OUR EYES, unlike other organs hidden deep within our bodies, sit in plain sight. They have been inspirations for artists, symbols for the superstitious, and objects of scientific fascination for centuries. In ancient Greece, medical pioneers cut them open in public dissections, revealing delicate layers of retina, cornea, and iris. In the early 10th century, Persian physician al-Razi discovered that the pupil dilates and contracts to control the amount of light that enters. Six centuries later, the Renaissance-era anatomist Vesalius sketched a cross-section of the orb—with some errors. But eyes themselves are imperfect: Just one fault could cause the whole organ to glitch or break down. 

It turns out that flaws are common in our vision. More than 7 million Americans have some form of vision loss, which can include partial or full blindness, according to a 2021 analysis of 25 years of data from the US Census, the Centers for Disease Control and Prevention, and others. Many of these conditions are present from birth. Mutations in particular regions of DNA can lead to incorrectly formed optical parts. This can distort a person’s sight, especially if the issues are in the retina, the layer of cells at the back of the eye that captures incoming light and transmits it to the brain. But what if we could give someone with limited vision a corrected version of their genetic material to fix the malfunctioning parts?

Currently, there is no way to fully reverse inherited forms of blindness, which are traditionally managed with adaptations rather than treatments. “I speak to a lot of parents who are really frustrated about the lack of standard of care,” says Shannon Boye, a professor in the pediatrics department at the University of Florida. “They’re desperate for cures.”

But understanding the genetic roots of the disability helps. In theory, if scientists can pinpoint the problematic or missing DNA that’s hampering a person’s vision, they can design a rectified copy. The new genetic code is loaded into harmless viruses that deliver therapeutic genes to selected cells, and the viruses are then injected into the affected eye. There, the replacement DNA instructs the eye to make the proteins it needs to see again. 

In practice, it’s not so easy. The Food and Drug Administration (FDA) has approved only one gene therapy to treat a form of blindness—the first gene therapy the agency ever greenlit. Called Luxturna, it was OK’d in the US in 2017 to treat patients with mutations that lead to Leber congenital amaurosis (LCA). In people with this uncommon flaw, light-detecting photoreceptor cells in the retina develop incorrectly, become malformed, or die, leading to rapid vision loss early in life. Luxturna provides the correct version of the gene, partially restoring vision.

“This was a godsend scenario,” says Claudio Punzo, an expert in vision genetics at the University of Massachusetts Chan Medical School. There are several types of LCA, but the retina degrades more slowly in the form of the disease that Luxturna treats, which creates a larger window for the gene therapy to work. What’s more, people with the condition are often completely blind, so even a small improvement in their sight is life changing.

After that first FDA approval, “Unfortunately, the field hit a lull,” Boye says. But she is confident that with new genetic tools, Luxturna’s success story can be replicated on a much larger scale. 

One big step has been designing better couriers for the corrected code. Many gene therapies use naturally harmless adeno-associated viruses, which researchers modify to home in on retinal photoreceptors or other key cell types. Boye imagines a modular system using a suite of viral vessels designed for different destinations, in which any gene can be loaded as cargo. 

“Will we get it to work for everyone? With every mutation? Most likely, yes, at some point,” says Punzo. “It just becomes a logistical problem.” There are hundreds of different mutations that can cause blindness, and finding the right gene to fix in the right cell is no small task. For genes that are too large to fit inside a virus, CRISPR editing technology might offer an alternative method to correct the mutation directly in the patient’s DNA. In 2022, biotech company Editas tried using CRISPR to treat a form of LCA by removing a mutation in the retinal gene CEP290, but it paused the trial when vision in only three out of the 14 participants improved.

For people with visual disabilities, the invasiveness of current treatments is another major hurdle. These methods typically require surgeries to deliver the gene close to the retina, a process that itself can cause mild retinal damage. For someone with a less severe disease, such as night blindness or color blindness, the risks may not be worth the modest benefit. Shots in parts of the eye farther from the retina would be less invasive, but they are not yet standard for gene therapy. Another appealing option would be eyedrops, which were recently used for the first time in an experimental treatment at the University of Miami on a 14-year-old boy with corneal scarring. After months of the topical treatment, his sight returned to near-normal levels.

Cost is another obstacle. When Luxturna first hit the market in 2018, its price tag was $425,000 per eye. In part, the expense comes from the meticulous process of making a virus that won’t harm a patient. But the other part of the equation is the biotech industry’s irresistible pitch: We can help you see again. For people who are progressively losing their vision, even slowing down the process could be priceless—or so gene therapy companies hope. 

Most major insurers cover one dose of Luxturna per eye for patients whose retinas are intact enough to heal. But the hopefuls may still be on the hook for out-of-pocket costs associated with the procedure, or the cost of travel to one of 14 certified treatment centers in the US. “[It’s] an insanely expensive treatment,” Punzo says. “If there are cheaper drugs that would work, I think it will change the market.”

Currently, dozens of gene therapy clinical trials for hereditary forms of blindness are in progress, and many more are in the planning stages. They span diverse conditions, including Stargardt disease (which causes fat to build up in the eye), achromatopsia (a form of color blindness), and retinitis pigmentosa (which makes the retina break down). But progress is slow: Many have been at it for more than a decade with years to go.

Boye knows this firsthand. She co-founded a company called Atsena Therapeutics that is currently conducting a clinical trial for a virus-delivered code to correct an LCA-causing mutation. Her confidence that gene therapies can reverse blindness stems from both data and patients’ stories. She recalls a young girl who got the corrective treatment: As her vision improved, the child was able for the first time to see snowflakes—delicate, magical, and unlike anything she had experienced in her life.

Read more PopSci+ stories.

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Today, the United Kingdom became the first country to give regulatory approval to a medical procedure that uses CRISPR gene editing. The Medicines and Healthcare products Regulatory Agency (MHRA) approved Casgevy, a therapy that will be used to treat sickle cell disease and beta thalassemia (also called β -thalassaemia). 

[Related: CRISPR breaks ground as a one-shot treatment for a rare disease.]

What are sickle cell disease and beta thalassemia? 

Both diseases are painful, life-long genetic conditions that are caused by errors in the genes for a protein called hemoglobin. Red blood cells use hemoglobin to carry oxygen around the body. Sickle cell disease is particularly common among people with Caribbean or African ancestry. The abnormal hemoglobin makes the blood cells crescent-shaped and hard. The misshapen cells then clump together and block the flow of oxygen to the organs, which causes extreme pain. The cells can then die off early, which leads to anemia. 

Beta thalassemia primarily affects patients with Mediterranean, south Asian, southeast Asian, and Middle Eastern backgrounds. It also causes anemia since the mody cannot make as much hemoglobin.  

Casgevy was developed by Boston’s Vertex Pharmaceuticals and Switzerland’s Crispr Therapeutics and could be used to replace bone marrow transplants. The companies estimate that roughly 2,000 people in the UK are now eligible for the therapy.

“I am pleased to announce that we have authorized an innovative and first-of-its-kind gene-editing treatment called Casgevy, which in trials has been found to restore healthy hemoglobin production in the majority of participants with sickle-cell disease and transfusion-dependent beta thalassaemia, relieving the symptoms of disease,” interim executive director of healthcare quality and access at the MHRA Julian Beach said in a statement. 

How does Casgey use CRISPR gene editing?

The new treatment uses the CRISPR-Cas9 gene editing technique, which enables scientists to make precise alterations to human DNA. French microbiologist, geneticist and biochemist Emmanuelle Charpentier and American biochemist Jennifer A. Doudna, who shared the 2020 Nobel Prize in Chemistry for their work. 

Casgevy uses stem cells taken from a patient’s bone marrow. The cells are then brought into a lab and the genes that are meant to switch on a functioning version of hemoglobin are edited with CRISPR. According to the MHRA, patients must then go through a “conditioning treatment.” This can involve taking a drug that suppresses the immune system, radiotherapy, or chemotherapy to get the body ready for an infusion of CRISPR-modified cells back into the body. The new treatment does not come with the risk of graft versus host disease the way that a traditional bone marrow transplant does.

[Related: These organisms have a natural gene-editing system that could be more useful than CRISPR.]

After the infusion, patients may need to remain in a hospital facility for at least a month. During this time, the treated cells will begin to “take up residence” in the bone marrow and make red blood cells that have a stable form of hemoglobin.

While seeking regulatory approval, the researchers performed a clinical trial of 45 patients with sickle-cell disease. Of this group, 29 patients have been in the trial long enough for the researchers to gauge how effective Casgevy is. Of these eligible patients, 28 were free of severe pain crises for at least 12 months after treatment.  

In the clinical trial of 54 patients with transfusion-dependent beta thalassemia, 42 patients have been in the trial long enough to determine efficacy. Of these, 39 did not require a red blood cell transfusion for at least 12 months after the treatment. The remaining three had more than a 70 percent reduction in the need for red cell transfusions. 

“This is a great step in the advancement of medical approaches to tackle genetic diseases we never thought would be possible to cure,” University of Hertfordshire geneticist Alena Pance said a statement released by the Science Media Centre. “Modifying the stem cells from the bone marrow of the patient avoids the problems associated with immune compatibility, i.e. searching for donors that match the patient and following immunosuppression, and constituting a real cure of the disease rather than a treatment.”

The United States Food and Drug Administration is evaluating this same treatment. On October 31, an advisory committee to the FDA said that treatment was safe for patients. It is expected to make a decision by December 8. 

A price for the therapy has not been announced, but it will likely be expensive. 

Previously

Despite its potential for good, CRISPR has been tainted with controversy and ripe for debate over the fear of being able to pick and choose genes for so-called “designer babies.” In 2018, Chinese scientist He Jiankui announced that he had created the first gene-edited babies in the world. He was found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison. This work furthered the debate of how to best regulate this powerful technique, with many saying that it shouldn’t be used to edit human genes that will be passed down to the next generation. 

Other experiments and trials with using the gene editing technique on rare diseases have continued. In 2021, a clinical trial for a drug called NTLA-2001 began, researchers attempted to treat six people with a rare genetic disease called transthyretin amyloidosis with a technology that delivers CRISPR directly to cells in the liver. The FDA cleared the trial to enter its critical third phase in October.

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The common stethoscope’s recognizable design has remained largely unchanged for decades for good reason—there’s really not much to improve at this point. When it comes to listening in on a patient’s internal soundtrack, the standard, adjustable bell connected via short rubber tubing to binaural earpieces is perfectly suited for helping assess respiratory and cardiac health.

Of course, a stethoscope can only relay vitals in person based on its specific placements; long term monitoring often requires extended clinical stays alongside bulky, wired devices. To solve these problems, a team of medical experts, researchers, and engineers at Northwestern University set out to design a new wearable capable of providing highly detailed, continuous, real-time information regardless of a patient’s environment. After painlessly adhering to specific areas of the chest, the resulting soft devices not only accomplish these goals, but already show immense promise for both adults, as well as premature babies often dealing with gastrointestinal complications and apneas.

[Related: Pill cuts lung cancer deaths in half, study says.]

“Currently, there are no existing methods for continuously monitoring and spatially mapping body sounds at home or in hospital settings,” John Rogers, a bioelectronics expert who oversaw the new tool’s design and development, said in a recent Northwestern University profile.

As detailed in a new study published in Nature Medicine, Rogers and fellow researchers placed a miniature battery, electronics, Bluetooth relay, flash memory drive, and two microphones within a 40mm long, 20mm wide, and 8 mm thick soft silicone casing—roughly the size of a stick of gum. Each microphone is positioned in opposing directions, into and outside the patient, to filter exterior ambient noises from a wearer’s bodily sounds. The team notes this is particularly helpful in situations such as lung monitoring, since the organ is simply too quiet when compared to noisy hospital surroundings.

Ankit Bharat, a thoracic surgeon who oversaw adult subject clinical device trials, describes it pretty succinctly in Northwestern’s November 16 announcement:

“Simply put, it’s like up to 13 highly trained doctors listening to different regions of the lungs simultaneously with their stethoscopes, and their minds are synced to create a continuous and a dynamic assessment of the lung health that is translated into a movie on a real-life computer screen.”

[Related: Almost everyone in the world breathes unhealthy air.]

Aside from adult lung and gastrointestinal health monitoring, the tiny wearables show incredible promise for infants—particularly those born with potential medical issues. Babies’ respiratory systems only fully mature during the third trimester of pregnancy, meaning many apnea and breathing disorders often accompany premature deliveries. Given these infants’ physical size, traditional stethoscopes are both impractical and too large to provide accurate, prolonged monitoring. And even for healthy delivered children, breathing and gastrointestinal issues are major concerns during their first five years. The team’s new wearables, however, account for these issues by providing a new, size-appropriate tool.

Every human body is host to a wide array of acoustic and tonal signatures. Once the particular sounds are documented, the team hopes their wearable will make it much easier to pick out irregularities stemming from serious, overlooked health issues. If detected early enough, such discoveries could potentially save countless lives.

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A team of scientists at Northwestern University have developed synthetic melanin that can accelerate healing in human skin. It is applied in a cream and can protect the skin from the sun and heal chemical burns, according to the team. The findings are described in a study published November 2 in the journal Nature npj Regenerative Medicine.

What is melanin?

Melanin is a pigment that is naturally produced in humans and animals. It provides pigmentation to the hair, eyes, and skin. It protects skin cells from sun damage by increasing pigmentation in response to the sun–a process commonly called tanning. 

“People don’t think of their everyday life as an injury to their skin,” study co-author and dermatologist Kurt Lu said in a statement. “If you walk barefaced every day in the sun, you suffer a low-grade, constant bombardment of ultraviolet light. This is worsened during peak mid-day hours and the summer season. We know sun-exposed skin ages versus skin protected by clothing, which doesn’t show age nearly as much.”

[Related: A new artificial skin could be more sensitive than the real thing.]

Aging in the skin is also due to simply getting older and external factors like environmental pollution. Sun damage, chronological aging, and environmental pollutants can create unstable oxygen molecules called free radicals. These molecules can then cause inflammation and break down the collagen in the skin. It is one of the reasons that older skin looks very different than younger skin. 

‘An efficient sponge’

In the study, the team used a synthetic melanin that was engineered with nanoparticles. They modified the melanin structure so that it has a higher free radical-scavenging capacity.

Researchers used a chemical to create a blistering reaction to a sample of human skin tissue in a dish. The blistering looked like a separation of the upper layers of the skin from each other and was similar to an inflamed reaction to poison ivy. 

They waited a few hours, then applied their topical melanin cream to the injured skin. The cream facilitated an immune response within the first few days, by initially helping the skin’s own free radical-scavenging enzymes recover. A cascade of responses followed where healing sped up, including the preservation of the healthy layers of skin underneath the top layers. The synthetic melanin cream soaked up the free radicals and quieted the immune system. By comparison, blistering persisted in the control samples that did not have the melanin cream treatment. 

“The synthetic melanin is capable of scavenging more radicals per gram compared to human melanin,” study co-author and chemist/biomedical engineer Nathan Gianneschi said in a statement.  “It’s like super melanin. It’s biocompatible, degradable,nontoxic and clear when rubbed onto the skin. In our studies, it acts as an efficient sponge, removing damaging factors and protecting the skin.”

According to the team, the super melanin sits on the surface of the skin once it is applied and isn’t absorbed into the layers below. It sets the skin on a cycle of healing and repair that is directed by the body’s immune system. 

[Related: The lowest-effort skincare routine that will still make your skin glow.]

Protection from nerve gas

Gianneschi and Lu are studying using melanin as a protective dye in clothing. The thought is the pigment could act as an absorbent for toxins, particularly nerve gas. 

“Although it [melanin] can act this way naturally, we have engineered it to optimize absorption of these toxic molecules with our synthetic version,” Gianneschi said in a statement

They are also pursuing more clinical trials for testing their synthetic melanin cream. In a first step, they recently completed a trial showing that the synthetic melanins do not irritate human skin. Since it protects tissue from high energy radiation, it could also be an effective treatment for burns cancer patients undergoing radiation therapy often experience. 

This research was funded by the United States Department of Defense and the National Institutes of Health.

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Thousands of years ago, ancient Egyptians used moldy bread to heal infected cuts and wounds. They may not have realized it, but their bizarre medical practice relied on fungi to create chemicals that kill infection-causing bacteria. This, in other words, was a very rough draft of an antibiotic drug. These types of molds helped Alexander Fleming discover penicillin centuries later. And now, to fight off superbugs, scientists are increasingly turning to another unorthodox source of germ-killers: healthy poop.

Specifically, fecal microbiota transplants are safe and effective in stopping the growth of antibiotic-resistant bacteria, according to a small study published today in Science Translational Medicine. If additional clinical trials prove to be successful, poop transplants could be a promising method in populations at risk of resistant infections, such as patients who get organ transplants. 

Antibiotics have saved millions from deadly infections, and human life expectancy jumped dramatically after their discovery. But their overuse has caused some bacterial strains to develop methods of protection against the medications. Antibiotic-resistant strains are a global problem that was responsible for 5 million deaths in 2019. On top of that is the concerning rise of superbugs, strains of bacteria with the highest resistance to multiple drugs. 

[Related: FDA approves first fecal transplant pill]

Once a patient is infected with antibiotic-resistant bacteria, “there’s not really a way to get rid of colonization,” says Michael Woodworth, an assistant professor of medicine at Emory University School of Medicine and lead author of the new study. “Right now, there are no FDA approved therapies.” In the past, clinicians tried to get rid of superbugs with additional antibiotics, which can set up a “vicious cycle” in which medication promotes the growth of even stronger antibiotic-resistant bacteria.

The idea to use poop transplants to defeat superbugs came after a growing body of evidence shows they can help treat tough C. difficile infections, a germ that patients can get in a hospital. In people who had received poop transplants, it looked as though they had fewer chances of catching the antibiotic-resistant bacteria. 

The new research was a Phase 1 clinical trial that enrolled 11 people awaiting kidney transplants. Organ recipients typically receive preventative antibiotics after their transplants, but this has not stopped an increasing amount of antibiotic-resistant UTI infections in this population.

In the study, people were randomly selected to receive a poop transplant immediately after getting a kidney, or a poop transplant later on if their stool samples showed positive signs of antibiotic-resistant bacteria after day 36. If people continued to be positive for the microbes, they had a second poop transplant. The authors used an enema to administer all the poop transplants, a route the study notes would have the lowest rate of side effects. To reduce the risk of passing harmful bacteria through the fecal transplants, screening tests checked for pathogens known to be resistant. 

The research team detected significant results in the two groups, despite the small number of participants (COVID disrupted patient enrollment in the study). All treatments were safe for people who received one or two poop transplants. Additionally, eight out of nine people were negative for antibiotic-resistant bacteria after 36 days.

Genetic analysis of the stool samples showed that the poop transplants helped reduce the number of superbugs. This decolonization of bacteria, while it was not directly tested, may help in preventing recurrent antibiotic-resistant infections. 

[Related: Finding the world’s super poopers could save a lot of butts]

“This provides the ground to start a large, randomized, controlled study to assess the effect of [fecal microbiota transplants] on decolonizing multi-drug-resistant organisms,” says Seifeldin Hakim, a gastroenterologist with Memorial Hermann in Houston who was not involved in the study. Theoretically, it would make sense that lowering the number of antibiotic-resistant bacteria in the gut would decrease the chances of clinical infection or sepsis, Hakim says, but more evidence-based results are needed to support this.

Woodworth says poop transplants provide a mix of “good” bacteria to improve colonic health and strengthen the gut barrier. It’s also possible that another biological mechanism is at work. Woodworth hypothesizes that the poop transplants might have driven competition between antibiotic-resistant bacteria and non-resistant germs of the same species. This may have contributed to bacterial strains becoming more susceptible to antibiotics.

Because the trial was an early phase test, there are many more questions to answer, Woodworth says, such as figuring out the proper dose. His team is currently conducting two other clinical trials to research wider applications for fighting drug-resistant pathogens. They are currently planning a larger follow-up study, too, among people who received kidney transplants to better understand how competition between strains might reduce bacteria colonization.

There are still some kinks to work out with using fecal transplants, says Woodworth. However, he hopes this study can act as a jumping off point for inspiring other microbiome-related treatments to fight off antibiotic-resistant bacteria. To guide the next generation of therapies, poop may be our society’s moldy bread.

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As cold and flu season approaches, pharmacy chain CVS announced that they are removing some over-the-counter allergy and cold medicines from their shelves since their active ingredient has been deemed ineffective as a decongestant when taken orally. The removed medications include Vicks Dayquill, Benadryl Allergy Plus Congestion, Sudafed PE, Vicks Sinex, and others that contain a decongestant called phenylephrine.

[Related: Why adult cold medicine is not good for children.]

A CVS spokesperson told CNBC that other oral cold medications that do not contain phenylephrine as the only active ingredient will remain on CVS’ shelves. Medications that contain phenylephrine account for about  $1.8 billion in annual sales, according to the Food and Drug Administration.

In September, an independent advisory committee to the FDA declared that phenylephrine is ineffective as a decongestant when taken in pill form. The panel refused to certify the effectiveness of these medications, adding that further trials to prove otherwise were required. 

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told CBS News last month. 

In 2006, phenylephrine began to be substituted for an ingredient called pseudoephedrine in many non-prescription cold and allergy medicines. Pseudoephedrine was restricted amid reports of it being used to make the illegal drug methamphetamine. Phenylephrine cannot be used to make meth and was considered a suitable replacement. These medications with pseudoephedrine are still considered safe and can be bought without a prescription, but are now behind the pharmacy counter and require a photo ID. 

Allergies and respiratory infections alert the body to send white blood cells to the sinuses, nose, and throat, which causes the creation of mucus and swelling in the nasal membranes. Phenylephrine temporarily reduces the swelling in the blood vessels in the nasal passages when it is administered in the nose. Some experts say that when taken in a pill form, phenylephrine gets absorbed by the gut and metabolized so well that only a small amount of the decongestant will make it to the bloodstream. 

According to a 2015 citizen petition asking the FDA to remove drugs with phenylephrine, the amount that gets into the bloodstream is not enough to actually reach the nose and work to clear congestion. Citizen petitions like this one are a way for consumer groups, industry groups, or individuals to call on the FDA to change regulations or take other administrative action. The American Academy of Allergy, Asthma & Immunology supported this citizen petition.

[Related: Why we still don’t have a vaccine for the common cold.]

Consumers should consult a medical professional to best determine what decongestant to take, but can look for those that contain pseudoephedrine or antihistamines like Claratin or Zyrtec. Nasal sprays that contain phenylephrine are also still considered effective, in addition to those that contain another ingredient called oxymetazoline.

In September, director of endoscopic skull base surgery and a professor of otolaryngology at Stanford Medicine Zara Patel, told CNN that seeing a medication removed from store shelves like this should not be a reason to distrust regulatory agencies.

“This is how science works. As we gain more information, recommendations may change, and that’s not a bad thing. That’s the wonderful thing about science. We can use new information and change our perspective,” said Patel. She is not affiliated with the FDA committee.

Other national pharmacy chains including Walgreens and Rite Aid have not yet announced if they are pulling these medications as well.

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Tianeptine, also known as “gas station heroin,” is officially off the market—at least in Florida. The Sunshine State recently joined eight other US states (Alabama, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio, and Tennessee) in forbidding sales of the over the counter pill, citing concerns for its high potential of abuse and addictive properties.

Florida’s attorney general issued an emergency ban in September after an increasing number of calls to the state’s Poison Control Center in the first half of 2023. A similar trend has been seen nationwide with 151 tianeptine poisoning cases in 2020. There are also reports of at least five fatal overdoses since the drug started being sold in the US. 

Tianeptine is still available at gas stations and convenience stores in 41 other states and is purchasable online. It’s up to individuals to know the dangers and avoid purchasing any related products. Here’s what you need to know.

What is tianeptine?

Tianeptine is a non-prescription antidepressant that has become a popular method of getting high in the US in the past decade. It’s even been found in powder form in counterfeit pills of hydrocodone and oxycodone. Some products market dietary supplements containing tianeptine under the brand names Tianaa, Tianna Green, Tianna Red, Tianna White, and ZaZa. Kelly Johnson-Arbor, a medical toxicologist based in Washington D.C., says some vendors claim tianeptine can improve brain function, treat opioid addiction, and help with anxiety, “but there is minimal literature supporting the use of tianeptine for these conditions.” While it may have potential to help with irritable bowel syndrome and chronic pain in medical settings, the threat of addiction appear to outweigh the benefits.

“Its unregulated status in the US also increases the potential for abuse or misuse, as there are no standard dosing recommendations [here] for this drug,” says Johnson-Arbor.

At higher doses, tianeptine starts affecting dopamine levels in addition to serotonin. This important hormone can contribute to addictive behavior by changing neural connectivity to reinforce an activity that brings feelings of pleasure and euphoria. The drug increases opioid activity in the brain, a similar mechanism of action seen in heroin.  

What are the dangers of using tianeptine?

Consumers are usually taking a gamble when they buy tianeptine products because they can’t know for sure how much of the drug they’re getting. This increases the risk of an unintentional overdose, along with other adverse side effects like lethargy, elevated blood pressure and heart rate, agitation, abdominal pain, tremors, and hallucinations.

Johnson-Arbor further warns that people may experience more unwanted side effects, including breathing difficulties, hallucinations, and excessive sleepiness, when combining tianeptine with other medications. Because of its high potential for drug abuse, those who regularly misuse the pills may exhibit withdrawal symptoms such as stomachaches and anxiety if they try to quit.

If you or someone you know develops unexpected symptoms after using tianeptine, contact Poison Control online at www.poison.org or by phone at 1-800-222-1222 for expert advice. Both options are free, confidential, and available 24 hours a day. If you’re trying to quit, help is available. Call the SAMHSA National Helpline at 1-800-662-4357 for substance use information and referrals for treatment.

Why isn’t tianeptine banned everywhere in the US?

Tianeptine is marketed as a prescription antidepressant in the European Union and some other countries. A few, including Turkey, have categorized tianeptine as a controlled substance. Johnson-Arbor says it’s reasonable to consider a similar classification of this drug in the US, but currently, there are no such plans.

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This week, the US Food and Drug Administration gave the green light to a device that uses ultrasound waves to blast apart tumors in the liver. This technique, which requires no needles, injections, knives, or drugs, is called histotripsy, and it’s being developed by a company called HistoSonics, founded by engineers and doctors from the University of Michigan in 2009. 

According to a press release, this approval comes after the results of a series of clinical trials indicated that it can effectively destroy liver tumors while being safe for patients. Now hospitals can purchase the device and offer it to patients as a treatment option. The machine works by directing targeted pulses of high-energy ultrasound waves at a tumor, which creates clusters of microbubbles inside it. When the bubbles form and collapse, they stress the cells and tissues around them, allowing them to break apart the tumor’s internal structure, leaving behind scattered bits that the immune system can then come in to sweep up. 

Here’s the step-by-step process: After patients are under anesthesia, a treatment head that looks uncannily like a pair of virtual reality goggles is placed over their abdomen. Clinicians toggle through a control screen to look at and locate the tumor. Then they lock and load the sound waves. The process is reportedly fast and painless, and the recovery period after the procedure is short.

Through a paired imaging machine, clinicians can also see that the sound waves are targeted at the tumor while avoiding other parts of the body. A robotic arm can also move the transducer to get better aim at the tumor region. In this process, the patient’s immune system can also learn to recognize the tumor cells as threats, which prevented recurrence or metastasis in 80 percent of mice subjects.

