After years of work, MAPS/Lykos was finally able to present MDMA to the FDA as a possible tool in the fight against PTSD, only to be denied in devastating fashion. Just why did the FDA reject MDMA-assisted therapy for PTSD?

In this episode, Joe interviews Ingmar Gorman, Ph.D.: clinical psychologist and co-founder and CEO of Fluence, a psychedelic education company.

Gorman served as a co-principal investigator and study therapist on MAPS’ Phase II and III clinical trials for MDMA-assisted psychotherapy for PTSD, and works with drug sponsors: training, developing the components for clinical trials, and designing therapy manuals. With his insider’s perspective, he discusses the reasons why he believes the FDA rejected MDMA-assisted psychotherapy for PTSD: from ICER’s 2.1 section of the report giving legitimacy to allegations they don’t have the authority to research, to Lykos not being able to defend some accusations due to confidentiality, to the damage caused over time (which likely influenced the decision) from attacks against Lykos from dissenters.

He discusses:

• How, despite abuse claims, the main allegations in the report were actually about the mishandling of data or influence of investigators on participants
• The complications of needing to follow study frameworks: Should your adverse experience be in the report if it happened outside the study window?
• How easily opposition can attack and demonize a faceless company, while forgetting the humanity of the people behind it
• Inner healing intelligence and the proposition that people have been indoctrinated into this concept by MAPS
• The need for journalists to research more and not just jump on a narrative

and more! 

Links

Fluencetraining.com

Journals.sagepub.com: Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder

Frontiersin.org: Psychedelic Harm Reduction and Integration: A Transtheoretical Model for Clinical Practice

Ingmar Gorman – MDMA Psychotherapy and how to get Involved with Psychedelic research

Elizabeth Nielson and Ingmar Gorman – The Importance of Psychedelic Integration Training for Therapists

Icer:org: Institute for Clinical and Economic Review Releases Draft Evidence Report on Treatment for Post-Traumatic Stress Disorder

Lykospbc.com: Lykos Therapeutics Statement on FDA Advisory Committee Meeting

Psychedelicalpha.com: Exclusive: Therapists and Trialists from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER’s Critical Draft Report

An Inside Look at the FDA and Early Drug Development, featuring: Dr. Amanda Holley

MAPS Podcast: Episode 33: Matthew Baggott – Beyond Fear – MDMA and Emotion

Researchgate.net: Preliminary evidence for the importance of therapeutic alliance in MDMA-assisted psychotherapy for posttraumatic stress disorder

Tactogen.com

YouTube: Breaking Points: OPEN WAR As FDA BLOCKS MDMA Therapy For Vets

Secondhallway.com: A Brief Statement on My Resignation from Psymposia