Enlarge / MDMA is now in the FDA's hands. (credit: Getty | PYMCA/Avalon)

The safety and efficacy data on the use of MDMA (aka ecstasy) for post-traumatic stress disorder therapy is "challenging to interpret," the Food and Drug Administration said in a briefing document posted Friday. The agency noted significant flaws in the design of the underlying clinical trials as well as safety concerns for the drug, particularly cardiovascular harms.

On Tuesday, June 4, the FDA will convene an advisory committee that will review the evidence and vote on MDMA's efficacy and whether its benefits outweigh its risks. The FDA does not have to follow the committee's recommendations, but it often does. If the FDA subsequently approves MDMA as part of treatment for PTSD, it would mark a significant shift in the federal government's stance on MDMA, as well as psychedelics, generally. Currently, the US Drug Enforcement Administration considers MDMA a Schedule I drug, defined as one with "no currently accepted medical use and a high potential for abuse." It would also offer a new treatment option for patients with PTSD, a disabling psychiatric condition with few treatment options currently.

As Ars has reported previously, the submission of MDMA for approval is based on two clinical trials. The first trial, published in Nature Medicine in 2021, involved 90 participants with moderate PTSD and found that MDMA-assisted psychotherapy significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given psychotherapy along with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

Enlarge / Holstein cows at a dairy farm. (credit: Getty | John Carl D'Annibale)

Another dairy farm worker in Michigan has been infected with avian influenza virus, state and federal health officials reported Thursday.

The case marks the third time the outbreak of bird flu in milking cows is known to have spilled over to a human. The dairy farm worker in Michigan, like the others, had close contact with H5N1-infected dairy cows, suggesting another case of cow-to-human transmission.

But the case reported today is notable for being the first one involving respiratory symptoms. In the first two cases, the dairy workers (one in Texas, the other in Michigan) reported only eye infections (conjunctivitis). This third case—also in Michigan but from a different farm—reported upper respiratory symptoms, including cough, congestion, and sore throat, as well as eye discomfort and watery discharge, but not conjunctivitis. The worker was given an antiviral (Tamiflu) and is said to be recovering. No other workers on the farm have shown symptoms, and the worker's household contacts are being monitored.

Enlarge / Panty liners, hygienic tampons, and sanitary pads. (credit: Getty | LOU BENOIST)

People in the US are starting their menstrual cycles earlier and experiencing more irregularities, both of which raise the risk of a host of health problems later in life, according to an Apple women’s health study looking at data from over 70,000 menstruating iPhone users born between 1950 and 2005.

The mean age of people's first period fell from 12.5 years in participants born between 1950 and 1969 to 11.9 years in participants born between 2000 and 2005, with a steady decline in between, the study found. There were also notable changes in the extremes—between 1950 and 2005, the percentage of people who started their periods before age 11 rose from 8.6 percent to 15.5 percent. And the percentage of people who started their periods late (at age 16 or above) dropped from 5.5 percent to 1.7 percent.

In addition to periods shifting to earlier starting ages, menstrual cycles also appeared to become more irregular. For this, researchers looked at how quickly people settled into a regular cycle after the start of their period. Between 1950 and 2005, the percentage of people obtaining regularity within two years fell from 76.3 percent to 56 percent.

Enlarge / Suri alpacas on a farm in Pennsylvania. (credit: Getty | Susan L. Angstadt)

Four backyard alpacas in southern Idaho have tested positive for highly pathogenic avian influenza (HPAI) H5N1, marking the first time bird flu has been detected in members of the fleecy camelid family, according to the US Department of Agriculture.

On Tuesday, the USDA announced that the agency's National Veterinary Services Laboratories confirmed the infection on a farm in Jerome County on May 16. While the infections are a first for the spitting llama relatives, the USDA said they weren't particularly surprising. The alpacas were in close contact with HPAI-infected poultry on the farm, which were "depopulated" this month. Of 18 alpacas on the affected farm, only four were found to be infected. There were no deaths documented, according to a report the USDA submitted to the World Organization for Animal Health.

