That is clearly beyond “boundary pushing” way into unethical behavior and was what I meant by “failing to screen investigators adequately.” Those investigators should never have been allowed to be in the study.
Also note that the concern that the panel stated was the “risk of boundary pushing.” Excluding the clearly unethical behavior noted above, therapy inherently includes the risk of boundary pushing. I question whether that is a risk of this treatment or of any treatment for PTSD.
Once the protocol has been approved by FDA for the study, data collection and analysis is out of the pharma company’s hands and controlled by a 3rd party. The company gets to make statements at the panel meeting because otherwise, there really isn’t anyone to present it. The way our system works right now, a new drug or device that requires a clinical study for FDA approval needs a sponsor to pay for the study and make the applications for approval. Otherwise, nothing gets done at all.
ETA: And it should be noted that this “pharma company” was formed by a PTSD patient advocacy group, not Martin Shkreli. If anything, this model would be a vast improvement over the current system where most trials are done only if the pharma company thinks they can make billions off the drug. FDA has processes for drugs that treat less common (a.k.a. Profitable) conditions, but they are underutilized. This seems like a model that could change that.
