FDA Commissioner Acknowledges Misrepresenting Convalescent Plasma Data

Headline Roundup August 25th, 2020

FDA Commissioner Stephen Hahn apologized Tuesday after scientists raised concerns over his use of data to support an emergency use authorization (EUA) for convalescent plasma as a COVID-19 treatment. Hahn, who said scientists’ criticism was “entirely justified,” initially mischaracterized a 35% relative mortality reduction in a small subgroup of patients as an “absolute risk reduction” among all patients. The studies used to justify the EUA were also criticized two weeks prior by Dr. Anthony Fauci and Dr. Francis Collins, prompting the FDA to delay the EUA.

Coverage in left-rated outlets tended to focus on scientists’ criticisms more than coverage in right-rated outlets. Some coverage in left- and center-rated outlets called Hahn’s statement an “apology," and some coverage in right-rated outlets used words like “clarified” and “acknowledged."

From the Left
13320

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 disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has...

Read full story
From the Left
13320

Dr. Stephen Hahn, commissioner of the Food and Drug Administration (FDA), apologized Monday for overstating the benefits of convalescent plasma as a coronavirus treatment during a press conference with President Donald Trump one day earlier.

"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," Hahn said in a thread of tweets posted in the middle of the first night of the Republican National Convention. "What I should have said better is that the data show [sic] a relative...

Read full story
Some content from this outlet may be limited or behind a paywall.
From the Right
13320

The head of the US Food and Drug Administration has clarified his remarks about a new COVID-19 treatment — and insisted politics had nothing to do with his agency’s decision to authorize its emergency use.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” FDA Commissioner Stephen Hahn tweeted.

“What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

Hahn also said the decision to authorize emergency use...

Read full story