The scientific journal Psychopharmacology retracted three papers on MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD) on Saturday due to “unethical conduct.”
The retractions came just a day after the U.S. Food and Drug Administration (FDA) rejected a new drug application from Lykos Therapeutics for its MDMA capsules, to be used alongside therapy, to treat PTSD. The FDA has requested Lykos to conduct an additional phase 3 study to further study the treatments safety and efficacy, according to Lykos.
In a note, Psychopharmacology said that it retracted the papers, which were published in 2020 and 2021, after being informed of “protocol violations amounting to unethical conduct” at one of the sites where the research was conducted.
The journal said that the study authors confirmed that they were aware of the violations when they submitted the papers but did not disclose the information or remove the data generated from the site from their analysis.
The editors added that the authors did not fully disclose their conflicts of interest. Several of the papers’ authors are affiliated with Lykos, including the company’s CEO Amy Emerson.
In 2015, a patient who was a trial participant at the site accused an unlicensed therapist of sexual assault, according to civil court documents. Lykos told STAT, which first reported the retractions, that it has filed a complaint regarding the retractions with the Committee on Publication Ethics. The company said it reported the violations to the FDA, Health Canada and other oversight bodies, however, it did not disclose the violations to the journal.
“The authors are actively working to correct all publications including these data with the appropriate disclosures to best preserve the integrity of the scholarly record,” Lykos said in a statement to STAT.
The retracted studies are separate from the phase 3 clinical trials Lykos submitted to to the FDA in its application.