Comment by vibrio

This is a summary of my view. The danger is an overly opinionated “leader” with strong opinions has veto power over expert fda review teams, the system fails and decisions are not made on data and consensus but rather ideology and self importance. Patients and even practicing Physicians cannot be expected to review the nuances of every aspect of clinical studies for therapies in their area. The FDA and expert advisory committees (do these still exist?) are crucial in providing a data-driven analysis. This should not be done by an outspoken “leader” that is confident that he is smarter than the rest of the field. (This isn’t limited to medicine,but that is a can of worms)