On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a scathing rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they framed as a “threat” to the FDA’s work and a danger to Americans’ health.

In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.

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© Getty | Joe Raedle

When the Trump administration brutally cut federal funding for biomedical research earlier this year, at least 383 clinical trials that were already in progress were abruptly canceled, cutting off over 74,000 trial participants from their experimental treatments, monitoring, or follow-ups, according to a study published today in JAMA Internal Medicine.

The study, led by researchers at Harvard, fills a knowledge gap of how the Trump administration’s research funding cuts affected clinical trials specifically. It makes clear not just the wastefulness and inefficiency of the cuts but also the deep ethical violations, JAMA Internal Medicine editors wrote in an accompanying editor’s note.

In March, the National Institutes of Health, under the control of the Trump administration, announced that it would cancel $1.8 billion in grant funding that wasn’t aligned with the administration’s priorities. The Harvard researchers, led by health care policy expert Anupam Jena, used an NIH database and a federal accountability tracking tool to find grants supporting clinical trials that were active as of February 28 but had been terminated by August 15.

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© Getty | Francis Chung

Legislation proposed in Arizona would provide millions of dollars in grant funding to expand research into psilocybin––the primary psychoactive component in magic mushrooms––as a potential treatment for certain mental health conditions.

The bill, introduced by a Republican lawmaker and backed by Democrats, “would put $30 million in grants over three years toward clinical trials using whole-mushroom psilocybin to treat mental health conditions like depression and PTSD,” the Arizona Mirror reports. 

The outlet reports that one of the bill’s biggest backers is Dr. Sue Sisely, an internal medicine physician who believes that psilocybin treatment could be a boon for ailing military veterans. 

“It’s curbed their suicidality, it’s put their PTSD into remission, it’s even mitigated their pain syndromes,” Sisely said of patients she has seen benefit from psilocybin, as quoted by the Arizona Mirror. “It’s shown evidence of promoting neurogenesis (the growth and development of nerve tissue). There’s all kinds of great things that are being uncovered, but they’re not in controlled trials—they’re anecdotes from veterans and other trauma sufferers.” 

According to the Mirror, “so far the only controlled trials on psilocybin to treat medical conditions have used a synthetic, one-molecule version of the substance, which is vastly different from a whole mushroom, which contains hundreds of compounds.”

“These agricultural products are very complex, and that is what people are reporting benefit from,” Sisley told the Arizona Mirror. “Nobody in the world has access to synthetic psilocybin unless you’re in one of these big pharma trials.” 

In the last decade, psilocybin has gone from the fringes to the mainstream, as researchers and policymakers have grown more amenable to mushrooms as an effective treatment for a variety of different disorders. 

It has also become the next frontier for drug legalization advocates, as states like Arizona consider measures that would expand its usage. 

To the north of the Grand Canyon State, advocates in Utah have launched a campaign to push legislators to legalize psilocybin for clinical and academic purposes.

“Numerous robust studies have shown that psilocybin therapy is beneficial in reducing treatment-resistant depression, anxiety, addiction, trauma, obsessive-compulsive disorder, and other mental health disorders. It is more effective than synthetic pharmaceuticals by a large margin. Psilocybin has also shown effectiveness in easing fear and anxiety in people with terminal cancer. For instance, a groundbreaking study performed by John Hopkins Medicine found that psilocybin reported better moods and greater mental health after participating in a single clinical dose,” Utah Mushroom Therapy, the group behind the campaign, says in a statement.

The group is looking to gin up public support for the treatment after the state’s Republican governor, Spencer Cox, signed a bill last year establishing a task force that will study psilocybin as a mental health treatment.

Utah Mushroom Therapy says that, in the wake of the task force, “legalizing and decriminalizing Psilocybin in Utah is now very likely but still needs public support.”

“The use of mushrooms has been documented in 15 indigenous groups in America and various religious communities in Utah. This petition supports those groups who wish to use psilocybin safely, sincerely, and as a necessary part of their religion. The use of psilocybin does not contradict other Utah cultures and is protected by the first amendment as well as the Religious Freedom Restoration Act. This petition is to advocate Utah law to protect the religious rights of Utahns,” the group says. 

“Psilocybin is a natural, non-toxic substance. Despite this, it is currently a Schedule I substance. Scientists have demonstrated it has profound medicinal value and believe serotonergic hallucinogens assist cognitive processes and should be decriminalized. Psychedelics can change perception and mood, help people soften their perspective and outlook, and process events that may otherwise lead to substance abuse, trauma, and criminal behavior,” it continues.

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