Genomic sequencing indicates that the H5N1 virus infecting the alpacas (B3.13) matches both the virus currently circulating among US dairy cows and the virus that infected birds on the farm.

Enlarge / Each of Precision's microelectrode arrays comprises 1,024 electrodes ranging in diameter from 50 to 380 microns, connected to a customized hardware interface. (credit: Precision)

Brain-computer interface company Precision Neuroscience says that it has set a new world record for the number of neuron-tapping electrodes placed on a living human's brain—4,096, surpassing the previous record of 2,048 set last year, according to an announcement from the company on Tuesday.

The high density of electrodes allows neuroscientists to map the activity of neurons at unprecedented resolution, which will ultimately help them to better decode thoughts into intended actions.

Precision, like many of its rivals, has the preliminary goal of using its brain-computer interface (BCI) to restore speech and movement in patients, particularly those who have suffered a stroke or spinal cord injury. But Precision stands out from its competitors due to a notable split from one of the most high-profile BCI companies, Neuralink, owned by controversial billionaire Elon Musk.

Enlarge / Fresh raw milk being poured into a container on a dairy farm on July 29, 2023, in De Lutte, Netherlands. (credit: Getty | Pierre Crom)

Despite the delusions of the raw milk crowd, drinking unpasteurized milk brimming with infectious avian H5N1 influenza virus is a very bad idea, according to freshly squeezed data published Friday in the New England Journal of Medicine.

Researchers at the University of Wisconsin-Madison squirted raw H5N1-containing milk from infected cows into the throats of anesthetized laboratory mice, finding that the virus caused systemic infections after the mice were observed swallowing the dose. The illnesses began quickly, with symptoms of lethargy and ruffled fur starting on day 1. On day 4, the animals were euthanized to prevent extended suffering. Subsequent analysis found that the mice had high levels of H5N1 bird flu virus in their respiratory tracts, as well their hearts, kidneys, spleens, livers, mammary glands, and brains.

"Collectively, our data indicate that HPAI [Highly Pathogenic Avian Influenza] A(H5N1) virus in untreated milk can infect susceptible animals that consume it," the researchers concluded. The researchers also found that raw milk containing H5N1 can remain infectious for weeks when stored at refrigerator temperatures.

Enlarge / American black bear seen along the Red Rock Parkway inside Waterton Lakes National Park in Alberta, Canada. (credit: Getty | Artur Widak)

In the summer of 2022, a family gathered in South Dakota for a reunion that included a special meal—kabobs made with the meat of a black bear that one of the family members had "harvested" from northern Saskatchewan, Canada, that May. Lacking a meat thermometer, the family assessed the doneness of the dark-colored meat by eye. At first, they accidentally served it rare, which a few family members noticed before a decision was made to recook it. The rest of the reunion was unremarkable, and the family members departed to their homes in Arizona, Minnesota, and South Dakota.

But just days later, family members began falling ill. One, a 29-year-old male in Minnesota, sought care for a mysterious illness marked by fever, severe muscle pains, swelling around his eyes (periorbital edema), high levels of infection-fighting white blood cells (eosinophilia, a common response to parasites), and other laboratory anomalies. The man sought care four times and was hospitalized twice in a 17-day span in July. It wasn't until his second hospitalization that doctors learned about the bear meat—and then it all made sense.

The doctors suspected the man had a condition called trichinellosis and infection of Trichinella nematodes (roundworms). These dangerous parasites can be found worldwide, embedded into the muscle fibers of various carnivores and omnivores, according to the Centers for Disease Control and Prevention. But, it's quite rare to find them in humans in North America. Between 2016 and 2022, there were seven outbreaks of trichinellosis in the US, involving just 35 cases. The majority were linked to eating bear meat, but moose and wild boar meat are also common sources.

