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Trump’s Self-Defeating Attacks on the FDA

If the president wants to help efforts to discover treatments for COVID, he should probably stop tweeting about them.
August 23, 2020
Trump’s Self-Defeating Attacks on the FDA
U.S. President Donald Trump answers questions in the press briefing room with members of the White House Coronavirus Task Force April 3, 2020 in Washington, DC. President Trump announced that Americans in virus hot spots should wear a mask when out in public as the death rate caused by coronavirus has nearly doubled in three days in New York City while the nation continues to reel from the impacts of COVID-19. (Photo by Win McNamee/Getty Images)

After distinguishing himself this week by his embrace of the conspiracy theorists at QAnon, President Trump posited early Saturday morning that the “deep state, or whoever” may also be hard at work at the FDA, determined to thwart his re-election by slowing down recruitment of patients to test promising new COVID-19 medicines.

Contributing to his ire, apparently: the FDA’s withdrawal of the Emergency Use Authorization for hydoroxychloroquine, announced in June, and the agency’s recent decision, reported by the New York Times last week, to withhold authorization of plasma therapy pending further data. According to the Times, top federal health officials—including top infectious-disease doctor Anthony Fauci, National Institutes of Health Director Francis Collins, and H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases—regarded the data generated to date, from over 35,000 COVID-19 patients, as “too weak” to justify authorization.

Hydroxychloroquine, a medicine that’s been used for decades in the treatment of malaria and some autoimmune conditions, has been championed by Trump and his trade advisor, Peter Navarro, who has famously quarreled with Fauci about it. Trump, controversially, has also cited the testimony of Dr. Stella Immanuel, roundly ridiculed for her reported belief in alien DNA, sex with demons, and a government partially run by reptiles and other aliens disguised as humans.

The idea of convalescent sera—using the blood of recovered patients to treat new patients fighting the same infection—has been around even longer. Emil von Behring received the Nobel Prize in 1901 for pioneering studies in this area. A number of groups are now working on developing therapies for SARS-CoV-2 based on this approach, and thousands of patients who have recovered from COVID-19 have contributed their blood to this effort.

What’s especially striking about Trump’s tweet is how profoundly counterproductive it likely is to both his own interests and those of the country.

His intuition that science (like all other human activity) doesn’t exist in the realm of pure objectivity, completely insulated from personal bias and political impulse, is of course correct. Academic physicians, data suggest, tend to lean strongly left, especially those in areas like pediatrics and infectious disease, a trend that seems to be accelerating. University medical researchers also, and understandably, tend to be the experts to whom the FDA, medical journal editors, and the media all turn to for input and advice, and it can be difficult at times to determine with certainty where the science expertise ends and the personal beliefs begins.

The extreme and highly personal attacks visited upon Moncef Slaoui, a highly respected former pharma R&D executive tapped to lead Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, highlights the degree of animus in the current political climate, impacting scientists and health officials across the political spectrum. Many public health officials have resigned or considered quitting after being threatened for simply doing their job. I’m aware of at least one academic researcher (who happens to be left-leaning) who was the subject of vicious, personal attack (including doxing) after reporting scientific data that were regarded as supportive of Trump.

A flawed if intriguing recent perspective on hydroxychloroquine suggests the medicine may have been unduly critiqued precisely because it was so ardently championed by Trump, though the author also notes that the president certainly didn’t help matters by overhyping preliminary early studies.

One conspicuous concern with Trump’s latest attack on the FDA is that it represents an attempt to work the ref, and make it more likely that future decisions will resolve in fashion he regards as more favorable to him—ideally in time for him to incorporate the news into his reelection campaign.

But perhaps less obviously, the president might also do well to recognize the urgent need for COVID-related drug and vaccine approvals and authorizations to be regarded as credible. After all, drugs will only be used if prescribing doctors believe the products could be helpful, and vaccines will only be accepted if both doctors and patients believe they are likely to be safe and effective.

As former FDA commissioner Scott Gottlieb has repeatedly emphasized, the pandemic’s impact on the economy is, and is likely to continue to be, driven in large measure by the behavior and personal choices of anxious citizens concerned about their safety.

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. This means delayed adoption of potentially valuable therapeutics, and a longer time to capture both the medical and economic benefit at the population level.

Administration officials could help this effort, and themselves, in two ways.

First, they should continue to support the aggressive development and evaluation of new medical products that could contribute to the management of COVID-19; the Warp Speed effort, for example, seems to have catalyzed remarkable, substantive progress in a remarkably short period of time, and Trump arguably hasn’t received adequate credit for this effort.

Second, critically, Trump should let the evaluation of research data play out, and not interfere with this process. This is, of course, the right thing to do, both scientifically and ethically. But even from a craven political perspective, it’s hard to imagine any effort to influence the evaluation process not backfiring in a way that inhibits progress.

It’s more than a little disconcerting to consider that scientific deliverance from this pandemic may hinge at least in part on the president’s ability to defer gratification by stepping away from his favorite outlet. It’s like Trump’s very own, very personal marshmallow test. How long can he resist?

Update (August 23, 2020, 6:30 p.m. EDT):

On Sunday afternoon, President Trump, flanked by HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, announced that an Emergency Use Authorization (EUA) has been granted for the use of convalescent plasma for the treatment of COVID-19. This comes only several days after senior federal health officials counseled against approval, according to the New York Times, viewing the data as insufficient. On Saturday, Trump suggested on Twitter that a “deep state” conspiracy might be at work within the FDA, inhibiting the development of COVID-related treatments; he tagged Commissioner Hahn in his tweet.

As Politico drolly observed on Sunday afternoon, “It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy’s use.” According to CNN, a source “close to the White House Coronavirus Task Force” says that “the FDA had reviewed additional data to inform its impending EUA decision.”

Perhaps the review of recently received data contributed to the FDA’s change of heart, though the timing, following closely on the heels of Trump’s tweet, feels more than a little suspicious—and concerning.

Will the FDA authorization of COVID-related medications now be viewed as driven by the president, based on his political needs, rather than by the medical researchers evaluating the data?  This would dramatically lower the credibility of the agency, and the confidence associated with FDA reviews. This would also prove especially problematic in the context of a potential vaccine, where success critically depends upon both an intrinsically effective product and the embrace of it by enough people.

If the lesson from the last 24 hours is that the FDA has surrendered its historical independence, and like so many others in this government, is now prepared to bend the knee in response to presidential tweets, then future COVID-related FDA authorizations and approvals, and the products that receive them, deserve to be viewed with profound skepticism, as would befit a process corrupted by presidential interference.

COVID research is too important—for the nation, which awaits safe and effective treatments, and for the president, who has fought so hard to accelerate the development of these therapies—to meet with this fate.

David Shaywitz

David Shaywitz is a physician-scientist at a biopharmaceutical company, an adjunct scholar at the American Enterprise Institute, and a lecturer in the Department of Biomedical Informatics at Harvard Medical School.