The journal Psychopharmacology has retracted three papers about MDMA-assisted psychotherapy due to data integrity concerns. These papers were published in 2020 and 2021, and many authors were affiliated with the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and its commercial spinout Lykos Therapeutics, including founder Rick Doblin and Lykos CEO Amy Emerson.
The retractions were a result of protocol violations and unethical conduct during a Phase 2 trial at the MP4 study site in Canada. An unlicensed therapist at this site was accused of sexual assault in civil court by a MAPS trial participant. The authors of the papers admitted that they knew about these ethical violations when they submitted the papers but did not disclose this information to the journal or remove the data from their analysis.
Boris Heifets, a neuroscience researcher at Stanford University, emphasized the importance of maintaining high ethical standards in psychedelic research. Issues with data integrity and research bias have been ongoing concerns during Lykos’ efforts to gain approval for MDMA-assisted therapy. The Institute for Clinical and Economic Review raised questions about the accuracy of serious adverse events reported in the research data.
The FDA recently rejected the treatment, stating that Lykos needed to conduct another Phase 3 trial to further study the drug’s safety and efficacy. Despite the retraction of the papers, some authors, including Doblin, believed that a correction would have been sufficient. Lykos has filed a complaint with the Committee on Publication Ethics to review the decision made by Psychopharmacology.
Activist groups have been urging regulators and academics to scrutinize the reliability of Lykos’ data, especially concerning reports of suicidality and assault among trial participants. The company acknowledged that they should have disclosed the ethical violations to the journal and expressed regret for not doing so.
Allison Feduccia, one of the authors, supported the retractions, stating that Psychopharmacology did not allow them to amend the data. Sasha Sisko, an activist, has been sharing information about ethical violations with the editor of Psychopharmacology for over a year.
The data in the retracted studies are different from the Phase 3 efficacy data submitted to the FDA. Earlier this year, it seemed likely that the FDA would approve the treatment based on positive results from two trials. However, sentiment changed following the ICER report and concerns about the research environment within Lykos.
Former employees of Lykos described a cult-like atmosphere within the organization, excessive hype around MDMA, and a lack of rigor in conducting the trials. FDA regulators were frustrated with the company’s failure to collect data on positive reactions to MDMA, such as feelings of euphoria.
In conclusion, the retractions of the papers highlight the importance of maintaining ethical standards in psychedelic research. The controversy surrounding MDMA-assisted psychotherapy underscores the need for transparency and accountability in clinical trials to ensure the safety and efficacy of treatments for patients with PTSD.