The ill-advised FDA decision to shamelessly endorse an unproven treatment for COVID-19 on national TV as a ‘historic breakthrough’ is wrong on so many counts that I do not even know where to begin.

What I can say, however, is that Dr. Hahn should immediately get on national TV and correct the dubious and misleading claim and make 4 statements:

1. I am sorry I failed the 18,000 dedicated public servants at the FDA by not standing up to POTUS’s unacceptable ad hominem. Your hard work is what makes this institution great and you have worked selflessly to earn the public’s trust. I am sorry for contributing to the erosion of that sacred trust. You deserve a better leader.

2. I am sorry for misleading the nation by embellishing the benefits of convalescent plasma therapy. There are uncertainties surrounding the benefit-risk of this treatment for COVID-19, and the only way to adjudicate these uncertainties is to conduct rigorously designed and analyzed randomized controlled trials.I failed to provide the appropriate caveats in communicating the limitations of non-randomized and quasi-randomized trials. You deserve a more trustworthy FDA commissioner.

3. I am sorry for allowing political expediency to substitute for valid scientific evidence to meet the requirement to support Emergency Use Authorization. Regulatory decision making deserves to be data- and science-driven.

4. I am sorry for using the FDA’s press office for trumpeting the achievements of the administration in their fight against the pandemic. The FDA should never be allowed to be the megaphone for the federal government to make tall claims or to gloat about false victories.

After he has made these statements, he should respectfully offer to resign in front of national TV. Perhaps, only then will his path to redemption begin in earnest.

 


 

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