US Food and Drug Administration Commissioner Dr. Stephen Hahn denied again on Monday that his agency had been pressured to authorize the use of plasma from coronavirus survivors as a Covid-19 treatment, but apologized for how he characterized data used in the decision. 

Some context: The White House announced the emergency authorization at a news briefing on Sunday, where President Donald Trump called the decision “historic.”

But Trump also suggested he pressured the agency. “I think there might have been a holdup, but we broke the logjam over the last week, to be honest,” Trump said at the briefing.

FDA’s response: Hahn told CNN Sunday he had not been pressured. In a series of tweets Monday, he repeated that assertion.

“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 tweeted.

“They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined,” he added. “The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”

“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. The convalescent plasma decision was made entirely by FDA scientists.”

But Hahn apologized for how he presented the data. He had previously said that the Mayo Clinic data showed use of convalescent plasma reduced the risk of death by 35%, and said that meant if 100 people got coronavirus, 35 would survive because of the treatment. 

But this was inaccurate; the study, which has not yet been peer-reviewed, showed that 8.7% of patients who were treated within three days of diagnosis died, compared to 11.9% of patients who were treated four days or more after their diagnosis — a difference of about 37%.

Those treated with plasma containing the highest levels of antibodies had a 35% lower risk of dying within a week compared to those treated with less-rich plasma. The study did not show the use of plasma reduced the overall death rate by 35%.  

“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,” Hahn acknowledged.

Source : CNN


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