Before MDMA was a party drug, there was a brief moment when it seemed it might become a part of the psychotherapist’s standard tool kit. The drug’s ability to lower inhibitions and foster communication seemed especially promising for couples therapy. That possibility ended in 1985, when the federal government officially classified the drug as a Schedule 1 substance, claiming it had no accepted medical use and a high potential for abuse. MDMA joined all the other Schedule 1 drugs — widely used recreationally but generally off-limits to researchers — but activists continued to advocate for its therapeutic benefits.
As part of our investigation into psychedelic therapies for our podcast Cover Story: Power Trip, we’ve been studying one of the leaders of the movement, a man named Rick Doblin. If the medical use of MDMA ever becomes mainstream, it will be mostly due to Doblin. The organization he leads as executive director, the Multidisciplinary Association for Psychedelic Studies (MAPS), is currently running the world’s most advanced clinical trials on MDMA-assisted psychotherapy for PTSD. Companies like Google and political megadonors like Rebekah Mercer and the Rockefellers donate to support MAPS, which had more than $19 million in revenue in 2020. In May 2021, Doblin’s work earned him a flattering profile in the New York Times, complete with a photo of him leaning against a tree and staring blissfully skyward. Michael Pollan even tweeted to promote Doblin’s TED Talk.
Born in 1953 and raised in Chicago, he was the son of a pediatrician and schoolteacher. As he puts it, after an eye-opening experience with LSD at age 18, he wanted to upend conventional thinking about psychedelics. “Once I realized the potential of psychedelics, I also realized that there was this massive backlash that had criminalized them and was wiping out psychedelic research all over the world,” he said in a 2020 radio interview. “So, out of fear and desperation at age 18, I told myself I would dedicate myself to psychedelic therapy and trying to bring back psychedelic research.” In countless interviews and hours of recorded presentations, he’s candid about his “pro-freedom-of-consciousness stance” and draws people in with his passion for psychedelics, especially MDMA. Doblin’s is a message of hope — about healing ourselves to heal the world.
He was 28 years old when he tried MDMA for the first time. It was 1982. “I was just stunned at how profound the experience was,” he said. “It was clear to me how tremendous it would be as an adjunct to psychotherapy.” Doblin quickly began promoting the drug’s positive effects. As he’s recounted in his TED Talk and on the Tim Ferriss Show podcast, in 1984, Doblin sold MDMA to the boyfriend of a woman named Marcela Ot’alora, who took the drug and recovered traumatic memories while under its influence. Doblin then offered to give her MDMA again, and later LSD — this time to help address the trauma those memories had resurfaced. Doblin hadn’t yet completed his undergraduate degree. Ot’alora, who discussed her experience in a 2019 interview, moved in with him for a month. She describes improving under his care, and she is now one of the lead therapists and trainers for MAPS.
For nearly four decades, Doblin has sought to reverse the federal ban on MDMA. While his collaborators sought to keep a low profile ahead of the DEA hearing, Doblin went on a media blitz. In 1985, he told this magazine, “I think if people are going to do stories, they might as well have the right information.” Commenting in that same article, one of Doblin’s colleagues said, “Rick is a good kid, but he may be single-handedly responsible for the emergency scheduling of MDMA by the government.”
Almost 30 years later, Doblin hasn’t wavered in his commitment to the cause. He encourages those with PTSD to “hang on” until the government approves MDMA for PTSD. “MDMA works,” he said simply in 2001. “It’s not been shown in clinical trials but I think that it’s my operating assumption that MDMA is both a safe and effective adjunct to psychotherapy.” MAPS has been conducting clinical trials of the drug-assisted psychotherapy for more than 20 years. The research is being done in pursuit of FDA approval, but other than that, everything else about the trial—its length, its methodology, and the involvement of activists like Doblin—has been unusual.
Doblin has an advanced degree, but it’s not in psychology. In 2001, he graduated with a Ph.D. in public policy from the Harvard Kennedy School. “We don’t actually do science,” he says of his work with MAPS. “We do political science.”
One of the reasons he chose MDMA for the clinical trials, he says, is because he believes it is a tamer psychedelic, one that might appear less frightening to the public. In devising his strategy, Doblin also sought out a sympathetic patient pool with bipartisan support: veterans with PTSD. “Most of the people that have PTSD are women who’ve been sexually abused or raped or domestic violence, and they’re sympathetic,” he told Marianne Williamson last year on her podcast, but “not quite as much as the veterans.” “Interpersonal violence and trauma,” he elaborated to us this month, “are uncomfortable subjects for many people, whereas combat-related trauma is widely recognized as a national responsibility to address.”
