Article retractions muddy MDMA waters after FDA denial
The journal Psychopharmacology has retracted three articles about MDMA-assisted psychotherapy, shortly after the FDA rejected approval of Lykos Therapeutics' therapy for post-traumatic stress disorder (PTSD).
The three papers include two covering pooled analyses of phase 2 trials of MDMA-assisted psychotherapy in PTSD, and a third on the effect that discontinuation of certain antidepressants can have on this type of treatment.
The decision to pull the papers has resulted in part from links between the authors and the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), from which Lykos Therapeutics – formerly known as MAPS PBC – spun out a few years ago.
The retractions also point to "protocol violations" at a study site by researchers associated with this project – referring to a case of sexual abuse by a therapist on a patient during a phase 2 trial in 2015 that was discussed at the FDA advisory committee meeting that resulted in a negative vote for Lykos' therapy.
"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," according to the retractions, which all have the same wording.
"Additionally, the authors also did not fully declare a potential competing interest," they continue, pointing out that two authors were affiliated with MAPS PBC.
According to the journal, Allison Feduccia of Project New Day – which promotes the use of psychedelic medicines for medical purposes - agrees with the retraction, but disagrees with the wording. Meanwhile, Lisa Jerome and Michael Mithoefer, who give their affiliation as MAPS PBC, and private practitioner Julie Holland disagree with it entirely.
While the impact of the retracted articles on Lykos' attempt to persuade the FDA to reconsider its decision to deny approval for midomafetamine remains to be seen, it comes at a particularly inopportune time for the company, just as it is seeking a meeting with the regulator to discuss a path forward for the programme.
Lykos' chief executive, Amy Emerson, has said that a new phase 3 trial sought by the FDA could take several years, and previously suggested it may be possible to address the agency's concerns with "existing data, post-approval requirements, or through reference to the scientific literature."
First formed in 1986, MAPS has the express purpose of working with the FDA and DEA to make MDMA-assisted talk therapy an approved, accepted, and available tool to treat PTSD.
MAPS founder Rick Doblin said after the FDA's decision that the organisation's determination to "shepherd a post-prohibition world where people have legal and equitable access to psychedelics for healing and personal growth" is unwavering.
"MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world, including those with high incidences of trauma and limited resources," he added.
