United States’ Food and Drugs Administration Commissioner Stephen Hahn on Tuesday apologised for overstating the benefits of treating coronavirus patients with convalescent plasma.
Hahn’s apology came after medical experts criticised his statement that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma, AP reported. This claim vastly overstated the findings of the Mayo Clinic. Medical experts subsequently called on Hahn to correct himself.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “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 added that the authorisation of the use of convalescent plasma for treating the coronavirus is not a final decision. He said the FDA will continue to monitor the use of the plasma and revoke its authorisation if needed.
In making the exaggerated claim, Hahn had echoed President Donald Trump, who had on Sunday called the FDA’s decision to authorise convalescent plasma a “historic breakthrough”, even though the benefits of the treatment are not yet certain. The announcement, made on the eve of the Republican National Convention, caused suspicion that it was politically motivated to offset critics of Trump’s handling of the pandemic.
“Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision,” Hahn said on Tuesday. “The decision was made by FDA career scientists based on data submitted a few weeks ago. They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.”
Hahn said the decision to authorise the plasma for Covid-19 treatment was based on 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,” Hahn emphasised. “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.”
On Monday, House of Representatives Speaker Nancy Pelosi, a Democrat, had called Hahn a disappointment and said House committees were looking into FDA actions.
The United States is the country most affected by the coronavirus. As of Tuesday, the country has reported over 57 lakh cases of the contagion, according to the Johns Hopkins University. More than 1.77 lakh people have died, but nearly 30 lakh have recovered.