The results sound promising, but Michael Ostacher, a professor of psychiatry and behavioral sciences at Stanford University who is not affiliated with Lykos and was not on the FDA panel, says there is a substantial problem: “It’s unclear whether participation in the study and this wait for the effect makes people better, not the effect of the drug itself.”
In medical research, the gold standard is considered to be a double-blind, placebo-controlled trial in which neither participants nor researchers know who is receiving the placebo or experimental treatment. However, the effects of psychedelics are so well known that it is easy for both volunteers and therapists to guess whether they have received them. Ostacher says the growing hype around psychedelics has created certain expectations for people participating in these studies.
“My main concern is that people in the study who did not receive MDMA will feel a lot of disappointment about not getting the drug, and this will have a big impact on how they report their symptoms,” he says. “In the same way, people who took MDMA, touted by proponents as a life-changing drug, would be inclined to report positively on their experience.”
This “unblinding” effect is a well-known puzzle not only for Lykos but for the entire field of psychedelics research, and scientists are currently considering alternative ways of designing studies to account for this potential bias.
Another issue concerns psychotherapy, i.e. talk therapy, used during trial sessions. While participants took MDMA or a placebo, two therapists were in the room to help them express and process memories and emotions during eight-hour sessions. Lykos describes the therapy as a “personalized experience,” but FDA committee members had concerns about the variability of therapeutic approaches and the extent to which patient outcomes could be attributed to the drug itself rather than the therapy.
Natalie Gukasyan, an assistant professor of psychiatry at Columbia University who studies psychedelics, says there’s “a lot of wiggle room” in Lykos manual about how you can conduct a therapy session. “If treatment is medication-assisted psychotherapy, intensive prescription therapy may be appropriate,” he says.
The FDA does not regulate therapy or certify psychotherapists, which raises the question of how therapy would be standardized. Gukasyan questions whether it is appropriate to involve Lykos in training therapists, as it could create a conflict of interest.
While some participants who testified Tuesday or submitted written comments to the committee described positive stories about the sessions and lasting benefits, others had negative experiences. In one particularly disturbing report, former trial participant Meaghan Buisson testified that her husband and wife therapists pinned her to the bed, stroking and cuddling her. (New York Magazine reported on Buisson’s experiences two years ago, posting a video this event.)
Another volunteer, Sarah McNamee, wrote that during her MDMA sessions, therapists told her she was “helping make history” and that she was “part of a movement.” According to McNamee, they encouraged her to report positively on the experience, claiming that her reactions during and after the trial could jeopardize the legalization of the drug. When her mental symptoms worsened, she was told she would feel better in six months.