Enlarge (credit: Getty | RJ Sangosti)

After an MDMA therapy for post-traumatic stress disorder dramatically failed to impress Food and Drug Administration advisers earlier this month, researchers are moving forward with another psychedelic—a slow-release oral dose of the hallucinogenic drug ketamine—as a therapy for treatment-resistant depression.

In a mid-stage, randomized, placebo-controlled clinical trial, researchers tested slow-release ketamine pills, taken twice weekly. The trial, sponsored by New Zealand-based Douglas Pharmaceuticals, found ketamine to be safe compared with placebo. At the trial's highest dose, the treatment showed some efficacy against depression in patients who had previously tried an average of nearly five antidepressants without success, according to the results published Monday in Nature Medicine.

But the Phase II trial, which started with 231 participants, indicated that the pool of patients who may benefit from the treatment could be quite limited. The researchers behind the trial chose an unusual "enrichment" design to test the depression treatment. This was intended to thwart the high failure rates generally seen in trials for depression treatments, even in patients without treatment-resistant cases. But even after selecting patients who initially responded to ketamine, 59.5 percent of the enriched participants still dropped out of the trial before its completion, largely due to a lack of efficacy.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC. (credit: Getty | Susan Walsh)

The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own expert review teams and two of its directors.

In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.

Elevidys initially gained an FDA approval last year, also over objections from staff. The therapy intravenously delivers a transgene that codes for select portions of a protein called dystrophin in healthy muscle cells; the protein is mutated in patients with DMD. Last year's initial approval occurred under an accelerated approval process and was only for use in DMD patients ages 4 and 5 who are able to walk. In the actions Thursday, the FDA granted a traditional approval for the therapy and opened access to DMD patients of all ages, regardless of ambulatory status.

Enlarge (credit: Diamond Shruumz)

Cases of illnesses linked to microdosing candies have more than doubled, with reports of seizures and the need for intubation, mechanical ventilation, and intensive care stays. But, there remains no recall of the products—microdosing chocolates, gummies, and candy cones by Diamond Shruumz—linked to the severe and life-threatening illnesses. In the latest update from the Food and Drug Administration late Tuesday, the agency said that it "has been in contact with the firm about a possible voluntary recall, but these discussions are still ongoing."

In the update, the FDA reported 26 cases across 16 states, up from 12 cases in eight states last week. Of the 26 reported cases, 25 sought medical care and 16 were hospitalized. No deaths have been reported.

Last week, the Centers for Disease Control and Prevention released a health alert about the candies. The agency noted that as of June 11, the people sickened after eating Diamond Shruumz candies presented to health care providers with a host of severe symptoms. Those include: central nervous system depression with sedation, seizures, muscle rigidity, clonus (abnormal reflex responses), tremor, abnormal heart rate (bradycardia or tachycardia), abnormal blood pressure (hypotension or hypertension), gastrointestinal effects (nausea, vomiting, or abdominal pain), skin flushing, diaphoresis (excessive sweating), and metabolic acidosis with increased anion gap (an acid-based disorder linked to poisonings).

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."