Psychopharmacology Retracts MDMA Therapy Studies Amid Ethical Concerns
The journal Psychopharmacology has retracted three studies on MDMA-assisted therapy, citing unethical practices at one of the research sites involved. The retracted papers included authors affiliated with Lykos Therapeutics, a pharmaceutical company whose recent application for MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) was rejected by the Food and Drug Administration (FDA).
Lykos Therapeutics clarified that the retracted research was not part of its FDA submission. The FDA denied the company's application due to issues such as missing data and flaws in the study design. The agency has requested Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine approved by federal regulators. Lykos has stated its intention to appeal the FDA's decision.
On Sunday, Lykos expressed disagreement with Psychopharmacology’s decision to retract the papers and announced plans to file a formal complaint with the Committee on Publication Ethics, an organization that sets standards for academic publications. The company maintains that the retracted studies are scientifically valid and provide valuable insights into potential PTSD treatments.
The ethical concerns raised by Psychopharmacology relate to an incident during a 2015 trial where an unlicensed Canadian therapist, Richard Yensen, who participated in the study, became sexually involved with a trial participant, Meaghan Buisson, after the dosing sessions had ended. Buisson later accused Yensen of sexual assault, while Yensen claimed the relationship was consensual and initiated by Buisson. Six months after the trial, Buisson relocated from Vancouver to British Columbia’s Cortes Island, where Yensen and his wife, a licensed therapist, resided.