Hahn Walks Back Statements on Convalescent Plasma’s Effectiveness

FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure.

Hahn apologized for his characterization of the treatment, which is now cleared for use in hospitalized coronavirus patients. The commissioner had said during the Sunday night White House announcement of the EUA that the data showed convalescent plasma provided a 35 percent improvement in survival, likening it to 35 out of 100 coronavirus patients surviving who wouldn’t have otherwise. HHS Health Secretary Alex Azar stood by the statistic, saying, “I don’t want you to gloss over this number” and calling it “a major advance.”

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn said in his apology, posted to his Twitter feed. “What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction.”

Hahn’s initial misrepresentation of the treatment’s benefits drew a wave of criticism from scientists, especially since the 35 percent number does not appear in the EUA itself. Peter Lurie, ex-FDA associate commissioner for public health strategy and analysis, said that the data actually showed that for every 100 people given the drug, about 5 percent are saved — significantly lower than the 35 percent figure the administration had touted.

“That’s if you believe the nonrandomized data, which you shouldn’t,” Lurie said. “I’m glad Hahn admitted his mistake when he overstated the benefits of convalescent plasma for COVID-19, but it was part of a press conference that relied on exaggeration, nonrandomized trials, cherry-picked data and subset analyses.”

Another former senior FDA official, ex-commissioner Scott Gottlieb, said that he believed there was nothing wrong with the evaluation that led to the EUA, but said “the way the public part was handled will erode precious public confidence.”

“You earn public confidence in small drops and you lose it in buckets,” he said.

Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, said that he was concerned about the administration’s presentation of the evaluated data, not the emergency clearance itself.

“What happened at that press conference was scary,” he said. “My criticism is not of the EUA, but of how the FDA commissioner and official spokespeople misrepresented what FDA scientists concluded about strength of evidence.”

Hahn has remained steadfast in his defense of the FDA’s independence in its regulatory decisions, offering reassurance Tuesday that the EUA was granted “based upon sound science and data.”  He noted that the agency is waiting for additional validation data and will revoke the EUA if necessary.

“The authorization of emergency use of convalescent plasma is not a final approval,” Hahn wrote in a Twitter post. “FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study.”

NIH Director Francis Collins and National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci had reportedly intervened last week to delay the EUA for convalescent plasma, arguing that the evidence to date was not strong enough (DID, Aug. 24). Their alleged intervention drew a backlash from President Trump during a press conference in which he accused FDA officials of political bias.

In a subsequent tweet on Aug. 22, Trump wrote that  “[t]he deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd.”

Political pressure on the FDA to get a COVID-19 therapeutic or vaccine approved and into the hands of the public has been a major concern as the election draws near. Following the agency’s EUA for convalescent plasma, House Committee on Energy & Commerce Democrats, including chairman Frank Pallone Jr. (D-N.J.), sent a letter to Hahn urging him to ensure the COVID-19 vaccine approval process remains pure and unshaped by the administration’s demands.

“We are increasingly concerned by the political pressure that is being exerted by this administration on FDA,” the lawmakers wrote. “This makes it all the more imperative that FDA take the threat to the public’s vaccine confidence into account when conducting the benefit-risk assessment of a potential COVID-19 vaccine.”

Mark Senak, an attorney and author of the Eye on FDA blog, said that the agency’s handling of the convalescent plasma EUA may have harmed public trust, which will be essential to curbing the pandemic in that many people must take an approved vaccine for it to be effective. He implored FDA to retain its independent decision-making and stick to its “gold standard.”

“In normal times when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional ‘gold standard’ in relation to the decision-making process for the approval of new treatments,” he said. “That standard is even more important now, as we approach a time when critical clinical data will be emerging around the various vaccine candidates now being studied.”

Read the lawmakers’ letter to Commissioner Hahn here: www.fdanews.com/08-25-20-FDALetter.pdf. — James Miessler