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Regulation

NIH: ‘Plasma should not be considered standard of care’

Borio, Topol applaud agency’s integrity

Sep 2, 2020 | 1:24 AM GMT

NIH’s updated COVID-19 treatment guidelines offer a rebuke to FDA’s authorization of convalescent plasma, a decision that has drawn wide criticism from former FDA officials and other KOLs in the life sciences. 

“There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19,”  NIH’s COVID-19 Treatment Guidelines Panel found. “Convalescent plasma should not be considered standard of care.”

The panel added that well-controlled, adequately powered, randomized clinical trials are needed to demonstrate the efficacy and safety of convalescent plasma.

The emergency use authorization (EUA), granted Aug. 23, was based on survival data from a subset of hospitalized patients who received convalescent plasma through an expanded use program run by the Mayo Clinic. There was no randomized control group.

While the EUA may have been justified, several former FDA officials told BioCentury at the time that President Donald Trump, FDA Commissioner Stephen Hahn, and HHS Secretary Alex Azar have damaged FDA’s credibility by politicizing the authorization decision and announcement, and questioned the scientific rationale (see “FDA Put Politics Ahead of Science”).

Some of those critics expressed their support of NIH’s statement Tuesday.

Luciana Borio, former acting FDA chief scientist, commended NIH for adhering to the evidence when issuing its guidelines. 

“Sticking to the facts allows NIH to maintain its credibility with the American public,” Borio told BioCentury.  “I urge clinicians to rely on this expert panel for guiding treatment decisions for their patients.”

Borio served in the Trump administration as the National Security Council’s director for medical and biodefense preparedness policy.

Eric Topol, who is founder and director of Scripps Research Translational Institute, tweeted, “We need to thank the @NIH Panel for standing up with the truth, issuing this update today, knowing it is at odds with @WhiteHouse @HHSgov and @US_FDA.”

In a Medscape commentary published Monday, Topol called on Stephen Hahn to resign as FDA commissioner or admit the agency had bowed to political pressure to grant EUAs of hydroxychloroquine, convalescent plasma and Veklury remdesivir.

NIH’s COVID-19 Treatment Guidelines Panel, which comprises several dozen representatives from federal agencies, professional medical societies and a community member, is tasked with reviewing data and scientific literature to develop guidelines that inform clinicians how to care for patients with COVID-19.

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