Welcome to The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.
Last week on the podcast, I spoke with Dr. Carlene MacMillan, psychiatrist and Chief Medical Officer of Osmind, about the FDA’s rejection of MDMA Assisted Therapy.
That conversation focused on some of the problems with the application, including potentially missing data, inaccurate or unreported adverse events, and the general uncertainty that both the Advisory Committee and FDA itself had with the work Lykos submitted.
Today’s conversation addresses the matter from another perspective, namely the inadequacy of the current regulatory regime for evaluating treatments that challenge the current epistemological paradigm and come from “outsider” organizations.
To make sense of this, I asked Nick Gillespie, Editor at Large of Reason Magazine, to come on the podcast to discuss the matter.
To say that Nick is critical of the FDA would be an understatement.
His position is that the latent mission of the FDA and other regulatory agencies is to maintain the existing power structures and commercial interests of the organizations they regulate rather than to protect public health, ensure public trust, or facilitate the availability of new treatments.
His views challenge mainstream narratives of both the right and the left, which makes him the perfect guest as we delve into the complexities of drug regulation, the FDA's role in approving psychedelic therapies, and the broader implications for personal autonomy in today’s world.
In this episode, we explore:
* The challenges of navigating the FDA's regulatory process for novel therapies like MDMA-assisted psychotherapy.
* The increasingly confusing political and ideological landscape
* Outdated and ossified regulatory institutions
* The prospect of individual states taking over regulatory responsibilities from the federal government
* The cultural and political dynamics that shape public opinion on psychedelics and other controlled substances.
* The evolving landscape of personal freedom in the context of healthcare and drug use.
* And much more.
And now, I bring you my conversation with Nick Gillespie.
Listen to the episode on Substack, Spotify, Google or Apple.
Credits:
* Hosted by Zach Haigney
* Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari
* Find us at thetripreport.com
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Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary
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