PT549 – Why Did the FDA Reject MDMA-Assisted Therapy for PTSD?, with Ingmar Gorman, Ph.D.

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! For links, head to the show notes page.