For its Phase 2 clinical trials, which began on August 25, 2004, MAPS sought out veterans and first responders for MDMA-assisted psychotherapy. By the time it submitted its End of Phase 2 report to the FDA, MAPS had given MDMA to 107 subjects with PTSD in six locations across the world, though not all the participants were veterans or first responders. They were given two or three eight-hour psychotherapy sessions after taking either MDMA or a placebo, spaced three to five weeks apart, along with psychotherapy sessions without any drug.
In a Phase 2 trial, researchers are looking for preliminary evidence that a drug is safe and effective and to understand any of its side effects. It can typically take up to two years to collect enough data — but MAPS’ Phase 2 trials took over a decade before the End of Phase 2 Meeting with the FDA in 2016 and are still ongoing, running concurrently with its current Phase 3 trials. When the results of its PTSD research were published, MAPS claimed, “Results in 107 international subjects have been extremely promising. Of 65 subjects interviewed one year after treatment, 66 percent no longer had PTSD.” The FDA has granted MDMA-assisted psychotherapy a “Breakthrough Therapy” designation. This status is intended to expedite the process of determining if the treatment demonstrates “substantial improvement over available therapy on a clinically significant endpoint.” It does not mean that the treatment is proved safe, effective, or better than any approved treatment. The FDA has also allowed MAPS to initiate an expanded access program, intended for patients with serious or life-threatening conditions who have no other treatment options and are unable to participate in clinical trials.
When Doblin talks about MDMA, he rarely dwells on the data involved. Rather, he talks up the potential of MDMA to “interrupt generational cycles of conflict and replace them with empathy and understanding.” He is open that his work on MDMA is part of a decades-long plan “for mainstreaming psychedelics into western culture, which will serve as a strategy for the human species to overcome the challenges of globalization and create a global spirituality shared by billions.” It’s a lofty goal and one many fans of alternative treatments are rooting for.
Still, some participants in MAPS-sponsored clinical trials have raised red flags. One Phase 3 participant told us her first drug sessions allowed her to process things she hadn’t been able to before. “I felt like I had been choking on it for years,” she said about her trauma. “And I finally, like, got it out.” But she also experienced severe mood drops and worsening symptoms as her treatment continued. She said that her therapists told her to “trust the process” and framed her suffering as part of the healing. Another PTSD sufferer, who went off his antidepressants as a condition of participating in the trial, said he told his therapists he wanted to go back on medication. He, too, was told to trust the process. Two more participants told us they suffered greatly as a consequence of going off their medications — they even became suicidal and went to the emergency room for help.
All four of these participants told us that, in many ways, they felt far worse off at the end of the trial than when they started. But at least three of them were counted as having improved during the trial, according to MAPS’ study data. They did not see their negative experiences in MAPS’ published papers on the trials or in its data submission to the FDA.
This includes Meaghan Buisson, one of the participants in the clinical trial we talked with extensively, who had PTSD, in part, from a history of sexual trauma. We watched videos she shared with us of her MDMA sessions, where we saw the therapist spooning her, touching her face, holding her wrists and pinning her down, and lying on top of her. At one point, the male therapist kisses her forehead, at another the female therapist kisses her hand. When she obtained a copy of the data MAPS gave to the FDA at the end of Phase 2, she spotted, in her view, an array of problems and explained them to us. We took her concerns to multiple experts who didn’t just share them — they added more.
One of the cornerstones of drug research is something called clinical equipoise: the idea that scientists should be neutral about whether the intervention they are investigating will work. “That’s the whole point of doing research,” Emma Tumilty, a lecturer in medical ethics at Deakin University, says. A biased investigator is more likely to produce flawed data, whether deliberately or not. “If the Catholic Church was going to set up a bunch of trials to tell you how holy water was efficacious for doing something,” Tumilty says, “we would all take those with a pinch of salt. And we might think it was because the Vatican wanted more gold or we might think it’s because they really believed in it. Their motivations really don’t matter, but they have a level of bias that you would generally think, ‘Well, I’d like somebody else to do that study.’”
MAPS took a different approach. “Researchers frequently have opinions about drugs or treatments they are evaluating,” a MAPS representative told us over email. “Scientific methodology is designed to reduce experimenter bias to the extent possible. The scientific methodology used in our Phase 3 studies was determined by FDA and agreed upon after a Special Protocol Assessment process.” MAPS encouraged its therapists to have personal experience with MDMA-assisted psychotherapy before treating others, which, according to a training manual, would provide “first-hand validation of and trust in the intelligence of the therapeutic process as it arises from an individual’s psyche.” Adherence raters tasked with monitoring the sessions to ensure that the therapists followed protocol were also believers in the cause. In 2013, one of the adherence raters, Zhenya Gelfand, wrote in a MAPS Bulletin, “I believe in the cause of psychedelic research to the very core, and I feel honored and privileged to have the opportunity to contribute to its reemergence. I am also hoping to someday be part of a therapy team working with psychedelic-assisted psychotherapy both in a research setting and—hopefully—in my psychiatric and wellness practice.” Ingrid Pacey, one of the clinical investigators in the Phase 2 study, says that there was pressure to “try and get this medicine, this MDMA — and other psychedelics in time — legalized.”
