized to be more portable, but it has been a struggle to make them completely implantable. Here it seems that the VAD technology may hold a solution, dispensing with compressors altogether and using instead the impeller devices, with dual right and left VAD working together.

Solutions seem tantalizingly close, but no one is anticipating an easy ride. The many failures over the years have certainly produced in scientists a humility and awe for the natural engineering of the heart.

Sian E. Harding is Emeritus Professor of Cardiac Pharmacology in the National Heart and Lung Institute at Imperial College London, where she led the Division of Cardiovascular Sciences and the BHF Centre for Cardiac Regeneration. She is the author of “The Exquisite Machine,” from which this article is excerpted.

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We’re used to slapping Band-Aids or gauze on cuts and other gashes, but researchers are exploring higher-tech ideas, too. Micro-thin smart bandages show promise as a potential new  method of medical treatment for patients suffering from chronic wounds such as diabetic ulcers. Like some of the tech that has preceded it, the latest iteration leverages electrotherapy to speed up healing time, but goes one step further—it’s capable of safely biodegrading once its task is complete.

Developed by researchers at Northwestern University and detailed in a study published this week with Science Advances, the project’s testing—so far, just in mice—has resulted in the first electrotherapy-delivering bioresorbable bandage, as well as the first example of a smart regenerative system.

[Related: A micro-thin smart bandage can quickly heal and monitor wounds.]

Between 15 and 20 percent of diabetes patients will develop an ulcer at some point in their lives. These injuries often go unnoticed due to diabetically induced nerve damage, and are slow to heal due to decreased blood circulation. The longer these wounds remain open or partially healed, the more likely they are to develop serious, sometimes life-threatening complications and infections.

To help cope with this, electrotherapy is a method of stimulating the healing process by attracting new blood flow toward a wound, but the treatment’s required tools and medical instruments have long been bulky, wired (because there needs to be a source for the electricity), and limited to monitored hospital settings. Smart electric bandages could one day soon provide an alternative, saving patients time, money, and lengthy doctor visits.

Here’s how it works: The new, flexible bandage encompasses the site of a wound, and features electrodes on both sides of the material. The inner face includes one electrode that sits atop the injury itself, while its ring-shaped partner surrounds the wound. The other side, meanwhile, hosts a coil to harvest power alongside a near-field communication (NFC) system to wirelessly transmit data. As electric currents ideally help the healing process, additional sensors keep an eye on the progress, and can alert doctors if there are any issues or complications.

[Related: This vibrating magnetic pill could one day help measure your guts.]

During the development stages, the team realized that electrodes made from incredibly thin layers of the metal molybdenum can safely biodegrade over time without impeding the healing process. In their studies on applying the new bandages to mice with diabetic ulcers, the team saw that most of the metal can be absorbed into the rodents within six months, with extremely little accumulation in any of the test animals’ organs. What’s more, healing times increased as much as 30 percent from as little as 30 minutes per day of electrotherapy stimulation.

Once larger animal testing is completed, the team hopes to move onto human trials. Because no drugs or controlled materials are included in the system, it’s possible that the bandage could move into the public sector much sooner than other treatment options needing FDA approval.

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The death of Tyre Nichols at the hands of Memphis police earlier this year has set off new questions about what public safety really means in America. While the five former officers are being charged for Nichol’s murder, there’s been scrutiny over how EMS responders handled the victim’s injuries after arriving on the scene.

On the night of January 7, paramedics responded to a call of a person being pepper sprayed. Despite the man laying bloody and in distress against a police vehicle, they failed to make their own assessment of the patient beyond what the officers told them. It took another 19 minutes for the EMTs to bring a stretcher out for him. 

The mistreatment Nichols endured from people trained to save lives is a grave reminder that America is built on a system designed to treat minority communities differently. One in every 1,000 Black men in the US will be killed by law enforcement, estimates a 2019 criminal justice study. Among young Black men between 25 and 29, police brutality ranks as the sixth leading cause of death. And more than half of police brutality cases go unreported, especially when they involve Black people. 

[Related: Racism is undeniably a public health issue]

In the wake of Nichols’s murder, medical organizations like the Association of American Medical Colleges released statements condemning the violence. But they didn’t address the fact that fear of being harmed by figures of authority can also carry over to medical institutions and personnel. Sirry Alang, an associate professor of Black Communities & the Social Determinants of Health at the University of Pittsburgh School of Education, says police brutality must be considered a public health crisis. “Police brutality literally kills people. It causes death and disability and it shifts relationships with healthcare providers that make people less likely to seek care.”

The roots of medical mistrust

Medical mistrust is the belief that people working in the medical field want to harm you or don’t have your best interests at heart. Alang says it tends to come from the concern of being treated differently because you are affiliated with a specific racial or gender group. 

Medical mistrust has been justified through American history. From the 1930s to the 1970s, public health researchers with the Tuskegee syphilis study infected hundreds of healthy Black men and intentionally withheld treatment when penicillin became available. What’s more, the bogus science of eugenics promoted the forced sterilization of thousands of people of color in the 20th century. 

Mistrust has also arisen, in part, because of the prejudices workers at medical institutions hold against certain groups of people. For example, Black patients are less likely to be prescribed pain medication than white patients, even if they are experiencing the same level of pain, because of a deep-rooted stereotype that they have “thicker skin.” The US mortality rate among Black mothers from complications during pregnancy is also three times higher than that of white mothers, in part because of the failure of doctors to understand the pain of Black women.

“People don’t seek healthcare as individuals,” explains Alang—their choices are shaped by personal experience and the experiences of others in their community. “One bad experience can influence the expectations of others in that network and make it easy for medical distrust to spread.”

Cycles of violence, trauma, and more mistrust 

Experiencing police brutality creates traumatic racial experiences that can subvert a person’s belief on what to expect when dealing with a figure of authority. Think about the end of an abusive romantic relationship. Even if you moved on, you might always be wary of your new partner and whether they’ll behave just as badly. Similarly, a traumatic experience with the police keeps you on edge of being mistreated in other areas. 

“If people in authoritative roles have showed they don’t respect you, you’ll be more suspicious of other authority figures like healthcare providers,” says Georges Benjamin, the executive director for the American Public Health Association. What’s more, exposure to police violence can force survivors to develop feelings of hopelessness and worthlessness and further convince them to avoid care—even when they need it.

[Related: Teen girls and queer youth are facing a crisis of hopelessness]

Another issue is that healthcare institutions support a broken public-safety system that often works against those who need it. Take emergency medical dispatches, for example. First responders tend to talk to the officer at the scene first instead of speaking with the harmed individual to figure out what happened. “They then come to you like an object it has to fix instead of a person,” says Alang. 

Crumbling police-community relations

The stress and trauma that comes from the threat of police brutality can cause long-term stress that wears down the body over time. For example, a 2016 study of Black residents living in highly policed areas of New York City found they were more likely to have poor health outcomes such as high blood pressure, regardless of whether or not officers stopped them. Benjamin says that the perception that law enforcement is not actually there to protect you can create community stress that keeps your body in a constant fight-or-flight mode.

Constant stress contributes to a higher risk of heart disease, stroke, and diabetes, along with a number of mental health conditions. But when people are apprehensive about how they will be treated for “overreacting” to the constant threat of police brutality, Alang says they are more likely to skip out on seeing or talking to their doctor about the source of their stress and trauma. They might also be less likely to adhere to medication or treatment plan. “The relationship between a healthcare provider and a patient is one of fundamental trust,” Benjamin explains. “If you don’t trust that individual, you might have some suspicions on their advice or you may not believe what they told you.”

Building a safer public health system

Reducing police violence is just one part of fixing medical mistrust; hospital, EMS groups, and public health organizations need to actively build rapport with communities grieving the loss of their members. Alang says putting out anti-racist press statements after a violent incident does little to reassure the public. Instead, both she and Benjamin advise medical institutions to take action in ways that make people feel heard or supported. 

This can come from changes like hiring a healthcare workforce that represents the patient population it’s treating, and setting up accessible mental health programs focused on addressing trauma and stress. Benjamin adds that medical institutions can work with law enforcement to build out community-based policing, including teaching them how to interact with people under stress. “Public health is not going to [completely] solve this police violence problem,” he says. “But we are part of the solution.”

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Moderna announced that it will keep its COVID-19 vaccine free of charge for even after the federal government stops paying for it.

“Everyone in the United States will have access to Moderna’s COVID-19 vaccine regardless of their ability to pay,” the pharmaceutical company wrote in a statement. “Moderna’s COVID-19 vaccines will continue to be available at no cost for insured people whether they receive them at their doctors’ offices or local pharmacies.”

[Related: Biden will end COVID-19 national emergencies in May. Here’s what that means.]

In their statement, the company also claimed that its patient assistance program will provide free vaccines for the “uninsured and underinsured,” after the federal government’s public health emergency expires, which should be in May. The company did not say how long the vaccines would remain free. 

Moderna faced criticism in January after it announced it was raising the market price from about $26 per shot to as much as $130. The vaccine was developed with the help of billions of federal tax dollars and private donations. Moderna CEO Stéphane Bancel is scheduled to testify before the Senate health committee on March 22 regarding the price for its COVID-19 vaccine when they are sold on the private market.

[Related: The FDA says get used to COVID-19 vaccine boosters.]

Moderna’s announcement of a potential price hike coincided with the Biden Administration informing Congress last month that it was moving towards ending the national public health emergency on May 11, 2023. This change would limit or end federal dollars towards the shots and leave uninsured Americans paying out of pocket for future boosters. 

The federal government had been paying for all COVID-19 vaccines despite insurance status, but ending the public health emergency means funds for federal support for programs aimed at serving the uninsured and those that explained testing, treatments, and Medicaid will dry up. Moderna says its patient assistance program is scheduled to be available after the public health emergency expires, though it is unclear for how long. 

The public health emergency was first declared by Health and Human Services Secretary Alex Azar on January 21, 2020. The national emergency was later declared by Former President Donald Trump in March 2020. President Biden has repeatedly extended both the national and public health emergencies since taking office in January 2021 and has extended them as recently as January 11.

In January, the World Health Organization (WHO) said that the coronavirus remains a global health emergency, despite a key advisory panel for the group finding that the pandemic may be nearing an “inflexion point” where higher levels of immunity could lower virus-related deaths. 

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Endoscopies are as commonplace as they are unpleasant. But a new device from engineers at MIT and Caltech could soon provide a simple, accurate alternative. According to MIT’s news release alongside a recent writeup by TechCrunch, researchers have designed an ingestible, pill-shaped sensor module that can be easily tracked outside a patient’s body via electromagnetic fields. Early trials indicate the method could one day offer an effective means to assess issues like constipation, gastroesophageal reflux disease, and gastroparesis.

The team’s findings, published Monday in Nature Electronics, showcase the early stages of what may eventually become a commonplace alternative to X-rays, nuclear imaging studies, and endoscopic assessments. The setup is relatively simple: after a test animal swallowed a module capsule containing the magnetic sensor, researchers then utilized an external coil to measure its travel distance and location. Naturally, the sensor’s magnetic reading weakened as it moved through a test animal’s digestive tract, farther away from the outside reference point reader.

[Related: Watch this metallic material move like the T-1000 from ‘Terminator 2’.]

“Using an external reference sensor helps to account for the problem that every time an animal or a human is beside the coils, there is a likelihood that they will not be in exactly the same position as they were the previous time,” explained Khalil Ramadi, one of the paper’s lead authors who is now an assistant professor of bioengineering at New York University. “In the absence of having X-rays as your ground truth, it’s difficult to map out exactly where this pill is, unless you have a consistent reference that is always in the same location.”

According to MIT, the sensor also includes a wireless transmitter that sends measurements to a nearby smartphone or computer through manual triggering, or at scheduled intervals. Researchers also indicated the system can support multiple capsules simultaneously without any compromise to accuracy. Any hypothetical slowdowns in movement could indicate issues such as blockages or inflammation.

[Related: Acrobatic beetle bots could inspire the latest ‘leap’ in agriculture.]

Ingestible medical tech appears to be on the rise. Recently, scientists developed a capsule containing safe, drug-delivering robots that could release medication once its exterior barrier deteriorated. There has also been impressive development in similarly digestible, “melting” magnetic materials that may soon be utilized in medication delivery.

For Ramadi and their teammates, next steps include hopefully expanding animal testing trials before moving on to potential human clinical studies. If all goes as planned, a much easier alternative to swallowing lengthy tubes could soon be an option for millions of patients dealing with gastrointestinal issues.

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While killer fungi might be on top of your nightmare list thanks to HBO’s The Last of Us, some mushrooms are really not all that bad—and maybe even beneficial. In fact, lion’s mane mushrooms (Hericium erinaceus) have been used to treat ailments and maintain health in traditional Chinese medicine since antiquity, according to Dae Hee Lee, a researcher at South Korean medical equipment company CNGBio Co.

In Europe, the use of mushrooms like lion’s mane mushroom (Hericium erinaceus) dates back to 450 BCE. Hippocrates (a Greek physician) found that it held potential anti-inflammatory properties and could cauterize wounds. 

But how exactly this fungi acts as medicine is pretty unknown. Recently, a team of researchers from Australia and South Korea have discovered an active compound from the edible lion’s mane mushroom that enhances memory and boosts nerve growth. The study published earlier this year in the Journal of Neurochemistry found that in preclinical trials, the mushrooms improve brain cell growth and memory. CNGBio Co supported and collaborated with the team on this study.

[Related: Oyster mushrooms release nerve gas to kill worms before eviscerating them.]

Previous studies have found that its compounds could be used to help regulate blood sugar and reduce high blood pressure, as well as other mental and brain health applications including treating depression, promoting recovery in brain injuries.

“Extracts from these so-called ‘lion’s mane’ mushrooms have been used in traditional medicine in Asian countries for centuries, but we wanted to scientifically determine their potential effect on brain cells,” said study co-author Frederic Meunier from the Queensland Brain Institute, in a statement. “Pre-clinical testing found the lion’s mane mushroom had a significant impact on the growth of brain cells and improving memory.”

Lion’s mane mushrooms grow on old or dead broadleaf tree trunks. Like many fungi, they’re composed of a visible fruiting body (the mushroom itself) and the mycelium–the bottom structure that looks like roots. Both the fruiting body and mycelium have compounds with potential health benefits.

The team studied how compounds in the mushrooms affected brain cells and found that it promoted the neurons to extend and connect to one another. “Using super-resolution microscopy, we found the mushroom extract and its active components largely increase the size of growth cones, which are particularly important for brain cells to sense their environment and establish new connections with other neurons in the brain,” said Meunier.

[Related: We may finally know how magic mushrooms help fight depression.]

According to the team, a future application of this compound could be protecting against neurodegenerative cognitive disorders such as Alzheimer’s disease.

“Our idea was to identify bioactive compounds from natural sources that could reach the brain and regulate the growth of neurons, resulting in improved memory formation,” said co-author Ramon Martinez-Marmol from the University of Queensland, in a statement.

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This past November, a patient asked optometrist Kaitlin Soracco to remove a bulge of skin on her eyelid. Such skin tags can be excised right there in the office using procedures Soracco studied and observed in optometry school almost a decade ago. Yet in California, where Soracco works, as well as in 32 other states, non-physician optometrists are not legally permitted to perform these treatments. So when Soracco saw this patient at Peach Tree Live Oak, a federally qualified health center north of Sacramento, she had to refer her to an ophthalmologist, a type of physician who specializes in treating the eyes. 

But such referrals can be difficult. Some ophthalmologists have stopped accepting Medicaid, the low-income health insurance program that supports 30 percent of all Californians, said Peach Tree CEO Greg Stone. In California, Medicaid payments for some laser procedures run 16 to 55 percent lower than Medicare reimbursements, which are, in turn, well below commercial insurance fees. For ophthalmology practices already filled with commercially insured patients, Stone said, accepting someone new on Medicaid doesn’t make sense financially. Consequently, for Medicaid patients, it can often take six months to be seen by a specialist, Soracco said.

A bill introduced in California last February sought to allow trained optometrists to remove small non-cancerous skin tags and perform several other procedures, including certain laser treatments, that are traditionally restricted to ophthalmologists. Supporters of the bill say that expanding optometrists’ scope of practice could help address longstanding challenges with health care access. “There’s a runaway demand for health care, and a declining population of providers,” Stone said.

Yet in September, California Gov. Gavin Newsom vetoed the bill, citing insufficient optometry education and training for the surgical procedures. After undergraduate studies, ophthalmologists must complete eight or more years of medical school and specialized clinical training, compared with four years of specialized education and training for optometrists.

The California Academy of Eye Physicians and Surgeons hailed the governor’s decision as a “major victory for patient safety” — as did the American Medical Association, which called the bill “a radical measure.” The American Academy of Ophthalmology had also opposed the legislation.

While the veto closed the book on this particular California bill, a similar bill is now under consideration in South Dakota and debate continues nationwide over whether optometrists should be allowed to perform procedures and make diagnoses that traditionally fall under the purview of ophthalmologists. At stake are questions of patient access and safety, and of financial competition between two overlapping professions.

Already, scientific progress and patient need have propelled the profession of optometry such that its practitioners now provide most primary eye care in the United States, routinely diagnosing and treating conditions that were outside of their scope of practice half a century ago. With continuing advances in a technology-driven field, turf wars in eye care will invariably continue, experts say, with lobbying money playing a key role in determining who is qualified to diagnose and treat a range of common eye conditions.

State legislatures have come to play a key role in this debate because any changes to optometrists’ scope of practice must be explicitly spelled out in law. Physicians, on the other hand, possess a medical license, which grants broad leeway to diagnose patients, prescribe medications, and — in the case of ophthalmologists and other surgeons — remove or repair tissues and organs.

Optometry’s pioneers initially embraced the idea that their work meaningfully differed from that of their medical colleagues. Some noted that a key job of optometrists — dispensing spectacles — benefitted from specialized training in engineering, mathematics, and optical physics, which many physicians lack. Until the 1970s, “we were a drugless profession, and many people were proud of that,” said John Amos, a retired optometrist and former dean of the School of Optometry at the University of Alabama at Birmingham.

In practice, however, the profession had begun dipping into medicine decades earlier. During World War I, the United States Army swelled its ranks to include, for the first time, nearsighted men. The dramatic rise in eye care demand spurred a transformation: Optometry evolved in the 1920s from apprenticeships with variable quality and format to a profession shaped by a standardized curriculum offered at schools across the country. That decade, all states passed laws acknowledging optometry as a licensed profession.

World War II and the Vietnam War pushed the field further, enlisting optometrists to serve in the Army and work at Veterans Administration hospitals — examining patients and, in some cases, performing duties virtually indistinguishable from physicians. During a yearlong stint as an optometry officer in Vietnam, Amos saw patients with pink eye and a wide range of other inflammatory conditions and eye injuries. “I treated everything,” he said.

Yet in civilian settings, diagnosing those conditions, let alone treating them, was off limits. When optometrists examined a patient and found signs of disease, they had to refer the patient to an ophthalmologist for the actual diagnosis.

In the 1970s, several noteworthy advances in eye care served as the impetus for scope expansion. Soft contact lenses were first approved by the Food and Drug Administration in 1971. Compared to hard lenses, which optometrists were already prescribing, soft contacts more often caused complications such as ulcers and eye infections. The conditions were generally treatable — using antibiotic drops and anti-inflammatories that had just hit the scene — but optometrists were not allowed to prescribe medication. This restriction meant that optometrists were similarly unable to offer their patients recently approved eye drops to prevent vision loss associated with glaucoma, a group of conditions — often caused by increased pressure in the eye — that is more common in older adults and can lead to loss of vision by damaging the optic nerve.

To stay competitive, optometrists decided to mobilize. Broadening their scope of practice would require optometrists to “go through the legislative process and change the law,” said Richard Castillo, who trained in optometry and ophthalmology decades ago and now teaches at Oklahoma College of Optometry at Northeastern State University.

Scope expansion required multiple waves of state legislation spanning several decades. During this time, optometrists were given some leeway to use diagnostic drugs, to make diagnoses, and to prescribe treatments. Often the initial laws were limited, and many states saw further rounds of legislation to expand them. In California, for example, optometrists gained some therapeutic privileges in 1996 but could not fully treat glaucoma until 2008. Glaucoma has no cure, but if caught early, medication can help reduce eye pressure and prevent vision loss.

Over time, with advances in medical equipment, ophthalmologists started seeing similar benefits treating some glaucoma patients with laser light, which lowers eye pressure promoting drainage of excess fluids. One such procedure, selective laser trabeculoplasty, has been studied for about three decades. When compared head-to-head with eye drops in a trial in the U.K. of patients with the most common type of glaucoma, laser treatment relieved eye pressure as safely and effectively as drops — and at lower cost to patients and providers.

This outpatient laser procedure is now considered a first-line therapy not only in ophthalmology but also, increasingly over time, in optometry. Before the recent California veto, similar bills extended laser authority to optometrists in 10 states, four since 2021. In total, some 225 state laws have been enacted since the 1970s to broaden the scope of optometric practice.

These legislative changes have come at significant financial cost. To secure therapeutic prescribing privileges in Alabama, for example, the state’s optometric association paid a top lobbying firm $100,000 per year and asked each member to donate, on top of their usual association dues, around $5,000 toward legislative efforts over a four-year period in the 1990s. Those contributions, totaling nearly $1 million, went to political candidates who the polls projected would win or had a reasonable shot, according to an article Amos wrote for Hindsight: Journal of Optometry History. Other states have applied similar strategies.

Though it’s hard to determine how much directly goes toward scope expansion efforts, total lobbying expenditures of California’s optometry and ophthalmology associations last year exceeded $1 million. During that period, the California Optometric Association spent more than $777,000 while the California Academy of Eye Physicians & Surgeons paid just under $300,000.

Experts disagree on what the new scope expansion laws mean for patients. To some, the statutes are troubling because they appear to undercut the science-backed foundation of mainstream medicine. “It’s not necessarily a training or an educational system that ends up defining what is safe and not safe,” said Stephen McLeod, CEO of the American Academy of Ophthalmology and former chair of ophthalmology at the University of California at San Francisco. “It really is legislative — a stroke of the pen.”

Others see the situation differently. “The law has to catch up with the training,” said Kristine Shultz, executive director of the California Optometric Association. Optometrists are no longer trained in loosely regulated apprenticeships. Instead, their four years of post-undergraduate training increasingly incorporate diagnosis and treatment of medical conditions.

Just as optometrists’ scope of practice has expanded over the past 50 years, so has the nature of their curriculum. By the time Soracco completed her four-year doctor of optometry degree in 2016, she and her classmates had learned to recognize and manage a range of eye conditions, including infections, inflammation, and diseases such as glaucoma. They learned which medications to prescribe. They learned how to determine if a skin tag might be cancerous. And by shadowing ophthalmologists in clinical rotations, they have observed firsthand how to use lasers and remove skin tags. “Every optometry school in America right now teaches these office procedures,” said Castillo.

What Soracco’s training did not offer was a chance to perform these methods on live human patients — a key point of contention from opponents of the scope expansion bill. “Treating a plastic eye is not the same thing as treating a real eye,” said Craig Kliger, executive vice president of the California Academy of Eye Physicians and Surgeons. “The tissue reacts totally differently.”

Furthermore, offering laser eye treatments requires much more than mastering the instrument. “The bigger issue is not the mechanics of the procedure itself in a particularly well-chosen patient,” said McLeod, “but choosing the right procedure for the right patient and managing any complications that happen afterward.” With such delicate tissue layers packed into a tiny organ, stakes are high. Often “you get one chance,” he said. “To try and reverse something you’ve done is incredibly difficult to do without some compromise to eye health.”

The National Institutes of Health considers laser surgeries a safe and effective first-line glaucoma treatment, yet case reports document examples of retinal damage resulting from accidental misuse. Researchers have tried to determine, on a broader level, whether optometrists have worse outcomes than ophthalmologists when performing the same laser procedures.

One analysis, published in 2016 in JAMA Ophthalmology, looked specifically at laser trabeculoplasty — one of the procedures on California’s recent scope expansion bill. The researchers analyzed Medicare claims data on 891 patients with glaucoma who received laser trabeculoplasty between 2008 and 2013 in Oklahoma, where optometrists have been offering this treatment for more than two decades. The study found that patients who saw an optometrist for the laser treatment were about twice as likely to undergo additional laser procedures in the same eye, compared with patients who had the initial procedure done by an ophthalmologist.

And in a 2021 analysis, optometrists had worse scores than ophthalmologists in Medicare’s payment incentive program, which rewards physicians based on quality metrics — reduction of eye pressure, for example.

On the surface, both studies would seem to urge caution about extending laser privileges to optometrists. Yet the data can be challenging to interpret. The laser trabeculoplasty study used Medicare billing data, which reports procedure rates but not patient outcomes. Lacking information about eye pressure changes or complications after treatment, some experts suggest it is hard to conclude that a higher volume of care translates to lower-quality procedures.

The payment incentive study is also hard to parse, in part because it is a generalized comparison — data on specific procedures are not available. Plus, performance metrics could be skewed by low-income patients, who are more likely to see an optometrist than an ophthalmologist, said study co-author Dustin French, a health economist in the ophthalmology department at Northwestern University Feinberg School of Medicine.

Aggregate data on health outcomes are notoriously difficult to track in the United States’ fragmented health care system. “There’s almost never a central repository,” said McLeod.

“We have incomplete data now,” he added, “and I don’t see the data getting any better anytime soon.” 

This makes it challenging to produce solid data to support scope expansion, or to refute it. It’s “all speculation and a matter of opinion and position,” French said.

It’s also tricky to compare professional training. Although ophthalmologists spend more total years in post-undergraduate training, the first segment covers medicine more broadly; whereas, the optometry curriculum focuses entirely on eye care — a point that optometrists highlight when advocating for scope expansion. Furthermore, for those wanting laser privilege, the vetoed California bill called for additional training that included 43 procedures on live humans. That would have gone “above and beyond” other states where optometrists got laser authority with very little live patient experience or even none at all, Shultz said.

On the whole, however, optometrists have much less experience treating disease. They mainly see healthy patients for routine eye exams, said Kliger. Ophthalmologists “see more pathology,” which gives them a broader, more nuanced understanding of eye diseases and how to treat them.

At first blush, each side of the scope debate puts the focus on patients. Optometry highlights the need to expand health care access while medicine stresses safety and quality of care.

Both sides also acknowledge that conversations on the ground center around different agendas. “I’ve been to enough department of ophthalmology meetings at enough hospitals where I can tell you the discussion is rarely about patient care when it comes to these scope battles,” said Castillo, a practicing ophthalmologist who teaches optometry students. More often, he added, those conversations revolved around market share, competition, reimbursements — the business of eye care.

Amos, the retired optometrist, agreed. “It is, at some level, always financial,” he said.

Up until the early 1990s, Castillo said, ophthalmologists who performed cataract surgeries earned more than $2,000 per eye. Nowadays, he continued, each procedure reimburses about $600. What happened? Over the years, the surgery became safer, faster, and more effective, which drove up demand in the aging U.S. population, and, in turn, prompted a steep drop in reimbursement rates. “If Medicare was still paying $2,000 per cataract surgery, Medicare would be broke — more broke than it is,” Castillo said. Ophthalmology, he added, “was a victim of their own success.”

Compensation is also a key concern for optometry. When Medicare was enacted in 1965, optometrists were not eligible for payment because the federal health insurance program only reimbursed physicians. It took two decades for optometry to gain inclusion — a historic legislative feat, in the view of leading professional bodies.

Given the steady march of scientific advancements in a technology-heavy specialty, friction over scope of practice in eye care is unlikely to subside. “It may not go on with the same rapidity,” said Amos, “but I suspect it will continue in one form or the other.”

This article was originally published on Undark. Read the original article.

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Researchers at Cleveland Clinic launched their next step in a study of a vaccine aimed at preventing triple-negative breast cancer. Triple-negative breast cancer is the most aggressive and lethal form of the disease, and accounts for roughly 10 to 15 percent of all breast cancers.

According to the American Cancer Society, the term “triple-negative breast cancer” means that the cancer cells don’t have estrogen or progesterone receptors (ER or PR) and also do not manufacture any or much of the protein called HER2. This means that the cells test negative on all three tests and these cancers don’t typically respond to hormonal or targeted therapies. These cancers are most common in patients under 40, who are Black, or who have a BRCA1 mutation. BRCA1 is a gene on chromosome 17 that typically helps to suppress cell growth and a person with certain mutations in the gene has a higher risk of developing some types of cancer. 

[Related: A single HPV vaccine dose can protect against cervical cancer.]

The new phase 1b study will enroll cancer-free individuals who are at a high risk for developing breast cancer. Participants have also decided to voluntarily undergo prophylactic mastectomy to lower their risk of developing breast cancer.

Higher risk individuals typically carry genetic mutations–such as BRCA1– that put them at risk of developing triple-negative breast cancer or have high familial risk for developing any type of breast cancer. 

The new phase of the trial will include roughly 6-12 patients and should wrap up by the end of 2023. Participants will receive three vaccinations administered two weeks apart and will be closely monitored for both side effects and immune response.

The vaccine is designed to work by targeting a lactation protein called alpha lactalbumin (α-lactalbumin). This protein is no longer found after lactation in normal, aging breast tissues, but is present in most triple-negative breast cancers. The vaccine is designed to prompt an immune response that attacks the tumor and keep it from growing if breast cancer develops. 

It is based on pre-clinical research led by the late Vincent Tuohy, who led breast cancer research at Cleveland Clinic’s Lerner Research Institute. It was his research with mice that showed that activating the immune system against α-lactalbumin was safe and effective in preventing breast tumors.

[Related: Personalized vaccines could help the immune system fight cancer.]

This study is funded by the United States Department of Defense and will be conducted at Cleveland Clinic’s main campus in Cleveland, Ohio. The phase 1b clinical trial is conducted in partnership with Anixa Biosciences, Inc. and follows the ongoing phase 1a study. The earlier phase began in 2021 and includes patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and do not have tumors, but are at high risk of recurrence. The phase 1a study is also expected to be complete in the fourth quarter of 2023.

“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd from the Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study, in a press release. “Long term, we are hoping that this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease.”

The first therapeutic cancer vaccine (Provenge) was approved by the Food and Drug Administration (FDA) in 2010, ushering in a new era of cancer treatment. Therapeutic vaccines work by using a patient’s own immune system to fight the disease and are preventative vaccines like those used for cervical cancer, measles, or hepatitis. 

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For patients experiencing conditions like kidney failure, treatments such as hemodialysis or dialysis can filter toxins from the blood when the kidneys can no longer keep a person healthy. It’s life saving, but it comes with the risk of dangerous staph infections in their blood, which can cause blood, skin, joint, and bone infections and pneumonia.

There are also some serious racial and economic discrepancies in the level of risk during dialysis treatments, according to the Centers for Disease Control and Prevention’s (CDC) Vital Signs Report released on February 6. Hispanic, Latino, and non-Hispanic Black Americans, as well as patients with a low socioeconomic status experience a higher rate of infection. 