Enlarge (credit: Getty | Jeffrey Greenberg)

As new diabetes and weight-loss drugs help patients curb appetites and shed pounds, food manufacturers are looking for new ways to keep their bottom lines plump.

Millions of Americans have begun taking the pricey new drugs—particularly Mounjaro, Ozempic, Wegovy, and Zepbound—and millions more are expected to go on them in the coming years. As such, food makers are bracing for slimmer sales. In a report earlier this month, Morgan Stanley's tobacco and packaged food analyst Pamela Kaufman said the drugs are expected to affect both the amounts and the types of food people eat, taking a bite out of the food and drink industry's profits.

"In Morgan Stanley Research surveys, people taking weight-loss drugs were found to eat less food in general, while half slashed their consumption of sugary drinks, alcohol, confections and salty snacks, and nearly a quarter stopped drinking alcohol completely," Kaufman said. Restaurants that sell unhealthy foods, particularly chains, may face long-term business risks, the report noted. Around 75 percent of survey respondents taking weight-loss drugs said they had cut back on going to pizza and fast food restaurants.

Enlarge / Holstein dairy cows in a freestall barn. (credit: Getty | )

A dairy farm worker in Michigan has tested positive for an H5 bird flu virus, marking the second human case of bird flu that has been linked to the unprecedented outbreak of highly pathogenic avian influenza H5N1 virus among dairy cows in the US.

According to the Centers for Disease Control and Prevention, the worker only experienced a mild eye infection and has since recovered, much like the first case in a dairy farm worker in Texas. The Michigan worker was being monitored for symptoms due to exposure—the person worked on a dairy farm with H5N1-infected cattle.

In a press briefing Wednesday afternoon, CDC Principal Deputy Director Nirav Shah said the person was taking part in an active surveillance system, in which the state's health department sent out a text message every day asking about the presence of any symptoms. The worker's infection was identified after the person responded that there were symptoms.

Enlarge / Trial participant Sherown Campbell manipulating a Rubik's Cube. (credit: UP-LIFT Trial)

With a zap of electricity from well-placed electrodes on the back of the neck, patients with tetraplegia can regain some modest yet potentially "life-changing" functioning of their hands and arms, according to data from a small clinical trial published Monday in Nature Medicine.

The relatively simple stimulation method—which requires no surgery—offers an accessible and more affordable non-invasive means for those living with paralysis to regain some meaningful function, the researchers behind the trial say. However, the therapy's further potential remains limited given that scientists have yet to fully understand exactly why it works.

For the trial, 60 patients with tetraplegia underwent the stimulation therapy over at least 24 sessions during a two-month period. At the end, 72 percent (43 patients) saw clinically meaningful improvements in both strength and functional performance. Further, 90 percent (54 patients) saw improvement from at least one strength or functional outcome. There were no serious adverse events reported.

Enlarge / A Neuralink implant. (credit: Neuralink)

Only about 15 percent of the electrode-bearing threads implanted in the brain of Neuralink's first human brain-chip patient continue to work properly, according to a report from The Wall Street Journal. The remaining 85 percent of the threads became displaced, and many of the threads that were left receiving little to no signals have been shut off.

In a May 8 blog post, Neuralink had disclosed that "a number" of the chip's 64 thinner-than-hair threads had retracted. Each thread carries multiple electrodes, totaling 1,024 across the threads, which are surgically implanted near neurons of interest to record signals that can be decoded into intended actions.

Neuralink was quick to note that it was able to adjust the algorithm used for decoding those neuronal signals to compensate for the lost electrode data. The adjustments were effective enough to regain and then exceed performance on at least one metric—the bits-per-second (BPS) rate used to measure how quickly and accurately a patient with an implant can control a computer cursor.

Enlarge / Packaging for Wegovy, manufactured by Novo Nordisk, is seen in this illustration photo. (credit: Getty | Jakub Porzycki)

With the debut of remarkably effective weight-loss drugs, America's high obesity rate and its uniquely astronomical prescription drug pricing appear to be set on a catastrophic collision course—one that threatens to "bankrupt our entire health care system," according to a new Senate report that modeled the economic impact of the drugs in different uptake scenarios.

