August 26 2020

Hospitalized COVID-19 patients in the U.S. have another treatment option in the U.S. after the FDA’s emergency authorization for convalescent plasma on Sunday. But the decision prompted pushback from experts who questioned the data and wondered whether the FDA granted its green light under pressure from President Donald Trump. 

In discussing the emergency use authorization Sunday, FDA Commissioner Stephen Hahn, M.D., said the treatment has been associated with a “35% improvement in survival.”

Experts were quick to point out the inaccuracies in the presentation, however, and point up the poor quality of the data, which came from an observational study, not a placebo-controlled trial. Even the FDA itself says “well-controlled randomized trials remain necessary.” 

The approval followed reports last week that NIH chief Francis Collins and NIAID head Anthony Fauci had advised the FDA to hold off on authorizing plasma because so far, the data were weak. Trump on Saturday tweeted that the "deep state or whoever" was deliberately delaying coronavirus therapies until after the election—an unfounded accusation—but by Sunday morning was trumpeting a "breakthrough" announcement at a press conference later in the day.

So far, under an expanded access program, about 70,000 patients have received the plasma treatment, according to the FDA. The U.S. government’s BARDA agency funded the early access program, and Mayo Clinic served as the lead healthcare institution. 

The FDA’s data are from a single-arm study, which means the plasma treatment wasn't pitted against any other treatment, not even a placebo—“which hence tells us little," Adam Gaffney, physician and Harvard Medical School instructor, said on Twitter.

The survival improvement number Hahn quoted reflects the difference between patients who received plasma with a low dose of antibodies versus a high dose, Gaffney added. Between those groups, the low dose patients appeared sicker, he added. 

In all, convalescent plasma “may or may not work” and “could be helpful or harmful,” Gaffney said. He called the 35% survival improvement claim “unfounded.” 

Still, two former FDA commissioners said the agency has the legal basis to issue the emergency use authorization. Scott Gottlieb, former FDA commissioner under Trump, tweeted that plasma is “probably incrementally helpful” to patients, and that the application “meets criteria” for an emergency use authorization. 

“But we need better evidence generation, and we need to keep FDA decisions with FDA,” Gottlieb added. “The FDA professional staff supported this. It’s their decision.” 

The FDA’s announcement came a day after Trump tweeted there are “deep state” members within the agency who are slowing the fight against the pandemic to hurt him politically.  

But Gottlieb backed the agency’s independent authority on Sunday, saying on CBS News’ Face the Nation he rejects the idea that FDA experts would “slow-walk anything or accelerate anything” based on political interests. 

Meanwhile, Robert Califf, former FDA head under President Barack Obama, tweeted that the move is legal and the data are “promising.” Still, most promising therapies fail under controlled testing, he added. 

“I believe the community will rally and get the trials done,” Califf said. 

Convalescent plasma can’t be mass-produced; its availability is contingent on blood donations from people who have recovered from COVID-19. The FDA, Trump and others are encouraging donations from patients who’ve recovered. 

The EUA comes after the agency tried a similar approach with hydroxychloroquine—under pressure from the president. Even after the agency revoked that EUA due to a lack of evidence, Trump tweeted on Saturday that “many doctors and studies disagree” with the move.