Dr. Stephen M. Hahn [@SteveFDA], is the 24th Commissioner of Food and Drugs for the @US_FDA under Donald Trump. Tonight, on Twitter, Hahn admitted he misled the public on the promise of convalescent plasma for COVID-19 patients.
"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma," he tweeted Monday night.
"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."
Here is Hahn's entire thread from Monday night.
Media coverage of FDA's decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA's 18,000 career employees, I want to reassure the American public about this commitment.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
The convalescent plasma decision was made entirely by FDA scientists.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
The authorization of emergency use of convalescent plasma is not a final approval. FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
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.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
