At the same time, the Food and Drug Administration came under heavy criticism
for its embrace of convalescent plasma therapy despite scant evidence.
Eric Topol, a respected cardiologist and the editor in chief of
Medscape, wrote an open letter to the FDA commissioner asking that he “tell the truth or resign.”
All of this comes as political pressure mounts for the FDA to approve a coronavirus vaccine before the November election. If the FDA succumbs to this pressure and a vaccine is released without proper safeguards, it could endanger health and erode trust — with consequences that persist long after covid-19 is brought under control.
Here’s what must be done to regain public confidence and turn this situation around.
Commit to total scientific transparency. The CDC, the FDA and other federal scientific institutions must share all the data they are using to make decisions. Cherry-picking data points to justify a desired outcome will only seed doubt, as the FDA commissioner discovered when he exalted the use of convalescent plasma based on a small data subset.
Be clear about the process. Which entity is making which decisions, and with what input from others? There is an advisory commission to advise the FDA on the covid-19 vaccine, for example. At what point in the approval process will the commission be engaged? What questions will be posed to its members? Their meetings should be held in advance of regulatory decisions and live-streamed for the public.
Set metrics in advance. Those in favor of expediting approval of therapeutics and vaccines have argued that pandemics require a different standard, with a more streamlined process and lower bar for approval than during normal times. What is that process, and what are those standards? The public has a right to know this now. Otherwise, it will rightly suspect that goal posts have been moved to justify politically motivated shortcuts.
Explain the rationale. When the CDC changed its testing guidelines to suggest that asymptomatic people who had been exposed to infected individuals no longer needed to be tested, we were left wondering why. Did the science change — was there a new study published that none of us are aware of? Was it because there aren’t enough tests? Or, worse yet, was it because the Trump administration wants to cover up the actual number of infections? In the absence of a clear, direct and timely explanation, it will be hard to understand and trust the federal government’s decisions.
Resume regular briefings. These don’t need to be done through the White House’s coronavirus task force. We have seen by now that having President Trump at these briefings will result in tangents at best and misinformation at worst, which will subsequently have to be cleaned up by his team. Rather, let’s hear from the scientists themselves.
Let the public in on what’s going on. On Monday, the House Select Committee on the Coronavirus Crisis revealed that the coronavirus task force had been giving private weekly reports to governors about hot spots and areas of concern. Such information should not be kept secret from the public, which needs it to make decisions such as whether to send kids back to school. Also, the better people understand the situation in their communities, the more likely they are to comply with recommendations such as mask mandates.
Engage experts. There are growing calls to establish an independent commission to evaluate vaccine data. I’m not sure I like this because of the precedent it sets: What happens in the future if there is an administration that is actually listening to the science, but an obstructionist Congress that misuses this structure?
There is another path. The CDC, the FDA and other entities can work to engage experts outside of the federal government. There are many public health leaders in academia, industry, and local and state government who seek assurance that decisions are based on scientific rigor and not political expediency. Convince us, and we can serve as validators and help inform the public of the meaning and evidence for regulatory decisions.
Until recently, our federal government’s top scientific institutions were venerated around the world for their expertise and uncompromising integrity. Now, they are on the verge of losing their credibility in the midst of a pandemic. The window to regain trust is closing. If it does, the harm to Americans’ health will be irreversible.