The Case for MDMA’s Approval Is Riddled With Problems

The results sounds promising, but Michael Ostacher, professor of psychiatry and behavioral sciences at Stanford University who’s not involved with Lykos and wasn’t on the FDA panel, says there’s a big problem: “It’s unclear whether or not the participation in the study and anticipation of the effect is what makes people better, rather than the impact of the drug itself.”

In medical research, a double-blinded placebo controlled trial—in which neither the participants nor the researchers know who gets a placebo or the experimental treatment—is considered the gold standard. But the effects of psychedelics are so well known that it’s easy for volunteers and therapists alike to guess whether they received it. Ostacher says the growing hype over psychedelics has created certain expectations for people enrolled in these studies.

“My main concern is that people in the trial who did not receive the MDMA would experience a lot of disappointment about not getting the drug, and that would have a large influence on how they reported their symptoms,” he says. “In the same fashion, the people who did get the MDMA, which has been advertised by advocates as a life-changing treatment, would be inclined to feel positive about their experience.”

This “unblinding” effect is a well-known conundrum not just for Lykos but for the entire field of psychedelics research, and scientists are currently considering alternative ways of designing trials to account for this potential bias.

Another issue surrounds the psychotherapy, or talk therapy, administered during the trial sessions. When participants took MDMA or placebo, two therapists were in the room to help them express and process their memories and emotions during eight-hour sessions. Lykos describes this therapy as a “personalized experience,” but FDA committee members had concerns with the variability in therapy approaches and how much of patient outcomes could be attributed to the drug itself versus the therapy.

Natalie Gukasyan, an assistant professor of psychiatry at Columbia University who studies psychedelics, says “there’s a lot of wiggle room” in the Lykos manual on how the therapy session can be conducted. “If the treatment is medication-assisted psychotherapy, maybe a little bit more of a prescribed therapy is appropriate,” she says.

The FDA does not regulate therapy, nor is it involved with credentialing of psychotherapists, which raises the question of how therapy would be standardized. Gukasyan wonders whether it’s appropriate for Lykos to be involved with training therapists because it could present a conflict of interest.

While some of the participants who testified on Tuesday or submitted written comments to the committee described positive stories of their sessions and lasting benefits, others had negative experiences. In one particularly troubling report, former trial participant Meaghan Buisson testified that her therapists, a married couple, pinned her down on a bed while stroking and cuddling her. (New York Magazine reported on Buisson’s experiences two years ago, publishing a video of this incident.)

Another volunteer, Sarah McNamee, wrote that during her MDMA session, her therapists told her she was “helping make history” and that she was “part of a movement.” According to McNamee, they encouraged her to give a positive report of the experience, saying her responses during and after the trial could jeopardize the drug’s legalization. When her mental health symptoms worsened, she was told she would feel better in six months.