The findings highlight well-documented healthcare inequities in the United States where race and socioeconomic status directly impacts health. 

The report used data from 2017 to 2020 to pinpoint common patterns among patients who contracted bloodstream infections. It found that in 2020, roughly 14,800 bloodstream infections were reported and 34 percent of them were caused by Staphylococcus aureus (S. aureus)—the bacterium that causes staph infections. The procedure relies on needles and catheters to circulate a patient’s blood through a machine that cleans it.

[Related: These doctors are fighting to make the kidney-donor system less racist.]

“Germs like staph can get into the patient’s bloodstream via these access points,” said acting principal deputy director of the CDC Debra Houry, in a briefing on February 6. “These infections can be serious or deadly, and some are resistant to some of the most common antibiotics used to treat them.”

Patients undergoing dialysis had an annual rate of staph infections that was 100 times higher than adults who are not on dialysis.

While the study found that staph infections dropped 40 percent between 2014 and 2019, it still shows that there’s a lot of work left to make dialysis treatments safe for all patients in the United States.

Hispanic, Latino, non-Hispanic Black Americans were disproportionately affected by dialysis-linked bloodstream infections, since there are race, ethnicity, and social determinants of health affect the development of end stage kidney disease. These populations are at a higher risk for kidney disease partially due to higher rates of diabetes and hypertension.

“Overall for Hispanic patients after adjusting for other factors, we found a 40 percent higher risk of bloodstream infection for that group,” said study author Shannon Novosad, dialysis safety team lead in the CDC’s Division of Healthcare Quality and Promotion, during the briefing. 

[Related: The US’s healthcare system discourages people from getting care, new study says.]

The type of access used in dialysis treatment was also important, as patients who were connected to a machine with a central venous catheter had a higher risk of infection. Using this method, a thin tube is directly inserted into a vein, typically in the neck or chest. The other end of the tube is outside of the body, where it can be exposed to germs. 

“Our data confirm this use of a central venous catheter as a vascular access type has six times higher risk for staph bloodstream infections, compared with the lower risk, lowest risk fistula access,” said Novosad. 

Using grafts (small, plastic tubes that are connected to an artery and a vein) and fistulas (which join an artery and a vein directly) were deemed to be safer methods by the report.

“Removing barriers to lower risk vascular access types for dialysis treatment is a critical step for preventing infection,” said Novosad. “It is vital to coordinate efforts among patients nephrologists, vascular access, surgeons, radiologists, nurses, nurse practitioners and social workers to reduce the use of central venous catheters for dialysis treatment. It’s also critical to educate patients on potential treatment options and vascular access types before they develop end-stage kidney disease.”

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Men taking erectile dysfunction pills may be adding years to their life, suggests a sweeping observational study published in early January. The research, published on January 13 in The Journal of Sexual Medicine, reported cardioprotective effects from sildenafil, the generic name for Viagra and Revatio. Sildenafil was originally developed as a heart medication before eventually becoming approved for ED. The findings support earlier claims during the drug’s development that it possesses cardiac benefits.

“In general, these drugs appear to be safe in regards to major adverse cardiovascular events,” says lead study author Robert Kloner, a professor of medicine at Keck School of Medicine at the University of Southern California, chief science officer at Huntington Medical Research Institutes, and lead author of the study. However, he cautions that the study only showed an association, not a causal relationship, between the drug and lowered risk of heart problems and mortality. The research was partially funded by Sanofi, a pharmaceutical company that produces the erectile dysfunction medication Cialis.

[Related: Viagra could have been a groundbreaking cure for period cramps]

Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by blocking an enzyme in the walls of blood vessels, which allows them to relax and widen, increasing blood flow, most notably in the penis. But it can also improve blood flow to other areas of the body and is currently approved as a treatment for pulmonary hypertension for both men and women in the US. Decades of research in men taking PDE5 inhibitors for erectile dysfunction suggests that the drug could also help treat other heart problems, although most of these studies lacked control groups and involved small sample sizes. Kloner and his colleagues were interested in studying other health benefits the drug provides in a much larger pool that would be more likely to use it—men with ED living in the US.

The study authors analyzed 14 years of medical records of men 18 years and older diagnosed with erectile dysfunction for at least one year. The patients were classified into two groups: The first group included more than 23,000 men who spent one or more years using PDE5 inhibitors like sildenafil, and the second group was made up of more than 48,000 men with no record of ever using these drugs.

Men who had taken PDE5 inhibitors showed a 13-percent lower chance of future heart problems that involve reduced blood flow to the cardiac muscle, such as a heart attack, stroke, or chest pain, versus men who have never taken the medications. What’s more, PDE5 users were 39 percent less likely to die from a cardiovascular-related death, and 25 percent less likely to die from any cause compared to the non-exposed group. 

The amount of pills they took also mattered. Men with ED prescribed the most PD5 inhibitors (an average of 191.2 tablets) showed the most reduced risk of heart issues (55 percent) and premature death (49 percent) than those given the lowest amount of pills (an average of 5.5 tablets). “The encouraging aspect of the study was that nearly all the endpoints were improved in the same direction that is in favor of PDE-5 inhibitor exposure. This finding was consistent across the study,” says Kloner.

At first glance, the positive results might make it seem like everyone should take ED treatments to stay heart-healthy. But that’s not the case, as the observational study design makes it difficult to rule out any other explanations. For one, it only measured the number of pills given to patients, not the number actually taken, says Rigved Tadwalkar, a cardiologist at Providence Saint John’s Health Center in California who was not involved in the research. “Filling a medication does not necessarily equal taking the medication.”

Men who chose to take Viagra could have also been heart-healthier from the start. A doctor may feel hesitant to prescribe the drug to someone with a history of poor cardiovascular health, says Rena Malik, a urologist and associate professor of surgery at the University of Maryland School of Medicine who also was not involved in the study. “When does sex become risky? It’s usually when you have really poor cardiac health, and that’s when you shouldn’t be having much sex.” What’s more, for those engaging in between-the-sheets activity, it may be the exertion itself that’s providing cardiovascular benefits. People who often have sex may already be fitter than someone who is not, Malik explains. “It’s possible they have less chronic pain, are more mobile, and are flexible.” Additionally, being intimate with someone could imply that they’re less lonely than someone without a partner. “We know loneliness is associated with mortality and poor heart health outcomes” Malik notes, all of which could contribute to a higher risk of cardiac-related mortalities.

But both Tadwalkar and Malik agree that the study findings shouldn’t be dismissed, even if there are several confounding variables. “There are many factors that could play a role, but PD5 inhibitors are vasodilators that allow for blood flow, so it makes sense that these could also be protective,” says Malik. She and Tadwalkar further noted that the study was well-executed and adds a lot of value to what we already know about PD5 inhibitors. Tadwalkar underscores that doctors may be more willing to use these drugs in patients with cardiovascular problems who want to take Viagra if there are no significant and harmful reactions to the drug. 

[Related: Research on aphrodisiacs is kind of unsatisfying]

PD5 inhibitors could also be prescribed to protect the heart health of women. While female patients were not part of the study, Kloner says the drugs have the capability of relaxing blood vessels and reducing mortality for them, too. A randomized, placebo-controlled clinical trial will be needed, however, to expand the findings to other populations and make more conclusive recommendations around PD5 inhibitors and any potential cardiac benefits.

“The issue is who is going to pay for a [clinical trial],” says Kloner. Because the drugs are generic, he says there has been low interest from pharmaceutical companies and the government to support a large erectile dysfunction-related analysis that isn’t based on preexisting data. “But perhaps with our study, there will be renewed interest in funding such a study,” he states, “[and possibly] allow for new indications for these drugs for the practice of preventative cardiology.”

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Nearly 2 million people, most of them Black or Latino men, are locked up in the United States. In October 2021, the National Institute of Justice, the research arm of the U.S. Department of Justice, published a report arguing that correctional officials should examine the biology of imprisoned people — their hormones, their brains, and perhaps even their genes.

The report describes a future in which corrections sounds a bit more like practicing medicine than meting out punishment. Correctional programs would gather information about incarcerated peoples’ cortisol levels, heart rate, genes, and brain chemistry, and more. They would then use that data to tailor interventions to specific individuals (say, offering one person mindfulness training, and another ADHD medication), and to help estimate the risk that someone will reoffend.

To some, such a proposal may sound invasive, even dystopian. The report’s author, Sam Houston State University biopsychosocial criminologist Danielle Boisvert, suggests it offers a chance to streamline a clunky system: By “excluding known biological and genetic factors that affect behavior,” she wrote in the report, “the criminal justice system may be suppressing its ability to fully benefit from its correctional efforts.” (Boisvert did not respond to requests for an interview.)

The DOJ report represents a new frontier in the discipline of biosocial criminology — a decades-long effort to bring biology back to the study of crime. Researchers in the field have scanned the brains of people convicted of murder and scoured the genomes of teenagers who belong to gangs. Biosocial criminology is “really a kind of smorgasbord of a lot of other disciplines, but trying to apply it to human behavior — and specifically antisocial behavior,” said J.C. Barnes, a biosocial criminologist at the University of Cincinnati.

Today, some of the nation’s top-ranked criminology programs are thriving hubs of biosocial research. Biosocial criminologists teach future prosecutors, law enforcement, and correctional officers.

But the rise of biosocial criminology has also sparked alarm among some scholars, who argue that the science is shoddy — and that racist ideas and assumptions animate the field. “The work that they’re doing is really serious, and really dangerous,” said Viviane Saleh-Hanna, a professor of crime and justice studies at UMass-Dartmouth.

Indeed, the use of biology has long divided criminologists. In the 19th and early 20th centuries, criminologists measured the skulls of imprisoned people and analyzed their bone structure. Often, they drew blatantly racist conclusions. Even as biosocial criminology grows more mainstream, it remains an open question whether the discipline can be disentangled from that racist past. A close review of the relevant literature shows that some biosocial criminologists have drawn on discredited ideas that describe Black people as inherently predisposed to crime.

Others, while steering away from writing about race, appear to largely tolerate that work. “There doesn’t seem to be a pushback against the folks who are writing about this in the field,” said Oliver Rollins, a medical sociologist at the University of Washington and the author of “Conviction: The Making and Unmaking of the Violent Brain,” a 2021 book about neuroscience and crime. “No one’s challenging these kind of racist components to the science, or the research.”

Talk with criminologists about biology, and one name comes up again and again: Cesare Lombroso. Born in 1835 in northern Italy, Lombroso trained as a physician. He soon grew fascinated with the physiology of people who had been convicted of crimes.

Lombroso dissected the corpses of people with criminal records, examined the feet of sex workers, and visited prisons to measure the dimensions of people’s heads. In his 1876 book “Criminal Man,” he concluded that some people were born with a predisposition to criminality — especially people he considered, without evidence, to fall lower in the evolutionary hierarchy, including southern Italians and people with African ancestry. A collection of human specimens, including 712 skulls, is now preserved in the Cesare Lombroso Museum of Criminal Anthropology in Turin. (Lombroso also asked that his own corpse, which he deemed as superior, be integrated into the collection; according to the museum’s scientific director Silvano Montaldo, the criminologist’s skeleton is currently on display, while his brain, as well as the soft tissues of his face, are “kept in the warehouses,” in accordance with “the indications of the Italian law regarding exposures of human remains.”)

Lombroso’s work has been widely discredited. But his influence, historians say, was considerable — including among eugenicists in the early 20th century who sought to identify and eliminate strains of what they saw as degeneracy in populations. “Criminologists consider it edifying to believe that a man can be saved by grace, but refuse to admit that he can be damned by germ plasm,” the American eugenicist Earnest Hooton complained in 1932, reporting on the results of a study of 16,000 incarcerated people. His conclusion: Biology mattered. “I am beginning to suspect that Lombroso, like Darwin, was right,” he wrote.

By the late 20th century, that legacy had left many criminologists hesitant to engage with biology. Still, amid advances in genetics and brain imaging, some scholars called for the field to explore a potential connection between biology and crime.

Among them was Anthony Walsh. A former police officer, Walsh entered graduate school in his mid-30s, moonlighting as a probation and parole officer to support his young family. By 1984, he was an assistant professor of criminal justice at Boise State University, preparing students for careers in the criminal justice system. His early research mostly examined sentencing guidelines and the probation process.

Over time, though, Walsh grew frustrated with his colleagues. He thought they spent too much time focusing on the social causes of crime. “Everything and everybody was accountable for the crime, except the guy who committed it,” he told Undark in a 2022 interview. In particular, Walsh wondered if fields like genetics and evolutionary biology could help explain why some people offend, and others do not.

Those kinds of inquiries could face backlash. For example, in 1992, the National Institutes of Health agreed to fund a conference on genetics and crime. The federal science agency later withdrew the funding after an uproar, fueled by revelations that a key organizer had once seemingly compared Black urban neighborhoods to jungles. Critics worried that genetics would become a high-tech tool for racial profiling.

Criminologists like Walsh did little to dispel such fears. In 1997, he and a colleague, Lee Ellis, drew on the speculative theories of a white-supremacist aligned psychologist to suggest that White people had evolved to be less violent than Black people, and that biology could explain why more Black people than White people end up imprisoned.

To most crime researchers, those claims have serious problems. Decades of research — in many disciplines — have documented how generations of racism, disenfranchisement, and uneven policing disproportionately direct Black people, poor people, and other marginalized groups into the criminal justice system.

At the same time, experts in human evolution say, biology is a terrible tool for explaining these kinds of racial disparities. For one thing, racial categories are just rough attempts to describe the biological variation among human beings, rather than fixed, coherent categories of people who have evolved along different trajectories. For another, even if scientists can sometimes identify average genetic differences among socially defined groups, those differences tend to be very slight — and have no obvious link to a complex social phenomenon like violent behavior.

It’s “just kind of fascinating that we would presume that there is something that’s so simplistic about complex behaviors, that it could map on to something like skin color in a fairly straightforward way,” said Deborah Bolnick, an expert in human evolution and genetics at the University of Connecticut.

Despite such concerns, Walsh and his co-author published their theory in the field’s flagship journal, Criminology. And Walsh soon found himself gaining new colleagues who were interested in biology and crime. Starting in the late 1990s, a growing number of criminologists turned to biology, aiming to integrate genetics, neuroscience, and sociology to produce more robust theories of crime. Some feared they would face professional repercussions for doing so. “My mentor, when I told him what I was doing, was like, ‘John, don’t do this,’” said John Paul Wright, a criminologist at the University of Cincinnati and an early proponent of using genetics to study crime. “He was worried about the consequences for my career.”

Wright and others called the emerging discipline biosocial criminology — a rebranding that was complete by 2009, when Walsh and a colleague edited a book, “Biosocial Criminology,” featuring essays from leading scholars in the young field. (Boisvert, the author of the DOJ report, contributed to a chapter.) A preface, written by another Cincinnati criminologist, Francis T. Cullen, acknowledged the discipline’s troubled history. Biosocial criminologists, he wrote, “will have to show how the new paradigm rejects its repressive heritage.”

Not everyone was convinced that biosocial criminology was so different from its predecessors.

Saleh-Hanna, the UMass-Dartmouth professor, began attending the annual American Society of Criminologists conference in the 1990s, as a student. She soon gravitated towards panels on biology and crime.

At these sessions, Saleh-Hanna sat in the back. She took notes. She rarely spoke. Usually, she said, she was the only Black person — in fact, the only person of color — in the room. “I always felt like I had a responsibility to my own communities to go and listen,” Saleh-Hanna told Undark. “I always knew that they were talking about us.”

The basic process described at the conference, Saleh-Hanna said, felt like a throwback to Lombroso: Scientists looked at the bodies of poor, marginalized people, isolated some biological characteristic, and used it to suggest that those people were inferior or dangerous. “They’re still doing that same work,” Saleh-Hanna said, “but they’re using this new scientific language.”

Saleh-Hanna has sometimes brought a Black colleague, Montclair State University criminologist Jason Williams, to the presentations. He said the sessions often involve all-White academic panels commenting on the biology of people who had been accused of crimes. “Here you are sitting up here on this panel, and you’re generalizing largely people of color, but then also poor Whites,” Williams said. “Anybody who’s really powerless, I think, gets the lower end of the stick with those theories, in those studies.”

Indeed, biosocial criminologists have sometimes used new techniques to circle back to an old conclusion: that biology can help explain why the criminal justice system locks up so many people of color. There’s scant scientific evidence to support that claim. Still, in the same 2009 volume in which Cullen urged the field to reject “its repressive heritage,” his University of Cincinnati colleague, Wright, wrote a chapter arguing that biological differences among racial groups explain disparities in crime.

Portions of the field would go on to celebrate those ideas: Despite Walsh’s ongoing writing about race and crime, the Biosocial Criminology Association honored him with its lifetime achievement award in 2014, citing his “invaluable impact on our current understanding of why people commit crime and delinquency.”

In 2015, six criminologists, several teaching at large public universities, published a sweeping “unified crime theory” in Aggression and Violent Behavior, a peer-reviewed criminology journal put out by scientific publisher Elsevier. In the paper, they draw heavily on the work of the late J. Philippe Rushton, a professor of psychology at the University of Western Ontario. Now largely discredited by the scientific community, Rushton spent much of his career arguing that White people have evolved to be smarter, more altruistic, and less violent than Black people. Twisting a theory from ecology, Rushton also argued that some racial groups have evolved to be more fertile — but, in a kind of tradeoff, have also evolved to be more aggressive, less able to exercise self-control, and less intelligent.

Many scientists now describe Rushton’s work as incoherent, riddled with errors, and blatantly racist; his own university eventually disavowed him. The theory is “pulp science fiction” that’s “draped in the lingo of evolutionary theory,” Yale University ecology and evolutionary biology assistant professor C. Brandon Ogbunu wrote in a recent essay for Undark.

Bolnick, the Connecticut researcher, said that Rushton’s theory treats humans as “reproductive machines,” in a way that doesn’t really reflect how people live. “It doesn’t map onto the way any human societies operate, or any families operate,” she said. And Rushton and his acolytes also selectively apply the theory, she said, in ways that mostly just repackage old stereotypes: For example, they spend little time considering the large families of White settlers in the 19th century U.S.

Still, for years, Rushton’s work was cited in the biosocial criminology literature. In the 2015 paper, the researchers drew on Rushton to speculate that this evolutionary path could help explain racial disparities in convictions.

Later that year, the lead author of the paper, Brian Boutwell, took to the right-wing magazine Quillette to complain that biosocial criminologists were being shunned by their colleagues. Around that time, Boutwell and one of his co-authors on the paper, Florida State University criminologist Kevin Beaver, appeared separately on the show of alt-right podcaster Stefan Molyneux to talk about the links between crime, biology, and race. (Wright, one of the Cincinnati professors, appeared on the show too.)

Shunned or not, the authors of the paper maintained active careers. Boutwell is now an associate professor at the University of Mississippi. One of his co-authors, J.C. Barnes, was until recently the chair of the Biopsychosocial Criminology division of the American Society of Criminology. Another co-author, Beaver, now directs the Biosocial Criminology Research & Policy Institute at Florida State University, and he maintains an affiliation with King Abdulaziz University in Saudi Arabia. (Beaver did not respond to requests for an interview.)

Many biosocial criminologists are skeptical of such work on race, and worry it will hamper their efforts to gain broader acceptance for their techniques, according to Julien Larregue, a sociologist at Université Laval in Quebec who has studied the field. But, he noted, that criticism is mostly informal: “If you look at publications, I don’t find a lot of pushback.”

In the broader field of criminology, though, some experts have raised questions about certain methods that biosocial researchers use. In particular, some have questioned efforts to draw a line from specific genes to criminality or antisocial behavior.

One of the most persistent critics has been Callie Burt, an associate professor at Georgia State University. Around 10 years ago, Burt was asked to review a paper examining genetics and crime. Trained in sociology, she quickly realized she didn’t have the tools to follow the argument. Undeterred, Burt dove into the genetics literature. “I’ve learned that we know a lot more about genetics than I realized,” she said. “But the more we learn, the more complicated things are.”

Burt had plenty to catch up on. The first sequencing of the full human genome, completed in 2000, was accompanied by a wave of new research aiming to tie specific genes to specific outcomes. Biosocial criminologists embraced that work. In the 2000s, some gravitated toward a then-trendy method called a candidate gene study, in which researchers look at whether a specific gene may be linked to certain traits. Some focused on a hypothesized link between violent behavior and a gene called MAOA. (“‘Gangsta Gene’ Identified in U.S. Teens” read one 2009 headline from ABC News, reporting on work by Beaver and colleagues.) But subsequent research has cast doubt on most candidate gene studies, including those purporting a connection between MAOA and violence. “That finding’s not in great shape,” said Michael “Doc” Edge, a population geneticist at the University of Southern California.

Recently, some biosocial criminologists, including Boutwell and Barnes, have been joining with behavioral geneticists and other scientists on genome wide association studies, or GWAS (pronounced GEE-wahs). The technique, pioneered in the past two decades, scans vast databases of genetic data, looking for correlations between particular genes and certain outcomes, such as height, IQ, or college graduation.

Burt and others argue that even these high-powered new studies rest on some misguided assumptions. Like many other experts, she’s skeptical that it’s possible to disentangle nature and nurture so neatly — in part because the categories of crime and antisocial behavior are themselves so slippery.

The problem, according to Burt and other experts, is that crime and antisocial behavior aren’t straightforward, easy-to-measure traits. Rather, these behaviors are socially constructed and highly variable. Something that’s a crime in one state — such as smoking pot — may be legal one state over. An aggressive action — such as punching someone repeatedly until they lose consciousness — may be celebrated in one context (a boxing ring) and illegal in another (a bar). And two people can be treated very differently for doing the exact same thing: Research suggests that Black elementary school children, for example, are likelier to receive disciplinary action than White children, independent of their actual behavior. And studies often find that Black adults who use drugs are likelier to be arrested and incarcerated than White adults who use drugs.

“We behave in context,” Burt said. She brought up an example: People who have “biological propensities — and I can agree that we have different ones — that might lead to impulsivity or risk-taking or even selfishness and disregard for other people, sort of predatory activities.” In an affluent environment, Burt said, someone with those traits may end up flourishing: They go to Wall Street, where their predatory behaviors lead to large paychecks. Meanwhile, “someone growing in inner city, with not those opportunities,” she added, “may end up engaging in predatory behaviors that are criminalized.”

Burt and other critics say that biosocial accounts of crime just don’t fully account for this complexity. A study linking, say, high testosterone levels with felonies runs the risk of implying that testosterone levels are immutable — and that felonies are somehow a set natural property, like the height of a person or the length of a day, rather than a contingent and shifting target.

Saleh-Hanna sees that as a fundamental problem in the field, one going all the way back to Lombroso. “He created this impression, that we still struggle with every day in this society, this impression that crime can be objectively scientifically defined external to the human perception,” she said. As a consequence, she added, “these notions of crime and criminality continue to be seen as natural parts of human societies.”

Certain biases, scholars say, also shape which kinds of crimes end up under the scrutiny of biological methods — and which do not. “We don’t have a notion that crimes of finance are explained by biology,” said Troy Duster, an emeritus professor of sociology at UC Berkeley. “‘Let’s take the DNA samples of the people who were involved in the Enron scandal’ — no one suggested that.” It’s only when Black, Brown, and poor White people are involved, Duster and other scholars suggest, that criminologists start to turn to biology to understand what might have gone wrong.

Recently, some genetics researchers have tried to address some of these concerns by broadening their target to “antisocial behavior” — a catchall category that can include criminal conviction, but also things like personality test results and behavior in school, although these, too, come with their own biases.

In 2013 Jorim Tielbeek, at the time a geneticist and crime scholar at VU Medical Center Amsterdam, founded the Broad Antisocial Behavior Consortium, or BroadABC, a global network of scholars who hope to uncover some of the genes associated with antisocial behaviors. (The group’s first paper, published in 2017, briefly cites some of Boutwell and his colleagues’ work involving Rushton.) In late October, the consortium published their most recent study, which draws on genetic data from more than 85,000 people.

How much that kind of research can explain remains disputed. For all the power of new tools like GWAS, some geneticists say, they have only highlighted how incredibly complex the relationship is between genes and their environment.

The process, these experts say, is even harder when studying a complicated social outcome like a criminal conviction. Eric Turkheimer, a behavior geneticist at the University of Virginia known for his skeptical takes, told Undark that he would be surprised if such approaches could account for even 1 percent of the variance among something like criminality, once researchers control for confounding factors. “And if that’s true,” he asked, “what good is it?”

Some biosocial criminologists say those sorts of concerns have pushed them to reconsider elements of their work. Boutwell, the University of Mississippi professor, said he has revised his thinking. “I think our sociological colleagues make a stronger case when they talk about the historical cultural factors that have underpinned the disparities that we see,” he said, adding that he no longer stands behind his previous work on race.

One of his collaborators, Barnes, also described changing his approach. Barnes grew up in South Carolina; his stepfather and two siblings work in law enforcement. As a graduate student, he studied with Kevin Beaver at Florida State; a senior scholar in the field described him, in an email, as “possibly the most articulate leader of the younger generation.” In an interview with Undark, Barnes said reading the work of Turkheimer and the behavioral geneticist Kathryn Paige Harden had pushed him to take a far more cautious approach to making claims about genetics and crime. He pointed to a more recent, measured paper on genetics and crime that he wrote in 2018. That paper calls on biosocial researchers to pay close attention to social and environmental factors, rather than focusing on genes in isolation. Still, the paper suggests that genetics could say something meaningful about why the criminal justice system incarcerates so many people of color. “The amount of time and care I put into that article,” he said, “is where I wanted things to be focused from there forward.”

Barnes said he’s grown more cautious in drawing conclusions about the complicated factors that drive people to crime. “It’s clear our genetic and biological makeup have an impact on our behavior,” Barnes said. “But can we get much more specific than that? I don’t think we can at this point.”

At least some criminologists have found themselves in a kind of gray area — at once skeptical of certain biosocial explanations of crime, but still open to the idea that biology plays some role in understanding violence and transgression.

When the criminologist Michael Rocque was in graduate school, he worked closely with the late Nicole Hahn Rafter, a feminist criminologist who devoted much of her career to studying Lombroso’s grim legacy, including his influence on the American eugenics movement. Working with Rafter, Rocque said in a recent interview, had an unexpected effect: It pushed him to consider how biology could still be used to responsibly to think about crime.

Today, Rocque is an associate professor at Bates College, and he has published studies documenting how bias affects the disciplinary action faced by young Black students. He’s also a co-author, with Barnes and another colleague, of a recent book on biopsychosocial criminology, and he occasionally uses biosocial methods in his work. “I have just read too much empirical research, and seen too much evidence that genes do matter,” he said. “They’re part of the story when it comes to understanding and explaining criminal behavior.”

Still, he cautioned, studies of things like genetics or neuroscience in crime often remain tentative — and not ready for applied use now. And if they ever are ready for applied use, he said, there will have to be protections in place to make sure their use is beneficial. “In my view, we’re not at the stage where any of this stuff can be put into practice in a responsible way,” said Rocque.

That hasn’t stopped some researchers from exploring potential applications. In fall 2021, the National Institute of Justice held an online symposium to announce a new volume on the study of people who desist from crime. “This volume is a significant achievement in the field of criminal justice research,” said Amy Solomon, a senior Department of Justice official appointed by Attorney General Merrick Garland, in introductory remarks.

Included in the volume was the 2021 report by Danielle Boisvert, the Sam Houston State criminologist. (Rocque also contributed a chapter.) In a presentation during the session, Boisvert discussed some of the many tools that a biologically-informed correctional system might use. At times, those tools seemed to blur the line between corrections and medical care: For example, Boisvert argued that neuropsychological and physiological testing could help identify developmental issues in incarcerated people, and allow them to receive appropriate care. Such testing could potentially help prisons better evaluate whether or not someone is likely to end up incarcerated again. In some cases, she argued, they may even make a case for keeping a person out of prison altogether.

Afterward, a DOJ staffer posed a question to Boisvert: How could these techniques avoid “condemning people from birth based on their biological characteristics?” Boisvert called for programs that focus on the way the environment manifests in the body — “trauma, abuse, neglect, substance use, traumatic brain injury, lead exposure” — rather than on people’s genes.

“There are other noninvasive low-cost ways that we can incorporate biological factors into assessments,” she said, “that don’t rely on DNA.”

Many experts remain skeptical that such interventions could ever do much to fix a criminal justice system they describe as systemically racist and deeply broken. “If you’re only making that system more efficient, then racism will continue to exist,” said Rollins, the University of Washington sociologist. Things like neurobiological models of crime, he said, aren’t able to address such fundamental problems.

“The only thing that they can really do,” he added, “is reinforce what’s already there.”

This article was originally published on Undark. Read the original article.

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On Thursday, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee unanimously voted to support a new plan simplifying future COVID-19 vaccines, making them similar to annual flu shots.

At the meeting, the advisory panel said that a single annual vaccine would be less confusing and more effective to health care workers and patients alike. 

In a 21 to 0 vote, the panel voted to direct Moderna, Pfizer/BioNTech, and Novavax to “harmonize” the first doses (or primary vaccination series) with the new bivalent booster shots that protect against the original strain of the virus and the newer Omicron variant. 

[Related: What’s really going on with myocarditis and COVID vaccines.]

“This is a consequential meeting to determine if we’ve reached the point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” said FDA’s David Kaslow, the Director of the Office of Vaccines Research and Review..

Under previous guidance, patients must first get two shots of the original vaccines (spaced weeks apart) and then a bivalent booster tailored to protect against the Omicron variant two months later. 

Members of the advisory panel were also supportive of a new approach that is more like the strategy seen with the annual flu vaccine. Currently, the annual flu vaccine is created each year to match whatever strain of the virus is circulating. This way, patients and healthcare professionals wouldn’t have to worry about how many shots they’ve already gotten and when they were administered. 

“I think this is a reasonable approach. We have to keep reminding ourselves that this is not influenza and we need to keep paying attention to that to make sure we don’t just follow that dogma because we’re used to doing it,” said Bruce Gellin, a temporary voting member of the panel and chief of global public health strategy for the Rockefeller Foundation’s pandemic prevention institute. “We’ll try this this time. I don’t think we’re setting it in stone and we’ll see how it goes. We may need to adjust along the way.”

The agency also addressed varying risks to people with different health status and ages in briefing documents released ahead of the meeting. ​“Most individuals may only need to receive one dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period of time.  Two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals),” the FDA wrote.

If a more dangerous COVID variant were to emerge, the FDA said it might reconsider the strain used in the vaccine at other times of the year on an “as-needed and emergent basis.”

Additionally, the timing of annual boosters was debated since COVID-19 hasn’t fallen into a seasonal pattern like the flu—instead  COVID-19 waves emerge periodically year round.  Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research said that there is some evidence SARS-2 is developing a seasonal pattern, but that comment was not universally agreed upon in the meeting. 

“When do we have to worry about the worst overwhelming of the hospitals? It will be when we have influenza, RSV, and potentially covid at the same time,” said Marks.

