The U.S. is facing a crisis of confidence in our government scientists
[image: image.png]
Robert Redfield, director of the Centers for Disease Control and
Prevention, speaks during a House Select Subcommittee on the coronavirus
pandemic hearing in Washington in July. (Pool New/Reuters)
Opinion by Leana S. Wen <>
Contributing columnist
September 2, 2020 at 4:03 p.m. CDT

Eight months into the biggest public health crisis of our lifetimes, the
United States is facing a related crisis: one of confidence in our federal
government’s top scientific institutions.

Last week, following alleged “top down” orders
from the White House, the Centers for Disease Control and Prevention issued new
on coronavirus testing that flew in the face of common sense and public
health. Major medical organizations issued immediate rebukes
governors vowed not to follow
the guidelines; and the former head of the National Institutes of Health
and the CEO of the Rockefeller Foundation wrote a joint op-ed
urging the American public to “ignore the CDC.”

At the same time, the Food and Drug Administration came under heavy
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.

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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

*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.

We are interested in hearing about how the struggle to reopen amid the
pandemic is affecting people's lives. Please tell us yours.

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.