Dr. Stephen Hahn, commissioner of the Food and Drug Administration (FDA), apologized Monday for overstating the benefits of convalescent plasma as a coronavirus treatment during a press conference with President Donald Trump one day earlier.
"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," Hahn said in a thread of tweets posted in the middle of the first night of the Republican National Convention. "What I should have said better is that the data show [sic] a relative risk reduction not an absolute risk reduction."
At the Sunday press conference, Trump declared the FDA's "historic" emergency use authorization (EUA) for convalescent plasma to be a treatment "breakthrough." The president also claimed that plasma "had an incredible rate of success" for treating COVID-19 patients, despite the fact that his own scientists and the FDA itself had expressed more reserved assessments.
The timing of the emergency announcement — one day before the Republican National Convention, and days after Trump alluded multiple times to "deep state" conspiracy theories of intentional election sabotage by the FDA — raised questions about the approval process. It also put Hahn in the crosshairs of critics who saw him as appeasing Trump politically.
Hahn explained his walk-back in an interview with Politico, saying that "I thought it was really important for the American people and the agency, the FDA, to correct that record" about the decision to authorize the use of plasma.
"I 100% stand behind" the agency's scientists, Hahn said. "As we get more data, if we have to change the EUA, we will change it," he added.
The FDA's original announcement read in part: "Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product."
However, the "scientific evidence" section of the announcement clarified that the safety and efficacy of plasma had not been definitively demonstrated, and the treatment "does not yet represent a new standard of care."
The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.
The timeline raised questions of political interference or pressure. Days before the press conference, the president suggested, without offering evidence, that FDA officials might have been slow-rolling the emergency approval until after the election.
"I hear great things about it . . . That's all I can tell you," Trump told reporters during a White House press briefing Wednesday, referring to the plasma treatment. "It could be a political decision, because you have a lot of people over there who don't want to rush things. Because they want to do it after Nov. 3, and you've heard that one before."
Trump later thanked Hahn at the conference, saying: "The FDA really stepped up, and especially over the last few days in getting this done."
The FDA placed a hold on emergency use status last week after health officials, including the nation's top infectious disease specialist Dr. Anthony Fauci and Director of the National Institutes of Health Dr. Francis Collins, expressed concern about supporting data, The New York Times reported.
Amid a nationwide surge in infections and deaths, Trump began speaking and tweeting frequently about therapeutic treatments in mid- to late-July.
On Aug. 2, three weeks before the FDA authorization, White House chief of staff Mark Meadows told John Dickerson on CBS News' "Face the Nation" that he expected an announcement about plasma soon:
What are we doing with therapeutics? We've got to give hope to the American people. Hopefully, we will — we will be able to not only have a vaccine, but have therapeutics for those who get this where, where it's not a death sentence. And we're making great progress. So we've already seen that with convalescent plasma. Hopefully, some good announcement in the coming days there.
During the intervening three weeks, Salon called and emailed the FDA several times with questions about a possible plasma announcement, beginning on the day after Meadows' announcement. The agency would either not respond to questions or say it had "no information to share."
Hours before announcing the Saturday press conference, Trump blamed the FDA "deep state" in a tweet for a politically-motivated delay to test therapeutics, which tagged Hahn.
"The 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. Must focus on speed, and saving lives! @SteveFDA," Trump wrote at the time.
Following that tweet, Salon asked the agency whether it was "part of an effort to encourage FDA to approve immune plasma therapeutic treatment." The FDA did not respond.
A follow-up the next morning similarly received no reply. An email sent a few minutes after the Sunday press conference — asking "How many times did the White House contact the FDA about immune plasma over the last four weeks?" — received a link to the agency's press announcement.
Speaking at that press conference, Trump claimed that blood plasma treatment had cut COVID-19 mortality by 35%. However, the truth is more narrow.
The FDA cited a Mayo Clinic study in its authorization announcement. That study found a 35% increase in the likelihood to survive another 30 days in patients younger than age 80, who were not on a respirator and who received plasma with high levels of antibodies within three days of diagnosis, as compared to patients who received plasma which had lower levels of antibodies. The study did not include a placebo group.
Immune plasma, or convalescent plasma, is a treatment which dates back at least a century and was used on patients in the 1918 flu pandemic. The therapy uses blood from recovered patients who have developed antibodies. In this use, plasma from their blood is given to COVID-19 patients in hopes of mitigating the effects of the disease.
Though scientists and medical experts are in agreement that the emergency authorization would likely make it easier for certain hospitals and clinics to access plasma, a promising treatment strategy which uses antibodies of recovered patients, many expressed alarm Sunday over Trump's rhetoric.
"I watched this in horror," Eric Topol, a physician and the director of the Scripps Research Translational Institute, told The Washington Post. "These are basically just exploratory analyses that don't prove anything. It's just extraordinary to declare this as a breakthrough . . . All this does is jeopardize ever getting the truth."
Carlos del Rio, the executive associate dean of the Emory School of Medicine, pointed to Trump's record with hydroxychloroquine.
"The problem is, the President, in my mind, has lost total credibility because of what he's done with hydroxychloroquine. He's touted so many things that don't work," del Rio said. "The reality is what we have today to treat COVID is extremely limited."
Dr. Scott Gottlieb, a former adviser to then-candidate Donald Trump's 2016 campaign, who also served as FDA Commissioner under Trump from March 2017 until Hahn took over in April 2019, told CNBC on Monday that the treatment might be "weakly beneficial."
"I think that this could be beneficial. It might be weakly beneficial. It doesn't look like a home run, but right now we're looking for singles and doubles," Gottlieb said. "There aren't really going to be any home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapeutics."
The FDA began allowing doctors to use plasma to treat COVID-19 patients on a case-by-case basis in late March. Clinical trials "remain ongoing," according to the press release Sunday.
In June, the FDA revoked its coronavirus emergency use authorization for anti-malarial drug hydroxychloroquine — an unproven COVID-19 treatment pushed relentlessly by the president, who at one point claimed to be taking it daily — citing increased likelihood of "serious cardiac adverse events and other serious side effects."
According to data compiled by Johns Hopkins University, the U.S. has reported about 5.7 million cases of COVID-19, with at least 176,809 deaths.