For decades, supporters of psychedelic drugs have come to Washington with provocative messages. Illegal and heart-changing substances like LSD and ecstasy should be approved by Americans working on depression, trauma and other difficult-to-treat conditions.
The presidential administration appears to have finally agreed.
“This series of treatments is working very hard to make sure that, given in a clinical setting, that will happen within 12 months,” Health Secretary Robert F. Kennedy Jr. recently told members of Congress.
His proposed timeline of green light psychedelic therapy was amazed even among the most bullish supporters of the drug. And that comes when psychedelics are invading deep red states like Texas. There, former Trump Minister secretary and former governor Rick Perry cast his full support behind the efforts.
The administration's psychedelic embrace sparked both concern and concern from people on the ground. They may be worried that the drug may be trusted if it appears they are running into the market or if it is closely linked to Kennedy, known for its controversial views on vaccines, antidepressants and fluorides.
“I'm very optimistic,” says Rick Doblin, who has been pursuing medical use of MDMA (or ecstasy) since the 1980s. “But I'm also worried that the message that the public might get is that “Well, RFK likes psychedelics and is now approved.” ”
The FDA could reconsider the MDMA under President Joe Biden, and the FDA rejected the MDMA as a treatment for post-traumatic stress disorder, citing defective data and suspicious studies. It probably took several years to seek new research. This was a big set-off for Doblin and other supporters who are hoping for the first US approval of medical psychedelics.
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But the agency appears to be ready to rethink. Reporting to Kennedy, FDA Chief Marty McCurry called the MDMA and other psychedelics “first priority” and announced the slate of initiatives that can be used to accelerate approval.
One new program promises to promote drugs that help “benefits to American health” by reducing review times from over six months to just one month. McCurry also proposes increased flexibility to specific drug requirements, potentially abandoning strictly controlled studies comparing patients to placebo groups.
This approach, considered essential for high quality research, has long been a stumbling point in psychedelic research, allowing patients to correctly infer whether they were almost always given drugs or dummy pills.
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The U.S. Department of Health and Human Services and the FDA have recently hired several new staff members with ties to the psychedelic movement.
“All of these are very promising signs that the administration is aware of the potential of psychedelics and is ready to approve them,” said Greg Ferenstein, a fellow at the Libertarian Reason Foundation, who consults psychedelic companies.
“We didn't hear anything about that in the Biden administration.”
A spokesman for HHS did not respond to requests for comment.
As a presidential candidate, Kennedy discussed how his son and several close friends benefited from using psychedelics to address grief and other issues.
Many veterans lobbying for psychedelic access have already met with Doug Collins, Trump's veteran secretary.
“What I've seen so far is positive,” Collins told the House of Representatives in May.
However, some experts are worried that hope and hype surrounding psychedelics are ahead of science.
Philip Collett, a psychiatry researcher at Yale University, says bypassing rigorous clinical trials could put patients at risk.
“If the RFK and the new administration are taking this work seriously, there are things we can do to save it in reality by meeting the medical benchmark,” Colette said. “I don't think that's going to happen.”
Texas is fully investigating Ibogaine as Washington officials weigh the future of psychedelics, with some states moving forward with their own projects in the hopes of fine-tuning the federal government. Oregon and Colorado have legalized psychedelic therapies.
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And last month, Texas approved $50 million to study Ibogaine, a powerful psychedelic made from shrubs native to West Africa, as a treatment for opioid addiction, PTSD and other conditions. Research grants – the biggest of any government of its kind – were passed with support from the state's former GOP governor, Perry, and combat veterans.
Ibogaine is on the US government's ultra-restrictive list of illegal Schedule 1 drugs, including heroin. That's why Texas advocates want to build a national movement to ease restrictions on research into its use.
“The government system moves slowly and inefficiently,” said Brian Hubbard of Ibogaine, a group formed with Perry.
“Sometimes they are constrained in terms of progress that can be made from within.”
Ibogaine is unique among the psychedelics in both its benefits and risks. Small studies and anecdotal reports suggest that this drug may dramatically alleviate addiction and trauma. It was sold for medical use in France for decades from the 1930s, and the drug can cause dangerous, irregular heart rhythms.
Some veterans who took the medication say they can manage risks, and the healing properties of ibogaine are well above antidepressants, mood stabilizers, counseling and other standard treatments.
Marcus Capone struggled to get angry, insomnia and mood swings 13 years later as a seal of the Navy. In 2017, with the promotion of his wife Amber, he agreed to try Ibogain as a last resort. He described his first Ibogain session as “a complete purge of everything.”
“But then I felt my weight was completely off my shoulder,” he said. “There's no more anxiety or depression, and life suddenly makes sense.”
Capones, a veteran who explores treatment solutions, or a nonprofit founded by veterinarians, has helped over 1,000 veterans travel abroad to receive ibogaine and other psychedelics.
But federal scientists were looking at the drug 30 years ago when the National Institute on Substance Abuse funded a preliminary study on its use as addiction treatment. This study was discontinued after identifying “cardiovascular toxicity.”
“It's going to be dead underwater,” said longtime NIDA director Nora Volkow in terms of earning FDA approval.
However, Volkow said her agency is interested in psychedelics, including Ibogaine, and is funding American drugmakers who work to develop safer, synthetic versions of drugs.
“I'm very interested in their pharmacological properties and how they affect their brains,” Volkau said.
“But you also have to make sure you don't fall into hype and be very aware that you are objective and strict when evaluating them.”
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