PT556 – The FDA, MDMA, and Public Perception: Was the FDA Fair to Lykos?, with Rick Doblin, Ph.D.
Oct 15, 2024
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Rick Doblin, Ph.D., is the founder of MAPS and a pioneer in psychedelic research. In this discussion, he shares insights on the FDA's handling of MDMA trials, emphasizing miscommunications that led to setbacks for Lykos Therapeutics. Doblin argues that neglecting public perception was a critical mistake and explores the bias at the FDA. He also highlights the need for better public education and drug policy reform, contrasting U.S. and European regulatory approaches while discussing innovative international MDMA therapy initiatives.
The FDA's shifting requirements during the MDMA approval process highlight the increasing caution around psychedelic substances and their therapeutic applications.
Public perception, influenced by media portrayal, plays a critical role in shaping FDA decisions, emphasizing the need for transparent communication from advocates.
Collaborative efforts between nonprofit organizations like MAPS and for-profit companies are essential for prioritizing patient welfare and advancing psychedelic research.
Deep dives
Regulatory Developments in MDMA Research
Recent FDA negotiations surrounding the approval process for MDMA have been pivotal in shaping its future in therapeutic settings. The dialogue acknowledged the complexities of creating a double-blind study when using such an impactful substance, necessitating a focus on dosage to ensure proper efficacy and safety. Studies highlighted that lower doses of MDMA could lead to therapeutic improvements, yet these doses were not as effective as therapy with no MDMA use, suggesting that careful dosing is essential for optimal outcomes. This rigorous research approach aims to establish a solid evidence base for the approval of MDMA as a treatment for conditions like PTSD.
Challenges with the FDA's Expectations
The. FDA's evolving demands during the MDMA approval process reflect a growing caution within regulatory bodies towards psychedelic substances. What began with a cooperative special protocol assessment has shifted to a more restrictive stance, requiring additional evidence of efficacy and safety that was previously negotiated. Notably, the FDA indicated a preference for therapy supported by therapists who possess extensive qualifications, which could delay research progress. These shifting requirements have prompted concerns about access to therapeutic solutions for patients needing timely care.
Impact of Media and Public Perception
The influence of media portrayal on public perceptions of psychedelics, including MDMA, has been significant in shaping FDA decisions. Criticism surrounding the validity of double-blind studies has surfaced, emphasizing the challenges in creating unbiased research conditions when participants can potentially identify their treatment. As negative narratives gain traction, it has become crucial for advocates within the psychedelic community to actively counter misinformation through public education and outreach. A proactive approach to storytelling and transparent communication is now more vital than ever in reshaping the discourse around psychedelic therapy.
The Role of Nonprofits and For-profits in Psychedelic Research
The current landscape of psychedelic research is characterized by a complex interaction between nonprofit organizations and for-profit companies. MAPS, as a nonprofit organization, has initiated extensive training programs for therapists, advocating for wider access to psychedelic therapy, while also participating in the regulation of such practices. The advent of for-profit entities in this space has introduced competitive dynamics that affect research direction and resource allocation, sometimes leading to conflicts in priorities. As developments continue, clear communication and collaboration between these sectors can ensure that therapeutic advancements prioritize patient welfare.
Plans for Future Developments and Public Education
As the conversation around psychedelic therapy evolves, there are strategic priorities on addressing drug policy reform and increasing public awareness. Initiatives focused on the decriminalization and regulation of psychedelics at the state and local levels aim to create a supportive environment for therapeutic practices. The collection of personal stories and firsthand accounts of the benefits of psychedelics can foster a groundswell of support, emphasizing their potential to aid those suffering from trauma. Ongoing efforts in public education and advocacy are essential in shifting perceptions and promoting progressive policy changes surrounding the use of psychedelics.
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.
