NIH Advisers Say Data Fails to Back Trump-Backed Plasma Therapy



A panel of experts convened by the National Institutes of Health undercut an emergency authorization issued just days ago by the Food and Drug Administration, saying there’s not enough evidence to recommend use of convalescent plasma for hospitalized coronavirus patients.

In an escalation of a dispute between federal agencies, the NIH advisers said an analysis of a study showed “no difference in 7-day survival overall” among those who received plasma containing high amounts of antibodies.

That statement contradicted claims made at a press conference by the head of the U.S Food and Drug Administration who said that convalescent plasma could reduce deaths by 35%.

“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” the NIH group said in a statement. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.”

The FDA granted emergency authorization on convalescent plasma on August 23rd, one day before the Republican national convention.

In an interview, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, denied that the new guidelines were a response to the FDA move. “The guidelines panel did not come out and criticize anyone or anything,” he said. “They were neutral” on using plasma in coronavirus patients.

FDA Commissioner Stephen Hahn denied political pressure was put on the agency to authorize the treatment even though it came after President Donald Trump complained of a “deep state” at the agency, The Hill noted.

Health experts also have noted that the FDA has in the past authorized hydroxychloroquine, which also was touted by the president, and the the authorization was later pulled back after further study.

The Centers for Disease Control and Prevention as well has received criticism for issuing new guidelines saying asymptomatic people do not need to be tested, The Hill noted.

Bloomberg News contributed to this report.


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