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.
I was rooting for this therapy, but not at the expense of exposing vulnerable people to all the hokum that Lykos was apparently trying to spike it with. FDA made the right call for now.
So how are you supposed to be able to double-blind a study involving MDMA? It seems essentially impossible, which makes it inevitable that this will always happen at every review, no?
Why is double-blinding so important in this specific instance to the point that it’s best that the buck stops here?
Seems like an easy way to kill momentum of a life-saving mental health treatment because it’s politically inconvenient (and maybe endangers existing pharmaceutical products?).
I have no fucking clue how you’re supposed to double blind it. Obviously the patients will realise if theyve been giving MDMA.
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.
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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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