Flawed, scandalous trials tank FDA expert support for MDMA therapy
Flawed, scandalous trials tank FDA expert support for MDMA therapy
Bias, missing data, and claims of a new-age cult overshadow positive patient results.
Run trials with an astounding number of easily avoidable flaws, win stupid prizes. It would be a shame for this to turn into an overall setback for psychedelic therapy.
Sure, the FDA could go against the recommendation, but that's a political nonstarter given the problems included sexual assault. We need studies that are unassailable on the data collection such that the psychoactive (qualitative) effects are just an outlier in the list of quantitative results.
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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. This therapy has the potential to allow for abuse and exploitation, the researchers claimed in their public comment. At least one participant in the trial has accused a therapist involved with the trial of sexual assault during the trial's therapy sessions.
Well I would hope something like this gets shut down.