Letter to Christi A. Grimm, Principal Deputy Inspector General for the Department of Health and Human Services - Wyden, Merkley Call for Investigation into Political Interference with Coronavirus Information

Letter

Dear Principal Deputy Inspector General Grimm:

We are writing to express our alarm regarding reports of widespread and ongoing political
interference in our nation's public health response to the COVID-19 pandemic, particularly at the
Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA).
Last week, many of us introduced the Science and Transparency Over Politics (STOP) Act in
order to ensure a thorough investigation into this political interference, a bill that must be swiftly
enacted. In the interim, however, we ask that you immediately investigate whether, and to what
extent, political interference has undermined the scientific and public health processes at the
operating divisions of the Department of Health and Human Services (HHS) during the COVID19 response, particularly CDC and FDA.

In the midst of a pandemic that has now claimed over 200,000 lives in the United States alone,
the American people rely on the expertise of our federal agencies to keep them safe. Our
communities, schools, health care providers, businesses, and families turn to agencies like the
CDC and FDA for guidance on how to make important decisions: when people should get tested,
how to protect children at home or in the classroom and workers on the job, and which
treatments to use to save a life. Public confidence in the scientific process is especially critical as
the FDA reviews COVID-19 vaccine candidates. The American people must trust the review
process is rigorous, science-driven, and apolitical. Since April 2020, as concerns about political
interference in our COVID-19 response have grown, the percentage of adults in the United States
who say they will be willing to get vaccinated for COVID-19 has fallen by 21 points, from 72%
to 51%.1

Now more than ever, stopping political pressure from undermining public health
experts is literally a matter of life and death.

