As flawed as the FDA and CDC might be, a world without them would be an absolute disaster. If you look at the design of the trial protocols and the requirements needing evaluation it is very logical as to why these steps are in place. Trials are designed to really understand how a drug works, who it works on and what the side effects are. You need a placebo group to evaluate whether a drug is working relative to nothing. It takes time to really see the mechanism in action. There is no trying to make it difficult, it is just difficult to see this stuff.

Look at the supplement market, drugs that are not FDA approved, The claims made by these companies and self proclaimed experts is scary.

The FDA is tasked most of the time with drugs that have very bad side effects but need to weigh the benefits against those side effects. It is a very grey area that hey have to approve a terrible drug that might work in a very narrow window. I would not want to be the one to make that call.

As much as we all know Leronlimab is very safe and it works, most of the world is just learning of it and has every responsibility to question and require trial support for the claims.