MDMA Therapy Papers Retracted Amid Ethical Concerns At Lykos Study Site

In a significant development in the field of psychedelic medicine, the journal Psychopharmacology has retracted three research papers on MDMA-assisted therapy due to what it described as unethical conduct at one of the study sites. As New York Times reported, the retraction has cast a shadow over Lykos Therapeutics, the company involved in the studies, whose recent application for MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) was rejected by the Food and Drug Administration (FDA).

Retraction Linked To Ethical Breach

The papers in question involve several authors affiliated with Lykos Therapeutics, a company formed by the Multidisciplinary Association for Psychedelic Studies (MAPS) to commercialize its proprietary MDMA-assisted therapy. The unethical conduct cited by Psychopharmacology relates to an incident in 2015, where an unlicensed Canadian therapist, who was part of the trial, engaged in a sexual relationship with a participant after the trial's dosing sessions had concluded.

According to court documents, the participant, Meaghan Buisson, later accused the therapist, Richard Yensen, of sexual assault. Yensen, who worked alongside his licensed therapist wife, claimed the relationship was consensual and initiated by Buisson. However, professional associations in both Canada and the United States strictly prohibit sexual relationships between therapists and their patients for at least two years following the conclusion of therapy. The relationship reportedly continued for over a year after the final session, raising serious ethical concerns.

FDA Rejection And Lykos's Response

Retraction of the papers coincides with the FDA’s decision last Friday to reject Lykos's application for MDMA-assisted therapy for PTSD, a move that would have marked the first federal approval of a psychedelic medicine. In a statement, Lykos disclosed that the FDA cited missing data and issues with the study design as reasons for the denial. The FDA has requested an additional clinical trial before reconsidering the application.

Lykos Therapeutics responded by announcing plans to appeal the FDA's decision. The company was quick to clarify that the research in the retracted papers was not included in its FDA application. However, the timing of these events has intensified scrutiny over Lykos’s practices and the broader ethical challenges in conducting psychedelics research.

Dispute Over the Retraction

In the statement, Lykos also expressed its disagreement with Psychopharmacology's decision to retract the papers and stated its intention to file a formal complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications. “The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” Lykos said, arguing that the ethical violations should have been addressed through a correction rather than a full retraction.

The company also acknowledged that it had failed to notify the journal about the ethical violations that occurred during the trial. MAPS, which conducted the original research, publicly acknowledged the incident in 2019 and reported it to both the FDA and Canadian health authorities.

Implications For Psychedelic Research

The retraction and ethical concerns it highlights underscore the vulnerabilities associated with psychedelic-assisted therapy, particularly in the context of patient safety during dosing sessions. Given the powerful effects of psychedelic substances, most clinical trials mandate the presence of two licensed mental health professionals. However, Lykos’s trials required only one practitioner to be licensed, a decision that has now come under scrutiny.