I read the Psychiatric Times article “FDA Issues CRL to Lykos for MDMA-Assisted Therapy.” The short story is that the FDA essentially told the drug company Lykos that their study of the efficacy of MDMA-assisted treatment of PTSD needs more work.
I tried to wade through the on-line documents of the FDA’s meeting on June 4, 2024. There are hundreds of pages and I didn’t go through every page of the transcript. The minutes were succinct and much easier to digest.
I’m going to simply admit that I’m biased against using psychedelics in psychiatry for personal and professional reasons. I’m not a research scientist. I’m a retired consultation-liaison psychiatrist. I saw many patients with a variety of psychiatric diagnoses including PTSD and substance use disorders. I’m not opposed to clinical research in this area, but I’m aware of the difficulty of conducting it.
In that regard, I want to also admit that I’m very susceptible to being influenced by a former colleague’s remarks about the quality of the research in question in the Lykos study. Dr. Jess G. Fiedorowicz, MD, PhD formerly was formerly on staff at University of Iowa Health Care. He’s now the Chief of Mental Health at The Ottawa Hospital where he’s also Professor and Senior Research Chair in Adult Psychiatry, Department of Psychiatry, University of Ottawa, Ontario. His remarks in the transcript are typical for his erudition and expertise as a clinician scientist.
It’s difficult to wade through the pages of the FDA transcript and I couldn’t digest all of it, by any means. But if you’re interested in reading both sides of this issue, it’s a good place to get the best idea of the committee members’ thinking about it. The minutes are much easier to read and provide a succinct summary.
I realize the Psychiatric Times article editor doesn’t agree with the FDA recommendations for further study of psychedelic-assisted psychotherapy for PTSD. It may or may not influence the University of Iowa’s study of psilocybin. In my opinion, the FDA did the right thing.
Go Retire Psychiatrist 