Numerous public reports have revealed that political appointees at HHS and the White House
have repeatedly interfered with, undermined, and even overruled career experts. In August, HHS
Secretary Azar reportedly overruled the FDA when he revoked the agency's ability to regulate
lab-developed diagnostic tests, including COVID-19 tests, potentially undermining the accuracy
of the results that patients receive from these tests.2 Also in August, the FDA paused its review
1A Trend That Worries Health Experts: As U.S. Gets Closer to COVID-19 Vaccine, Fewer People Say They'd Get One, Morning
Consult (Sept. 11, 2020) (https://morningconsult.com/2020/09/11/vaccine-acceptance-public-poll/). 2 HHS chief overrode FDA officials to ease testing rules, Politico (Sept. 15, 2020)
(https://www.politico.com/news/2020/09/15/hhs-alex-azar-overrode-fda-testing-rules-415400).
Ms. Christi A. Grimm
October 1, 2020
Page 2
of convalescent plasma for the treatment of COVID-19 in response to requests from the National
Institute of Health to continue looking at the data, but then rushed to issue an emergency use
authorization (EUA) for the treatment following consistent and direct pressure from the President
and White House officials, raising concerns that issuance of the EUA was premature and
motivated by political pressure.3
That same month, guidance reportedly developed by HHS and
the White House Coronavirus Task Force was published to the CDC's website--seemingly
without approval from the CDC--recommending that asymptomatic individuals do not need to
be tested, even after exposure to someone with COVID-19.4 This guidance contradicted clear
advice from career CDC officials and other public health experts. Following public outcry, this
guidance was reversed, but only after nearly a month during which COVID-19 may have further
spread through our communities after the CDC appeared to be discouraging testing.5 We have
now also learned that the White House may have pressured the CDC to "play down" the risk of
bringing children back to school for in-person learning, including attempts to influence both
CDC guidance and reports.6
Unfortunately, this political interference appears to be permeating the Department. Reports
suggest political interference may have affected data reporting and the publication of scientific
reports. In July 2020, without clear or sufficient justification, hospitals were directed to stop
reporting COVID-19 health data to the CDC, the primary repository of the nation's public health
data, and instead report the information to HHS.7
Further, according to public reports, political
appointees at HHS have sought to review, alter, and delay the CDC's Morbidity and Mortality
Weekly Reports (MMWR), which provide the latest information and recommendations on public
health threats, including COVID-19.8 Health care providers, researchers, and public health
professionals rely on the accurate, unbiased nature of these reports. According to public reports,
MMWRs may have been altered or delayed for weeks or even months, withholding critical
information from our nation's public health practitioners.
These political attacks appear to have extended even to individual scientists. According to
records obtained by the New York Times, political officials at HHS, including in both the
communications office and White House liaison's office, have lashed out at career CDC officials
3 Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next?, New York Times (Sept. 12, 2020)
(https://www.nytimes.com/2020/09/12/us/politics/trump-coronavirus-treatment-vaccine.html). 4 C.D.C. Testing Guidance Was Published Against Scientists' Objections, New York Times (Sept. 17, 2020)
(https://www.nytimes.com/2020/09/17/health/coronavirus-testing-cdc.html). 5 CDC updates, again, guidelines on testing people without coronavirus symptoms, CNN (Sept. 18, 2020)
(https://www.cnn.com/2020/09/18/health/covid-testing-guidance-update-cdc-bn/index.html). 6 Behind the White House Effort to Pressure the C.D.C. on School Openings, New York Times (Sept. 28, 2020)
(https://www.nytimes.com/2020/09/28/us/politics/white-house-cdc-coronavirus-schools.html). 7 Department of Health and Human Services, COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital
Laboratory, and Acute Care Facility Data Reporting (July 29, 2020) (https://www.hhs.gov/sites/default/files/covid-19-faqshospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf). 8 Political Appointees Meddled in C.D.C.'s "Holiest of the Holy' Health Reports, New York Times (Sept. 12, 2020)
(https://www.nytimes.com/2020/09/12/us/politics/trump-coronavirus-politics-cdc.html); Centers for Disease Control and
Prevention, Morbidity and Mortality Weekly Report (MMWR) (https://www.cdc.gov/mmwr/publications/index.html) (accessed
Sept. 30, 2020).
Ms. Christi A. Grimm
October 1, 2020
Page 3
for sharing basic facts about COVID-19 with the public.9 At least one public health expert--
Rick Bright, the former Director of the Biomedical Advanced Research and Development
Authority--has alleged that he was retaliated against for emphasizing the threat of COVID-19
and resisting political pressure in making certain purchases or approvals pushed by White House
and other Administration officials.10 These actions have a profound chilling effect on our public
health experts, undermining the response to COVID-19 and putting lives at risk.
Last week, after reports that the FDA was close to issuing guidance setting forth tougher criteria
for authorizing COVID-19 vaccines for emergency use, President Trump suggested at a press
conference that the plan "sounds like a political move," and said the White House "may or may
not" approve the guidance.11 The White House has reportedly asked FDA to provide detailed
justification for the guidance.12 According to a top FDA official, White House objections may
prevent the FDA from releasing the guidance.
13
The consistent pattern running through these reports of political interference is the ongoing effort
to minimize the seriousness of the virus. This message directly harms millions of Americans and
jeopardizes public trust in science and our COVID-19 response. To safeguard the health and
well-being of all Americans during this ongoing pandemic, we ask that you immediately open an
investigation into political interference with the scientific work done by experts at HHS. As part
of your review, we ask that you specifically address the following issues:
1. What is the extent of political interference at the CDC, FDA, and other key public health
agencies involved in the response to COVID-19?
2. What impact has political interference had on the work of public health experts at HHS,
including career officials at its operating divisions, and COVID-19 response efforts?
3. Has all public guidance issued on the CDC's website or otherwise attributed to the
CDC--including guidance pertaining to testing for the virus that causes COVID-19 and
re-opening schools for in-person learning--been developed and approved by CDC
personnel and gone through the standard CDC scientific review process?
4. How has the editorial and publication process for MMWRs changed from years past, and
to what extent have political appointees attempted to alter or delay MMWRs? What has
been the impact of these interventions on the timing and content of MMWR reports?
9 Emails Detail Effort to Silence C.D.C. and Question Its Science, New York Times (Sept. 18, 2020)
(https://www.nytimes.com/2020/09/18/us/politics/trump-cdc-coronavirus.html).
10 Ousted vaccine official alleges he was demoted for prioritizing "science and safety', Washington Post (May 5, 2020)
(https://www.washingtonpost.com/health/2020/05/05/rick-bright-hydroxychloroquine-whistleblower-complaint/). 11 Trump says he may not approve stricter FDA guidelines for vaccine approval, The Hill (Sept. 24, 2020)
(https://thehill.com/changing-america/well-being/prevention-cures/518005-trump-says-he-may-not-approve-stricter-fda). 12 Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference,
Washington Post (Sept. 25, 2020) (https://www.washingtonpost.com/politics/2020/09/25/coronavirus-vaccine-trumpinterference/). 13 Top FDA vaccine official says vaccine guidance may never be released, Politico (Sept. 28, 2020)
(https://www.politico.com/news/2020/09/28/fda-vaccine-guidance-may-not-be-released-422648).
Ms. Christi A. Grimm
October 1, 2020
Page 4
5. Have all applicable laws, rules, regulations, and policies--including the requirements of
HHS's, CDC's, and FDA's scientific integrity and communications policies--been
followed in the development and issuance of public guidance, reports, or policy changes?
6. Have any complaints been filed or issues been raised with the designated scientific
integrity official regarding any of the events described above?
7. What role, if any, have entities outside of HHS--including the White House, the Office
of Management and Budget, or the Office of Science and Technology Policy--played in
developing, revising, and issuing guidance, reports, or policy changes at the CDC or
FDA?
At a time when tens of thousands of Americans are dying from COVID-19 every month, we
must do everything we can to ensure the federal government's response is effective, unbiased,
and trustworthy. We thank you for your prompt attention to this matter.
Sincerely,

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