[Goose]

Nothing in your post contradicts my point that the only reason we are talking about this drug, is Trump. He bizarrely claimed/lied to take it prophylactically, and criticized the FDA for revoking the EUA, based on nothing but his big ol brain. We know of whistleblowers within the FDA who were concerned that the initial push for drug was political and not scientific. Trump has continued to tout it, and seeks to find any kook with a white coat to back him. The only other national leader pumping it is his right wing, anti-science friend Bolsonaro, hardly a coincidence.

The FDA is usually pretty immune to political pressure in the "normal" sense.

Do you think our executive branch has been functioning normally the past 3 years?

No, I don't think the "executive branch" in the person of Trump and his appointees could be considered as "functioning normally" in the past 3 years. HOWEVER, it must be remembered that the vast majority of people who work for the executive branch are not political appointees and are not beholden to Trump or to God. These are the people who make things work day to day. They are the FDA and CDC and places like that, with all their flaws and advantages. Presidents come and go but these people stay for a very long time if they want to do so. The political appointees find out very quickly that "I was here when you came and I will be here when you are gone". For better or worse (right now, probably for better) the Chief Executive and his minions can only affect things in a limited way. That is probably the only thing holding our government together right now IMHO.

Many have lamented that they consider themselves a law unto themselves with no responsibility to anyone else.

Who are the many you refer to here?

I am referring to people I know in pharma who deal with the FDA on a regular basis. They have great respect for the FDA as an institution, and for many (not all) of the people who work there. There is no question that these people are aware that they have effectively absolute power. If they tell you that you must do something in your clinical trial, even if their reason makes no sense, you basically have to do it. Many of the people at the FDA are knowledgeable but not real willing to change their minds. Often they do a great job, but sometimes they don't.

As a group, they are very risk averse. They all seem to be aware that asking you to be more conservative than you want to be has no down side to the FDA. It may delay the treatment availability, in fact it may render the treatment financially infeasible because the trial cost would be too high. However, the public isn't going to know about that, and if somebody complains they can wrap themselves in the "protecting the public" flag.

Everybody recognizes the FDA has a tough job. They have to balance risk vs benefit. Generally they try hard to do that in a professional manner. They will almost universally err on the side of caution. Unfortunately, some of the standards they set are of necessity somewhat arbitrary, as the "right answer" isn't known. That is an area where they are often too hard-headed in my friends view. Some endpoints that have what appears to be reasonable justification are rejected out of hand. That is hard to deal with.

[Goose]

Nothing in your post contradicts my point that the only reason we are talking about this drug, is Trump. He bizarrely claimed/lied to take it prophylactically, and criticized the FDA for revoking the EUA, based on nothing but his big ol brain. We know of whistleblowers within the FDA who were concerned that the initial push for drug was political and not scientific. Trump has continued to tout it, and seeks to find any kook with a white coat to back him. The only other national leader pumping it is his right wing, anti-science friend Bolsonaro, hardly a coincidence.

The FDA is usually pretty immune to political pressure in the "normal" sense.

Do you think our executive branch has been functioning normally the past 3 years?

No, I don't think the "executive branch" in the person of Trump and his appointees could be considered as "functioning normally" in the past 3 years. HOWEVER, it must be remembered that the vast majority of people who work for the executive branch are not political appointees and are not beholden to Trump or to God. These are the people who make things work day to day. They are the FDA and CDC and places like that, with all their flaws and advantages. Presidents come and go but these people stay for a very long time if they want to do so. The political appointees find out very quickly that "I was here when you came and I will be here when you are gone". For better or worse (right now, probably for better) the Chief Executive and his minions can only affect things in a limited way. That is probably the only thing holding our government together right now IMHO.

Many have lamented that they consider themselves a law unto themselves with no responsibility to anyone else.

Who are the many you refer to here?

I am referring to people I know in pharma who deal with the FDA on a regular basis. They have great respect for the FDA as an institution, and for many (not all) of the people who work there. There is no question that these people are aware that they have effectively absolute power. If they tell you that you must do something in your clinical trial, even if their reason makes no sense, you basically have to do it. Many of the people at the FDA are knowledgeable but not real willing to change their minds. Often they do a great job, but sometimes they don't.

As a group, they are very risk averse. They all seem to be aware that asking you to be more conservative than you want to be has no down side to the FDA. It may delay the treatment availability, in fact it may render the treatment financially infeasible because the trial cost would be too high. However, the public isn't going to know about that, and if somebody complains they can wrap themselves in the "protecting the public" flag.

Everybody recognizes the FDA has a tough job. They have to balance risk vs benefit. Generally they try hard to do that in a professional manner. They will almost universally err on the side of caution. Unfortunately, some of the standards they set are of necessity somewhat arbitrary, as the "right answer" isn't known. That is an area where they are often too hard-headed in my friends view. Some endpoints that have what appears to be reasonable justification are rejected out of hand. That is hard to deal with.