NEW YORK — It was a milestone for the psychedelic movement: The Department of Veterans Affairs’ top doctor stood at the podium and praised the advocates who have spent decades healing potential of mind-altering drugs.
During an unannounced appearance at a psychedelic conference in New York, the VA’s Dr. Shereef Elnahal said his agency was ready to begin rolling out MDMA-Assisted Therapy for Post-Traumatic Stress Disorder once the regulators approved it.
“The VA needs to be, as we have always been, first in line with the mental health needs of our veterans,” Elnahal told attendees at the May meeting. He also highlighted the “tremendous, groundbreaking” research on the drug by MAPS, or the Multidisciplinary Association for Psychedelic Studies, the leading nonprofit organization that advocates for the medical and legal use of hallucinogenic drugs.
But hopes for the first-of-its-kind approval of MDMA were quickly dashed a few weeks later when Food and Drug Administration advisers voted overwhelmingly against the drugciting flawed data, questionable research and potential safety and addiction risks. The panel’s recommendation is not binding, but the FDA is expected to delay or reject approval when it makes a decision in mid-August.
The potential rejection has sent shockwaves through the psychedelic community, including war veterans who have spent years lobbying for the drug, also known as ecstasy or molly. The lobbying effort has long been intertwined with MAPS, which has funded or supported some of the most outspoken veterans supporting psychedelic therapy.
Duke University’s Dr. Harold Kudler met with veterans and MAPS leaders when he was the VA’s chief adviser on mental health. He believes FDA experts are right to be skeptical about the science behind the drug, which he says has been drowned out by messages from MAPS and its leader, Rick Doblin, who began pursuing MDMA approval in the mid-1980s.
“Rick is the most compelling advocate within the scientific community that I’ve ever seen. You want to believe him because he’s offering you something you desperately need — an effective treatment for PTSD,” Kudler said. “But I think the FDA committee got a glimpse 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 rack by two dozen scientists and pharmaceutical executives — many with backgrounds in psychedelic research — who supported MDMA’s approval.
Earlier this year, MAPS changed the name of its drug development division to Lykos Therapeutics, making the new company raise funds from external investors.
In addition to deficiencies in the Lykos studies, FDA panelists raised concerns 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 those claims.
Casey Tylek, an Army veteran, says he has experienced none of that participate in the studyWhen he asked researchers for guidance in evaluating the drug’s effect, Tylek said he was repeatedly turned down and told to evaluate the treatment without any outside influence.
Tylek says he was “pessimistic” when he started the process, but he credits MDMA-assisted therapy with resolving the anger, fear and trauma stemming from a rocket attack in Iraq.
“It basically rewrote that memory in my head and how it functioned,” Tylek said. “I was able to just let it go and not be attached to it anymore.”
Kudler and other researchers would like to see the MDMA results confirmed in larger studies separate from the psychedelic community.
That work would take years. Veterans who support the treatment say it would endanger patients with PTSD who haven’t been helped by antidepressants and other existing therapies. According to government figures, veterans have a suicide rate 70% higher than the general population, with 18 veteran suicides a day in 2021.
Jon Lubecky, who served in both the Marines and the Army, says he attempted suicide five times after returning from his deployment to Iraq in 2006. After struggling with PTSD for years, he signed up for a MAPS trial in 2014. He credits MDMA-assisted therapy with curing his condition.
Since then, Lubecky has told his story hundreds of times in media interviews, congressional hearings and private meetings with military officials and federal lawmakers, including conservatives like Sen. Rand Paul and Rep. Dan Crenshaw.
Lubecky worked as a consultant for MAPS for more than five years. But he rejects the idea that he merely promoted the agenda of psychedelic boosters who want to see the drugs fully legalized.
“I’m not doing this to end the drug war or any of those other things,” he said. “I’m doing this for my friends.”
Lubecky’s work helped the VA secure $20 million in funding to conduct its own studies of psychedelics, including MDMA and ketamine.
Part of the reason for that research: Many veterans are now leaving the U.S. to receive psychedelic therapy at clinics in Mexico, Peru and other countries where it is more accessible.
A nonprofit organization, 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 weeklong retreat in Peru using ayahuasca, the psychedelic brew associated with indigenous Amazonian cultures. After the experience, he said he was able to overcome the anxiety, anger and depression that had weighed him down after three deployments to Afghanistan.
Gould said MAPS deserves credit for launching research that could ultimately 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 are either not heard or they get pushed to the back of the line.”
Heroic Hearts hosted an event on Capitol Hill earlier this month, where several lawmakers and veterans called for MDMA approval.
Gould doesn’t expect the FDA to reject MDMA outright. Instead, he and others say the agency could ask Lykos to conduct additional studies.
Even if the company can’t conduct that study quickly, experts say others could benefit if they can avoid the pitfalls of Lykos’ MDMA application, including a small patient population with little diversity and a high risk of bias.
Dozens of other pharmaceutical companies learning psilocybinLSD and other psychedelics against depression, anxiety and addiction.
Dr. John Krystal, a professor of psychiatry at Yale University, said the Lykos setback “will hopefully ensure that future studies are conducted in ways that give reviewers more confidence in the effectiveness and safety of these drugs.”
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.