FDA CHIEF WALKS BACK COMMENTS ON EFFECTIVENESS OF CORONAVIRUS PLASMA TREATMENT
FDA CHIEF WALKS BACK COMMENTS ON EFFECTIVENESS OF CORONAVIRUS PLASMA TREATMENT
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FDA CHIEF WALKS BACK COMMENTS ON EFFECTIVENESS OF CORONAVIRUS PLASMA TREATMENT
CNBC logo FDA chief walks back comments on effectiveness of coronavirus plasma treatment
The authorization will allow health-care providers in the U.S. to use the plasma to treat hospitalized patients with Covid-19.
The FDA's emergency use authorization came a day after President Trump accused the agency of delaying enrollment in clinical trials for vaccines or therapeutics.
The criticism from Trump and action from the FDA led some scientists to believe the authorization, which came on the eve of the GOP national convention, was politically motivated.
a man wearing a suit and tie smiling at the camera: Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020.© Provided by CNBC Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020.
FDA Commissioner Dr. Stephen Hahn is walking back comments on the benefits of convalescent plasma, saying he could have done a better job of explaining the data on its effectiveness against the coronavirus after authorizing it for emergency use over the weekend.
Hahn came under intense criticism from scientists after he said at a White House press briefing Sunday that a Mayo Clinic study found the treatment resulted in a 35% improvement in survival. However, in its authorization, the agency cited more complicated findings from Mayo Clinic researchers on the use of plasma.
The study found that patients younger than 80 years old who were not on a respirator and received plasma with a high level of antibodies within three days of diagnosis were about 35% more likely to survive another 30 days compared with patients who received plasma with a low level of antibodies. A weakness of the Mayo study was that it did not include a controlled group of patients receiving a placebo.
In a series of tweets Monday night, Hahn said the criticism from scientists was correct.
"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," Hahn said. "What I should have said better is that the data show a relative risk reduction not an absolute risk reduction."
The authorization will allow U.S. health-care providers to use the plasma to treat suspected or confirmed infections in hospitalized patients. The FDA's decision to authorize emergency use came a day after President Donald Trump accused the agency of delaying enrollment in clinical trials for Covid-19 vaccines or therapeutics. The criticism from Trump and action from the FDA led some scientists to believe the emergency use was politically motivated, especially since it was announced on the eve of the republican National Convention. Last week, Trump touted the benefits of the treatment, saying he heard "great things about it" and then he questioned whether its emergency use approval was being slow-walked by bureaucratic opponents until after the Nov. 3 elections.