More Transparency & a Bigger Tent Needed for Federal Covid Response

With the realization that the virus is unlikely to be eradicated, public health agencies have begun to consider what life looks like as we live with Covid-19. This presents a golden opportunity to reimagine how these agencies operate and to reflect on the lessons we’ve learned over the last few years. Critically, instead of quashing scientific debate, these agencies must change course to encourage robust debate within the scientific community to arrive at the best possible public health strategies.  

For example, in October of 2020, when a group of epidemiologists from Stanford, Oxford, and Harvard, among others, issued a public statement calling for an approach they dubbed “Focused Protection,” which concentrated on shielding the most vulnerable from Covid-19, the immediate reaction from NIH Director Francis Collins was to call them “fringe” scientists and to order “a quick and devastating published take down of [the approach’s] premises.”  

Today, federal health authorities are effectively promoting the idea of focused protection that they once aimed to take down. As the FDA Commissioner recently explained: “Most people are going to get Covid.” So instead of trying to shield everyone from getting this virus, the agencies are finally focusing on protecting the most vulnerable. 

Our country has some of the most incredible academic institutions the world has ever known. We should be making full use of this brain trust, not taking an approach that seeks to “take down” scientists who voice opposition. This approach has had, and will continue to have, a chilling effect on open scientific debate. 

Such open debate also requires open access to data and information. For that reason, federal health agencies must make public all the available data on Covid-19 and the vaccines that the government has already collected. Instead, as The New York Times recently reported, the CDC “has published only a tiny fraction of the data it has collected.” The CDC’s justification was that most of the data was “not yet ready for prime time.” When it comes to data collected by a taxpayer-funded federal agency over two years of a pandemic affecting the lives of all Americans, “not yet ready for prime time” simply isn’t good enough.

The lack of transparency is not unique to the CDC. The FDA, for instance, repeatedly promised transparency regarding Pfizer’s Covid-19 vaccine, and federal law explicitly calls for this data to be publicly available. But when a group of highly credentialed scientists requested the data the FDA relied upon to license the Pfizer shot, the FDA produced nothing. The scientists, through my law firm, had to file a lawsuit to get the data. Even then, the FDA sought permission from a federal court to take until 2096 to fully produce the data. 

The good news is that the judge soundly rejected this request, directing the FDA to produce all the data in a matter of months because he recognized what the FDA should have known and embraced from the beginning of the pandemic: Transparency and inclusion are vital for scientific inquiry. In issuing the order for transparency, the judge quoted James Madison explaining that a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy.”  

The scientists’ lawsuit against the FDA reminds us that our legal system has a role to play in ensuring transparency. It is also a testament to the importance of the American justice system in that it can hold the powerful – even the government – to account.  

Our federal health agencies would do well to remember James Madison’s warning and welcome scrutiny and open debate. It is time they adopt these principles for the good of all Americans. 

Aaron Siri is the managing partner of Siri & Glimstad LLP and has extensive experience in a wide range of complex civil litigation matters, with a focus on civil rights involving mandated medical procedures, class actions, and high-stakes disputes.