A Thought About MAPS' Phase 3 Trial
What are the chances of a Black Swan result?
I was listening, again, to Rick Doblin speak with Rob Reid about the currently-underway phase 3 trial of MDMA for PTSD, which everyone in the psychedelic space is excited about and watching earnestly.
First of all, Rick and the folks at MAPS need to be commended for dotting their I’s and crossing their T’s so meticulously because I would imagine that they are the first not-for-profit to take a drug this far in the FDA’s approval process, receive Breakthrough Therapy status and have an Expanded Access Program agreement in place.
Incredible vision, work and strategy.
But what if phase 3 doesn’t go as planned? What if it is a flop and the results are underwhelming?
Given the results of phase 2 it would appear that they have their ducks in a row and have established safe benchmarks with the FDA and everyone is expecting it to be smooth sailing.
But what if it doesn’t go as planned?
Here’s the idea: the popularity of the emerging psychedelic science will cause patients who are not as far down the ‘desperation curve’ to seek treatment and this could lead to underwhelming results.
In my work as an acupuncturist I specialize in musculosketal pain. I often see people who have ‘tried everything’ and it is these people for whom positive engagement, education, reassurance, acupuncture, and rehab exercises have the best results.
They have been through the ringer of injections, medications, PT, Chiro, maybe even surgery. No one has explained to them how pain works. By the time they get to me it is often a matter of shifting their perspective and offering reassurance, stimulating the nervous system and getting them moving. They are desperate and they will work for it.
When someone doesn’t have the fear that they will ever get better or has been sore for just a few days, the treatments that I offer don’t work as well.
Could this phenomena happen with psychedelic therapy?
Could the effect size be diminished by enrolling patients who are not as traumatized? Is the willingness to surrender during a trip a function of how badly people want to get better? And is this a function of how far down the treatment funnel they have already gone?
I could be way out of line here and this hypothesis could simply show my ignorance of 1) study design 2) trauma and recovery 3) biology.
But maybe it is another reason we’re not considering, but it does seem that the field as a whole is very confident that both MDMA and Psilocybin will be available in a treatment format soon, and I wonder if anyone is thinking about the possibility that it doesn’t happen.