Psychedelics Today

PT556 – The FDA, MDMA, and Public Perception: Was the FDA Fair to Lykos?, with Rick Doblin, Ph.D.

Informações:

Sinopse

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 pub