While the approval of the device is a big step for broadening the options for cancer treatments, the use of sound waves in medicine is not new. Another platform called Exablate Prostate by Insightech was cleared by the FDA for human trials in prostate cancer patients (although clearance is not quite the same thing as an approval). Nonetheless, the results have been encouraging. The histotripsy technique is being applied in many preclinical experiments for tumors outside of the brain, such as in renal cancer, breast cancer, pancreatic cancer, and musculoskeletal cancer. 

Beyond tumors, a similar technique called lithotripsy, which uses shock waves, has been a treatment for breaking apart painful kidney stones so they become small enough for patients to pass. 

Watch the device at work below:

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Adjusting to prosthetic limbs isn’t as simple as merely finding one that fits your particular body type and needs. Physical control and accuracy are major issues despite proper attachment, and sometimes patients’ bodies reject even the most high-end options available. Such was repeatedly the case for a Swedish patient after losing her right arm in a farming accident over two decades ago. For years, the woman suffered from severe pain and stress issues, likening the sensation to “constantly [having] my hand in a meat grinder.”

Phantom pain is an unfortunately common affliction for amputees, and is believed to originate from nervous system signal confusions between the spinal cord and brain. Although a body part is amputated, the peripheral nerve endings remain connected to the brain, and can thus misread that information as pain.

[Related: We’re surprisingly good at surviving amputations.]

With a new, major breakthrough in prosthetics, however, her severe phantom pains are dramatically alleviated thanks to an artificial arm built on titanium-fused bone tissue alongside rearranged nerves and muscles. As detailed in a new study published via Science Robotics, the remarkable advancements could provide a potential blueprint for many other amputees to adopt such technology in the coming years.

The patient’s procedure started in 2018 when she volunteered to test a new kind of bionic arm designed by a multidisciplinary team of engineers and surgeons led by Max Ortiz Catalan, head of neural prosthetics research at Australia’s Bionics Institute and founder of the Center for Bionics and Pain Research. Using osseointegration, a process infusing titanium into bone tissue to provide a strong mechanical connection, the team was able to attach their prototype to the remaining portion of her right limb.

Accomplishing even this step proved especially difficult because of the need to precisely align the volunteer’s radius and ulna. The team also needed to account for the small amount of space available to house the system’s components. Meanwhile, the limb’s nerves and muscles needed rearrangement to better direct the patient’s neurological motor control information into the prosthetic attachment.

“By combining osseointegration with reconstructive surgery, implanted electrodes, and AI, we can restore human function in an unprecedented way,” Rickard Brånemark, an MIT research affiliate and associate professor at Gothenburg University who oversaw the surgery, said via an update from the Bionics Institute. “The below elbow amputation level has particular challenges, and the level of functionality achieved marks an important milestone for the field of advanced extremity reconstructions as a whole.”

The patient said her breakthrough prosthetic can be comfortably worn all day, is highly integrated with her body, and has even relieved her chronic pain. According to Catalan, this reduction can be attributed to the team’s “integrated surgical and engineering approach” that allows [her] to use “somewhat the same neural resources” as she once did for her biological hand.

“I have better control over my prosthesis, but above all, my pain has decreased,” the patient explained. “Today, I need much less medication.” 

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Gregory Breed doesn’t remember exactly when he began suffering from symptoms of a chronic prostate infection. The 62-year-old estimates they began when he was in his mid-20s. By his early 30s, he was taking painkillers for lower back pain, a common outcome of the disease. Over the years, his doctors put him on course after course of oral antibiotics: trimethoprim-sulfamethoxazole and levofloxacin. But a few months after he stopped taking the drugs, his infection would return.

Prostate infections or prostatitis, one of the most common urinary tract issues in adults, are notorious for recurrence as antibiotics often can’t penetrate tissue deep enough to kill all the bacteria. Over time, with repeated exposure to medicine, the E. coli causing Breed’s infection was becoming increasingly drug-resistant, meaning the bacteria developed the ability to evade and survive treatment. To make matters worse, Breed’s immune response was growing more severe. Between 2000 and 2010, he was hospitalized with sepsis, a life-threatening condition caused by the immune system’s overreaction to an infection, at least five times. Each time he would recover, only to battle another flare-up.

“Greg was constantly in the practice,” Ismail Jimada, Breed’s doctors between 2018 and 2022, says. “We were running out of solutions.”

Breed routinely maxed out his health insurance, paying thousands of dollars out of pocket for his medical bills. The infections took a toll on his loved ones and work life. “I have a very supportive family, but it was hard,” Breed recalls. “There were a lot of years there I didn’t get to be around my family near what I would have liked to.” Some days he struggled to get up and manage his small business selling pipes for oil wells. With limited options for medical care in rural Wyoming, he sought out infectious disease specialists across the country. But with the E. coli in his prostate already resistant to many go-to antibiotics, they didn’t have many treatments to offer him.

Breed’s infection was just one of more than 2.8 million cases of drug-resistant infections recorded by the Centers for Disease Control and Prevention in the US each year. Illnesses that defy antibiotics, antifungals, or other antimicrobials are challenging, if not altogether impossible to treat. More than 35,000 Americans die from drug-resistant infections annually. Globally, that number likely exceeds one million. In 2021 the World Health Organization declared antimicrobial resistance “one of the top 10 global public health threats facing humanity.” Antibiotics are a cornerstone of modern medicine; as pathogens like E. coli , Candida auris, and HIV develop a tolerance to the remedies, common infections, routine dental procedures, and surgeries could become life-threatening. Just in time, however, scientists and physicians are turning to an obscure, decades-old antidote to get drug-resistant infections back under control.

A race to replace antibiotics

Antimicrobial resistance is just another consequence of evolution: Bacteria, fungi, and other microorganisms are constantly adapting unique survival mechanisms to keep up with humans and a changing world. Still, researchers believe the overuse and misuse of antimicrobials in medicine and agriculture is accelerating the emergence and spread of resistance. New drugs capable of killing these evolving microbes could stave off the problem—but it takes millions of dollars and more than a decade of research and development to put out such a product. There hasn’t been a novel class of antibiotics since the 1980s, in part because most major pharmaceutical companies have stopped trying to discover one.

Out of desperation, Breed began scouring the internet for alternative treatments. Sometime in late 2017 or early 2018, he stumbled across a Ted talk by UC San Diego epidemiologist Steffanie Strathdee. In it, Strathdee describes an ill-fated trip to Egypt in 2015 where her husband, Tom Patterson, contracted a drug-resistant infection caused by Acinetobacter baumannii. When they arrived home in California, Patterson fell into a coma; his organs began to shut down. The bacteria behind his infection was already resistant to all known antibiotics.

Strathdee also turned to the internet and found a glimmer of hope: a treatment first discovered in 1917 that had been used in the Soviet Union for decades but largely overlooked by the rest of the world. The method taps bacteriophages, a type of virus that infects and kills bacteria, to combat infections. Scientists have long known that there are billions of different bacteriophages, or “phages,” on the planet. They often live in sewers and other germ-filled places and are highly specific, killing only one or sometimes a few strains of bacteria with no documented harm to humans.

Strathdee reached out to scientists publishing phage research at the time. She thought if they could find a virus that could infect and kill the specific A. baumannii strain causing her husband’s infection, then he might have a chance to survive. Researchers at Texas A&M University immediately responded to her urgent e-mail and started hunting for the right type to combat the culprit. After just a few weeks, they found a few candidate specimens and mailed them to California. The treatment would be experimental—there were no known cases of intravenous phage therapy in the US at the time, according to Strathdee—so Patterson’s clinical team requested emergency use authorization from the Food and Drug Administration (FDA). It was granted within a day. At the UC San Diego Medical Center, doctors injected the phages into Patterson’s abdomen, and a few days later, directly into his bloodstream. Less than a week after the treatment began, Patterson woke up, kissed his daughter’s hand, and went on to make a full recovery.

Building a new path

In 2018, Strathdee co-founded the Center for Innovative Phage Applications and Therapeutics, or IPATH, at UC San Diego to further develop phage therapy for drug-resistant infections. Later that same year, Breed e-mailed the group inquiring if method might also work for his chronic prostate infection. The IPATH team got to work sending specimens of Breed’s E. coli to a network of phage researchers around the country, searching for an effective phage match for much of 2019. It was ultimately provided by the TAILOR lab at the Baylor College of Medicine, which creates “customized phage cocktails for no-hope cases when antibiotics and standard of care have failed,” its founder Anthony Maresso says. Then it took just about one day to receive compassionate use authorization from the FDA.

In January 2020, Breed and his wife flew to San Diego to begin the phage treatment, which IPATH provided for free. “I was excited but extremely nervous about it. When you think about putting the substance they tell you the phage is derived from into your body, it’s not a real good thought,” Breed says. (He’s referring to sewage, the most common source for effective phages.) “Especially when they hook you up and say, ‘Okay, we’re gonna watch and see what happens,’ and you know there’s not a whole lot of people ahead of you who have done it. It’s a really scary situation to be in.”

The IPATH team injected phages into Breed’s catheter. For the next two weeks, he continued with the procedure twice a day, according to Saima Aslam, an infectious diseases physician and IPATH’s clinical lead. Breed’s symptoms—pain, fever, and urinary problems—faded. After six months, laboratory tests confirmed there was no detectable E. coli in his prostate. It has remained that way ever since, and Breed has not suffered any adverse effects from the undertaking.

In high demand

A separate study published in 2023 reported that 11 of 20 patients in the US who received phage therapy for infections caused by mycobacterium had favorable clinical responses. The IPATH team itself has treated 18 patients, including Breed, with phage therapy in the past five years and has had a success rate of 82 percent, Aslam says. She and other physicians and phage researchers are calling for additional research and clinical trials to better understand phage therapy and set forth best practices. There are more than 20 ongoing clinical trials—many for people with cystic fibrosis or prosthetic joint infections—–registered with the US government now.

The current ad-hoc model of sending samples to researchers across the country in hopes for a phage match often delays time to treatment. It usually takes about four to six months to scour repositories—or sewers—for a good phage match, Aslam explains, which means that patients should be in somewhat stable condition to be a candidate. (The FDA typically approves phage therapy for critically ill patients within 24 hours and for more stable patients within 30 days.) The method is also not sustainable for large-scale use. The US government and several universities around the world are working to compile databases that list their discovered phages and the bacterial strains they target. Several biotechnology companies with private collections have also sprung up in recent years; some researchers are even developing and patenting genetically modified phages that are shelf stable or can target more than one type of infection-causing bacteria.

While there is still a long road ahead, phage therapy is one of the few tested solutions for drug-resistant infections—and could some day be comparable, if not cheaper, to the cost of antibiotics. Aslam envisions that in the future, different phage products will be available at pharmacies just like other medicines. But for now, the therapy is proving lifesaving and life changing for lucky individuals like Breed and Patterson. “I have three young grandkids … I was to the point that I was wondering if I really was gonna enjoy the time with them,” Breed says. While he still has some lingering side effects from such prolonged antibiotic use, in terms of quality of life, “it is a thousand times better than it was” before the phages entered the battle.

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This article is republished from The Conversation.

Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s.

How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know. Plato and Aristotle discussed and wrote about the ageing process over 2,300 years ago.

The pursuit of understanding the secrets behind exceptional longevity isn’t easy, however. It involves unravelling the complex interplay of genetic predisposition and lifestyle factors and how they interact throughout a person’s life. Now our recent study, published in GeroScience,, has unveiled some common biomarkers, including levels of cholesterol and glucose, in people who live past 90.

Nonagenarians and centenarians have long been of intense interest to scientists as they may help us understand how to live longer, and perhaps also how to age in better health. So far, studies of centenarians have often been small scale and focused on a selected group, for example, excluding centenarians who live in care homes.

Huge dataset

Ours is the largest study comparing biomarker profiles measured throughout life among exceptionally long-lived people and their shorter-lived peers to date.

We compared the biomarker profiles of people who went on to live past the age of 100, and their shorter-lived peers, and investigated the link between the profiles and the chance of becoming a centenarian.

Our research included data from 44,000 Swedes who underwent health assessments at ages 64-99—they were a sample of the so-called Amoris cohort. These participants were then followed through Swedish register data for up to 35 years. Of these people, 1,224, or 2.7 percent, lived to be 100 years old. The vast majority (85 percent) of the centenarians were female.

Twelve blood-based biomarkers related to inflammation, metabolism, liver and kidney function, as well as potential malnutrition and anaemia, were included. All of these have been associated with ageing or mortality in previous studies.

The biomarker related to inflammation was uric acid—a waste product in the body caused by the digestion of certain foods. We also looked at markers linked to metabolic status and function including total cholesterol and glucose, and ones related to liver function, such as alanine aminotransferase (Alat), aspartate aminotransferase (Asat), albumin, gamma-glutamyl transferase (GGT), alkaline phosphatase (Alp) and lactate dehydrogenase (LD).

We also looked at creatinine, which is linked to kidney function, and iron and total iron-binding capacity (TIBC), which is linked to anaemia. Finally, we also investigated albumin, a biomarker associated with nutrition.

Findings

We found that, on the whole, those who made it to their hundredth birthday tended to have lower levels of glucose, creatinine and uric acid from their sixties onwards. Although the median values didn’t differ significantly between centenarians and non-centenarians for most biomarkers, centenarians seldom displayed extremely high or low values.

For example, very few of the centenarians had a glucose level above 6.5 earlier in life, or a creatinine level above 125.

For many of the biomarkers, both centenarians and non-centenarians had values outside of the range considered normal in clinical guidelines. This is probably because these guidelines are set based on a younger and healthier population.

When exploring which biomarkers were linked to the likelihood of reaching 100, we found that all but two (alat and albumin) of the 12 biomarkers showed a connection to the likelihood of turning 100. This was even after accounting for age, sex and disease burden.

The people in the lowest out of five groups for levels of total cholesterol and iron had a lower chance of reaching 100 years as compared to those with higher levels. Meanwhile, people with higher levels of glucose, creatinine, uric acid and markers for liver function also decreased the chance of becoming a centenarian.

In absolute terms, the differences were rather small for some of the biomarkers, while for others the differences were somewhat more substantial.

For uric acid, for instance, the absolute difference was 2.5 percentage points. This means that people in the group with the lowest uric acid had a 4 percent chance of turning 100 while in the group with the highest uric acid levels only 1.5 percent made it to age 100.

Even if the differences we discovered were overall rather small, they suggest a potential link between metabolic health, nutrition and exceptional longevity.

The study, however, does not allow any conclusions about which lifestyle factors or genes are responsible for the biomarker values. However, it is reasonable to think that factors such as nutrition and alcohol intake play a role. Keeping track of your kidney and liver values, as well as glucose and uric acid as you get older, is probably not a bad idea.

That said, chance probably plays a role at some point in reaching an exceptional age. But the fact that differences in biomarkers could be observed a long time before death suggests that genes and lifestyle may also play a role.

Karin Modig is an associate professor of epidemiology at the Karolinska Institutet.

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

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This article was originally published on KFF Health News.

Last year, a student fell unconscious after walking out of a bathroom at Central High School in Pueblo, Colorado. When Jessica Foster, the school district’s lead nurse, heard the girl’s distraught friends mention drugs, she knew she had to act fast.

Emergency responders were just four minutes away. “But still four minutes — if they are completely not breathing, it’s four minutes too long,” Foster said.

Foster said she got a dose of naloxone, a medication that can rapidly reverse an opioid overdose, and gave it to the student. The girl revived.

Forty-five miles away in Colorado Springs, Mitchell High School officials didn’t have naloxone on hand when a 15-year-old student overdosed in class in December 2021 after snorting a fentanyl-laced pill in a school bathroom. That student died.

Colorado Springs’ school district has since joined Pueblo and dozens of other districts in the state in supplying middle and high schools with the lifesaving medication, often known by one of its brand names, Narcan. Since passage of a 2019 state law, Colorado has had a program that allows schools to obtain the medicine, typically in nasal spray form, for free or at a reduced cost.

Not all schools are on board with the idea, though. Though more districts have signed on since last year, only about a third of Colorado districts had enrolled in the state’s giveaway program at the start of this school year. And within the dozen counties with the highest drug overdose death rates in the state, many school districts had not signed up in the face of ongoing stigma around the need for the overdose reversal medication.

The federal Substance Abuse and Mental Health Services Administration recommends that schools, including elementary schools, keep naloxone on hand as fatal opioid overdoses rise, particularly from the potent drug fentanyl. And 33 states have laws that expressly allow schools or school employees to carry, store, or administer naloxone, according to Jon Woodruff, managing attorney at the Legislative Analysis and Public Policy Association, which tracks naloxone policies across the country.

Among those, about nine states require at least some K-12 schools to store naloxone on-site, including Illinois, whose requirement goes into effect in January. Some states, such as Maine, also require that public schools offer training to students in how to administer naloxone in nasal spray form.

Rhode Island requires all K-12 schools, both public and private, to stock naloxone. Joseph Wendelken, a spokesperson for the Rhode Island Department of Health, said in the past four years naloxone was administered nine times to people ages 10 to 18 in educational settings.

In early September, the medication also became available over the counter nationally, though the $45 price tag per two-dose package has some addiction specialists worried it will be out of reach for those who need it most.

But the medicine still isn’t as publicly widespread as automated external defibrillators or fire extinguishers. Kate King, president of the National Association of School Nurses, said reluctance to stock it in schools can stem from officials being afraid to provide a medical service or the ongoing cost of resupplying the naloxone and training people to use it. But the main hang-up she’s heard is that schools are afraid they’ll be stigmatized as a “bad school” that has a drug problem or as a school that condones bad choices.

“School districts are very careful regarding their image,” said Yunuen Cisneros, community outreach and inclusion manager at the Public Education & Business Coalition, which serves most of the state’s school districts. “Many of them don't want to accept this program, because to accept it is to accept a drug addiction problem.”

That’s the wrong way to think about it, King said. “We really equate it to our stock albuterol for asthma attacks, our stock epinephrine for anaphylactic reactions,” she said.

Colorado health officials could not say how often naloxone had been used on school grounds in the state. So far this year, at least 15 children ages 10 to 18 have died of fentanyl overdoses but not necessarily in schools. And in 2022, 34 children in that age group died, according to the state Department of Public Health and Environment. That included 13-year-old José Hernández, who died in August 2022 from a fentanyl overdose at home just days after starting eighth grade at Aurora Hills Middle School. His grandmother found his body over the bathroom sink in the early morning.

With the arrival of this new school year, supplies of naloxone are on hand for kids in more Colorado schools. Last year, state lawmakers appropriated $19.7 million in federal aid to the Naloxone Bulk Purchase Fund, which is accessible to school districts, jails, first responders, and community service organizations, among others.

“It’s the most we’ve ever had,” said Andrés Guerrero, manager of the state health department’s overdose prevention program.

According to data provided by Colorado’s health department, 65 school districts were enrolled in the state program to receive naloxone at low or no cost at the start of the school year. Another 16 had reached out to the state for information but hadn’t finalized orders as of mid-August. The remaining 97 school districts either didn’t stock naloxone at their schools or sourced it from elsewhere.

Guerrero said the districts decide whom to train to administer the medicine. “In some cases, it's just the school nurses. In some cases, it's school nurses and the teachers,” he said. “And in some cases, we have the students as well.”

In Durango, the 2021 death of a high schooler galvanized students to push for the right to carry naloxone with them to school with parental permission — and to administer it if need be — without fear of punishment.

It took picketing outside a school board meeting to get permission, said Hays Stritikus, who graduated this spring from Durango High School. He’s now involved in drafting legislation that would expressly allow students across the state to carry and distribute Narcan on school grounds.

“The ultimate goal is a world where Narcan is not necessary,” he said. “But that's just not where we live.”

Some health experts disagree that all schools should stock naloxone. Lauren Cipriano, a health economist at Western University in Canada, has studied the cost-effectiveness of naloxone in secondary schools there. While opioid poisonings have occurred on school grounds, she said, high schools tend to be really low-risk settings.

More effective strategies for combating the opioid epidemic are needle exchange sites, supervised drug consumption sites, and medication-assisted treatment that reduces cravings or mutes highs, Cipriano said. But those approaches can be expensive compared with naloxone distribution.

“When the state makes a big, free program like this, it looks like they're doing something about the opioid epidemic,” she said. “It's cheap and it looks like you're doing something, and that's, like, political gold.”

Denver Public Schools, the largest school district in Colorado, started stocking naloxone in 2022, said Jade Williamson, manager of the district’s healthy schools program.

"We know some of the students are on the forefront of these things before older generations,” Williamson said. “To know where to find it, and to access it when needed through these adults who've trained, whether that's a school nurse or a school administrator, I think it brings them some sense of relief."

The state’s seven largest districts, with more than 25,000 students each, all participate in the state program. By contrast, a KFF Health News analysis found, only 21 percent of districts with up to 1,200 students have signed up for it — even though many of those small districts are in areas with drug overdose death rates higher than the state average.

Some school districts figured out a path to getting naloxone outside of the state program. That includes Pueblo School District 60, where lead nurse Foster gave naloxone to a student last year.

The Pueblo school district gets naloxone at no cost from a local nonprofit called the Southern Colorado Harm Reduction Association. Foster said she tried signing up for the state program but encountered difficulties. So she decided to stick with what was already working.

Moffat County School District RE-1 in Craig, Colorado, gets its naloxone from a local addiction treatment center, according to district nurse Myranda Lyons. She said she trains school staffers on how to administer it when she teaches them CPR.

Christopher deKay, superintendent of Ignacio School District 11Jt, said its school resource officers already carry naloxone but that the district enrolled in the state program, too, so that schools could stock the medication in the nursing office in case a resource officer isn’t around.

“It’s like everything — like training for fire safety. You don’t know what’s going to happen in your school,” said deKay. “If the unthinkable happens, we want to be able to respond in the best way possible.”

This story was produced with reporting assistance from El Comercio de Colorado.

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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Wearable sensors can already monitor a variety of important health characteristics. But they are still far short when it comes to detecting hormonal levels, particularly for women. A new device designed by researchers at Caltech, however, is specifically tailored to measure one of women’s most vital and influential hormones. According to the team’s study, recently published in Nature Nanotechnology, their new wearable sensor can detect and assess users’ estradiol levels by just analyzing sweat droplets.

Estradiol, the most potent form of estrogen, is a crucial component in women’s health. Not only is it necessary in regulating reproductive cycles and ovulation, but this hormone’s levels are directly correlated to issues ranging from depression, to osteoporosis, to even heart disease. Currently, estradiol monitoring requires blood or urine samples collected either in-clinic or at-home. In contrast, Caltech’s new sensor, created by assistant professor of medical engineering Wei Gao, only needs miniscule amounts of sweat collected via extremely small automatic valves within its microfluidic system.

[Related: This organ-failure detector is thinner than a human hair.]

The sensor’s reliance on sweat to measure estradiol isn’t only impressive due to its non-invasive nature; according to Caltech’s announcement, the hormone is about 50 times less concentrated in sweat than in blood.

The wearable’s monitoring system utilizes aptamers—short, single-strand DNA capable of binding to target molecules like artificial antibodies. Gao’s team first attached aptamers to a surface imbued with inkjet-printed gold nanoparticles. The aptamers then could bind with targeted molecules—in this case, estradiol. Once connected, the molecule gets recaptured by other titanium carbide-coated gold nanoparticles known as “MXenes.” The resultant electrical signal can be wirelessly measured and correlated to estradiol levels via a simple-to-use smartphone app.

To actually collect the sweat samples, the sensor uses tiny channels controlled by automatic valves to allow only fixed amounts of fluid into the sensor. To take patients’ sweat composition differences into consideration, the device also consistently calibrates via information collected on salt levels, skin temperature, and sweat pH.

This isn’t Gao’s first sweat sensor, either—previous variants also could detect the stress hormone cortisol, COVID-19, as well as a biomarker that indicates inflammation.

“People often ask[ed] me if I could make the same kind of sweat sensor for female hormones, because we know how much those hormones impact women’s health,” Gao said via Caltech’s announcement. With further optimization, the new estradiol sensor could help users attempting to naturally or in vitro conceive children, as well as aid those necessitating hormone replacement therapies. According to Gao, the team also intends to expand the range of female hormones they can detect, including another ovulation-related variant, progesterone.

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In Overmatched, we take a close look at the science and technology at the heart of the defense industry—the world of soldiers and spies.

IF A BUILDING COLLAPSES or a bomb goes off, there are often more people who need medical treatment than there are people who can help them. That mismatch is what defines a mass casualty incident. The military’s most famous R&D agency, DARPA, wants to figure out how to better handle those situations, so more people come out of them alive.

That’s the goal of what the agency is calling the DARPA Triage Challenge, a three-year program that kicks off November 6 and will bring together medical knowledge, autonomous vehicles, noninvasive sensors, and algorithms to prioritize and plan patient care when there are too many patients and not enough care—a process typically called triage. Teams, yet to be named, will compete to see if their systems can categorize injured people in large, complex situations and determine their need for treatment.

A sorting hat for disasters

Triage is no simple task, even for people who make it part of their profession, says Stacy Shackelford, the trauma medical director for the Defense Health Agency’s Colorado Springs region. Part of the agency’s mandate is to manage military hospitals and clinics. “Even in the trauma community, the idea of triage is somewhat of a mysterious topic,” she says. 

The word triage comes from the French, and it means, essentially, “sorting casualties.” When a host of humans get injured at the same time, first responders can’t give them all equal, simultaneous attention. So they sort them into categories: minimal, minorly injured; delayed, seriously injured but not in an immediately life-threatening way; immediate, severely injured in such a way that prompt treatment would likely be lifesaving; and expectant, dead or soon likely to be. “It really is a way to decide who needs lifesaving interventions and who can wait,” says Shackelford, “so that you can do the greatest good for the greatest number of people.”

The question of whom to treat when and how has always been important, but it’s come to the fore for the Defense Department as the nature of global tensions changes, and as disasters that primarily affect civilians do too. “A lot of the military threat currently revolves around what would happen if we went towards China or we went to war with Russia, and there’s these types of near-peer conflicts,” says Shackelford. The frightening implication is that there would be more injuries and deaths than in other recent conflicts. “Just the sheer number of possible casualties that could occur.” Look, too, at the war in Ukraine. 

The severity, frequency, and unpredictability of some nonmilitary disasters—floods, wildfires, and more—is also shifting as the climate changes. Meanwhile, mass shootings occur far too often; a damaged nuclear power plant could pose a radioactive risk; earthquakes topple buildings; poorly maintained buildings topple themselves. Even the pandemic, says Jeffrey Freeman, director of the National Center for Disaster Medicine and Public Health at the Uniformed Services University, has been a kind of slow-moving or rolling disaster. It’s not typically thought of as a mass casualty incident. But, says Freeman, “The effects are similar in some ways, in that you have large numbers of critically ill patients in need of care, but dissimilar in that those in need are not limited to a geographic area.” In either sort of scenario, he continues, “Triage is critical.”

Freeman’s organization is currently managing an assessment, mandated by Congress, of the National Medical Disaster System, which was set up in the 1980s to manage how the Department of Defense, military treatment facilities, Veterans Affairs medical centers, and civilian hospitals under the Department of Health and Human Services respond to large-scale catastrophes, including combat operations overseas. He sees the DARPA Triage Challenge as highly relevant to dealing with incidents that overwhelm the existing system—a good goal now and always. “Disasters or wars themselves are sort of unpredictable, seemingly infrequent events. They’re almost random in their occurrence,” he says. “The state of disaster or the state of catastrophe is actually consistent. There are always disasters occurring, there are always conflicts occurring.” 

