Enlarge / Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company's headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023. (credit: Getty | Carsten Snejbjerg)

After some persuasion from Sen. Bernie Sanders (I-Vt.), the CEO of Novo Nordisk will testify before lawmakers later this year on the "outrageously high cost" of the company's diabetes and weight-loss drugs—Ozempic and Wegovy—in the US.

CEO Lars Jørgensen will appear before the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is chaired by Sanders, in early September. The agreement came after a conversation with Sanders in which the CEO reportedly "reconsidered his position" and agreed to testify voluntarily. As such, Sanders has canceled a vote scheduled for June 18 on whether to subpoena Novo Nordisk to discuss its US prices, which are considerably higher than those of other countries.

The independent lawmaker has been working for months to pressure Novo Nordisk into lowering its prices and appearing before the committee. In April, Sanders sent Jørgensen a letter announcing an investigation into the prices and included a lengthy set of information requests. In May, the committee's investigation released a report suggesting that Novo Nordisk's current pricing threatens to "bankrupt our entire health care system."

Enlarge / Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006. (credit: Getty | Jb Reed)

The Centers for Disease Control and Prevention on Thursday warned that a federal indictment of an allegedly fraudulent telehealth company may lead to a massive, nationwide disruption in access to ADHD medications—namely Adderall, but also other stimulants—and could possibly increase the risk of injuries and overdoses.

"A disruption involving this large telehealth company could impact as many as 30,000 to 50,000 patients ages 18 years and older across all 50 US states," the CDC wrote in its health alert.

The CDC warning came on the heels of an announcement from the Justice Department Thursday that federal agents had arrested two people in connection with an alleged scheme to illegally distribute Adderall and other stimulants through a subscription-based online telehealth company called Done Global.  The company's CEO and founder, Ruthia He, was arrested in Los Angeles, and its clinical president, David Brody, was arrested in San Rafael, California.

Enlarge / The Mod Easy Sidecar (credit: Mod Bikes)

As some Ars readers may recall, I reviewed The Maven Cargo e-bike earlier this year as a complete newb to e-bikes. For my second foray into the world of e-bikes, I took an entirely different path.

The stylish Maven was designed with utility in mind—it's safe, user-friendly, and practical for accomplishing all the daily transportation needs of a busy family. The second bike, the $4,299 Mod Easy Sidecar 3, is on the other end of the spectrum. Just a cursory glance makes it clear: This bike is built for pure, head-turning fun.

The Mod Easy 3 is a retro-style Class 2 bike—complete with a sidecar that looks like it's straight out of Indiana Jones and the Last Crusade. Nailing this look wasn't the initial goal of Mod Bike founder Dor Korngold. In an interview with Ars, Korngold said the Mod Easy was the first bike he designed for himself. "It started with me wanting to have this classic cruiser," he said, but he didn't have a sketch or final design in mind at the outset. Instead, the design was based on what parts he had in his garage.

Enlarge / Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. (credit: Getty | Robyn Beck)

The US Supreme Court on Thursday struck down a case that threatened to remove or at least restrict access to mifepristone, a pill approved by the Food and Drug Administration for medication abortions and used in miscarriage care. The drug has been used for decades, racking up a remarkably good safety record in that time. It is currently used in the majority of abortions in the US.

The high court found that the anti-abortion medical groups that legally challenged the FDA's decision to approve the drug in 2000 and then ease usage restrictions in 2016 and 2021 simply lacked standing to challenge any of those decisions. That is, the groups failed to demonstrate that they were harmed by the FDA's decision and therefore had no grounds to legally challenge the government agency's actions. The ruling tracks closely with comments and questions the justices raised during oral arguments in March.

"Plaintiffs are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others," the Supreme Court noted in its opinion, which included the emphasis on "by others." The court summarized that the groups offered "complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact," and the court found that "none of these theories suffices" to prove harm.

Enlarge / Diamond Shruumz's "extremely potent" infused cones in "sprinkles" flavor. (credit: Diamond Shruumz)

More people have reported severe poisonings in an ongoing outbreak marked by people seizing and needing to be intubated after consuming microdose candies made by Diamond Shruumz, the Food and Drug Administration reported Tuesday.

There are now at least 12 reported cases across eight states. All 12 people were ill enough to seek medical care, and 10 needed to be hospitalized. The symptoms reported so far include seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, the FDA reported.

In Tuesday's update, the FDA also expanded the products linked to the illnesses. In addition to all flavors of Diamond Shruumz's Microdosing Chocolate Bars, the agency's warning now covers all flavors of the brand's Infused Cones and Micro Dose and Macro Dose Gummies.

Enlarge (credit: Getty | Yui Mok)

The strain of H5N1 bird flu isolated from a dairy worker in Texas was 100 percent fatal in ferrets used to model influenza illnesses in humans. However, the virus appeared inefficient at spreading via respiratory droplets, according to newly released study results from the Centers for Disease Control and Prevention.

The data confirms that H5N1 infections are significantly different from seasonal influenza viruses that circulate in humans. Those annual viruses make ferrets sick but are not deadly. They have also shown to be highly efficient at spreading via respiratory droplets, with 100 percent transmission rates in laboratory settings. In contrast, the strain from the Texas man (A/Texas/37/2024) appeared to have only a 33 percent transmission rate via respiratory droplets among ferrets.

