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# Dr. Brian Pace FDA OPH Comment
- URL: https://ghost.psymposia.com/dr-brian-pace-fda-oph-comment/
- Published: 2024-06-04T21:13:28.000Z
- Updated: 2026-09-29T01:02:05.000Z
- Author: Mike Elliott
- Tags: Videos, #youtube, #youtube-transcript

## Transcript

*This transcript was generated automatically from YouTube's captions, then cleaned up by removing filler words, repeated words and background sounds. It may still contain errors.*

[\[00:00\]](https://www.youtube.com/watch?v=rwrxRp69ggY&t=0s&ref=ghost.psymposia.com) My name is Brian Pace I am a lecturer teaching psychedelic studies in the department of Plant Pathology at the Ohio State University I am also a co-author of the citizen petition which raised serious concerns about the NDA under review I thank the FDA for granting extended time in this response to our petition no conflicts I submit that lyos is a therapy cult that uses the application under review to further mystical and utopian goals this lend explains the mounting allegations against them regarding research misconduct and clinical trial participant Harms in my paper right-wing psychedelia I analyze lyos leadership's simply stated aims for institutional instrumentalizing the drug under review to change people's beliefs as part of an ongoing project of global spiritual conversion this spiritual conversion underlies their promise of solutions to more material concerns like bringing about world peace or solving climate

[\[01:03\]](https://www.youtube.com/watch?v=rwrxRp69ggY&t=63s&ref=ghost.psymposia.com) Change while these are not the first dubious promises to be made by applicants before this agency they are perhaps the most grandiose I'm obligated to State the obvious MDMA assisted therapy for PTSD is not going to result in the quote spiritualization of humanity unquote and such claims are the Prophecies of a therapy cult next slide the FDA is under no obligation to evaluate these spiritual claims but this agency is tasked with monitoring institutional review board compliance and act when study sponsors confess to Casual human experimentation with the drug under consideration at burningman that Leos leadership felt comfortable admitting this while clinical trials were ongoing betrays a lack of internal accountability and an organizational culture of deep impunity Leos has exploited this lack of monitoring and sanction from the FDA in fact they're

[\[02:04\]](https://www.youtube.com/watch?v=rwrxRp69ggY&t=124s&ref=ghost.psymposia.com) Betting on it next slide at South by Southwest this year lyos CEO Amy Emerson shared that patients presenting increased suicidal adiation is quote actually part of the process unquote of psychedelic therapy in the same breath she acknowledged that committing instances like these to medical records would be poorly received by Gatekeepers of Public Health omission of ad events is one of the specific allegations leveled against the applicant as I mentioned in my written comment an organization convinced it's on a mission to save the world might find justification of any means to do so next slide but the fda's broadest mission is that of protecting public health patients living with PTSD need rigorously tested care not the faith healing of a therapy cult's latest Rebrand of laying on of hands the concerns I share today aren't about the safety of MDMA but rather the people who have been administering and supervising

[\[03:06\]](https://www.youtube.com/watch?v=rwrxRp69ggY&t=186s&ref=ghost.psymposia.com) This medicine harms and misconduct will scale if they're allowed to train and certify therapists thank you