MDMA papers retracted for ‘unethical conduct’ on heels of Lykos’ FDA rejection
MDMA papers retracted for ‘unethical conduct’ on heels of Lykos’ FDA rejection
The medical journal Psychopharmacology on Saturday retracted three papers related to the use of the psychiatric substance MDMA for the treatment of post-traumatic stress disorder.
The decision to pull the studies was driven by “protocol violations amounting to unethical conduct” at one of the study sites, according to the journal’s retraction note. The authors of the studies also confirmed to Psychopharmacology that they knew of these breaches when they submitted their manuscript “but did not disclose this information to the journal or remove data generated by this site from their analysis.”
Many of the authors failed to fully disclose a “potential competing interest,” according to the retraction notice, while some of the researchers were affiliated with either the Multidisciplinary Association for Psychedelic Studies or one of its subsidiaries, which funded and provided the MDMA used in the studies.
Allison Feduccia, an author in all three studies, agreed with the retraction but disputes the language that Psychopharmacology used in the retraction note. In an interview with STAT News, Feduccia said that she only agreed to the retraction because the journal would not allow them to amend the studies’ data.
Other researchers on the studies—including Michael Mithoefer, Lisa Jerome, Berra Yazar-Klosinski and Rick Doblin—registered their disagreement with the retraction. The remaining authors did not return Psychopharmacology’s request for comment.
Saturday’s retraction comes just a day after the FDA rejected Lykos Therapeutics’ investigational MDMA-assisted regimen for post-traumatic stress disorder (PTSD). In its Complete Response Letter, the regulator said that Lykos’ application “could not be approved based on data submitted to date” and called for an additional Phase III trial.
