Psychedelic Trials: Comprised Data?

In his thoughtful letter, Dr. Balon calls for debate among ethicists about whether data from psychedelic research trials in which subjects who were allegedly sexually abused should be used.

Concern about heightened risk for sexual abuse in the context of treatment with psychedelic agents is expressed in the resource document written in 2022 by the APA Ethics Committee, which states: “Under the influence of psilocybin or MDMA, patients may become more suggestible and easier to manipulate. Patients may experience intense attachment and transference, including of a sexual nature. For these reasons, clinicians working with these substances must carefully uphold boundaries.”

Dr. Balon points to allegations of sexual abuse in the MDMA-assisted psychotherapy for PTSD trials conducted by Lykos Therapeutics (formerly MAPS Public Benefit Corporation), which are under review by the FDA. The FDA’s Psychopharmacologic Drugs Advisory Committee recommended on June 4 against approval. The Institute for Clinical and Economic Review (ICER) concluded the month prior as well as in a final report in June that the research evidence was insufficient to endorse MDMA-assisted psychotherapy for PTSD.

With respect to the incidence of sexual abuse in the MDMA trials, the ICER review concludes, based on public reports, that “sexual boundaries were severely crossed with at least one patient in a Phase II trial.” To my knowledge, sexual boundary violations described by the participant in the Phase II trial in Canada have not been reported by other participants in that or other Phase II or Phase III trials. Concerns about this serious occurrence as well as other potential methodological and ethical problems, however, have been reported to Health Canada (Canada’s equivalent of the FDA), the FDA, and the U.S. Department of Health and Human Services (HHS). Although these regulatory bodies did not shutter the studies, the details of their investigations have not been shared publicly.

Sexual misconduct should not be tolerated in any clinical care or research environment, and if it occurs, the perpetrators should face severe consequences for this violation of ethics and trust. However, decisions about discarding clinical trials data based on methodological or ethical violations need to evaluate the extent to which violations may have critically undermined the integrity of the research overall. They also need to consider the ramifications of discarding data for the hundreds of study participants who incurred inconvenience and risk to advance knowledge as well as the potential of delaying the development of new treatments for disabling and life-threatening conditions.

This important area of research deserves to have any ethical and safety concerns openly debated and addressed. Additional disclosure of information from the investigations of the MDMA trials by Health Canada, the FDA, and HHS would likely help clarify the nature and extent of purported violations and enable stakeholders, bioethicists, and the public to evaluate the integrity of these trials. ■

JONATHAN E. ALPERT, M.D., PH.D.

Chair, Council on Research

American Psychiatric Association

Chair, Department of Psychiatry and Behavioral Sciences

Montefiore Medical Center and Albert Einstein College of Medicine