The results sound promising, but Michael Ostacher, a professor of psychiatry and behavioral sciences at Stanford University, who is not involved with Lykos and was not part of the FDA panel, says there’s a big problem: “It’s not clear whether “Participation in the study and anticipation of the effect is what makes people better, rather than the impact of the medication itself.”
In medical research, a double-blind, placebo-controlled trial, in which neither the participants nor the researchers know who receives 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 to guess whether they received them. Ostacher says the growing buzz around psychedelics has created certain expectations among people enrolled in these studies.
“My main concern is that the people in the trial who didn’t receive MDMA would feel very disappointed about not receiving the drug, and that would have a big influence on how they reported their symptoms,” he says. “Likewise, people who received MDMA, which its advocates have heralded as a life-changing treatment, would be inclined to feel positive about their experience.”
This “unblinding” effect is a well-known conundrum not only for Lykos but for the entire field of psychedelic research, and scientists are currently considering alternative ways of designing trials to account for this potential bias.
Another issue revolves around 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 were concerned about variability in therapeutic 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 about how the therapy session can be carried out. “If the treatment is medication-assisted psychotherapy, perhaps a little more prescribed therapy is appropriate,” she says.
The FDA does not regulate the therapy or participate in the licensure of psychotherapists, raising the question of how the therapy would be standardized. Gukasyan questions whether it is appropriate for Lykos to participate in training therapists because it could present a conflict of interest.
While some of the participants who testified Tuesday or submitted written comments to the committee described positive stories of their sessions and lasting benefits, others had negative experiences. In one particularly disturbing report, former trial participant Meaghan Buisson testified that her therapists, a married couple, pinned her to a bed while they fondled and hugged her. (New York magazine reported on Buisson’s experiences two years ago, posting a video of this incident.)
Another volunteer, Sarah McNamee, wrote that during her MDMA session, her therapists told her she was “helping to make history” and that she was “part of a movement.” According to McNamee, she was encouraged to give a positive account of her experience, saying that her responses during and after her trial could jeopardize the legalization of the drug. When her mental health symptoms worsened, she was told she would feel better in six months.