There is also a debate among scientists if updating the COVID-19 vaccines really does make them more effective and some critics of the FDA’s proposed new strategy argue that investing in developing better vaccines that are more appealing to people, such as intranasal vaccines that could also help curb transmission of the disease, and more robust vaccination campaigns might be more effective.

[Related: Omicron boosters are the future of COVID vaccines in the US.]

“Particularly now when Congress is not allocating new funds for COVID response, we have to be especially judicious in how we spend our money and what would be most cost-effective,” Celine Gounder, a senior fellow at the Kaiser Family Foundation, told NPR. “It’s unclear whether updating the booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage.”

Uptake of vaccine boosters remains slow. Roughly 40 percent of adults over 65 and only 16 percent of those 5 years and older have received the latest COVID-19 booster. 

In a separate development on Thursday, the FDA also halted the emergency use authorization (EUA) of Evusheld, a monoclonal antibody treatment used to prevent COVID-19 in immunocompromised people who are less likely to generate a robust immune response from vaccination. The treatment does not appear to protect against the variants currently circulating.

The agency advised those who are infected to seek medical care and ask about antiviral treatments like Paxlovid, remdesivir, or molnupiravir, which do work against currently circulating variants.

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Among an overwhelming number of other life changes, over 23 million Americans adopted new pets during the COVID-19 pandemic lockdowns. Since then, the country’s influx of animal ownership has frequently strained veterinarians’ availability and resources, causing some states such as Michigan and Indiana to ease restrictions on veterinary client patient relationships (VCPR) laws previously requiring an initial in-person, hands-on animal examination before prescribing many medications or treatments.

Now that pandemic restrictions are largely lifted, however, expert groups including American Veterinary Medical Association (AVMA) have begun urging a return to traditional VCPR regulations, arguing that telehealth can’t replace at least early in-person examinations from professionals. One of the country’s most popular online pet suppliers, however, is leading a concerted push to change that—despite many critics’ concerns. 

[Related: Outdoor cats spread disease and harm public health.]

What Amazon aims to do for human telehealth, Chewy hopes to accomplish for your pets. Enter their Connect with a Vet feature, which allows pet owners to speak with professionals on a variety of issues and concerns, although the feature doesn’t allow for actions like prescription orders. Instead, the portal’s experts can advise pet owners on conditions, and help determine if an issue is an emergency requiring more immediate, in-person vet visits.

The feature launched two years’ ago, hasn’t been able to expand as widely as it could if regulations modernized for telehealth, Chewy CEO Sumit Singh argued earlier this week on CNBC.

“Why? Because when you research pet health, you’ll find that there’s a specific term called VCPR,” he says. As such, Chewy has donated untold sums of money to a lobbying group called the Veterinary Virtual Care Association, which urges states to ease their remote animal examination laws. 

[Related: Toddlers may be wired to help their dog friends.]

Medical care for animals requires vastly different regulations and guidelines, and while many veterinarians aren’t opposed to telehealth in very certain circumstances, some remain staunch in the beliefs that it simply is no substitute for in-person examinations and treatment. To some veterinary experts, such as Linda Isaacson, a veterinarian in Brooklyn, New York, speaking with CNBC, the potential costs outweigh the benefits. “I think it works better for human medicine, but for animals, you know, it wasn’t ideal,” Isaacson said of her experiences with similar online services. “It’s not like a person that can tell you how they’re feeling or sit still or show you something.”

Still, it’s unlikely that companies such as Chewy will abandon efforts to garner larger footholds in the animal telehealth industry—in some instances, it could feasibly be an alternative for pet owners already constrained by a lack of options. 

But for now, many professional vet organizations remain committed to traditional methods of treatment.“Without a VCPR, any advice provided through electronic means should be general and not specific to a patient, diagnosis or treatment,” reads AVMA’s current telemedicine guidelines.

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This article was originally featured on KHN.

For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.

As a transgender woman, Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.

“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’”

So Rainey drives around 170 miles round trip every six months to get a supply of estrogen from a clinic in Memphis, Tennessee, to take home with her.

The obstacles Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural U.S. often face: a general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.

“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Dr. Morissa Ladinsky, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama-Birmingham.

Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly 1 in 6 transgender adults in the U.S. live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.

One in 3 trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. Additionally, a third of all trans individuals report having to teach their doctor about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.

A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as all transgender adults to travel 25 to 49 miles for routine care.

In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.

Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.

Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.

Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Dr. Justin Bailey, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.

On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.

Some medical schools, like the one at UAB, have pushed for change. Since 2017, Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.

For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.

In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.

Since UAB launched its program, students’ reactions have improved significantly, she said.

This progress is being replicated by other medical schools, said Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”

Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a four-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.

For many years, doctors failed to recognize the need to learn about gender-affirming care, said Dr. Caroline Kirsch, director of osteopathic education at the University of Wyoming Family Medicine Residency Program-Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Kirsch, who has participated in the ECHO Colorado program.

“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”

Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans kids without necessary care.

Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.

“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Amazon’s latest foray into the healthcare industry is arguably its most dramatic push yet, but with it comes major concerns from healthcare experts and critics.

On Tuesday, Amazon announced the unveiling of RxPass, a subscription service benefit for Prime members initially offering over 50 commonly prescribed generic medications alongside free two-day shipping. For a flat rate of $5 per month, Prime members can now refill any of their medications included in the program after verifying eligibility and prescription information, regardless of existing insurance coverage.

[Related: Amazon telehealth service goes live in 32 US states.]

RxPass represents a potentially major new phase for Amazon’s previously slow-but-steady foray into the national healthcare industry. Late last year, the Big Tech giant debuted Amazon Clinic, a telehealth service connecting consumers with licensed professionals to help treat common conditions such as acne, allergies, and asthma while also providing prescriptions such as birth control. Amazon Pharmacy has also offered its customers medication fulfillment alternatives since 2020, but the arrival of RxPass could offer one of the most enticing healthcare alternatives for Prime members. 

That said, some critics aren’t so sure about its actual consumer reach, noting its limitation to Prime subscribers paying at least $139 annually for their memberships. “I just don’t know that it’s expanding access to a new set of patients,” Karen Van Nuys, a University of Southern California economist focused on drug pricing, told The Washington Post on Tuesday. Van Nuys also cited the existence of similarly priced services like Mark Cuban’s CostPlus Drug Co., which launched last year.

With RxPass’ newfound potential convenience comes major potential privacy costs, as well. Firstly, Amazon had an extremely troubling track record with data security well before it pushed further into the lucrative and high-consequence healthcare sector. And even with improved privacy safeguards, Health Insurance Portability and Accountability Act (HIPAA) regulations only ensure patient record confidentiality as soon as they begin interacting with health service providers. All the information leading up to that exact moment is up for grabs, which Amazon could theoretically devour for its own marketing purposes. For instance, you may search Amazon prescriptions related to chronic heartburn, but ultimately decide against purchasing your antacid medication through RxPass—only to soon begin receiving a suspiciously targeted flurry of “Prime Deal” Tums coupons in your email inbox.

[Related: Amazon’s layoffs will cut nearly twice as deep as previously warned.]

Unfortunately, the current state of the American healthcare industry is such that patients remain ethically stuck between a rock and a hard place. The US spends exorbitantly more on health care costs than any other wealthy country, only to still fall behind in life expectancy rates. And the pharmaceutical equivalents of independent bookstores to redirect your money are often rare. Not to mention, trusting private companies’ with data as sensitive as health records in lieu of no better options could point to much larger problems within the existing system.

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In the two years since the COVID vaccines became available to the public, they have become a popular target for misinformation. Anti-vaccine activists have made some wild claims—the vaccines alter DNA, cause infertility, and implant magnetic devices for the government to track your every move—with no credible scientific evidence. But they have managed to accomplish one goal: More Americans than ever are hesitant about getting a vaccine.

So whenever a person has a rare side effect from the COVID vaccines, news spreads rapidly. For example, Florida’s surgeon general recommended boys between 18 to 39 should not get the mRNA shots, citing a questionable state analysis that claimed the risk of cardiac death jumped up by 84 percent after immunization. More recently, people were quick to blame Buffalo Bills player Damar Hamlin’s sudden cardiac arrest in early January on the NFL’s mandatory COVID vaccine requirement. Cardiologists, however, were just as quick to debunk the notion with more realistic medical explanations.

Infectious disease experts have been investigating the risk of myocarditis since the beginning of the pandemic. Thousands of studies have been published on COVID, and some have found a connection between myocarditis with both the virus and the vaccines. Here are the answers we have so far.

What is myocarditis?

Myocarditis is a disease that causes inflammation in a middle layer of the heart muscle called the myocardium. The inflammation affects muscle cell function and the heart’s electrical system, causing irregular heart beats and interfering with pumping blood to and from the body. The inflammation results from your body’s immune response overreacting to an infection it’s currently fighting. Viruses are the common cause of most myocarditis infections and are responsible for 1.5 million cases every year.

A majority of myocarditis cases are mild and self-resolving, says Keren Hasbani, a pediatric cardiologist at Pediatrix Pediatric and Congenital Cardiology Associates of Texas. Most go away in less than two weeks without complications or need to go to the hospital. 

[Related: A good night’s sleep can boost cardiac health]

Myocarditis persisting for longer than two weeks is considered chronic and can create severe complications. The longer inflammation stays in the heart, the weaker the muscle becomes. Continued injuries to heart cells can lead to permanent scarring of cardiac tissue, which can cause the condition to come back and increase the risk of stroke, heart attack, heart failure, or death.

Myocarditis can strike anyone, at any age. However, the heart condition appears to occur at twice the rate in young men than women.

What does myocarditis feel like?

In some myocarditis cases, it is possible for a person to go about their day without knowing that their heart is inflamed. When there are symptoms, they could mimic those of a viral infection, including fever, vomiting, headaches, and a sore throat. 

The most common presenting sign of the condition is a discomfort or a feeling of tightening in the chest area. Hasbani says the pain can happen anywhere between your left side to the chest bone area. Rather than the soreness you feel when you pull a pectoral muscle, Hasbani says myocarditis chest pain is often described as aches originating from a place much deeper inside the body. “People usually say it’s different from any kind of chest pain they’ve felt before.”

Individuals with myocarditis also tend to describe rapid or abnormal heart beats because the inflammation affects the heart’s electrical system. Since the organ is not functioning to its full potential, blood is not being properly distributed to other parts of the body. This can lead to symptoms such as shortness of breath, especially as the chest pain makes it difficult to take big deep breaths. The lack of oxygen can then spur on lightheadedness and fainting spells. Less common symptoms include swelling in the legs, ankles, and feet from the lack of blood distribution.

While Hasbani says it’s extremely rare, myocarditis can be life-threatening when the weakened heart cannot meet the demands of the body. In these scenarios, a person would need to be hospitalized and given medication such as adrenaline to keep the heart pumping. Doctors may also have to provide a life support machine to oxygenate and pump the blood. This allows the heart to rest and recover from the damage myocarditis inflicted. 

Is there a relationship between myocarditis and COVID?

COVID infections can cause severe and life-threatening cases of myocarditis, but the overlap is still slim. Forty out of every 1 million people are estimated to develop myocarditis 28 days after testing positive. The chances of inflammation increases among people with severe COVID illness that requires hospitalization and people with preexisting health conditions such as high blood pressure and obesity.

A 2021 study from the Centers for Disease Control and Prevention (CDC) found the risk of myocarditis is 16 times higher among unvaccinated people with COVID than unvaccinated people who have never had the disease. It also found that men and adults 50 years and older are more vulnerable to the condition. Among unvaccinated children under 16, myocarditis risk was 37 times higher in those with COVID infection than their healthy peers. 

[Related: What patients find at long COVID clinics: rejection, outdated therapies, and unanswered questions]

Hasbani says the reason why people with myocarditis from a COVID infection have more serious complications is because the body is already overworked from dealing with the extensive damage the virus is causing to other organs like the lungs, kidneys, and GI tract. Inflammation in the heart may take a backseat to all the other ongoing bodily issues and take longer to resolve. In children under 16, the CDC speculates that COVID-induced myocarditis might actually be a sign of multisystem inflammatory syndrome, which is a potentially deadly condition associated with the coronavirus. 

Can COVID vaccines cause myocarditis?

Yes, but the chances are extremely rare. One August 2022 study in England calculated the rate of hospitalizations and deaths related to myocarditis in more than 42 million people 13 and older. The subjects consisted of two different groups: individuals fully vaccinated with either the AstraZeneca, Moderna, or Pfizer-BioNTech vaccines, and unvaccinated individuals who tested positive for COVID. The researchers found a 0.007-percent chance—that’s 2,681 out of 43 million vaccinated adultsof being hospitalized or dying from vaccine-related myocarditis. Only 0.001 percent occurred within 28 days of receiving a COVID vaccine or booster. A separate study from October 2022 estimated that the myocarditis risk is seven times greater in unvaccinated versus vaccinated individuals. 

So far only the mRNA vaccines have been associated with myocarditis. The risk appears to be higher in people with a second dose of the Moderna shot than the Pfizer-BioNTech one, says Jayne Morgan, a cardiologist and clinical director of the COVID task force at Piedmont Hospital in Atlanta. The large-scale study done in England last year showed more overlap of myocarditis cases with a second Moderna dose. Meanwhile, another 2022 study measured a two- to threefold higher chance of developing myocarditis after a second Moderna vaccine, with the association being the strongest among men and people between 18 to 39. Still, Morgan warns that the rate is small compared to that of unvaccinated populations with COVID.

[Related: The truth about COVID, vaccines, ED, and infertility]

Though incidence is low, research points to young men under 40 having the highest risk of developing myocarditis, says Morgan. A September 2022 study in Israel reported 28 mild cases of myocarditis after a the Pfizer-BioNTech booster shot—out of nearly four million adults. The results showed that men between the ages of 16 to 19 had the highest risk of myocarditis (a 1 in 15,000 chance), followed by men between the ages of 20 to 24. All individuals made a full recovery after spending an average of 3.5 days in the hospital.

There is no official explanation for why young men have a greater risk of myocarditis. Some COVID researchers have hypothesized that the SARS-CoV-2 spike protein that the mRNA vaccines were designed from might trigger an overly active immune response that causes inflammation in the heart. That doesn’t mean the vaccine causes the infection, warns Hasbani: Instead, the immune system is responding to the vaccine in a way that also happens to react with heart cells in the myocardium. The effect is nearly always temporary.

Myocarditis existed well before COVID vaccines

Hasbani says any medical treatment, including vaccines, has side effects, including ones that involve the heart. The smallpox vaccine, for example, helped eliminate smallpox worldwide in 1980, but was later found to have a 10-percent risk of mild myocarditis.

One likely reason we know more about the risks of myocarditis for the COVID vaccine is that “we haven’t vaccinated this amount of people this quickly for one specific illness, and followed a large population this closely,” Hasbani explains.

With all the facts, both experts stress that the small risk of myocarditis does not outweigh the severe complications you can get from a SARS-CoV-2 infection. For instance, long COVID remains an issue for millions of patients and has been associated with far more persisting heart problems. “Giving you and your family a vaccine is much safer than taking your chance on COVID,” Hasbani adds.

If the vaccine does cause cardiac inflammation in someone, there is little chance the condition would cause a heart failure. A January 2022 analysis of more than 17 million people found just 627 cases (or 0.0035 percent) of COVID vaccine-related myocarditis. Of those, 626 individuals fully recovered and one individual died. To put that into perspective, the National Institute of Health website states: “Your chance of getting myocarditis after getting a COVID vaccine is less than the chance of being struck by lightning during your lifetime.”

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Feeling flat or emotionally unavailable can be a common side-effect of serotonin reuptake inhibitors (SSRIs), a widely used class of anti-depressants. About 40 to 60 percent of patients taking SSRI’s are believed to experience limited enjoyment or feel emotionally dull.

A small study published January 22 in the journal Neuropsychopharmacology is shedding light on why this “emotional blunting,” or the dulling of both good and bad emotions, may happen. The study finds that the drugs affect reinforcement learning, which allows us to learn from our environment and actions.

[Related: The first new FDA-approved antidepressant in decades goes up your nose.]

“Emotional blunting is a common side effect of SSRI antidepressants. In a way, this may be in part how they work—they take away some of the emotional pain that people who experience depression feel, but, unfortunately, it seems that they also take away some of the enjoyment,” said Professor Barbara Sahakian, a co-author and professor of psychology the University of Cambridge, in a statement. “From our study, we can now see that this is because they become less sensitive to rewards, which provide important feedback.”

SSRIs target serotonin, a chemical in the brain called the “pleasure chemical” or the “happiness molecule” that carries messages between nerve cells. According to the National Health Service (NHS), more than 8.3 million patients in England received an antidepressant during 2021 and 2022. In the United States, prescriptions for anti-anxiety and antidepressants increased by an estimated 21 percent following the COVID-19 pandemic.

A team led by researchers at the University of Cambridge and the University of Copenhagen looked into the long term clinical use of SSRIs. They recruited 66 healthy volunteers and gave 32 of them an SSRI called escitalopram and the other 34 took a placebo. According to the team, this drug is known to be one of the best-tolerated antidepressants available on the market and the study participants took them over 21 days.

The participants completed self-reported questionnaires and were given a series of tests that assessed learning, inhibition, executive function, reinforcement behavior, and decision-making.

In terms of attention and memory (also called ‘cold’ cognition), there were no significant differences. There also weren’t any differences in ‘hot’ cognition, or the cognitive functions that involve emotions.

The key novel finding of the tests was a reduced reinforcement sensitivity on two tasks for the group taking escitalopram compared to those taking the placebo.

[Related: A link to depression might be in your gut bacteria.]

The team used a probabilistic reversal test, where a participant was shown two stimuli (A and B). If they chose A, they would receive a reward four out of five times. If they chose B, they would only get a reward one time out of five. The participants weren’t told this rule, but would have to figure it out themselves. At some point during the test, the probabilities would switch, forcing participants to learn a new rule.

Compared with those taking the placebo, the participants taking escitalopram were less likely to use both the positive and negative feedback to guide their learning of the task. The participants on the antidepressants were 23 percent less sensitive to this stimuli switch, which suggests that escitalopram affected sensitivity to the rewards and the individual’s ability to respond accordingly.

This could also explain one big difference the team found in the self-reported questionnaires: volunteers taking escitalopram had more difficulty reaching orgasm when having sex, a widely-reported side effect of the medication.

“Our findings provide important evidence for the role of serotonin in reinforcement learning,” said Christelle Langley, a co-author also from the Cambridge Department of Psychiatry, in a statement. “We are following this work up with a study examining neuroimaging data to understand how escitalopram affects the brain during reward learning.”

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This article was originally featured on ProPublica.

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. Series: Post-Roe America Abortion Access Divides the Nation

Online pharmacies that sell abortion pills are sharing sensitive data with Google and other third parties, which may allow law enforcement to prosecute those who use the medications to end their pregnancies, a ProPublica analysis has found.

Using a tool created by the Markup, a nonprofit tech-journalism newsroom, ProPublica ran checks on 11 online pharmacies that sell abortion medication to reveal the web tracking technology they use. Late last year and in early January, ProPublica found web trackers on the sites of at least nine online pharmacies that provide pills by mail: Abortion Ease, BestAbortionPill.com, PrivacyPillRX, PillsOnlineRX, Secure Abortion Pills, AbortionRx, Generic Abortion Pills, Abortion Privacy and Online Abortion Pill Rx.

These third-party trackers, including a Google Analytics tool and advertising technologies, collect a host of details about users and feed them to tech behemoth Google, its parent company, Alphabet, and other third parties, such as the online chat provider LiveChat. Those details include the web addresses the users visited, what they clicked on, the search terms they used to find a website, the previous site they visited, their general location and information about the devices they used, such as whether they were on a computer or phone. This information helps websites function and helps tech companies personalize ads.

But the nine sites are also sending data to Google that can potentially identify users, ProPublica’s analysis found, including a random number that is unique to a user’s browser, which can then be linked to other collected data.

“Why in the world would you do that as a pharmacy website?” said Serge Egelman, research director of the Usable Security and Privacy Group at the International Computer Science Institute at the University of California, Berkeley. “Ultimately, it’s a pretty dumb thing to do.”

Representatives for the nine sites did not respond to requests for comment. All were recommended on the popular website Plan C, which provides information about how to get abortion pills by mail, including in states where abortion is illegal. Plan C acknowledged that it does not have control over these sites or their privacy practices.

While many people may assume their health information is legally protected, U.S. privacy law does little to constrain the kind or amount of data that companies such as Google and Facebook can collect from individuals. Tech companies are generally not bound by the Health Insurance Portability and Accountability Act, known as HIPAA, which limits when certain health care providers and health plans can share a patient’s medical information. Nor does federal law set many limits on how companies can use this data.

Law enforcement can obtain people’s data from tech companies such as Google, whose privacy policies say the companies reserve the right to share users’ data with law enforcement. Google requires a court order or search warrant, which law enforcement can obtain with probable cause to believe a search is justified. The company received more than 87,000 subpoenas and search warrants in the U.S. in 2021, the most recent year available; it does not provide a breakdown of these requests by type, such as how many involved abortion medication.

In a statement, Steve Ganem, product director of Google Analytics, said: “Any data in Google Analytics is obfuscated and aggregated in a way that prevents it from being used to identify an individual and our policies prohibit customers from sending us data that could be used to identify a user.”

Google pledged last year that it would delete location history data related to people’s visits to abortion and fertility clinics, but the company has not announced any changes since then related to data involving abortion pill providers or how it handles government requests for data. A Google spokesperson did not respond when asked whether the company has turned over any data to law enforcement about users of online pharmacies that provide abortion medication or whether it has been asked to do so.

“This is problematic and dangerous — both the potential access that law enforcement has to figure out who is violating our new state bans and that we’ve let tech companies know so much about our private lives,” said Anya Prince, a law professor at the University of Iowa who focuses on health privacy. “It shows us how powerful this data is in scary ways.”

Medication abortion

Using medications to induce an abortion involves taking two drugs. Mifepristone blocks the hormone progesterone, effectively stopping the growth of the pregnancy. Misoprostol, taken a day or two later, helps the uterus contract, emptying it of pregnancy tissue. This drug combination is the most commonly used method of abortion, accounting for more than half of abortions in the U.S.

Demand for the drugs is expected to grow amid reproductive health clinic closures and the enactment of a cascade of state laws banning abortion since the Supreme Court overturned Roe v. Wade last June.

At least 13 states now ban all methods of abortion, including medication abortion, though some allow exceptions for medical emergencies, rape or incest. People who are unable to shoulder the cost of traveling to states where abortion is legal are increasingly turning to online pharmacies to buy abortion pills without prescriptions. The mail-order pills can be taken at home, and they’re generally cheaper than abortion services provided in clinics — about $200 to $470 from online pharmacies, compared to about $500 for a first-trimester abortion conducted in a clinic.

Approved by the U.S. Food and Drug Administration in 2000, mifepristone — the first tablet in the two-step regimen — can be used to help end pregnancies in their first 11 weeks. The agency initially restricted the drug, requiring patients to get it from clinicians in person.

Mifepristone became more accessible during the COVID-19 pandemic, when the FDA temporarily relaxed the requirement that people visit providers in person to get the drug. The agency scrapped the requirement altogether in December 2021, allowing people to obtain abortion medication through the mail after a telemedicine appointment.

Then, on Jan. 3, the FDA published new rules allowing retail pharmacies to dispense mifepristone to people who have prescriptions, potentially expanding access to medication abortion. But those rules do not help pregnant people in more than a dozen states where abortion bans prevent pharmacies from offering the drug.

A week later, Alabama’s attorney general said that anyone using abortion pills could be prosecuted under a state law that penalizes people for taking drugs while pregnant — despite the state’s abortion ban, which excludes abortion seekers and penalizes providers instead. He then appeared to back off his statement, saying the law would be used only to target providers.

Nineteen states already ban the prescription of abortion drugs through telehealth, meaning people in those states must see a clinician in person or find abortion medication online on their own. Many appear ready to do the latter. After a draft of the Supreme Court’s abortion decision leaked last May, internet search traffic for medication abortion surged. Dozens of people have posted descriptions online of their experiences getting abortion pills, some in restrictive states. One Reddit user recounted their ordeal on an abortion subgroup in October: “I’m in TX so i ordered through abortion RX. It said it’ll be here soon like 5-6 days. I’m extremely nervous I’m doing this by myself, but I’ve looked and don’t have a lot of time to make a decision. This is the fastest way.”

A new legal era

Just two states — Nevada and South Carolina — explicitly outlaw self-managed abortion. But that hasn’t stopped prosecutors in other states from charging people for taking abortion drugs.

Prosecutors have cited online orders of abortion pills as evidence in cases charging people with illegal abortions in several states, including Georgia, Idaho and Indiana. And in at least 61 cases from 2000 through 2020 spread across more than half the states in the country, prosecutors investigated people or ordered their arrest for allegedly self-managing abortions or helping someone else to do so, according to a report by If/When/How, a reproductive justice advocacy organization. In most of these cases, people had used medication for their abortions.

Those prosecutors interested in criminalizing abortion are aided by state and private surveillance.

“This is an entirely new era,” said Ari Waldman, a professor of law and computer science at Northeastern University. “We’re moving to a modern surveillance state where every website we visit is tracked. We have yet to conceptualize the entire body of laws that could be used to criminalize people getting abortions.”

Law enforcement can use people’s behavior when visiting websites that sell abortion pills as evidence to build cases against those suspected of having abortions. Investigations and charges in these cases overwhelmingly stem from reports to law enforcement by health care providers, trusted contacts or the discovery of fetal remains, legal experts say. Once authorities launch an investigation, they can use online searches for abortion pills as part of the evidence.

“This information can tell a district attorney that you went to an abortion website and you bought something,” Waldman said. “That might be enough to get a judge to get a warrant to take someone’s computer to search for any evidence related to whatever abortion-related crime they’re being charged with.”

This was true even under the more limited abortion restrictions under Roe. For example, in 2017, prosecutors in Mississippi charged Latice Fisher with second-degree murder after she lost her pregnancy at 36 weeks. Prosecutors used her online search history — including a search for how to buy abortion pills online — as evidence. Fisher’s murder charge was eventually dismissed.

“We have a private surveillance apparatus that is wide and is largely unregulated,” said Corynne McSherry, legal director at the Electronic Frontier Foundation, a nonprofit that promotes digital rights. “Now Google knows what you’re searching. This is a real threat. If any third party has your information, it means your data is no longer in your control and it could be sought by law enforcement. This is 100% a worry.”

Opting out

Many people aren’t aware of how to opt out of sharing their data. Part of the problem is that when users visit online pharmacies that share users’ information with third parties such as Google, their information can then be shared with law enforcement if allowed by the privacy policies of those third parties.

“The mere fact that you’ve used the online pharmacy to buy abortion medication, that info is now collected by Google and it is now subject to the privacy policy of Google such that you have no way of opting out of that, because it’s entirely separate from the website you went to,” Waldman said.

Users can install a web browser, such as Brave or Firefox, that offers privacy protections. They can also install browser extensions to block third-party trackers and adjust the privacy settings on their browsers. But these steps aren’t always foolproof. Tech companies can still subvert them using hidden tools that users cannot see, and they likely retain vast troves of data that are beyond users’ control.

“Individuals are not going to solve this problem; technical solutions aren’t going to solve this problem,” said Chris Kanich, associate professor of computer science at the University of Illinois at Chicago. “These trillion-dollar companies of the economy aren’t going anywhere. So we need policy solutions.”

Congressional lawmakers have spent years discussing a national data privacy standard. The bill that has made the most progress is the American Data Privacy and Protection Act. Introduced last June by a bipartisan group of lawmakers who intended to strengthen consumer data protections, the bill limited companies from using any sensitive data, including precise geolocation information or browsing histories, for targeted advertising or other purposes. Companies would have been required to get consumers’ express consent before sharing sensitive data with third parties. The legislation passed out of its assigned House committee in July.

Another bill, the My Body, My Data Act, also introduced last summer, would limit the reproductive health data that companies are allowed to collect, keep and disclose.

But neither bill has passed. The My Body, My Data Act had few, if any, Republican supporters. Plus, legislators couldn’t reach an agreement over whether the American Data Privacy and Protection Act should supersede state privacy laws such as the California Consumer Privacy Act of 2018, which provides data privacy protections for consumers in the state.

Privacy experts say the most effective way to protect users’ data is for online pharmacies that sell abortion medication to stop collecting and sharing health-related data.

Companies selling abortion pills should immediately stop sharing data with Google, said Cooper Quintin, senior staff technologist at the Electronic Frontier Foundation.

“Web developers may not have thought they were putting their users at risk by using Google Analytics and other third-party trackers,” Quintin said. “But with the current political climate, all websites, but especially websites with at-risk users, need to consider that helping Google, Facebook and others build up records of user behavior could have a potentially horrific outcome. You can’t keep acting like Roe is still the law of the land.”

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Access to gender-affirming hormones significantly improves the mental health and overall life satisfaction of transgender and nonbinary teens, finds a new study published January 18 in The New England Journal of Medicine. In one of the longest and largest studies looking at psychological outcomes, the authors’ conclusions further support the idea of gender-affirming care as a life-saving treatment.

“The authors provide a compelling defense for maintaining access to gender-affirming care for adolescents,” says Melina Wald, a child and adolescent psychologist and clinical director of the gender identity program at Columbia University Medical Center who was not affiliated with the study. For instance, the team found teens felt more comfortable in their bodies, who they are as it relates to their gender, and their mental state when they took therapeutic hormones. 

A June 2022 report estimates 1.6 million people over the age of 13 identify as transgender in the US. Among the 13- to 17-year-olds identifying as transgender or nonbinary, the number has nearly doubled from previous estimates in 2017. A common experience transgender youth wrestle with is gender dysphoria—a feeling of discomfort and distress when your sex assigned at birth does not match your gender identity. Left untreated, gender dysphoria is associated with an increase in suicide attempts and self-harm among trans teens. A branch of the National Institute of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, funded the latest study to try to address the issue.

“There has been a lack of awareness in the past about the unique health needs and research opportunities for transgender and gender diverse populations,” a representative of the institute told Popular Science in an email. “Research in this area is important for expanding the evidence currently guiding the clinical care of transgender and nonbinary youth.”

One of the most effective ways to combat gender dysphoria is to make a person’s physical appearance more in line with their gender identity, and hormone therapy can help. Gender-affirming hormones—such as estrogen, testosterone blockers, progesterones—are a common medical path for transgender individuals to develop feminine or masculine features that help them feel more like their authentic selves. However, one long-standing complaint from critics against gender-affirming care is that it can cause “psychological mutilation” with some arguing hormone therapy “indoctrinates” children to continue treatment as adults, speculating that they would have been happier to not. The misinformation surrounding the dangers of gender-affirming care have fueled transphobic legislation that withholds medical care from adolescents.