He describes the global state of disaster as “continuous,” which makes the Triage Challenge, he says, “timeless.”

What’s more, the concept of triage, Shackelford says, hasn’t really evolved much in decades, which means the potential fruits of the DARPA Triage Challenge—if it pans out—could make a big difference in what the “greatest good, greatest number” approach can look like. With DARPA, though, research is always a gamble: The agency takes aim at tough scientific and technological goals, and often misses, a model called “high-risk, high-reward” research.

Jean-Paul Chretien, the Triage Challenge program manager at DARPA, does have some specific hopes for what will emerge from this risk—like the ability to identify victims who are more seriously injured than they seem. “It’s hard to tell by looking at them that they have these internal injuries,” he says. The typical biosignatures people check to determine a patient’s status are normal vital signs: pulse, blood pressure, respiration. “What we now know is that those are really lagging indicators of serious injury, because the body’s able to compensate,” Chretien says. But when it can’t anymore? “They really fall off a cliff,” he says. In other words, a patient’s pulse or blood pressure may seem OK, but a major injury may still be present, lurking beneath that seemingly good news. He hopes the Triage Challenge will uncover more timely physiological indicators of such injuries—indicators that can be detected before a patient is on the precipice.

Assessment from afar

The DARPA Triage Challenge could yield that result, as it tasks competitors—some of whom DARPA is paying to participate in the competition, and some of whom will fund themselves—with two separate goals. The first addresses the primary stage of triage (the sorting of people in the field) while the second deals with what to do once they’re in treatment. 

For the first stage, Triage Challenge competitors have to develop sensor systems that can assess victims at a distance, gathering data on physiological signatures of injury. Doing this from afar could keep responders from encountering hazards, like radioactivity or unstable buildings, during that process. The aim is to have the systems move autonomously by the end of the competition.

The signatures such systems seek may include, according to DARPA’s announcement of the project, things like “ability to move, severe hemorrhage, respiratory distress, and alertness.” Competitors could equip robots or drones with computer-vision or motion-tracking systems, instruments that use light to measure changes in blood volume, lasers that analyze breathing or heart activity, or speech recognition capabilities. Or all of the above. Algorithms the teams develop must then extract meaningful conclusions from the data collected—like who needs lifesaving treatment right now. 

The second focus of the DARPA Triage Challenge is the period after the most urgent casualties have received treatment—the secondary stage of triage. For this part, competitors will develop technology to dig deeper into patients’ statuses and watch for changes that are whispering for help. The real innovations for this stage will come from the algorithmic side: software that, for instance, parses the details of an electrocardiogram—perhaps using a noninvasive electrode in contact with the skin—looking at the whole waveform of the heart’s activity and not just the beep-beep of a beat, or software that does a similar stare into a pulse oximeter’s output to monitor the oxygen carried in red blood cells. 

For her part, Shackelford is interested in seeing teams incorporate a sense of time into triage—which sounds obvious but has been difficult in practice, in the chaos of a tragedy. Certain conditions are extremely chronologically limiting. Something fell on you and you can’t breathe? Responders have three minutes to fix that problem. Hemorrhaging? Five to 10 minutes to stop the bleeding, 30 minutes to get a blood transfusion, an hour for surgical intervention. “All of those factors really factor into what is going to help a person at any given time,” she says. And they also reveal what won’t help, and who can’t be helped anymore.

Simulating disasters

DARPA hasn’t announced the teams it plans to fund yet, and self-funded teams also haven’t revealed themselves. But whoever they are, over the coming three years, they will face a trio of competitions—one at the end of each year, each of which will address both the primary and secondary aspects of triage.

The primary triage stage competitions will be pretty active. “We’re going to mock up mass-casualty scenes,” says Chretien. There won’t be people with actual open wounds or third-degree burns, of course, but actors pretending to have been part of a disaster. Mannequins, too, will be strewn about. The teams will bring their sensor-laden drones and robots. “Those systems will have to, on their own, find the casualties,” he says. 

These competitions will feature three scenarios teams will cycle through, like a very stressful obstacle course. “We’ll score them based on how quickly they complete the test,” Chretien says, “how good they are at actually finding the casualties, and then how accurately they assess their medical status.” 

But it won’t be easy: The agency’s description of the scenarios says they might involve both tight spaces and big fields, full light and total darkness, “dust, fog, mist, smoke, talking, flashing light, hot spots, and gunshot and explosion sounds.” Victims may be buried under debris, or overlapping with each other, challenging sensors to detect and individuate them.

DARPA is also building a virtual world that mimics the on-the-ground scenarios, for a virtual version of the challenge. “This will be like a video-game-type environment but [with the] same idea,” he says. Teams that plan to do the concrete version can practice digitally, and Chretien also hopes that teams without all the hardware they need to patrol the physical world will still try their hands digitally. “It should be easier in terms of actually having the resources to participate,” he says. 

The secondary stage’s competitions will be a little less dramatic. “There’s no robotic system, no physical simulation going on there,” says Chretien. Teams will instead get real clinical trauma data, from patients hospitalized in the past, gathered from the Maryland Shock Trauma Center and the University of Pittsburgh. Their task is to use that anonymized patient data to determine each person’s status and whether and what interventions would have been called for when. 

At stake is $7 million in total prize money over three years, and for the first two years, only teams that DARPA didn’t already pay to participate are eligible to collect. 

Also at stake: a lot of lives. “What can we do, technologically, that can make us more efficient, more effective,” says Freeman, “with the limited amount of people that we have?” 

Read more PopSci+ stories.

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The 2023 Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman, two of the scientists whose work helped pave the way for mRNA vaccines against COVID-19. Karikó is a biochemist from Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania. Karikó was also senior vice president and head of RNA protein replacement at BioNTech until 2022 and has been an advisor for the company. Weissman is a vaccine researcher at the University of Pennsylvania’s Perelman School of Medicine and Director of the Penn Institute for RNA Innovations.

[Related: How does an mRNA vaccine work?]

The prize is awarded by the Nobel Assembly of Sweden’s Karolinska Institute medical university and comes with its signature gold medicine and about $1 million (11 million Swedish crowns). 

“Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel wrote in a press release. 

A potential game changer for vaccines

Previously, growing viruses, or at least pieces of viruses, were necessary to make a vaccine. The viruses were often cultivated in giant vats of cells or in or in chicken eggs, like the majority of flu shots. The viruses are then purified before being made into a vaccine.  

Using messenger RNA (mRNA) in vaccines is very different. It starts with a snippet of genetic code that brings instructions for making proteins. If the right virus protein is selected for the vaccine, then the body produces its own defenses against the virus. 

Genetic information encoded in DNA is transferred to mRNA, which is used as a blueprint for protein production in our cells. During the 1980s, efficient methods for producing mRNA without cell culture began. This process, called in vitro transcription, accelerated the development of molecular biology applications to several fields, but using mRNA technologies for vaccines had several roadblocks. In vitro transcribed mRNA was considered unstable and challenging to deliver since it required scientists to develop sophisticated carrier lipid systems to enclose the mRNA and produced some early inflammatory reactions. 

[Related: The FDA just green-lit America’s first COVID vaccine.]

Karikó was devoted to the idea of using mRNA for vaccines and other therapeutics during the 1990s when she became colleagues with Weissman. Weissman was interested in dendritic cells, which are important for immune surveillance and triggering vaccine-induced immune responses. 

The breakthrough

The two began to focus on how different RNA types interact with the immune system and noticed that the dendritic cells recognize in vitro transcribed mRNA as a foreign substance. This leads to their activation and release of inflammatory signaling molecules.mRNA from mammalian cells did not give rise to the same reaction,  the panel wrote. Different types of mRNA, therefore, must be distinguishable.

RNA contains four bases that are abbreviated A, U, G, and C. These letters correspond to the letters of genetic code in DNA A, T, G, and C. Karikó and Weissman knew that bases in RNA from mammalian cells are often chemically modified, and in vitro transcribed mRNA is not. They then wondered if the absence of altered bases in the in vitro transcribed RNA could explain unwanted inflammatory reactions. 

To learn more, they created different variants of mRNA which had unique chemical alterations at their bases. They delivered these to dendritic cells and the results were huge.  

The inflammatory response was almost wiped out when these base modifications were included in the mRNA. This was a seismic shift in scientific understanding of how cells recognize and respond to different forms of mRNA. . Their results were published in 2005.

COVID-19 and The Future

Interest in mRNA technology began to accelerate with their discovery. In 2010 several companies were working on developing the method for viruses such as Zika virus and MERS-CoV.

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

After the COVID-19 pandemic began, two base-modified mRNA vaccines encoding the SARS-CoV-2 surface protein were developed at a breakneck pace. Two highly effective vaccines were approved in December 2020.

One of the major advantages of mRNA technology was that vaccines could be made in extremely large quantities since their main components are made in laboratories, Exeter University infectious disease expert Bharat Pankhania told the Associated Press.  mRNA tech could be used to refine vaccines for diseases including Ebola, malaria, and dengue, as well as help immunize people against auto-immune diseases like lupus and even some types of cancer.

The laureates will receive their awards at ceremonies on December 10. The 2022 medicine prize was awarded to Svante Pääbo for sequencing the genome of the Neanderthal. Other past winners include Karl Landsteiner in 1930 for the discovery of human blood groups and co-winner Alexander Fleming for the discovery of penicillin in 1945.

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Needles are one of the best ways to quickly deliver a drug, but for many, getting jabbed is an unpleasant experience. One in four adults has an intense fear of needles, which could deter people from vaccines or treatments. In some cases—like those with diabetes—skipping out on insulin shots could be life-threatening. While there are other routes of administration, such as through the mouth, drugs containing proteins or large molecules may not be absorbed as well orally. Or they wind up digested in the gastrointestinal tract. Scientists are eager to find less invasive alternatives to needles that still get drugs where they need to go.

Jean-Christophe Leroux, a professor in drug formulation and delivery at ETH Zurich in Switzerland, has one idea: transform an injectable into an oral drug absorbed through the buccal mucosa, the lining of the inner cheek. However, past research attempts at using cheek patches were foiled by the mouth’s wet surface, which weakened adhesion. For inspiration, Leroux and his colleagues turned to a master of underwater suction—the octopus.

In a new study published today in Science Translational Medicine, senior author Leroux and his team replicated the suckers found at the end of an octopus’s arms. Using 3D printing, they created a rubbery but strong suction patch that delivers drugs through the inner cheek. The majority of participants in a small human trial reported that the suction patch was a comfortable fit and they would prefer this method to needle injections. 

“We have developed a very simple and easy to apply delivery system that could potentially replace injectables for several kinds of drugs,” Leroux says.

Octopuses use their grippy suckers to stay anchored in churning oceans or grab squirming prey.  “The starting point was mimicking the good suction these creatures had to strongly stick to wet surfaces,” Leroux adds.

Their sucker-based model has a few advantages over swallowing a pill. Because the delivery system is placed in a cheek for absorption over time, the patch can be removed if needed. The domed cup also protects the drugs inside from dissolving in saliva. 

A small trial in dogs showed drugs delivered by suction patch were effectively absorbed. The team applied patches, loaded with a diabetes tablet called desmopressin, to the mouths of three beagles. This peptide drug—a chain of amino acids—is poorly absorbed when taken orally. But after placing the suction patch, the researchers found higher concentrations of the drug in the dogs’ bodies. “We were really impressed by the level of absorption that we would get with such a simple system,” Leroux says. 

[Related: This pill delivers medication days or weeks after it’s swallowed]

Still, when compared with drug concentrations in the dogs after injections, the patches weren’t quite as effective. One upside, however, was that the dogs appeared to be more comfortable with the patch, which remained on their cheeks for three hours without falling off or causing irritation.

The research makes a significant advance in using the inner cheek as an administration site for peptides, says David Brayden, a professor of advanced drug delivery in the University College Dublin in Ireland who was not affiliated with the study. Previous attempts to apply drugs via cheeks mostly used doses of small molecules that are easily absorbed, but not larger peptides. “No buccal formulation or device has ever been approved for peptide administration, despite a 20-year effort,” he says.

Humans seemed to tolerate the patches, too. Forty adult volunteers wore  suction patches (loaded with water, not drugs) for 30 minutes. They added a strand of dental floss tied to the patch and people’s clothes to prevent  accidental swallowing. During that half-hour, the volunteers walked, talked, and rinsed their mouths. Thirty-five of the 40 patches stayed on; the study authors say the fallen five were probably placed improperly. 

An hour after applying the patch, 75 percent of people said they felt no discomfort. Examining  the inner cheeks with an endoscopic camera, the researchers saw no scarring or changes to the mouths’ tissue. About 92 percent of people found the suction patch generally comfortable. And nearly 83 percent said if they had to take a drug daily, they’d prefer using the patch over a needle.

[Related: This drug-delivery soft robot may help solve medical implants’ scar tissue problem]

“These are innovative studies that seek to identify new feasible methods and sites for [non-oral] drug delivery,” says Daniel Drucker, a professor of medicine at the University of Toronto in Canada who was not involved in the study. The canine trials showed the patch still has a pretty poor absorption of peptide drugs overall, he notes, but because people tolerated it so well, it could be an important foundation for  future approaches to chronic disease therapies. 

Larger safety trials—including wearing the device for longer than a half hour—will help refine how well people tolerate the patch. The researchers also need to show patients can wear it for simulated daily or weekly treatments. Once they have completed a larger safety trial, the next phase will be to test the effectiveness of the drug-loaded patch in people to assess how it compares with the absorption of pills and tablets. 

This drug delivery system could be publicly available in a few years, if all goes well, Leroux says. Or sooner: “We could potentially be even faster because of the simplicity of the technology and because we can use drugs that are already approved.”

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On Tuesday, Elon Musk’s controversial brain-computer interface startup Neuralink announced it received an independent review board’s approval to begin a six-year-long human clinical trial. Neuralink’s application for quadriplegic volunteers, particularly those suffering from spinal column injuries and ALS, is now open. Less than a day later, however, a Wired investigation revealed grisly details surrounding the deaths of the monkeys used in Neuralink’s experiments–deaths that Elon Musk has denied were directly caused by the implants. 

Almost simultaneously a medical ethics organization focused on animal rights filed a complaint with the Securities and Exchange Commission urging SEC to investigate Neuralink for alleged “efforts to mislead investors about the development history and safety of the device.” In Thursday’s email to PopSci, the committee urged potential Neuralink volunteers to reconsider their applications.

[Related: Neuralink is searching for its first human test subjects]

“Patients should have serious concerns about the safety of Neuralink’s device,” wrote Ryan Merkley, director of research advocacy for the committee, which was founded in 1985 and has over 17,000 doctor members. “There are well-documented reports of company employees conducting rushed, sloppy experiments in monkeys and other animals.”

According to Merkley and Wired’s September 20 report, Neuralink experiments on as many as 12 macaque monkeys resulted in chronic infections, paralysis, brain swelling, and other adverse side effects, eventually requiring euthanasia. The FDA previously denied Neuralink’s requests to begin human clinical trials, citing concerns regarding the implant’s electrodes migrating within the brain, as well as perceived complications in removing the device without causing brain damage. FDA approval was granted in May of 2023.

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

Elon Musk first acknowledged some Neuralink test monkeys died during clinical trials on September 10, but denied their deaths were due to the experimental brain-computer interface implants. He did not offer causes of death, but instead claimed all monkeys chosen for testing were “close to death already.”

Wired’s investigation—based on public records, as well as interviews with former Neuralink employees and others—offers darker and often horrific accounts of the complications allegedly suffered by a dozen rhesus macaque test subjects between 2017 and 2020. In addition to neurological, psychological, and physical issues stemming from the test implants, some implants reportedly malfunctioned purely due to the mechanical installation of titanium plates and bone screws. In these instances, the cranial openings allegedly often grew infected and were immensely painful to the animals, and some implants became so loose they could be easily dislodged.

In his email to PopSci, Merkley reiterated the FDA’s past concerns regarding the Neuralink prototypes’ potential electrode migrations and removal procedures, and urged Musk’s company to “shift to developing a noninvasive brain-computer interface, where other researchers have already made progress.”

As Wired also notes, if the SEC takes action, it would be at least the third federal investigation into Neuralink’s animal testing procedures. Reuters detailed “internal staff complaints” regarding “hack job” operations on the test pigs in December 2022; last February, the US Department of Transportation opened its own Neuralink investigation regarding allegations of the company unsafely transporting antibiotic-resistant pathogens via “unsafe packaging and movement of implants removed from the brains of monkeys.”

During a Neuralink presentation last year, Musk claimed the company’s animal testing was never “exploratory,” and only focused on fully informed decisions. Musk repeatedly emphasized test animals’ safety, stressing that Neuralink is “not cavalier about putting devices into animals.” At one point, he contended that a monkey shown in a video operating a computer keyboard via Neuralink implant “actually likes doing the demo, and is not strapped to the chair or anything.”

“We are extremely careful,” he reassured his investors and audience at the time.

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Researchers have coaxed common silkworms to spin a more durable, eco-friendlier spider silk—all it took was a few genetic modifications and hundreds of thousands of silkworm egg microinjections.

Synthetic commercial fabrics like nylon are notoriously harmful to the environment because of the carbon footprint from their production processes, as well as their tendency to shed microplastics during wash cycles. Although natural alternatives such as spider silk are incredibly attractive, farming spiders at an industrial scale is difficult given their comparatively low production rates, as well as their tendency to eat one another.

But what if another creature could produce ostensibly the same material in bulk, without all the cannibalism? Junpeng Mi’s team at Donghua University in Chinadid are moving towards that outcome using a combination of CRISPR gene editing and guided egg alterations, creating silkworms that spin silk identical to arachnids. As detailed in their paper recently published in Matter, the team’s breakthroughs have produced fibers which scientists claim are already six times tougher than bulletproof Kevlar.

[Related: A new kind of Kevlar aims to stop bullets with less material.]

In recent years, researchers have improved upon traditional silk’s durability, as well as created artificial spider silk. Even so, the latter’s manufacturing procedures weren’t great at applying a vital surface layer of lipids and glycoproteins to help the silk hold up to sunlight and humidity.

Mi’s team is the first to create silkworms whose excretions are ostensibly identical to spiders’ web material.

“Spider silk stands as a strategic resource in urgent need of exploration,” Mi said in a September 20 statement. “The exceptionally high mechanical performance of the fibers produced in this study holds significant promise in this field. This type of fiber can be utilized as surgical sutures, addressing a global demand exceeding 300 million procedures annually.”

[Related: Silkworm-inspired weaving techniques can produce better nanofibers.]

To create their silkworm-spider fibers, Mi and their fellow researchers first implanted spider silk protein genes from Araneus ventricosus, an East Asian orb-weaving spider, into silkworm DNA. From there, the team further modified the genetic makeup to ensure the transplanted proteins cooperated with silkworm glands to produce properly spun fibers.

The results went above and beyond the team’s hopes, offering a mix of high tensile strength and toughness alongside far more flexibility than anticipated. According to Mi’s team, the new silk manufacturing methods could boost advancements in biomedical engineering, aerospace technology, military capabilities, and other smart materials.

“This concept of ‘localization,’ introduced in this thesis, along with the proposed minimal structural model, represents a significant departure from previous research,” Mi said in their statement. “We are confident that large-scale commercialization is on the horizon.”

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Neuralink, Elon Musk’s brain-computer interface startup, is seeking human volunteers to participate in its first clinical trial. In a September 19 announcement, the company says its Precise Robotically Implanted Brain-Computer Interface (PRIME) Study will test a “groundbreaking investigational medical device” in test subjects already suffering from quadriplegia due to amyotrophic lateral sclerosis (ALS) or cervical spinal cord injuries.

Once implanted via surgical robot using ultra-fine, flexible wiring, the preliminary BCI device reportedly will wirelessly transmit data to an external computer to decode patients’ movement intentions. Neuralink’s ultimate goal for the (PRIME) Study is to grant its volunteers the ability to wirelessly control a computer mouse or keyboard with their brains.

The company faced numerous setbacks leading up to the study’s final approval by an independent institutional review board and its first hospital site. Despite promises from Musk as far back as 2019 regarding the technology’s imminent arrival, Neuralink reportedly only first sought the FDA’s approval for human clinical testing approval in 2022. The regulatory body denied Neuralink’s request at the time, citing concerns over potential brain injuries resulting from BCI devices’ faulty wiring and overheating, as well as complications regarding its removability. In May, the FDA finally granted Neuralink an investigatory device exemption (IDE).

[Related: Neuralink’s request for human trials of brain implants was reportedly rejected by the FDA.]

But even before its applications to begin human clinical trials, Neuralink repeatedly drew ire from critics and watchdogs concerning its treatment of test animals. In a December 2022 Reuters exposé, “internal staff complaints” concerning animal welfare issues described “hack job” procedures resulting in over 1,500 dead test subjects since 2018. The report also revealed the employees’ accounts prompted the US Department of Agriculture’s Inspector General to launch a probe into the matter. Since then, the USDA’s investigation received its own share of criticism over bias and conflicts of interest.

Neuralink has so far demonstrated successful BCI integration with rats, as well as shared footage of a macaque monkey playing Pong via a wired prototype brain implant. Meanwhile, similar BCI devices have been in various development stages for years—some of which already achieve and surpass the goals for Neuralink’s PRIME Study. Earlier this year, researchers at Stanford University demonstrated devices that successfully translated an ALS patient’s thoughts to words to aid in communication. Meanwhile, another company backed by Jeff Bezos and Bill Gates announced in February 2023 that its researchers successfully implanted a “neuroprosthesis” device in four human subjects.

During a public Neuralink presentation in December 2022, Musk expressed hopes that human trials would begin within six months’ time.

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This article is republished from The Conversation.

Edmund K. LeGrand is an adjunct professor of biomedical and diagnostic sciences at the University of Tennessee and Joe Alcock is a professor of emergency medicine at the University of New Mexico.

When you’re sick with a fever, your doctor will likely tell you it’s a sign that your immune system is defending you against an infection. Fever typically results from immune cells at infected sites sending chemical signals to the brain to raise the set point of your body’s thermostat. So, you feel chills when the fever starts and feel hot when the fever breaks.

However, if you were to ask your doctor exactly how fever protects you, don’t expect a completely satisfactory answer.

Despite scientific consensus that fever is beneficial in fighting infections, exactly how is contentious. We are a veterinary pathologist and an emergency physician interested in applying evolutionary principles to medical problems. The evolution of fever is a classic conundrum because fever’s effects seem so harmful. Besides making you feel uncomfortable, you may also worry you’ll dangerously overheat. It is also metabolically costly to generate that much heat.

In our research and review, we propose that since fever occurs throughout much of the animal kingdom, this costly response must have benefits or it never would have evolved or been retained across species over time. We highlight several important but rarely considered points that help explain how the heat of fever helps your body fight infections.

How fever fights infection

Infections are caused by pathogens. Pathogens can be microbes such as certain species of bacteria, fungi or protozoans. If microbes or viruses have infected your cells and are using them to replicate, your own cells can also be considered pathogens and are treated that way by your immune system.

The main explanation for how fever helps control infections is that higher temperatures put heat-induced stress on pathogens, killing them or at least inhibiting their growth. But why would the somewhat higher body temperatures of fever—an increase of about 1.8 to 5.4 degrees Fahrenheit (1 to 4 degrees Celsius)—which can’t even kill your own healthy cells, harm such a wide variety of pathogens?

Immunologists have noted that slight heat makes immune cells work better. The implication is that fever is needed to enhance their defensive function. However, from an evolutionary perspective, it seems strange to require the massive energy cost of generating a fever just to get more activity from immune cells, especially since there are already plentiful and faster molecular signals available to activate them.

In addition to heat, slightly low oxygen levels and slight acidity also boost immune cell function. Since these stressful conditions also occur at infected sites, it makes sense that immune cells evolved to have their maximum functionality match their stressful working conditions. In fact, since anything in a state of growth is inherently vulnerable to stress—and pathogens are typically growing—researchers, including one of us, have proposed that a function of immune cells is to actively make local conditions stressful to preferentially harm the growing pathogens.

Heating up pathogens locally

Inflammation is a local defensive response to infection. It typically involves heat, pain, redness and swelling in the areas where the immune system is most active. While some scientists are aware that infected sites generate heat, many believe that the feeling of warmth from inflammation is only from dilated blood vessels bringing in warmer blood from core body tissues.

However, researchers have found that inflamed tissues, even in core body tissues, are up to 1.8 to 3.6 degrees F (1 to 2 degrees C) warmer than adjacent normal tissues, so warmth is not just a byproduct of more blood flow. Much of that extra heat is coming from the immune cells themselves. When they generate reactive oxygen species to kill pathogens in a process known as the respiratory burst, substantial heat is also produced. To date, however, the temperatures involved have not been measured.

While cells can tolerate a wide range of temperatures, all cells experience a sharp decline in their ability to grow and survive at higher temperatures. For mammalian cells, and presumably the pathogens that infect them, even a single degree or two above temperatures around 113 degrees F (45 degrees C) is almost always deadly. So the heat of fever adds to already warmer local temperatures.

There is evidence that pathogens are exposed to temperatures that are much higher than the body temperature routinely measured with a thermometer in the emergency department. A 2018 study finding that local temperatures can be as high as 122 degrees F (50 degrees C) in mitochondria—the powerhouse of the cell—came as a surprise to researchers. The heat mitochondria generate is put to good use in warming the body and for fever. Likewise, we suggest that the local heat the respiratory burst produces at the surface of immune cells helps kill pathogens.

Heat and other stressors

Immune cells target pathogens with a variety of stressors meant to kill or inhibit them. These include reactive oxygen species, toxic peptides, digestive enzymes, high acidity and nutrient deprivation. Most chemical reactions are sped up by increased temperatures, so it isn’t surprising that heat enhances these defenses.

Researchers have shown heat to be synergistic with low oxygen and acidity in killing pathogens. Notably, neither febrile temperatures nor iron restriction on their own were able to inhibit the growth of the infectious bacteria Pasteurella multocida, but they could when combined. The stress of heat doesn’t act alone when controlling infections.

The standard view that the heat of fever kills pathogens and enhances immune responses is correct but incomplete. Fever’s ability to control infections comes from the few extra, but critical, degrees it adds to enhance existing locally generated heat to harm vulnerable growing pathogens. And fever also always acts with other defenses, never alone.

At more than 600 million years old, fever is an ancient feature of life on this planet that deserves respect. In fact, you owe it to infection-fighting heat that you are still here—alive—to read this. Something to think about the next time you’re sick.

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

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This article was originally published on KFF Health News.

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17 percent of the U.S. population got it—compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who should get the covid booster?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower—though not zero—for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When should you get it?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who will pay for it?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines. For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will this new booster work against the current variants of covid?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why are some doctors not gung-ho about the booster?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism. Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection—in most people. Many doctors think the focus should be on vaccinating those truly at risk.

With new covid boosters, plus flu and RSV vaccines, how many shots should I expect to get this fall?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine—for older adults—against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said. Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year.

Has this booster version been used elsewhere in the world?

