FDA chief clarifies plasma treatment approval, says he overstated effects of COVID-19 therapy

FDA chief clarifies plasma treatment approval, says he overstated effects of COVID-19 therapy
Posted at 9:38 AM, Aug 25, 2020
and last updated 2020-08-25 10:38:44-04

WASHINGTON (AP) — 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.

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.

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

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