[Related: Exploring the common misconceptions regarding trans and non-binary identities]

“Gender-affirmative care is safe, effective, and even lifesaving,” argues Michelle Forcier, a professor of pediatrics specializing in gender, sexual and reproductive health at Brown University not involved in the study. “Children should not be pawns of politicians [who hold] safe, effective healthcare hostage for political and personal goals. Most legislators are not qualified as medical experts in gender-affirming care and have no business inserting themselves in the clinical setting.” 

Forcier says that a patient’s decision to start and participate in gender-affirmative care is a personal and private one that should only be discussed with the child, caregivers, and their medical team. Popular Science reached out to multiple study authors for comment, but they had either declined or did not respond in time of publication.

The current study recruited 315 transgender and nonbinary youth between 12 to 20 undergoing gender-affirming hormone therapy from clinical sites in Chicago, Boston, San Francisco, and Los Angeles. About 60.3 percent of participants were transmasculine and 58.7 percent were non-Latinx white. The teens started gender affirming hormones at different stages of development, with 25 already on puberty blockers before the study. From July 2016 to June 2019, psychologists used several psychosocial tests from the National Institute of Health to track any depression or anxiety symptoms the teens experienced, as well as positive effects from treatment and their life satisfaction every six months.

During the two-year study period, teens who felt their appearance reflecting more of their gender identity after gender-affirming care reported more propensity towards positive emotions  and greater life satisfaction. Youths that initiated gender-affirming care earlier already came in with lower baseline levels of depression and anxiety than those who started hormone therapy in late puberty. 

[Related: LGBTQ+ health networks helped make urban neighborhoods more resilient against COVID]

Regarding race, non-Latinx white youth showed a more significant decrease in depressive symptoms than other ethnicities and mixed race groups. However, the results may not be generalized to reflect the Black community, as there was an underrepresentation of Black participants in the study. In addition, Wald says that tracking and comparing the outcomes of youth who did not pursue hormone therapy at the study clinics would help inform any differences across transgender youth who do not have access to this type of care.

One notable observation was that transmasculine, but not transfeminine teens, showed a significant reduction in symptoms related to anxiety and depression. The differences may lie in the hormones they are receiving. Gina Sequeira, the co-director of the Seattle Children’s Gender Clinic who was not involved in the study, says patients taking testosterone see physical changes congruent with their gender identity at a faster rate than people taking estrogen. Estrogen takes longer to reduce testosterone’s masculinizing effects on the body and develop feminine features. 

“A patient on testosterone, for example, would start noticing a deepening of the voice usually within the first six months,” describes Sequeira. “For estrogen, changes like breast development take years and my suspicion is that patients may not have achieved the breasts they wanted at the two-year mark.” 

Despite all the benefits observed with gender-affirming hormone therapy, it is not a cure-all for gender dysphoria. In the study, 11 participants disclosed that they experienced suicidal ideation and two had died by suicide during the two-year period. All experts say the findings emphasize the need for a multifaceted approach to care. 

“Gender-affirmative hormones offer some benefit and relief, but youth are still navigating a potentially hostile world around them,” says Forcier, who adds that after the treatment, people may still experience a body that is not aligned with their gender identity. 

Having support at home and in the local community “can’t be understated,” says Sequeira. She adds that the more spaces a young person is affirmed in their gender identity—in healthcare settings, school, sports—the better their mental health.

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The National Institute of Allergy and Infectious Diseases (NIAID) announced on January 18 that a Phase 3 clinical trial of a human immunodeficiency virus (HIV) vaccine in development from Johnson & Johnson (J&J) has failed. The vaccine proved to be ineffective at preventing infection.

Janssen, the vaccine division of J&J, began running this trial in 2019. It was stopped after a scheduled review, which revealed that there were roughly as many new HIV infections among people in the vaccine arm as in the placebo arm.

The trial, which is part of the Mosiaco study, had 3,900 volunteers across multiple countries, including Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the United States. The trial focused on cisgender and transgender people who have sex with men due partially to these populations’ vulnerability to the virus.

[Related: The first woman has been cured of HIV using donor stem cells.]

“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, Janssen’s head of global therapeutics and vaccines, in a statement. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”

This vaccine was given in four injections over one year and was based on “mosaic” immunogens, where the vaccine is built using components (or pieces) that feature elements of multiple HIV subtypes. The goal was for the vaccine to start an immune response to a broad range of HIV strains and used a common cold virus (adenovirus 26) to deliver antigens. This is the same the same antigen delivery system that J&J’s COVID-19 vaccine used. It was the only HIV vaccine in late-stage clinical trials.

In an interview with The New York Times, former NIAID director Anthony Fauci said that the news is “disappointing, but it isn’t the end of the effort toward developing a vaccine. There are other strategic approaches.”

Multiple HIV vaccine candidates have stalled over the past few decades. In 2021, Imbokodo trial (a Phase 2b trial of a similar vaccine candidate) stopped when data indicated that it was not preventing infections. The vaccine was being studied in women in sub-Saharan Africa.

According to some experts, this defeat sets progress towards a vaccine back by three to five years, but other options are in early-stage trials. In January 2022, Moderna began Phase I clinical trials for an HIV vaccine that uses the same mRNA technology as the pharmaceutical company’s COVID-19 vaccine.

Additionally, a small phase 1 clinical trial of another experimental two-dose HIV vaccine found that it could induce crucial broadly neutralizing antibody precursor B cells in 97 percent of study participants without significant side effects. These results were published in the journal Science in December 2022. “At the most general level, the trial results show that one can design vaccines that induce antibodies with pre-specified genetic features, and this may herald a new era of precision vaccines,” said William Schief, study co-author and researcher at The Scripps Research Institute, in a December press release.

[Related: The first people have received an experimental mRNA HIV vaccine.]

HIV is no longer a death sentence in wealthy countries due to medications that reduce viral load, or the amount of the virus in the blood. There are currently pills and bimonthly injections that can prevent infection in HIV negative individuals. However, these medications can be inaccessible to the people who need it most, and HIV treatment must be taken for the rest of a patient’s life after diagnosis.

HIV still infects about 1.5 million people each year and kills roughly 650,000. The virus attacks the body’s immune system and destroys white blood cells, weakening immunity against other opportunistic infections.

“The ultimate prevention modality for any infection, particularly viral infection, is a vaccine that’s safe and effective,” Fauci said. “That’s the reason why the field is going to continue to pursue very active research in that area.”

According to the Centers for Disease Control and Prevention (CDC), some of the best ways to prevent HIV infection using wearing condoms during sexual intercourse, not sharing needles, and continually testing for sexually transmitted disease and infections.

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On January 17, Moderna announced that data from a late-stage clinical trial for the company’s experimental messenger RNA (mRNA) vaccine for respiratory syncytial virus (RSV) was 83.7 percent effective at preventing at least two symptoms, such as cough and fever, in adults 60 and older.

“RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities,” Abdullah Baqui, a principal investigator for the study sites in Bangladesh and professor at Johns Hopkins Bloomberg School of Public Health, said in a statement. “This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas.”

[Related: Is it flu or RSV? It can be tough to tell.]

The study was conducted in roughly 37,000 participants age 60 and older and the data analysis was performed after 64 of the participants contracted the virus. Moderna plans to release the full data at an upcoming medical meeting and will seek approval from the Food and Drug Administration (FDA) during the first half of 2023.

“Today’s results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older. These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine. We look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference,” said Stéphane Bancel, Moderna’s Chief Executive Officer, in a statement.

Currently, there is no vaccine to prevent RSV infection and Moderna, Pfizer, and GSK are working to get their vaccines out to the public. In 2022, Pfizer and GSK filed applications for regulatory approval in the United States and late-stage trial results found that Pfizer’s RSV vaccine was 66.7 percent effective in preventing two or more symptoms.

[Related: How our pandemic toolkit fought the many viruses of 2022.]

In Europe, an antibody treatment called nirsevimab from Sanofi and AstraZeneca gained the European Commission’s marketing authorization to prevent the virus in newborns and infants. This treatment is under review by the FDA for use in the US.

While RSV produces symptoms similar to a cold, it can be fatal for young children and older adults. According to the CDC, about 60,000 to 120,000 older adults are hospitalized and between 6,000 to 10,000 die due to RSV infection every year.

Cases of RSV began appearing earlier than usual during the 2022-2023 RSV season, but cases have ticked downward after peaking in November 2022. RSV surged in the US and Europe this alongside the flu and COVID-19 as part of a “tripledemic” that has been straining hospitals and has even caused shortages of children’s pain relievers and fever reducers.

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This post has been updated with additional information. It was originally published on January 17.

The US Navy is adding more medical vessels to its fleet, to better meet the needs of the force across theaters. The next produced Expeditionary Fast Transports, a vessel type already in production, will be built with modifications to serve as medical ships when needed. 

After the medically modified transports are constructed, the next ship built will be a new dedicated medical vessel. This Expeditionary Medical Ship will be designed to offer medical care where larger hospital ships cannot go. Before the Navy builds this newer class, it will learn to fill the role by adapting a familiar frame.

Tucked away in the Navy’s 2023 Justification Book, a document that outlines the why and what of its budget requests, are two notes about the medical adaptation of these ships. Expeditionary Fast Transports (confusingly abbreviated EPF) “will have modifications to conduct a Role 2 Enhanced (R2E) Medical Transport mission which will include enhanced medical capabilities to support embarked Medical Military Detachment (MILDET) teams while retaining the ability to perform high-speed intra-theater sealift.” 

That means, in essence, that these will be medical-capable transports, but ones that can also do the workhorse job of moving people and goods from ship to shore and back.

The book also notes that after building a few modified transports, the next built “will be an Expeditionary Medical Ship (EMS) Variant,” which is the one that will be designed with medical care at the forefront of its mission. 

“The ship’s builders and Navy officials say this reimagined vessel, the Expeditionary Medical Ship, is especially designed for easy movement and rapid response in the shallow littorals and vast expanses of a future operating theater like the Pacific,” reports Hope Seck at Sandboxx. “And the service is working to develop a complement of skilled medical personnel trained and ready to deploy onboard these ships to provide triage care almost anywhere in the world.”

The Navy has three of the EPF-template medical transports under contract, with funding secured for three EMS ambulance ships to follow, according to shipbuilder Austal USA.

To understand what sets these medical capable Expeditionary Fast Transports and the upcoming Expeditionary Medical Ships apart from existing medical vessels, it’s important to understand the hospital ships it is designed to augment.

Hospital shipping 

Medical ships are an accommodation to the grim reality of war. Wherever the Navy goes, sailors will need medical attention, and those facilities can accommodate the various marines, soldiers, and other compatriots injured and within reach of a hospital ship. The Navy currently operates two large hospital ships, the USNS Comfort and USNS Mercy, which barged into public consciousness when deployed to render aid in the first waves of the COVID-19 pandemic in the United States. That aid rendered appears to have been less than expected, though not nothing.

Pandemic relief is an outlier job for the vessels, which are constrained not just by size but speed, making them most useful as a hospital that can be parked in a deep harbor or anchored offshore, treating patients as they arrive. The USNS Comfort in particular boasts a long record of surgeries at sea, in support of US and allied forces in the Gulf and Iraq wars. Both Mercy and Comfort have also been deployed for disaster relief, where the hospital ships trained personnel and stockpiles of blood make them a powerful resource for treating injury. 

And both hospital ships were converted from former oil tankers, and fit into a long history of commercial vessels adapted into hospital ships. Converted vessels come ready-made, but they lack the dedicated military design features to accommodate specific military missions.

Getting the medical supplies from storage on a hospital ship to patients in need often, but not always, involves bringing the patients aboard. In 2016, researchers tested using drones to deliver blood from ship to shore, an approach that could help get aid to people injured and unable to reach port.

Hospital ships can also receive patients by helicopter, thanks to a landing pad. That kind of arrival is vital for the injured but limited in capacity for transporting large numbers of people to the care they need. With 15 patient wards, 80 ICU beds, and accommodations for 1,300 people, the Comfort and Mercy can treat the people brought to it, but they cannot get everywhere. And, with a top speed of 20 mph, they are slow going even in the best of times. 

To get care closer and faster, the Navy has selected a smaller, faster ship in the ambulance role.

Catamaran ambulance

Smaller than full-scale hospital ships, the ships in the Expeditionary Fast Transport class are already expanding how and where the Navy can operate, by providing supply and transport support for the fleet. The EPFs can sustain an average speed of 40 mph at sea, twice as fast as the hospital ships, and they can operate in shallower waters and less developed ports, with a draft of only 15 feet. The ship’s catamaran design offers great stability, especially important for the difficult tasks of surgery and sea.

When it comes to moving people and goods, the existing EPFs can carry up to 544 metric tons of cargo, and beyond a crew of 41, can accommodate 416 passengers, with 312 of those in airline-style seats and 104 in more proper berths. As presently designed, the EPFs can land helicopters as large as the CH-53 Super Stallion.

In the envisioned medical role, beyond converting some of that space to treatment facilities, EPF maker Austal says that the landing deck will be enhanced to accommodate V-22 Ospreys. This, combined with 10 ICU beds, 23 ward beds, and two operating rooms, would make the ship able to function as a floating hospital in miniature, providing care to match the needs of the remote coasts it can access.

This article has been updated to include additional information about how many ships of each type will be produced.

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This article was originally published on KHN.

Controlled substances became a little less controlled during the pandemic. That benefited both patients (for their health) and telehealth startups (to make money).

Some potentially addictive medications — like buprenorphine and Adderall — are now far more available online to patients because of regulatory changes. Given the scarcity of qualified doctors to treat some of the behavioral health conditions associated with these drugs, like opioid use disorder or attention-deficit/hyperactivity disorder, doctors’ new ability to prescribe online or, in some cases, by telephone is a huge change. But easier access to the drugs has both upsides and downsides, since they’re often dispensed without accompanying therapy that improves the odds of a patient’s success.

Pre-pandemic, patients sometimes traveled several hours for addiction care, said Emily Behar, director of clinical operations for Ophelia, a New York startup serving people with opioid addictions. Or patients might be struggling with multiple jobs or a lack of child care. Such obstacles made sustaining care fraught.

“How do you reach those people?” she asked.

It’s a question preoccupying much of the behavioral health sector, complicated by the reality that most patients with opioid use disorder aren’t in treatment, said Dr. Neeraj Gandotra, chief medical officer of the Substance Abuse and Mental Health Services Administration.

Increased access to telehealth has started to provide an answer. Behar, the startup executive, says its patients can see expert providers at their convenience. Missed appointments are dropping, say many in the industry.

The startup has secured solid funding — nearly $68 million, according to Crunchbase, an industry database — but addiction specialists and other prescribers of controlled substances online are a mixed group. Some are nonprofits; others are large startups attracting scrutiny from the news media and law enforcement for allegedly sloppy prescription practices.

The influx of new providers is attributable to loosened requirements born of pandemic-era necessity. To help patients get access to care while maintaining physical distance, the Drug Enforcement Administration and SAMHSA waived restrictions on telehealth for controlled substances.

But whether those changes will endure is uncertain. The federal government is working piecemeal to codify new rules for prescribing controlled substances, in light of the health care system’s pandemic experience.

On Dec. 13, SAMHSA issued a proposal to codify telehealth regulations on opioid treatment programs — but that affects only part of the sector. Left unaddressed — at least until the DEA issues rules — is the process for individual providers to register to prescribe buprenorphine. The new rules “get us at least a little bit closer to where we need to go,” said Sunny Levine, a telehealth and behavioral health lawyer at the firm Foley & Lardner, headquartered in Milwaukee.

Congress also tweaked rules around buprenorphine, doing away with a long-standing policy to cap the number of patients each provider can prescribe to. Ultimately, however, the DEA is the main regulatory domino yet to fall for telehealth providers.

In addition, pharmacies are taking a more skeptical stance on telehealth prescriptions — especially from startups. Patients were getting accustomed to using telemedicine to fill and refill their prescriptions for medications for some controlled substances, like Adderall, primarily used to treat ADHD. A shortage of Adderall has affected access for some patients. Now, though, some pharmacies are refusing to fill those prescriptions.

Cheryl Anderson, one Pennsylvanian with ADHD, said she sought online options because of her demanding schedule.

“My husband is frequently out of town, so I don’t have someone to reliably watch the baby to go to an in-person appointment,” she said. It was tough, with three kids, to find the time. Telehealth helped for about half of 2022. Previously, the DEA and state governments imposed tough rules on obtaining controlled substances from online pharmacies.

But in September, after her doctor wrote a refill prescription, she got a phone call saying her local pharmacy wouldn’t dispense medications if the prescription came through telehealth. Other local pharmacies she called took the same position.

Those denials seem to reflect a broader cultural shift in attitudes. Whereas patients and politicians hailed telemedicine at the beginning of the pandemic — first for its safety but also for its increased convenience and potential to extend care to rural areas and neighborhoods without specialists — hints of skepticism are creeping in.

The telehealth boom attracted shady actors. “You had a lot of people who saw an opportunity to do things that were less than scrupulous,” particularly in the behavioral health market, said Michael Yang, a managing partner at the venture capitalist firm OMERS Ventures. Skeptical media coverage has proliferated of startups that, allegedly, shotgun prescriptions for mental health conditions without monitoring patients receiving those medications. “It’ll settle down.”

The startups pose quandaries for local pharmacists, said Matt Morrison, owner of Gibson’s Pharmacy in Dodge City, Kansas.

Pharmacists have multiple obligations related to prescriptions, he said: to make sure incoming prescriptions are from legitimate physicians and that they’re connected to an actual health condition before filling the order. The sense around the industry, Morrison said, is that prescriptions from startups are tricky. They might come from a distant provider, whom the pharmacist can’t contact easily.

Those qualms pose difficulties for addiction treatment. Persuading pharmacists to fill prescriptions is one of the biggest administrative tasks for Ophelia, Behar said. Still, the shift online has been helpful.

“Telehealth picks up the gaps,” said Josh Luftig, a founding member of CA Bridge, a program based in Oakland, California, that helps patients in emergency departments initiate treatment for substance misuse. The supply of care providers wasn’t enough to meet demand. “Across the board, there’s been a lack of access to treatment in the outpatient setting. Now all they need is a phone and to get to a pharmacy.”

Treatment is more efficient for patient and provider alike, providers say. “The majority of our patients prefer to have a telehealth experience,” he said. “The telehealth appointments are more efficient. It increases the capacity of each person involved.”

Well-established organizations also report success: Geisinger, a large mid-Atlantic health system, said 94% of participants in one maternity-focused program were compliant, spokesperson Emile Lee said.

Ophelia, which started up just before the pandemic, expected to treat patients both in-office and online. “We have an office in Philadelphia we’ve never used,” she said. Now the company labors every few months — in anticipation of the end of state and federal public health emergencies — to make sure that the end of the associated looser rules doesn’t lead to disruptions in care for their patients.

More clarity on the future of online treatment could result from permanent regulations from the DEA. What the agency’s rule — which would create a registration process for providers interested in prescribing controlled substances online — will say is “anyone’s guess,” said Elliot Vice, an executive specializing in telehealth with the trade group Faegre Drinker. That rule has been pending for years. “To see this still not move, it is puzzling.”

The agency, which declined to comment specifically for this article, pointed to previous statements praising increased access to medication-assisted treatment.

“There shouldn’t be any change in the rules for telehealth,” Luftig said. “It would be the most horrific thing in terms of access for our communities. It would be an unmitigated disaster.”

[Correction: This article was updated at 10:30 a.m. ET on Jan. 11, 2023, to correct the location of Foley & Lardner’s headquarters.]

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This article was originally featured on Outdoor Life.

This week the Texas Department of State Health Services began airdropping oral rabies vaccines along the southern border. The state’s Oral Rabies Vaccination Program is meant to protect wildlife populations, particularly foxes and coyotes, in the region from contracting or transmitting the deadly disease.

“Our goal is to vaccinate wildlife, with target species being coyotes and gray foxes, along the border to maintain herd immunity and to keep past variants from being reintroduced or new variants from entering Texas,” ORVP director Dr. Susan Rollo explained in a press release.  

The department plans to drop nearly 814,000 of the vaccine baits from airplanes and helicopters over the next two weeks. The first flight was scheduled to take off from Edinburg on Tuesday morning. Other flights will be departing from airports in Del Rio and Alpine. The program is expected to cost around $2 million, and funding is being provided by the State of Texas along with the USDA’s Animal and Plant Health Inspection Service.

The edible baits look like small silica packets, and they will be spread out across 18 counties in South Texas, with an average density of 64 to 70 baits per square mile. Dr. Rollo said these vaccines are proven safe for ingestion in 60 species of mammals and birds, but she cautioned that the department should still be contacted if a human or domestic animal is exposed to one of the baits.

Airdropping Vaccines to Prevent the Spread of Rabies   

The TDSHS has been airdropping vaccine baits for wildlife in South and West Central Texas for 29 years now. The first airborne bait drop took place in South Texas in 1995, and it helped control a localized outbreak of a domestic dog/coyote variant of the rabies virus.

“The number of animal cases caused by this [domestic dog/coyote] variant dropped from 122 cases in 1994—the year before the first vaccine bait drop—to zero in 2000,” the department explains. The state has only seen two cases of the variant in the time since (one in 2001 and one in 2004), and both of those were discovered within a mile of the US-Mexico border.

This program was expanded in West Central Texas in 1996 to target the gray fox rabies variant. These airdrops also proved successful in lowering the number of rabies cases in the area from 244 in 1995 to zero in 2009. When the gray fox variant cropped back up there in 2013, the state’s targeted airdrop campaign helped eliminate it yet again.

“In May 2013, a cow infected with the gray fox rabies virus was identified in Concho County, leading to an ORVP contingency response with vaccine baits dropped in 2013, 2014, and 2015 throughout a 2,500 square mile area around the case,” the department says. “No additional gray fox rabies virus variant cases have been identified in Texas, and there have been no human cases of rabies attributable to these rabies virus variants since the ORVP began.”

The rabies virus is “virtually 100% fatal” in both animals and humans once clinical symptoms appear, according to the World Health Organization. But it’s also what the WHO calls a “vaccine-preventable” disease, and the agency estimates that more than 29 million people around the world receive a post-bite vaccination every year. Vaccinating people and animals before they contract the disease is much less common, but the WHO points out that these “mass vaccination campaigns” have proven effective in different settings throughout Africa, Asia, Europe, and the Americas.

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This article was originally republished from The Conversation.

Bringing a new drug to market costs billions of dollars and can take over a decade. These high monetary and time investments are both strong contributors to today’s skyrocketing health care costs and significant obstacles to delivering new therapies to patients. One big reason behind these barriers is the lab models researchers use to develop drugs in the first place.

Preclinical trials, or studies that test a drug’s efficacy and toxicity before it enters clinical trials in people, are mainly conducted on cell cultures and animals. Both are limited by their poor ability to mimic the conditions of the human body. Cell cultures in a petri dish are unable to replicate every aspect of tissue function, such as how cells interact in the body or the dynamics of living organs. And animals are not humans – even small genetic differences between species can be amplified to major physiological differences.

Fewer than 8% of successful animal studies for cancer therapies make it to human clinical trials. Because animal models often fail to predict drug effects in human clinical trials, these late-stage failures can significantly drive up both costs and patient health risks.

To address this translation problem, researchers have been developing a promising model that can more closely mimic the human body – organ-on-a-chip.

As an analytical chemist, I have been working to develop organ and tissue models that avoid the simplicity of common cell cultures and the discrepancies of animal models. I believe that, with further development, organs-on-chips can help researchers study diseases and test drugs in conditions that are closer to real life.

What are organs-on-chips?

In the late 1990s, researchers figured out a way to layer elastic polymers to control and examine fluids at a microscopic level. This launched the field of microfluidics, which for the biomedical sciences involves the use of devices that can mimic the dynamic flow of fluids in the body, such as blood.

Advances in microfluidics have provided researchers a platform to culture cells that function more closely to how they would in the human body, specifically with organs-on-chips. The “chip” refers to the microfluidic device that encases the cells. They’re commonly made using the same technology as computer chips.

Not only do organs-on-chips mimic blood flow in the body, these platforms have microchambers that allow researchers to integrate multiple types of cells to mimic the diverse range of cell types normally present in an organ. The fluid flow connects these multiple cell types, allowing researchers to study how they interact with each other.

This technology can overcome the limitations of both static cell cultures and animal studies in several ways. First, the presence of fluid flowing in the model allows it to mimic both what a cell experiences in the body, such as how it receives nutrients and removes wastes, and how a drug will move in the blood and interact with multiple types of cells. The ability to control fluid flow also enables researchers to fine-tune the optimal dosing for a particular drug.

The lung-on-a-chip model, for instance, is able to integrate both the mechanical and physical qualities of a living human lung. It’s able to mimic the dilation and contraction, or inhalation and exhalation, of the lung and simulate the interface between the lung and air. The ability to replicate these qualities allows researchers to better study lung impairment across different factors.

Bringing organs-on-chips to scale

While organ-on-a-chip pushes the boundaries of early-stage pharmaceutical research, the technology has not been widely integrated into drug development pipelines. I believe that a core obstacle for wide adoption of such chips is its high complexity and low practicality.

Current organ-on-a-chip models are difficult for the average scientist to use. Also, because most models are single-use and allow only one input, which limits what researchers can study at a given time, they are both expensive and time- and labor-intensive to implement. The high investments required to use these models might dampen enthusiasm to adopt them. After all, researchers often use the least complex models available for preclinical studies to reduce time and cost.

Lowering the technical bar to make and use organs-on-chips is critical to allowing the entire research community to take full advantage of their benefits. But this does not necessarily require simplifying the models. My lab, for example, has designed various “plug-and-play” tissue chips that are standardized and modular, allowing researchers to readily assemble premade parts to run their experiments.

The advent of 3D printing has also significantly facilitated the development of organ-on-a-chip, allowing researchers to directly manufacture entire tissue and organ models on chips. 3D printing is ideal for fast prototyping and design-sharing between users and also makes it easy for mass production of standardized materials.

I believe that organs-on-chips hold the potential to enable breakthroughs in drug discovery and allow researchers to better understand how organs function in health and disease. Increasing this technology’s accessibility could help take the model out of development in the lab and let it make its mark on the biomedical industry.

Chengpeng Chen, Assistant Professor of Chemistry and Biochemistry, University of Maryland, Baltimore County. Chengpeng Chen receives funding from the NIH.

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The lifespan of humans has grown in the past two centuries from an average of 30 to 72 years old. Despite this impressive change in health, our longevity pales in comparison to the rockfish. Rockfish can live over 100 years on the seafloor of shallow waters, spending most of their days hiding under rocks. (Some have been reported to live over 200 years). The secret to rockfish longevity is more complex than stumbling on an underwater fountain of youth. Geneticists at Harvard propose that the answer could lie with how they control their genes.

A new study published today in Science Advances found that rockfishes have a complex genetic network that likely influences the species’ length of life. These same genes also seem to be found in humans. “The way fish are regulating traits like longevity is actually very similar to how mammals are regulating longevity,” says lead study author Stephen Treaster, a postdoctoral research scientist at Boston Children’s Hospital and Harvard Medical School. Understanding these genetic variations involved in longevity in animals like a rockfish could one day help with treating age-related diseases in humans. 

“It’s exciting to see rockfish genomics in the spotlight,” says Joseph Heras, an assistant professor of biology at California State University, San Bernardino, who was not involved in the study. “For many years, there have been many speculations around rockfish longevity, but now with modern genomic techniques, studies like this one provide more insight into the topic.”

[Related: Could reptiles and amphibians hold the key to the fountain of youth?]

While the rockfish is considered one of the longest-lived fishes, they have a wide range in lifespan. But the exact genetic mechanism that determines how long or short a rockfish will live remained a mystery. The study authors unraveled the genetic code of 23 different rockfish species that live from 22 to 108 years. Across all tissue samples, the team found a common network of genes involved with insulin signaling—a well-known regulator of aging that may have evolved as a survival tactic to better conserve energy. A 2021 study found that the longest-lived rockfish were more likely to express three types of genes, including those influencing the insulin signaling pathway. The new findings bring more evidence that insulin-regulating genes are a main contributor to rockfish longevity.

“The authors were able to confirm and extend on many of the observations we recently made in our sequencing of rockfish genomes, including the increased constraint on pathways associated with insulin signaling,” says Peter Sudmant, an assistant professor of integrative biology at the University of California, Berkeley, and senior investigator of the 2021 study.

But there was an additional result that was unexpected, says Treaster. The team identified another set of genes found across all rockfish that were involved in flavonoid metabolism. Flavonoids are chemicals produced in plants with anti-inflammatory, antimutagenic, and anticancer properties. Since they are known to be associated with modulating several cellular signaling and enzymatic pathways, the authors suggest flavonoid metabolism could induce anti-aging effects. According to Sudmant, the authors’ emphasis that flavonoid metabolism could play an important role in extending lifespan is a “very interesting and novel pathway to follow up on.” 

After identifying two potential genetic contributors to rockfish longevity, the team searched for any similar connections in human genes. They found the flavonoid metabolism genes are not only found in humans but are significantly linked to survival. “We have these two completely different vertebrate models, humans and rockfish, and both of them have the same pathway associated with longevity,” Treaster says.

[On PopSci+: Has the fountain of youth been in our blood all along?]

Rockfishes are not the oldest living vertebrates (a 392-year-old Greenland shark nabbed the title in 2016) and are not a typical animal model to study aging. While short-lived invertebrates such as fruit flies and roundworms are more likely to be selected to study changes in lifespan, they may not apply to vertebrates like humans who live an average of 70 to 75 years. 

Unlike other long-lived species, the shift in rockfish longevity was not a one-off event. Treaster says different lineages of rockfish evolved independently to have a lengthy lifespan. “This magnitude of change is unheard of, especially in vertebrates,” he says. This gave scientists an opportunity to “wash out unrelated changes” and hone in on relevant longevity contributors that are shared by the whole species.

While Treaster is excited about identifying an association between longevity and genes in the flavonoid metabolism pathway, he knows there’s a long way to go to understand how those genes/the link help with survival. Next, his team plans to genetically modify the genes involved in insulin and flavonoid metabolism in zebrafish to see if they could reverse signs of aging. Understanding exactly what these genes are doing—and if they can be manipulated—to extend lifespan can be valuable information for slowing down the aging process in humans. “The end goal of all this research is to intervene or prevent all these age-related diseases—cancer, Alzheimer’s, heart disease—that we have a difficult time solving with modern medicine,” says Treaster. 

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This article was originally featured on The Conversation.

Cell migration, or how cells move in the body, is essential to both normal body function and disease progression. Cell movement is what allows body parts to grow in the right place during early development, wounds to heal and tumors to become metastatic.

Over the last century, how researchers understood cell migration was limited to the effects of biochemical signals, or chemotaxis, that direct a cell to move from one place to another. For example, a type of immune cell called a neutrophil migrates toward areas in the body that have a higher concentration of a protein called IL-8, which increases during infection.

In the past two or three decades, however, scientists have started to recognize the importance of the mechanical, or physical, factors that play a role in cell migration. For example, human mammary epithelial cells – the cells lining the milk ducts in the breast – migrate toward areas of increasing stiffness when placed on a surface with a stiffness gradient.

