The FDA has faced scrutiny for its decision on plasma shortly after President Trump asserted that the agency might be part of an attempt to sabotage his campaign.
Photo: Sarah Silbiger/Getty ImagesFood and Drug Administration officials pushed back Tuesday against claims that their decision to authorize antibody-rich convalescent blood plasma for Covid-19 patients had been politicized.
The FDA “reviewed data from multiple sources, including over a dozen published studies,” as well as recent data from a national expanded access study sponsored by the agency and led by the Mayo Clinic in Rochester, Minn., in making its decision, according to a statement from Peter Marks, a senior official involved in the decision.
The agency authorized convalescent plasma—derived from patients who have survived the virus—on Sunday as a potentially effective product against the new coronavirus, after President Trump criticized the FDA as delaying such an authorization. He asserted on Twitter Saturday that the agency might be part of a “deep state” attempt to sabotage his re-election campaign.
That, in turn, brought claims that Mr. Trump had pressured the FDA, which agency officials rejected.
In his statement, Dr. Marks underscored what the agency said Sunday—that the potential benefits of the product outweigh potential risks. That standard meets requirements for authorization during a public-health emergency.
“Given the safety profile observed, the totality of evidence regarding potential efficacy more than adequately met the ‘may be effective’ standard for granting an emergency-use authorization,” Dr. Marks, director of the FDA Center for Biologics Evaluation and Research, said.
FDA Administrator Stephen Hahn said on CBS Tuesday morning that this agency’s decision wasn’t influenced by political pressure. He said he had inadvertently mischaracterized some details at a White House press conference Sunday, but that the authorization “was based on sound science and data.”
“We had been working on this for six weeks,” Dr. Hahn said, and “the timing was based on when we got the data.”
The agency’s scientists found in an analysis that Covid-19 patients who received plasma with high levels of antibodies appeared to have an approximately 35% survival advantage over patients who were given lower doses of the material. Patients who benefited were under age 80, hospitalized and within three days of being diagnosed.
Drs. Hahn and Marks pointed out that the data are short of a gold-standard clinical study, which would require patients to be randomly assigned to receive plasma and others to a control group such as a placebo. Such randomized, controlled clinical trials are currently taking place.
Dr. Hahn said in the CBS interview that he had accidentally inflated the data, saying that data suggest that 35 out of 100 patients could survive with the plasma product.
That incorrect statement would be what is known as an advantage in “absolute risk.” In fact, the researchers found a “relative risk” survival advantage, meaning that patients who got the high-antibody plasma survived at a roughly 35% higher rate than those who got a lower dose.
The FDA has been taking fire for what some claim to be a politically influenced decision.
“We are increasingly concerned by the political pressure that is being exerted by this administration on FDA,” Rep. Frank Pallone Jr. (D., N.J.), chairman of the House Energy and Commerce Commission, said Monday,
Dr. Marks said the FDA action wasn’t affected by the president’s statements or White House pressure.
“Although the effect size with the administration of Covid-19 convalescent plasma varies somewhat from study to study,” Dr. Marks said Tuesday, “the FDA notes that there appears to be roughly a 35% relative improvement in the survival rates of certain hospitalized patients.”
“I feel like I enjoy a very good relationship with the president,” said Dr. Hahn, whom Mr. Trump nominated to lead the agency last year.
The White House didn’t immediately respond to a request for comment.
Write to Thomas M. Burton at tom.burton@wsj.com and Amy Dockser Marcus at amy.marcus@wsj.com
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FDA Officials Reject Claims That Convalescent Plasma Decision Was Politicized - The Wall Street Journal
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