Nope, although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

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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Turmeric seems to be everywhere these days—on spice shelves, sprinkled on lattes, in beauty products. While the beloved golden spice has long been touted for health benefits, albeit not always backed up by extensive research, a new study in BMJ Evidence-Based Medicine found that turmeric shows signs of being just as or more effective for indigestion than some conventional over-the-counter drug options.

The study, led by Krit Pongpruil, an associate professor of preventative and social medicine at Thailand’s Chulalongkorn University, randomly assigned 206 patients between the ages of 18 and 70 with recurrent upset stomachs into three treatment groups. One group got two large capsules of curcumin, a naturally active component to turmeric and a dummy capsule, another got a small omeprazole capsule and two summy capsules four times a day, and the last group got omeprazole and turmeric capsules. 

Omeprazole is a common treatment for stomach problems such as acid reflux and ulcers. It works as a proton pump inhibitor, which reduces the amount of acid made by stomach glands, but can also cause health concerns after long term use, like micronutrient deficiencies and fracture risks, according to the study authors. 

[Related: For decades, turmeric’s ultra-golden glow had a deadly secret.]

Assessments were taken after days 28 and 56, and the researchers found that the results between the three groups were similar, which points to the efficacy of turmeric, according to the authors. “The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects,” they wrote in their findings. 

Of course, this study should be taken with a grain of salt, especially since the group of patients was so small. “I don’t think this one study alone is enough for me to say, ‘I recommend this,’” Yuying Luo, a gastroenterologist and assistant professor of gastroenterology at the Icahn School of Medicine at Mount Sinai, told CNN. “Proceed with caution.” It’s crucial to also check with your doctor to make sure that turmeric doesn’t interact poorly with any other medicines before taking it—some case studies have linked curcumin and liver injury, Luo told CNN.

Further studies are needed to see if a taste of turmeric could replace or supplement medicines to help with gastrointestinal issues and more (and if you need to take it in pill form for the effects to kick in). Until then, enjoy your favorite heartily-spiced, turmeric-filled foods, but don’t expect them to make your stomach problems vanish.

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Human bodies can reject organ transplants at any time—sometimes even years after the procedure itself. When this occurs, time is of the essence to potentially save not only the organ’s viability, but the life of a patient. Unfortunately, noticeable symptoms of organ rejection can show up late, but a tiny new medical device is showing immense promise in offering dramatically earlier detection times.

As detailed in a new study published September 8 in the journal Science researchers at Northwestern University have developed an ultra-thin, soft implant that adheres directly to a transplanted organ’s surface to monitor its health. In small animal clinical trials involving kidney transplants, rejection warning signs were identified as much as three weeks earlier than current methods.

[Related: The first successful pig heart transplant into a human was a century in the making.]

“I have noticed many of my patients feel constant anxiety—not knowing if their body is rejecting their transplanted organ or not. They may have waited years for a transplant… [t]hen, they spend the rest of their lives worrying about the health of that organ,” Lorenzo Gallon, a transplant nephrologist at Northwestern Medical who led the study’s clinical portion, said in a statement. “Our new device could offer some protection, and continuous monitoring could provide reassurance and peace of mind.”

According to John A. Rogers, a bioelectronics expert who led device development for the project, identifying rejection earlier can allow physicians to administer various therapies to prevent a patient from losing the organ, or even their lives.

“In worst-case scenarios, if rejection is ignored, it could be life threatening,” Rogers said via Friday’s statement. “The earlier you can catch rejection and engage therapies, the better. We developed this device with that in mind.”

At 0.3 cm wide, 0.7 cm long, and just 220 microns thick, the new sensor is thinner than a single human hair and smaller than your pinky fingernail. The device’s tininess is key to its ability to adhere, slipping beneath a kidney’s fibrous renal capsule layer to rest directly against the organ. Once positioned, the device’s extremely sensitive thermometer measures kidney temperature fluctuations as miniscule as 0.004 degrees Celsius. A miniature coin cell battery currently powers the device alongside Bluetooth capabilities to wireless stream data results to researchers.

Since tissue inflammation is often an early sign of complications, researchers were alerted much faster to potential problems than currently available detection methods like creatine and blood urea monitoring. Due to normal body fluctuations, those existing options are also far less reliable and sensitive than the new device.

“Bodies move, so there is a lot of motion to deal with. Even the kidney itself moves,” Rogers continued, explaining that the organ’s soft tissue isn’t ideal for suturing. “These were daunting engineering challenges, but this device is a gentle, seamless interface that avoids risking damage to the organ.”

Moving forward, the team intends to begin larger animal trials, along with potentially expanding to test on organs such as livers and lungs. They also hope to integrate new power sources capable of externally recharging the device’s battery, thus offering a more permanent monitoring solution.

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With the changing weather comes virus season. Throughout the pandemic, infectious disease experts have seen an uptick in COVID cases during the fall and winter as more people stay indoors. The latter half of the year is also the time when SARS-CoV-2 mutates into other variants. And this year is no exception. Researchers are keeping an eye on the new variant BA.2.86, or Pirola, as it spreads in multiple countries. Meanwhile, back in August, the Centers for Disease Control and Prevention (CDC) announced a new Omicron variant called Eris had become the dominant coronavirus strain in the US.

“The Eris variant appears to be more transmissible compared to prior variants, which may mean that it will be easier for more people to get infected from a given exposure. Also, people who have previously been infected or vaccinated may get infected with this new variant,” says Sherrill Brown, a medical director of infection prevention at AltaMed in California. 

Though Eris has been responsible for an increasing number of COVID hospitalizations in the US, infectious disease experts have not seen signs yet that it causes more severe illness. In fact, Brown says the Eris variant appears no more dangerous than the ones we’ve faced in the past.

With long COVID complications and immunocompromised individuals in mind as well, it doesn’t hurt to stay prepared if cases surge through the end of 2023. Like the flu and other respiratory viruses, some health experts are now calling COVID endemic—the average person will probably get it several times in their life. But the good news is the US is in a much better position now than three years ago with a range of preventative methods, from medical-grade masks and antiviral treatments to updated vaccine formulas. In mid-September, the Food and Drug Administration approved new booster shots, which are tweaked to defend against XBB.1.5, an Omicron variant.

Following an advisory committee vote in favor of this Omicron-targeting vaccine, the CDC is encouraging everyone who is eligible to get a shot for the upcoming fall and winter season. “We have more tools than ever to prevent the worst outcomes from COVID-19,” said CDC director Mandy Cohen in a news release. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

Is it time to mask up again?

The US government has lifted all masking mandates, so there is no requirement to wear one in public anymore. That said, private businesses and hospitals may demand face coverings on their property if there is another COVID wave.

For the most part, the decision to mask is personal. Sarah Hochman, the section chief of infectious diseases at NYU Langone Tisch Hospital, says people need to evaluate how far they’re willing to risk getting sick. A person who is immunocompromised or has other lung conditions like asthma, for example, may want to start masking up again because the risk of COVID complications in this group is higher. If you’re planning to see friends and family this season, a properly placed mask would tremendously reduce the risk of infection. “It has been a personal choice for the past year and a half and everyone has their own threshold on where they are concerned enough to mask in situations,” Hochman notes. Masking is also helpful in general for protecting against other respiratory viruses such as the flu and RSV.

[Related: Masks can work—even if you’re the only one wearing them]

A good way to evaluate your individual risk is to check the latest numbers of COVID hospitalization in your local area. Hochman says hospital data is a more reliable source of information given that the CDC and local health departments have not been reporting recently as much on case numbers; people can find these stats on their local state or county health department’s website. Additionally, regional or national data could be inaccurate because more people are doing home tests or not testing at all. In most places, however, hospitalized patients are still being tested for the virus. “It’s really more of a tip of the iceberg type of measure because you’re only measuring COVID in the sickest patients, but it can still indicate what’s going on,” Hochman explains.

When will new COVID boosters be available?

The Biden administration is looking at a mid-September rollout date for the new boosters. The bivalent COVID shot currently protects against the original coronavirus and two Omicron variants, BA.4 and BA.5. With the new update, the vaccine will include protection against the Omicron variant XBB.1.5. 

Eris is a close but not exact match to XBB.1.5 as it is a descendent of XBB.1.9.2. Still, infectious disease experts have a strong suspicion the new shots will provide some protection against this new variant. “Most of the circulating variants are still related to the XBB.1.5 strain, so there should be fairly good protection from severe disease with this updated vaccine,” says Brown.

Once the booster becomes publicly available, you can get it in the same places you received your prior vaccines, including doctor’s offices, pharmacies, and local health clinics. Some states and counties may have websites set up to help people find a vaccine administration center close to them. Remember that all COVID vaccines should still be free, regardless of insurance or immigration status. 

What happens if you get COVID again?

Masks and boosters cut your risk for re-infection, but they won’t completely prevent it. To prepare, make sure to keep some at-home rapid test kits on hand. Hochman recommends having one to two tests for every person in the household. 

[Related: How to check if your at-home COVID test has expired]

If you test positive, notify your doctor immediately. They can prescribe you the antiviral pill Paxlovid, which is most effective within five days of developing symptoms. You’ll also want to take time off work and other obligations to rest and drink enough fluids for a proper recovery. 

Isolate from others at home for at least five days to avoid spreading the virus. If you need to go out or see other people, make sure to wear a high-quality mask.

This post has been updated to include more regulatory information about this fall’s COVID boosters. It was originally published on September 5.

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An important email appeared in the inboxes of a small group of health care workers north of Boston as this summer started. It warned that local temperatures were rising into the 80s.

An 80-plus-degree day is not sizzling by Phoenix standards. Even in Boston, it wasn’t high enough to trigger an official heat warning for the wider public.

But research has shown that those temperatures, coming so early in June, would likely drive up the number of heat-related hospital visits and deaths across the Boston region.

The targeted email alert the doctors and nurses at Cambridge Health Alliance in Somerville, Massachusetts, got that day is part of a pilot project run by the nonprofit Climate Central and Harvard University’s Center for Climate, Health, and the Global Environment, known as C-CHANGE.

Medical clinicians based at 12 community-based clinics in seven states — California, Massachusetts, North Carolina, Oregon, Pennsylvania, Texas, and Wisconsin — are receiving these alerts.

At each location, the first email alert of the season was triggered when local temperatures reached the 90th percentile for that community. In a suburb of Portland, Oregon, that happened on May 14 during a springtime heat wave. In Houston, that occurred in early June.

A second email alert went out when forecasts indicated the thermometer would reach the 95th percentile. For Cambridge Health Alliance primary care physician Rebecca Rogers, that second alert arrived on July 6, when the high hit 87 degrees.

The emails remind Rogers and other clinicians to focus on patients who are particularly vulnerable to heat. That includes outdoor workers, older adults, or patients with heart disease, diabetes, or kidney disease.

Other at-risk groups include youth athletes and people who can’t afford air conditioning, or who don’t have stable housing. Heat has been linked to complications during a pregnancy as well.

“Heat can be dangerous to all of us,” said Caleb Dresser, director of health care solutions at C-CHANGE. “But the impacts are incredibly uneven based on who you are, where you live, and what type of resources you have.”

The pilot program aims to remind clinicians to start talking to patients about how to protect themselves on dangerously hot days, which are happening more frequently because of climate change. Heat is already the leading cause of death in the U.S. from weather-related hazards, Dresser said. Letting clinicians know when temperatures pose a particular threat to their patients could save lives.

“What we’re trying to say is, ‘You really need to go into heat mode now,’” said Andrew Pershing, vice president for science at Climate Central, with a recognition that “it’s going to be more dangerous for folks in your community who are more stressed.”

“This is not your grandmother’s heat,” said Ashley Ward, who directs the Heat Policy Innovation Hub at Duke University. “The heat regime that we are seeing now is not what we experienced 10 or 20 years ago. So we have to accept that our environment has changed. This might very well be the coolest summer for the rest of our lives.”

The alerts bumped heat to the forefront of Rogers’ conversations with patients. She made time to ask each person whether they can cool off at home and at work.

That’s how she learned that one of her patients, Luciano Gomes, works in construction.

“If you were getting too hot at work and maybe starting to feel sick, do you know some things to look out for?” Rogers asked Gomes.

“No,” said Gomes slowly, shaking his head.

Rogers told Gomes about early signs of heat exhaustion: dizziness, weakness, or profuse sweating. She handed Gomes tip sheets she’d printed out after receiving them  along with the email alerts.

They included information about how to avoid heat exhaustion and dehydration, as well as specific guidance for patients with asthma, chronic obstructive pulmonary disease (COPD), dementia, diabetes, multiple sclerosis, and mental health concerns.

Rogers pointed out a color chart that ranges from pale yellow to dark gold. It’s a sort of hydration barometer, based on the color of one’s urine.

“So if your pee is dark like this during the day when you’re at work,” she told Gomes, “it probably means you need to drink more water.”

Gomes nodded. “This is more than you were expecting to talk about when you came to the doctor today, I think,” she said with a laugh.

During this visit, an interpreter translated the visit and information into Portuguese for Gomes, who is from Brazil and quite familiar with heat. But he now had questions for Rogers about the best ways to stay hydrated.

“Because here I’ve been addicted to soda,” Gomes told Rogers through the interpreter. “I’m trying to watch out for that and change to sparkling water. But I don’t have much knowledge on how much I can take of it.”

“As long as it doesn’t have sugar, it’s totally good,” Rogers said.

Now Rogers creates heat mitigation plans with each of her high-risk patients. But she still has medical questions that the research doesn’t yet address. For example: If patients take medications that make them urinate more often, could that lead to dehydration when it’s hot? Should she reduce their doses during the warmest weeks or months? And, if so, by how much? Research has yielded no firm answers to those questions.

Deidre Alessio, a nurse practitioner at Cambridge Health Alliance, also has received the email alerts. She has patients who sleep on the streets or in tents and search for places to cool off during the day.

“Getting these alerts makes me realize that I need to do more homework on the cities and towns where my patients live,” she said, “and help them find transportation to a cooling center.”

Most clinics and hospitals don’t have heat alerts built into electronic medical records, don’t filter patients based on heat vulnerability, and don’t have systems in place to send heat warnings to some or all of their patients.

“I would love to see health care institutions get the resources to staff the appropriate outreach,” said Gaurab Basu, a Cambridge Health Alliance physician who co-directs the Center for Health Equity Advocacy and Education at Cambridge Health Alliance. “But hospital systems are still really strained by covid and staffing issues.”

This pilot program is an excellent start and could benefit by including pharmacists, said Kristie Ebi, founding director of the Center for Health and the Global Environment at the University of Washington.

Ebi has studied heat early-warning systems for 25 years. She says one problem is that too many people don’t take heat warnings seriously. In a survey of Americans who experienced heat waves in four cities, only about half of residents took precautions to avoid harm to their health.

“We need more behavioral health research,” she said, “to really understand how to motivate people who don’t perceive themselves to be at risk, to take action.”

For Ebi and other researchers, the call to action is not just to protect individual health, but to address the root cause of rising temperatures: climate change.

“We’ll be dealing with increased exposure to heat for the rest of our lives,” said Dresser. “To address the factors that put people at risk during heat waves, we have to move away from fossil fuels so that climate change doesn’t get as bad as it could.”

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

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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Scar tissue, also known as fibrosis, is the scourge of medical device implants. Even when receiving potentially life saving drug treatments, patients’ bodies often form scarring around the foreign object, thus eventually forcing the implant to malfunction or fail. This reaction can drastically limit a procedure’s efficacy, but a new breakthrough combining soft robotics and artificial intelligence could soon clear the troublesome hurdle.

According to a new study published with Science Robotics, a collaboration between researchers at MIT and the University of Galway resulted in new medical device tech that relies on AI and a malleable body to evade scar tissue buildup. 

“Imagine a therapeutic implant that can also sense its environment and respond as needed using AI,” Rachel Beatty, co-lead author and postdoctoral candidate at the University of Galway, said in a statement. “This approach could generate revolutionary changes in implantable drug delivery for a range of chronic diseases.”

The technology’s secret weapon is its conductive, porous membrane capable of detecting when it is becoming blocked by scar tissue. When this begins to occur, a machine learning algorithm kicks in to oversee an emerging treatment known as mechanotherapy, in which soft robotic implants inflate and deflate at various speeds and sizes to deter scar tissue formation.

[Related: A micro-thin smart bandage can quickly heal and monitor wounds.]

Ellen Roche, an MIT professor of mechanical engineering and study co-author, explains that personalized, precision drug delivery systems could greatly benefit from responding to individuals’ immune system responses. Additionally, such devices could reduce “off-target effects” while ensuring the right drug dosages are delivered at the right times.

“The work presented here is a step towards that goal,” she added in a statement.

In training simulations, the team’s device could develop personalized, consistent dosage regimes in situations involving significant fibrosis. According to researchers, the new device’s AI could effectively control drug release even in a “worst-case scenario of very thick and dense scar tissue,” per the August 31 announcement.

According to Garry Duffy, the study’s senior author and a professor of anatomy and regenerative medicine at the University of Galway, the team initially focused on using the new robot for diabetes treatment. “Insulin delivery cannulas fail due to the foreign body response and have to be replaced often (approx. every 3-5 days),” told PopSci via email. “If we can increase the longevity of the cannula, we can then maintain the cannula for longer with less changes of the set required by the person living with diabetes.”

Beyond diabetes, they envision a future where the device can be easily adapted to a variety of medical situations and drug delivery regimens. According to Duffy, the advances could soon “provide consistent and responsive dosing over long periods, without clinician involvement, enhancing efficacy and reducing the need for device replacement because of fibrosis,” he said in the August 31 statement.

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Elizabeth Amirault had never heard of a Narx Score. But she said she learned last year the tool had been used to track her medication use.

During an August 2022 visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain, she said. She received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like Narx Scores are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. Narx Scores and an algorithm-generated overdose risk rating are produced by health care technology company Bamboo Health (formerly Appriss Health) in its NarxCare platform.

Such systems are designed to fight the nation’s opioid epidemic, which has led to an alarming number of overdose deaths. The platforms draw on data about prescriptions for controlled substances that states collect to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind the formulas used are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work.

Lacking the ability to see inside these systems leaves only clues to their potential impact. Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened. Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. She’d been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

Bamboo Health said that NarxCare can show providers all of a patient’s scores on one screen, but that these tools should never replace decisions made by physicians.

Some patients say the tools have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

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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This article was originally published on Undark.

For as long as he can remember, Ken Pressey has had severe allergies to cats. They would trigger hives, runny nose, and watery eyes. Still, like many of the tens of millions of people in the United States who suffer from allergies, Pressey for years did not bother getting treated, or even diagnosed. When cats came near, he just avoided them. 

But that tactic has gotten tougher. During the pandemic, Pressey started dating a woman he’s now engaged to marry—and she has two cats. Being with the cats “was absolute chaos,” said the 30-year-old, who lives in Seattle. “I started having asthma attacks.”

Pressey’s primary care physician suggested allergy shots. This century-old approach, a form of immunotherapy, works by exposing the body to small, increasing doses of the culprit substance. Unlike over-the-counter pills and nasal sprays, which only relieve symptoms, shots address the root cause: They help the body build long-term tolerance to the allergens. The treatment is not a cure, but experts say it can bring relief in around 85 percent of patients who try it. And it’s not just a matter of curbing some sneezing. Beyond springtime sniffles, allergies make it hard to concentrate, leading to missed work and school. They can also disrupt sleep, trigger asthma, and contribute to mood disorders.

The procedure for alleviating this misery with allergy shots requires time and diligence. Typically, patients need injections once or twice a week for the first three to six months, then monthly jabs for three to five years. Each office visit also requires a half hour of monitoring after the shot in case of serious reactions, such as wheezing or throat swelling, which are rare but need immediate attention if they occur.

With these scheduling demands, allergy shots were a no-go for Pressey, an engineer with the United States Merchant Marines who often works overseas for months at a time. “I would not be able to keep up,” he said. While looking into alternatives, he recalled a conversation about allergy treatments while stationed in Europe several years earlier, when he heard a coworker say, “We do allergy drops. We don’t do shots. Why would you want to get stabbed by a needle?”

His colleague was referring to a form of sublingual immunotherapy, or SLIT, which builds immune tolerance to allergens administered daily under the tongue. The drops are formulated using the same liquid extracts in skin-based allergy tests, and research suggests the approach works—and is safe for patients to do at home. SLIT drops are a mainstay in Europe, Canada, and Latin America. In the United States, although some medical providers offer the drops off-label, prescribing the treatment remains limited for complex reasons related to regulatory purview and clinic revenue.

That means accessing SLIT drops can be tricky, even for highly motivated patients. “I did quite a bit of extensive reading,” Pressey said. The hardest part, he added, was finding a SLIT provider. Although he managed to connect with several doctors who offer the drops, their clinics were far away. Eventually Pressey went to a forum for allergies on Reddit, which led him to try a consult with Curex, one of more than a half dozen virtual health companies that have started selling allergy tests and SLIT directly to consumers.

Some of these companies launched during the pandemic when telehealth was rising and Covid concerns kept some allergy sufferers from going to clinic to get shots. The companies’ services focus on diagnosis and treatment of environmental allergies such as pets, dust, pollens, and grasses.

As more health services move online, patients have greater access to treatments but often sacrifice the continuity of traditional physician-patient relationships. As with other areas of medicine, finding allergy care has become a buyer-beware dilemma: Financial incentives and legal complications prevent SLIT from going mainstream with allergists, and so the challenge of making this treatment available and cost-effective has largely landed in the hands of non-allergist practitioners and business executives.

Allergen immunotherapy traces its roots to a pioneering experiment published in 1911. In that study, a pair of young British researchers rounded up patients and showed that injecting their arms with grass pollen toxins could calm their hay fever—which the researchers measured by dripping pollen extract into the patients’ eyes and noting the extent of burning and itching. With little understanding of the cells and molecules involved, physicians refined this method and, in 1954, confirmed its benefits in a double-blind trial. 

As the shots regimen gained popularity with physicians, the procedure proved quite safe overall, but news of several patient deaths in the early 1980s led some researchers to explore other ways to treat allergies without injections. Their efforts gave rise to sublingual immunotherapy—the liquid drops now offered by direct-to-consumer companies—and, initially, otolaryngologists, or ear, nose, and throat specialists saw potential in what appeared to be a gentler, more convenient allergy treatment.

Otolaryngology is primarily a surgical specialty. But allergies lie at the root of some of the complications that ENT physicians treat, and often present a roadblock. Whenever allergies cropped up as an underlying cause for his patients’ polyps and nasal disease, they “would never go for allergy therapy because, you know, it was always just shots,” said Chris Thompson, an ENT-trained head and neck surgeon in Austin, Texas, who opened his practice in 1997. 

Over the next decade, research continued on sublingual immunotherapy. By 2007, there was “growing consensus that specific sublingual immunotherapy (SLIT) does actually work,” according to one review in the Journal of Allergy and Clinical Immunology. In a 2009 position paper, the World Allergy Organization acknowledged SLIT as a viable treatment. Enterprising doctors began offering this type of immunotherapy.

Still, key details about the technique, such as what doses are needed to achieve benefit, seemed murky. “You could literally go to one doctor and get something that was 10,000 times weaker than what you might get from another doctor,” Thompson said. “There was no standardization.” 

Allergists were intrigued by sublingual therapy, but very few at the time offered it in clinic. According to a 2007 survey by the American College of Allergy, Asthma, and Immunology, just 5.9 percent of practicing allergists said they were using SLIT, and by 2011 that figure had only edged up to 11.4 percent. Most respondents cited the lack of FDA-approved products as a barrier.

Nevertheless, interest in sublingual immunotherapy grew in the ENT realm. Professional societies included symposiums about SLIT at their annual meetings and formed subgroups devoted to this new approach. Some otolaryngology group meetings offer courses for physicians to get started with SLIT, Thompson said.

Thompson watched the field a while, noting SLIT’s research progress amid overall trends in allergen immunotherapy, which largely persist today. Shots, despite being the bread and butter of U.S. allergy clinics, are vastly underused. Just 2 or 3 percent of newly diagnosed patients who are recommended for the treatment, actually choose it. Relative to the hordes of patients buying over-the-counter Zyrtec, Thompson said, the number who receive immunotherapy “doesn’t even register.”

One way to make a dent, Thompson figured, was to “offer a therapy people will want.” Thompson opened a second practice, Aspire Allergy & Sinus, in 2012, with a focus on sublingual drops. By then, SLIT seemed promising, Thompson said. “We thought, gosh, this is such a great opportunity.” 

A decade later, a similar ambition is fueling direct-to-consumer companies.

There are trade-offs between in-clinic and at-home allergy testing and treatment. When it comes to allergy diagnoses, physicians typically take a detailed clinical history and then use testing, if needed, to confirm the patient’s allergies. Skin testing is the preferred diagnostic among allergists. It has a quick, visual readout—red lumps, or wheals, that form on the patient’s skin 15 to 30 minutes after getting pricked with potential allergens during an office procedure—but it can’t be done at home.

A second type of test checks a patient’s blood for immune proteins called immunoglobulin E (IgE) antibodies. IgE antibodies bind to a specific allergen—say, pollen or peanut—and trigger release of the chemical histamine, which makes people sneeze, itch, swell up, and, occasionally, go into anaphylaxis. Patients can get the blood test at a lab or, increasingly, at home; some online companies sell kits where customers use a provided finger-prick device to apply drops of their blood onto a card, which they can mail to a lab for analysis.

But blood tests can be tricky to interpret, said Robert G. Hamilton, an expert in diagnostic allergy and immunology testing at Johns Hopkins University School of Medicine. A positive result signals the presence of IgE antibody, which “means you’ve become sensitized to the substance,” he said, “but it doesn’t mean you will manifest any allergic symptoms.”

There’s another potential snag. If a patient purchases a home kit and receives results before talking with a physician, confirmation bias can creep in, said Edwin Kim, an allergist-immunologist at the University of North Carolina School of Medicine. If a patient tests positive for dust, for example, the doctor could “ask a thousand questions on dust” until they think they can prove that the patient is “dust-allergic,” he said.

Still, at-home tests and procedures can reach a far broader pool of patients, as it can be difficult to get an in-person appointment with an allergist. At Oregon Health and Science University, “we are booked out through the end of the year,” said allergist-immunologist Shyam Joshi. And at UNC School of Medicine, an academic hub that draws referrals from all over the state and even neighboring states, Kim sees firsthand how patients struggle with their treatment schedule. “We may see them as a great candidate for allergy shots, but you can’t realistically ask people to drive two, three, four hours every week, week after week,” he said.

And allergy shots are not risk-free. While the process goes smoothly for many patients, some develop red, swollen arms after their injection. Occasionally, a shot can trigger an asthma flare-up or a whole-body anaphylactic reaction, said Nikhila Schroeder, an allergist in Huntersville, North Carolina, recalling her own observations about a decade ago when administering shots during her allergy and immunology fellowship. Given all these limitations, “I started to just wonder,” Schroeder said, “Are there any other ways we could do this?”

More recently, that same realization hit Gene Kakaulin, a New York City health care entrepreneur. He was commiserating with a friend in 2018 about his allergies to cats, dust, and pollens, and how things had gotten so bad in his teen years that he tried shots. They were “a pain,” said Kakaulin. “I couldn’t stick with them.” 

