FDA commissioner says he overstated effects of virus therapy

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observation.

"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 tweeted.

Data compiled by a preliminary study at the Mayo Clinic compared convalescent plasma results in patients who got a high dose of the antibodies versus those who got a low dose of antibodies. The comparison was not between the number of patients who received plasma and those who got none at all.

"It’s extraordinary to me that a person involved in clinical trials could make that mistake," said Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest. "It’s mind-boggling."

Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will not approve any vaccine that doesn’t meet preset standards for safety and efficacy.

Lurie said Hahn’s performance at the press conference undermined his credibility, particularly among FDA staff.

"I think within the agency his credibility is massively reduced as a result," Lurie said.

On Monday, House Speaker Nancy Pelosi, a Democrat, called Hahn a "disappointment" and said House committees were looking into FDA actions.