Tumilty explained how a trial where the researchers already believe their experimental treatment works raises a number of dangerous issues. For one, people need to be able to withdraw from the study for any reason — this safeguard is “one of the most key tenets in research. It goes all the way back to the Nuremberg code.” If the study fails to provide a clear exit strategy with good support, it functions as coercion for participants who might otherwise leave.
Unfortunately, some patients found it difficult to leave the trial, citing MAPS’ study protocol that dictates that participants can’t be on antidepressants, a requirement enforced by the FDA. Tumilty was concerned that such patients might be discouraged from resuming their medications if they experienced symptoms of depression. “If they withdraw,” she asked, “who’s supporting them in the period until they’re back in some kind of treatment-positive situation?”
In 2018, MAPS began its Phase 3 trial of MDMA-assisted psychotherapy—the final step before it can apply for FDA approval for the treatment. From the beginning, though, the study was unusual. Typically, Phase 3 trials include thousands of participants; this one is expected to include about 200. The trial design was also atypical. Researchers stopped collecting participant data five (or fewer) weeks after the final “integration session,” which experts we’ve spoken to have remarked is a very short follow-up period.
Based on the report that MAPS submitted to the FDA at the end of Phase 2, Tumilty believes the trials shouldn’t have progressed to Phase 3 in the first place. MAPS could not be sure, she said, if researchers in Phase 2 had stuck to the study’s protocols across study sites — a practice known as adherence. Maintaining consistency of treatment across sites and sessions is what supports the claim that improvements were caused by the same intervention—in this case, the MDMA-assisted psychotherapy. To ensure consistency ahead of its Phase 3 trial, MAPS told us that it “compares MDMA-assisted therapy to an identical therapy protocol with placebo to evaluate the effectiveness of MDMA-assisted therapy.” In an interview for our podcast, MAPS’ senior medical director, Dr. Michael Mithoefer, admitted that adherence in the Phase Two trial was imperfect. “We were doing a best practices type of supervision, but it wasn’t as robust as we have now. And obviously it was not as robust as we need it to be.” If MAPS was not doing robust adherence, it makes it hard to know if the psychotherapy was actually “identical” between placebo and MDMA groups.
There were also issues with data pooling. Each study site in the trials submitted to the FDA in the End of Phase 2 briefing was very small. The largest had 28 participants, the two smallest had five and six participants. MAPS pooled all these studies together. They had different clinicians, some administered different doses of MDMA, some had different numbers of sessions, some were blinded, and others were “open label” (participants knew they were getting MDMA). One site took 15 baseline scores and compared them to only five outcome scores. A footnote to that row on the table reads simply, “Subjects dropped out without providing outcome data, but were included in baseline.”
“In my mind, it doesn’t pass Phase 2 because there’s no robust data that shows that their intervention has an effect that they can isolate,” Tumilty told us. “Now, I mean, they’re going to say it does because of the pooled data, but … they’re not similar enough; there’s too much variation between them.”
Another problem with the trial’s design is inherent to the FDA itself. The FDA doesn’t regulate psychotherapy; it regulates drugs. Some people view this as the FDA operating outside its own scope in regulating the MAPS clinical trials. When asked about this issue, the FDA declined to comment.
What happens in the treatment sessions is, to the outside world, a black box. MAPS’ 2017 therapist training manual lists 13 different types of interventions, noting that “Elements of each of these psychotherapeutic approaches may occur spontaneously in MDMA-assisted therapy.” They include such esoteric practices as psychosynthesis (which can involve sensory overload) and Holotropic Breathwork (which involves hyperventilating to induce an altered state). In an interview we conducted with MAPS’ chief of therapy training and supervision, we discovered that she was unfamiliar with the allowance of such “spontaneous” occurrences from these 13 modalities.
The approach appears to center the therapists’ instinct. The manual reads, “It is not expected that therapists will have complete or even near-complete adherence scores. Attempting to achieve very high adherence for its own sake may interfere with the effectiveness of the therapy by distracting therapists or stifling their intuition and creativity.”