And now, instead of focusing on just the effect of the “solid” environment of cells, researchers are turning toward their “fluid” environment. As a theoretician trained in applied mathematics, I use mathematical models to understand the physics behind cell biology. My colleagues Sean X. Sun and Konstantinos Konstantopoulos and I were among the pioneering scientists who discovered how water and hydraulic pressure influence cell migration through theoretical models and lab experiments. In our recently published research, we found that human breast cancer cell migration is enhanced by the flow and viscosity of the fluids surrounding them, clarifying one of the factors influencing how tumors metastasize.

How fluids affect cell migration

Cells in the human body are constantly exposed to fluids of different physical properties. Water is one such fluid that can direct cell migration. For example, we found that how water flows across the membranes of breast cancer cells influences how they move and metastasize. This is because the amount of water traveling in and out of a cell causes it to shrink or swell, inducing movement by translocating different parts of the cell.

The viscosity, or thickness, of body fluids varies from organ to organ, and from health to disease, and this can also affect cell migration. For example, the fluid between cancer cells in tumors is more viscous than the fluid between normal cells in healthy tissues. When we compared how quickly breast cancer cells move in confined channels filled with fluid of normal viscosity versus fluid of high viscosity, we found that cells in high viscosity channels counterintuitively sped up by a significant 40%. This discovery was unexpected because the fundamental laws of physics tell us that inert particles should slow down in high viscosity fluids due to increased resistance.

We wanted to figure out the mechanism behind this surprising result. So we identified what molecules were involved in this process, discovering a cascade of events that allow high viscosity environments to enhance cell motility.

We found that high viscosity fluids first promote the growth of protein filaments called actin, which open channels in the cell’s membrane and increase water intake. The cell expands from the water, activating another channel that takes in calcium ions. These calcium ions activate another type of protein filament called myosin that induces the cell to move. This cascade of events induces cells to change their structure and generate more force to overcome the resistance imposed by high viscosity fluid, meaning the cells aren’t inert at all.

We also discovered that cells retained “memory” after exposure to a high viscosity medium. This meant that if we put cells in a high viscosity medium for several days and then returned them to a normal viscosity medium, they would still move at a faster speed. How cells retain this memory is still an open question.

We then wondered whether our findings on viscous memory would remain true in animals, not just in Petri dishes. So we exposed human breast cancer cells to a high viscosity medium for six days, then placed them in a normal viscosity medium. We then injected the cells into chicken embryos and mice.

Our results were consistent: Cells pre-exposed to a high viscosity medium had an increased ability to leak into surrounding tissues and metastasize compared to cells that were not pre-exposed. This result demonstrates that the viscosity of the fluids in a cell’s surrounding environment is a mechanobiological cue that promotes cancer cells to metastasize.

Implications for cancer treatment

Cancer patients usually don’t die from the original source of the tumor, but from its spread to other parts of the body.

When cancer cells travel through the body, they move into spaces that will have varying fluid viscosity. Understanding how fluid viscosity affects the movement of tumor cells could help researchers figure out ways to better treat and detect cancer before it metastasizes.

The next step is to build imaging and analysis techniques to precisely examine how cells from various types of lab animals respond to changes in fluid viscosity. Identifying the molecules that regulate how cells respond to changes in viscosity could help researchers identify potential drug targets to reduce the spread of cancer.

Yizeng Li is an Assistant Professor of Biomedical Engineering at Binghamton University. Li receives funding from National Science Foundation.

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This article was originally featured on KHN.

In March, a Frontier Airlines flight was headed from Phoenix to Las Vegas when a female passenger stopped breathing. The flight attendant yelled in the cabin for help.

A passenger who was trained as a wilderness first responder, Seth Coley, jumped into action and found the woman was unresponsive and had a weak pulse. Coley dug through the plane’s medical kit but couldn’t find an oropharyngeal airway, a tool that was supposed to be there and that he needed to help the woman breathe. Instead, he cleared the airway by manipulating her neck.

Afterward, Coley sent a message to Denver-based Frontier Airlines via an online customer service form: “I saved somebody’s life on one of your flights,” he wrote. “I would like to speak about the medical kit you guys have on your flights. You are missing some very valuable and simple things. She almost died.”

Americans are flying at levels reaching pre-pandemic numbers. While covid-19 ushered in new health and cleaning protocols designed to make airplane travel safer, incidents like Coley’s raise questions about airlines’ readiness for medical emergencies because of incomplete or insufficient medical kits and the training of flight crews, who often rely on other passengers in emergencies.

Frontier did not respond to KHN’s requests for comment about that incident or its emergency kits. But Coley’s experience illustrates the risks travelers take every time they board a flight. For every 20,000 passengers who take a flight on a U.S.-based airline, there is one medical event — defined as any health-related incident, not only emergencies — according to estimates from airplane medical services company MedAire.

The Federal Aviation Administration requires commercial aircraft to carry at least one sealed emergency medical kit containing a minimum of 25 specified instruments and medications, plus first-aid kits and automated external defibrillators. But the FAA does not track data on the use of those kits during in-flight medical emergencies. Instead, the agency leaves it to the airlines to inspect the kits and replace them if the seals are broken.

“Ensuring complete, sealed emergency medical kits are present is part of the cabin crew’s preflight inspection,” FAA spokesperson Ian Gregor said in a statement.

But, as Coley and other passengers who have responded to an in-flight emergency have found out, an item required in a medical kit can sometimes be missing. Some items the FAA doesn’t require, such as the overdose reversal drug naloxone, are carried voluntarily by some airlines. The agency has issued guidance recommending items to add to the kits, but they are not yet mandated.

Gregor said the FAA investigates all reports of issues with medical kits and ensures any concerns are addressed. He did not respond to a KHN request for details on the number of reports investigated, their outcomes, or whether the emergencies described in this article were among those investigated.

In June, Boston surgeon Dr. Andrea Merrill was aboard a Delta Air Lines flight when she assisted in a medical emergency and found the kit fell short of what she needed.

It needs “a glucometer, epi pen, and automatic blood pressure cuffs — it’s impossible to hear with a disposable stethoscope in the air,” Merrill tweeted to Delta after the incident. “Please improve this for passenger safety!”

After Merrill’s tweet went viral, Delta followed up with her, saying it would switch to automatic blood pressure cuffs and “real” stethoscopes, as well as consider glucometers at gates. Merrill declined an interview request.

KHN asked U.S. airlines to detail their medical emergency protocols and the contents of their medical kits. Seven responded with limited information: Alaska, Allegiant, Hawaiian, JetBlue, Southwest, Sun Country, and United. All said that their kits meet or exceed FAA requirements and that they train their staff to respond to medical emergencies. Many airlines also contract with a MedAire service called MedLink that connects flight crews with a medical professional on the ground in an in-flight emergency.

Allegiant officials said passengers with medical conditions should not assume their planes will have everything they need in an emergency. “Although our crews are trained to respond to a wide array of unplanned medical emergencies, we want to remind readers who have anticipated medical needs to bring their own medical supplies in carry-on luggage and not rely on aircraft emergency equipment,” Allegiant spokesperson Andrew Porrello said in a statement.

Delta, along with American, Frontier, and Spirit, did not respond to requests for comment. A 2019 article on the Delta website said its flight attendants are given training in first aid and CPR. Additionally, Delta wrote that its medical equipment exceeds FAA requirements. The airline mentioned it uses STAT-MD, a service that lets flight crews consult with trained personnel at the University of Pittsburgh Medical Center.

The FAA requires flight attendants to receive specific medical training, but medical professionals who have intervened as passengers during an in-flight emergency said the crew is not always quick to respond.

“Passengers believe that there are probably more safeguards in place than there actually are,” said Dr. Comilla Sasson, a Denver-area emergency physician and associate clinical professor at the University of Colorado.

Sasson was on a United Airlines flight in 2018 when a passenger passed out. When she volunteered to help, crew members asked for proof that she was a doctor as she mobilized to check the passenger’s vital signs. Sasson questioned the extent to which crew members are trained to help in medical emergencies, saying other health care providers have told her about their own experiences of aiding a passenger in need while the flight personnel stood aside.

“It’s interesting to me that the airlines really kind of depend on the kindness of strangers in a lot of ways, much more so than I would think,” Sasson said.

The goodwill of a fellow passenger is something Bay Area resident Meera Mani is thankful for after a 2011 experience. She was on a United flight from Toronto to San Francisco when her now-deceased father, then in his 80s, began showing concerning symptoms: The right side of his face and arm drooped. Worried her dad was having a stroke, Mani shouted for help but was frustrated by flight attendants’ slow response.

“And then finally, I said: ‘Is there a doctor on the flight?’” Mani recounted.

There was. The doctor used a defibrillator to stabilize her father.

“It was very clear to me that the [flight] staff were completely flummoxed,” Mani said. “They had the equipment, they took it out, they gave it to him, but the doctor took care of it.”

United helped organize an ambulance to meet Mani and her father on the ground at the San Francisco airport and later called to see if her dad was OK. He ended up being diagnosed with a condition that could lead to fainting.

MedAire, which runs the MedLink consulting service, said it covers around 70% of the U.S. market but declined to specify airlines. Dr. Paulo Alves, MedAire’s global medical director of aviation health, said 98% of medical events are managed on board and are non-life-threatening, while 2% are serious cases that might divert a flight.

Alves said his company also provides medical consultations before passengers board a flight.

“An airplane — although I love aviation — is never the best place for you to have a medical event,” Alves said. “The first line of prevention is actually preflight.”

Alves also defended the contents of airlines’ medical kits. The medically trained volunteers who step in to help fellow passengers in an emergency may expect resources available in a hospital, but “the airplane is not a hospital. You cannot carry everything,” he said.

Mani said she would like to see airlines disclose which medical emergencies they’re trained to address — potentially on flight safety cards. Sasson said it would be helpful if airlines clearly shared information about what medical supplies are available on board.

“I think the general public doesn’t realize how much of a crapshoot it is when they’re up in the air that somebody with some sort of medical training will know what to do, if something were to happen,” Sasson said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Every new year, many people vow to lose weight—and 2023 is no different.  Pledging to eat healthy or hit up the gym are two of the top resolutions among Americans this year. If you’ve been scrolling through TikTok, however, you might have seen a third option for your weight loss goals: several TikTokers are injecting themselves weekly with a Type 2 diabetes drug called Ozempic, claiming it can help quickly trim your tummy. Kim Kardashian is rumored to have used the drug to fit into Marilyn Monroe’s dress for the Met Gala (though she has denied this) and Elon Musk has tweeted that he’s a fan.

Now, Ozempic’s newfound status as a weight loss hack has infiltrated TikTok, which is causing the drug to fly off the shelves. But the increased demand for the injection has also sparked a drug shortage worldwide, leaving people with diabetes without a means to get their prescribed medication. As the trend takes off, multiple health professionals are questioning the safety of using an off-label drug and its long-term effectiveness for keeping the weight off.  

For people just looking to get skinny, quick, “it’s not meant to be a short-term solution to weight loss, and it’s very expensive with people paying close to $1,000 [if not covered by insurance],” explains Rose Lin, an endocrinologist at Providence Saint John’s Health Center in Santa Monica. Lin advises the drug is not medically necessary for people without diabetes or obesity when diet and exercise can give better results for your overall health. 

[Related: ‘Hormone diets’ might work—but not for the reason you think]

Ozempic is the brand name for a drug called semaglutide. It’s approved by the Food and Drug Administration (FDA) as a once-weekly injection to control blood sugar levels in people with Type 2 diabetes. It is also approved as a treatment to reduce the risk of heart problems for people with Type 2 diabetes and known heart disease.

Semaglutide mimics a hormone called glucagon-like peptide-1 (GLP-1) that binds to GLP-1 receptors. The activated receptors stimulate the pancreas to release insulin when blood sugar levels rise. GLP-1 also has a secondary role in appetite control. Like GLP-1 hormone, semaglutide slows down the digestive process so food sits in the stomach for longer periods of time, giving you the sensation of feeling full. This feeling of satiety sends a message to the brain which blocks the release of hunger hormones that cause food cravings. 

Weight loss is a known side effect of diabetic patients who are on semaglutide drugs. However, Ozempic, in particular, is not prescribed for weight loss purposes. There is another version of semaglutide called Wegovy that was FDA approved in 2021 as a weight management injection for adults with obesity. “Generally this would be for people carrying excessive weight,” explains Lin. People who are prescribed Wegovy are considered obese (a BMI of 30 or higher) or overweight (BMI of 27 or higher) with a secondary condition or disease that may cause obesity. A 68-week clinical trial found that middle-aged adults with obesity who took weekly injections of Wegovy lost an average of 35 pounds, while participants in the control group only lost an average of 6 pounds.

Semaglutide is an effective weight loss mitigation strategy for people with obesity, but experts warn that being skinny does not equate to being healthy. “There are no easy fixes for weight loss,” says Silvana Obici, chief of endocrinology and metabolism at Stony Brook Medicine. 

[Related: Why most diets don’t work—and what to try instead]

If you don’t need to be on the medication to manage diabetes, you probably shouldn’t be using it as semaglutide does pose some safety risks. One common side effect of semaglutide is nausea from having food stay in your stomach for long periods of time. “I’ve had patients have nausea to the point of vomiting or dry heaving,” describes Lin. Other common side effects of semaglutide drugs include stomach pain, diarrhea, and constipation. While rare, there is a possibility of developing thyroid tumors, as a past study in rodents found them after semaglutide injections. Carcinogenic effects in humans remain under dispute. There have also been reports of gallbladder problems in people taking semaglutide with symptoms ranging from yellowing of the skin or eyes, upper stomach pain, and fever.

Obici also warns that Ozempic is not very effective for sustaining long-term weight loss. People using the drug will not be able to maintain the weight loss without a healthy diet and regular exercise. “An unhealthy lifestyle when taking Ozempic might obliterate the beneficial [weight loss] effects of the drug,” she says. A 2021 clinical trial found people regained most of the weight they lost after discontinuing semaglutide injections. 

Due to this temporary weight loss, it may cause people to continue to use semaglutide drugs like Ozempic for extended periods of time. Obici and Lin are concerned that long-term reliance on Ozempic for weight loss will exacerbate the global drug shortage. It’s a serious problem for diabetic patients who are struggling to access the drug. “We’ve had people over the past month or two calling in and telling us they cannot get the drug for their diabetes,” says Lin. “We’re giving them samples when we can, but a lot of times there’s just no supply.”

There are alternative drugs that people with diabetes can take instead, but the shortage of Ozempic is causing a ripple effect with other injectable GLP-1 agonist drugs. The FDA has reported a shortage of other diabetic drugs such as Tirzepatide and several doses of Trulicity. Novo Nordisk, the pharmaceutical company that manufactures both Ozempic and Wegovy, announced they have Wegovy back in stock and are working to resolve the Ozempic shortage by early 2023.

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This article was originally featured in Undark.

Brad Fuller was a toddler when he contracted polio in 1952 and was sent to a hospital miles from his northeast Pennsylvania home. He stayed there for nine months, enduring long stints in an iron lung, a large metallic ventilator that helped him breathe. Fuller’s parents were allowed only rare visits. His earliest memory is of a nurse holding him in a mineral pool, instructing him to kick his legs.

That year marked the epidemic’s peak, when roughly 58,000 American children and adults developed polio and 3,000 of them died. In this respect, Fuller was lucky. The disease spared him, leaving only a weakened left leg and right arm. He was able to play tennis and football and train as a clinical psychologist. He built a career leading non-profits while teaching part time at St. Joseph’s University in Philadelphia. Despite his childhood ordeal, Fuller said, he felt invincible.

Then, in his 40s, a new doctor offered to treat his post-polio. Fuller was taken aback. It was the first time he’d heard the term. But the symptoms, like increased muscle weakness and poor balance, had been creeping up. At one point, he’d fallen and injured his knee. He now wears a full leg-brace and because he falls so often, he has taught himself to land easily. “I think if I was a typical person” — a person without a background in mental health — “I would have immediately gone into denial,” he said.

Scientists believe that the poliovirus has been around for thousands of years, but it did not cause epidemics until the late 1800s, when countries like the United States and the United Kingdom began to experience waves of increasing severity. By the 1940s and early 50s, the polio terror was killing or paralyzing more than a half million people globally each year. To treat the overwhelming number of sick people, hospitals created the first intensive care units. Many of those ICU patients were children and young adults.

Then came a pair of highly effective vaccines, the first of which was licensed in 1955. Case rates plummeted within a matter of years, and the virus was soon eradicated from entire countries. The vaccines are widely viewed as a triumph of public health. “My mother would have given anything to have a vaccine” for her children, recalls Fuller. But for those who had already been infected and survived, there was a downside. Polio “supposedly disappeared,” Fuller said. “That means research stopped.”

This history is bittersweet for patients who now struggle with post-polio syndrome, or PPS, which affects 25 to 40 percent of survivors. As adults, these individuals face an array of new symptoms stemming from their initial infection — everything from pain and renewed muscle weakness to fatigue to problems speaking and swallowing. PPS affects up to 300,000 people in the U.S., and globally the figure could be as high as 15 to 20 million people, according to some estimates. Most polio survivors in developed countries are 65 and older, said Marny Eulberg, a physician with PPS who ran one of the first dedicated clinics in the U.S. Survivors in the developing world are often younger.

Fuller was fortunate in another respect. His physician recognized the signs of PPS. Many patients struggle for years to find an explanation for their various symptoms, only to find out, once they receive a diagnosis, that there are no approved treatments and few specialists who can help them manage their condition. The exact cause of PPS remains unknown, and it has confounded researchers seeking a cure. Further research could elucidate polio’s long-term effects and stall patients’ physical decline, say the handful of scientists still studying the condition, but funding is scarce.

“The sentiment in all the funding bodies is polio has disappeared. So are we going to put money in it?” said Frans Nollet, a leading figure in European post-polio research who heads a specialty clinic at Amsterdam University Medical Centers. “It’s difficult,” he continued. “People think the disease has vanished, but the patients are still here.”

Like polio itself, post-polio syndrome is thought to have been around since ancient times. But it didn’t capture the medical world’s attention until the generation of young polio patients from the 1940s and 50s reached adulthood.

That’s when Marilyn Fletcher, a physician and polio survivor, approached the National Institutes of Health for help. In 1982, after repeated phone calls and visits to the federal agency, Fletcher landed a meeting with the neurologist Marinos Dalakas. At least 20 polio survivors in and around Washington D.C. were experiencing new symptoms, she told him. These individuals had even coined a new term, “post-polio syndrome,” to describe their condition. Thousands of people across the U.S. could have similar symptoms, Fletcher maintained. Those in D.C. were frustrated that the medical community was ignoring them.

Dalakas was initially skeptical and took no action. But a month later, he received a call to meet Fletcher at the Surgeon General’s office. Everett C. Coop, newly appointed to the position, “expressed his concern about the emerging phenomenon of PPS as described by Dr. Fletcher,” wrote Dalakas in a 1995 paper. Soon thereafter, Dalakas headed up a first-of-its-kind survey to learn more.

The survey was sent to 2,800 individuals with medical records indicating a polio-related disability. At least 2,500 people replied, often sending letters and personal photographs along with their questionnaires. “Many of the responses contained details which were highly emotional and stimulating,” Dalakas recalled in an email to Undark. For example, a 50-year-old man who’d contracted polio at 19 was struggling to drive or even dress himself. The devastating toll of PPS quickly became clear to Dalakas.

But how to define this new condition was less obvious. Collectively, the study participants reported a wide variety of ailments, with the onset of new symptoms occurring years to decades after the initial infection, often when survivors were in their 30s, 40s, or 50s. Because of this heterogeneity, experts disagree even today about what constitutes PPS. An official diagnosis requires a 15- or 20-year period of stability without new weakness or impaired movement.

Yet Frances Quinn, who contracted polio as a 1-year-old, said her symptoms have never truly been stable. At age 14, she felt growing weakness in her upper right arm and in her thumb. Her health care provider, she said, attributed these changes to adolescence and her accompanying loss of baby fat. “There’s a lot of stuff said about PPS that’s not really based on good science,” said Quinn, who worked as a physicist in the U.K. government for most of her life. “PPS is diagnosed when the patient decides that something is wrong and also finds someone who will listen to them.”

Katharina Stibrant Sunnerhagen, a professor of rehabilitation medicine at the University of Gothenburg in Sweden, raised similar objections. “My problem is that, for instance, if you had polio as a 1-year-old, when is your condition steady?” Childhood and adolescence encompass periods of rapid physical growth and development. Strictly speaking, an individual who survives polio as a baby must wait until the completion of puberty before their 15- to 20-year period of stability can even commence.

PPS was formally redefined by the World Health Organization in February of 2022, when it updated its International Classification of Diseases. The WHO now calls PPS “post-polio progressive muscular atrophy.” Critics have argued that the redefinition does not reflect the spectrum of symptoms patients may endure, increasing the risks that patients will receive the wrong sort of care. Why change it at all? asked Quinn. “It took 40 years of work to get PPS recognized and creating more names only adds to confusion.” Some sufferers also worry that disability payments could be affected although, for now, practitioners in the U.S. and U.K. still refer to the older classification.

Government recognition of PPS as a disability has been important because symptoms often appear in mid-life, making it difficult for some patients to sustain their careers. Carol Ferguson, a polio survivor and mother, used to work at a Pennsylvania bed-and-breakfast but was obliged to quit when she could no longer stand all day. “My physicians made it very clear that that part of my life was over,” she said.

Some post-polio patients originally had mild symptoms. Others needed leg braces, calipers, or an iron lung. For the latter group, the reemergence of symptoms can feel like a deal gone sour. Eulberg contracted polio in 1950, when she was four. She recalls being promised that if she just worked hard enough, she would be able to walk without a leg brace. In junior high that promise was fulfilled. But decades later, her muscles started to weaken and she realized she needed a brace again. It “felt like a failure,” she told a Medscape reporter in 2020.

There are also unexpected risks. In rare instances, anesthesia can prove fatal for those with PPS, who may need as little as half the dose of typical adults because of an increased sensitivity to sedatives and other drugs. They may have difficulty breathing or swallowing, or be slow to rouse after treatment, possibly having the same vulnerabilities as other patients with neuromuscular disorders. John MacFarlane, a campaigner and former president of the European Polio Union, had given a talk about PPS to the British Medical Association. While leaving the conference building, his wheelchair tipped into a pothole and toppled over. He later needed an operation to pin and plate his arm. He told Undark that it took him 14 hours to wake up after surgery.

For many years, Ferguson, the former B&B worker, didn’t even realize that she’d been infected with the poliovirus. When she came down with a fever at the age of two, just a year before vaccines became available, she recalls, her parents assumed it was a “summer flu.” Ferguson developed a drop foot at age 11, and a doctor suggested polio as the possible cause. But Ferguson’s mother was dubious, and the disease was not mentioned again. Feelings of self-blame may have contributed to the situation, said Ferguson. At the time, many parents believed that if they simply kept a clean house, their children would not fall ill.

Ferguson grew up a clumsy kid who stumbled a lot. As an adult, she fell while ice skating and had to undergo a minor surgery. She woke up three days later in intensive care. The anesthesiologist, she recalls, probed for details that might explain why it had taken so long for her to wake. When she mentioned her summer flu, he warned, “Don’t ever leave that out of your medical history again.” The physician suspected that the flu had actually been polio and that Ferguson was experiencing the condition’s lingering effects. But he did not provide an official diagnosis of PPS.

For that, patients must undergo a battery of blood tests, scans, and X-rays to rule out other health conditions. Ferguson recalls starting along this path and encountering several doctors who thought she had multiple sclerosis; another was sure she had a brain tumor (“That’s the kind of thing that really messes with your head,” she said). When those conditions were eventually ruled out, a neurologist at the University of Pennsylvania conducted a diagnostic test called an EMG, which evaluates the function of motor neurons. Ferguson recalls lying in bed with needles in her leg, her husband holding her hand to ease her pain as the test recorded electrical activity in her muscles. She told Undark that partway through, the physician called his students to the room to show them what a case of “old polio” looked like.

For Ferguson, it was a moving moment. Her journey to diagnosis had come to an end. “We finally had it,” she said. “Everything else had been ruled out.”

For help managing her symptoms, which included deepening fatigue and a weak leg, Ferguson went to a polio clinic in Englewood, New Jersey. Like other clinics, this one provided access to an array of specialists, including rehabilitative physicians, occupational therapists, physical therapists, nutritionists, and orthotists — specialists who make braces and splints. Ferguson had been walking 10,000 steps a day, trying to keep healthy. At the clinic, she learned that she was over-using frayed muscles. This kind of insight, and the clinic’s care more broadly, are what ultimately “saved me,” Ferguson said.

Despite their benefits, polio clinics have been shutting down, said Carol Vandenakker-Albanese, a professor of health sciences who runs a clinic at UC Davis. Many physicians who once specialized in treating the disease have retired, she said, estimating that only about two dozen polio specialists currently practice in the U.S. With most survivors now in their 60s and 70s, few young clinicians want to take up the mantle.

Four specialists told Undark that there is a concerning lack of knowledge among their medical colleagues about PPS. Despite a steady trickle of published studies since the 1980s, many doctors are too busy to keep up with the science and simply “don’t believe in PPS,” said Richard Bruno, who trained in psychophysiology and led the Englewood clinic where Ferguson was treated. In Sweden, a patient told Sunnerhagen that when she asked her family physician if ankle pain could stem from childhood polio, the doctor replied, “Polio is a vaccine.”

Ferguson now volunteers with a Pennsylvania-based support group that she helped establish, which offers a list of recommended specialists and publishes newsletters and personal stories. Support groups exist in other states too, providing patients with an opportunity to swap details about symptoms and possible treatments and share tips for educating their doctors and advocating for themselves. In Germany, a doctor with PPS has argued that patients could benefit from medical cannabis, and he has developed a protocol to help patients with their symptoms. But, he said, insurers and other physicians are reluctant to accept the therapy.

Brad Fuller, the survivor whose first memory is of being in a mineral pool, would like to see the U.S. government offer more support to PPS patients. Some of them need braces or wheelchairs in order to continue living productive lives, but such mobility aids, he said, are “outrageously expensive.”

“Basically,” said Eulberg, who councils patients at the clinic she founded in Wheat Ridge, Colorado, “we’re telling polio survivors, ‘Yes, it would be wonderful if every health care provider you encountered knew a lot about polio, but that ain’t going to happen. You’re going to have to be your own advocate.’”

In 2001, Antonio Toniolo, a microbiologist and physician, experienced a serious car accident. To recover from his injuries, he spent two years visiting a rehabilitation clinic, where he encountered middle-aged polio survivors who were seeking help for their muscle weakness. At the time, Toniolo was working at the University of Insubria Medical School in Italy. The survivors, he recalls, started referring to him as “Doctor” and asking, “What do you know about polio?”

Then, as now, the cause of PPS was not well understood. Researchers know that the initial infection kills some of the body’s motor neurons, the cells that facilitate communication between muscles and the brain. Over time, some of these neurons regrow dramatically, reaching 7 or 8 times normal size, but they are unable to maintain themselves and eventually start to die off. But why this die-off happens, and why some patients are more affected than others, remain a mystery.

Throughout the 1980s and 90s, researchers focused on defining PPS and on trying to understand its underlying causes. After studying that literature, Toniolo began to wonder if the poliovirus might still be present in the blood of survivors — something earlier research had suggested — and causing their new symptoms. In 2013, he gathered blood and spinal fluid from 100 post-polio patients and compared the samples with those from a control group of about 50 survivors who weren’t experiencing PPS. He found traces of poliovirus in samples of about two-thirds of the PPS patients, compared with very few of the control group’s samples. The still-circulating virus, he posited, could cause inflammation or even cell death in those patients. This would mean the condition might respond to antiviral drugs.

Toniolo shared this preliminary data at a couple of PPS-related events and in a mid-study report published in 2015. But the research was never finalized or published in a scientific journal. “This was expensive research that needed funds and competent people,” he wrote to Undark in an email. “Thus, due to lack of funds and my retirement at the end of 2018, the work has not been completed.”

As of yet, nobody has tested whether PPS might respond to antivirals. A major multi-center study led by Dalakas is focusing on whether certain proteins in the blood of healthy donors could help neutralize proteins called cytokines that scientists have detected in the blood and spinal fluids of some PPS patients. Researchers hope that the therapy, called IVIG, will calm the cytokines and stabilize the immune system, thereby improving patients’ quality of life.

The treatment has been trialed in Sweden without conclusive results and was available for a while in some countries, Nollet from the Amsterdam University Medical Centers said, but because it was considered not sufficiently proven, insurers were reluctant to cover it. Whatever the outcome of this study — which is sponsored by a Spanish company, Grifols — it will be helpful for patients to know whether it works or not, said Nollet, whose clinic is among those taking part.

The Swedish government is rearranging care of rare diseases so that polio survivors will be treated at expert centers, a decision driven by recent events: Last summer, health officials reported that the poliovirus had paralyzed an unvaccinated man living in an under-vaccinated community in New York. It was the first U.S. case in years. As of early October, the virus still appeared to be spreading in several under-vaccinated parts of the state. In 2022, for the first time in decades, poliovirus was also detected in Israel, Malawi, Mozambique, and the U.K., alarming public health officials and spurring calls for vaccination campaigns.

Observing the cases in New York helped the Swedish government understand that a polio outbreak “is something that can actually happen again, even here,” said Sunnerhagen, whose own PPS research is part of an application for special status at her university hospital. Her clinic serves about a thousand post-polio patients, a largely Swedish cohort alongside a younger group of individuals who immigrated to Sweden from countries where the disease was never eradicated. “We need to spread the knowledge,” she said, to draw attention to the fact that polio patients are still present in society. Sunnerhagen doesn’t expect all physicians to be experts in the condition but she hopes that they will at least know to make the referral.

For now, patients are still driving much of their medical care.

Ferguson said she understands why a physician might be stumped by a multi-symptom disease triggered by a long-ago infection. “But to totally deny that this exists is heartbreaking,” she said. “I’m a living example that a very mild or unapparent case of a virus can leave lifelong damage.”

This article was originally published on Undark. Read the original article.

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Various research groups have been teasing the idea of an AI doctor for the better half of the past decade. In late December, computer scientists from Google and DeepMind put forth their version of an AI clinician that can diagnose a patient’s medical conditions based on their symptoms, using a large language model called PaLM. 

Per a preprint paper published by the group, their model scored 67.6 percent on a benchmark test containing questions from the US Medical License Exam, which they claim surpassed previous state-of-the-art software by 17 percent. One version of it performed at a similar level to human clinicians. But, there are plenty of caveats that come with this algorithm, and others like it. 

Here are some quick facts about the model: It was trained on a dataset of over 3,000 commonly searched medical questions, and six other existing open datasets for medical questions and answers, including medical exams and medical research literature. In their testing phase, the researchers compared the answers from two versions of the AI to a human clinician, and evaluated these responses for accuracy, factuality, relevance, helpfulness, consistency with current scientific consensus, safety, and bias. 

