If there were verified instances of hiding adverse events, there wouldn’t be a recommendation for a third trial. The therapy would be rejected with no chance of additional trials by this sponsor. And to be clear, there was no accusation of data not being reported. There was vague accusation of investigators downplaying potential adverse events with trial patients. Typically, the data isn’t controlled directly by either the trial sponsor or even the investigators. The data is controlled by a 3rd-party Clinical Research Organization (CRO) that has no vested interest in the outcome of the trial. At best, an investigator could put their thumb on the scale with patients. The sponsor has zero control over the data.
Potential for abuse? Compared to opioids!?! At least MDMA isn’t physically addictive. That concern seems overblown.
The concern from the panel about functional unblinding is a tough one, but it has to be solvable. I’m sure other drugs have had the same issue. Maybe there is a relatively safe stimulant that can be used instead of placebo for the control group if they do another trial.
The biggest legitimate concern is that the sponsor didn’t do a good enough job screening investigators. But concern about the risk “boundary pushing” by therapists seems strange. I mean, that comes with the territory. It’s almost like there was bias within the panel against therapy itself.
Ultimately, a 9-2 result from the advisory panel is tough to overcome. FDA almost always follows the panel’s advice. It does sound like a third trial is warranted, if they have the money to do it.