"This suggests that A/Texas/37/2024-like viruses would need to undergo changes to spread efficiently by droplets through the air, such as from coughs and sneezes," the CDC said in its data summary. The agency went on to note that "efficient respiratory droplet spread, like what is seen with seasonal influenza viruses, is needed for sustained person-to-person spread to happen."

Enlarge / A Diamond Shruumz chocolate bar, which come in a variety of flavors. (credit: diamondshruumz.com)

Various federal and state health officials are sounding the alarm on Diamond Shruumz-brand Microdosing Chocolate Bars. The candy, said to be infused with mushrooms, has been linked to severe illnesses, including seizures, loss of consciousness, confusion, sleepiness, agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, according to an outbreak alert released by the Food and Drug Administration on Friday.

So far, eight people across four states have been sickened—four in Arizona, two in Indiana, one in Nevada, and one in Pennsylvania, the FDA reported. Of the eight, six have been hospitalized.

"We are urging the public to use extreme caution due to the very serious effects of these products," Maureen Roland, director of the Banner Poison and Drug Information Center in Phoenix, said in a press release earlier this week.

Enlarge / Precision’s Layer 7 Cortical Interface array. (credit: Precision)

Work toward brain-computer interfaces has never been more charged. Though neuroscientists have toiled for decades to tap directly into human thoughts, recent advances have the field buzzing with anticipation—and the involvement of one polarizing billionaire has drawn a new level of attention.

With competition amping up in this space, Ars spoke with Ben Rapoport, who is a neurosurgeon, electrical engineer, and co-founder of the brain-computer interface (BCI) company Precision Neuroscience. Precision is at the forefront of the field, having placed its BCI on the brains of 14 human patients so far, with two more scheduled this month. Rapoport says he hopes to at least double that number of human participants by the end of this year. In fact, the 3-year-old company expects to have its first BCI on the market next year.

In addition to the swift progress, Precision is notable for its divergence from its competitor's strategies, namely Neuralink, the most high-profile BCI company and headed by Elon Musk. In 2016, Rapoport co-founded Neuralink alongside Musk and other scientists. But he didn't stay long and went on to co-found Precision in 2021. In previous interviews, Rapoport suggested his split from Neuralink related to the issues of safety and invasiveness of the BCI design. While Neuralink's device is going deeper into the brain—trying to eavesdrop on neuron signals with electrodes at close range to decode thoughts and intended motions and speech—Precision is staying at the surface, where there is little to no risk of damaging brain tissue.

Enlarge / An MMR and VAR vaccine ready for a pediatric vaccination at Kaiser Permanente East Medical offices in Denver in 2015. (credit: Getty | Joe Amon)

For years, the US Centers for Disease Control and Prevention has bluntly stated the truth: "Vaccines do not cause autism," the agency affirms on its website. Yet, nearly a quarter of Americans still don't believe it.

In an April 2024 survey by the Annenberg Public Policy Center (APPC) of the University of Pennsylvania, 24 percent of US adults denied or disputed that the CDC ever said that. Specifically, the survey asked them to assess the accuracy of the statement that the CDC has said there is no evidence linking vaccines to autism. Six percent called the statement "very inaccurate," and 18 percent said it was "somewhat inaccurate." An additional 3 percent responded that they were "not sure." Of the remaining 73 percent, only 41 percent considered it "very accurate," and 32 percent said it was "somewhat accurate."

The results are largely unchanged from responses in 2018 when survey respondents were asked the same question. In that year, 26 percent of adults reported that the statement was "very inaccurate" or "somewhat inaccurate."

Enlarge / MDMA pills up close. (credit: Getty | Universal History Archive)

After a remarkably sensational regulatory drug review, advisers for the Food and Drug Administration on Tuesday voted overwhelmingly against approving midomafetamine (MDMA, aka ecstasy or molly) as part of therapy for post-traumatic stress disorder.

In a response to the question, "Do the available data show that the drug is effective in patients with posttraumatic stress disorder?" advisers voted 9 "no" to 2 "yes" against MDMA.

The votes come after a full-day meeting in which the independent expert advisers heard detailed reviews of clinical trial data from the company that proposed the therapy—Lykos, formerly MAPS—as well as internal FDA reviews.

Enlarge / Children checking their weight. (credit: Getty | BSIP)

Kids and teens with a high body mass index (BMI) were 29 times more likely to have a high fat mass index compared with youths who had lower BMIs, making the controversial metric a "very good screening tool," according to a study published Monday in the journal Pediatrics.

The study adds to the long-standing debate about the use of BMI, which has always been an imperfect proxy for assessing a person's body fat, aka adiposity. Last year, the American Medical Association adopted a strongly worded policy calling out the calculation's "significant limitations" and "historical harms," including "racist exclusion," because its use is largely based on white populations. But other experts have pushed back, arguing that the maligned metric is still a quick low-cost tool for assessing the health and risks of patients.

BMI, calculated by dividing a person's weight in kilograms by their height in meters squared, has long been used as a shorthand way of assessing a person's adiposity. In children, high BMIs are associated with cardiovascular disease risks later in life. But, the metric can also be misleading. Because it is based solely on weight and height, it does not distinguish between fat and lean mass. As such, athletes with relatively large amounts of lean muscle mass can easily have BMIs that put them in the overweight or obesity categories, while those with little lean mass but high fat mass can still have BMIs in a normal range. BMI also does not tell clinicians anything about body fat distribution, which can be important for health risks. And research has found that the relationship between BMI and adiposity can differ by race and ethnicity. For instance, at the same BMI, Black children tend to have less adiposity than white children.

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.