If just half of the adults in the US with obesity start taking a new weight-loss drug, such as Wegovy, the collective cost would total an estimated $411 billion per year, the analysis found. That's more than the $406 billion Americans spent in 2022 on all prescription drugs combined.

While the bulk of the spending on weight-loss drugs will occur in the commercial market—which could easily lead to spikes in health insurance premiums—taxpayer-funded Medicare and Medicaid programs will also see an extraordinary financial burden. In the scenario that half of adults with obesity go on the drug, the cost to those federal programs would total $166 billion per year, rivaling the programs' total 2022 drug costs of $175 billion.

Enlarge (credit: Sarah Dussault/MediaNews Group/The Mercury News via Getty Images)

An autopsy report of a Massachusetts teen who tragically died hours after eating an ultra-spicy tortilla chip suggested that his death was due to the high dose of spice in the chip and a congenital heart defect, according to reporting by the Associated Press.

Harris Wolobah, a previously healthy 14-year-old from Worcester, died September 1, 2023 hours after eating the chip—a 2023 Paqui One Chip Challenge chip—which were sold individually, wrapped in tin foil, and seasoned with two of hottest peppers in the world, the Naga Viper pepper and the Carolina Reaper pepper. Paqui sold the chip with a challenge in which eaters were dared to consume the chip, wait as long as possible before eating or drinking anything, and post the aftermath on social media, where the challenge went viral.

Harris' mother, Lois Wolobah, immediately suspected the chip was involved in his untimely death. At the time, she reportedly said she picked him up from school after getting a call from the nurse. He was clutching his stomach and, about two hours later, lost consciousness and was rushed to the hospital, where he died. She reported that he had no known medical conditions at the time.

Enlarge (credit: Getty | Spencer Platt)

The North Carolina State Senate on Wednesday voted 30–15, along party lines, in favor of a Republican bill that would make it illegal for people in the state to wear a mask in public for health reasons. The bill is now moving to the House, where it could potentially see changes.

The proposed ban on health-based masking is part of a larger bill otherwise aimed at increasing penalties for people wearing masks to conceal their identity while committing a crime or impeding traffic. The bill was largely spurred by recent protests on university and college campuses across the country, including North Carolina-based schools, against the war in Gaza. In recent months, there have been demonstrations in Raleigh and Durham that have blocked roadways, as well as clashes on the nearby campus of the University of North Carolina at Chapel Hill. Some demonstrators were seen wearing masks in those events.

But the bill, House Bill 237, goes a step further by making it illegal to wear a mask in public for health and safety reasons, either to protect the wearer, those around them, or both. Specifically, the bill repeals a 2020 legal exemption enacted amid the COVID-19 pandemic, which allowed for public health-based masking for the first time in decades.

Enlarge / A child cools off under a water sprinkler. (credit: Getty | JASON SOUTH)

In 1989, a city in Utah upgraded its drinking water system, putting in a whole new system and repurposing the old one to supply cheap untreated water for irrigating lawns and putting out fires. That meant that the treated water suitable for drinking flowed from new spigots, while untreated water gushed from the old ones. Decades went by with no apparent confusion; residents seemed clear on the two different water sources. But, according to an investigation report published recently by state and county health officials, that local knowledge got diluted as new residents moved into the area. And last summer, the confusion over the conduits led to an outbreak of life-threatening illnesses among children.

In July and August of 2023, state and local health officials identified 13 children infected with Shiga toxin-producing Escherichia coli (STEC) O157:H7. The children ranged in age from 1 to 15, with a median age of 4. Children are generally at high risk of severe infections with this pathogen, along with older people and those with compromised immune systems. Of the 13 infected children, seven were hospitalized and two developed hemolytic uremic syndrome, a life-threatening complication that can lead to kidney failure.

