OT: FDA Panel Recommends Against MDMA for PDTS

Bad data seemed to be the primary reason. This para jumped out at me:

While the study took steps to “blind” study participants, there was considerable discussion around the fact many of those in the study could tell they had received the experimental drug, leading to what’s known as “functional unblinding,” which can ultimately affect the results.

I can see the problem here. The cohort who received MDMA were tripping their brains out, and everybody especially the participate knew exactly what was happening. There is zero question who got the placebo.

But here’s the kicker:

For example, one of those studies showed 67% of participants in the MDMA treatment arm no longer met the diagnostic criteria for PTSD following three dosing sessions with MDMA, compared to about 32% in the placebo group who underwent the therapy sessions but did not receive an active drug.

Nearly 70% cure in just three sessions. This is almost too good to be true. Even if all of this is due to the placebo effect…why not? This is a fantastic result. With results this good why shouldn’t we incorporate the placebo effect into medical practice?

If indeed this is all placebo. But what if some or all isn’t? These are still fantastic results. Sure, you can invalidate data on technical grounds, but do we want technically sound data or a cure for PTSD?

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The Captain

recommends against acronyms

FDA MDMA PDTS

There is already a well-documented case of two therapists in the Phase 2 trials with a participant who said they engaged in inappropriate contact with her while she was under the influence of MDMA. The videos of the two therapists in bed with the participant were eventually made public by a podcast.

Geez, it’s always the most depraved among us who ruin it for everyone else.

Lots of challenges in studying these types of drugs for therapeutic purposes. Hopefully they figure out how to address the concerns and improve research.

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