An experimental method that allows so much variability puts greater power in the therapists’ hands. Such power combined with limited public understanding of what the psychotherapy is supposed to look like increases the risk of abuse. Doblin wrote about this risk in his Ph.D. dissertation: “One method of reducing the opportunities for sexual abuse is to require that therapists work in teams, with two treatment professionals required to be present in the room with the patient during the active phase of the treatment session.” Today, MAPS uses this team approach, but only requires one therapist to be licensed. If an unlicensed therapist harms a vulnerable patient, there’s no licensing board or professional standards by which to hold them accountable.
Amid celebration of their positive results, some participants, including Buisson, say MAPS is responsible for creating the conditions in which they were harmed in their clinical trials.In November 2021, we asked Doblin what Buisson’s experience in the clinical trial had taught him. Doblin replied, “I don’t know that we could have done anything differently.” Though MAPS did initiate a compliance review days after that interview, they also gave us different answers about who had watched the footage from Meaghan’s sessions, and when. In March of this year, a MAPS spokesperson told the CBC that MAPS staff didn’t actually watch the videos until after our November interview. In response to fact-checking questions for this article, Doblin claimed he has learned from Buisson’s abuse but did not explain further. When pressed about the disturbing practices shown in Meaghan Buisson’s clinical trial videos on a panel at University of Pennsylvania in March, Doblin said that he thought MDMA might offer strength to patients trying to resist therapist abuse. He elaborated to us, “When facing abuse from a therapist, MDMA-assisted therapy may offer strength to resist, but it may also make someone more suggestible.”
On October 2, 2021, after we had been investigating the flaws in the research conducted by MAPS for six months, we teamed up with two bioethicists and two clinical-trial participants with research backgrounds to submit a complaint to the FDA’s Office of Compliance Oversight via the U.S. Department of Health and Human Services. The problems we had uncovered were of such severity that we were unwilling to wait until the podcast went live. We were concerned, based on what we had learned, that participants who were actively enrolling in Phase 3 trials were at risk.
We became more concerned upon learning that, after Phase 3, MAPS plans to enroll 80 children with PTSD in its MDMA study, which MAPS says is required by the FDA. (“For traumatized children the sooner you can treat them the better,” Doblin told New Atlas in 2018. “Why wait until they become adults and have a horrible adolescence, then it’s even harder to treat them. We will be using smaller doses and trying to figure out exactly how to do it.”) Dr. Alicia Danforth urged caution regarding administering children psychedelics in a 2021 paper where she noted that “obtaining truly informed consent or assent is a delicate issue when considering novel psychiatric treatments for children that could have life-long ramifications, including resentment that the decision was made for them and thus undermining their sense of agency.” We believe that the failure of MAPS and the FDA to address the harms that have occurred to adult participants in Phase 2 and Phase 3 trials significantly underscore Dr. Danforth’s calls for caution.
The complaint we submitted ran to 30 pages. We identified 16 issues with research ethics and integrity, which we hoped these regulatory agencies would investigate. Two of our key concerns were: “(1) Unreported adverse events (including suicidality) in Phase 2 and Phase 3;” and (2) “Video has shown investigator misconduct involving grossly inappropriate touch: restraining, gagging, laying on top of/physically pinning down, kissing, and cuddling in bed with/caressing a participant on MDMA, which was immediately visible on recorded sessions and should have been addressed by sponsors/supervisors in immediate intervention.” The severity of these events, and MAPS’ responses to them, highlight what we believe to be urgent safety concerns that merit prompt investigation and mitigation in order to protect current participants.
We submitted the same complaint to Health Canada on March 4, 2022. On April 8, Health Canada announced it would conduct a review of MAPS’ MDMA trials.
The FDA told us that since receiving our complaint, it has participated in a workshop alongside some of the MAPS researchers we believe to bear responsibility for the issues with the MAPS trials and research. The FDA did not explain how this addressed our concerns, nor did it request any additional information, such as video from Buisson’s sessions, which we offered to make available for regulatory review.
On March 30, the complaint signatories sent the FDA additional information, including links to the videos. In a letter received by the complaint signatories dated May 5, an FDA spokesperson acknowledged that the video footage “raises serious concerns.” The spokesperson went on to say the FDA “cannot comment on the specific development program you discuss, or actions related to your inquiry.”
MAPS’ Phase 3 clinical trials for MDMA-assisted psychotherapy for PTSD are ongoing, having just completed enrollment for its second Phase 3 trial. In November 2021, when asked what could derail FDA approval, Rick Doblin told New York, “If we had several people in the MDMA group kill themselves, that would call into question the safety of what we’re doing.” Several of the participants we have spoken to say they worked hard to survive after the MAPS clinical trial. They hope that it doesn’t take the suicide of one of their peers for something to change.
