President Donald Trump announcing a “historic breakthrough” against COVID-19 over the weekend sure looked like an attempt to grab some favorable headlines ahead of this week’s Republican National Convention.
It’s not hard to understand the desperation: Trump doesn’t have much good news to offer. The pandemic’s death toll in the U.S. is approaching 200,000. The death rate, measured relative to population, is already among the worst in the developed world. And while other countries are welcoming kids to school, resuming live sports and reopening restaurants, the U.S. remains stuck trying to combat a virus still ravaging parts of the country.
Not all of this is Trump’s fault, obviously. But plenty of it is.
He hasn’t paid attention to evidence. He has shown contempt for scientific advisers. He has grasped at quick fixes rather than patiently working with scientists and fellow elected leaders to craft effective, long-term policies.
All of these tendencies were on display Sunday, when Trump announced the Food and Drug Administration had authorized wider use of convalescent plasma therapy, in which COVID-19 patients get infusions of antibodies derived from the blood of people who have already recovered from the disease.
The president described it as “a truly historic announcement in our battle against the China virus that will save countless lives.”
Some of the nation’s best-known public health experts were aghast at the administration’s claims on the treatment’s potential ― and, more importantly, at Trump’s badgering of the FDA to get approval in the days leading up to the announcement.
He’s jeopardizing the agency’s independence, they warn, at precisely the moment when that independence is critical to success.
The Therapy Is Probably Fine, But Nobody Is Sure Of Its Value
Convalescent plasma therapy is not a new concept. Scientists first tried it successfully in the late 19th century, when they used animal blood serum to help treat cases of diphtheria. But it only works for some diseases.
As physicians were scrambling to treat the novel coronavirus outbreak exploding across the U.S. earlier this year, the FDA authorized “expanded use” of plasma therapy, which meant it was available through clinical studies or by special request from physicians. More than 70,000 patients have since gotten the treatment, and it appears to be safe.
For the last few weeks, the FDA has been wrestling with whether to authorize plasma therapy on a nonexperimental basis, which would mean doctors could prescribe it on the spot. Advocates, including Arturo Casadevall, who is the chairman of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, have said loosening the restrictions would enable wider use of the therapy, especially in smaller hospitals that might struggle with the administrative burdens of expanded use programs.
The main evidence in favor of wider use comes from a study, based on Mayo Clinic data, comparing two groups of people ― one that got plasma infusions with high numbers of antibodies, and one that got plasma infusions with low numbers of antibodies. Mortality after one week among the patients who got the high-antibody plasma was 8.7%, while mortality among the patients who got the low-antibody plasma was 11.9%. There was a similar differential after one month.
But that study had severe limitations. The researchers didn’t have a control sample that got a placebo, and the two groups may not have been totally random. Plenty of researchers think plasma therapy helps, at least marginally, but nobody is sure. And pretty much everybody with scientific credibility agrees there needs to be more study in order to get some more definitive findings.
Three of the nation’s most highly respected scientists have made this argument: Francis Collins, head of the National Institutes of Health; Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; and H. Clifford Lane, clinical director at the allergy and infectious disease institute. They had been urging the FDA to maintain plasma therapy’s experimental status, and last week took the extraordinary step of stating their concerns publicly.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told The New York Times.
Trump Pestered The FDA, And Scientists Are Furious
How much that counsel mattered to FDA decision-makers is unclear. But last week, as word circulated that the agency might be balking at wider approval, Trump accused “the deep state, or whoever, over at the FDA” of trying to sabotage his reelection chances. Two days later, the FDA went ahead with the emergency authorization and Trump announced it at a White House press conference, hours after teasing it with a tweet saying “very good news” was on the way.
“It has proven to reduce mortality by 35%,” Trump said. “It’s a tremendous number.”
“I’ve been optimistic about convalescent plasma as therapy. But optimism isn’t science.”
- Ashish Jha, incoming dean of the Brown University School of Public Health
Two administration officials — Health and Human Services Secretary Alex Azar and FDA Commissioner Stephen Hahn — appeared alongside Trump and made similar claims. The FDA followed up with an official announcement touting “Another Achievement in Administration’s Fight Against Pandemic,” a boosterish endorsement that longtime agency watchers said they had never seen before.
Scientists around the country recoiled at those statements, noting that the available research doesn’t “prove” anything ― including that plasma is beneficial, let alone that it reduces mortality by more than one-third.
