05/06/2024
After two decades of extraordinary and extraordinarily successful clinical trials using M**A and psychotherapy to treat otherwise untreatable PTSD, overseen from start to end by the FDA, an “independent” panel has advised the agency to throw out the positive results of three phases of trials with several thousand subjects and deny approval. The panel’s reasoning is that though the trials showed the vast majority of subjects had significant and lasting improvement, those results could not be trusted, for two reasons. One: They claim the fact that the doses of M**A were combined with a what they described as a grab bag of therapeutic techniques made it impossible to know how much of the improvements might have been due to the talk therapy and not the effects of the drug. Two: Since like all psychedelics, M**A has a unique impact on consciousness, most trial subjects knew whether they had been given M**A or the placebo, making a double-blind (in which neither the therapists nor the patients knew which subjects were given the test drug) impossible to attain.
To the first point, it was not a grab bag of therapeutic techniques, but one highly delineated approach documented in a treatment manual and inculcated in extensive training for all study therapists. Secondly, and perhaps most important, is the criticism of the failure of a full blinding. If a drug impacts conscious experience in a unique and unmistakable way, there is no way to disguise it. Should that mean that any such drug, no matter how beneficial, should be banned because of it?
There is still a strong possibility the FDA, which as mentioned earlier has closely monitored this research through all three phases of trials and has consulted on the design from day one, will dismiss the panel’s recommendation when it meets in August, approving the M**A therapy model. If they don’t, accepting the panel’s recommendation, they are dooming millions of Americans to suffer from a debilitating and sometimes life destroying illness who might otherwise find relief from a process that has proven to be effective and remarkably safe over two decades.