Adriana Porter Felt, a software engineer that works on Google Chrome who was not a part of the paper, noted on Twitter that the version of the model that answered medical questions similarly to human clinicians accounts for the added feature of “instruction prompt tuning, which is a human process that is laborious and does not scale.” This includes carefully tweaking the wording of the question in a specific way that allows the AI to retrieve the correct information. 

[Related: Google is launching major updates to how it serves health info]

The researchers even wrote in the paper that their model “performs encouragingly, but remains inferior to clinicians,” and that the model’s “comprehension [of medical context], recall of knowledge, and medical reasoning improve with model scale and instruction prompt tuning.” For example, every version of the AI missed important information and included incorrect or inappropriate content in their answers at a higher rate compared to humans. 

Language models are getting better at parsing information with more complexity and volume. And they seem to do okay with tasks that require scientific knowledge and reasoning. Several small models, including SciBERT and PubMedBERT, have pushed the boundaries of language models to understand texts loaded with jargon and specialty terms.  

But in the biomedical and scientific fields, there are complicated factors at play and many unknowns. And if the AI is wrong, then who takes responsibility for malpractice? Can the source of the error be traced back to a source when much of the algorithm works like a black box? Additionally, these algorithms (mathematical instructions given to the computer by programmers) are imperfect and need complete and correct training data, which is not always available for various conditions across different demographics. Plus, buying and organizing health data can be expensive. 

Answering questions correctly on a multiple-choice standardized test does not convey intelligence. And the computer’s analytical ability might fall short if it were presented with a real-life clinical case. So while these tests look impressive on paper, most of these AIs are not ready for deployment. Consider IBM’s Watson AI health project. Even with millions of dollars in investment, it still had numerous problems and was not practical or flexible enough at scale (it ultimately imploded and was sold for parts). 

Google and DeepMind do recognize the limitations of this technology. They wrote in their paper that there are still several areas that need to be developed and improved for this model to be actually useful, such as the grounding of the responses in authoritative, up-to-date medical sources and the ability to detect and communicate uncertainty effectively to the human clinician or patient. 

The post This AI is no doctor, but its medical diagnoses are pretty spot on appeared first on Popular Science.

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Buffalo Bills safety player Damar Hamlin collapsed on the field during Monday night’s football game versus the Cincinnati Bengals after a blow to the chest. Hamlin immediately became unresponsive, falling into cardiac arrest and prompting medical staff to start life-resuscitating measures. On Thursday, the Bills reported that the football star has woken up and is “neurologically intact.” Hamlin remains in critical condition and on a ventilator, but his doctors have said he can communicate via writing with his first words asking who won the game. 

As of this reporting, there is no official diagnosis or explanation of what triggered Hamlin’s cardiac arrest. Hamlin’s condition has been called an “unprecedented situation” and something people haven’t “ever seen before” in the professional football community. It has not only shaken the National Football League (NFL) but has shone a light on having medical resources available to make sure contact sports are as safe as possible. 

While there’s always a risk of injury during contact sports, medical research on football has often focused on head trauma such as concussions. Cardiac injuries, on the other hand, are less common. “Think about how many blows to the chest are delivered every week in hockey, lacrosse, basketball, and baseball with no lasting trauma,” says Hal Andrew Skopicki, the chief of cardiology at Stony Brook Medicine in New York who was watching the Bills and Bengals game live. One 2013 study on 107 cases of sudden cardiac arrest found only 20.5 percent of footballers survived and with a little more than half having an on-site defibrillator—a device that shocks the heart to restore a normal heartbeat. However, while these sports-related cardiac injuries are incredibly rare, they can be fatal, Skopicki cautions.  

What happens to your heart during cardiac arrest?

Our hearts beat around 100,000 times a day to pump blood throughout the body, explains Skopicki. Hearts use electricity to create a heartbeat. A group of heart cells work together as a pacemaker to create electricity, which transmits through the heart and gets it to contract and relax. The group of heart cells are “like an on-off switch that shoots electricity in the heart which tells it when to squeeze,” explains Shephal Doshi, director of cardiac electrophysiology and pacing at Providence Saint John’s Health Center. 

Cardiac arrest occurs when the heart’s electrical system malfunctions. A misconnection or over-connection, for instance, can short-circuit the electrical system and cause the heart to stop squeezing, meaning no blood is getting pumped out into the body, including the brain. Heart attacks, a common cause of sudden cardiac arrest, obstruct blood flow to the heart. The blockage deprives heart cells of oxygen, which affects their electrical impulses, resulting in an abnormal heart rhythm.

[Related: CPR can save lives. Here’s how (and when) to do it.]

Muscle problems can also cause electrical instability. People who fall into this category often have a type of heart defect. Hypertrophic cardiomyopathy is one condition where the heart muscle thickens, causing scarring that may not allow the electrical system to function correctly. Dilated cardiomyopathy is another heart muscle disease where the left ventricle is stretched out, making it difficult for the organ to pump blood.

What do we know about Damar Hamlin’s collapse?

The Bills and medical officials have not disclosed Hamlin’s health history to the public, and it’s not known whether he has a preexisting condition that could have triggered cardiac arrest. However, professional athletes undergo rigorous screenings to detect health conditions like hypertrophic cardiomyopathy or a congenital heart defect ahead of time, says Liz Gardner, a sports medicine orthopedic surgeon for Yale Medicine. (The NFL is often selective when sharing player injury and health information with the public.)

Some medical experts have speculated that Hamlin’s collapse may have to do with a condition called commotio cordis. This is a rare situation where a strike to the chest occurs during a certain point in the heartbeat cycle. The heartbeat cycle consists of different electrical waves that mechanically stimulate the heart. The T wave is a vulnerable 20-millisecond interval when the heart rests before it begins the next beat. A blunt impact to the chest in this short time period can reset the heart inappropriately and change its rhythm, leading to cardiac arrest. Hamlin’s cardiac arrest “it’s most likely not a genetic abnormality or a weak heart, but really just a case of bad luck and unfortunate timing,” says Matthew Martinez, director of sports cardiology at Morristown Medical Center. 

Commotio cordis could happen to anyone with a healthy heart. Because the condition is based on the timing of the blow to the chest, there are no screenings or medical tests to predict it. While the condition is often seen in athletes between the ages of 8 and 18, Martinez says it’s unlikely Hamlin’s age, 24, had anything to do with it. Commotio cordis can be life-threatening. Experts say the decisive factor is the time between when the heart stops beating and resuscitation. That timing also impacts the likelihood of long-term damage to organs, including the brain.

Skopicki says Hamlin fell backwards without trying to break his fall, which usually happens when the brain shuts off. “When you see a person go down like that, the thought immediately turns to whether or not the heart is pumping blood out to the brain,” he explains. “Your brain cells can only go about five minutes without oxygen.”

What are the chances of a full recovery from sudden cardiac arrest?

Sudden cardiac arrest has only happened a handful of times in the sports world. Danish soccer player Christian Eriksen experienced cardiac arrest during a Euro 2020 match against Finland. Eriksen made a full recovery and was later fitted with an implantable cardioverter defibrillator, a type of pacemaker that releases a small jolt to stabilize an irregular heart rhythm. He resumed playing 8 months later. Others have not been so lucky. St. Louis Blues defense player Jay Bouwmeester went into cardiac arrest and collapsed on the bench during a 2020 hockey game. He recovered three days later but had to retire from professional play. In a 2017 soccer match, former Dutch midfielder Abdelhak Nouri experienced cardiac arrest, which left him  in a coma for 13 months. He later woke up with permanent brain damage.

For Hamlin, there is some good news. Gardner told Popular Science the football star has the best chance for recovery, considering the rapid response of the medical team. Medical personnel took 10 seconds to reach Hamlin and started resuscitation, which went on for nine minutes. The athlete was also intubated by the time the ambulance arrived on the field.

“Not only was he in a setting where a defibrillator was immediately available, but CPR was provided right away.” Only 12 percent of people with cardiac arrest survive, although giving CPR can triple a person’s survival chances. 

[Related: We have no idea how dangerous football really is]

Without more details on his condition, it’s too soon to predict when Hamlin will walk out the hospital, much less play football again. Doshi says that considering the extent of the injury, it’s going to be a tough road to recovery and could be some time before he could be ready to play again on a competitive level. “But I’m sure many would agree that sports is secondary to being alive,” he says.

The incident is a grave reminder that football can be a dangerous sport that goes beyond entertainment. Gardner says it’s wonderful that the NFL had first responders who quickly rushed to the scene to perform CPR, but that’s not always the case with nonprofessional sports. High school football, for example, is one area where on-site medical care is virtually nonexistent. She says if high schools are slashing budgets, there’s a possibility that medical resources needed in case of cardiac events or concussions could be downsized. “If we are going to support and sponsor contact sports, there is a level of responsibility to do that safely.”

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As a child, I loved it when my mom cleaned my earwax. It was a regular ritual: I would lay my head in her lap as she shined a flashlight down my tiny ear canal. Very gently, she scraped and scooped my goopy earwax with the curved end of a thin bamboo stick decorated with a cute little doll, called a mimikaki in Japanese. For thousands of years, ear cleaning in many Asian cultures has been an act of affection. But this intense fascination with ridding our ear holes of the stuff is pretty universal: The ancient Romans created specialized ear tweezers, medieval Europeans made metal spoons, and the Vikings cleaned their ears with picks of gold. 

“All cultures seem to be obsessed with removing earwax,” says Henry Ou, a pediatric otolaryngologist at Seattle Children’s Hospital and the University of Washington. 

Despite all of our creative removal efforts, earwax coats the canal for a reason—and it’s best if you leave it be, Ou says. Even though it might clog your earphones or stain your pillows (I can relate), earwax is a significant and necessary substance. Whether crusty or creamy, you should appreciate this bodily secretion—the contents of which is unique to you—for keeping our ears healthy and clean. 

What exactly is earwax? 

Earwax, scientifically referred to as “cerumen,” is a concoction of three main ingredients: oils, sweat, and dead skin cells. “What percentage of each varies depending on the person,” says Ou. “Everyone’s composition is slightly different.” 

The skin in your ear grows constantly, he explains. When dead skin cells shed, they migrate from inside to the outer ear, which is helped by two earwax components: Sweat and oil. The sweat, which may contribute to earwax aroma, is secreted from specific organs called apocrine glands, also found in the groin, armpits, and nipples. 

[Related: It’s never too early to start protecting your hearing]

The oily discharge comes from sebaceous glands around the hair follicles in the outer canal. How much oil your glands produce plays a role in the viscosity and texture of the golden globs, says Yu-lan Mary Ying, an otolaryngologist and associate professor at Rutgers New Jersey School of Medicine. 

“When we have different oil content, we all make different consistency and that’s very individualized,” she says. Some people may have more oil glands than others, or have glands that are more productive. The difference in oil might explain where there’s a great diversity of wax types, “from very dry, flaky to very thick, kind of like candle wax or butter,” says Ying.

What role do your genes play? 

While earwax consistency runs the gamut from flaky to syrupy, people typically fall into two camps: wet or dry earwax. Dry earwax tends to be lighter shades of yellow or even gray, whereas wetter earwax is often darker gold or brown. Wet earwax may have a stronger odor. 

These distinct characteristics of earwax types are rooted in your genetics. Wet earwax is common in populations such as those of European and African descent, while dry earwax is more prevalent in East Asians. That makes me an outlier. I’ve always struggled with sticky, gooey wet earwax that always seems to get on everything—earbuds, pillowcases, beanie caps. A 2006 Nature Genetics study identified that the gene ABCC11 was responsible for what earwax type we have, and found that wet earwax was the more dominant trait than dry.

[Related: How to clean AirPods and other headphones]

While scientists have tried to identify which type of earwax has superior health or evolutionary benefits, Ou says he’s not entirely convinced by current research. Although, he adds, your environment may influence it: A 2011 study showed some associations with earwax type and climates—wet being more common in warmer areas, while dry was favored in cooler climates.  

Does your earwax ever change? 

Not really. It might seem like kids produce a lot more earwax, but it’s actually because they have little ear canals. “It won’t take much to block it,” says Ou. “Because the canal is smaller, it’s harder for the wax to get out on its own.” 

It’s possible for more subtle changes in earwax, though, as you get older, Ying explains. Sweat and oil glands become less productive as we age, and skin generally becomes drier. It might also cause earwax to become dry and flaky.

The ears, nose, and throat share the same space, which means an infection from a virus or bacteria could impact all of them at the same time. Some have believed that your ears produce more earwax when you’re sick, but there’s little evidence to support this. A cold, flu, or allergies might make your ears feel plugged, but that’s likely from fluid buildup caused by swollen tubes linking your ears and throat, explains Ying. “When you have nasal congestion from tonsillitis or major inflammation from a sore throat, the [tubes] can be blocked, so your ears feel full,” she says. 

Most infections won’t alter your earwax. But there are more severe cases, like a ruptured eardrum, swimmer’s ear, or serious head injury, where the consistency can change into a liquidy pus—sometimes referred to as “runny ears.” As secretions and drainage leak from an infected middle ear, it can mix with the wax, Ou says. 

Ear, nose, and throat doctors may collect the drainage-wax mixture to culture it and see whether it contains fungi or bacteria. This helps guide antibiotic or antifungal treatments. Some research groups have explored using earwax as a tool in toxicology, such as detecting drug use, in the same way hair or urine might be analyzed.Others have looked into earwax to measure hormone levels such as cortisol. 

Why is earwax important? 

Regardless of the texture or type you have, earwax serves as a line of defense in the external ear canal. Studies have shown that the substance contains antibacterial and antifungal proteins, which can prevent infections. It also creates a slightly acidic environment that harmful microbes dislike. Importantly, the viscous material keeps the inside of your ear nice and moist. 

“It serves as a protective, natural lubricant,” says Ying. “Think of skin on the rest of your body. You have to have a natural production of oil to prevent you from being so dry.” 

Your ears are no different. Without that lubrication, your ears would feel itchy, tempting you into scratching, which risks irritating or breaking the delicate skin that lines your canal. A tiny nick to this natural barrier can allow in bacteria and cause swimmer’s ear or other infections. Even worse, if you poke too deep, you might end up puncturing your eardrums. Plus, earwax also helps capture dust, debris, and other things that might fall into your canal.

[Related: For the love of God, please stop sticking things into your ear]

This all said, while you really shouldn’t pick at your earwax, sometimes clinicians do need to remove it. Too much of it can affect hearing; for instance, tinnitus, a constant ringing in the ear, can be due to excessive earwax, explains Ou. People who wear hearing aids or hearing assistive devices are more prone to earwax buildup and have to be on top of wax removal appointments to avoid severe impactions or additional hearing loss. “If we need to see your eardrum and we can’t see it because earwax is in the way, then we’ll use tools to carefully clear it,” he says. “But there’s really not a lot of reasons.” 

Sticking things in your ear on your own, particularly those prized cotton swabs, winds up pushing more wax deeper inside the ear than whatever you take out. This could cause even worse buildups. Instead, over-the-counter mineral oils or saline drops can help soften the wax and it’ll clear out on its own, says Ou. If that doesn’t work, seek medical attention.

“If your ears are really full, you shouldn’t even try using Q-tips, you shouldn’t do anything,” Ying says. “Just make an appointment and let us take a look.”

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This story was originally featured on KHN.

Larry McMahon, who turned 80 in December, is weighing whether to undergo a major surgery. Over the past five years, his back pain has intensified. Physical therapy, muscle relaxants, and injections aren’t offering relief.

“It’s a pain that leaves me hardly able to do anything,” he said.

Should McMahon, a retired Virginia state trooper who now lives in Southport, North Carolina, try spinal fusion surgery, a procedure that can take up to six hours? (Eight years ago, he had a lumbar laminectomy, another arduous back surgery.)

“Will I recover in six months — or in a couple of years? Is it safe for a man of my age with various health issues to be put to sleep for a long period of time?” McMahon asked, relaying some of his concerns to me in a phone conversation.

Older adults contemplating major surgery often aren’t sure whether to proceed. In many cases, surgery can be lifesaving or improve a senior’s quality of life. But advanced age puts people at greater risk of unwanted outcomes, including difficulty with daily activities, extended hospitalizations, problems moving around, and the loss of independence.

I wrote in November about a new study that shed light on some risks seniors face when having invasive procedures. But readers wanted to know more. How does one determine if potential benefits from major surgery are worth the risks? And what questions should older adults ask as they try to figure this out? I asked several experts for their recommendations. Here’s some of what they suggested.

What’s the goal of this surgery? Ask your surgeon, “How is this surgery going to make things better for me?” said Margaret “Gretchen” Schwarze, an associate professor of surgery at the University of Wisconsin School of Medicine and Public Health. Will it extend your life by removing a fast-growing tumor? Will your quality of life improve by making it easier to walk? Will it prevent you from becoming disabled, akin to a hip replacement?

If your surgeon says, “We need to remove this growth or clear this blockage,” ask what impact that will have on your daily life. Just because an abnormality such as a hernia has been found doesn’t mean it has to be addressed, especially if you don’t have bothersome symptoms and the procedure comes with complications, said Drs. Robert Becher and Thomas Gill of Yale University, authors of that recent paper on major surgery in older adults.

If things go well, what can I expect? Schwarze, a vascular surgeon, often cares for patients with abdominal aortic aneurysms, an enlargement in a major blood vessel that can be life-threatening if it bursts.

Here’s how she describes a “best case” surgical scenario for that condition: “Surgery will be about four to five hours. When it’s over, you’ll be in the ICU with a breathing tube overnight for a day or two. Then, you’ll be in the hospital for another week or so. Afterwards, you’ll probably have to go to rehab to get your strength back, but I think you can get back home in three to four weeks, and it’ll probably take you two to three months to feel like you did before surgery.”

Among other things people might ask their surgeon, according to a patient brochure Schwarze’s team has created: What will my daily life look like right after surgery? Three months later? One year later? Will I need help, and for how long? Will tubes or drains be inserted?

If things don’t go well, what can I expect? A “worst case” scenario might look like this, according to Schwarze: “You have surgery, and you go to the ICU, and you have serious complications. You have a heart attack. Three weeks after surgery, you’re still in the ICU with a breathing tube, and you’ve lost most of your strength, and there’s no chance of ever getting home again. Or, the surgery didn’t work, and still you’ve gone through all this.”

“People often think I’ll just die on the operating table if things go wrong,” said Dr. Emily Finlayson, director of the UCSF Center for Surgery in Older Adults in San Francisco. “But we’re very good at rescuing people, and we can keep you alive for a long time. The reality is, there can be a lot of pain and suffering and interventions like feeding tubes and ventilators if things don’t go the way we hope.”

Given my health, age, and functional status, what’s the most likely outcome? Once your surgeon has walked you through various scenarios, ask, “Do I really need to have this surgery, in your opinion?” and “What outcomes do you think are most likely for me?” Finlayson advised. Research suggests that older adults who are frail, have cognitive impairment, or other serious conditions such as heart disease have worse experiences with major surgery. Also, seniors in their 80s and 90s are at higher risk of things going wrong.

“It’s important to have family or friends in the room for these conversations with high-risk patients,” Finlayson said. Many seniors have some level of cognitive difficulties and may need assistance working through complex decisions.

What are the alternatives? Make sure your physician tells you what the nonsurgical options are, Finlayson said. Older men with prostate cancer, for instance, might want to consider “watchful waiting,” ongoing monitoring of their symptoms, rather than risk invasive surgery. Women in their 80s who develop a small breast cancer may opt to leave it alone if removing it poses a risk, given other health factors.

Because of Larry McMahon’s age and underlying medical issues (a 2021 knee replacement that hasn’t healed, arthritis, high blood pressure), his neurosurgeon suggested he explore other interventions, including more injections and physical therapy, before surgery. “He told me, ‘I make my money from surgery, but that’s a last resort,” McMahon said.

What can I do to prepare myself? “Preparing for surgery is really vital for older adults: If patients do a few things that doctors recommend — stop smoking, lose weight, walk more, eat better — they can decrease the likelihood of complications and the number of days spent in the hospital,” said Dr. Sandhya Lagoo-Deenadayalan, a leader in Duke University Medical Center’s Perioperative Optimization of Senior Health program.

When older patients are recommended to POSH, they receive a comprehensive evaluation of their medications, nutritional status, mobility, preexisting conditions, ability to perform daily activities, and support at home. They leave with a “to-do” list of recommended actions, usually starting several weeks before surgery.

If your hospital doesn’t have a program of this kind, ask your physician, “How can I get my body and mind ready” before having surgery, Finlayson said. Also ask: “How can I prepare my home in advance to anticipate what I’ll need during recovery?”

What will recovery look like? There are three levels to consider: What will recovery in the hospital entail? Will you be transferred to a facility for rehabilitation? And what will recovery be like at home?

Ask how long you’re likely to stay in the hospital. Will you have pain, or aftereffects from the anesthesia? Preserving cognition is a concern, and you might want to ask your anesthesiologist what you can do to maintain cognitive functioning following surgery. If you go to a rehab center, you’ll want to know what kind of therapy you’ll need and whether you can expect to return to your baseline level of functioning.

During the covid-19 pandemic, “a lot of older adults have opted to go home instead of to rehab, and it’s really important to make sure they have appropriate support,” said Dr. Rachelle Bernacki, director of care transformation and postoperative services at the Center for Geriatric Surgery at Brigham and Women’s Hospital in Boston.

For some older adults, a loss of independence after surgery may be permanent. Be sure to inquire what your options are should that occur.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Since 2013, medical professionals have increasingly turned to a device called the iKnife for finding potential breast and brain cancers. The iKnife, an electric toothbrush-sized instrument that works by ingeniously combining electrosurgery alongside mass spectrometry. First developed by researchers at Imperial College London, the iKnife uses tiny electrical pulses to vaporize tissues, while a spectrometer array analyzes the ensuing smoke to detect potentially cancerous cells. The “smart” surgical tool has often shortened biopsy wait times while also allaying some of patients’ stress in the ensuing decade—and recently, Imperial College London’s iKnife team announced its capabilities are expanding.

[Related: More Americans are surviving cancer now than ever.]

As first reported by The Guardian, the iKnife’s technology shows promise in identifying patients’ endometrial cancers with an almost 90 percent accuracy rate. “The iKnife reliably diagnosed endometrial cancer in seconds, with a diagnostic accuracy of 89 percent, minimizing the current delays for [patients] whilst awaiting a histopathological diagnosis,” the team wrote in a paper published in the research journal, Cancers, adding that the innovation could “pave the way for new diagnostic pathways.”

Abnormal or irregular bleeding often occurs for postmenopausal people because of often benign reasons such as noncancerous polyps or a result of hormone replacement therapy. That said, postmenopausal bleeding is considered to be one of endometrial cancers’ major early indicators, and experts suggest patients always schedule medical examinations if bleeding begins. The iKnife’s potential new ability to near-instantly assess problematic tissue could drastically alleviate the stress that comes during these previously lengthy, sometimes weeks’ long wait periods, says Imperial College London’s research team.

[Related: Why doctors almost never say cancer is ‘cured.’]

Research lead, Sadaf Ghaem-Maghami, explained to The Guardian that with a positive predictive value of 94 percent, the iKnife could soon “immediately reassure” someone of an extremely low likelihood of cancer, while also expediting additional testing and treatment for those with potentially positive biopsies.

The researchers’ initial testing compared iKnife’s results with traditional diagnostic methods for 150 people’s biopsy tissue samples. Following a future major clinical trial, the iKnife’s newest capability could become yet another widespread feature for the smart device.

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The Food and Drug Administration (FDA) announced its plan to officially allow participating pharmacies to offer abortion pills under a regulatory change made on January 3. A prescription is still required to receive the pills. Abortion pills are already used in over 50 percent of pregnancy terminations in the United States. They have become more sought out following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned the federal right to abortion in June 2022. As some conservative states have severely restricted or banned the procedure, abortion pills have become the focus of legal and political battles.

[Related: What’s the difference between morning-after pills and abortion medications?]

In roughly half of the country, current abortion bans or restrictions will make it very difficult or illegal for pharmacies to provide abortion pills. In states where abortion procedures remain legal, pharmacies may face public pressure from healthcare providers, abortion rights advocates, and the general public. It is also possible that national pharmacy chains like CVS, Walgreens, and Rite Aid could decide to offer the medication in those states, while not providing it in their stores in states with more restrictive laws.

A medication called mifepristone blocks the pregnancy hormone progesterone and is the first pill that can be taken in this procedure. It is followed by another medication called misoprostol, that can be obtained with a traditional prescription.

The two pills work differently, but in conjunction are safe and effective. After mifepristone blocks the hormone necessary for pregnancy development, misoprostol, taken 24 to 48 hours after mifepristone, causes contractions that expel pregnancy tissue. Misoprostol is used for many different medical conditions, including protecting the stomach against ulcers, and has not been as tightly regulated.

The medications have a 95 to 99 percent success rate at ending a pregnancy. The FDA authorized mifepristone for use within the first 10 weeks of pregnancy, however some clinics and telemedicine providers have started to offer it up to 12 or 13 weeks into pregnancy. Some studies suggest that the pills are safe and effective within in that time frame and the World Health Organization (WHO) supports using the medication through 12 weeks gestation.

Previously, mifepristone could only be prescribed, ordered, and dispensed by a certified healthcare provider, which then sent the pills either through the mail or through a pharmacy. The FDA temprarily began allowing the pills to be sent through the mail and stopped enforcing a rule that required patients to get mifepristone earlier in the COVID-19 pandemic.

The FDA said that it would permanently lift the requirement that patients obtain mifepristone in person from a health provider in December 2021 and it officially removed the in-person requirement for mifepristone yesterday.

Two requirements remain in place—healthcare providers must be certified to show they have the medical knowledge and ability to treat abortion and patients must complete a consent form.

While the FDA did not release a statement, it updated their website stating the pharmacies that become certified to do so can give the pills directly to a patient who has a prescription from a certified provider.

[Related: What science tells us about abortion bans.]

Laws concerning abortion pills vary by state, with some states like Illinois, New Mexico, and Virginia allowing an option to receive prescriptions via telehealth. Patients can also travel to states where where abortion is legal to get the pills, however that option costs both time and money.

Danco Laboratories markets mifepristone under the brand name Mifeprex. In a statement, Danco said, “At a time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy.”

CVS said that the nationwide chain is reviewing the updated requirements. “We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy”. Walgreens is also reviewing the changes.

The regulatory change also comes after a legal opinion from the Justice Department declaring that federal law allows the US Postal Service to deliver abortion drugs. In the opinion dated December 23, 2022, the Office of Legal Counsel cited the 1873 Comstock Act. It said the act “does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

The opinion added “because there are manifold ways in which recipients in every state may lawfully use such drugs, including to produce an abortion, the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”

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This article was originally featured on Undark.

In November 2016, virologist David Evans traveled to Geneva for a meeting of a World Health Organization committee on smallpox research. The deadly virus had been declared eradicated 36 years earlier; the only known live samples of smallpox were in the custody of the United States and Russian governments.

Evans, though, had a striking announcement: Months before the meeting, he and a colleague had created a close relative of smallpox virus, effectively from scratch, at their laboratory in Canada. In a subsequent report, the WHO wrote that the team’s method “did not require exceptional biochemical knowledge or skills, significant funds, or significant time.”

Evans disagrees with that characterization: The process “takes a tremendous amount of technical skill,” he told Undark. But certain technologies did make the experiment easier. In particular, Evans and his colleague were able to simply order long stretches of the virus’s DNA in the mail, from GeneArt, a subsidiary of Thermo Fisher Scientific.

If DNA is the code of life, then outfits like GeneArt are printshops — they synthesize custom strands of DNA and ship them to scientists, who can use the DNA to make a yeast cell glow in the dark, or to create a plastic-eating bacterium, or to build a virus from scratch. Today there are dozens, perhaps hundreds, of companies selling genes, offering DNA at increasingly low prices. (If DNA resembles a long piece of text, rates today are often lower than 10 cents per letter; at this rate, the genetic material necessary to begin constructing an influenza virus would cost less than $1,500.) And new benchtop technologies — essentially, portable gene printers — promise to make synthetic DNA even more widely available.

But, since at least the 2000s, the field has been shadowed by fears that someone will use these services to cause harm — in particular, to manufacture a deadly virus and use it to commit an act of bioterrorism.

Meanwhile, the United States imposes few security regulations on synthetic DNA providers. It’s perfectly legal to make a batch of genes from Ebola or smallpox and ship it to a U.S. address, no questions asked — although actually creating the virus from that genetic material may be illegal under laws governing the possession of certain pathogens.

Whether that’s a legitimate cause for alarm is under debate. Some experts say that creating a virus from synthetic DNA remains prohibitively difficult for most scientists, and that fears of an attack are often overblown. At the same time, new nonprofit initiatives, fueled by money from Silicon Valley philanthropists, and at times evoking worst-case scenarios, are pushing for more stringent protections against the misuse of synthetic DNA. Implementing effective security, though, is tough — as is enforcing any kind of norm in a sprawling, multinational industry.

“It’s not that I’m worried about something happening tomorrow. But the reality is, this capability is increasingly powerful in terms of how long the DNA fragments can be, what you can create with them, the ability of recipients to then assemble the DNA fragments into a new virus,” said Gregory Koblentz, a biodefense researcher at George Mason University. “This is the kind of thing that we really should be more proactive on — and try to get ahead of the curve.”

Perhaps the most prominent scientist sounding warnings about the danger of unchecked DNA synthesis is Kevin Esvelt, a biotechnologist at MIT. In conversation, Esvelt moves quickly between technical detail and Cassandra-like alarm. He often talks about Seiichi Endo, a Japanese virologist who, in 1987, joined the apocalyptic Aum Shinrikyo sect. Endo helped carry out a poison gas attack on the Tokyo subway, and the group tried — but seemingly failed — to obtain Ebola virus.

Since then, creating pathogens has gotten easier, thanks in part to the wider availability of synthetic DNA. “It’s really hard for me to imagine a graduate-trained virologist from Kyoto University being unable to assemble an influenza virus today,” Esvelt said.

As Esvelt describes it, the problem of synthetic biology is about power: New technologies have handed a group of scientists the keys to build unfathomably dangerous bugs. Very few — perhaps none — of those scientists has any wish to exercise this grim superpower. But, Esvelt argues, it’s only a matter of time before the next Endo comes along.

By Esvelt’s back-of-the-napkin estimate, perhaps 30,000 scientists worldwide have the skills to build a strain of pandemic influenza, provided they can find someone to synthesize the DNA for them. The consequences of unleashing such a pathogen could be catastrophic.

“No individual can make a nuke,” Esvelt said. “But a virus? That’s very doable, unfortunately.”

Not everyone buys those figures. “There are 1000s of virologists, but far fewer with these skills,” virologist Angela Rasmussen wrote on Twitter in November, in a thread suggesting that Esvelt’s work overstates the risks of a bioterror attack. “Infectious clones aren’t something you can whip up in a garage,” she continued — even with a full set of DNA on hand.

