US health secretary Robert F Kennedy Jr said he wants psychedelic therapies approved within a year, surprising even the staunchest supporters of the drugs.
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For decades, proponents of psychedelic drugs have pushed a provocative message: Illegal, mind-altering substances like LSD and ecstasy should be approved for patients grappling with depression, trauma and other hard-to-treat conditions.
In the United States, a presidential administration finally seems to agree.
“This line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months,” US health secretary Robert F Kennedy Jr recently told members of Congress.
His suggested timeline for green-lighting psychedelic therapy surprised even the most bullish supporters of the drugs.
The Trump administration's embrace of psychedelics has sparked both excitement as well as concern from those in the field, who worry the drugs might be discredited if they appear to be rushed onto the market or are too closely linked with Kennedy, who is known for controversial views on vaccines, antidepressants, and fluoride.
“I’m quite optimistic,” says Rick Doblin, whose organisation has pursed the medical use of MDMA (or ecstasy) since the 1980s. “But I’m also worried that the message the public might get is ‘Well, RFK likes psychedelics and now it’s approved'".
US regulators may reconsider MDMA
Under former US President Joe Biden, the Food and Drug Administration (FDA) rejected MDMA as a treatment for post-traumatic stress disorder (PTSD), citing flawed data and questionable research.
Regulators called for a new study, likely taking several years. It was a major setback for Doblin and other advocates hoping to see the first US approval of a psychedelic for medical use, and European researchers said it likely set the field back there as well.
But the agency appears ready to reconsider. FDA chief Marty Makary, who reports to Kennedy, has called the evaluation of MDMA and other psychedelics “a top priority,” announcing a slate of initiatives that could be used to accelerate their approval.
One new programme promises to expedite drugs that serve “the health interests of Americans,” by slashing their review time from six months or more to as little as one month. Makary has also suggested greater flexibility on requirements for certain drugs, potentially waiving rigorous controlled studies that compare patients to a placebo group.
That approach, considered essential for high-quality research, has long been a stumbling point for psychedelic studies, in which patients can almost always correctly guess whether they’ve received the drug or a dummy pill.
Links to psychedelic advocates
US health agencies also recently hired several new staffers with ties to the psychedelic movement.
“These are all very promising signs that the administration is aware of the potential of psychedelics and is trying to make overtures that they’re ready to approve them,” said Greg Ferenstein, a fellow at the libertarian Reason Foundation, who also consults for psychedelic companies.
As a presidential candidate, Kennedy discussed how his son and several close friends benefited from using psychedelics to deal with grief and other issues.
But some experts worry the hope and hype surrounding psychedelics has gotten ahead of the science.
Philip Corlett, a psychiatric researcher at Yale University, says bypassing rigorous clinical trials could set back the field and jeopardise patients.
"If RFK and the new administration are serious about this work, there are things they could do to shepherd it into reality by meeting the benchmarks of medical science," Corlett said. “I just don’t think that’s going to happen.”
Nora Volkow, the longtime director of the US National Institute on Drug Abuse, said her agency remains interested in psychedelics. It is funding a US drugmaker that's working to develop a safer, synthetic version of ibogaine, which is a potent psychedelic made from a shrub that's native to West Africa.
Texas recently launched a $50 million (€42.7 million) trial to test ibogaine as a treatment for opioid addiction, PTSD, and other conditions.
“I am very intrigued by their pharmacological properties and how they are influencing the brain,” Volkow said.
“But you also have to be very mindful not to fall into the hype and to be objective and rigorous in evaluating them".
