This post is part of a series of quarterly roundups on scientific integrity.
In the third quarter of 2020, public confidence in the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) suffered as we saw signs that politics is interfering with the agencies’ responses to COVID-19. While CDC employees and an Immigration and Customs Enforcement (ICE) whistleblower reminded us that racism is still a problem at federal agencies and COVID-19 vaccine trials fail to enroll enough Black participants, the Trump administration lashed out against racial sensitivity trainings. The Environmental Protection Agency (EPA) used an early application of its not-yet-finalized “transparency” rule to ignore evidence that the pesticide chlorpyrifos harms children’s brain development.
At CDC and FDA, political interference intensifies and public trust declines
To control coronavirus spread and limit deaths from COVID-19, local decisionmakers and the public must trust the federal agencies that provide guidance and approve drugs and vaccines. Yet, over the past few months, disturbing actions at CDC and FDA have sparked serious concerns about political interference in what should be science-driven processes. A recent KFF tracking poll found that trust in CDC dropped 16 points between April and early September, and 62 percent of respondents worried that political pressure will lead FDA to rush approval of a coronavirus vaccine without making sure it’s safe and effective.
After President Trump criticized CDC guidance on school reopening as being tough and expensive and made clear that he wanted schools to reopen, CDC published a new statement on “The Importance of Reopening America’s Schools this Fall,” along with new “tools and resources.” The statement came from a working group convened by the Department of Health and Human Services (HHS), reportedly had limited involvement from CDC, and emphasized the harms related to a lack of in-person schooling while downplaying COVID-19’s threats to children; its publication followed weeks of pressure from the White House on CDC to get the agency itself to issue such a statement. A month later, CDC quietly updated its guidance on COVID-19 testing to state that people who have been exposed to the coronavirus but don’t have symptoms “do not necessarily need a test.” This prompted an outcry, because it’s well known that people without symptoms can still spread the virus, and it turned out that the revised guidance wasn’t written by CDC scientists. CDC has now revised this guidance to say that those who’ve been in close contact with an infected person should get a test—but it’s not so easy to repair the damage to the public’s trust in the agency. Another decision CDC made that seems to have had political motivations was to abruptly change the procedure for hospitals to report COVID-19 data, so that they are now sending their information to a private contractor rather than CDC.
Another alarming revelation came in September, when we learned that HHS appointees Michael Caputo and Paul Alexander had been delaying publication of, and requesting changes to, reports in CDC’s flagship Morbidity and Mortality Weekly Report (MMWR)—and Alexander even wanted to halt publication until the process could be modified to allow him to review and make line edits prior to each issue’s publication. MMWR is one of the most valued and trustworthy sources of information on disease spread and public health outcomes, and it has published many important reports on COVID-19. The reaction to this news in the public health community was “shock and horror.” Alexander, who had also sought to influence National Institute of Allergy and Infectious Diseases director Anthony Fauci’s statements to the media, was dismissed from HHS, and Michael Caputo, who also promoted dangerous conspiracy theories in a Facebook Live appearance, took a 60-day medical leave.
At a press conference the day before the start of the Republican National Convention, FDA Commissioner Stephen Hahn gave a misleading figure that vastly overstated the effectiveness of convalescent plasma, a COVID-19 treatment for which FDA was announcing an emergency use authorization (EUA). He later apologized for overstating the treatment’s benefits, but experts remain concerned that evidence to date suggests limited benefits from convalescent plasma, and that the EUA could make it hard to run randomized controlled trials to get a more definitive answer on its effectiveness. Meanwhile, the Trump administration’s optimistic public statements about vaccine development worried many public health experts, who feared that promising early results could lead to political pressure for FDA to rush approval of a vaccine before the election. HHS Secretary Alex Azar’s move to bar FDA from signing any new rules, instead reserving that power for himself, has also not inspired confidence. In apparent recognition of public concern, nine pharmaceutical and biotechnology companies took the unusual step of issuing a public statement pledging that they would only seek approval for COVID-19 vaccines demonstrated to be safe and effective in Phase 3 clinical studies. Seven former FDA commissioners warned, “If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”
These actions and others have prompted experts, organizations, and members of Congress to demand better. They have called for full safety and efficacy reviews of potential COVID-19 vaccines at FDA; better shielding of CDC from political interference; letting science and scientists guide the COVID-19 response; a halt to sidelining science and scientists; a reversal of HHS’s rule to shift hospital COVID-19 data reporting from CDC to a private contractor (also here, here, and here); and a halt to “anti-science rhetoric.”
Looking ahead: FDA held a public meeting of the Vaccines and Related Biological Products Advisory Committee on October 22 to discuss “the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.” The Science and Transparency Over Politics (STOP) Act introduced by Senator Charles Schumer (D-NY) would create a task force to investigate any political interference in the COVID-19 response of any government health agency.
Racism at federal agencies
In early July, news broke of a letter to CDC director Robert Redfield signed by more than 1,200 current employees calling on the agency to address “ongoing and recurring acts of racism and discrimination” that Black employees have faced for years. The letter’s authors point out that the inequities affect how the agency addresses pressing public health issues, from chronic diseases to COVID-19. They identify seven areas for change and make 33 specific recommendations, including an independent review of hiring, grading, and performance evaluation to identify any bias and/or discrimination, and mandatory training on implicit bias for all staff within 30 days of onboarding and annually thereafter.
