[BostonCard]

The evidence has generally (but not universally) been negative in a number of different settings, including as a preventative, for patients with mild disease, and for hospitalized patients.  I think when Gottlieb said "early on" he meant "early on" in the pandemic (as in, back in March and April), not "early on" in the infection.

BC

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Any prior "admin FDA" would never have approved it for emergency use based on the limited and poor data available at that point.

No prior FDA ever has been involved in anything like this epidemic. You may recall that the FDA was slammed for its slow approvals of some testing. The FDA is usually pretty immune to political pressure in the "normal" sense. They don't turn over the staff every time we get a new president, and they do not react well to attempts by the administration to influence their process or their speed. Many have lamented that they consider themselves a law unto themselves with no responsibility to anyone else. In reality, they are not immune to what is going on around them. They have both approved and not approved things recently that surprised lots of people. Since "off label" use of hydroxychloroquine was possible anyway, the approval really didn't change much. Reimbursement would be problematic in both cases, so no change there either.

That might make sense if the FDA were giving out EUA's to other drugs with a similar level of evidence (or lack thereof), but HCQ was the only drug that got an EUA on the basis of non-randomized trials.  I think HCQ aside, the FDA has been fairly responsible in terms of waiting for the results of randomized trials and then promptly offering an EUA, for example, in the case of remdisivir.  But hydroxchloroquine was an outlier in being given an EUA on the basis of flimsier evidence than any other COVID-19 drug.

BC

[BostonCard]

The evidence has generally (but not universally) been negative in a number of different settings, including as a preventative, for patients with mild disease, and for hospitalized patients.  I think when Gottlieb said "early on" he meant "early on" in the pandemic (as in, back in March and April), not "early on" in the infection.

BC

---

Any prior "admin FDA" would never have approved it for emergency use based on the limited and poor data available at that point.

No prior FDA ever has been involved in anything like this epidemic. You may recall that the FDA was slammed for its slow approvals of some testing. The FDA is usually pretty immune to political pressure in the "normal" sense. They don't turn over the staff every time we get a new president, and they do not react well to attempts by the administration to influence their process or their speed. Many have lamented that they consider themselves a law unto themselves with no responsibility to anyone else. In reality, they are not immune to what is going on around them. They have both approved and not approved things recently that surprised lots of people. Since "off label" use of hydroxychloroquine was possible anyway, the approval really didn't change much. Reimbursement would be problematic in both cases, so no change there either.

That might make sense if the FDA were giving out EUA's to other drugs with a similar level of evidence (or lack thereof), but HCQ was the only drug that got an EUA on the basis of non-randomized trials.  I think HCQ aside, the FDA has been fairly responsible in terms of waiting for the results of randomized trials and then promptly offering an EUA, for example, in the case of remdisivir.  But hydroxchloroquine was an outlier in being given an EUA on the basis of flimsier evidence than any other COVID-19 drug.

BC