Dr. Neşe Devenot FDA OPH Comment
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] For the record you have three minutes my name is n Deo and I'm a researcher at John's Hopkins University with expertise in psychedelic bioethics I co-authored a citizen petition to extend the open public hearing at this meeting Leos claims its training program will reduce the risk of boundary violations by teaching the specific psychological intervention from its clinical trials but the clinical trials failed in this regard this committee has been misled by lyos to believe that this intervention was non-directive and empathetic next slide lyos has obscured its actual intervention and its submissions to the FDA this intervention is acknowledged in this 2015 paper by founder Rick doblin next slide doblin admits that laos's entire therapeutic approach is based on stanislav gra spiritual teachings and that the essence of that treatment approach is a death rebirth process although this specific intervention isn't in any of the briefing documents that were submitted to the committee it is associated with identifiable patterns of harm across like clinical trials next
[01:02] Slide lcos intervention is described more fully in the book integral psychedelic therapy two of its three editors were lyos trainers and phase three therapists and it was endorsed by prominent members of laos's inner circle next slide in this book Veronica gold ao's supervisor trainer and phase three therapist describes pinning down a patient as their distress escalated to the point of shouting go away get your effing hands away from me end quot but gold did not stop as demonstrated by the many lyos therapists who endorsed this abusive practice this is an accepted component of the intervention that lyos presented to this committee as necessary for positive patient outcomes next slide Leos would like this committee to believe that significant boundary violations were limited to a single phase 2 participant although this participant Enlisted the media to draw attention to the dangers of liosis therapy the components of her on camera physical assault are still explicitly taught as part of laos's intervention
[02:02] Next slide after submitting my 17 Page written comments to this committee I was connected with a phase 3 participant whose PTSD symptoms were exacerbated by laos's clinical trial I learned they were under the care of therapist Veronica gold and they continue to experience flashback Nightmares of the specific intervention that lyos expects this committee to support next slide Leos argues that its training will ensure that boundaries are maintained but its intervention heightens risks for participants by incentivizing boundary violations in addition to gross violations in Phase 2 previously unreported violations include lyos senior leadership having sexual encounters with a vulnerable individual who was then recruited into phase three the most significant Harms in liosis clinical trials were not caused by MDMA but by the people who were entrusted to supervise its Administration if the committee would like additional information I'm happy to provide it thank you