In September, horrifying news about migrant women detained by ICE undergoing sterilization without their consent provided a glaring reminder of the need for federal agencies to address racism within their own operations. This atrocity joins the long, shameful list of reproductive injustices perpetuated in the US against Black, Hispanic, and Native American women and those who live in poverty or with disabilities. Whistleblower Dawn Wooten, a licensed practical nurse at the Georgia facility where the abuses occurred, filed the complaint about multiple unsafe and unethical practices.
Reproductive injustice is only one of the forms of unethical behavior by US clinicians and researchers that have harmed Black people and resulted in understandable wariness of the medical and public health system. Given this history, it’s hardly surprising that Black people are underrepresented in COVID-19 vaccine trials—a situation that needs to change, especially given that structural racism leaves Black people at elevated risk of coronavirus infection.
At a time when federal agencies should be redoubling their efforts to advance racial equity, the White House Office of Management and Budget (OMB) instead issued a memo that suggests without convincing evidence that agencies’ racial sensitivity trainings are “divisive, anti-American propaganda.” An executive order requires federal agencies to combat “race and sex stereotyping and scapegoating,” and OMB has instructed agencies to review their trainings for possible conflicts with the directive, including by searching for the terms “critical race theory,” “white privilege,” “systemic racism,” and “unconscious bias.” Senior political appointees must approve any spending for diversity and inclusion, and OMB warns that noncompliance will result in consequences. “Banning such trainings as the OMB memorandum and Executive Order do threatens to undermine decades of equal employment opportunity efforts and blindfold policymakers who should be working to eliminate racial disparities in health care, employment, and other critical sectors of society,” warned Representative Carolyn Maloney (D-NY) and colleagues on the House Oversight and Government Reform Committee in a letter asking OMB to provide more information about the changes.
Looking ahead: A group of 173 members of Congress, led by Representative Pramila Jayapal (D-WA), have demanded the Department of Homeland Security’s inspector general conduct an immediate investigation into allegations ICE whistleblower Dawn Wooten raised. Senator Cory Booker (D-NJ) has called for a hearing into the rollback of anti-racial bias trainings for federal employees.
EPA ignoring evidence on pesticide—and potentially much more
Five years ago, EPA scientists reviewed the evidence and concluded that agricultural use of the pesticide chlorpyrifos was linked to a range of health harms, including neurodevelopmental problems in children exposed in utero. Shortly after taking office, the Trump administration halted the agency’s plan to ban chlorpyrifos from agriculture, claiming that the science was not yet settled. Courts disagreed, and a federal appeals court ordered EPA to issue a final ruling on the ban. Now, in deciding not to ban chlorpyrifos, EPA has issued a new assessment of the pesticide’s health effects that contradicts its earlier assessment—because this time EPA ignored several important epidemiological studies. To justify those exclusions, EPA relied on the rationale of a not-yet-finalized rule that allows the agency to give less consideration to studies that do not release their raw data.
Researchers and health advocates sounded the alarm in 2018 when EPA introduced a rule that would sharply restrict the studies it could consider when crafting regulations. The agency claims that its requirement for study authors to release their underlying data is necessary for transparency, but it has failed to demonstrate that the change would solve any serious existing problem. It has also failed to give a convincing explanation of how it can consider the best available science when downweighting or excluding studies for which researchers cannot release data because they assured study participants of confidentiality—a common, and ethical, practice in health research. The chlorpyrifos action suggests that EPA will simply fail to consider much of the best available science. Opposition to the original and revised versions of the rule has been strong, but the administration is moving ahead with it nonetheless. The final rule is now with the White House Office of Management and Budget, its last stop before it is published in final form.
Looking ahead: A consolidated appropriations bill passed by the House states that EPA may not use any funds to implement or enforce the “transparency” rule. The Senate has received the bill but has not voted on it.
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- What Trump Said about COVID-19 in Private Versus What He Said in Public
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- Shortened Census Schedule Cuts Data Review Time
- A Biased Science Board Threatens Future Fetal Tissue Research
- How Politics and Bureaucracy Halted the Promise of the Abortion Pill
- New Legislation Would Increase Oversight of Agency Relocations
- Re-Fund the EPA
- Brennan Center for Justice tracker: Trump Administration Abuses Thwart US Pandemic Response
- Brennan Center for Justice recommendations: Executive Actions to Restore Integrity and Accountability in Government
- Center for Reproductive Rights fact sheet: The COVID-19 Pandemic is Exacerbating a Human Rights Crisis in Maternal Health
- Center for Reproductive Rights and Ibis Reproductive Health resource: Evaluating Abortion Restrictions and Supportive Policy Across the United States
- Climate Science Legal Defense Fund guidelines: Participating in Political Activities: Guidelines for Federally Employed and Federally Funded Scientists
- Climate Science Legal Defense Fund model policy: Model Scientific Integrity Policy for Agencies, Universities, and Other Research Institutions
- Environmental Protection Network recommendations: Resetting the Course of EPA
- National Nurses United report: Sins of Omission: How Government Failures to Track Covid-19 Data Have Led to More Than 1,700 Health Care Worker Deaths and Jeopardize Public Health
- National Partnership for Women & Families fact sheet: Bad Medicine: The Government’s Restriction on Medication Abortion
- Open the Government resource: Open Government Jobs
- Project on Government Oversight report: Stifling Dissent: How the Federal Government’s Channels for Challenging Policies from Within Fall Short
- Union of Concerned Scientists resource: COVID-19 Disinformation: How to Spot It—and Stop It
- Union of Concerned Scientists report: A Toxic Relationship: Extreme Coastal Flooding and Superfund Sites