hcq fda trials bkmk
Bureaucrats doing what bureaucrats gonna do.
They protect their processes above all else and hide behind the word “science.”
They are married to clinical trials not necessarily for the science but because that is what the process is. Those trials are about data and not necessarily about how a drug is supposed to work.. Those trials are about playing the government’s game. In theory it is about efficacy and safety, or at least it is supposed to be.
In this case we have a regime involving two known drugs with known side effects. We have a known (in general) biochemical process that a virus follows. The drugs have a known effect on that process. So why not try it?
The FDA doesn’t care. As long as there is a new, off label use involved, they approach this as is the drug were experimental, as if they had never been approved in the first place. Oh sure, they may allow that off label use. But as far as the bureaucrats are concerned, until you pass their sacred process, that off label use is purely “cowboy.”
And moving the Fauci’s of the world off of that view requires what the regulations says it requires and nothing less will do. Trials must be done, months and years must pass. That is the way.