Trump’s Rogan-inspired psychedelics order stokes cautious optimism
Trump’s Rogan-inspired psychedelics order stokes cautious optimism
President Trump’s executive order loosening research restrictions on psychedelic medicine, which was kick-started by a text to Trump from podcaster Joe Rogan, could help legitimize an industry that’s long operated in the shadows.
Advocates and researchers said they are optimistic about a potential shift in how the government views psychedelic drugs, but without further action, they aren’t expecting widespread access to Americans who need urgent mental health treatments.
Research into psychedelic drugs like psilocybin, MDMA and ibogaine, which has been embraced by combat veterans and conservative lawmakers, has been notoriously slow and difficult largely because of federal restrictions.
Even as studies have shown the potential benefit of psychedelic drugs in treating mental health disorders, researchers have been stymied.
Psychedelics have been banned since former President Nixon’s war on drugs in the 1970s. They are classified under the government’s most restrictive category as Schedule I; illegal, high-risk drugs that have no accepted medical use and a high potential for abuse.
Trump’s executive order calls on federal agencies — like the Food and Drug Administration (FDA), the Department of Justice and the Drug Enforcement Administration (DEA) — to cut through that longstanding red tape.
“One of the bottlenecks to getting controlled substances approved once they show convincing clinical data was the rescheduling process,” former FDA Commissioner Scott Gottlieb said in a recent interview on CNBC’s “Squawk Box.”
“So the president gave a nudge to FDA and DEA working together,” Gottlieb said.
In an Oval Office event Saturday, Trump touted “historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs.”
“In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression, including our cherished veterans,” Trump said.
The order directs the FDA to work with the DEA on a pathway for terminally ill patients to access experimental psychedelic drugs.
It will also provide $50 million for state-level research into ibogaine and offer a pathway for the drug to be studied in the first human trials.
The $50 million could benefit Texas the most, as the state launched a research program into the drug but couldn’t find a private company to help develop it into a drug for FDA approval.
Ibogaine has the potential to help alleviate opioid withdrawal symptoms, but the drug is off-limits domestically. Most Americans travel to clinics in Mexico, Costa Rica, Portugal and Brazil, where the treatment can cost tens of thousands of dollars.
“It’s disturbing to me and to the president that hundreds, in fact, thousands of veterans are having to travel to Mexico or other countries to experiment with interventions that hold great promise,” Health Secretary Robert F. Kennedy Jr. said Saturday in the Oval Office.
“We need to get this promising treatment here,” Kennedy told Sen. Tommy Tuberville (R-Ala.) during a hearing on Wednesday. “We need to do the proper studies and make it available to these vets, and we’re doing that right away.”
The FDA will also issue national priority review vouchers this week for three psychedelics, which will fast-track approval for promising therapies, agency Commissioner Marty Makary said.
Frederick Barrett, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins School of Medicine, said he is encouraged that the administration is calling attention to potential mental health treatments that have long been stigmatized.
“I think we owe it to the millions of Americans who are suffering from mental illness to try everything we can to bring forward, the most responsible and safe options. So my hope is that this executive order will help us to do just that,” Barrett said.
Kennedy has made easing research into psychedelic drugs a priority, and the executive order comes as more Republican lawmakers are embracing their potential to treat conditions like post-traumatic stress disorder, depression and substance abuse.
Notably, Trump said the issue was only recently put on his radar by Rogan.
“Joe is an amazing guy, and he wrote me a little note about this, and I had it checked out,” Trump said.
Rogan recounted how he texted Trump about research around ibogaine and received a quick response: “Sounds great. Do you want FDA approval? Let’s do it.”
“It was literally that quick,” Rogan said.
Centers for Medicare and Medicaid Services Administrator Mehmet Oz said the order was written in less than a week.
“The president just would not take no for an answer,” Oz said. “This was an unimaginable task in one week to be able to go from a series of connections and communications with Joe Rogan” and then to Kennedy to complete the order.
But despite the newly aggressive push, federal officials acknowledged that much of the research is still in the early stages.
“I do want to emphasize this is something that we’re still studying, and we have to keep studying,” National Institutes of Health Director Jay Bhattacharya said. “We have to figure out the right way to make sure we administer it, that it’s safe, that we don’t just take it for granted, we already know everything, because we don’t.”
Andrew Kessler, the founder of behavioral health consultancy Slingshot Solutions, said medications shouldn’t exist in a vacuum.
Fast-tracking research and approval is helpful, he said, but shouldn’t be considered a substitute for investments in recovery and behavioral health. There is no single answer to any aspect of public health, let alone mental health and substance use disorders, he said.
“No matter how front and center you put [psychedelic research] the reality is it can be years, if not decades, before we see a product that is on the market that can be of any kind of great assistance,” Kessler said.
“That’s not going to help the 70,000 people who overdose in the next 12 months. If you’re praising this and you think this is a great idea, then there’s plenty of room on the bandwagon for you to also support everything else we need, like a strong SAMHSA [Substance Abuse and Mental Health Services Administration], a strong Medicaid system, a strong VA [Department of Veterans Affairs] and everything else. You got to be all in on this.”
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