Federal Health Agencies Push Back Against Political Interference

Food And Drug Administration Headquarters In Maryland

WHITE OAK, MD – JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)


Less than a month before the election and one week into President Trump’s own disease course, the White House is experiencing pushback from its foremost federal health agencies.

On Tuesday, the Food and Drug Administration (FDA) released stricter guidelines for authorizing Covid-19 vaccines, despite the best efforts of the current administration to block them. The decision came shortly after the Centers for Disease Control and Prevention (CDC) revised its own safety guidelines to reaffirm the possibility of airborne transmission, resolving what has been a matter of contention for months.

Both reversals are welcome developments for those of us who fear the White House has overstepped one too many boundaries to advance its own electoral agenda. Between slackening the criteria for emergency use authorizations and trumpeting promises of vaccines by Election Day, the potential for political interference to overdetermine a decision as consequential as approving a vaccine is alarming, to say the least.

Why President Trump and his campaign would prefer more leniency in the criteria for vaccine approval isn’t difficult to see. One of the requirements included in the new FDA guidelines is a follow-up period to late-stage clinical trials that allows vaccine developers to continue monitoring volunteers for adverse side effects for at least two months—an addendum that all but prevents any of the current candidates from receiving clearance before November 3.

As much as we all want a vaccine to arrive as soon as humanly possible, the stakes are simply too high for safety not to come first. Another requirement, for instance, is that at least five cases of serious illness must develop in the placebo group—the volunteers who aren’t receiving the vaccine—before an application for approval can be submitted. This benchmark helps developers gauge whether a vaccine can prevent severe symptoms as effectively as those mild and moderate—a more than reasonable cause for delay, as it is for the most vulnerable among us that a vaccine arguably matters most.

In addition to prioritizing safety over speed, the FDA vaccine guidance serves a broader purpose: creating a common standard all companies must adhere to, and in the process reassuring onlookers who suspect preferential treatment or foul play. Some states have so little trust in the current administration that they have pledged to conduct their own evaluations of any federally authorized vaccine. As for the general public, recent surveys show that the number of Americans age 18 and over who would “definitely or probably get a vaccine” for Covid-19 has dropped more than 20 percent since May. The new guidelines will reintroduce a measure of regulatory rigor that has thus far been minimized—and hopefully earn back some public trust.

Similar questions of ultimate authority and accuracy have arisen with the CDC safety guidelines, which over the course of the pandemic became a trusted source of information for so many, from parents and educators to health providers and local health authorities. When the CDC modified its description of how the virus spreads to include airborne transmission last month—finally joining the consensus shared by hundreds of scientists around the world—only to delete it days later, confusion abounded. CDC representatives later claimed the update had been posted on accident, but the flip-flop was too abrupt and confusing to be explained away so easily.

The possibility that aerosols, or small respiratory particles, might be enough to transmit the virus from one person to another is a primary motivation for mask-wearing—one of the public health measures belittled by President Trump and disavowed by some of his supporters. In the grand scheme of things, the question of whether to include or exclude one piece of information may seem like small potatoes. But in lieu of vaccines, drug treatments, or a national action plan of any kind, our ability to protect ourselves from infection remains tied to our ability to learn as much as we can about Covid-19 and modify our everyday behaviors and routines accordingly.

Our federal health agencies play a critical role in collating and disseminating this expertise, especially in times of crisis. As of Monday, the CDC has once again added language affirming the possibility that aerosols, or small respiratory particles, are one way the virus can be transmitted. While their choice of words this time around is decidedly more evasive, acknowledging the virus is “sometimes be spread by airborne transmission” rather than outright calling it airborne, at least now the record reflects what we know based on scientific evidence.

With faith in our national institutions on the decline, we need reassurance now more than ever that our health authorities are acting in the interest of the general public, rather than politicians or pharmaceutical companies. On October 22, an FDA advisory committee will meet to discuss and settle the legal requirements for authorizing a Covid-19 vaccine. Let us hope any judgment they reach can hold steady in the face of potential political backlash.


Read full article on Forbes

Originally published in Forbes (October 8, 2020)

© William A. Haseltine, PhD. All Rights Reserved.