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Flawed, scandalous trials tank FDA expert support for MDMA therapy
(arstechnica.com)
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this post was submitted on 05 Jun 2024
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In response to this point, the FDA stunningly admitted in the meeting that it had overlooked the fact that the company didn't plan on collecting that data while it was designing the trial.Lykos also did not collect enough data on the known cardiovascular effects of MDMA, which could pose significant risks to patients with high blood pressure and heart arrhythmias.
They also claimed that the touch-based psychotherapy technique that Lykos used for the trial ties to dubious cult-like new-age psychospiritual therapy, which, among other things, intends to bring about a "global spiritualized society" and suggests suicidal ideation stems from suffering that occurred in the birth canal.
"Unfortunately, there potentially has been some misconduct ... that has really polluted or corrupted our ability to interpret the data," advisor and psychiatry expert Walter Dunn, of the University of California Los Angeles, said at the end of the meeting.
The FDA does not regulate psychotherapy, and the advisory committee members had several questions about how to standardize a therapy technique that is not yet based on evidence.
Advisor and psychologist Melissa Decker Barone, of the VA Maryland Health Care System, summarized the general feeling of the committee in the discussion period.
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