Zach Adelman, a biologist who studies disease vectors at Texas A&M University, echoed those points — and questioned Esvelt’s broader approach. “It sounds like his typical scare tactics,” he wrote in an email to Undark. “Could a single, dedicated, malicious individual still make their own flu strain while avoiding detection? Maybe, but even in ideal circumstances these experiments require a substantial amount of resources.”

Even if someone manages to illicitly make a virus, carrying out a bioterror attack is still difficult, said Milton Leitenberg, a biosecurity expert at the Center for International and Security Studies at the University of Maryland. “All of this is unbelievably exaggerated,” he said, after reviewing testimony Esvelt delivered to a U.S. House of Representatives subcommittee in 2021 about the the risks of deliberately caused pandemics.

Still, while experts may differ about the degree of risk, many agree that some kind of security for synthetic DNA is warranted — and that current systems may need an upgrade. “I do think that it’s worthwhile having a way of screening synthetic DNA that people can order, to make sure that people aren’t able to actually reconstruct things that are select agents, or other dangerous pathogens,” Rasmussen told Undark.

For years, some policymakers and industry leaders have pushed to beef up security for DNA synthesis.

In the 2000s, when the gene synthesis industry was in its early days, policymakers grew concerned about potential misuse of the companies’ services. In 2010, the U.S. government released a set of guidelines, asking synthetic DNA providers to review their orders for red flags.

Those guidelines do not have the force of law. Companies are free to ignore them, and they can ship almost any gene to anyone, at least within the U.S. (Under federal trade regulations, exporting certain genes requires a license.) Still, even before the government released its guidelines, major synthetic DNA providers were already strengthening security. In 2009, five companies formed the International Gene Synthesis Consortium, or IGSC. “The growth of the gene synthesis industry depends on an impeccable safety record,” the then-CEO of GeneArt wrote in a statement marking the consortium’s launch.

Consortium members agree to screen their customers. (They won’t ship, for example, to P.O. boxes.) And they agree to screen orders, too, following standards that Koblentz says are actually stricter than the federal guidelines.

But some companies never joined. According to one commonly cited estimate, non-IGSC members account for approximately 20 percent of the global DNA synthesis market. That’s little more than an educated guess. “We don’t really know, to be honest,” said Jaime Yassif, who leads the biological policy team at the Nuclear Threat Initiative, a think tank in Washington, D.C. And some companies, she and other analysts say, appear not to be screening at all.

Indeed, spend a few minutes on Google searching for synthetic DNA, and it’s easy to find non-IGSC companies advertising their services. It’s difficult to tell what kind of security measures — if any — those companies have in place.

In a brief phone call, Lulu Wang, an account manager for the Delaware-registered company Gene Universal, said the company did screen orders. She did not provide details, instead referring additional questions to an email address; the company declined to answer them. KareBay Biochem, a provider registered in New Jersey, did not reply to emailed questions. A man who answered the company’s phone, upon learning that he was talking to a reporter, said “Sorry, I have no comments,” and hung up.

Azenta Life Sciences, a Nasdaq-traded company, provides “complete gene synthesis solutions,” according to its website, after acquiring the synthetic DNA provider Genewiz in 2018. Nowhere does its website mention biosecurity. In an email, Azenta director of investor relations Sara Silverman wrote that the company “performs a biosecurity screen,” but declined to provide details. She did not answer a question about why Azenta had not joined the IGSC.

The industry as a whole has uneven security. “There’s no standardization process, there’s no certification, there’s no outside body checking to see how well your system does,” said James Diggans, head of biosecurity at Twist Bioscience, who currently chairs the board of the IGSC. As a result, he said, “companies invest along a broad spectrum of how much they want to put effort into this process.”

There are also financial incentives to cut corners. Existing DNA screening systems take a strand of DNA from an order and compare it against a database of so-called “sequences of concern.” If there’s a match, a bioinformatics expert reviews the order — a process that is expensive and time consuming. “It is certainly an unfair competitive advantage,” Diggans said, “if you decide not to invest in security, or if you decide to invest minimally in security.”

One solution, some experts say, is to use free, simple, high-quality screening software. In the coming months, two such initiatives are slated to launch.

One system, called SecureDNA, launched as a limited-access pilot this month, with plans to be widely available by the end of 2023. At its core is a database of billions of very short pieces of genetic information, the exact contents of which are a closely guarded secret. A small group of scientists — Esvelt, who is part of the SecureDNA team, calls them “curators” — will eventually maintain and update the tool, which is based in Switzerland. Orders are encrypted and routed to the SecureDNA servers. There, an automated system looks for matches between the order and the database. From initial tests, the SecureDNA team reports in a recent paper, the model is difficult to fool, and the researchers predict it will rarely produce false alarms. (The team plans to submit the paper to peer review after testing SecureDNA on more real-world orders.)

Whether companies will actually get on board remains unclear. In order to maximize security, the system is a bit of a black box. No company so far has committed to turning over its screening process to SecureDNA, Esvelt said, although some companies have agreed to test it.

In 2020, Yassif, at the Nuclear Threat Initiative, began developing a different screening tool in partnership with the World Economic Forum and an advisory panel of experts. Called the Common Mechanism for DNA Synthesis Screening and slated to launch in 2023 under the auspices of a new international organization, the tool will be distributed to companies, who can then use the software to search orders for potential red flags.

“The basic idea is, if we give a tool to companies to make it cheaper and easier to do the right thing, then it’s going to be very appealing for them to just take it,” said Yassif.

Government officials are also moving to encourage more robust screening. Two years ago, the U.S. Department of Health and Human Services began the process of updating its 2010 guidelines, which experts say have become dated. The new guidelines are slated to come out in 2023. Among other changes, they are likely to ask companies to start screening orders for shorter pieces of DNA, rather than just focusing on orders for longer stretches of genetic material. (The goal is to prevent people from buying many short pieces of DNA and then stringing them together into something high-risk.)

In August 2022, California Gov. Gavin Newsom signed into effect a bill requiring the California State University system to only buy synthetic DNA from companies that screen their orders, and requesting that the University of California system do the same.

“This is the first legal requirement in the U.S. for a user of synthetic DNA to pay attention to the security safeguards that are in place for what they’re ordering,” said Koblentz, the George Mason University expert, who consulted on the bill.

Ultimately, Koblentz said, the federal government should do more to incentivize good screening. For example, major federal science funders could give grants on the condition that institutions buy their DNA from more secure providers, using their market power, he said, “to require researchers to use biosecurity safeguards.”

So far, there appear to be no plans to apply those kinds of incentives. “Adherence to the revised guidance, like adherence to the 2010 guidance, is voluntary,” wrote Matthew Sharkey, a federal scientist working the new guidelines, in an email. And, he added, “no federal agency currently requires compliance with them as a condition for research funding.”

Amid other pressing global concerns, biosecurity experts have sometimes struggled to draw attention to the issue. A 2020 essay Koblentz wrote for The Bulletin of the Atomic Scientists is titled “A biotech firm made a smallpox-like virus on purpose. Nobody seems to care.”

Recently, much of the urgency around synthetic DNA security has come from the effective altruism community: A loose-knit movement, centered in Silicon Valley, that aims to take a rational approach to doing the most good possible. Supporters often throw their energy behind pressing public health issues like malaria treatment, as well as more rarefied concerns, such as rogue artificial intelligence or governance in outer space.

The movement has grown in prominence in the past decade, becoming a major funder of initiatives to prevent human-caused pandemics. Two effective altruism groups, Effective Giving and Open Philanthropy, are underwriting Yassif’s project. Yassif used to work at Open Philanthropy, which is also backing SecureDNA. (In August, Esvelt told Undark that the group was in talks to receive funding from the FTX Future Fund, an effective altruism venture linked to the cryptocurrency exchange FTX. They did not finalize an arrangement, according to Esvelt, and FTX collapsed spectacularly in November amid allegations of misusing customer funds.)

Despite these concerns about bioterrorism, the risks remain largely theoretical. Leitenberg, the Maryland biosecurity scholar, began working on biological weapons issues in the 1960s. In a 2005 paper, he argued that people in the field often overstate the risks posed by bioterrorists.

As Leitenberg argues, the U.S. has spent billions of dollars in the past two decades preparing for a bioterrorism attack — but the threat, at least so far, has not materialized. “The real bioterrorists,” he said, “still haven’t made a single thing.” Lab accidents, he argues, pose a far greater risk than a rogue actor.

What’s clear is that the challenge of regulating the synthetic DNA industry is only compounding — in particular because it’s getting easier to manufacture DNA. If DNA synthesis companies are printshops, a new generation of startups are now making at-home printers: so-called benchtop machines, some retailing for under $100,000, that make it possible to custom-print DNA in the laboratory.

Both SecureDNA and the Common Mechanism hope to one day allow companies to incorporate security tools directly into benchtop devices, so that they can remotely block the production of certain sequences.

The new benchtop technology, said Yassif, has the potential to dramatically expand the circle of people with access to custom-made DNA. The technology, she cautioned, is still in its infancy. “I don’t think the sky is falling today,” Yassif said. But, she added, “I think it’s a wakeup call that we need to be thinking about this now, and building in security now.”

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If you feel like everyone’s getting sick right now, you’re not wrong. Seasonal illnesses—including the flu, RSV, and COVID—are surging strongly and leaving families scrambling to stock up on medicine. A recent children’s Tylenol and ibuprofen shortage has left shelves empty and added to the stress of caring for a sick child. The pharmacies that do have some children’s pain relief medication available are limiting purchases. With a lack of options, one alternative parents and caregivers might think of doing is giving adult cold medication.

But this is the wrong move. Medical experts say that under no circumstance should parents give adult doses or cut up adult medications to give to children. “Adult medicine has not been necessarily tested or approved for use in kids, so you’re putting your own child at risk for more complications,” says William Chu, pediatrician and medical director at Pediatrix Primary + Urgent Care of Texas. Not only is it ineffective but if administered incorrectly, it could be fatal. 

No meds is better than the wrong meds 

Depending on the age, children have no need to take over-the-counter (OTC) meds when they are sick. According to the American Academy of Pediatrics, children less than 4 years old shouldn’t be given cough and cold medication. Most cases resolve on their own, plus these medicines are not very effective for this age group. “The research doesn’t show that there’s a lot of benefit to giving cough and cold medicines to kids,” says Chu. “Most of the time it’s more risky to give, and by giving adult medicines you’re only increasing the risk with none of the benefit.” If your kid is between 4 to 6, Chu advises exercising extreme caution on using OTC pain relievers and consulting a doctor first.

[Related: Is it flu or RSV? It can be tough to tell.]

Younger kids, for instance, are unable to swallow pills, so giving them a Tylenol pill to swallow could be a choking hazard. Additionally, giving adult medications incurs serious side effects, including nausea, stomach pain, and even death. “Very high doses of these cough and cold medications can be fatal for children,” says Norma Perez, a pediatrician with AltaMed Health Services based in California.

The extensive list of side effects stems from the ingredients in medicine. Decongestants, for example, are stimulatory and a high dose of it could increase blood pressure and cause seizures. Dextromethorphan, a common cough suppressant, can slow breathing, increase heart rate, and induce a coma if an excess is ingested. Acetaminophen and ibuprofen are safe at normal doses, but large amounts could lead to severe liver damage, drowsiness, and abdominal pain. 

Medication doses are intentionally different for adults and children 

Most medicines have overlapping ingredients to treat multiple symptoms, which could increase the risk of an overdose. And the chances of a child overdosing on adult pain relievers is very high because of body size. Drugs like “acetaminophen and ibuprofen are not based on age but weight,” says Perez. “Depending on how much they weigh, that’s what we calculate for what’s an appropriate dose for children.” The one or two pills recommended on the bottle have been calculated for an adult weight, and that dose could be higher than normal for a child. One exception is if a child weighs over 95 pounds or who is over the age of 12. Chu says it’s generally safe for teenagers to have adult doses of OTC medicines.

Cutting up a pill or tablet won’t help lower the dose, warns both experts. “A lot of these medications are not designed to be effective when you break it up,” says Perez. What’s more, you’re still providing a “guesstimate” of an appropriate dose; there’s no way of knowing whether you’re providing too much or too little to your child. Crushing up medicine could also make it harder for a child to ingest. Chu says “it may be difficult to swallow a jagged pill or if it’s ground and mixed with something there is going to be a taste issue.”

[Related: Here are the cold and flu remedies that actually work]

What’s a caregiver to do?

If you’re still having trouble finding children’s pain relievers, there is some good news. A lot of home remedies are helpful for relieving flu, RSV, and COVID symptoms. Honey soothes sore throats and is possibly better than usual treatment of care such as OTC cold medication and antibiotics. It also helps with cough suppression, including coughs produced by post nasal drip. “The thickness coats and protects the throat, giving you relief,” explains Perez. Honey also has antimicrobial properties that can destroy pathogens responsible for upper respiratory tract infections. She recommends giving half to a full teaspoon of honey to kids older than one year of age. 

To help with nasal congestion, a humidifier or a steamy shower could alleviate that stuffiness, especially if done right before bed. The hot steam helps to thin out mucus allowing for clearer lung and nasal airways. The relief provided from steam inhalation will help kids breathe more comfortably, and in turn, sleep more comfortably. Another way to help with a stuffy nose is by using OTC nasal sprays every two to three hours, though both experts warn not to make your own at home. You can buy nasal saline sprays at your local pharmacy and depending on the symptoms.

With all these respiratory viruses, Chu says caregivers have a right to be worried. The best course of action is to manage your child’s symptoms and keep them comfortable. If there’s any lingering concerns, see your pediatrician or take your child to urgent care.

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Worm spit, aka silk, has inspired a relatively simple, new process of nanofiber weaving that could advance everything from wound bandages to flexible electronics.

As unappealing as it may all sound, the popular, luxurious fabric indeed stems from a two-protein compound secreted by its namesake worm, which uses its threads to help weave cocoons. However, a team of Chinese researchers have also found that—apart from expensive sheets—humans can produce far more uniform micro- and nanofibers by imitating silkworms’ head movements as they secrete, pull, and weave their silk.

[Related: How researchers leveled up worm silk to be tougher than a spider’s.]

The group recently showcased their work in a new paper published with the American Chemical Society’s journal, Nano Letters. At first, researchers poked microneedles into foam blocks soaked in a polyethylene oxide solution, then pulled the needs away via a procedure known as microadhesion-guided (MAG) spinning to create nanofiber filaments that are thousands of times smaller than a single strand of human hair.

Existing nanofiber production methods are either slow and expensive, or otherwise result in inefficient, wadded material. By imitating silkworms’ weaving movement, however, the team found they could create an array of products—pulling the foam blocks straight away from one another offered orderly fibers, while a vibrating retraction crossweaved the material. Twisting the setup gave a similarly shaped “all-in-one” fiber. Regardless of the array, the results proved to clump far less than existing methods.

[Related: Watch this bird-like robot make a graceful landing on its perch.]

Going a step further, however, the team realized that the microneedling step wasn’t actually needed at all—the foam’s abrasive surface was enough to pull apart the polyethylene oxide solution into nanofilaments. It was so simple, in fact, that one can use the foam stretching method to hand-wrap a nanofiber bandage around a person’s wrist. In their experiments, the team utilized an antibiotic fiber to ensure a sterile, bacterial growth-inhibiting dressing that easily washes off with warm water, offering a potential new medical application in the near future.

Turning to the animal world for inspiration consistently offers impressive discoveries and advancements in tech and robotics, whether it’s for weaving, flying, running, or capturing. 

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Due to increased demand, pharmacy chains CVS and Walgreens have limited purchases of children’s pain relievers and fever reducers. The demand comes amid a “tripledemic” surge of respiratory infections including flu, respiratory syncytial virus (RSV), and COVID-19. Particularly vulnerable to RSV, the virus has hospitalized more than four out of every 1,000 children under the age of five this season, according to the CDC.

In November, the spike in illnesses led to a 65 percent increase in the sale of children’s fever reducers and medications compared to November 2021, according to the Consumer Healthcare Products Association (CHPA). The association represents some of the companies that make the medications including Tylenol manufacturer Johnson & Johnson, Haleon the maker of Advil, and Perrigo, which manufacturers generic store brands.

[Related: Is it flu or RSV? It can be tough to tell.]

In a statement, CHPA said that it doesn’t yet have a timeline for when the supply may catch up with demand and stressed that the manufacturers were working to replenish the medications as quickly as possible.

At Walgreens, customers are limited to online purchases of six over-the-counter fever reducers per purchase, but the company does not currently have an in-store limit.

“Due to increased demand and various supplier challenges, over-the-counter pediatric fever reducing products are seeing constraint across the country,” said Walgreens, said in a statement. Walgreens added that the limits are, “in an effort to help support availability and avoid excess purchases.”

CVS also cited the increased demand for these items for their two-product per person limit on both online and in-store purchases. A spokesperson for CVS told The New York Times, “We can confirm that to ensure equitable access for all our customers, there is currently a two (2) product limit on all children’s pain relief products. We’re committed to meeting our customers’ needs and are working with our suppliers to ensure continued access to these items.”

The American Academy of Pediatrics (AAP) is urging parents “not to panic” if they are unable to find fever-reducing medicine. “These medicines are not curative. They don’t alter the duration of the illness or anything like that. They are essentially purely for comfort,” Sean O’Leary, chair of the Committee on Infectious Diseases for the AAP, told NPR earlier in December. “Fevers from common respiratory viruses in and of themselves are not harmful.”

[Related: No, you can’t get the flu from a flu shot.]

While weekly RSV hospitalizations have recently decreased, the number hospitalizations is still higher than normal for this time of year.

Daniel Ganjian, a pediatrician at Providence Saint John’s Health Center, told PopSci in October that RSV exposure early in life helps train the immune system and most RSV infections occur in babies whose immune systems are still developing. Beginning in early 2020, children did not attend as many in-person activities, which lowered their chance of infection and the creation of an appropriate immune defense. “They have zero antibodies because these kids, who were 1 and 2 during the pandemic, were not exposed to RSV,” Ganjian said. “Now they’re getting it for the first time and they’re getting severe reactions,” he said. Infected infants may cough and wheeze for about two weeks, but most babies make a full recovery. A 2022 study in The Lancet estimates that RSV caused 7 percent of infant deaths, with most occurring in children under 3.

Wearing a face mask, staying up to date with flu and COVID-19 vaccination, good hand-washing, and other general health practices can help prevent infection from respiratory infections.

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This article was originally featured on The Conversation.

When the COVID-19 pandemic first emerged, many wildlife disease researchers like me were not too surprised. Some were intrigued it hadn’t happened sooner; after all, it is our job to observe, describe and study pandemic dynamics in animals.

Amphibians, for example, have been undergoing a global panzootic – the animal version of a pandemic – for decades. In the late 1990s, researchers identified the amphibian chytrid fungus, which causes the often-lethal disease chytridiomycosis, as the probable culprit behind frog and salamander declines and extinctions from Australia to Central America and elsewhere that began 10, 20 or even 30 years before.

Scientists have found this pathogen on every continent that amphibians inhabit, and the extensive global amphibian trade has likely spread highly lethal strains around the world. The amphibian chytrid fungus is widespread in some geographic regions, and, like the virus that causes COVID-19, it can mutate rapidly and take new forms that cause varying disease severity.

Conservation translocation is an increasingly popular way to recover species that have experienced extensive population declines. It involves moving organisms to reestablish populations that have gone extinct, supplement existing ones or establish new ones in areas where the species was not previously present. However, when the amphibian chytrid fungus is prevalent in the landscape, frogs are likely to get sick again, hampering the success of translocation.

To avoid the setbacks of disease, researchers are using a tool often employed against human pandemics: inoculations akin to vaccines.

In our recent study, my research team and I inoculated threatened California red-legged frogs against chytrid fungus before translocation by exposing them to the chytrid fungus in the laboratory. We wanted to see if we could activate their immune systems and give them an advantage over the fungus once they are released. Our results were unexpected.

Nothing a cocktail won’t cure

Since 2017, Yosemite National Park has been actively translocating California red-legged frogs to Yosemite Valley, where the chytrid fungus is already present. We used a small subset of these translocated frogs in our study.

We collected wild frog eggs at a place where the species is thriving, about 100 miles northwest of Yosemite Valley, then raised them in captivity at the San Francisco Zoo. Once they metamorphosed into juvenile frogs, we bathed 20 in a “cocktail” of four live, active strains of the fungus. After three weeks, they were given a bath of an antifungal drug to halt the infection. Another 40 frogs that were not exposed to the fungus were also given a bath of an antifungal drug.

Then we reexposed the 20 previously infected frogs to the fungus a second time, while 20 previously uninfected frogs were exposed to the fungus for the first time. We wanted to see how frogs with a second infection – namely, those that were “vaccinated” – compared with those that were infected only once.

What we found was surprising: 35% of frogs infected only once successfully cleared the infection without vaccination or an antifungal drug. This suggested that they have some measure of innate immunity, meaning their immune system’s first line of defense was able to fight off the fungus. In addition, frogs infected a second time had a 31% overall lower rate of infection than those that were infected only once. This suggested that the vaccinelike treatment also works by stimulating adaptive immunity, meaning their immune system learned to recognize the fungus from their first exposure and fight it off more efficiently. None of the frogs died from their fungal infections.

Before releasing them to the wild, we treated the frogs with an antifungal drug and monitored to make sure they were disease-free. We attached tiny transmitters with beaded belts around their waists so we could track their infections and survival over three months.

Unexpectedly, we found no difference in disease burden between the frogs that had never been infected and those that had been previously infected in the laboratory. This suggests that immunizing this species for chytrid fungus, at least in Yosemite, may be unnecessary to ensure their survival after reintroduction.

Indeed, the California red-legged frogs released into Yosemite Valley are thriving three years after our experiment and six years after their first translocation. They are hibernating successfully through the cold winters and emerging early in the spring for reproduction.

Hope for the future

Our study takes a new approach to the emerging tool of inoculation against the chytrid fungus. By combining ex situ, or laboratory, experiments with in situ, or in the field, implementation, we put lab observations to the test in the real world. This type of work strengthens collaborations between wildlife managers and zoos, which are increasingly needed as the biodiversity crisis accelerates.

Though California red-legged frogs in Yosemite Valley didn’t seem to need vaccinations, this doesn’t mean that other imperiled amphibian species around the world do not. Research on chytrid inoculations in other species have had mixed results, ranging from not improving survival to reducing infection burden associated with increased survival. One of the primary challenges of this approach to conservation is that even if vaccination increases survival after initial release, this immunity does not carry forward to successive generations.

There is hope, however. Researchers are working to identify the genetic signatures associated with immunity to the chytrid fungus. If successful, breeding programs can artificially select for – and perhaps even gene-edit – protective traits to give frogs a leg up on a pathogen that has devastated amphibian populations worldwide.

Andrea Adams is a Researcher in Ecology at the University of California, Santa Barbara. Andrea Adams previously received funding from the Yosemite Conservancy for conducting this research as a postdoctoral researcher at Yosemite National Park. Funding for her current academic appointment is received from the U.S. Fish and Wildlife Service.

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Chemists are paving a road to recycle discarded SIM cards, not for electronics, but for medicine. 

SIM cards, which allow your phone to connect to your network provider, contain bits of nickel, copper, silver, and gold. Now, researchers at Imperial College London and the University of Cagliari in Italy have discovered a low-impact way to recycle gold from this electronic waste, and reuse it in chemical reactions for drug manufacturing. The process could help save e-waste from landfills and also reuse precious metals that would otherwise have to be mined. Their findings were described earlier this month on December 9 in the journal ACS Sustainable Chemistry & Engineering.

“I think that if we can find better ways to use the waste that we generate and recover the metal, then we don’t have to rely so much on mining,” says James Wilton-Ely, the lead researcher of the study and a professor of chemistry at Imperial College London. “It also helps us solve the waste problem that we have, which at the moment is piling up.”

To develop a recycling method, the researchers first bought a bag of 200 used SIM cards off of Ebay. Then they ground up the SIM cards, stripped the plastic, and recovered the base metals, such as nickel and copper. Then, in order to extract the gold, they used a green, safe reagent called a sulfur ligand, a molecule that attaches to a central metal atom. What they were left with was a gold compound—but gold in this form isn’t reusable in electronics. The SIM card’s gold compound can’t be returned to the pure metal gold without processing it further, which is energy intensive. This means the cards couldn’t be recycled into more electronics. 

“It is not viable economically to convert that gold recovery product into new circuit boards or new SIM cards,” Wilton-Ely says. “But instead, we found a different use for it.” 

[Related: Inside the high-powered process that could recycle rare earth metals]

Rare metals, such as gold, can also be catalysts for speeding up chemical reactions that help create useful compounds, such as pharmaceutical compounds. Gold nanoparticles, for instance, have been studied as catalysts for industry since the 1980s. So, the team from Imperial College London tested whether the gold compound recovered from the SIM cards could be used to increase the rate of chemical reactions commonly used in the manufacturing of drugs. The compound could be employed as a catalyst to make a number of pharmaceutical drugs, like the anti-inflammatory pain-relief drug Diflunisal, and the arthritis anti-inflammatory medication Oxaprozin. While the researchers haven’t yet used the recycled gold compound to produce any actual drugs, the process shows an alternative use for this discarded e-waste. 

“We’re now realizing that you don’t have to just convert everything back into what it was used for originally,” Wilton-Ely says.

Currently, many catalytic reactions use precious metals, including gold, platinum, iridium, and palladium that are mined, which takes a lot of energy and produces pollution. The metals are also only found in a few places on Earth and can be tricky to extract depending on geopolitical factors. For instance, Russia is a major producer of palladium and nickel, which can experience market disruptions if trade sanctions are imposed.

“As chemists, we always think of these elements as being very precious,” Wilton-Ely says. “And so it’s a real shock to think of so many of these elements being thrown away routinely in waste electronic and electrical equipment.”

[Related: Your old computer could be a better source of metals than a mine]

And dumpster diving for electronics could prove to be a boon for essential metals—giving a second life to our disposed devices. “By weight, a computer contains far more precious metals than mined ore, providing a concentrated source of these metals in an ‘urban mine,’” says Sean McCarthy, a Ph.D. student leading the research in the lab at Imperial College, in a press release.

The research team’s recycling process isn’t limited to SIM cards. Scientists can apply this method to recycle circuit boards and printer cartridges as well, the authors say. While the team is exploring more applications, pharmaceutical companies haven’t yet come knocking for the research. Gold is still only starting to be employed in the design of pharmaceutical drugs. But Wilton-Ely says it’s only a matter of time. 

“The adoption of what we’re doing at the moment, I’m sure will happen,” says Wilton-Ely. “But it will be in the future once the benefits of gold-catalyzed reactions make it into the design of pharmaceutical plants.”

*Correction (December 20, 2022): This story has been updated to link to a study and fix the phrasing of gold nanoparticle use in catalytic reactions in industry.

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As an outbreak of Ebola virus disease continues in Uganda, there is some progress in preventing future outbreaks. The results of two randomized, placebo-controlled trials analyzing three Ebola vaccine administration strategies published Wednesday in the New England Journal of Medicine show promising results.

According to the National Institutes of Health (NIH), “antibodies were produced in response to the vaccine regimens beginning at 14 days after the first vaccination and continued to be detectable at varying levels—depending on the vaccine and regimen used—in both children and adults for one year.”

[Related: Uganda’s Ebola outbreak is ‘rapidly evolving,’ according to WHO.]

Enrollment for these trials began in 2017, and the volunteers for the study are from Guinea, Liberia, Sierra Leone, and Mali. One of the study’s main goals was to identify the best vaccination strategies to curtail future Ebola outbreaks. The trials were conducted simultaneously and shared a placebo arm. A total of 1,400 adults and 1,401 children (age 1 to 17 years-old) were randomized to receive two injections of either placebo or Ebola vaccine in one of three different regimens.

One vaccine regimen was a dose of the Johnson & Johnson vaccine followed by a booster dose of a vaccine supplied by Bavarian Nordic eight weeks later. A second regimen was two doses of a vaccine made by Merck, given eight weeks apart. The third regimen included one dose of the Merck vaccine followed by a placebo injection eight weeks later.

All of the regimens produced antibodies 14 days after the first of two shots and these antibodies were detectable at varying levels in both children and adults for one year, depending on the vaccine and regimen.

[Related: Ebola hasn’t been cured yet, but two experimental drugs are showing significant progress.]

“The researchers say this finding is notable because vaccines against Ebola virus disease are typically administered during an outbreak and so information about how rapidly a vaccine produces an antibody effect is of potential use in efforts to protect at-risk populations,” wrote the NIH in a statement.

However, these vaccines target the Zaire strain of the virus, not the Sudan strain of Ebola. The Sudan strain is behind Uganda’s current outbreak that began in September and has caused at least 55 deaths and 142 confirmed cases, according to the The World Health Organization (WHO). There are signs that the outbreak is easing, including a hospital discharging the last known patient with Ebola on December 2. Uganda additionally received doses of a vaccine that targets the Sudan strain for use in a clinical trial last week.

The agency stresses that the results aren’t able to assess protection from the disease because the level of antibody response that correlates with vaccine-induced protection against infection or disease is not currently known. “As no participants contracted Ebola virus disease during the trial, the investigators were not able to assess protection from disease,” the NIH writes.

According to the researchers in this study, some of the strength of the trials include outstanding retention of volunteers throughout the process, community engagement ,and trust-building efforts. “Long-term follow up of the participants in this trial is taking place to determine if and when booster doses might be needed,” Brian Greenwood, a study co-author from the London School of Hygiene & Tropical Medicine, told Reuters.

In 2019, European regulators approved and the WHO prequalified Merck’s Ebola vaccine Ervebo. Johnson & Johnson’s vaccine Zabdeno received clearance from European regulators in 2020 and clearance from the WHO in 2021. Mvabea, made by Bavarian Nordic and used in the used in the Johnson & Johnson regimen, also received approval in 2020 and prequalification in 2021.

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This story has been updated.

This week, the Food and Drug Administration (FDA) changed their emergency use authorizations (EUAs) for the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines to now include children from 5 years to six months old. The Centers for Disease Control and Prevention (CDC) followed up with its own announcement to expand use of the vaccine to the same age group.

The bivalent vaccines were first authorized by the FDA in August for adults and in some teens. Both the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines have mRNA components that correspond with the original COVID-19 strain and the Omicron variant (specifically the BA.4 and BA.5 lineages). The formula provides better protection against COVID-19 caused by the now year-old Omicron variant, according to the FDA.

[Related: FDA green lights Omicron-targeting mRNA vaccine boosters.]

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert M. Califf in a press release. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

Here is what parents and caregivers of children from six months to five years old need to know:

• Children can receive the updated bivalent booster two months after completing their primary series of the monovalent (or original) Moderna COVID-19 Vaccine.
• Children that haven’t begun their three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or haven’t gotten the third dose of their primary series, will now get the bivalent Pfizer-BioNTech vaccine as that third booster dose after two doses of the original vaccine.
• Children who have already completed their three-dose primary series with the original Pfizer-BioNTech COVID-19 vaccine are not currently eligible for a booster dose of an updated bivalent vaccine at this time. The FDA expects that children in this age group who have already completed their primary vaccination series still have strong protection against the most serious outcomes of the virus, even from the Omicron variant. The agency also expects more data on giving an updated bivalent booster dose for these children in January 2023.

