Dear James,

I wanted to put together an article and video explaining my perspective on the FDA's recent decision of not approve MDMA-assisted therapy for the treatment of PTSD (at least at this time). You can read more on my point of view below and click the text here, picture above, or button below to watch the accompanying video.

I have to admit that I'm both disappointed with the FDA's decision and the way that protocol violations were handled by MAPS/Lykos researchers when it came to discussions with regulators and disclosure of what had occurred. I wish MDMA-assisted therapy was approved and feel the FDA could have taken that route. I also respect and feel I can empathize with their position to not cut any corners themselves in this situation.

In many ways, I do not think the circumstance of a pharmaceutical company withholding information regarding safety, adverse effects, or protocol violations to regulatory agencies is unique. This is unfortunately common in the industry and may even be closer to the rule than an exception. It could be that regulators are 'picking on' MDMA assisted therapy in this regard or applying a higher standard that it has than at other junctures. This is perhaps unfair, although I would prefer a world where companies did not omit information from their studies and would support uniform enforcement of better standards in clinical research generally.

I can truly recognize the novelty of the situation for the FDA and could even applaud them for demanding the safety and efficacy is unshakably demonstrated and that the information they're evaluating carries full integrity. This is a historic approval that would require revision of the schedule of controlled substances. This is an approval with a therapy modality attached and the therapy modality employed in studies appears diverse and lacking standardization. It really is unchartered territory for regulators and approving an agent sponsored by a company that was caught minimizing or excluding information pertaining to the safety of the study drug is a good reason to take a pause instead of rushing a breakthrough therapy over the finish line. It is a big let down for the psychedelic community and persons suffering from PTSD, yet I cannot squarely blame the FDA for not approving it given the information that has come to light. 

Overall, my understanding of the protocol violations leads me to believe they were infrequent amongst participants yet egregious in nature for those affected. This may not greatly skew the overall data sets and I do think that the information generated from existing clinical trials supports a favorable risk-benefit ratio, acceptable safety profile, and is definitely a breakthrough for treatment of PTSD. I am optimistic that if Lykos can conduct another phase III trial and address the FDA's concerns that approval can still occur. What could be done in response to raise awareness of the psychological vulnerability that can be precipitated with MDMA or other psychedelics? I am in favor of placing warnings on the prescribing information for MDMA or even all psychedelics regarding the potential lowered vulnerability, increased suggestibility, and development of inappropriate bonds or relationships. This seems like a straight forward way to acknowledge this potential in ways parallel to other drugs with special risks.

While this rejection surely stings in the short term, I believe there is an opportunity here to conduct research with higher integrity, set a standard above the rest of the industry, double down on safety information, and address real concerns with the information generated and effects of these substances. There is also an opportunity to re-focus advocacy efforts in sectors relating to religious freedom or spiritual wellbeing. I hope to see the psychedelic field rise to the occasion and take full advantage of this call to grow. 

Wishing you great health and abundant resilience. Click the button below to hear an expansion of my thoughts on this topic.

Kind regards,

Ben

Ben Malcolm, PharmD, MPH

Spirit Pharmacist