Psychedelic Pioneer Is Unfazed about MDMA’s Prospects, Despite FDA Setback

The Washington Post / Daniel Gilbert

18:05 JST, August 28, 2024

Rick Doblin spent more than 30 years trying to turn the psychedelic drug MDMA into an accepted medical treatment for post-traumatic stress disorder. Earlier this month, the Food and Drug Administration finally ruled: Denied.

It was a crushing blow for Doblin, founder of the nonprofit Multidisciplinary Association for Psychedelic Studies, with the FDA demanding a new clinical study that would take multiple years and could cost millions of dollars to complete. But the psychedelic crusader insists he’s unfazed.

“I’m not going to go smoke pot and hang out on my couch for the next 20 years,” he said in an interview, criticizing the agency for failing to grasp the drug’s potential to relieve suffering. He has plans to continue fighting to get MDMA – also known by the street name ecstasy – accepted by the medical establishment, with projects to provide the drug to refugees and trauma survivors around the world.

Still, it has been a brutally rough stretch for Doblin and MAPS, which over decades have shepherded an illegal psychedelic drug through clinical trials to prove its therapeutic value. Lykos Therapeutics, which was until this year the for-profit arm of MAPS, conducted two major studies showing MDMA combined with therapy benefited people with PTSD over a placebo. But the FDA cited doubts about the underlying data, echoing concerns from an advisory panel.

Lykos said on Aug. 15 it would lay off 75 percent of its staff and Doblin, who had been on the board since MAPS created it in 2015, would depart.

Psychedelic drugs like MDMA, psilocybin, LSD and ibogaine have in recent years shed some of their stigma as drugs of abuse, with academic researchers and biotech companies carrying out rigorous scientific trials that have demonstrated promise in treating mental health disorders. Investors have poured hundreds of millions of dollars into such efforts.

Many consider Doblin a visionary, the driving force behind the first application of its kind for a psychedelic that the FDA accepted for review, but the regard is not universal. Critics say that the evangelizing by Doblin and MAPS – which extends to endorsing therapists taking MDMA themselves – has skewed their scientific work.

In recent years, MAPS has allowed employees to use marijuana while performing certain jobs, a policy Doblin has called “smokable tasks,” if they and their managers believe they can do them better while high. For Doblin, that has included editing regulatory submissions, he said in 2021.

MAPS said employees are prohibited from being under the influence “to the extent that such drug impairs the employee’s ability to safely perform” a job. Doblin and MAPS have advocated for therapists to have “a single self-experience” with MDMA in a controlled clinical setting to foster understanding and empathy with patients, a spokeswoman said.

The organization disputes that its activism has biased its science, saying that “many steps have been taken to protect the scientific integrity of the trials, in collaboration with the FDA.”

Doblin said leaving the Lykos board was a mutual decision. He is speaking out now after months of relative silence, even as questions mounted about the integrity of the studies that supported MDMA’s safety and effectiveness. He said he’d wanted to address these concerns earlier but deferred to Lykos, which he said exercised control of MAPS’ communications and asked him to refrain.

“The tail was wagging the dog all of a sudden,” Doblin said.

Lykos didn’t respond to questions about Doblin’s comments. In a statement, the company said, “We take to heart the FDA’s decision on our application and are in the midst of undertaking the additional work needed to do to bring this potential pioneering therapy to the millions of veterans, sexual assault survivors and all who need a new treatment for PTSD.”

One major obstacle for Lykos was navigating a bedrock principle in clinical trials that participants shouldn’t know whether they are getting the actual drug or a placebo, a concept known as blinding. That is all but impossible with the consciousness-distorting properties of MDMA, and the vast majority of trial participants knew if they got the drug. While other psychoactive drugs have run into such challenges, the MDMA trials were unique in involving therapists who could also tell whether patients were getting the drug – and potentially inject bias that tilted outcomes in favor of the treatment group.

Doblin, whose dissertation explored designing clinical trials for psychedelics, pushed back on this worry. He said therapists were doing the best they could for patients in the placebo group, evidenced by the 47.6 percent of placebo subjects in one trial who improved to the point that they no longer qualified for a PTSD diagnosis. (For those who received MDMA and therapy, 71.2 percent didn’t qualify for the PTSD diagnosis by the end of the trial).

The therapists “were not trying to game the system,” he said. “The results in the placebo group are the proof of that.”

Further complicating the data, about 40 percent of participants in the Lykos clinical trials had previously used MDMA illicitly. That led some members of an independent advisory committee to question whether those participants were predisposed to expect a benefit, potentially biasing the results.

Doblin pointed to a Lykos presentation that concluded the treatment outcomes were “comparable” for participants who had taken MDMA previously and those who had not. The bigger point, he said, is that using MDMA before the trials hadn’t resolved the participants’ PTSD. “It’s not about the drug, it’s about the therapeutic context that the drug makes more effective,” he said.

Doblin became interested in psychedelics as an undergraduate at New College in Sarasota, Fla. His early experiences filled him with a sense of interconnectedness that he compared to “what a lot of the astronauts talked about, looking back at the Earth from space,” he said at a 2022 event. “I decided that if more people could have this experience, this could be the antidote to evil.” (He “doesn’t believe psychedelics alone will save the world,” a spokeswoman said).

His exploration veered into the scientific, political and legal realms, as he tried unsuccessfully to block the Drug Enforcement Administration from criminalizing MDMA in the 1980s. The way forward, he decided, was winning approval from the FDA.

In that quest, MAPS has raised more than $140 million through philanthropy. It formed a for-profit subsidiary in 2015 to develop and commercialize MDMA-assisted therapy, an organization that became Lykos, which is now majority controlled by private investors.

Doblin is steering MAPS to look globally. He rattled off a project in Somaliland, another working with Syrian refugees in Denmark, and an initiative in Bosnia with survivors of the Srebrenica massacre. MAPS is supporting efforts to bring MDMA to Europe, buoyed by a report from a Dutch state commission recommending the government allow MDMA therapy.

MAPS is also exploring new uses for MDMA, including couples therapy, though Doblin acknowledged “it’s not clear that FDA would ever approve for couples therapy.”