“There is no breakthrough,” Eric Topol, founder and director of the Scripps Research Translational Institute, wrote in a tweet, adding that Hahn had “caved to Trump’s pressure” to say there was.
Even scientists who think convalescent plasma treatment has potential worry that the announcement will discourage participation in random trials, making it more difficult to conduct the research necessary to pinpoint how much the treatment can help and under what circumstances.
“I’ve been optimistic about convalescent plasma as therapy,” tweeted Ashish Jha, incoming dean of the Brown University School of Public Health. “But optimism isn’t science. We need results of adequately powered randomized trials. Issuing an [Emergency Use Authorization] without it would make such trials harder. And erode the credibility of the FDA. And ultimately, harm people with COVID.”
“Bottom line for EUA is this:nif you end up hospitalized, your doctor won’t know if plasma is helpful or not,” Jha wrote in a follow-up tweet.
Thomas File, president of the Infectious Diseases Society of America, also issued a statement opposing the FDA’s decision. “While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,” File said.
Not every expert was so critical of the decision itself. Scott Gottlieb, who was FDA commissioner earlier in the Trump administration and who has won acclaim for his sober, independent-minded writings during the pandemic, offered a careful endorsement of the decision.
“Plasma may provide a benefit, and it could be meaningful for certain patients, but we need more evidence to prove it,” Gottlieb said. “The data FDA had supports an authorization for emergency use, where the standard is ‘may be effective’ but we need better studies to confirm preliminary findings.”
Separately, however, Gottlieb has also been warning about political interference with the FDA.
This isn’t the first time Trump pressured the FDA, after all. And the last last time, when he clamored for approval of hydroxychloroquine, didn’t end well. Months after approving emergency use of the malaria drug as a treatment for COVID-19, the FDA revoked it in reaction to reports of dangerous cardiac side effects.
The limited potential benefits didn’t outweigh the documented risks of allowing wide use of the treatment, the FDA decided.
Trump has continued to tout the drug as a COVID-19 treatment anyway. He was tweeting about it on Sunday and made a joke about it during a convention session the following night.
Damaging FDA Credibility Could Mean More Suffering
Hahn apologized Monday for overstating the research findings. But neither Trump nor his top advisers seem to have misgivings about the statements on behalf of plasma — or the public attacks on the FDA.
On the contrary, White House chief of staff Mark Meadows said during an appearance on ABC News’ “This Week” that Trump was merely looking out for Americans’ well-being. “He had to make sure that they felt the heat,” Meadows said. “If they don’t see the light, they need to feel the heat because the American people are suffering.”
But pressuring the FDA can lead to more suffering by damaging public trust in the agency — at a time when looming decisions over vaccines makes that trust more important than ever.
Trump is already agitating for fast-track approval, according to reports in the Financial Times and New York Times, despite widespread concerns that even the most promising vaccine candidates might need more time than Trump wants to give them.
“The more Trump is seen to be putting his finger on the scale, the less credible new treatments will likely be seen.”
- David Shaywitz, biopharmaceutical entrepreneur and American Enterprise Institute scholar
Hahn has been assuring Americans that his agency will not approve a vaccine before it is safe to do so. But if it looks like the FDA rushed the process, people already suspicious of vaccines may doubt the agency’s word and refuse to get it.
This isn’t an especially partisan or ideological point of view ― or, at least, it doesn’t have to be. Among those warning Trump to back off are conservatives like David Shaywitz, a physician, biopharmaceutical entrepreneur and scholar at the conservative American Enterprise Institute.
“The more Trump is seen to be putting his finger on the scale, the less credible new treatments will likely be seen by doctors and patients alike—including those that might truly be effective,” Shaywitz wrote at The Bulwark on Sunday. “This means delayed adoption of potentially valuable therapeutics, and a longer time to capture both the medical and economic benefit at the population level.”
But recognizing the importance of FDA credibility would require thinking past this week’s headlines and recognizing that the pandemic won’t go away with wishful thinking.
These are precisely the sorts of things Trump has failed to do over the past few months ― like in late winter, when he ignored warnings and downplayed the coronavirus threat until the pandemic was already overwhelming health care providers, or in the late spring and early summer, when he pushed to resume regular activity even when public health experts warned that doing so would cause cases to spike.
He didn’t listen, cases spiked as predicted, and it goes a long way to why so many Americans are suffering ― emotionally, financially and, of course, medically. Now Trump appears to be making the same mistakes all over again. It’s a desperate bid for a pre-election boost. It’s also dangerous.