The results look promising, but there’s a big problem, says 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. And the expectation of that effect is what makes people feel better rather than the effect of the drug itself.”
In medical research, double-blind placebo-controlled trials, in which neither participants nor researchers know who is receiving a placebo or experimental treatment, are considered the gold standard. However, the effects of hallucinogens are so well known that it is easy for both volunteers and therapists to guess whether they have been given hallucinogens or not. Ostacher said the increased hype around psychedelics has created certain expectations for those who enroll in these studies.
“My biggest concern is that clinical trial participants who did not receive MDMA will experience a lot of disappointment about not receiving the drug, which will have a huge impact on how they report their symptoms,” he says. “In the same way, people who receive MDMA, which advocates tout as a life-changing treatment, may end up feeling positive about their experience.”
This “unblinding” effect is a well-known challenge not only for Lykos, but for the entire field of psychedelic drug research, and scientists are currently considering alternative ways to design trials to account for this potential bias.
Another issue related to psychotherapy, or talk therapy, administered during trial is as follows. When participants took MDMA or a placebo, two therapists were in the room and helped them express and process their memories and emotions during the eight-hour session. Although Lykos described the treatment as a “personalized experience,” FDA committee members were concerned about the diversity of treatments and that a significant portion of patient outcomes may be attributable to the drug itself rather than the treatment.
“There’s a lot of wiggle room,” says Natalie Gukasyan, an assistant professor of psychiatry at Columbia University who studies psychedelics. Lycos Manual About how the therapy sessions work. “If the treatment is medication-assisted psychotherapy, perhaps the prescribed treatment is a little more appropriate,” she says.
The FDA does not regulate the treatment nor is it involved in the certification of psychotherapists, which raises questions about how the treatment will be standardized. Gukasyan wonders whether it would be appropriate for Lykos to participate in the training of therapists, as this could create a conflict of interest.
Some of the participants who testified Tuesday or submitted written comments to the committee described positive stories and lasting benefits from the sessions, while others had negative experiences. In her particularly troubling report, former experiment participant Meaghan Buisson testified that her therapist, a married couple, pinned her to her bed while he stroked and hugged her. (New York Magazine reported on Booysen’s experience two years ago, post video of this incident.)
Another volunteer, Sarah McNamee, wrote that during MDMA sessions, therapists told her she was “helping make history” and was “part of the movement.” According to McNamee, they encouraged her to report her positive experience, telling her that her reactions during and after her experiment could jeopardize the legalization of the drug. As her mental health symptoms worsened, she was told she would feel better in six months.
