Fierce Biotech report
Psychopharmacology has pulled three articles about midstage clinical trial data assessing Lykos Therapeutics’ investigational MDMA candidate for treating post-traumatic stress disorder (PTSD). The journal cited “unethical conduct” at a research site as the reason for the retraction.
The article removals are related to protocol violations at a study site that was involved in phase 2 trials assessing midomafetamine, an MDMA capsule designed to be delivered alongside psychological intervention that was just denied FDA approval on Friday. The studies included in the retracted articles were not the same studies that underpinned Lykos’ request for FDA approval.
Authors with their names attached to the papers have subsequently confirmed they were aware of the protocol violations when the articles were submitted for publication but didn’t say anything about it to Psychopharmacology nor exclude the data coming from the site, according to the retraction notices.
One of the authors is Lykos CEO Amy Emerson, while several other authors are associated with Lykos’ parent company Multidisciplinary Association for Psychedelic Studies (MAPS) or a MAPS subsidiary dubbed MAPS Public Benefit Corporation.
Retraction Note: Psychopharmacology (2020) 237:2485–2497
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.
Allison A. Feduccia agrees with this retraction but disagrees with the wording of the retraction notice. 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.
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The online version of the original article can be found at https://doi.org/10.1007/s00213-020-05548-2.
