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As a former state public health official, I’m troubled. I never imagined political pressure would ever drastically influence decisions by the Federal Food and Drug Administration or the Centers for Disease Control and Prevention. These agencies are traditionally very independent and science-based. Physicians and other health professionals have relied on the integrity of these institutions and their leaders for the very best information, recommendations, regulations and policy development.
Faith in the FDA and CDC has been shaken. These agencies have been compromised by a presidential administration for political purposes. Not only does this result in loss of confidence among health professionals but also with the public.
First were the recommendations from the CDC regarding the reopening of businesses. Those guidelines were altered after issued because of the Trump administration’s insistence that they were too detailed. Next up were the CDC’s school reopening recommendations, also modified after the administration objected that they were too “tough.”
Although CDC Director Dr. Robert Redfield always denies political pressure, the CDC issued new COVID-19 testing guidelines for asymptomatic individuals. The guidance suggested that these people, even after a high-risk exposure, didn’t necessarily require testing, which is inconsistent with established best practices. That guidance was later reversed after a public outcry and despite the president’s insistence that less testing was desirable.
There is credible evidence that politically-appointed Health and Human Services officials commandeered these and other guidelines. They censored or edited CDC public reports over the objections of CDC scientists to make them consistent with the president’s COVID-19 response positions, circumventing the customary CDC scientific review.
FDA Commissioner Dr. Stephen Hahn issued an emergency use authorization for hydroxychloroquine without sufficient data demonstrating efficacy and safety. The president was strongly advocating for the drug’s use, and it appeared that Hahn buckled under pressure—to the horror of health experts. When it became obvious that the drug had no benefit and actually produced harm, the authorization was rescinded.
Independent health experts also felt that the emergency authorization for convalescent plasma for treatment and the expanded authorization for remdesivir were issued without sufficient evidence of efficacy. The data used by Hahn to justify convalescent plasma approval were not only poorly controlled, but they were used “mistakenly” in a very misleading way to claim an inflated 35% reduction in mortality. He later apologized for his mistake, a mistake even a medical student shouldn’t have made. A few days before, Hahn had indicated that convalescent plasma was not yet ready for emergency use authorization.
The administration’s threat of forcing premature approval of vaccines without adequate efficacy and safety data and short-circuiting clinical trials was real. That threat heightened when the FDA announced a more stringent and lengthened emergency use authorization protocol. Fortunately, the FDA and vaccine companies appear to have navigated around this potential political interference and preserved the integrity of the approval process.
The sacrifice of CDC and FDA credibility, through surrender and acquiescence, extends potentially beyond the current administration’s actions. It portends that future pervasive political influence over science is possible, regardless of who sits in the Oval Office, undermining confidence in venerated institutions essential to the public’s health. Very scary.•
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Feldman is a family physician, author, lecturer and former Indiana State Department of Health commissioner for Gov. Frank O’Bannon. Send comments to ibjedit@ibj.com.
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