FDA Chief Hahn Should Resign For Overstating Value of Convalescent Plasma on COVID-19 Patients

FDA chief Dr. Stephen Hahn apologized today for overstating the effects of convalescent plasma in the treatment of COVID-19.

The apology came less than 48 hours after Hahn appeared with President Trump to announce the FDA had made an emergency authorization of convalescent plasma for COVID-19 patients. Trump hailed the announcement as "a very historic breakthrough" on the eve of the opening of the Republican National Convention claiming the treatment "to be safe and very effective." The President along with HHS Secretary Alex Azar and Dr. Hahn also claimed 35 out of every 100 COVID-19 patients treated with convalescent plasma would survive drawing ire from the medical community. Hahn now states:

I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.

The emergency authorization was based on a study by the Mayo Clinic which monitored the use of convalescent plasma in hospitals throughout the country. But the Mayo Clinic emphasized the study was not a clinical trial conducted under controlled conditions:

It is important to note that the EAP (Expanded Access Program) is not and was not intended to be a clinical trial to determine the efficacy of convalescent plasma. It was established by the FDA as a program to increase access to plasma to help severely ill patients at the height of the pandemic and to determine the safety of plasma transfusions. The current observations might indicate factors that may impact effect of treatment and help direct the randomized clinical trials that are needed to establish efficacy. The intent was to offer a procedure that had a history of use at a time when there was no known treatment for this deadly condition.

No data existed as to what dose might be appropriate. Inclusionary criteria were broad; exclusionary minimal. There was no standardized treatment protocol. Enrollment sites were very diverse, from university hospitals to community hospitals. Personnel training was minimal as was the fine detail of data reported.

So Trump's announcement was anything but a historical breakthrough and Hahn knew it yet went along with the charade. Of course, Trump has put the FDA under enormous pressure. But Hahn should have stood his ground and refused to become a political prop much less reiterate Trump's misleading statements thereby further endangering public health beyond the nearly 180,000 deaths in this country which have resulted from COVID-19. 

Notwithstanding his apology, Hahn's statements damage his credibility in such a way to undermine public confidence in future statements he might make at the behest of President Trump with regard to COVID-19. As such I believe Hahn should resign.