Last month, in August of 2024, the FDA rejected the legalization of MDMA (otherwise known as (Ecstasy) for therapeutic use in the treatment of PTSD. While a blow to the psychedelic community as a whole, the reasons for the rejection are based largely in ethical issues and dual relationships and there actually may be a silver lining to the FDA decision.
Rick Doblin, PHD is at the center of the controversy and admittedly had clear motivations for
legalizing MDMA outside of a medical or science/ research perspective: he owns the company Lykos that makes the drug and sponsors the studies and also heads a nonprofit called MAPS or Multidisciplinary Association for Psychedelic Studies that does broad research on psychedelic drugs.
There was also some controversy over ethical violations in the case studies with MDMA
involving the most egregious violation: sexual assault and cover up. It happened in Canada and involved a couple who were psychiatrists and a woman client that was assaulted while under the influence of the study drug and this was not investigated properly or reported. This later caused the retraction of scientific articles published about the case without full disclosure of what happened.
There continues to be a dozen studies using MDMA for mostly PTSD happening around the
country at research hospitals and through the Veterans Administration. These studies are in part related to Lykos or are outright sponsored by the drug maker and it is yet to be seen how they will navigate the issues that have emerged. One thing for certain is that this gives other MDMA manufacturers a chance to make headways in a market largely dominated by Lykos and a clear monopoly.
I had the opportunity to discuss the MDMA rejection with one of the research doctors who is
working with veterans and the VA through OHSU. Dr. Chris Stuaffer is leading a study on the
effects of MDMA on vets with PTSD and he says that it is unlikely his work will change. He said that it is going to take more time and research to get to legal status but it is probably only a couple of years away and it opens up other possibilities for the business side of things.
Dr. Stauffer is fairly confident in the efficacy of MDMA on PTSD and that it will prove itself with time. This gives the opportunity to get the solid foundation and the science better understanding while also allowing other manufacturers a chance to develop their formulations. There is also the possibility of other types of MDMA being developed and all of these things lead to a healthier legal market.
This also opens up the use other psychedelics for PTSD instead of trying to pigeonhole MDMA as the only one that works. In fact, both Psilocybin and Ketamine have made their mark in treating this condition as well and they are both currently legal in some form. The more tools in the belt is always going to be better depending on the type of PTSD so maybe shifting the focus from one drug to others isn’t bad.
What seemed like a huge blow and a nail in the coffin of psychedelic therapy maybe less
impactful as time goes on and the research continues. It was exciting to talk with someone who is so directly involved with this and I appreciate that he spared me the time.
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