A Boulder-based therapist said he's baffled and disappointed by federal regulators’ decision last month not to approve a therapy using MDMA, also known as ecstasy, to treat PTSD. Bruce Poulter was a lead therapist in the study by Lykos Therapeutics, a company that oversees research into mental health therapies using psychedelics.
Poulter said the study, compiled by research clinics around the world, clearly demonstrated the benefits of what’s known as MDMA-assisted therapy for PTSD. It involves taking the drug three times over several months under the close supervision of two therapists with follow-up sessions around each experience. He said in the Phase III study, 71 percent of participants no longer met the criteria for PTSD.
Poulter said the FDA’s decision is particularly disappointing since there hasn’t been a new treatment for PTSD since the late 1980s when the class of drugs known as SSRIs emerged. And he said those drugs can have significant side effects and don’t work for everyone.
“We actually do have something that is effective. It is safe,” Poulter said. “So if we're making decisions based on data, I would say the FDA is not following the data.”
Poulter characterized the decision as an enormous setback for those seeking treatment for PTSD. He said the condition often leads to suicidal thoughts and suicide because sufferers feel they have no outlet to escape the recurrent symptoms.
“People are dying as a result of this diagnosis,” he said. “So I really struggle with the impact that that decision has had on the people with PTSD.”
Many people are familiar with PTSD, or Post Traumatic Stress Disorder as a condition that afflicts veterans who’ve witnessed violence in combat, but it also affects people who’ve experienced a traumatic event like a car accident as well as survivors of sexual assault and domestic abuse.
It is characterized by recurrent memories or “re-experiencing symptoms,” like nightmares, intrusive memories and “avoidance symptoms,” which mean people avoid people, places and conversations that trigger a traumatic experience. Poulter said PTSD can lead to sleep disturbances, angry outbursts and exaggerated responses to noises or settings.
One of the study’s subjects, Scott Ostrom, a veteran who underwent treatment at the Boulder clinic, said in an interview with CPR News in 2022 that the therapy helped him rediscover the person he was before his two deployments in Iraq. He says one session in particular triggered a memory that enabled him, with the help of the therapists, to get to the root of his PTSD.
“It was about the first time that I was getting ready to step off on a combat mission … I had called my father on a satellite phone and I confessed to him that I was scared,” Ostrom recalled. “And he told me, ‘Don't worry, you're with the best-trained guys, you are one of the best-trained guys. Your training will take over.’ And he was right.”
Ostrom said he came to understand that conversation was a catalyst that led him to develop a new persona he calls “The Bully” in order to survive the pressure of combat. He said MDMA-assisted therapy helped him begin to shed that persona. Ostrom, who has since moved from Colorado to Hawaii, said the benefits have been long-lasting.
MDMA has had a complicated history since it was formulated in 1912 by Merck as a compound to promote blood clotting. It was rediscovered in the 1970s by biochemist Alexander Shulgin and subsequently used as a therapeutic tool by some psychiatrists. In 1985, it became a Schedule I drug, which means it’s illegal except in a research setting, although it continues to be used as a recreational drug.
In a statement to CPR News, Lycos, the company that oversaw the research, said it is "pursuing all available regulatory pathways" to get the treatment approved ... and is working to address the FDA's concerns and resolve any scientific disagreements.”
The FDA declined to respond to specific questions about why the treatment wasn’t approved but said it typically makes the decision when there is a question about safety, efficacy or the manner in which research was conducted. But it left open the possibility that Lykos could submit additional data in the future.
Bruce Poulter surmises the FDA move may have had more to do with a lack of precedent in being tasked with not just a drug, but a therapy as well. He said he believes that factor added a significant complication to the approval process. But, he says, if more research and data is required, he and others will continue their efforts to convince the FDA to approve what he sees as a life-saving therapy.
If you or someone you know needs mental health support, the Suicide and Crisis Lifeline is available 24 hours a day by calling 988.