By contrast, home therapy has lower time demands and less pain and risk—while still desensitizing the immune system by repeated exposures to the allergen. Both approaches produce similar immune changes, though their speed and magnitude, and the types of antibodies involved, can differ. Generally, the immune effects show up faster and stronger with shots, whereas they might take longer with sublingual treatment. It’s hard to compare these changes scientifically—especially since immunotherapy is usually a personalized treatment with dose amounts and escalations tailored to each patient, said Schroeder, whose North Carolina allergy clinic specializes in SLIT.

In studies that have tried to compare the immunotherapy approaches head-to-head, shots seem to do “the same or better” on effectiveness, said Hugh Windom, an allergist in Sarasota, Florida, and on safety, “SLIT always wins.”

Sublingual immunotherapy has been available in the U.S. for decades. SLIT drops, which can treat many different allergens together and are not covered by the Food and Drug Administration, have been offered by at least one allergy clinic since 1970, and by pioneering ENT physicians since the 2010s. In 2014, the FDA approved several tablets that dissolve under the tongue. Three tablets treat grass or ragweed allergies, and a fourth gained approval in 2017 for dust mite allergies.

Still, only about 15 percent of some 2 million allergy immunotherapy patients in the U.S. are using a sublingual version, with the majority on drops, according to market research provided to Undark by Jorge Alderete, who has advised direct-to-consumer allergy companies and other health care startups, and serves on the board of a private equity-backed allergy practice in Houston. An estimated 85 percent of U.S. allergy immunotherapy patients are receiving shots.

One reason is tradition. “We are, of course, wedded to shots because we’ve been doing them for a hundred years,” said Windom.

Another reason relates to versatility. Most allergy patients are allergic to more than one substance, yet allergists tend to prefer FDA-approved products—SLIT tablets—and they only treat a single allergen. Shots, on the other hand, can be tailored to treat many of the patient’s allergens at once. In use for more than a century, allergy shots came to be regulated by the FDA and typically get covered by insurance. SLIT drops can also be customized for multiple allergies, but since the extracts are not FDA-approved for under-the-tongue use and do not have a billing code, patients often must pay out of pocket.

Clinic revenue also plays a role. When an allergist sees a patient and recommends a medication, such as an antihistamine, they charge for a single office visit. Allergy shots bring in more revenue. (Exactly how much revenue can be difficult to estimate, as costs can vary significantly clinic to clinic.) When a patient goes on the shots, three to five years of office treatments at weekly to monthly intervals can amount to dozens of billable visits. Plus, with each visit the clinic charges for mixing the specialized treatment and administering the shot, said Alderete. From a business perspective, he said, immunotherapy is “an annuity.” 

Unlike shots, which are billed as a procedure, SLIT tablets are a prescribed drug. “If you’re going to ask an allergist, hey, do you want to do shots and make money off of it, or prescribe something to Walgreens,” Kim said, it’s understandable that tablets aren’t preferred by allergists in the U.S. Customized SLIT drops are prepared in-house at some clinics, or physicians can send the prescription to a compounding pharmacy.

In the drops form, SLIT does square well with shots on versatility—both can address combinations of allergens with adjustable dosing and escalations—but per-patient profit margins can be higher with shots, said Alderete.

This is in part because of doctors’ costs associated with purchasing and preparing the allergen extracts. Though different forms of immunotherapies use the same source material, SLIT preparations can be “significantly more concentrated than even the top doses of allergy shots,” said allergist and immunologist Sakina Bajowala, who offers both treatments at her allergy practice outside of Chicago. In one analysis of immunotherapy regimens for birch allergy, the total amount of allergen administered over the course of a year was 30 times greater with SLIT compared with shots. And office-made SLIT, Bajowala said, can make doctors’ margins even slimmer: “The more extract used, the more costly the drops.”

ENT practices are more willing to offer a less lucrative therapy because, unlike allergists, their revenue mostly comes from surgeries, so SLIT is “a bit of an ancillary service,” said Thompson.

But on the whole, SLIT drops remain far from mainstream, even as interest in this mode of treatment grows.

After hearing about his friend’s needle-free therapy—SLIT drops—Kakaulin made a round of calls to practices in New York so he could try SLIT himself. His symptoms improved “within a few months,” which helped him sleep and exercise better, he said. To this day, the drops remain a part of Kakaulin’s morning routine—“two minutes under the tongue right after brushing teeth when I shave.” 

Along the way, he co-founded Curex, one of several online allergy companies that got off the ground during the pandemic as telemedicine soared. While just 1 percent of allergy appointments took place virtually before the pandemic, that figure jumped to 54 percent one month into lockdown. Across medicine, telehealth shot up 78-fold between February 2020 and April 2020, according to an analysis, from the consulting firm McKinsey, and after a year remained 38 times higher than pre-pandemic.

Meanwhile, brick-and-mortar clinics took a hit. “A lot of allergy offices closed because of Covid concerns, and then people who were supposed to get shots were left out in the cold,” said Kim.

Direct-to-consumer allergy companies capitalized on this perfect storm, luring customers with glowing testimonials, free quizzes, and heaps of online advertising. Their social media ads showcase sublingual drops as a “convenient alternative to allergy shots” with “no trips to the doctor’s office or prickly needles.”

Some of these companies also offer allergy testing. Curex can send a phlebotomist to administer blood tests to patients with eligible zip codes. Wyndly, a company headquartered in Lakewood, Colorado, ships a $249 test kit to the customer’s home. New York City-based Nectar also sells home tests and lets patients upload results of previous allergy testing. Based on test results and a medical consult, the companies sell formulated sublingual drops on subscription plans, some at $99 per month or less. “We think there are tens of millions of Americans who could benefit,” said Kakaulin, who had helped start a prescription savings company before launching Curex in 2020.

To reach those millions of potential customers, companies that sell allergy drops face similar financial challenges as allergy practices. The average SLIT patient “produces 70 or 80 percent less revenue than an allergy shot patient,” Kakaulin said. So instead of trying to maximize per-patient profit, Curex is trying to “maximize some of our efficiencies and provide everyday low prices,” he said.

Toward this end, nationwide direct-to-consumer companies, as well as large multi-site allergy practices, can negotiate lower pricing on allergen extracts and other supplies because they order huge volumes. Small practices often do not get these discounts and thus have higher backend costs if they choose to offer off-label SLIT.

Amid these financial considerations, there’s also a mindset difference between serving patients and winning customers. With a business model that relies on “one thing,” Bajowala said, it’s in a direct-to-consumer company’s interest to create ads that say, “well, the thing we’re offering is the best, so why would you even want to consider the other thing?”

Some allergists worry that direct-to-consumer companies hasten a broader trend: the decline of the practitioner-patient relationship. When patients begin a new treatment, they “need to know when is it going to start working, how to monitor for side effects, and if there’s a problem, who are you going to go to?” said Anne Maitland, an allergist-immunologist at Icahn School of Medicine at Mount Sinai in New York City and the director of allergy and immunology at the Metrodora Institute in Salt Lake City, Utah. 

At direct-to-consumer companies, details about what’s in the treatment and who’s providing the medical care are also somewhat of a black box. Pressey, the Merchant Marine with the cat allergy, said that if he were to request a consult at Curex, for instance, it would not be with the provider who did his intake. “That person doesn’t work there anymore,” he said. And if he ever wanted to stop his subscription and continue SLIT treatment elsewhere, Curex does not “give you the exact mixture that you’re getting treated for,” Pressey said.

As for staffing, Nectar relies heavily on primary care physicians with training in allergy immunotherapy, but a public relations spokesperson denied a request to interview one of these providers. Regarding the number of doctors in the Curex network, Kakaulin declined to answer. “I’d rather not talk about specifics of the business,” he said. “We’d prefer to have certain information kind of private.”

While the approach lacks transparency, patients often can’t access information in traditional health care settings, either. In a health care system that favors standardized protocols, insurance reimbursements and clinic business priorities may compel physicians to recommend certain treatments, making it hard for patients to learn about the full spectrum of options, said Schroeder, whose clinic offers SLIT using a direct-care model, where patients pay the provider directly rather than using traditional fee-for-service insurance. 

In fact, the allergy clinic might be one of the hardest places to get clear information about treatment options. That’s in part because of a lawsuit from almost a decade ago. In 2014, the American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy, Asthma & Immunology (ACAAI), and several other allergy groups were sued by United Allergy Services, a company that helps primary care physicians and other non-specialists diagnose and treat allergies.

The company alleged that allergists who decried UAS practices were restricting the market and limiting patient access to allergen immunotherapy. As part of a settlement, the allergy groups issued a policy statement requiring members to minimize litigation risk by complying with antitrust laws. As Matt Bell, an allergist in Fayetteville, Arkansas, explained it, the lawsuit is “why we are hesitant to talk.” The settlement terms “basically stated that AAAAI had to keep their mouths shut,” said David Stukus, an allergist at Nationwide Children’s Hospital in Columbus, Ohio, who declined to speak about specific companies or services.

And depending on where and how a patient finds SLIT, their experiences can vary widely. With rising demand for allergy care and limited allergist availability, patients can get allergy treatment from many sources besides their local allergist — including ENT practices, primary care doctors, pediatricians, urgent care, emergency rooms, naturopathic doctors, and direct-to-consumer companies. “If you do SLIT at different places, it won’t necessarily be the same. The people may have different levels of expertise,” said Schroeder, who learned the ins and outs of sublingual therapy at Allergy Associates of La Crosse, a Wisconsin clinic that has offered this treatment for environmental and food allergies since 1970. Nevertheless, she said, there’s a role for all these various avenues as long as patients understand the complexities and “know what they’re pursuing.”

So far, the direct-to-consumer drops seem to be working well for Pressey. Before starting treatment in 2021, he struggled with frequent allergy-induced asthma attacks. “I couldn’t make it 24 hours with a cat in the house,” he said in a recent interview. Now “it’s about two and half weeks before I even remember that I have asthma.” 

Pressey still has questions about the therapy and about Curex—like how long the benefits will last and whether the company will survive. Even when scouring Reddit in spring 2021, he could not find answers to these questions. Nevertheless, “I’m a firm believer in new technology,” he said. “You know what, if no one tries it, then no one will ever get the answers.”

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

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Originally published by The 19th. We’re answering the “how” and “why” of health and abortion news. Sign up for our daily newsletter.

Extreme heat has already made pregnancy more dangerous. Now, it is also complicating efforts to control when and how someone becomes pregnant: Record heat waves across the country could threaten access to effective pregnancy tests, condoms and emergency contraception pills. 

All of these items can sustain serious damage in extreme heat, rendering them ineffective when used. And all have become critical resources for people living in states with abortion bans and who are trying to avoid pregnancy. In those states, few options exist to terminate an unintended pregnancy other than acquiring abortion pills online or traveling out of state for care.

Many states that have banned abortion are experiencing broiling summers, including Texas, Louisiana, parts of Mississippi and Arkansas. Florida—where abortion is banned after 15 weeks of pregnancy and a six-week ban could take effect later this year—has also recorded unusually high temperatures. 

“People aren’t thinking about the effects of extremely hot heat for all kinds of medical care,” said Rachel Rebouché, dean at the Temple University School of Law, who studies reproductive health law. “And, specific to reproductive health care, people aren’t thinking about condoms and contraception and reproductive health as essential health care.”

In some states that restrict or ban abortion, abortion funds—which typically aid people in paying for the procedure—have put more emphasis on distributing supplies to prevent pregnancy and to detect it early, even while noting that even the most effective contraception isn’t foolproof. Almost all of the supplies they ship are heat-sensitive.

The Yellowhammer Fund, which serves people mostly in Alabama and Mississippi, mails emergency contraception to people in those two states as well as in parts of Florida. Jane’s Due Process, a Texas-based organization, has for the past three years given people kits including emergency contraception, pregnancy tests and condoms. The Lilith Fund, an abortion fund in Texas, recently began distributing “post-abortion” kits for people traveling out of state for care, which include pregnancy tests, condoms and thermometers. 

Pregnancy tests generally should be stored at a temperature between 36 and 86 degrees Fahrenheit. Emergency contraception pills should be kept between 68 and 77 degrees, per the Food and Drug Administration, though they can be transported in temperatures ranging between 59 and 86 degrees. For condoms, the World Health Organization recommends an average shipment temperature no warmer than 86 degrees, noting that peak temperatures shouldn’t exceed 122 degrees and that condoms could be damaged if they are stored at above 104 degrees for an extended period of time. 

Extreme heat has already complicated efforts to disseminate contraceptive supplies. Last month, staff from the Lilith Fund reported heat damage to about $3,500 worth of pregnancy tests, thermometers and condoms, the result of a temporary air-conditioning outage at a storage facility in San Antonio. The organization was able to raise money from supporters to replace those items, but will be factoring heat risk in future budgets.

“It’s on our radar, and it’s on the radar of our partners as well,” said Cristina Parker, the fund’s communications director. “This definitely has an impact on our budget, no doubt.”

Other organizations haven’t experienced similar damage. But organizers and health scholars indicated concern that the unusually warm summer—with temperatures across much of the South consistently surpassing 100 degrees Fahrenheit at a higher frequency than usual—will undercut people’s ability to access heat-sensitive reproductive health supplies.

“One thing we’ve always stressed is do not keep kits in your car, especially in Texas heat,” said Graci D’Amore, who coordinates the distribution of reproductive health kits for Jane’s Due Process. “It’s 120 degrees in the car, and Plan B needs to be kept at below 80 degrees for it to maintain efficacy.”

Jane’s Due Process stores its supplies in an air-conditioned office building. But the fear of losing power is more pressing than it was even a few years ago, before a winter snowstorm—also unusual for the state—caused a massive power outage.

“The fear and threat of the [power] grid failing—I think it’s on everyone’s mind,” D’Amore said. 

Many organizations, including the Yellowhammer Fund and the Texas family planning provider Every Body Texas, distribute emergency contraception through the mail. But even if medications are stored in a climate-controlled atmosphere, they risk exposure to heat while waiting in someone’s mailbox, at their doorstep or in a delivery vehicle. In those cases, there is little health or reproductive rights organizations can do other than encourage people to bring mail in as quickly as possible.

“When I bring in packages, even when they have not been outside for very long, the contents have been hot to the touch,” said Elizabeth Sepper, a health law professor at the University of Texas at Austin. “There’s no way to control what happens once it leaves your hand.”

The heat burden, Sepper and others noted, doesn’t fall equally. People who don’t have access to regular air-conditioning in their homes or cars are more likely to be exposed to extreme heat and to potentially risk damage to family planning and reproductive health supplies. Those who seek abortions and who have to travel out of state, which can mean several hours or even days’ worth of driving, could also suffer more. 

“Even people who have cars with functioning air conditioners will find their car engines or air-conditioning can struggle in long travel in this heat,” Sepper said. “If you’re in a car that doesn’t have functioning air-conditioning or that might struggle to make long distances in the heat—we will see for poorer people, the travel out of state will become even more onerous than it already is.”

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An estimated one-in-four Americans have a tattoo, but it’s safe to say pretty much all of them are visible to the naked eye in some shape or form. But thanks to new breakthroughs in nanoengineering, tattooing can now be done at the cellular level—not for artistic expression, per se, but for a myriad of potential medical benefits.

According to research published this month via Nano Letters, engineers at Johns Hopkins University have developed a miniscule tattooing procedure capable of adhering to individual, live cells. Instead of ink, however, experts attached gold arrays to fibroblasts, cells that sustain body tissue. The team, led by professor of chemical and biomolecular engineering David Gracias, then treated the arrays with molecular glues before transferring them directly onto cells via a dissolvable hydrogel laminate. According to JHU on August 7, the final results are akin to scannable QR codes and barcodes.

[Related: Tattoos are permanent, but the science behind them just shifted.]

“We’re talking about putting something like an electronic tattoo on a living object tens of times smaller than the head of a pin,” David Gracias said via the statement. “It’s the first step toward attaching sensors and electronics on live cells.”

What makes the new technique so particularly impressive is that “tattooing” the cells does not adversely affect their health or lifespan. According to researchers, attaching optical and electronic sensors to individual cells has previously caused been tricky, but methods like the tattoos could hopefully allow such technology to be one day deployed in real-world medical settings.

Nanoscale cellular tattooing could open up entirely new avenues of health monitoring for medical experts. As Gracias explains, doctors could hypothetically track the health of isolated cells, thereby potentially identifying, diagnosing, and treating diseases far earlier than is currently possible.

“If you imagine where this is all going in the future, we would like to have sensors to remotely monitor and control the state of individual cells and the environment surrounding those cells in real time,” said Gracias.

The current tattoo tech has a few limitations at the moment—namely, that its lifespan maxes out at around 16 hours. The method is also only compatible at the moment with certain cells such as fibroblasts. Going forward, the team intends to increase the nanoarrays’ durability, longevity, and complexity, while also opening up the technique to a host of other cell varieties.

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On August 4, the United States Food and Drug Administration (FDA) approved zuranolone to treat postpartum depression. The medication is now the first FDA-approved oral pill available in the US to treat postpartum depression. The serious mental illness can develop in roughly 1 in 7 new mothers following childbirth and is one of the leading causes of maternal mortality. 

[Related: The important difference between postpartum psychosis and postpartum depression.]

The first-of-its-kind treatment will be sold under the brand named Zurzuvae and is a once-daily pill taken over 14 days. 

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,”  director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research Tiffany R. Farchione said in a statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Some of the depression symptoms common in new mothers include changes in appetite and sleep. However clinicians say the more severe symptoms that might signal postpartum depression include feelings of sadness, hopelessness, guilt, or worthlessness in addition to trouble bonding with the baby. Severe symptoms can include suicidal thoughts. 

Postpartum depression often ends on its own within a few weeks, but it can continue for months or even years. The standard course of treatment includes talk therapy and/or antidepressants, which do not help everyone and can take weeks to work. 

The FDA’s pill approval is based on two company studies that demonstrated that new moms who took Zurzuvae had fewer signs of depression over a four- to six-week period, compared with those who did not take the medication. The benefits were measured by a psychiatric test and appeared within only three days for many of the patients in the trial.

As part of the approval, the FDA added a warning to Zurzuvae’s labeling indicating that it can impact the ability to drive, and patients may be able to assess how impaired they are by the drug. The FDA says patients should not should not drive or operate heavy machinery for at least 12 hours after taking the medication. Zurzuvae’s most common side effects include dizziness, drowsiness, fatigue, diarrhea, the common cold, and urinary tract infection. The FDA also said that it could cause suicidal thoughts and behavior, may also cause harm to a fetus, and that patients should use effective contraception while taking the drug and for a week after stopping. 

[Related: A link to depression might be in your gut bacteria.]

Zurzuvae is manufactured by Sage Therapeutics, which has a similar infused medication called Zulresso that’s given intravenously over three days in a medical facility. Zulresso was approved by the FDA in 2019, but it is not widely used largely due to the logistics of administering it and the roughly $34,000 cost. 

In February, the FDA accepted an application from Biogen and Sage Therapeutics for the approval of zuranolone and granted a priority review. The drug is part of an emerging class of medications from Sage called neurosteroids. These medications stimulate a different pathway in the brain than older antidepressants which target a chemical linked to emotions and mood called serotonin.

Kimberly Yonkers, a Yale University School of Medicine psychiatrist specializing in postpartum depression, told the Associated Press that Zurzuvae effect is “strong” and the medication will likely be prescribed in those who haven’t responded to treatment with antidepressants. However, she did say the FDA should have required more follow-up data on how patients fared after additional months of treatment.

“The problem is we don’t know what happens after 45 days,” said Yonkers, who was not involved in the study. “It could be that people are well or it could be that they relapse.”

All women should be screened for postpartum depression during the early days of a pregnancy, and a first step should be contacting an obstetrician or midwife for help if not screened. Additional resources for postpartum depression include the national maternal mental health hotline (1-833-852-6262) and Postpartum Support International.

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The Centers for Disease Control and Prevention (CDC) is recommending that all infants under eight months old should get a new antibody shot aimed to protect the body against severe cases of respiratory syncytial virus (RSV). The agency’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on August 3 to recommend the injection to protect babies beginning this fall. 

[Related: FDA approves long-acting medication to protect babies from RSV.]

In July, the Food and Drug Administration approved nirsevimab, which is the first long-acting medication to protect babies and toddlers from RSV. The lung-attacking virus sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States. RSV season typically lasts from November through March.

CDC director Mandy Cohen signed off on the recommendation and it will be added to the CDC’s childhood immunization schedule. ACIP also unanimously recommended that certain infants between the ages of eight to 19 months should receive a second dose of nirsevimab to help them stay healthy during their second RSV season if they have any underlying health issues that put them at a higher risk of hospitalization. 

“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said in a statement. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”

In a second unanimous vote, ACIP also recommended that certain infants ages eight to 19 months get a second dose of nirsevimab to help them through their second RSV season, if they have underlying health issues that put them at higher risk for hospitalization.

Vaccines for older adults were FDA approved in May, but there are currently no vaccines for babies. The FDA is expected to make a decision on an RSV vaccine for pregnant people, with the goal of passing along protection on to newborns, later in August.

Importantly, nirsevimab is not a vaccine for RSV. It is a lab-made antibody for babies that helps their immune systems fight off the virus and is also the first first form of passive immunization added to the routine childhood immunization schedule. Passive immunizations do not require the body to manufacture antibodies against pathogens the way that vaccines do. Instead, they sent protective antibodies to attack the virus.

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

ACIP voted to add the antibody shot to the federally funded Vaccines for Children Program. This program provides free immunizations to children who may have difficulty accessing them. 

Nirsevimab was developed by AstraZeneca and Sanofi and is expected to be ready for the fall RSV season and will be sold under the brand name Beyfortus. Sanofi reportedly said that if this shot is recommended for all infants, it will cost $495 per dose for private payers and $395 through Vaccines for Children. 

The cost of the drug could make it difficult for some doctors to stock up on nirsevimab and complicate billing. However, getting this recommendation from ACIP means that families will not pay an out-of-pocket cost due to the Affordable Care Act. It may take up to 18 months for this coverage to kick-in, as insurers have a year to add implement coverage of new treatments that will then take effect in the new plan year. 

According to CBS News, director of the National Center for Immunization and Respiratory Diseases José Romero closed the meeting by saying, “I would be remiss if I didn’t say that today is a historic event. I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and wellbeing of children in the United States. I think that this will mark one of the major accomplishments of the ACIP.”

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Your body contains the stuff of rocks: the calcium-based minerals in bones and teeth. In a process called biomineralization, you produce these materials that harden and stiffen as they grow. So do the bodies of other bony, toothed animals. It’s in shells, too: Iridescent mother-of-pearl forms via biomineralization.

But, historically, biologists struggled to observe how this process worked. Now, scientists have been able to observe it in vivid 3D. Bones and tEEth Spatio-Temporal growth monitoring (BEE-ST), as its creators have named their technique, involves adding dye to nascent bones or budding teeth, then watching the color spread as their host components grow.

BEE-ST’s creators published their work in the journal Science Advances today. If its authors are correct, then this work could be a boon for people who aren’t just studying how bones and teeth grow, but people who want to control that growth themselves.

“Currently, there are no available tools for precise monitoring and measuring the pace of tooth growth in space and time,” says Jan Křivánek, a developmental biologist at Masaryk University in Brno, Czechia, and one of the paper’s authors. BEE-ST, they hope, may change that.

[Related: This new synthetic tooth enamel is even harder than the real thing]

A few methods can accomplish parts of that goal. Today, scientists and medics can rely on a technique called micro-computed tomography, in which they scan an object with X-rays from multiple angles, then stitch the scans together into a 3D image. While this does give observers a 3D perspective, it also only gives a snapshot—moments in time, rather than a coherent sequence of development.

Another potential option is dye. Bone-watchers have known for decades that dye and substances like it can bind with the calcium in these organs. But this is far from a perfect option to watch how calcium-based structures grow. For one, to see into a bone, you typically have to remove the calcium from your sample, which removes the dye. You can get around this by taking a slice of the tooth or bone, but that only gives you a 2D shadow of the larger 3D picture.

Křivánek and his colleagues wanted to see how mouse teeth grew, but they also wanted a more sophisticated way of seeing calcium. So, they decided to adapt the dye method. Fortunately, in the last several years, researchers had developed techniques to see into a tooth without removing the calcium. They could insert dye into a growing tooth or bone and take 3D images of it over time. Every few days, the researchers added batches of new dye to lab mice. The result, when the scientists later placed the teeth under a microscope, was a sequence of stripes: each one marking a different injection.

[Related: We finally know why we grow wisdom teeth as adults]

In the process, they realized that their technique could be used for more than just mouse teeth. They next showed it could work in a mouse’s bones. Then they expanded from mice to representatives of other provinces in the animal kingdom, administering dye to a menagerie of vertebrates: chameleons (reptiles), junglefowl (birds), frogs (amphibians), and zebrafish (fish).

All of this took Křivánek and colleagues several years, but in the end, they think they have created a reliable process for watching how teeth and bones grow. But that doesn’t mean it only serves this purpose. “We strongly believe it will be further tuned for other applications,” Křivánek says.

One of them is a field called tissue engineering, the science and craft of manipulating the tissues of the human body. A “tissue” can be anything from skin to muscle to internal organs—to stronger materials like the hard, tough matter found in bone and tissue. With tools such as stem cells, scientists can strengthen tissue, improve it, or even try to replicate it from scratch. This technology can help heal cracked bones or regenerate missing teeth.

But, in order to engineer anything, would-be bonesmiths first need to understand how their materials behave as they grow. That, Křivánek thinks, is where something like their method could enter the picture. “We basically opened doors,” he says. “Let’s see how the scientific community will use it.”

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On July 18, 2020, a diving accident injured a man’s C4 and C5 vertebrae, resulting in a total loss of movement and sensation below his chest. After participating in a first-of-its-kind clinical trial, however, Keith Thomas is now regaining sensations and movement in his hands just months after receiving AI-enabled microchip brain implants. What’s more, he is experiencing lasting improvements to his wrist and arm functions outside of the lab setting, even after turning off the devices.

“This is the first time the brain, body and spinal cord have been linked together electronically in a paralyzed human to restore lasting movement and sensation,” Chad Bouton, a professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes, the developer of the tech, and the trial’s principal investigator said in a statement in July. “When the study participant thinks about moving his arm or hand, we ‘supercharge’ his spinal cord and stimulate his brain and muscles to help rebuild connections, provide sensory feedback, and promote recovery.”

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

To pull off the potentially revolutionary rehabilitation, Bouton’s team at Northwell Health in New York first spent months mapping Thomas’ brain via functional MRIs, eventually locating the exact regions responsible for his arms’ movements, as well as his hands’ sensation of touch. From there, neurosurgeons conducted a 15-hour operation—some of which occurred while Thomas was awake—to properly place two chips to restart movement, and three more in the area controlling touch and feeling in his fingers.

The intense procedure also included the installation of external ports atop Thomas’ head, which researchers connected to an AI program used to interpret his brain activity into physical actions—a system known as thought-driven therapy. When the AI receives his mind’s inputs, it then translates them into signals received by non-invasive electrodes positioned over both his spine and forearm muscles to stimulate movement. Additional sensors placed atop his fingertips and palms additionally transmit pressure and touch data to the region of his brain designated for sensation.

After only four months of this therapy, Thomas regained enough sensation in his fingers and palm to hold his sister’s hand, as well as freely move his arms at more than double their strength prior to the trial. The team has even noted some astounding natural recovery, which researchers say could permanently reduce some of his spinal damage’s effects, with or without the microchip system in use.

