Lykos MDMA therapy papers retracted by medical journal
Lykos MDMA therapy papers retracted by medical journal
Psychopharmacology retracted three papers by Lykos (MAPS PBC) researchers, including a meta-analysis of MDMA trials, a long-term follow up study, and a study on discontinuing SSRIs
Updated August 12, 2024 with information about a third retracted paper
Yesterday, the journal Psychopharmacology retracted three papers reporting the results of studies conducted by Lykos Therapeutics (previously known as MAPS PBC). The retractions came one day after the FDA declined to approve Lykos’ MDMA-assisted therapy (MDMA-AT) for the treatment of post traumatic stress disorder. In a complete response letter to Lykos’ new drug application, the FDA asked Lykos to perform a third phase 3 clinical trial.
The first retracted paper, published in 2019, is a meta-analysis of six phase 2 clinical trials of Lykos MDMA-AT. It has ten authors, including a chief architect of Lykos’ clinical protocols Michael Mithoefer, his research partner and wife Anne Mithoefer, Lykos chief scientific officer Berra Yazar-Klosinski, Lykos CEO Amy Emerson, and MAPS founder and Lykos executive board member Rick Doblin.
The second retracted paper, published in 2020, reports on a long-term follow up study of six phase 2 clinical trials. It has six authors, including Yazar-Klosinski, Michael Mithoefer, Emerson, and Doblin.
The third retracted paper, published in 2021, reported the results of a study that explored the effects of gradually discontinuing treatment with selective serotonin reuptake inhibitors (SSRIs) prior to receiving treatment with MDMA. Its authors include Allison A. Feduccia, Lisa Jerome, Michael Mithoefer, and Julie Holland.
Independent journalist Sasha Sisko sent Psychopharmacology editors a request for retractions in 2023.
According to retraction notices for the first two articles:
“The Editors have retracted this article after they were informed of protocol violations amounting to unethical conduct at the MP4 study site by researchers associated with this project. The authors have subsequently confirmed that they were aware of these violations at the time of submission of this article, but did not disclose this information to the journal or remove data generated by this site from their analysis. Additionally, the authors also did not fully declare a potential competing interest. Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS. As is stated in the Funding declaration, MAPS fully funded and provided the MDMA that was used in this trial, and MAPS PBC organised the trial.”
Only one co-author, Allison A. Feduccia, the co-founder and CEO of Psychedelic Support, “agrees with this retraction but disagrees with the wording,” states each retraction notice. Feduccia worked for MAPS PBC (now called Lykos) for over five years as a clinical trial leader, clinical data scientist, and senior clinical data scientist.
The first retraction further states, “Michael C. Mithoefer, Lisa Jerome, Anne Mithoefer, Mark Wagner, Berra Yazar-Klosinski, and Rick Doblin disagree with this retraction. Zach Walsh stated that they neither agree nor disagree with this retraction. The remaining authors did not respond to correspondence from the Publisher about this retraction.”
The second retraction states, “Michael C. Mithoefer, Lisa Jerome, Berra Yazar-Klosinski, and Rick Doblin disagree with this retraction. The remaining authors did not respond to correspondence from the Publisher about this retraction.”
Joar Øveraas Halvorsen, associate professor of psychology at the Norwegian University of Science and Technology, posted about the retractions this morning.
This is a developing story, and more details will surely emerge. It is unclear what these retractions could mean for Lykos and the potential third phase 3 trial requested by the FDA.
*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.
Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University, the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an visiting fellow at the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.