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FDA advisors say no to MDMA. What’s the impact? With Josh Hardman
Jun 21, 2024
In this engaging discussion, Josh Hardman, founder and editor of Psychedelic Alpha, tackles the FDA's recent rejection of MDMA for PTSD therapy. He explores the complexities of the FDA advisory process and highlights the challenges in data gaps and potential biases in clinical trials. Hardman delves into the future of psychedelic treatments and the rising importance of non-hallucinogenic therapies. The conversation also touches on the implications for insurance coverage and regulatory pathways, painting a vivid picture of the evolving landscape in mental health treatment.
56:55
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Quick takeaways
- The FDA advisory committee's negative vote on MDMA-assisted therapy for PTSD highlights a growing skepticism toward psychedelic treatments in mainstream medicine.
- Significant concerns regarding trial methodologies and safety data raised during the FDA meeting underscore the challenges facing psychedelic therapy regulation.
Deep dives
FDA Decision on MDMA Therapy
The upcoming decision by the FDA regarding the approval of MDMA-assisted therapy for PTSD is highly anticipated, with significant implications for patients, therapists, and the broader psychedelic industry. Approval could validate the extensive work done by startups and researchers in the field, effectively legitimizing psychedelic treatments as viable options for mental health care. Conversely, a denial would impact existing and future clinical trials focused on similar therapeutic avenues, potentially stalling the momentum gained in this burgeoning sector. The notion of a 'yes' vote resonates not only with therapeutic advancements but also reflects broader acceptance of alternative treatments within medical practice.
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Discover
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Listen to the best highlights from the podcasts you love and dive into the full episode