A presidential administration finally seems to agree.
One new program 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.
The U.S. Department of Health and Human Services and FDA 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. “We didn’t hear anything about that in the Biden administration”
A spokesperson for HHS did not respond to a request for comment.
As a presidential candidate, Kennedy discussed how his son and several close friends benefited from using psychedelics to deal with grief and other issues.
“What we’re seeing so far is positive,” Collins told House lawmakers in May.
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 jeopardize 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.”
And last month, Texas approved $50 million to study ibogaine, a potent psychedelic made from a shrub that’s native to West Africa, as a treatment for opioid addiction, PTSD and other conditions. The research grant — the largest of its kind by any government — passed with support from the state’s former GOP governor, Perry, and combat veterans, some who have traveled to clinics in Mexico that offer ibogaine.
Ibogaine is on the U.S. government’s ultra-restrictive list of illegal, Schedule 1 drugs, which also includes heroin. So advocates in Texas are hoping to build a national movement to ease restrictions on researching its use.
“Governmental systems move slowly and inefficiently,” said Bryan Hubbard of Americans for Ibogaine, a group formed with Perry. “Sometimes you find yourself constrained in terms of the progress you can make from within.”
Ibogaine is unique among psychedelics in both its purported benefits and risks. Small studies and anecdotal reports suggest the drug may be able to dramatically ease addiction and trauma. It was sold for medical use in France for several decades starting in the 1930s, but the drug can also cause dangerous irregular heart rhythms, which can be fatal if left untreated.
Some veterans who have taken the drug say the risks can be managed and ibogaine’s healing properties go far beyond antidepressants, mood stabilizers, counseling and other standard treatments.
Marcus Capone struggled with anger, insomnia and mood swings after 13 years as a Navy Seal. In 2017, at the urging of his wife Amber, he agreed to try ibogaine as a last resort. He described his first ibogaine session as “a complete purge of everything.”
“But afterward I felt the weight just completely off my shoulders,” he said. “No more anxiety, no more depression, life made sense all of a sudden.”
A nonprofit founded by the Capones, Veterans Exploring Treatment Solutions, or VETS, has helped over 1,000 veterans travel abroad to receive ibogaine and other psychedelics.
But federal scientists have looked at the drug before — three decades ago, when the National Institute on Drug Abuse funded preliminary studies on using it as an addiction treatment. The research was discontinued after it identified “cardiovascular toxicity.”
“It would be dead in the water,” in terms of winning FDA approval, longtime NIDA director Nora Volkow said.
But Volkow said her agency remains interested in psychedelics, including ibogaine, and is funding an American drugmaker that’s working to develop a safer, synthetic version of the drug.
“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.”
