Public health experts on Monday raised alarm over President Donald Trump's overstating of the efficacy of convalescent plasma and his suggestion that the Food and Drug Administration purposefully held up approval of the potential Covid-19 treatment just before the agency authorized its expanded use.
The FDA gave emergency approval for the use of antibody-rich plasma on Sunday, a day after the president publicly suggested—with no evidence and not for the first time—that "the deep state, or whoever" at the agency was slowing down the approval process to harm his reelection chances.
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
— Donald J. Trump (@realDonaldTrump) August 22, 2020
"By bludgeoning the FDA with his conspiracy theory, Trump will make whatever the agency does now look like it is being shaped by his political pressure on it," wrote Washington Post columnist Greg Sargent.
At Stat News, reporter Ed Silverman called the president's remarks "terribly wrongheaded" and suggested they could ultimately endanger public health.
Comments like Trump's "continually raise the specter of political interference with a key agency during a severe public health crisis," Silverman wrote. "Who would trust a vaccine that is being rushed out the door just so Trump can say he delivered what everyone wants as soon as possible? His tweets are about his reelection, not our well-being."
Public health experts say studies conducted so far have shown that convalescent plasma, taken from coronavirus patients who have recovered from Covid-19 and have high levels of antibodies, shows promise as a potential treatment for the illness, which has killed more than 170,000 people in the United States.
The treatment has only been used on 70,000 patients so far, however, and has only shown to provide benefits for some of them, "lessening the severity or shortening the length of Covid-19 illness" in certain people after they are hospitalized.
Typically, the FDA requires broader randomized trials before approving a drug or treatment, and skipping over that step could undermine confidence in treatments or vaccines that eventually prove more effective, experts said Monday.
Dr. Eric Topol, a scientist and director of the Scripps Research Translational Institute, told the Post that he watched "in horror" on Sunday as Trump was joined by Health and Human Services Secretary Alex Azar and FDA Commissioner Stephen Hahn as he declared that convalescent plasma is "a major therapeutic breakthrough."
"These are basically just exploratory analyses that don't prove anything," Topol said of the studies that exist so far of plasma. "It's just extraordinary to declare this as a breakthrough... All this does is jeopardize ever getting the truth."
Trump claimed the use of convalescent plasma has been "proven to reduce mortality by 35%," a claim which shocked scientists and doctors familiar with the studies.
The research has actually shown that certain patients younger than 80 who were given plasma with high levels of antibodies within three days of diagnosis were about 35% more likely to survive at least a month than patients who received plasma with lower levels of antibodies, according to the FDA.
"This is categorically wrong," tweeted Dr. Rachel Clarke, a British palliative care physician. "The reduction is at most 3.5%—in a poorly designed study with no control arm."
This piece repeats the FDA’s claim that convalescent plasma reduce #COVID19 mortality by 35%.
This is categorically wrong. The reduction is at most 3.5% - in a poorly designed study with no control arm.
Trump’s politicised FDA debases science. https://t.co/CP1wBtpuKA
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— Rachel Clarke (@doctor_oxford) August 24, 2020
Other experts also corrected the president on social media.
This "35% mortality reduction" is a very misleading figure.
The study compared early vs late plasma therapy; not a Randomized Controlled Trial (RCT) of plasma vs placebo.
— Dr. Safa Mote (@SafaMote) August 24, 2020
Both HHS Secretary and FDA Commissioner misled folks about the convalescent plasma study at the press conference. 35% was not CP vs control in any trial. It was CP early vs late. Not a trial! It’s beginning to sound like rushed HCQ drama all over again. #COVID19 https://t.co/twx3BvYhXS
— Eric Feigl-Ding (@DrEricDing) August 24, 2020
The president's claims about plasma were "beginning to sound like rushed [hydroxychloroquine] drama all over again," tweeted epidemiologist Eric Feigl-Ding, referring to the president's promotion of the anti-malarial drug earlier this year. Hydroxychloroquine has not been shown to effectively treat or prevent the coronavirus in randomized, controlled studies, but the FDA gave emergency authorization to the drug earlier this year after the president aggressively pushed the medication as a treatment and claimed to take it as a prophyalctic. The FDA revoked the authorization in June, but Trump and his supporters have continued to promote its use, particularly on social media.
While classifying the use of convalescent plasma to treat Covid-19 as an "interesting strategy," Carlos del Rio of the Emory School of Medicine said Monday that the president's claim that it is a "breakthrough" should not be taken at face value.
"The problem is, the president, in my mind, has lost total credibility because of what he's done with hydroxychloroquine," del Rio told the Post. "He's touted so many things that don't work. The reality is what we have today to treat Covid is extremely limited."
The authorization for the expanded use of plasma comes as the White House is insisting a coronavirus vaccine could be approved in the U.S. before phase three trials—the final studies of a drug before it is approved for the marketplace—are complete. White House officials reportedly told Democratic leaders that the administration may approve a vaccine as early as September, even though phase three trials for a vaccine developed by U.K.-based pharma company AstraZeneca just began in the U.S. days ago. Trump's campaign advisers reportedly refer to a pre-election vaccine as "the holy grail."
While public health experts are hoping life-saving Covid-19 treatments and vaccines are discovered as soon as possible, tweeted University of Washington biology professor Carl Bergstrom, Trump's political interference in the scientific process of testing treatments raises concerns about misinformation in the president's claims.
To be clear, I don't have a position on whether convalescent plasma is safe or effective. It's presumably somewhat safe and there's reason to hope for efficacy.
What upsets me is the political interference. And Trump doesn't have a good record of suggested treatments!
— Carl T. Bergstrom (@CT_Bergstrom) August 24, 2020
What's clear, between this announcement, the HHS power play over FDA, Trump's recent tweets, and the long-term pattern of interference, is that Trump sees it as fair game to push misinformation about coronavirus therapies and vaccines so long as it helps him get re-elected.
— Carl T. Bergstrom (@CT_Bergstrom) August 24, 2020
"Infectious disease epidemiologists find ourselves in the odd position of criticizing as irresponsible claims that we desperately hope to be true," Bergstrom said.