The new technology’s implications are already extremely promising, says Northwell Health’s team, and show that it is possible to reforge the brain’s neural pathways without the use of pharmaceuticals. According to Thomas, his progress alone has already been life changing.

“There was a time that I didn’t know if I was even going to live, or if I wanted to, frankly. And now, I can feel the touch of someone holding my hand. It’s overwhelming,” Thomas said on July 28. “… If this can help someone even more than it’s helped me somewhere down the line, it’s all worth it.”

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The living relatives of Henrietta Lacks have reached a settlement with the biotechnology company that took her cervical cells without her knowledge over 70 years ago. Lacks’ descendants sued Massachusetts-based Thermo Fisher Scientific in 2021, accusing the leaders of profiting off of a racist medical system.

[Related: Five Reasons Henrietta Lacks is the Most Important Woman in Medical History.]

“The exploitation of Henrietta Lacks represents the unfortunately common struggle experienced by Black people throughout history,” the complaint from the family reads. “Too often, the history of medical experimentation in the United States has been the history of medical racism.”

In 1951, tissue was taken from a tumor on Lacks’ cervix when she sought treatment for cervical cancer at Johns Hopkins. Scientists quickly discovered that these “HeLa cells” had some incredibly special properties. They survived and thrived in laboratories, instead of quickly dying after being taken out of the body. The HeLa cell line has been reproduced numerous times ever since, and has become a cornerstone of modern medicine. Lacks’ cells have become a baseline for medicine and enabled numerous medical and scientific innovations including the development of genetic mapping, cancer treatments, HIV/AIDS treatments, and the polio and COVID-19 vaccines. 

Despite Lacks’ outsized impact, her family had never been compensated. Currently, the terms of the settlement are confidential. Prominent civil rights attorney Ben Crump represented the Lack family and said that both parties are “pleased” the matter was resolved outside of court, according to the Associated Press. The announcement also came on August 1, which would have been Lacks’ 103rd birthday.

“I can think of no better present… than to give her family some measure of respect for Henrietta Lacks, some measure of dignity for Henrietta Lacks, and most of all some measure of justice for Henrietta Lacks,” Crump said at a press conference on Tuesday morning, according to CBS News. The family present at the press conference included Lacks’ only living son and some of her grandchildren.

[Related: Racism is undeniably a public health issue.]

Lacks was a tobacco farmer from southern Virginia and was raising five children when the tumor on her cervix was discovered. She was only 31 when she died and was buried in an unmarked grave.

In a statement, Johns Hopkins Medicine officials said they reviewed all of the university’s interactions with Lacks and her family after the publication of Rebecca Skloot’s bestselling book, The Immortal Life of Henrietta Lacks in 2010. While acknowledging an ethical responsibility, Johns Hopkins said the medical system “has never sold or profited from the discovery or distribution of HeLa cells and does not own the rights to the HeLa cell line.”

On July 25, Senators Chris Van Hollen (D-Maryland) and Ben Cardin (D-Maryland) both introduced a bill to posthumously award Lacks the Congressional Gold Medal. “Henrietta Lacks changed the course of modern medicine,” Van Hollen said in a statement announcing the bill. “It is long past time that we recognize her life-saving contributions to the world.”

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This article is republished from The Conversation.

As a veterinary science researcher, equine surgeon and sports medicine and rehabilitation specialist, I’ve seen firsthand the similarities between horses and humans.

Both horses and people with endocrine disorders like Type 2 diabetes can suffer multiple types of musculoskeletal disorders. For example, horses with pituitary pars intermedia dysfunction—similar to Cushing’s disease in people—suffer from tendon and ligament degeneration. Horses can also experience muscle loss, which can cause joint instability. That, and the chronic low-grade inflammation associated with endocrine disorders, can contribute to osteoarthritis.

There’s a principle in medicine called One Health, which says that animals, humans and the environment are inextricably connected—for one to be healthy, all must be healthy. It also means that we can learn a lot about our own health by studying the health of animals, and vice versa, including the many parallels in endocrine disorders between humans and horses.

Human and horse endocrine systems

Your endocrine system produces hormones that support many of your body’s basic functions, including growth and development, metabolism, sleep and more. Your hormones also play a role in the health of your bones, tendons and ligaments. Some endocrine disorders change how your body produces and releases hormones and can lead to osteoporosis, arthritis, ligament injury and other orthopedic diseases.

Humans aren’t the only species affected by this dynamic—horses are, too. In fact, approximately 20 percent of horses and over 34 percent of people in the U.S. are affected by endocrine disorders such as metabolic syndrome. These disorders are often accompanied by obesity.

For both species, the degree to which endocrine disorders are connected to obesity and its associated negative health effects is complex. As mammals, horses and people share similar anatomy and endocrine physiology, and researchers have noted their parallel genetic links between obesity and metabolic disease.

Like people, obese horses with endocrine disorders often develop low-grade inflammation. Inflammation is a normal response to injuries and sickness. But chronic, low-grade inflammation can have long-term negative effects on the body. For example, low-grade inflammation is associated with metabolic osteoarthritis in people, and my laboratory is studying this possible link in horses.

In people, childhood obesity, which is related to maternal obesity, is associated with a type of joint disease called osteochondrosis. Foals born from obese mares are also predisposed to this same type of joint disease.

Research to note

Because of the similarities between people and horses, research on diagnostics and treatments for metabolic conditions could provide health benefits to both species.

For example, a class of drug called glucagonlike peptide-1 agonists, which includes such brands as Trulicity (dulaglutide) and Ozempic (semaglutide), is commonly used to treat metabolic syndrome and Type II diabetes in people. This class of medication is also effective in treating these conditions in horses, similarly slowing down how quickly food empties the stomach and blunting glucose release into the bloodstream.

Another class of drugs called sodium-glucose cotransporter protein-2 inhibitors, which include such treatments as Jardiance (empagliflozin) and Farxiga (dapagliflozin), are used to treat Type 2 diabetes in people and a similar condition in horses. These drugs alter the kidneys’ ability to absorb sugar from urine such that the body eliminates some of the glucose it would normally absorb. This greatly reduces blood insulin spikes, which can help prevent obesity, metabolic syndrome and cardiovascular disease in both horses and people.

Some dietary supplements, such as resveratrol, especially when used in combination with an amino acid called leucine, also help with weight loss, mobility and insulin sensitivity in people and horses. Lowering blood insulin concentrations can also prevent horses from developing laminitis, a disease that inflames tissues in hooves that can necessitate euthanasia because of incurable pain.

Expanding precision medicine

I find one of the most exciting avenues of research in both animals and people to be the expansion of precision medicine. Instead of the standard one-size-fits-all protocol, precision medicine uses information from a person’s genes, environment and medical history to create a customized treatment plan. For example, precision medicine is often applied in oncology when doctors gather genetic information about the patient’s tumor to inform which treatments might work best for them.

In horses, precision medicine currently focuses on DNA-based diagnostic tests to inform exercise regimens, treatment and breeding decisions. Recent work with horses also suggests that measuring the heritability of certain metabolic traits could be used to screen for metabolic syndrome in the future.

Within precision medicine, doctors aim to get a full-picture view of an individual and their metabolic health by using multiomic analysis. Multiomics entails looking at multiple “omics”–or information from a range of biological disciplines, such as epigenomics, lipidomics, genomics and transcriptomics–to better treat an individual patient.

The more researchers learn from individual patients, including horses, the better doctors will be able to treat every patient. My lab and others use multiomic analysis to generate data that may one day help us identify more effective and safer therapies for horses and–likely–people with metabolic conditions.

Jane Manfredi is an associate professor of pathobiology and diagnostic investigation at Michigan State University. Manfredi receives funding from the Michigan Alliance for Animal Agriculture, USDA NIFA, AAVMC CIVME. Michigan State University provides funding as a founding partner of The Conversation US.

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

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This article was originally published on KFF Health News.

Corlee Morris has dieted throughout her adult life.

After her weight began climbing in high school, she spent years losing 50 or 100 pounds then gaining it back. Morris, 78, was at her heaviest in her mid-40s, standing 5 feet 10½ inches and weighing 310 pounds. The Pittsburgh resident has had diabetes for more than 40 years.

Managing her weight was a losing battle until Morris’ doctor prescribed a Type 2 diabetes medication, Ozempic, four months ago. It’s one in a new category of medications changing how ordinary people as well as medical experts think about obesity, a condition that affects nearly 4 in 10 people 60 and older.

The drugs include Ozempic’s sister medication, Wegovy, a weight loss drug with identical ingredients, which the FDA approved in 2021, and Mounjaro, approved as a diabetes treatment in 2022. (Ozempic was approved for diabetes in 2017.) Several other drugs are in development.

The medications reduce feelings of hunger, generate a sensation of fullness, and have been shown to help people lose an average of 15 percent or more of their weight.

“It takes your appetite right away. I wasn’t hungry at all and I lost weight like mad,” said Morris, who has shed 40 pounds.

But how these medications will affect older adults in the long run isn’t well understood. (Patients need to remain on the drugs permanently or risk regaining the weight they’ve lost.)

Will they help prevent cardiovascular disease and other chronic illnesses in obese older adults? Will they reduce rates of disability and improve people’s ability to move and manage daily tasks? Will they enhance people’s lives and alleviate symptoms associated with obesity-related chronic illnesses?

Unfortunately, clinical trials of the medications haven’t included significant numbers of people ages 65 and older, leaving gaps in the available data.

While the drugs appear to be safe — the most common side effects are nausea, diarrhea, vomiting, constipation, and stomach pain — “they’ve only been on the market for a few years and caution is still needed,” said Mitchell Lazar, founding director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania Perelman School of Medicine.

Given these uncertainties, how are experts approaching the use of the new obesity medications in older people? As might be expected, opinions and practices vary. But several themes emerged in nearly two dozen interviews.

The first was frustration with limited access to the drugs. Because Medicare doesn’t cover weight loss medications and they can cost more than $10,000 a year, seniors’ ability to get the new drugs is restricted.

There is an exception: Medicare will cover Ozempic and Mounjaro if an older adult has diabetes, because the insurance program pays for diabetes therapies.

“We need Medicare to cover these drugs,” said Shauna Matilda Assadzandi, a geriatrician at the University of Pittsburgh who cares for Morris. Recently, she said, she tried to persuade a Medicare Advantage plan representative to authorize Wegovy for a patient with high blood pressure and cholesterol who was gaining weight rapidly.

“I’m just waiting for this patient’s blood sugar to rise to a level where diabetes can be diagnosed. Wouldn’t it make sense to intervene now?” she remembered saying. The representative’s answer: “No. We have to follow the rules.”

Seeking to change that, a bipartisan group of lawmakers has reintroduced the Treat and Reduce Obesity Act, which would require Medicare to cover weight loss drugs. But the proposal, which had been considered previously, has languished amid concerns over enormous potential costs for Medicare.

If all beneficiaries with an obesity diagnosis took brand-name semaglutide drugs (the new class of medications), annual costs would top $13.5 billion, according to a recent analysis in The New England Journal of Medicine. If all older obese adults on Medicare — a significantly larger population — took them, the cost would exceed the total spent on Medicare’s Part D drug program, which was $145 billion in 2019.

Laurie Rich, 63, of Canton, Massachusetts, was caught off guard by Medicare’s policies, which have applied to her since she qualified for Social Security Disability Insurance in December. Before that, Rich took Wegovy and another weight loss medication — both covered by private insurance — and she’d lost nearly 42 pounds. Now, Rich can’t get Wegovy and she’s regained 14 pounds.

“I haven’t changed my eating. The only thing that’s different is that some signal in my brain is telling me I’m hungry all the time,” Rich told me. “I feel horrible.” She knows that if she gains more weight, her care will cost much more.

While acknowledging difficult policy decisions that lie ahead, experts voiced considerable agreement on which older adults should take these drugs.

Generally, the medications are recommended for people with a body mass index over 30 (the World Health Organization’s definition of obesity) and those with a BMI of 27 or above and at least one obesity-related condition, such as diabetes, high blood pressure, or high cholesterol. There are no guidelines for their use in people 65 and older. (BMI is calculated based on a person’s weight and height.)

But those recommendations are problematic because BMI can under- or overestimate older adults’ body fat, the most problematic feature of obesity, noted Rodolfo Galindo, director of the Comprehensive Diabetes Center at the University of Miami Health System.

Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan, a system with five hospitals, suggests physicians also examine waist circumference in older patients because abdominal fat puts them at higher risk than fat carried in the hips or buttocks. (For men, a waist over 40 inches is of concern; for women, 35 is the threshold.)

Fatima Stanford, an obesity medicine scientist at Massachusetts General Hospital, said the new drugs are “best suited for older patients who have clinical evidence of obesity,” such as elevated cholesterol or blood sugar, and people with serious obesity-related conditions such as osteoarthritis or heart disease.

Since going on Mounjaro three months ago, Muriel Branch, 73, of Perryville, Arkansas, has lost 40 pounds and stopped taking three medications as her health has improved. “I feel real good about myself,” she told me.

When adults with obesity lose weight, their risk of dying is reduced by up to 15 percent, according to Dinesh Edem, Branch’s doctor and the director of the medical weight management program at the University of Arkansas for Medical Sciences.

Still, weight loss alone should not be recommended to older adults, because it entails the loss of muscle mass as well as fat, experts agree. And with aging, the shrinkage of muscle mass that starts earlier in life accelerates, contributing to falls, weakness, the loss of functioning, and the onset of frailty.

Between ages 60 and 70, about 12 percent of muscle mass falls away, researchers estimate; after 80, it reaches 30 percent.

To preserve muscle mass, seniors losing weight should be prescribed physical activity — both aerobic exercise and strength training, experts agree.

Also, as older adults taking weight loss drugs eat less, “it’s critically important that their diet includes adequate protein and calcium to preserve bone and muscle mass,” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh.

Ongoing monitoring of older adults having gastrointestinal side effects is needed to ensure they’re getting enough food and water, said Jamy Ard, co-director of Wake Forest Baptist Health’s Weight Management Center.

Generally, the goal for older adults should be to lose 1 to 2 pounds a week, with attention to diet and exercise accompanying medication management.

“My concern is, once we put patients on these obesity drugs, are we supporting lifestyle changes that will maintain their health? Medication alone won’t be sufficient; we will still need to address behaviors,” said Sukhpreet Singh, system medical director at Henry Ford’s weight management program.

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 kffhealthnews.org/columnists to submit your requests or tips.

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IN ONE OF HUMANITY’S many possible futures, the fearless explorers tasked with climbing cloud-splitting mountains in oxygen-poor atmospheres or charting the low, darkened craters of various alien landscapes would never perish from injuries during perilous scouting expeditions. Nor would they fall ill or sustain genetic damage, thanks to supercharged hypersleep chambers that would heal otherwise fatal wounds. As it is today, astronauts don’t have the luxury of being unprepared—instead they must be equipped to deal with all sorts of medical mishaps, especially as they experiment with long-term spaceflight beyond the far side of the moon. 

Current human-rated spacecraft come stocked with emergency supplies to assist the crew, mostly everyday things like Band-Aids and aspirin, but also more specialized items like hydromorphone injections and those all-too-famous space blankets. While astronauts on the International Space Station (ISS) have relied on these, as well as telemedicine calls, to treat ailments and keep a clean bill of health, the fact is, being on another world could put a serious dent in the capacity of emergency medical care. NASA notes that all crew members are trained to handle the medical devices on board—but if a complex surgery is needed and the patient can’t be quickly flown back to Earth, the trainees would have to forge on with limited tools and experience. Thankfully, the worst they’ve faced so far is blood clots.

To plan for these inevitable crises, space agencies have latched on to the science of 3D bioprinting to help revolutionize regenerative medicine for life in the cosmic abyss and on the ground. Researchers have already made strides in bioprinting—the process of generating living cells and medical products in a manner similar to 3D printing—creating tissues, skin grafts, and eventually, whole organs for future transplants, as well as artificial bones that could become “spare parts” for injured astronauts. 

But as demand for smaller, more compact technologies grows, another class of machines has been rocketing to new heights. Capable of stretching, squeezing, bending, and even twisting to fulfill their tasks, “soft robots” are fabricated with materials inspired by living tissue such as human skin, instead of the rigid structures used in traditional remote-controlled systems. This allows robotic instruments to interact more safely with our bodies and lets surgeons perform complicated procedures with more accuracy and precision, says Sheila Russo, an assistant professor at Boston University who specializes in mechanical engineering design for miniaturized surgical robots.

“I work in a field where we build robots that can help patients survive,” Russo explains. “We as engineers listen to people that have problems, and we want to engineer a robotic solution to it.” She likes to point to Big Hero 6’s Baymax as a fictional example of an autonomous soft robot that successfully heals people, either with the various medical devices it’s equipped with or by offering helpful advice. 

Though the doodads in development won’t be able to simply hug anyone’s aches and pains away (yet), they’re lightweight and relatively cheap to produce, making them easy to transport to remote locations, says Russo. For instance, one lab at King’s College in the UK is trying to address the limitations of ultrasound by creating adaptable soft robots that can withstand high-energy sound waves. 

As these prototypes gain traction within the greater medical field, there’s still a long list of quirks and challenges to tackle. But their endless potential could help humans endure extreme circumstances both on Earth and in the stars.  

Acting much like a medical endoscope, this tiny, multifunctional robotic arm (about 0.8 inches in diameter) can be used to fix damaged body parts directly inside a patient’s body. Conventional devices rely on large desktop printers to create artificial tissues, which can then either be kept and grown until mature or implanted directly into the body. But this high-cost method often poses risks, such as structural damage to the faux organ during transport, tissue injuries, and contamination once the part is brought out of a sterile environment. 

The flexible in situ 3D bioprinter (F3DB), on the other hand, works by accessing hard-to-reach areas of the body via small incisions or through natural orifices such as the mouth or anus. “About 90 percent of the human body has a tubular structure,” says Thanh Nho Do, a senior lecturer at UNSW Sydney and one of the team leads for the project. “If you can develop the technology, [robots] can navigate along this way in any desired direction.” 

Once positioned in the target area, F3DB’s multiaxis printing head, which is mounted on a snakelike extendable arm, bends its nozzle to print in three different directions, delivers water to wash away blood and tissue, and acts as an electric scalpel to flag and sever cancerous lesions or tumors. It’s so versatile in its applications that it could potentially be used as an all-in-one surgical tool for medical professionals, says Do. 

Although this tool is still more than half a decade away from human trials, researchers plan to continue using haptic technology—sensor-filled gadgets that can convey tactile information—to manipulate the device, so the system could one day be easily controlled in extreme environments, such as on space stations or in lunar or Martian settlements. 

A recent addition to the ISS, the 3D BioFabrication Facility (BFF) and Advanced Space Experiment Processor are two separate payloads that combine to make a powerful 3D bioprinting laboratory. In collaboration with the ISS National Lab and the Uniformed Services University of the Health Sciences Center for Biotechnology, Redwire’s researchers plan to use it to re-create part of a human knee in space—specifically the meniscus, cartilage that helps absorb shock and stabilizes the joint. If successful, it could be the first step in helping to treat severe knee injuries for US military service members on Earth. 

“A torn meniscus is one of, if not the most common issue that our military have,” says Ken Savin, the aerospace manufacturing company’s chief scientist. “[It’s] a day-to-day issue that a lot of people have and translates to the general population, so it’s a great target to go after.” The printer itself, which is about the size of a dorm fridge, cultures pre-harvested adult stem cells into a solution called bio-ink. 

After being warmed, fed with liquid nutrients, and stimulated to grow, the mixture can be layered into precise, ultrafine structures aboard the ISS and then shipped back to Earth. Strong gravitational forces cause the soft tissues to spread apart like puddles of water, but in space, they can be expected to hold their form due to the microgravity inherent to the ISS, says Savin. 

“When you remove gravity, you open up a whole new field of science,” Savin says. “It allows you to do things and see things that were otherwise hidden.” Once the ISS is decommissioned (which will happen after 2030), Redwire aims to continue advancing its biomanufacturing research aboard Blue Origin’s planned space station, Orbital Reef. 

While the company is now still in the early planning stages of the meniscus project, Savin expects it to be a stepping stone to many other medical breakthroughs, including individualized heart patches that restore cardiac function. Depending on the size of the 3D-printed tissue, production would likely take less than a day. And that’s not the only way BFF would move anatomical technologies along. With future commercialization, the portable lab could help organ-donation hopefuls avoid long wait times and subpar inorganic replacements.

Inspired by plant roots, pollen tubes, and fungi, engineers at the University of Minnesota recently developed a process that allows soft robots to exhibit a level of movement called tip growth, previously seen only in nature. Organisms use this method to add new cells to the ends of their bodies, enabling them to generate large, specific structures over time, cross harsh terrain with ease, and navigate via external stimuli like light or chemical signals. 

In 2022, researchers were able to mimic this process in their own robotic prototype by using a technique called photopolymerization, which uses light to transform liquid molecules into solid materials. It’s a popular 3D-printing strategy in the medical field, specifically for creating accurate anatomical models of patients’ bodies, but in this novel application, it allows a soft robot to build its own body from a liquid monomer solution as it navigates complex environments. 

Capable of a number of exploratory tasks as it slinks along its path, this inchworm-like device can grow up to speeds of about 5 inches per minute, stretch up to about 5 feet, and avoid and even deflect obstacles to reach the deepest recesses of the human body. The tool could be especially helpful for medical fields like gynecology and urology, according to Timothy Kowalewski, an associate professor of mechanical engineering at the University of Minnesota and a member of the project. He also sees it making a difference in procedures like automated intubation and heart attack treatment, where soft catheters are pushed through blood vessels to stabilize a patient. 

Not all soft robots are meant to turn humans into cyborgs with fancy mechanical parts. One bioprinter prototype, developed by the German Aerospace Center, was designed to accelerate an astronaut’s own healing process, says Michael Becker, the project manager for the program. 

Like other innovations in space-centered healthcare, the BioPrint FirstAid Handheld Bioprinter will use cells collected from astronauts before the mission to prepare cartridges of personalized bio-ink for emergency wound treatment, like fixing up superficial lesions and even bone fractures. Likely the first-ever handheld version of a bioprinter in space, the device resembles a compact glue gun—complete with a printing head, guide wheels, and room to hold two bio-ink cartridges for easy access and use. 

While the machine was created to be completely manually operated, the actual printing process takes only a few minutes, Becker explains. “You basically put the printer on your arm or somewhere else and drive over the injured skin.” The nozzle then pushes the solution out to create a plaster-like wound covering. In 2021, ESA astronaut Matthias Maurer demonstrated the technology using simulated cells during a training session on Earth, and he did it again in 2022 during his Cosmic Kiss mission on the ISS.

Having a handheld bioprinter along on a long-duration spaceflight would allow the crew to quickly provide personalized medical care, but the creators need to clear two hurdles first: determining just how many bio-ink cartridges would be needed for a given interplanetary journey and figuring out how to store them in a stable environment. “The challenge right now [is] to create ink where these cells can survive for long-term missions,” says Becker. 

The team hopes the astronaut-friendly tool finds alternative uses, such as in research missions to harsh environments like Antarctica or for bedridden patients. 

Another robot designed to print tissues and organs inside the human body in a minimally invasive manner, the ferromagnetic soft catheter robot (FSCR) stands out from its counterparts because it relies on magnets to move about. 

“This work provides two very new ideas,” says Jianfeng Zang, a professor at Huazhong University of Science and Technology whose work revolves around bridging the gap between hard machines and the soft human body. “One, in that we can do minimally invasive bioprinting, and the second one is that we use a magnetic system to do it.” 

Usually, these kinds of medical machines use motors to propel themselves through the patient’s body. But Zang’s group disperses particles of the rare-earth metal neodymium down the center of their catheter-shaped robot, which also doubles as a bioprinter capable of fabricating complex structures. The device can be swiftly steered via an external computer-controlled magnet to transport materials like drugs or injectable bio-inks through narrow, winding environments. It’s also highly durable because neodymium retains its magnetism for hundreds of years.

Researchers are working to miniaturize the device, which is currently a fraction of an inch, even further. It could one day offer physicians finer control over the instrument’s movements and allow them to complete complex procedures without radioactive X-rays. 

“We just want to use magnetic robots to treat some disease or do some precise surgery that existing technology cannot do,” says Zang. “It’s our dream.”

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What do kidney and pancreas transplants have to do with airplane regulations?

Tucked into the hundreds of pages of legislative language to reauthorize the Federal Aviation Administration is a provision to change the life-or-death process by which human organs are flown commercially from donor to recipient.

But where on the plane organs are stowed during flights has been a long-standing issue for organ procurement organizations.

The sweeping measure, which is pending in Congress and faces a Sept. 30 deadline, aims to change regulations and move organs to the cabin from an aircraft’s cargo hold. Organizations managing organ transport consider it an opportunity to secure legislative relief from a system they say adds more hurdles to the task of shipping organs.

It used to be that a member of a transplant team could take a packaged organ to a plane’s gate and hand it off to the aircraft’s crew, who would stow it in the cockpit or on the flight deck. This access “allowed us to really expedite the process,” said Jeff Orlowski, president and CEO of LifeShare Oklahoma, a nonprofit organ procurement organization in the state. But the terrorist attacks of 9/11 led to tighter security protocols, including a rule that permitted only people with tickets to go through Transportation Security Administration checkpoints.

“In our case, we don’t have a ticket,” said Casey Humphries, logistics service line leader of the United Network for Organ Sharing, the nonprofit contracted by the federal government to manage the nation’s transplant system. “We’re not booked as a passenger on a plane,” she said. Instead, they’re part of the relay network bringing the organs to people in need. Airport employees who work behind security checkpoints have an airport badge and usually get in through a designated entrance.

Another consequence of the 2001 policy changes was that donor organs flown on commercial airplanes—which are mostly kidneys—were stashed in cargo spaces below the wing along with boxes and luggage, said Humphries.

But shipping organs as cargo requires they be at the airport for loading one to two hours before takeoff. “That’s a significant time before the wheels go up for the plane,” said Orlowski. And that variable—the “hours that the organ is going to just sit, going nowhere”—has to be factored into decisions about where it can be sent, he said. Donated organs can’t be treated like a golf bag or an Amazon box. They are delicate and have an imminent expiration date, which for kidneys is usually within 24 hours of surgical removal.

Since January 2022, around 80 percent of organs recovered in Oklahoma were sent to another state to be transplanted, Orlowski said. And of the organs LifeShare recovers, about 35 percent of them are flown commercially. Since kidneys can survive in a cooler longer than other organs, nearly all organs that travel on commercial flights are kidneys.

The first choice for transporting an organ, he said, is usually to drive it to its destination; it’s cheaper, and the transplant team can be more watchful.

But that’s not always an option, especially in rural areas. Orlowski said there are only two transplant centers within driving distance of LifeShare’s Oklahoma City base, in Dallas and Fort Worth, Texas. So his team relies on commercial airlines for transportation.

The current air travel security rules also cause geographic disparities, as fewer cargo-carrying planes fly in and out of smaller airports in rural areas, compared with airports in bigger cities.

“We need something that is available 24 hours a day because organs are available 24 hours a day,” Humphries said.

Charter planes can be a backup option, but one flight can cost organ procurement organizations thousands of dollars, whereas cargo shipping costs usually come in at less than $500 per flight, Orlowski said.

