As a physician and former state public health official, I’m troubled.
I never imagined that political pressure would ever drastically influence the decisions of 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 to serve their patients and communities.
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, inconsistent with established public-health expert best practices. That guidance was later reversed after a public outcry and despite the president’s insistence that less testing was desirable rather than more.
There is credible evidence that politically-appointed health and human services officials commandeered these and other guidelines. They censored or edited official 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. Another excellent example was the guidance for safe reopening of places of worship.
CDC scientists were intimidated, silenced, and their expertise marginalized with the message that the Administration’s changes were not optional.
FDA Commissioner Dr. Stephen Hahn issued an Emergency Use Authorization (EUA) 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.
The EUA for convalescent plasma for COVID-19 treatment and the expanded EUA for remdesivir were also felt by independent health experts to be 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. That political pressure was rushing approval was obvious; a few days before Hahn indicated that convalescent plasma was not yet ready for EUA.
The administration’s threat of forcing premature approval of COVID-19 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 EUA protocol. Fortunately, the FDA and vaccine companies navigated around this potential political interference and preserved the integrity of the EUA 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 public confidence in venerated institutions essential to the public’s health. Very scary.
Dr. Richard Feldman is an Indianapolis family physician and the former Indiana State Health commissioner. Send comments to [email protected]