What is involved with MDMA-assisted therapy?
UC expert discusses recent FDA decision with WVXU's Cincinnati Edition
Earlier this month, the Food and Drug Administration declined to approve MDMA-assisted therapy for PTSD. The University of Cincinnati's Stephen Rush, MD, joined WVXU's Cincinnati Edition to discuss the decision and the future of MDMA and other psychedelic psychiatric treatments.
Rush said there have been allegations of unethical conduct in the trial submitted to the FDA for review, including allegations of sexual abuse. While the official reasoning behind the FDA's decision has not been released, he said additional concerns over bias and insufficient blinding most likely caused the denial.
"Typically, we want to have research studies that are double blind, which means that neither the scientist or researcher performing the treatment nor the patient knows if they are receiving the drug that’s being requested for approval or the placebo," said Rush, associate professor of clinical psychiatry in UC's College of Medicine, medical director of ambulatory services and a UC Health physician. "Patients, scientists and the therapists running the trial were already members of a community that had strong prior beliefs about the value of psychedelic drugs and the treatment of psychiatric illness. That can turn into bias when it creates a significant pressure for the results of these trials to be favorable."
Rush said the FDA denial following this specific trial does not mean the end of research into using MDMA and other psychedelics in psychiatric treatment.
"I think psychedelics are a very exciting area of research in psychiatry and some of the preliminary evidence fires and fuels that excitement within me," he said. "Right now, I think this looks like an issue with the company rather than with the potential for MDMA to have a postiive effect on PTSD."
Listen to the Cincinnati Edition segment.
Featured photo at top of pills on a countertop. Photo/FotografiaBasica/iStock.
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