Although the security protocol has been in place for more than two decades, transplant advocates say this is the first time they have sought a legislative reversal, and they are optimistic about the outcome.

The provision to allow organs back in cabins is included in both the Senate and House versions of the reauthorization bill. Some hot-button parts of the bill, though, such as an increase in the mandatory retirement age for pilots, could stall progress. The House Transportation and Infrastructure Committee approved its version on June 14, and at press time it was being debated on the House floor. The Senate Committee on Commerce, Science and Transportation is expected to consider its version this month, according to Senate staffers.

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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This article was originally featured on Hakai Magazine, an online publication about science and society in coastal ecosystems. Read more stories like this at hakaimagazine.com.

A bleary-eyed predawn traveler walking through the arrivals hall of Iceland’s Keflavik Airport blinks at a sight that’s hard at first to register: an enormous advertisement showing a shirtless man holding an infant. The man’s torso and visible arm show a swath of pucker-patterned skin. He looks half-aquatic, like a member of some superhero universe.

As it happens, this sleep-deprived analysis isn’t far off. The baby-holding man, Pétur Oddsson, is a power station worker. In 2020, he endured a 60,000-volt electrical shock; it left almost half his body covered in deep thermal burns that charred layers of his skin off. Such deep and extensive burns can be fatal—skin damaged in this way can’t make new cells to regenerate, and infections can easily set in. But Oddsson’s life was spared by an ingenious invention: grafted cod skin—7,000 square centimeters of it. The procedure adorned Oddsson’s upper body with the permanent, distinct imprint of scales.

Oddsson’s cod skin grafts are a marvel of medical technology. But they also represent something else: the manifestation of an unusual and ambitious experiment in environmental efficiency. The skin grafts are just one of a slew of products—including Omega-3 capsules, cold virus pretreatment sprays, and dog snacks—made from what was once Iceland’s cod catch detritus. They come largely from the efforts of 100% Fish—a project spurred by the incubator Iceland Ocean Cluster in collaboration with research institutes and private companies to determine how to repurpose byproducts from the country’s US $2-billion seafood sector.

So far, enterprising Icelanders have unlocked uses for almost 95 percent of a cod—a pretty recent jump forward. In 2003, people only knew what to do with about 40 percent of the fish.

Árni Mathiesen, the cluster’s senior adviser and the country’s former fisheries minister, says the 100% Fish Project has created jobs and manifested once-scarce domestically produced goods. It has also, adds Alexandra Leeper, the cluster’s head of research and innovation, provided lower-impact fish meal for a burgeoning aquaculture industry. Relatedly, 100% Fish is looking beyond cod, too. A company called Nordic Fish Leather is upcycling farmed salmon skin into leather for accessories and another, Primex, is extracting chitosan from the shells of wild-caught Atlantic northern shrimp, which can be used as a blood-clotting agent.

The cod skin grafts are the brainchild of Fertram Sigurjonsson, a chemist and the founder of biotech company Kerecis, which is part of the 100% Fish Project. The grafts come in several sizes—wide strips, for large wounds; glove shapes, for hands; and granules, which act like putty in smaller wounds—and have been used to treat thousands of burn victims, diabetes patients with open wounds, and women with infected C-sections. Doctors can perform some of these procedures with pigskin grafts, but those are harvested from animals engineered for the purpose. The fish skin, conversely, comes from cod caught for human consumption by fishermen in Sigurjonsson’s northwestern hometown of Isafjordur. (Fishermen who also own valuable shares in his company.)

Sigurjonsson says Kerecis currently transforms a mere 0.01 percent of Icelandic cod skins into grafts. But as demand grows, and as Kerecis’ research and development department determines more uses—they’re investigating breast reconstruction—he’s looking to expand.

By weight, a cod is about eight percent skin. Beyond making for good grafting material, cod skin is rich in collagen, a supplement for human skin, ligament, and bone health. Cod skin easily sheds this protein when it’s boiled in water with enzymes, says Hrönn Margrét Magnúsdóttir. She’s the founder of a collagen supplement and energy drink company called Feel Iceland, which uses collagen derived from 700 tonnes of fish skin per year.

Bones account for at least 35 percent of a cod’s weight. Icelandic companies have long dried fish heads and spines with the country’s abundant geothermal energy and exported them to Nigeria, where they’re the base of a protein-rich soup. But Margrét Geirsdóttir, a project manager at Matís, a food and biotechnology research institute that partners with the Iceland Ocean Cluster, says the unpredictability of that market has sent researchers looking for new applications—such as extracting calcium for supplements.

By far the most challenging holdouts to whole-fish use are the blood and eyeballs, says Geirsdóttir.

According to Icelandic lore, squeezing the liquid from a redfish eyeball onto a wound prevents infection. Matís scientists followed this up, studying whether cod eyeballs might have antiseptic properties. No such luck. They also had a project, says Geirsdóttir, to see whether the eyes contained valuable fats. They do, she says, “but it’s such a low amount and you would need to [extract] it by hand, so it’s not paying off.”

Fish blood, accounting for 10 percent of a fish’s weight, might be used to make products like those made from the blood of land animals, such as sausage filler, fish feed, or fertilizer. Yet Geirsdóttir says the hardest part about working with fish blood is collecting it. On a commercial fishing boat, cod are quickly bled to maintain their freshness. Convincing skeptical fishermen to invest in storing the fish intact means proving the endeavor is worthwhile.

There is an optimistic precedent, however. Fishermen once tossed cod livers overboard; now they’re an expensive delicacy that fishermen are happy to preserve. What changed? Several years back, Geirsdóttir says, fishermen began to see high profits from the sale of cod liver. “Then they started to see the value in it,” she says.

This article first appeared in Hakai Magazine and is republished here with permission.

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On Monday July 17, the Food and Drug Administration approved the first long-acting medication  to protect babies and toddlers against respiratory syncytial virus (RSV). The lung-attacking virus sends about 58,000 children under five to the hospital and kills 100 to 300 infants every year in the United States. 

[Related: Flu and RSV hybrid virus studied in a lab for the first time.]

Nirsevimab is a ready-made injectable antibody that can bind to RSV and block the virus from infecting healthy cells. It is not a vaccine, but instead, is a form of passive immunity. 

For most healthy people, RSV manifests as a cold, but the virus can be life-threatening for the elderly and the very young. Nirsevimab was approved for infants and children up to two years old who face increased risk of severe RSV. Babies can receive a single injection to protect against their first RSV season, which typically starts in the fall and peaks in the winter in the US. Children up to two can then receive a second dose during their next RSV season. 

“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research John Farley said in a statement. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.” 

Nirsevimab will be sold under the brand name Beyfortus and is already approved for use in the United Kingdom, Europe, and Canada. Pharmaceutical company Sanofi, who developed the drug with AstraZeneca, did not immediately say that the price of the treatment would be in the US.  

According to an FDA analysis, nirsevimab was roughly 70 percent effective at reducing the risk that a baby would need to see a doctor for RSV and was about 78 percent effective at preventing hospitalizations compared with a placebo in the clinical trials that led to the drug’s approval. It was generally safe and well tolerated in the trials, with less than one percent of babies having skin reactions after the shots that went away with treatment. 

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

“We run this gauntlet every year — RSV season,” pediatric infectious disease specialist at the Cleveland Clinic in Ohio Frank Esper told CNN “We see a lot of these infants. They come in; they can’t breathe. That’s the problem. That’s what RSV does. It causes so much swelling and secretions in their breathing tubes, called the bronchioles, that they just can’t get enough oxygen.”

Advisers to the Centers for Disease Control and Prevention will meet in early August to recommend exactly who should receive the drug. recommend exactly who should get the drug.

The approval is welcome after multiple decades of setbacks in research for RSV. The FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer in May and the agency is expected to make a decision on a vaccine for pregnant people next month.

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On July 13, the Food and Drug Administration (FDA) approved an over-the-counter birth control pill that can be sold without a prescription for the first time in the United States. The pill is sold under the brand name Opill and will be the most effective birth control method available without a prescription. Oral contraceptives are more effective in preventing pregnancy than barrier methods such as condoms, according to the Cleveland Clinic.

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

Nonprescription availability of the drug, generic name norgestrel, should reduce barriers to access by allowing individuals to obtain oral contraception without seeing a health care provider first, according to the FDA. Roughly half of the 6.1 million annual pregnancies in the US are unintended, which have been linked to negative maternal and perinatal outcomes.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni said in a statement today. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non prescription contraceptive methods in preventing unintended pregnancy.”

Opill’s manufacturer Perrigo Company said that it will most likely be available in stores and online retailers in early 2024, but did not specify how much the medication would cost. However, Perrigo’s global vice president for women’s health Frédérique Welgryn, called the move a “groundbreaking expansion for women’s health in the US,” and said that the company was committed to making Opill “accessible and affordable to women and people of all ages.” 

Perrigo submitted several years of research to the FDA that demonstrates that women can understand and follow the instructions for using the pill. Today’s approval also came despite some concerns from FDA scientists on whether individuals with some underlying medical conditions would understand that they shouldn’t take Opill.

Like with many birth control pills, Opill should be taken at the same time every day for effectiveness. The most common side effects include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.

Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health overturned the federal right to abortion in June 2022, accessibility to contraception has become an increasingly  urgent issue. Even before that decision, the move to develop an over-the-counter birth control pill received support from groups such as the American Medical Association and the American College of Obstetricians and Gynecologists.

[Related: What we know about hormonal birth control and breast cancer risk.]

“We’re thrilled by the FDA’s historic decision to approve Opill as the first ever over-the-counter birth control pill,” executive director of the National Latina Institute for Reproductive Justice and Free the Pill coalition steering committee member Lupe M. Rodríguez said in a statement. “Over-the-counter access to birth control will greatly reduce the barriers that prevent Latinas/xs from getting the care they need, including barriers due to transportation, cost, language, and documentation. If this is implemented correctly, expanding access to birth control will allow our communities the freedom to make meaningful decisions about our lives and futures. Now we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”

Today’s FDA action only applies to Opill which is in an older class of contraceptives that are sometimes called minipills. These contain a single synthetic hormone and typically have fewer side effects than combination hormone pills. 

Some women’s health advocates hope that this major decision will signal more over-the-counter birth control options and even for abortion pills in the future. 

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Researchers at MIT have created a tiny, cucumber-inspired soft robot capable of scooting around otherwise hard-to-reach, three-dimensional environments using a single, weak magnetic field. As first detailed last month in an open access paper published with Advanced Materials, an inchworm-like mechanism made from strategically magnetized rubber polymer spirals shows immense promise in maneuvering through spaces as tiny as human blood vessels.

[Related: Seals provided inspiration for a new waddling robot.]

Before this newest wormbot, locomotive soft bots required moving magnetic fields to control their direction and angle. “[I]f you want your robot to walk, your magnet walks with it. If you want it to rotate, you rotate your magnet,” Polina Ankeeva, the paper’s lead author and a professor of materials science and engineering and brain and cognitive sciences, said in a statement. “If you are trying to operate in a really constrained environment, a moving magnet may not be the safest solution,” Ankeeva added. “You want to be able to have a stationary instrument that just applies [a] magnetic field to the whole sample.”

As such, the MIT research team’s new design isn’t uniformly magnetized like many other soft robots. By only magnetizing select areas and directions, just one magnetic field can create “a movement-driving profile of magnetic forces,” according to MIT’s announcement.

Interestingly, engineers turned to cucumber vines’ coiled tendrils for inspiration: Two types of rubber are first layered atop one another before being heated and stretched into a thin fiber. As the new thread cools, one rubber contracts while the other retains its form to create a tightly wound spiral, much like a cucumber plant’s thin vines wrapping around nearby structures. Finally, a magnetizable material is threaded through the polymer spiral, then strategically magnetized to allow for a host of movement and directional options.

Because of each robot’s customizable magnetic patterns, multiple soft bots can be individually mapped to move in different directions when both exposed to a single, uniform weak magnetic field. Additionally, a subtle field manipulation allows the robots to vibrate—thus allowing the tiny worms to carry cargo to a designated location, then shake it off to deliver a payload. Because of their soft materials and relatively simple manipulation, researchers believe such mechanisms could be used in biomedical situations, such as inching through human blood vessels to deliver a drug at a precise location.

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On July 6, the Food and Drug Administration (FDA) fully approved the first drug shown to slow down Alzheimer’s disease. Sold under the brand name Leqembi (generic name lecanemab), this is the first time that a drug meant to slow the disease’s progression, and not only target its symptoms, has been granted full regulatory approval. 

[Related: One big reason why Alzheimer’s might be going undetected in the US.]

Leqembi is manufactured by Japanese drugmaker Eisai and the United States-based drugmaker Biogen. The drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s. 

During a phase 3 clinical trial of the new drug, disease progression was slowed by 27 percent over an 18-month period in 1,795 patients with mild cognitive impairment or early-stage Alzheimer’s. The medication also reduced sticky beta-amyloid plaques that can accumulate in the brains of people with the disease.

“[This] action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research Teresa Buracchio said in a press release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

The new approval means that Leqembi should be widely covered by Medicare, which primarily serves adults 65 and older. Until this approval, the federal insurance program has only covered the cost of Leqembi for patients in certain clinical trials. This expanded coverage means that an estimated one million Medicare patients are potential candidates for the treatment, and that people with Medicare who are in the early stages of Alzheimer’s could access the drug at an affordable price. Both companies have said the treatment will cost roughly $26,500 annually without insurance.

“It’s not something that’s going to stop the disease or reverse it,” Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center, told NPR. “But it may slow down progression of the disease and may give people more meaningful time with their families. It’s very exciting that we’re targeting the actual pathology of the disease.”

In January, Leqembi received accelerated approval from the FDA due to its ability to remove beta-amyloid from the brain in those in early stages of the disease that affects more than 6.5 million Americans. Full or traditional approval reflects the FDA’s assessment that the drug also helps preserve thinking and memory. 

[Related: One secret to excellent memory in old age? Giant neurons.]

The Alzheimer’s Association has previously worked to accelerate the drug’s approval, and called it “an important development for people living with Alzheimer’s disease and their families.” However, some critics have mentioned the lack of diversity in the drug’s testing pool—specifically Black patients.

According to the FDA, Alzheimer’s disease is currently irreversible, progressive, and slowly destroys memory and thinking skills. Eventually, the ability to carry out simple tasks. Its specific cause is unknown, but it is generally characterized by changes in the brain. Some of these changes include the formation of amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections.

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This article was co-reported by The Markup and KFF Health News.

Looking for an at-home HIV test on CVS’ website is not as private an experience as one might think. An investigation by The Markup and KFF Health News found trackers on CVS.com telling some of the biggest social media and advertising platforms the products customers viewed.

And CVS is not the only pharmacy sharing this kind of sensitive data.

We found trackers collecting browsing- and purchase-related data on websites of 12 of the U.S.’ biggest drugstores, including grocery store chains with pharmacies, and sharing the sensitive information with companies like Meta (formerly Facebook); Google, through its advertising and analytics products; and Microsoft, through its search engine, Bing.

The tracking tools, popularly called “pixels,” collect information while a website runs. That information is often sent to social media firms and used to target ads, either to you personally or to groups of people that resemble you in demographics or habits. In previous investigations, The Markup found pixels transmitting information from the Department of Education, prominent hospitals, telehealth startups, and major tax preparation companies.

Pharmacy retailer websites’ pixels send a shopper’s IP address—a sort of mailing address for a person’s computer or household internet—to social media giants and other firms. They also send cookies, a way of storing information in a user’s browser that in this case helps track a user from page to page as the user browses a retailer’s site. Cookies can sometimes also associate individuals on a site with their account on a social media platform. In addition to the IP address and cookies, the pixels often send information about what you’ve clicked or bought, including sensitive items, such as HIV tests.

“HIV testing is the gateway to HIV prevention and treatment services,” said Oni Blackstock, the founder of Health Justice and a former assistant commissioner for the New York City Bureau of HIV/AIDS Prevention and Control, in an interview.

“People living with HIV should have control over whether someone knows their status,” she said.

Many retailers shared other detailed interaction data with advertising platforms as well. Ten of the retailers we examined alerted at least one tech platform when shoppers clicked “add to cart” as they shopped for retail goods, a capacious category that included sensitive products like prenatal vitamins, pregnancy tests, and Plan B emergency contraception.

Supermarket giant Kroger, for instance, informed Meta, Bing, Twitter, Snapchat, and Pinterest when a shopper added Plan B to the cart, and informed Google and Nextdoor, a social media platform on which people from the same neighborhood gather in forums, that a shopper had visited the page for the item. Walmart informed Google’s advertising service when a shopper browsed the page of an HIV test, and Pinterest when that shopper added it to the cart.

A previous investigation from The Markup found that Kroger used loyalty cards to track, analyze, and sell an array of data about customers to advertisers.

Using Chrome DevTools, a tool built into Google’s Chrome browser, The Markup and KFF Health News visited the websites of 12 of the U.S.’ biggest drugstores and examined their network traffic. This monitoring tool allowed us to see what information about shopping habits and, in some cases, prescriptions, were sent to third parties.

Over the course of the investigation, retailers frequently changed their trackers—sometimes activating them, sometimes removing them. Some retailers appeared to be taking steps to limit tracking on sensitive items.

For example, Walgreens’ website prevented some trackers from activating on the pages of some products, which included Plan B and HIV tests. This code didn’t prevent all tracking, though: Walgreens’ site continued sending Pinterest information about those sensitive items a user added to the cart.

Walgreens shared a new policy after learning of The Markup and KFF Health News’ findings. Spokesperson Fraser Engerman said that while the chain already had a “robust privacy program,” it would no longer share browsing data related to reproductive health and HIV testing. Engerman also told us that “Pinterest confirmed that the data will be deleted and that it has not been used for advertising purposes.” Crystal Espinosa, a spokesperson for Pinterest, said the company “can confirm that we will be deleting the data Walgreens requested.”

The pharmacy vs. the pharmacy aisle

In the U.S., drugstores and grocery stores with associated pharmacies are only partially covered by the Health Insurance Portability and Accountability Act, or HIPAA. The prescriptions picked up from the pharmacy counter do have this protection.

But in a separate section, sometimes confusingly called the pharmacy aisle, stores also often sell over-the-counter medications, tests, and other health-related products. Consumers might think such purchases have similar protections to their prescriptions, but HIPAA only covers the pharmacy counter’s clinical operations, such as dispensing prescriptions and answering patients’ questions about medication.

This distinction can be confusing enough inside the brick-and-mortar location of a retailer. But the line can become even harder to make out on a website, which lacks the clarifying delineations of physical space.

What’s more, descriptions about what will happen with retail data are generally in retailers’ privacy policies, which can usually be found in a link at the bottom of their webpages. The Markup and KFF Health News found them murky at best, and none of them were specific about the parts of the site that were covered by HIPAA and the parts that weren’t.

In the “Privacy Notice for California Residents” part of its privacy policy, Kroger says it processes “personal information collected and analyzed concerning a consumer’s health.” But, the policy continues, the company does not “sell or share” that information. Other information is sold: According to the policy, in the last 12 months, the company sold or shared “protected classification characteristics” to outside entities like data brokers.

Kroger spokesperson Erin Rolfes said the company strives to be transparent and that, “in many cases, we have provided more information to our customers in our privacy notices than our peers.”

Brokering of general retail data is widespread. Our investigation found, though, that some websites shared sensitive clinical data with third parties even when that information would be protected at a HIPAA-covered pharmacy counter. Users attempting to schedule a vaccine appointment at Rite Aid, for example, must answer a survey first to gauge eligibility.

This investigation found that Rite Aid has sent Facebook responses to questions such as:

• Do you have a neurological disorder such as seizures or other disorders that affect the brain or have had a disorder that resulted from a vaccine?
• Do you have cancer, leukemia, AIDS, or any other immune system problem?
• Are you pregnant or could you become pregnant in the next three months?

The Markup and KFF Health News documented Rite Aid sharing this data with Facebook in December 2022. In February of this year, a proposed class-action lawsuit based on similar findings was filed against the drugstore chain in California, alleging code on Rite Aid’s website sent Facebook the time of an appointment and an identifier for the appointment location, demographic information, and answers to questions about vaccination history and health conditions. Rite Aid has moved to dismiss the suit.

After the lawsuit was filed, The Markup and KFF Health News tested Rite Aid’s website again, and it was no longer sending answers to vaccination questions to Facebook.

Rite Aid isn’t the only company that sent answers to eligibility questionnaires to social media firms. Supermarkets Albertsons, Acme, and Safeway, which are owned by the same parent company, also sent answers to questions in their vaccination intake form—albeit in a format that requires cross-referencing the questionnaire’s source code to reveal the meaning of the data.

Using the Firefox web browser’s Network Monitor tool, and with the help of a patient with an active prescription at Rite Aid, KFF Health News and The Markup also found Rite Aid sending the names of patients’ specific prescriptions to Facebook. Rite Aid kept sharing prescription names even after the company stopped sharing answers to vaccination questions in response to the proposed class action (which did not mention the sharing of prescription information). Rite Aid did not respond to requests for comment, and as of June 23, the pixel was still present and sending the names of prescriptions to Facebook.

Other companies shared data about medications from other parts of their sites. Customers of Sam’s Club and Costco, for example, can search names of prescriptions on each retailer’s website to find the local pharmacy with the cheapest prices. But the two websites also sent the name of the medication the user searched for, along with the user’s IP address, to social media companies.

Many of the retailers The Markup and KFF Health News looked at did not respond to questions or declined to comment, including Costco and Sam’s Club. Albertsons said the company “continually” evaluates its privacy practices. CVS said it was compliant with “applicable laws.”

Kroger’s Rolfes wrote that the company’s “trackers disclose product information, which is not sensitive health information unless one or more inferences are made. Kroger does not make any inferences linking the product information collected or disclosed by trackers to an individual’s health condition.”

A huge regulatory challenge

Pharmacies are just one facet of a huge health care sector. But the industry as a whole has been roiled by disclosures of tracking pixels picking up sensitive clinical data.

After an investigation by The Markup in June 2022 found widespread use of trackers on hospital websites, regulatory and legal attention has homed in on the practice.

In December, the Department of Health and Human Services’ Office for Civil Rights published guidance advising health providers and insurers how pixel trackers’ use can be consistent with HIPAA. “Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures” of protected health information to tracking technology or other third-party vendors, according to the official bulletin. If implemented, the guidance would provide a path for the agency to regulate hospitals and other providers and fine those who don’t follow it. In an interview with an industry publication in late April, the director of the Office for Civil Rights said it would be bringing its first enforcement action for pixel use “hopefully soon.”

Lobbying groups are seeking to confine any regulatory fallout: The American Hospital Association, for example, sent a letter on May 22 to the Office for Civil Rights asking that the agency “suspend or amend” its guidance. The office, it claimed, was seeking to protect too much data.

This year the Federal Trade Commission has pursued action against companies like GoodRx, which offers prescription price comparisons, and BetterHelp, which offers online therapy, for alleged misuse of data from questionnaires and searches. The companies settled with the agency.

Health care providers have disclosed to the federal government the potential leakage of nearly 10 million patients’ data to various advertising partners, according to a review by The Markup and KFF Health News of breach notification letters and the Office for Civil Rights’ online database of breaches. That figure could be a low estimate: A new study in the journal Health Affairs found that, as of 2021, almost 99 percent of hospital websites contained tracking technologies.

One prominent law firm, BakerHostetler, is defending hospitals in 26 legal actions related to the use of tracking technologies, lawyer Paul Karlsgodt, a partner at the firm, said during a webinar this year. “We’ve seen an absolute eruption of cases,” he said.

Abortion- and pregnancy-related data is particularly sensitive and driving regulatory scrutiny. In the same webinar, Lynn Sessions, also with BakerHostetler, said the California attorney general’s office had made specific investigative requests to one of the firm’s clients about whether the client was sharing reproductive health data.

It’s unclear whether big tech companies have much interest in helping secure health data. Sessions said BakerHostetler had been trying to get Google and Meta to sign so-called business associate agreements. These agreements would bring the companies under the HIPAA regulatory umbrella, at least when handling data on behalf of hospital clients. “Both of them, at least at this juncture, have not been accommodating in doing that,” Sessions said. Google Analytics’ help page for HIPAA instructs customers to “refrain from using Google Analytics in any way that may create obligations under HIPAA for Google.”

Meta says it has tools that attempt to prevent the transfer of sensitive information like health data. In a November 2022 letter to Sen. Mark Warner (D-Va.) obtained by KFF Health News and The Markup, Meta wrote that “the filtering mechanism is designed to prevent that data from being ingested into our ads.” What’s more, the letter noted, the social media giant reaches out to companies transferring potentially sensitive data and asks them to “evaluate their implementation.”

“I remain concerned the company is too passive in allowing individual developers to determine what is considered sensitive health data that should remain private,” Warner told The Markup and KFF Health News.

Meta’s claims in its letter to Warner have been repeatedly questioned. In 2020, the company itself acknowledged to New York state regulators that the filtering system was “not yet operating with complete accuracy.”

To test the filtering system, Sven Carlsson and Sascha Granberg, reporters for SR Ekot in Sweden, set up a dummy pharmacy website in Swedish, which sent fake, but plausible, health data to Facebook to see whether the company’s filtering systems worked as stated. “We weren’t warned” by Facebook, Carlsson said in an interview with KFF Health News and The Markup.

Carlsson and Granberg’s work also found European pharmacies engaged in activities similar to what The Markup and KFF Health News have found. The reporters caught a Swedish state-owned pharmacy sending data to Facebook. And a recent investigation with The Guardian found the U.K.-based pharmacy chain LloydsPharmacy was sending sensitive data—including information about symptoms—to TikTok and Facebook.

In response to questions from KFF Health News and The Markup, Meta spokesperson Emil Vazquez said, “Advertisers should not send sensitive information about people through our Business Tools. Doing so is against our policies and we educate advertisers on properly setting up Business Tools to prevent this from occurring. Our system is designed to filter out potentially sensitive data it is able to detect.”

Meta did not respond to questions about whether it considered any of the information KFF Health News and The Markup found retailers sending to be “sensitive information,” whether any was actually filtered by the system, or whether Meta could provide metrics demonstrating the current accuracy of the system.

In response to our inquiries, Twitter sent a poop emoji, while TikTok and Pinterest said they had policies instructing advertisers not to pass on sensitive information. LinkedIn and Nextdoor did not respond.

Google spokesperson Jackie Berté said the company’s policies “prohibit businesses from using sensitive health information to target and serve ads” and that it worked to prevent such information from being used in advertising, using a “combination of algorithmic and human review” to remedy violations of its policy.

KFF Health News and The Markup presented Google with screenshots of its pixel sending the search company our browsing information when we landed on the retailers’ pages where we could purchase an HIV test and prenatal vitamins, and data showing when we added an HIV test to the cart. In response, Berté said the company had “not uncovered any evidence that the businesses in the screenshots are violating our policies.”

KFF Health News uses the Meta Pixel to collect information. The pixel may be used by third-party websites to measure web traffic and performance data and to target ads on social platforms. KFF Health News collects page usage data from news partners that opt to include our pixel tracker when they republish our articles. This data is not shared with third-party sites or social platforms and users’ personally identifiable information is not recorded or tracked, per KFF’s privacy policy. The Markup does not use a pixel tracker. You can read its full privacy policy here.

This article was co-published with The Markup, a nonprofit newsroom that investigates how powerful institutions are using technology to change our society. Sign up for The Markup’s newsletters.

