Regulations
The FDA, MDMA, and Public Perception: Was the FDA Fair to Lykos?
October 15, 2024
Featuring: Rick Doblin, Ph.D.
The psychedelic space was dealt a huge blow when the FDA decided not to approve MDMA-assisted therapy for PTSD under Lykos’ proposal. Was the FDA fair to Lykos? And what are the next steps for Lykos and MAPS?
The psychedelic space was dealt a huge blow when the FDA decided not to approve MDMA-assisted therapy for PTSD under Lykos’ proposal. Was the FDA fair to Lykos? And what are the next steps for Lykos and MAPS?
In this episode, Joe interviews Rick Doblin, Ph.D.: founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), and former board member at Lykos Therapeutics, MAPS’ public benefit subsidiary.
Doblin tells his side of the story: that the FDA’s concerns with double blinding not working had been fully addressed ahead of time, that they had negotiated agreements that were no longer agreed to when new FDA employees came on board, that there was a lot of confusion from going back and forth with the FDA on how Phase 3 studies should be designed, and more. He believes that Lykos made a massive mistake in assuming that provable science was more important than public opinion, and that ignoring critics who were saying whatever they wanted caused them to lose control of the narrative – which clearly influenced the advisory committee. While Lykos figures out their next steps with the FDA, MAPS is focusing their attention on what they feel is most important in light of this ruling: better public education and drug policy.
He talks about:
- How there’s a bias at the FDA to be harsh: Does automatically saying no just make it look like you’re being rigorous?
- The work of the Dutch government in researching MDMA, and Lykos’ odd decision to not highlight any of it
- Massachusetts’ Legalization and Regulation of Psychedelic Substances initiative, and the huge opportunity for progress at the local level
- Why federal agents at Burning Man work so hard to give tickets to attendees for smoking cannabis
- Why sharing stories of your positive experiences with psychedelics is so important
and more!
MAPS has announced that 2025’s Psychedelic Science conference will be in Denver, June 16-20, and will have experiential opportunities before and after. If you’d like to donate to MAPS, please do so here.
Links
MAPS Podcast- Episode 33: Matthew Baggott – Beyond Fear – MDMA and Emotion
Psychedelicalpha.com: Exclusive: David Hough on Lykos’ Path to Resubmission
Imdb.com: Of Night and Light: The Story of Iboga and Ibogaine
