NEW YORK — It was a landmark moment for the psychedelic movement: The Department of Veterans Affairs’ top doctor took the stage, praising advocates who have spent decades promoting the Healing potential of mind-altering drugs.
In an unannounced appearance at a psychedelic conference in New York, the VA’s Dr. Shereef Elnahal said his agency was ready to begin implementing MDMA-Assisted Therapy for Post-Traumatic Stress Disorder as soon as regulators approve it.
“The VA has to be first, as we have been, with the mental health needs of our veterans,” Elnahal told attendees at the May meeting. He also highlighted the “incredible and groundbreaking” research on the drug carried out by MAPS, or the Multidisciplinary Association for Psychedelic Studies, the leading nonprofit organization advocating medicine and legal use of hallucinogenic drugs.
But expectations for MDMA’s unprecedented approval were dashed a few weeks later, when Food and Drug Administration advisers voted overwhelmingly against the drug, citing flawed data, questionable research conduct, and potential safety and addiction risks. The panel’s recommendation is non-binding, but the FDA is expected to delay or withhold approval when it makes its decision in mid-August.
The potential rejection sent shockwaves through the psychedelic community, including combat veterans who spent years lobbying for the drug, also known as ecstasy or molly. The advocacy effort has long been intertwined with MAPS, which has funded or supported some of the most vocal veterans supporting psychedelic therapy.
Dr. Harold Kudler of Duke University met with veterans and MAPS leaders while serving as the VA’s chief consultant on mental health services. He believes FDA experts are justifiably skeptical of the science behind the drug, which he says has been drowned out by messaging from MAPS and its leader, Rick Doblin, who began seeking MDMA approval in the mid-1990s. 1980.
“Rick is the most persuasive advocate for the scientific community I have ever seen. You want to believe him because he is offering you something you urgently need – an effective treatment for PTSD,” Kudler said. “But I think the FDA committee had an idea of how much of this is Rick’s zeal and how much is real.”
MAPS declined to make Doblin available for an interview. Instead, the group pointed to a recent declaration by two dozen scientists and pharmaceutical executives – many with experience in psychedelic research – supporting the approval of MDMA.
Earlier this year, MAPS changed the name of its drug development arm to Lykos Therapeutics, allowing the new company to raise funds from external investors.
In addition to deficiencies in the Lykos studies, FDA panel members expressed concern about separate allegations that some MAPS-affiliated researchers suppressed negative study results or coached patients to inflate positive results. The FDA says it is investigating these allegations.
Casey Tylek, an Army veteran, says he experienced none of this while participating in the study. When he asked researchers for guidance in evaluating the drug’s effect, Tylek said he was repeatedly rebuffed and told he should evaluate the treatment without any outside influence.
Tylek says he was “pessimistic” going into the trial, but credits MDMA-assisted therapy with resolving anger, anxiety and trauma stemming from a rocket attack in Iraq.
“It basically rewrote that memory in my mind and how it worked,” Tylek said. “I was able to just let it go and not get caught up in it.”
Kudler and other researchers say they want to see MDMA’s results confirmed in larger studies that have no ties to the psychedelic community.
This work would take years. Veterans who support the treatment say it would endanger patients suffering from PTSD who have not been helped by antidepressants and other existing therapies. The suicide rate among veterans is 70% higher than the general population, according to government data, with 18 veteran suicides per day in 2021.
Jon Lubecky, who served in the Marines and Army, says he tried to kill himself five times after returning from deployment to Iraq in 2006. After years of struggling with PTSD, he signed up for a MAPS test in 2014. He credits MDMA-assisted therapy to cure your condition.
Since then, Lubecky has told his story hundreds of times in press interviews, congressional hearings and private meetings with military officials and federal lawmakers, including conservatives like Sen. Rand Paul and Rep. Dan Crenshaw.
Lubecky has worked as a MAPS consultant for more than five years. But he rejects the idea that he was merely promoting the agenda of psychedelic boosters who want to see drugs completely legalized.
“I’m not in this to end the war on drugs or any of these other things,” he said. “I’m in this for my friends.”
Lubecky’s work helped secure $20 million in funding for the VA to conduct its own studies on psychedelics, including MDMA and ketamine.
Part of the rationale for this research: Many veterans now leave the U.S. to undergo psychedelic therapy at clinics in Mexico, Peru and other countries where it is more accessible.
A nonprofit group, Heroic Hearts Project, currently has a waiting list of more than 1,000 veterans seeking financial and logistical support to travel abroad. A former Army Ranger, Jesse Gould, founded the group after returning from a week-long retreat in Peru using ayahuasca, the psychedelic drink associated with indigenous Amazonian cultures. After the experience, he said he was able to overcome the anxiety, anger and depression that overwhelmed him after three tours in Afghanistan.
Gould says MAPS deserves credit for starting research that could eventually help thousands of veterans.
“I think MAPS has done more for the veteran community in this area than most politicians have done in the last 20 years,” said Gould, whose group has no financial ties to MAPS. “Time and time again, our needs go unnoticed or go to the back of the line.”
Heroic Hearts hosted an event on Capitol Hill earlier this month where several House lawmakers and veterans called for the approval of MDMA.
Gould doesn’t expect the FDA to flatly reject MDMA. Instead, he and others say the agency may ask Lykos to conduct additional studies.
Even if the company can’t quickly conduct this investigation, experts say others could benefit from avoiding the pitfalls of Lykos’ MDMA application, including a small patient population with little diversity and a high potential for bias.
Dozens of other pharmaceutical companies They are studying psilocybinLSD and other psychedelics for depression, anxiety and addiction.
John Krystal, a professor of psychiatry at Yale University, said the Lykos setback “will hopefully ensure that future studies are conducted in a way that gives reviewers greater confidence about the efficacy and safety of these medications.”
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