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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Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth—something that hasn’t been required in more than three years.

During the covid-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

Regulators said they decided to extend the current regulations—which don’t require an in-person appointment — until November 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until November 11, 2024, to come into compliance with the agency’s future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to health care and helping prevent medication misuse.

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it’s important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet their telehealth prescriber. Instead, they could visit a local health care provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

“It could end up being a very sticky wicket” for some patients to access care, she said. “It’s not going to be easy, but it sounds like it’s doable.”

Some health care providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He’s worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it’s also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as “a situation where there’s not a clear benefit, but there are substantial harms for at least some patients,” including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

“I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety,” Jordan said.

Jordan said it’s important for health care practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn’t even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn’t support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days’ worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in health care were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should have to go see her telehealth provider in person to maintain her prescriptions.

“I would have to get on a plane to go to Florida. I’m not going to do that,” she said. “If the government forces me to do that, that’s wrong.”

Holiman said her primary care doctor doesn’t prescribe injectable hormones and that she shouldn’t have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, health care, and professional groups, such as the American Medical Association.

The physicians’ organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company’s patients in Alabama couldn’t switch to in-state prescribers because many weren’t taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men and people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

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.

Subscribe to KFF Health News’ free Morning Briefing.

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A team of researchers has uncovered a new biological editing system that could potentially be even more precise than CRISPR gene editing. It’s based on a protein called Fanzor, and this new finding is the first programmable RNA-guided system discovered in eukaryotes. The new RNA-editing system is described in a study published June 28 in the journal Nature. 

[Related: CRISPR breaks ground as a one-shot treatment for a rare disease.]

Eukaryotes include fungi, plants, and animals whose cells have a nucleus. CRISPR was first discovered in organisms called prokaryotes, which are single-celled and do not have a nucleus. Discovering an editing system like this that works in eukaryotes could expand biological editing’s reach and possibly its precision.

The team shows how Fanzor proteins use RNA as a guide to precisely target DNA as well as how Fanzors can be reprogrammed to edit the genome of human cells. RNA serves multiple functions in the body, including coding, decoding, regulating, and expressing genes. The Fanzor system could also be more easily delivered to the body’s tissues and cells as therapeutics than CRISPR systems.

The study also shows that RNA-guided DNA-cutting mechanisms are present in both unicellular nucleus-lacking prokaryotes and multicellular nuclei endowed eukaryotes. 

“CRISPR-based systems are widely used and powerful because they can be easily reprogrammed to target different sites in the genome,” co-author and biochemist at the Massachusetts Institute of Technology (MIT) Feng Zhang said in a statement. “This new system is another way to make precise changes in human cells, complementing the genome editing tools we already have.”

One of the primary goals of the Zhang lab is developing genetic medicines that can modulate human cells by pinpointing specific genes and processes. They are looking beyond CRISPR to see if other RNA-programmable systems exist in the natural world. 

The team is building on a 2021 discovery of a class of RNA-programmable systems in prokaryotes called OMEGAs. That research highlighted some similarities between prokaryotic OMEGA systems and the Fanzor proteins in eukaryotes, and suggested that Fanzor enzymes could also be using an RNA-guided mechanism to target and cut DNA.

In the new study, the team isolated Fanzors from fungi, algae, and amoeba species, and a common clam called the Northern Quahog. A biochemical characterization of the Fanzor proteins showed that they are DNA-cutting endonuclease enzymes that use nearby non-coding RNAs known as ωRNAs. These  ωRNAs target particular sites in the genome, and it is the first time this mechanism has been found in eukaryotes like the clam, according to the authors.

[Related: What is a pangenome? Scientists just released their first draft.]

“These OMEGA systems are more ancestral to CRISPR and they are among the most abundant proteins on the planet, so it makes sense that they have been able to hop back and forth between prokaryotes and eukaryotes,” co-author and postdoctoral fellow at the Zhang lab Makoto Saito said in a statement. 

To investigate Fanzor’s potential as a future genome editing tool, the team showed that it can generate insertions and deletions at targeted genome sites within human cells like the cut and paste tool in a document. They found that the Fanzor system was initially less efficient at snipping DNA than CRISPR systems, but introducing a combination of mutations into the protein significantly increased its activity. 

According to the team, the Fanzor system can be reprogrammed to target specific genome editing technology for future research and therapeutics, just like the current CRISPR-based systems. There are also more systems like this in nature just waiting to be found.  

“Nature is amazing. There’s so much diversity,” said Zhang. “There are probably more RNA-programmable systems out there, and we’re continuing to explore and will hopefully discover more.”

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If you don’t know what a pangolin is, then today is your lucky day. Primarily found in tropical regions of Africa and Asia, the tiny, adorable, sadly endangered creature is the only mammal known to be covered completely in overlapping scales composed of durable keratin—the same material that makes up your nails and hair. When needed, the flexible scales’ structure allows a pangolin to curl up into a defensive ball—a novel evolutionary design that recently inspired a team of engineers’ newest invention.

[Related: The Pangolin Finally Made It Onto The List Of The World’s Most Protected Animals.]

As described in a paper published on June 20 with Nature Communications, researchers at the Max Planck Institute for Intelligent Systems in Germany created a robot that could mimic a pangolins’ roly-poly resiliency. Instead of doing so for protection, however, the miniature robot uses its scaly design to quickly traverse environments while simultaneously carrying small payloads. With an added ability to heat to over 70 degrees Celsius (roughly 158 degrees Fahrenheit), the team’s barely two-centimeter-long robot shows immense promise for delivering medication within patients, as well as helping in procedures such as mitigating unwanted internal bleeding.

The pangolin-inspired robot features a comparatively simple, two-layer design—a soft polymer layer studded in magnetic particles, and a harder exterior layer of overlapping metal scales. Exposing the robot to a low-frequency magnetic field causes it to roll into a cylindrical shape, and subsequently directing the magnetic field can influence the robot’s movement. While in this rolled shape, the team showed that their pangolin-bot can house deliverables such as medicine, and safely transport them through animal tissues and artificial organs to a desired location for release.

[Related: These 2D machines can shapeshift into moving 3D robots.]

Exposing their robot to a high-frequency magnetic field, however, offers even more avenues for potential medical treatment. In such instances, the pangolin robot’s metals heat up dramatically, providing thermal energy for situations such as treating thrombosis, cauterizing tumor tissues, or even stopping internal bleeding. “Untethered robots that can move freely, even though they are made of hard elements such as metal and can also emit heat, are rare,” reads a statement from the Planck Institute, adding that researchers’ new robot “could one day reach even the narrowest and most sensitive regions in the body in a minimally invasive and gentle way and emit heat as needed.”

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When urologic oncologist Dan Theodorescu thinks about his 25 years of research on bladder cancer, he remembers being in a flow. “When you hit something, you know in your gut that it’s really important and everything works out because you’re onto something.” His latest study, published on June 21 in the journal Nature, provides a clearer picture on why men have a greater risk for bladder cancer.

The trailblazing findings draw a clear connection between the disease and damage to the Y chromosome—the genetic structure that largely distinguishes male from female in mammals at birth. Bladder cancer is a sexually dimorphic disease with men making up a disproportionate amount of cases. In fact, men have a 1 in 28 chance of developing the cancer, compared to women, who have a 1 in 91 chance. Theodorescu, now the director of Cedars-Sinai Cancer, sought to understand why men are more prone to developing this type of cancer. Beyond risk factors like smoking cigarettes, he narrowed his decades-long search to changes in hormones and chromosomes. Previous work in the field had found that an increase in androgens, which are produced in the testes and ovaries, interferes with the body’s ability to fight off cancerous tumors. However, until this current study, few researchers focused on the role of chromosomes in bladder cancer.

As men get older, they naturally see the Y chromosome disappear in some cells. It’s a common phenomenon—at least 40 percent of men partially lose their Y chromosome by age 70. Previous research has linked that loss with several health problems, including an increase in heart failure, Alzheimer’s disease, and premature death. 

[Related: What is a pangenome?]

Theodorescu and his team started by studying several bladder cancer cell lines (a population of cells bred from a single common cell). They grew and isolated two sets of cells from male mice whose fathers had either kept or lost the Y chromosome. Tumor cells without a Y chromosome were more likely to exhibit aggressive growth than those with the Y chromosome. 

The next step involved pooling together 16 cancer cells from mice containing a normal Y chromosome with 16 cells missing a Y chromosome. Both cell lines had a similar growth rate. However, when they studied the same cell lines in animals, the authors noticed the tumor cells containing a Y chromosome did not grow as well as cells without a Y chromosome. 

While the cell models hint at the sex chromosome’s role in cancer development, they don’t explain why it makes bladder tumors grow more aggressively. One hypothesis is that tumor cells without a Y chromosome grow faster because they have an easier time evading a person’s immune system. To test this possibility, the researchers injected Y-positive and Y-negative cells into mice bred without an immune system. Both tumor cells grew at the same rate, unlike in the cell lines where natural defenses were intact. “This was the clue that Y-negative cells were messing with the immune system somehow,” Theodorescu says.

Another experiment used genetically engineered mice missing various pieces of their immune system and found that immune cells responsible for fighting infection, called T cells, were the ones most affected by the loss of the Y chromosome. “We compared T cells from Y-negative to Y-positive tumors and found Y-negative tumors are doing things to T cells to get them exhausted,” Theodorescu explains. “An exhausted T cell can no longer destroy the tumor.”

The study might provide some insights on biological processes like adaptive immunity that are affected by disappearing Y chromosomes, says Chris Lau, a professor of medicine at the University of California, San Francisco who studies the human Y chromosome in his own research. “This could very well be the mechanism contributing to the disadvantage that seems to doom men with a mosaic loss of the Y chromosome in many other diseases, in which the immune system could play a role.” 

Of course, the million-dollar question is whether doctors can use this knowledge to help patients with bladder cancer. One option includes immune checkpoint inhibitors. This common form of immunotherapy blocks the receptors that tumors use to send signals that confuse T cells. It also teaches T cells how to recognize cancer cells. When Theodorescu’s team administered immune checkpoint inhibitors to mice, they found those with Y-negative tumors responded better to treatment than Y-positive tumors.

[Related: A ‘living’ cancer drug helped two patients stay disease-free for a decade]

A new project Theodorescu and his colleagues are currently working on is seeing how many genes on the X chromosome are duplicates of genes found in the Y chromosome, also known as paralogs. Any mutations of these paralogs would cause a loss of gene function that could contribute to immune evasion in women, potentially adding to the risk of bladder cancer. Another issue the team is investigating is what happens to men who lose their Y chromosome and have mutations in Y-related genes on the X chromosome. “The loss may give you a worse cancer, but the response to immunotherapy could be even better,” Theodorescu notes. 

If all goes well, Theodorescu says he plans to use the data from his recent work to create a test that would predict a person’s response to immunotherapy for any cancer. Additionally, the findings could help enhance immunotherapy and make it more effective against Y-negative tumors. Theodorescu is also not discounting the possibility of boosting immune response against other types of cancer. “If this pans out,” he says, “we may be in a situation where we could use this platform to discover combination therapies that could potentially cure a significant number of patients than checkpoint inhibitor therapy alone.”

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Hal Dempsey wanted to “escape Missouri.” Arlo Dennis is “fleeing Florida.” The Tillison family “can’t stay in Texas.”

They are part of a new migration of Americans who are uprooting their lives in response to a raft of legislation across the country restricting health care for transgender people.

Missouri, Florida, and Texas are among at least 20 states that have limited components of gender-affirming health care for trans youth. Those three states are also among the states that prevent Medicaid — the public health insurance for people with low incomes — from paying for key aspects of such care for patients of all ages.

More than a quarter of trans adults surveyed by KFF and The Washington Post late last year said they had moved to a different neighborhood, city, or state to find more acceptance. Now, new restrictions on health care and the possibility of more in the future provide additional motivation.

Many are heading to places that are passing laws to support care for trans people, making those states appealing sanctuaries. California, for example, passed a law last fall to protect those receiving or providing gender-affirming care from prosecution. And now, California providers are getting more calls from people seeking to relocate there to prevent disruptions to their care, said Scott Nass, a family physician and expert on transgender care based in the state.

But the influx of patients presents a challenge, Nass said, “because the system that exists, it can’t handle all the refugees that potentially are out there.”

In Florida, the legislative targeting of trans people and their health care has persuaded Arlo Dennis, 35, that it is time to uproot their family of five from the Orlando area, where they’ve lived for more than a decade. They plan to move to Maryland.

Dennis, who uses they/them pronouns, no longer has access to hormone replacement therapy after Florida’s Medicaid program stopped covering transition-related care in late August under the claim that the treatments are experimental and lack evidence of being effective. Dennis said they ran out of their medication in January.

“It’s definitely led to my mental health having struggles and my physical health having struggles,” Dennis said.

Moving to Maryland will take resources Dennis said their family does not have. They launched a GoFundMe campaign in April and have raised more than $5,600, most of it from strangers, Dennis said. Now the family, which includes three adults and two children, plans to leave Florida in July. The decision wasn’t easy, Dennis said, but they felt like they had no choice.

“I’m OK if my neighbor doesn’t agree with how I’m living my life,” Dennis said. “But this was literally outlawing my existence and making my access to health care impossible.”

Mitch and Tiffany Tillison decided they needed to leave Texas after the state’s Republicans made anti-trans policies for youth central to their legislative agenda. Their 12-year-old came out as trans about two years ago. They asked for only her middle name, Rebecca, to be published because they fear for her safety due to threats of violence against trans people.

This year, the Texas Legislature passed a law limiting gender-affirming health care for youth under 18. It specifically bans physical care, but local LGBTQ+ advocates say recent crackdowns also have had a chilling effect on the availability of mental health therapy for trans people.

While the Tillisons declined to specify what treatment, if any, their daughter is getting, they said they reserve the right, as her parents, to provide the care their daughter needs — and that Texas has taken away that right. That, plus increasing threats of violence in their community, particularly in the wake of the May 6 mass shooting by a professed neo-Nazi at Allen Premium Outlets, about 20 miles from their home in the Dallas suburbs, caused the family to decide to move to Washington state.

“I’ve kept her safe,” said Tiffany Tillison, adding that she often thinks back to the moment her daughter came out to her during a long, late drive home from a daylong soccer tournament. “It’s my job to continue to keep her safe. My love is unending, unconditional.”

For her part, Rebecca is pragmatic about the move planned for July: “It’s sad, but it is what we have to do,” she said.

A close call on losing key medical care in Missouri also pushed some trans people to rethink living there. In April, Missouri Attorney General Andrew Bailey issued an emergency rule seeking to limit access to transition-related surgery and cross-sex hormones for all ages, and restrict puberty-blocking drugs, which pause puberty but don’t alter gender characteristics. The next day, Dempsey, 24, who uses they/them pronouns, launched a GoFundMe fundraiser for themself and their two partners to leave Springfield, Missouri.

“We are three trans individuals who all depend on the Hormone Replacement Therapy and gender affirming care that is soon to be prohibitively limited,” Dempsey wrote in the fundraising appeal, adding they wanted to “escape Missouri when our lease is up at the end of May.”

Dempsey said they also got a prescription for a three-month supply of hormone therapy from their doctor in Springfield to tide them over until the move.

Bailey withdrew his rule after the state legislature in May restricted new access to such treatments for minors, but not adults like Dempsey and their partners. Still, Dempsey said their futures in Missouri didn’t look promising.

Neighboring Illinois was an obvious place to move; the legislature there passed a law in January that requires state-regulated insurance plans to cover gender-affirming health care at no extra cost. Where exactly was a bigger question. Chicago and its suburbs seemed too expensive. The partners wanted a progressive community similar in size and cost of living to the city they were leaving. They were looking for a Springfield in Illinois.

“But not Springfield, Illinois,” Dempsey quipped.

Gwendolyn Schwarz, 23, had also hoped to stay in Springfield, Missouri, her hometown, where she had recently graduated from Missouri State University with a degree in film and media studies. She had planned to continue her education in a graduate program at the university and, within the next year, get transition-related surgery, which can take a few months of recovery.

But her plans changed as Bailey’s rule stirred fear and confusion.

“I don’t want to be stuck and temporarily disabled in a state that doesn’t see my humanity,” Schwarz said.

She and a group of friends are planning to move west to Nevada, where state lawmakers have approved a measure that requires Medicaid to cover gender-affirming treatment for trans patients.

Schwarz said she hopes moving from Missouri to Nevada’s capital, Carson City, will allow her to continue living her life without fear and eventually get the surgery she wants.

Dempsey and their partners settled on Moline, Illinois, as the place to move. All three had to quit their jobs to relocate, but they have raised $3,000 on GoFundMe, more than enough to put a deposit down on an apartment.

On May 31, the partners packed the belongings they hadn’t sold and made the 400-mile drive to their new home.

Since then, Dempsey has already been able to see a medical provider at a clinic in Moline that caters to the LGBTQ+ community — and has gotten a new prescription for hormone therapy.

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Earlier this month, the American Medical Association adopted a new policy on the use of body mass index (BMI), which has been widely used since 1972, in clinical settings. The AMA suggests that going forward, physicians should also consider factors like the fat stored in the abdominal cavity and around the organs (visceral fat), a body adiposity index that uses hip circumference and height, along with genetics, metabolic factors, and the percentage of fat, bone, and muscle in a patient’s body.

[Related: There are better ways to measure body fat than BMI.]

BMI has been criticized by patients and some physicians for its inability to distinguish muscle from fat among numerous other factors, making it a flawed indicator of how much body fat a person actually has. Athletes with large amounts of lean muscle can end up labeled as “overweight” since muscle weighs more than fat, and fat distribution, not just quantity, has an effect on people’s health. 

BMI is also steeped in racial exclusion in medicine and “historical harm.” It is based on a roughly 200 year old calculation called the the Quetelet index, which was created by Adolphe Quetelet, a Belgian mathematician and statistician looking to use height and body weight to characterize “normal man.”

“The new policy was part of the AMA Council on Science and Public Health report which evaluated the problematic history with BMI and explored alternatives,” the AMA wrote in a statement on June 14. “BMI is based primarily on data collected from previous generations of non-Hispanic white populations.” 

BMI is calculated by dividing a person’s weight by their height squared. A BMI of less than 18.5 is  considered underweight, whereas a “healthy weight” is up to 24.9. Overweight is considered 25 to 29.9 a patient is considered obese with a BMI of 30 and above.

The AMA said that BMI “loses predictability when applied on the individual level” compared to being a general way to assess correlation of body fat. The new policy addresses BMI’s known limitations, noting that it doesn’t differentiate between lean and fat body mass or account for differences between racial and ethnic groups, age, or biological sex. 

A report supporting this recent policy change cites that women tend to have more body fat than men and Asian people have more body fat than white people—both are examples of differences between demographic groups. The BMI also does not take into account where body fat is distributed on the body, the authors say. 

Carrying more visceral fat (or having a more “apple-shaped” body) is considered a greater risk for heart disease and type-2 diabetes than being “pear-shaped” (carrying weight around the thighs, legs, and butt). Different groups also tend to carry this weight differently.

[Related: Why is it more dangerous to have belly fat?]

The AMA also notes that BMI is used because it is an inexpensive tool. It can be used to determine insurance rates, determine qualifications for surgery, and can even be a factor in adopting a child. 

“Health care professionals use a variety of types of numerical information to assess patient health, with common ones being blood pressure, blood glucose, body mass index (BMI) etc,” Wajahat Mehal, an MD and Director of the Yale Metabolic Health and Weight Loss Program at Yale Medicine told PopSci. “No single number gives a complete assessment of patient health and the recent AMA guidelines highlight the usefulness and limitations of using the BMI. These are excellent guidelines and emphasize the need to use a variety of numerical indicators, in addition to BMI, to obtain a complete assessment of patient health.”

Some doctors say that it will be difficult to completely erase BMI from your next physical exam. 

“There are other ways of assessing body fat,” Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine, told CNN. However, “they’re not as easy and as inexpensive as BMI. I’m not sure we can throw out BMI until we have other measures that are as easy to use,” he said, adding that BMI should not be a gatekeeper for patients seeking weight loss treatment. 

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If you or someone you know may be experiencing a mental health crisis, contact the 988 Suicide & Crisis Lifeline by dialing “988,” or the Crisis Text Line by texting “HOME” to 741741.

CHARLESTON, S.C. — Melanie Gray Miller, a 30-year-old physician, wiped away tears as she described the isolation she felt after losing a beloved patient.

“It was at the end of a night shift, when it seems like bad things always happen,” said Miller, who is training to become a pediatrician.

The infant had been sick for months in the Medical University of South Carolina’s pediatric intensive care unit and the possibility that he might not improve was obvious, Miller recalled during an April meeting with physicians and hospital administrators. But the suddenness of his death still caught her off guard.

“I have family and friends that I talk to about things,” she said. “But no one truly understands.”

Doctors don’t typically take time to grieve at work. But during that recent meeting, Miller and her colleagues opened up about the insomnia, emotional exhaustion, trauma, and burnout they experienced from their time in the pediatric ICU.

“This is not a normal place,” Grant Goodrich, the hospital system’s director of ethics, said to the group, acknowledging an occupational hazard the industry often downplays. “Most people don’t see kids die.”

The recurring conversation, scheduled for early-career doctors coming off monthlong pediatric ICU rotations, is one way the hospital helps staffers cope with stress, according to Alyssa Rheingold, a licensed clinical psychologist who leads its resiliency program.

“Often the focus is to teach somebody how to do yoga and take a bath,” she said. “That’s not at all what well-being is about.”

Burnout in the health care industry is a widespread problem that long predates the covid-19 pandemic, though the chaos introduced by the coronavirus’s spread made things worse, physicians and psychologists said. Health systems across the country are trying to boost morale and keep clinicians from quitting or retiring early, but the stakes are higher than workforce shortages.

Rates of physician suicide, partly fueled by burnout, have been a concern for decades. And while burnout occurs across medical specialties, some studies have shown that primary care doctors, such as pediatricians and family physicians, may run a higher risk.

“Why go into primary care when you can make twice the money doing something with half the stress?” said Daniel Crummett, a retired primary care doctor who lives in North Carolina. “I don’t know why anyone would go into primary care.”

Doctors say they are fed up with demands imposed by hospital administrators and health insurance companies, and they’re concerned about the notoriously grueling shifts assigned to medical residents during the early years of their careers. A long-standing stigma keeps physicians from prioritizing their own mental health, while their jobs require them to routinely grapple with death, grief, and trauma. The culture of medicine encourages them to simply bear it.

“Resiliency is a cringe word for me,” Miller said. “In medicine, we’re just expected to be resilient 24/7. I don’t love that culture.”

And though the pipeline of physicians entering the profession is strong, the ranks of doctors in the U.S. aren’t growing fast enough to meet future demand, according to the American Medical Association. That’s why burnout exacerbates workforce shortages and, if it continues, may limit the ability of some patients to access even basic care. A 2021 report published by the Association of American Medical Colleges projects the U.S. will be short as many as 48,000 primary care physicians by 2034, a higher number than any other single medical specialty.

A survey published last year by The Physicians Foundation, a nonprofit focused on improving health care, found more than half of the 1,501 responding doctors didn’t have positive feelings about the current or future state of the medical profession. More than 20% said they wanted to retire within a year.

Similarly, in a 2022 AMA survey of 11,000 doctors and other medical professionals, more than half reported feeling burned out and indicated they were experiencing a great deal of stress.

Those numbers appear to be even higher in primary care. Even before the pandemic, 70% of primary care providers and 89% of primary care residents reported feelings of burnout.

“Everyone in health care feels overworked,” said Gregg Coodley, a primary care physician in Portland, Oregon, and author of the 2022 book “Patients in Peril: The Demise of Primary Care in America.”

“I’m not saying there aren’t issues for other specialists, too, but in primary care, it’s the worst problem,” he said.

The high level of student debt most medical school graduates carry, combined with salaries more than four times as high as the average, deter many physicians from quitting medicine midcareer. Even primary care doctors, whose salaries are among the lowest of all medical specialties, are paid significantly more than the average American worker. That’s why, instead of leaving the profession in their 30s or 40s, doctors often stay in their jobs but retire early.

“We go into medicine to help people, to take care of people, to do good in the world,” said Crummett, who retired from the Duke University hospital system in 2020 when he turned 65.

Crummett said he would have enjoyed working until he was 70, if not for the bureaucratic burdens of practicing medicine, including needing to get prior authorization from insurance companies before providing care, navigating cumbersome electronic health record platforms, and logging hours of administrative work outside the exam room.

“I enjoyed seeing patients. I really enjoyed my co-workers,” he said. “The administration was certainly a major factor in burnout.”

Jean Antonucci, a primary care doctor in rural Maine who retired from full-time work at 66, said she, too, would have kept working if not for the hassle of dealing with hospital administrators and insurance companies.

Once, Antonucci said, she had to call an insurance company — by landline and cellphone simultaneously, with one phone on each ear — to get prior authorization to conduct a CT scan, while her patient in need of an appendectomy waited in pain. The hospital wouldn’t conduct the scan without insurance approval.

“It was just infuriating,” said Antonucci, who now practices medicine only one day a week. “I could have kept working. I just got tired.”

Providers’ collective exhaustion is a crisis kept hidden by design, said Whitney Marvin, a pediatrician who works in the pediatric ICU at the Medical University of South Carolina. She said hospital culture implicitly teaches doctors to tamp down their emotions and to “keep moving.”

“I’m not supposed to be weak, and I’m not supposed to cry, and I’m not supposed to have all these emotions, because then maybe I’m not good enough at my job,” said Marvin, describing the way doctors have historically thought about their mental health.

This mentality prevents many doctors from seeking the help they need, which can lead to burnout — and much worse. An estimated 300 physicians die by suicide every year, according to the American Foundation for Suicide Prevention. The problem is particularly pronounced among female physicians, who die by suicide at a significantly higher rate than women in other professions.

A March report from Medscape found, of more than 9,000 doctors surveyed, 9% of male physicians and 11% of female physicians said they have had suicidal thoughts. But the problem isn’t new, the report noted. Elevated rates of suicide among physicians have been documented for 150 years.

“Ironically, it’s happening to a group of people who should have the easiest access to mental health care,” said Gary Price, a Connecticut surgeon and president of The Physicians Foundation.

But the reluctance to seek help isn’t unfounded, said Corey Feist, president of the Dr. Lorna Breen Heroes’ Foundation.

“There’s something known in residency as the ‘silent curriculum,’” Feist said in describing an often-unspoken understanding among doctors that seeking mental health treatment could jeopardize their livelihood.

Feist’s sister-in-law, emergency room physician Lorna Breen, died by suicide during the early months of the pandemic. Breen sought inpatient treatment for mental health once, Feist said, but feared that her medical license could be revoked for doing so.

The foundation works to change laws across the country to prohibit medical boards and hospitals from asking doctors invasive mental health questions on employment or license applications.

“These people need to be taken care of by us, because really, no one’s looking out for them,” Feist said.

In Charleston, psychologists are made available to physicians during group meetings like the one Miller attended, as part of the resiliency program.

But fixing the burnout problem also requires a cultural change, especially among older physicians.

“They had it worse and we know that. But it’s still not good,” Miller said. “Until that changes, we’re just going to continue burning out physicians within the first three years of their career.”

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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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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.

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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.

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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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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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This article was originally featured on The Conversation.

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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