Treatment claims

FDA chief issues mea culpa for his plasma treatment claims

While the therapy is considered safe, plasma has not yet been proven effective against the coronavirus.

By CAITLIN OPRYSKO

FDA Commissioner Stephen Hahn issued a mea culpa late Monday, conceding that he had overstated the benefits of convalescent plasma as a treatment of coronavirus at a news conference last weekend with President Donald Trump.

Hahn had been the subject of intense criticism following his appearance Sunday alongside the president.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” the commissioner said in a string of tweets. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

While the therapy is considered safe, plasma has not yet been proven effective against the coronavirus.

But in announcing the Food and Drug Administration's granting of an emergency use authorization for the treatment on Sunday, the White House billed the decision as a “historic announcement.”

The authorization was based on anecdotal data from a 70,000-person program run by the Mayo Clinic. Hahn defended the use of that data to issue the emergency use authorization, arguing that FDA scientists made the decision to approve emergency use of the treatment “a few weeks ago” and that while questions may remain about its efficacy, “the safety profile is well defined.”

At Sunday's news conference, Hahn did not dispute the president's assessment that plasma is a "very effective" treatment. Citing the Mayo Clinic program, the FDA commissioner said "if you are one of those 35 out of 100 people who these data suggest survive as a result of it, this is pretty significant.”

But as Hahn later conceded, that statistic distorts the findings from the Mayo program. Scientists found that patients given plasma early in their illness fared better than those who received it later. But the Mayo study lacked a control group that would have let them compare the outcomes of those who received plasma against those who did not — the only way to prove whether the treatment works.

Several leading scientists — including a Johns Hopkins University researcher leading randomized, controlled trials of plasma — have said they can’t figure out how the administation arrived at its 35-to-1 statistic, based on the data the Mayo team published this month.

In a statement released Sunday, the FDA said plasma “does not yet represent a new standard of care based on the current available evidence.”

“We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program,” Hahn wrote on Twitter on Monday. “The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”

Hahn’s defense comes as his agency has already faced pressure from all sides as it races to get a coronavirus vaccine to market in record time.

The FDA commissioner has worked in recent weeks to rebut concerns that his agency might bow to political pressure as it expedites oversight of work on coronavirus treatments and vaccines. Hahn has offered assurances that the FDA won’t sacrifice the safety or efficacy of a coronavirus vaccine for the sake of speed — even as the president is pushing the agency to move faster.

The commissioner’s actions Sunday, which came after Trump accused the FDA of slow-walking the therapy to harm his reelection, renewed many public health experts' fears that the administration will rush through a Covid-19 vaccine without proof that it works.

In an interview with POLITICO, Hahn explained that “I thought it was really important for the American people and the agency, the FDA, to correct that record” the plasma decision, which he said he wanted to stress was made by career officials.

"I 100 percent stand behind” the scientists at the Center for Biologics Evaluation and Research and its director, Peter Marks, Hahn added. “As we get more data, if we have to change the EUA, we will change it.”