Psychiatrist Chris Aiken and PMHNP Kellie Newsome discuss the recent FDA rejection of MDMA therapy for PTSD, exploring issues like boundary violations and functional unblinding. They analyze biases in medication trials, potential risks of MDMA, and the advocacy for its medical use in treating PTSD. The podcast also explores cardiovascular risks of MDMA, therapist influence on patient outcomes, and the need for standardized evaluation methods.
MDMA-assisted therapy faced FDA rejection due to concerns over boundary violations and functional unblinding.
Challenges in assessing efficacy and biases hindered the approval of MDMA for PTSD therapy.
Deep dives
MDMA-Assisted Therapy Rejected by FDA Panel
The FDA panel voted against approving MDMA-assisted psychotherapy for PTSD, citing concerns such as sexual boundary violations and functional unblinding. Despite a chance for approval, a majority of panel members were against it, with worries about potential biases affecting patient experiences and reporting of symptoms.
Challenges in Maintaining Blinding and Boundary Violations
Functional unblinding posed a significant challenge in the MDMA trials, with patients and therapists often able to discern who received MDMA. Some therapists allegedly influenced patients to report better recovery outcomes to support drug approval, raising ethical concerns about boundary violations. These issues, coupled with factors like recruitment biases and researchers' strong commercial and ideological biases, complicated the assessment of MDMA-assisted therapy efficacy.
Concerns Over Safety, Efficacy, and Potential Bias
MDMA's potential for dangerous side effects, boundary violations, and challenges in blinding raised skepticism over its therapeutic use. Questions around the therapy's efficacy compared to existing treatments like exposure therapy further fueled doubts about its breakthrough status. The need to address biases, risks of diversion, and misuse, alongside hefty costs and restructuring of psychiatric care, emphasized the complexity and uncertainties surrounding MDMA-assisted psychotherapy.
Chris Aiken, MD and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.
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