FDA commissioner says criticism for misrepresenting convalescent plasma stats is warranted

The head of the Food and Drug Administration (FDA) on Monday said criticism for his praise of convalescent plasma treatment was warranted, but denied the decision to authorize the emergency use of the treatment for COVID-19 patients was politically motivated.

“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,” FDA Commissioner Stephen Hahn said in a lengthy Twitter post.

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

During a press conference announcing the decision on Sunday, Hahn touted the therapy by saying a study found it resulted in a 35 percent improvement in survival. 

“A 35 percent improvement in survival is a pretty substantial clinical benefit.  What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma,” Hahn said.

The 35 percent statistic was also cited by Health and Human Services Secretary Alex Azar, as well as by President Trump. 

But the data did not actually show that.

There was evidence that using a higher dose of plasma was better than a lower one, but because there were no randomized control trials of the treatment, there wasn’t enough evidence to show it was any better than a placebo.

Hahn, who has extensive experience as a cancer researcher, came under fire from experts who said he should have known better than to misrepresent the findings of the study.

Late Monday, Hahn tweeted a correction.

The FDA’s decision to issue an emergency use authorization came after Trump launched extraordinary attacks on the agency, accusing scientists of being part of the “deep state” and slow-walking treatments. It has led to concerns the decision was politically motivated.

Hahn on Monday denied that.

“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,” Hahn said in a lengthy Twitter post.

“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,” Hahn said.

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

Sunday’s announcement marked a turnaround for the FDA. Last week, top American health officials including National Institutes of Health Director Francis Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, intervened to stop the agency from issuing an emergency use authorization, The New York Times reported.