[Related: Omicron boosters are the future of COVID vaccines in the US.]

Patients who get the bivalent vaccines may see similar side effects that followed previous doses mRNA COVID-19 vaccines. The updated fact sheets for both bivalent COVID-19 vaccines provides more information about the potential side effects, as well as the risks of myocarditis and pericarditis. 

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

The news comes as hospital systems around the US continue to be stretched thin by a “tripledemic” of flu, COVID-19, and respiratory syncytial virus (RSV). According to the CDC, 14 children have died from the flu nationwide.

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This article was originally featured on KHN.

Assisted living communities too often fail to meet the needs of older adults and should focus more on residents’ medical and mental health concerns, according to a recent report by a diverse panel of experts.

It’s a clarion call for change inspired by the altered profile of the population that assisted living now serves.

Residents are older, sicker, and more compromised by impairments than in the past: 55% are 85 and older, 77% require help with bathing, 69% with walking, and 49% with toileting, according to data from the National Center for Health Statistics.

Also, more than half of residents have high blood pressure, and a third or more have heart disease or arthritis. Nearly one-third have been diagnosed with depression and at least 11% have a serious mental illness. As many as 42% have dementia or moderate-to-severe cognitive impairment.

“The nature of the clientele in assisted living has changed dramatically,” yet there are no widely accepted standards for addressing their physical and mental health needs, said Sheryl Zimmerman, who led the panel. She’s co-director of the Program on Aging, Disability, and Long-Term Care at the University of North Carolina-Chapel Hill.

The report addresses this gap with 43 recommendations from experts including patient advocates, assisted living providers, and specialists in medical, psychiatric, and dementia care that Zimmerman said she hopes will become “a new standard of care.”

One set of recommendations addresses staffing. The panel proposes that ratios of health aides to residents be established and that either a registered nurse or a licensed practical nurse be available on-site. (Before establishing specific requirements for various types of communities, the panel suggested further research on staffing requirements was necessary.)

Like nursing homes and home health agencies, assisted living operators have found it hard to retain or hire staff during the covid-19 pandemic. In a September 2021 survey, 82% reported “moderate” or “high” level of staffing shortages.

Dr. Kenneth Covinsky, a geriatrician and professor of medicine at the University of California-San Francisco, witnessed staffing-related problems when his mother moved to assisted living at age 79. At one point, she fell and had to wait about 25 minutes for someone to help her get up. On another occasion, she waited for 30 minutes on the toilet as overworked staffers responded to pagers buzzing nonstop.

“The nighttime scene was crazy: There would be one person for 30 to 40 residents,” said Covinsky, the author of an editorial accompanying the consensus recommendations. Eventually, he ended up moving his mother to another facility.

The panel also recommended staffers get training on managing dementia and mental illness, on medication side effects, on end-of-life care, on tailoring care to individual residents’ needs, and on infection control — a weakness highlighted during the height of the pandemic, when an estimated 17% more people died in assisted living in 2020 compared with previous years.

“If I were placing my parent in assisted living, I certainly would be looking not just at staffing ratios but the actual training of staff,” said Robyn Stone, senior vice president of research at LeadingAge and co-director of its long-term services and supports center at the University of Massachusetts-Boston. LeadingAge is an industry organization representing nonprofit long-term care providers. Stone said the organization generally supports the panel’s work.

The better trained staff are, the more likely they are to provide high-quality care to residents and the less likely they are to feel frustrated and burned out, said Dr. Helen Kales, chair of the Department of Psychiatry and Behavioral Sciences at UC Davis Health.

This is especially important for memory care delivered in stand-alone assisted living facilities or a wing of a larger community. “We have seen places where a memory care unit charges upwards of $10,000 a month for ‘dementia care’ yet is little more than a locked door to prevent residents from leaving the unit and not the sensitive and personalized care advertised,” wrote Covinsky and his University of California-San Francisco colleague Dr. Kenneth Lam in their editorial.

Because dementia is such a pervasive concern in assisted living, the panel recommended that residents get formal cognitive assessments and that policies be established to address aggression or other worrisome behaviors.

One such policy might be trying non-pharmaceutical strategies (examples include aromatherapy or music therapy) to calm people with dementia before resorting to prescribed medications, Kales said. Another might be calling for a medical or psychiatric evaluation if a resident’s behavior changes dramatically and suddenly.

Further recommendations from the panel emphasize the importance of regularly assessing residents’ needs, developing care plans, and including residents in this process. “The resident should really be directing what their goals are and how they want care provided, but this doesn’t always happen,” said Lori Smetanka, a panel member and executive director of the National Consumer Voice for Quality Long-Term Care, an advocacy organization.

“We agree with many of these recommendations” and many assisted living communities are already following these practices, said LaShuan Bethea, executive director of the National Center for Assisted Living, an industry organization.

Nonetheless, she said her organization has concerns, especially about the practicality and cost of the recommendations. “We need to understand what the feasibility would be,” she said, and suggested that a broad study look at those issues. In the meantime, states should examine how they regulate assisted living, taking into account the increased needs of the residents, Bethea said.

Because the nation’s roughly 28,900 assisted living communities are regulated by states and there are no federal standards, practices vary widely and generally there are fewer protections for residents than are found in nursing homes. Some assisted living facilities are small homes housing as few as four to six seniors; some are large housing complexes with nearly 600 older adults. Nearly 919,000 individuals live in these communities.

“There are many different flavors of assisted living, and I think we need to be more purposeful about naming what they are and who they’re best suited to care for,” said Kali Thomas, a panel member and an associate professor of health services, policy, and practice at Brown University.

Originally, assisted living was meant to be a “social” model: a home-like setting where older adults could interact with other residents while receiving help from staff with daily tasks such as bathing and dressing. But given the realities of today’s assisted living population, “the social model of care is outmoded,” said Tony Chicotel, a panel member and staff attorney with California Advocates for Nursing Home Reform.

Still, he and other panelists don’t want assisted living to become a “medical” model, like nursing homes.

“What’s interesting is you see nursing homes pushing to get to a more homelike environment and assisted living needing to more adequately manage the medical needs of residents,” Chicotel told me, referring to the current pandemic-inspired reexamination of long-term care. “That said, I don’t want assisted living facilities to look more like nursing homes. How this all will play out isn’t at all clear yet.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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During last week’s public “show and tell” demonstrating Neuralink’s latest advancements towards achieving an affordable human brain-computer interface, co-founder and CEO Elon Musk pointed towards videos of seemingly healthy test animals with early versions of the product implanted in their heads. On stage, Musk reiterated previous claims that Neuralink was “not cavalier about putting devices into animals,” and that test subjects like their displayed macaque named Sake “actually likes” performing the tests. “He is not strapped to the chair or anything,” Musk added.

But a new, startling exclusive published this morning courtesy of Reuters, however, details a much more troubling company culture. The claims are so substantial, in fact, that they convinced the US Department of Agriculture’s Inspector General to launch a previously undisclosed federal probe regarding violations of the Animal Welfare Act.

[Related: Elon Musk hopes humans will be testing Neuralink brain implants in the next six months.]

Neuralink’s records reviewed by Reuters cite roughly 1,500 animals killed since experiments began in 2018, including over 280 pigs, sheep, and monkeys. Sources urged skepticism over that number, however, given that the company is not required by federal law to keep precise statistics on the tally of test subjects. Although animals are routinely euthanized as humanely as possible following medical testing for postmortem analysis purposes, the investigation highlighted at least four experiments involving 86 pigs and two monkeys that were compromised by human error.

“The mistakes weakened the experiments’ research value and required the tests to be repeated, leading to more animals being killed,” explained Reuters, citing current and former employees’ descriptions of a “pressure-cooker environment” that frequently led to unpreparedness and mistakes.

Reuters’ findings show that the environment appears directly tied to Musk’s insistence on speeding up measurable benchmarks and public results for Neuralink’s deliverable—a brain-computer interface implant initially aimed at restoring physical movement and vision for users in the disabled, paralyzed, and blind communities. Both sources speaking with Reuters and internal documents reviewed by Reuters cite Musk’s direct communications with Neuralink employees as confirmation, with one email sent by Musk in February complaining that, “In general, we are simply not moving fast enough. It’s driving me nuts!”

[Related: Brain interfaces aren’t nearly as easy as Elon Musk makes them seem.]

According to the report, multiple employees recalled Musk telling them to work as if “they had a bomb strapped to their heads,” which reportedly resulted in numerous “hack jobs” causing test animals’ unnecessary suffering and death. The findings also cited fatal mistakes, include utilizing the incorrect kind of surgical glue on monkeys, placing experimental implants on the wrong vertebrae of pigs, as well as installing the wrong-sized devices in sheeps’ skulls.

The reportedly botched, rushed experiments stand in stark contrast with Neuralink’s and Musk’s desired quality of life for their animals. Sources in the report indicated the company’s housing facilities are commendable, likening them to a “Monkey Disneyland,” and one employee recounted to Reuters that Musk previously stating he wanted his company’s test subjects to be “the happiest animals” while alive.

Musk last week estimated that Neuralink human trials could begin as soon as this summer, pending FDA approval.

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In early 2020 I developed a disabling case of long COVID, which sent me on a never-ending search for adequate care. Three of the most prominent long COVID clinics in Los Angeles turned me away because I wasn’t able to obtain a test for the virus when I fell ill, an experience shared by many patients who were infected early in the pandemic, when resources were still nonexistent or scarce. But in late 2021 I was able to make an appointment at Keck Medicine of USC’s COVID Recovery Clinic. I was hopeful that I would be seen by a doctor with experience treating complex chronic illnesses since some infectious diseases such as SARS, mono, and Lyme are known to result in long-term conditions.

The same December, I was seen by a family medicine physician and physical therapist. The clinicians met with me for an hour and later referred me to a neurologist—who I wouldn’t be able to see for four months—and prescribed me an antidepressant that the physician said may help my headaches. I was told to follow up in one to three months despite the severe side effects that fractionated my work hours, made my hobbies of rock climbing and running impossible, and altered every aspect of my life. Before my appointment wrapped, I asked about possible treatments based on up-to-date long COVID research, but was turned down because of my symptom profile. I left defeated and hopeless.

My experience is not unique. This summer, the US Census Bureau reported that close to 16 million American adults are living with long COVID, a debilitating condition that lasts at least four weeks beyond an initial coronavirus infection and affects multiple organ systems. It has been observed in all age groups, and has placed stress on the US healthcare model that relies on short doctor’s visits. Even though high-demand clinics, sometimes called post-COVID care centers, now offer services for the illness, many fail the very patients they have set out to help. Long COVID patients share anecdotes about how the clinics they are admitted to often turn a blind eye to the gravity of their needs and fail to incorporate knowledge learned from myalgic encephalomyelitis, or ME, and other infection-associated illnesses.

[Related: Long COVID can manifest in dozens of ways]

ME, which is sometimes called chronic fatigue syndrome, is a disease that often appears in the wake of an infection. In a small observational study recently done on long COVID patients, nearly half met the diagnostic criteria for ME, including substantial impairment in both physical and cognitive function alongside post-exertional malaise—a flare-up of symptoms that typically appear a day after cognitive or physical exertion—and fitful sleep. It also can cover cognitive impairment or orthostatic intolerance, meaning the inability to remain upright without extreme dizziness and other symptoms. While most people living with long COVID or ME developed their illness after infection, a very rare group of people are known as vaccine-injured, meaning they developed similar symptoms after getting the coronavirus jabs. 

Clinics informed by ME offer insight into managing long COVID with treatment and education, providing a rubric for how other recovery centers could operate. Their approach also exposes the structural neglect of complex chronic illnesses in the US. 

Lucinda Bateman, founder and medical director of the Bateman Horne Center in Salt Lake City, is one of a small number of ME specialists in the county. She has been treating and researching the illness for more than three decades. “I can tell you from our close assessments that many people with long COVID become severe enough and chronic enough to meet these criteria [for ME/CFS],” she says. “So I would consider them SARS-CoV-2 induced ME/CFS.”

Hard-to-find care

Inaccessibility is one of the most prominent barriers to post-COVID clinics. Most require a positive test and a referral from a patient’s primary care physician. With nearly 26 million people uninsured in the US and many more who are inadequately covered, seeing a primary care physician can be a financial burden, especially if patients are chronically ill and unable to work.

Distance is another factor. According to the COVID-19 Longhauler Advocacy Project, the US has more than 400 long COVID clinics and rehabilitation centers, but few exist in rural locations and only around a dozen focus on pediatric long COVID patients. Traveling long distances is an enormous burden on long COVID patients, who may be bed- or housebound. What’s more, many physicians continue to consider their patients’ symptoms (and sometimes even their colleagues’ symptoms) to be psychosomatic, or the result of stress or anxiety, which can make getting a referral to a clinic challenging.

If a patient is able to clear these barriers despite their extreme fatigue, cognitive impairment, and cluster of more than 100 other possible symptoms, they typically encounter months-long waiting lists to be admitted to clinics.

Desireé Parker, a 39-year-old from Pennsylvania, had to wait almost half of a year to be seen by the University of Pittsburgh Medical Center’s Post-COVID Recovery Clinic. When she had her first appointment this summer, she says the clinic ordered some lab work and gave her basic informational handouts. “It was just very generic,” she recounts from her experience. “It was like a packet of internet sources … I expected a lot more after waiting patiently for five months.”

Beyond these forms of inaccessibility, patients say some doctors at long COVID clinics aren’t aware of recent studies of the disease, which link it to markers of complex chronic illnesses like microclots and autoimmune responses, reactivated viruses like Epstein-Barr, and common concurrent diagnoses like postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and others.

One of the least-acknowledged, but most-critical-to-address questions of long COVID is how it overlaps with ME. Before the COVID pandemic began, as many as 2.5 million Americans were already living with ME. Because the disorder has been stigmatized and underfunded for decades, few physicians are are able to diagnose and treat it. In fact, less than one-third of medical school curricula in the US include education about ME.

These systemic issues are now having a resounding impact on people seeking comprehensive long COVID care. Sara, a 30 year-old who wished to omit her last name, says that in the fall of 2021, when she had a virtual appointment with MedStar Health COVID Recovery Program in Maryland, her doctor told her that her symptoms were due to untreated anxiety and depression—a common experience for patients with chronic illness, particularly women and people of color. She worked with a lawyer to attempt to get the psychosomatic note off her record because she said it might put the private long-term disability insurance that she was applying for in jeopardy.

“At best, he was ignorant,” Sara says about her doctor at the clinic. “And at worst, he was actively being harmful.” Her concerns inspire a larger question of how post-COVID care centers are screening patients for the complex list of markers for the disease. When I reached out to a representative of MedStar to ask if their clinic believed long COVID and its concurrent diagnoses were psychosomatic despite vast scientific literature showing the disease affecting multiple organ systems, I didn’t receive a response. Sara left MedStar’s clinic and later went to George Washington Medical Faculty Associates COVID-19 Recovery Clinic in the D.C. metro area. There she had a promising initial visit where they diagnosed her with dysautonomia—an umbrella term for disorders of the autonomic nervous system including syndromes like POTS—and referred her to a cardiologist for further care. But the facility closed this summer and transitioned their patients to primary care providers, an emerging trend in the US and abroad.

Outdated therapies

Because so many physicians are uninformed about ME, some at long COVID clinics prescribe therapies that have been proven to be harmful to patients who experience post-exertional malaise (PEM). Graded exercise therapy (GET)—a controversial form of physical therapy for ME and long COVID which slowly increases exercise over time— worsens patients’ symptoms who experience PEM. “Graded exercise therapy implies that you can exercise yourself into fitness and resolve the illness,” Bateman says. “When in reality, that’s not the case.”

Jordan, a 23-year-old who wished to omit his last name, says he was referred for pulmonary rehabilitation after two visits to Houston Methodist’s COVID-19 Recovery Clinic in the spring of 2022. He followed a program of increased aerobic exercise resembling GET for about a month. “24 hours after I finished each session I’d get a flare-up of symptoms,” he says.

Jordan says he has been living with long COVID symptoms since getting his second COVID-19 vaccination dose in May 2021. Before that, he had two prior SARS-CoV-2 infections. Though there are few studies on post-vaccine side effects, some immunologists believe it may provide clues on the biology of long COVID.

His symptoms got progressively worse as he followed the GET-like program, leading to lightheadedness and “burning” headaches. When Jordan mentioned this to a nurse practitioner at the Houston Methodist clinic, he says he was told to continue exercising, do cognitive behavioral therapy, and come back in six months.

A spokesperson for Houston Methodist wrote to me that they do not prescribe GET at their post-COVID clinic, but that if a patient at the clinic requires pulmonary rehabilitation a respiratory therapist may recommend a “gradual exercise regimen” based on that individual’s needs. Jordan says his therapy included an increase in the length of the time of the exercises, which is a feature of GET. I asked by email if and how the clinic—or any medical professionals the clinic refers to—prescribes the therapy to patients with PEM, but didn’t receive a response.

Jordan left the clinic in summer and was recently admitted to Baylor’s Post COVID Care Clinic in Texas after a five-month wait. He says he feels heard at the clinic and that his primary provider is much better informed about ME and its ties to long COVID.

“The issue is that for most clinicians the disease is incredibly complex,” says Jaime Seltzer, the director of scientific and medical outreach at the advocacy group #MEAction. Clinicians who are faced with this level of complexity, she says, may turn to treatments like GET because they are based on simple hypotheses. 

The most prominent study used to employ GET is the 2004-2011 PACE Trial, which has been debunked as an outdated standard of care in a recent ME consensus recommendation written by Bateman and 22 other co-authors. The CDC even removed recommendations for GET from its website in 2017. The therapy is also not recommended for people with ME by the National Institute for Health and Care Excellence, which offers guidelines for health and care in England, nor is it recommended for long COVID patients who experience PEM by the World Health Organization.

“There is a lot you can do for ME/CFS,” Seltzer says. “There’s no cure, but that’s not the same thing as saying it cannot be managed.” She points out that many people with ME have grown frustrated with the narrative that long COVID is a new and mysterious illness, and says that it perpetuates an excuse for clinicians to not be blamed for failing to help. “It is absurd that they are turning away good information because of stigma.”

Akiko Iwasaki, an immunologist at Yale School of Medicine and a leading long COVID researcher, agrees with Seltzer: Had there been more research and funding devoted to studying ME, she says, we would have been much better prepared to deal with long COVID. “I’m hoping that any insights we gain from long COVID will also apply to [ME].”

Managing ME

In preliminary research posted online this August, Iwasaki and her colleagues found altered immune cell activity, blood abnormalities, low cortisol levels, and signs of reactivated Epstein-Barr virus in long COVID patients. She says that their findings warrant an immediate need for randomized clinical trials to target these syndromes. Long COVID clinics would be a natural place for them to begin. “As a scientist I’d like to know all the pieces of the puzzle first,” she explains, “But we don’t have that luxury, we have to start trialing to find something that works now.”

Iwasaki’s top candidates for potential therapies to study include antivirals, like the drug Paxlovid, which will undergo its first clinical trial to alleviate inflammation and other long COVID symptoms in January. Early results from a widescale study on veterans found that the treatment with nirmatrelvir—one of the two pills used in the treatment—can slightly decrease the risk of long COVID if taken during the acute phase. Iwasaki also hopes to investigate other therapies that target the reactivated Epstein-Barr virus and inflammation associated with long COVID, as well as cortisol supplementation therapies.

But until more long COVID clinics begin testing potential therapies, Iwasaki says that at the very least there should be “open communication” between these clinics so that they can share insights about what works for patients and what doesn’t. Programs should standardize their training for physicians, too, which may be helped by the Biden administration’s proposed Centers of Excellence, so long as the model prioritizes infection-associated illnesses like ME. 

Iwasaki underscores that each clinic should be set up so that patients can see many specialists in one visit. “That would be very helpful because people with long COVID often have brain fog that makes it very difficult to maneuver 12 different appointments,” she says.

One emerging model hoping to lead in this space is RTHM, Seltzer says. The new virtual long COVID clinic was co-founded by clinicians and researchers whose care is informed by their own patient experience with ME and other infection-associated illnesses. It sees patients virtually in five states, and targets ME, POTS, MCAS, and other conditions that often accompany long COVID. Seltzer is helping to shape the program’s educational resources.

Long COVID patients have begun visiting clinics and practices like RTHM that specialize in ME, even though the programs may be out of network with major health insurance carriers for some of their services. The nonprofit research advocacy group Solve M.E. shares a list of 17 doctors specializing in ME on their website; #MEAction has similarly compiled an international list of providers and allies. But many of these specialists are nearing retirement age at a time when their expertise is required by millions of survivors.

[Related: Getting COVID more than once might be even worse than we thought]

At Bateman’s ME clinic in Utah, she hired and trained two advanced practice clinicians to see long COVID patients, after she noticed a surge in need in late 2020. Like other medical experts I spoke with, she says the best way to address the growing need for ME and long COVID clinicians is to educate all healthcare workers about the illness. She also emphasizes that it’s necessary to put pressure on powerful agents like health insurance companies and academic institutions to recognize ME. “We need skilled chronic illness managers to coordinate the care of people with long COVID and other post-viral conditions,” she explains, far beyond those working in a few clinics.

In the meantime, Bateman recommends long COVID patients do the same thing she has been telling ME patients for years. “Become very well-informed yourself,” she says, advising individuals to read broadly about their own condition from ME non-profits, patient-led research groups, and papers written by ME specialists. “Secondly, work with a provider that you can communicate with and learn about long COVID together. It’s easier to train up a trusted doctor than to go searching for [ME specialists] when the numbers are still so low.” 

At some point, long COVID will become enough of an issue that it will demand change, Bateman says, but she worries about how many people will have to suffer until then. “I’m hopeful that the response to long COVID will improve. But I would like to see it move more quickly and include all of the people with post-viral syndromes who are in need.”

The post What patients find at long COVID clinics: rejection, outdated therapies, and unanswered questions appeared first on Popular Science.

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Almost three years into the pandemic, the spotlight isn’t just on COVID medicine anymore. While booster shots and take-home antiviral pills gave us new tools to fight the infectious disease, health researchers and drug makers regained momentum in other crucial areas, like organ transplants, STI prevention, and white-whale therapies for alopecia and HIV. At the same time, AI deepened its role as a diagnostic aid, while mental health services got an accessibility boost across the US. We know the pandemic isn’t over—and other pathogens and illnesses are likely lurking undetected—but the progress we make in medical labs, factories, and care centers can help nurse societies back to health before the next storm hits.

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Grand Award Winner

AuriNova by 3DBio Therapeutics: A replacement ear that’s made from ear cells

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About 1,500 people in the US are born each year with absent or underdeveloped external ears. Traditional reconstruction techniques might fix the cosmetic issue, but a new 3D-printed ear transplant, called AuriNovo, offers a living substitute. The implant is made with proteins, hydrogel, and a patient’s own cells, giving it far more flexibility than any constructed with synthetic materials; plus, the procedure is less invasive than, say, transplanting tissue from a patient’s ribs. To build the replacement, a surgeon first takes a sample of an individual’s ear tissue to separate and culture the cartilage-making cells. Then, based on a 3D scan of the fully formed ear on the patient, the part is printed with collagen-based “bio ink” and surgically inserted above the jaw. A 20-year-old woman from Mexico was the first to get the implant this June. 3DBio Therapeutics, the New York-based regenerative medicine company behind AuriNovo, hopes to use the technology to one day create other replacement body parts, like noses, spinal discs, and larger organs. 

Paxlovid by Pfizer: The first take-home treatment for COVID-19

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COVID therapies have come a long way since the start of the pandemic, and now include several antiviral drugs and monoclonal antibodies. But Pfizer’s Paxlovid was the first oral treatment for the disease to receive emergency authorization from the FDA, meaning it can be obtained with a prescription. It’s also highly effective: Clinical trials show it reduces hospitalization and death from the virus up to 90 percent more than a placebo. The remedy is a combination of two pills: nirmatrelvir, which prevents the novel coronavirus from replicating, and ritonavir, which causes the body to metabolize nirmatrelvir more slowly. The drug does have downsides—it can interact with other medications and sometimes causes a foul aftertaste. Plus, rare cases of rebound COVID symptoms and positive tests have occurred in people following Paxlovid treatment, although research indicates that the latter might be related to the immune system responding to residual viral RNA. Still, it represents a crucial new safeguard for healthcare providers and the public.

EVO Visian Implantable Collamer Lenses by STAAR Surgical: Combining the perks of contacts and laser surgery

STAAR Surgical

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Most cases of nearsightedness and astigmatism, which is blurred vision caused by an irregularly shaped cornea, can be fixed with laser eye surgery. But the procedure requires some corneal tissue to be removed and often leaves recipients with lingering dry eyes. EVO ICL provides an alternative with a minimally invasive new way to correct or reduce both conditions. During the approximately hour-long procedure, a flexible collagen-containing lens is implanted between the iris and natural lens. The implant is meant to sit in the eye permanently, but can also be plucked out by an ophthalmologist if needed. In published clinical trial results, close to 88 percent of patients reported 20/20 or better and nearly all achieved 20/32 or better distance vision after six months. The lenses also block some UV rays for added protection.

Olumiant by Eli Lilly and Incyte: Long-term relief for severe alopecia

Eli Lilly and Incyte

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More than 300,000 people of all ages in the US live with severe alopecia areata, a condition that causes the immune system to attack hair follicles, leading to patchy baldness on the scalp and elsewhere. Hair loss in the nose and ears can affect patients’ hearing and allergies, and a lack of eyelashes can leave people vulnerable to eye irritation from dust. Olumiant, the first medication to secure the FDA’s approval for severe alopecia, can help hair grow back over the entire body. It belongs to a group of drugs called JAK inhibitors, which block certain inflammation-promoting enzymes. It was originally greenlit by the agency in 2018 to treat some forms of rheumatoid arthritis, but in clinical trials for alopecia, it helped roughly a third of participants to regrow up to 80 percent of their hair by 36 weeks, and nearly half after a year. Other JAK inhibitors in development could provide alternatives for patients who don’t fully respond to Olumiant.

AIR Recon DL by GE Healthcare: Sharper MRIs in half the time

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Laying motionless for an hour or longer in a magnetic scanner can be a claustrophobic and sometimes nauseating experience. A next-level neural network by GE Healthcare reduces the stress on patients, while filtering out visual noise from movement or faulty processing. The software combs through raw radio-wave data from MRI machines and turns the most accurate bits into high-resolution 3D images. Originally, the AI-reconstructed images had to be stitched together—but the updated tech, which received FDA approval this September, delivers in one go. The speedy precision can cut exam times in half, help hospitals and clinics serve more patients, and possibly improve the rate of diagnosis by giving radiologists a much cleaner view of tissues, bones, masses, and more.

ONE Male Condom by ONE: Latex that works for anal sex

ONE

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At first glance this condom isn’t all that different from those by other brands. It’s made from natural latex, comes in three thicknesses, and has a wide range of sizes for best fit. But the contraceptive is the first to also be clinically tested for STI protection during anal sex—and has proven to be extremely effective. In studies involving 252 male-male couples and 252 male-female couples, the condoms had a less than 2-percent chance of breakage, slippage, discomfort, and adverse events (which included urinary tract infections and bacteria and viruses spread during sex). With such a healthy showing, the company earned the FDA nod to label the product as “safe for anal sex.” With widespread availability, there’s hope that the condom can help beat back a record rise in chlamydia, gonorrhea, syphilis, and other STIs.

Bivalent COVID-19 vaccines by Moderna and Pfizer-BioNTech: A one-shot-fits-all approach

Ringo Chiu, AFP via Getty Images

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One of the niftiest features of mRNA vaccines such as Moderna and Pfizer-BioNTech’s COVID shots is that they can be tweaked and scaled up quickly to keep up with an ever-changing virus. This August, the FDA authorized the first bivalent COVID boosters, modified with new genetic data to target both the original version of SARS-CoV-2 and the Omicron sub-variants BA.4 and BA.5. Just how much added protection the bivalent shots offer against the latest versions of COVID remains to be seen, although in early results, the Pfizer-BioNTech booster increased antibodies against the BA.4 and BA.5 sub-variants by up to 11 times, while the Moderna booster did so by up to 15 times. Experts anticipate that the bivalent COVID vaccines, which are available to all adults and children ages 5 and older in the US, could save thousands of lives if the virus surges again this winter. 

Umbilical cord blood transplant for HIV by Fred Hutchinson Cancer Research Center and Weill Cornell Medicine: The right cells for viral resistance

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There are now three official cases of patients in long-term HIV remission—but this one might be the most promising for the millions around the world living with the virus. In 2017, an unidentified American received a blood transplant packed with genes that were resistant to the pathogen behind AIDS. More than four years later, her doctors at Weill Cornell Medicine confirmed that the procedure at Fred Hutchinson Cancer Research Center had indeed made her free of the disease. The miraculous sample was specifically taken from a relative’s umbilical cord blood cells, which were still in the process of maturing and specializing, making it easier for the transplant to take. Previous attempts to cure the disease depended on bone marrow donations that carry a mutated gene only known in Northern Europeans. This alternative treatment makes transplants more accessible for patients from other ethnic backgrounds, so their bodies can fight HIV in the long run as well.

988 Suicide and Crisis Lifeline by SAMSHA: Streamlining the call for help 

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When you have a general emergency, you might call 911. But for people experiencing a mental crisis, the number has been a lot less intuitive. This July, however, the Suicide and Crisis Lifeline, run by the US Department of Health and Human Services since 2005, fully switched over to a three-digit code that’s easy to punch in: 988. The shortcut was years in the making, but required major collaboration with the Federal Communication Commission to connect every phone service provider to the alternative number. Since it went live, officials have reported shorter hold times and a 45-percent increase in use compared to August 2021, including on a specialized veteran hotline. The service shakeup also came with $177 million for states and tribes to support the transition in different ways, like alleviating surcharges, setting up call centers, and integrating crisis relief with existing or new emergency responses.

eCoin Peripheral Neurostimulator by Valencia Technologies: A discreet implant for bladder control 

Valencia Technologies

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Pads, vaginal seals, and skin patches can be a burden for anyone who has to deal with urinary incontinence on a daily basis. A new electrode device, about as small as a nickel and implanted above the ankle, nips the issue in the bud in a more private and convenient way. Incontinence typically occurs when the muscles in and around the bladder contract too often or too much. To prevent leaks and constant trips to the toilet, the eCoin sends low-key shocks through the tibial nerve, targeting the pelvic organs and relaxing the bladder wall. A doctor can control the intensity of the pulses with a remote, making the device more customizable for a broad range of patients. Neurostimulators have become a vanguard treatment for different nervous system conditions, including chronic back pain and even paralysis—but few are so adaptable as this.

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