Preliminary genetic analyses of STEC O157:H7 from two of the children suggested that the children's infections were linked to a common source. So, health officials quickly developed a questionnaire to narrow down the potential source. It soon became clear that the irrigation water—aka untreated, pressurized, municipal irrigation water (UPMIW)—was a commonality among the children. Twelve of 13 infected children reported exposure to it in some form: Two said they drank it; five played with UPMIW hoses; three used the water for inflatable water toys; two used it for a water table; and one ran through sprinklers. None reported eating fruits or vegetables from home (noncommercial) gardens irrigated with the UPMIW.

Enlarge / Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity. (credit: Getty | Michael Siluk)

A large, long-term trial of the weight-loss medication Wegovy (semaglutide) found that people tended to lose weight over the first 65 weeks on the drug—about one year and three months—but then hit a plateau or "set point." But that early weight loss was generally maintained for up to four years while people continued taking the weekly injections.

The findings, published Monday in Nature Medicine, come from a fresh analysis of data from the SELECT trial, which was designed to look at the drug's effects on cardiovascular health. The trial—a multicenter, double-blind, randomized, placebo-controlled trial—specifically enrolled people with existing cardiovascular disease who also were overweight or obese but did not have diabetes. In all, the trial included 17,604 people from 41 countries. Seventy-two percent of them were male, 84 percent were white, and the average age was about 62 years old.

Last year, researchers published the trial's primary results, which showed that semaglutide reduced participants' risk of heart attack, stroke, and cardiovascular-related deaths by 20 percent over the span of a little over three years.

Enlarge / A glass of fresh raw milk in the hand of a farmer. (credit: Getty | Pierre Crom)

To drink raw milk at any time is to flirt with dangerous germs. But, amid an unprecedented outbreak of H5N1 bird flu in US dairy cows, the risks have ratcheted up considerably. Health experts have stepped up warnings against drinking raw milk during the outbreak, the scope of which is still unknown.

Yet, raw milk enthusiasts are undaunted by the heightened risk. The California-based Raw Milk Institute called the warnings "clearly fearmongering." The institute's founder, Mark McAfee, told the Los Angeles Times this weekend that his customers are, in fact, specifically requesting raw milk from H5N1-infected cows. According to McAfee, his customers believe, without evidence, that directly drinking high levels of the avian influenza virus will give them immunity to the deadly pathogen.

Expert Michael Payne told the LA Times that the idea amounts to "playing Russian roulette with your health." Payne, a researcher and dairy outreach coordinator at the Western Institute for Food Safety and Security at UC Davis, added, "Deliberately trying to infect yourself with a known pathogen flies in the face of all medical knowledge and common sense."

Enlarge / Opal Sandy (center), who was born completely deaf because of a rare genetic condition, can now hear unaided for the first time after receiving gene therapy at 11 months old. She is shown with her mother, father, and sister at their home in Eynsham, Oxfordshire, on May 7, 2024. (credit: Getty | Andrew Matthews)

There are few things more heartwarming than videos of children with deafness gaining the ability to hear, showing them happily turning their heads at the sound of their parents' voices and joyfully bobbing to newly discovered music. Thanks to recent advances in gene therapy, more kids are getting those sweet and triumphant moments—with no hearing aids or cochlear implants needed.

At the annual conference of the American Society for Gene & Cell Therapy held in Baltimore this week, researchers showed many of those videos to their audiences of experts. On Wednesday, Larry Lustig, an otolaryngologist at Columbia University, presented clinical trial data of two children with profound deafness—the most severe type of deafness—who are now able to hear at normal levels after receiving an experimental gene therapy. One of the children was 11 months old at the time of the treatment, marking her as the youngest child in the world to date to receive gene therapy for genetic deafness.

On Thursday, Yilai Shu, an otolaryngologist at Fudan University in Shanghai, provided a one-year progress report on six children who were treated in the first in-human trial of gene therapy for genetic deafness. Five of the six had their hearing restored.