Federal Public Health Agency Reforms: CDC, FDA, NIH
Preparing for the Next Health Emergency
Aaron Kheriaty, MD
The COVID-19 pandemic demonstrated how catastrophic a micromanaging, misinformed, centralized, and politicized federal government can be. Basic human rights, medical choice, and the doctor–patient relationship were trampled without scientific justification and for extended periods of time. Excess deaths, not due to COVID-19, skyrocketed because of forced lockdowns, isolation, vaccine-related mass firings, and colossal disruptions of the economy and daily rhythms of life.
The federal government’s public health apparatus has lost the public’s trust. Before the next national public health emergency, this apparatus must be fundamentally restructured to ensure a transparent, scientifically grounded, and more nimble, efficient, transparent, and targeted response that respects the unique needs and input of patient populations and providers.
Every one of the overreaching policies during the pandemic—from lockdowns and school closures to mask and vaccine mandates or passports—received its supposed legal justification from the state of emergency declared (and renewed) by the HHS Secretary. Tellingly, however, the threshold for what constitutes a public health emergency—how many cases, hospitalizations, deaths, etc.—was never defined. For the sake of democratic accountability, we must know with clarity what will trigger the next emergency declaration and, just as important, what will trigger its end.
Unaccountable bureaucrats like Anthony Fauci should never again have such broad, unchecked power to issue health “guidelines” that will certainly be the basis for federal and state mandates. Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions because they believe it may lead to hesitancy on the part of the public. The only way to restore public trust in HHS as an institution capable of acting responsibly during a health emergency is through the best of disinfectants—light.
Instituting Greater Transparency, Accountability, and Oversight
The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.
All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, “public–private partnerships” is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.
We must shut and lock the revolving door between government and Big Pharma. Regulators should have a long “cooling off period” on their contracts (15 years would not be too long) that prevents them from working for companies they have regulated. Similarly, pharmaceutical company executives should be restricted from moving from industry into positions within regulatory agencies.
Finally, HHS should adopt metrics across the agency that can objectively determine the extent to which the agency’s policies and programs achieve desired health and welfare outcomes (not agency outputs). What is not measured is not achieved.
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
COVID and Structural Reform
COVID-19 exposed the Centers for Disease Control and Prevention (CDC) as perhaps the most incompetent and arrogant agency in the federal government. CDC continually misjudged COVID-19, from its lethality, transmissibility, and origins to treatments. We were told masks were not needed; then they were made mandatory. CDC botched the development of COVID tests when they were needed most.
When it was too late, we were told to put our lives on hold for “two weeks to flatten the curve;” that turned into two years of interference and restrictions on the smallest details of our lives. Lockdowns and school closures induced massive health and economic harms without commensurate health-related benefits. Congress should ensure that CDC’s legal authorities are clearly defined and limited to prevent a recurrence of any such arbitrary and vacillating exercise of power.
The CDC should be split into two separate entities housing its two distinct functions. On the one hand, the CDC is now responsible for collecting, synthesizing and publishing epidemiological data from the individual states—a scientific data-gathering function. This information is crucial for medical and public health researchers around the country. On the other hand, the CDC is also responsible for making public health recommendations and policies—an inescapably political function. At times, these two functions are in tension or clear conflict. In February 2022, for example, it was reported that “[t]wo full years into the pandemic, the agency leading the country’s response to the public health emergency has published only a tiny fraction of the data it has collected,” much of which “could [have helped] state and local health officials better target their efforts to bring the virus under control.” A CDC spokesman said that one of the reasons was “fear that the information might be misinterpreted.”[1]
These distinct functions should be separated into two entirely separate agencies with a firewall between them. We need a national epidemiological agency responsible only for publishing data and required by law to publish all of the data gathered from states and other sources. A separate agency should be responsible for public health with a severely confined ability to make policy recommendations.
The CDC can and should make assessments as to the health costs and benefits of health interventions, but it has limited to no capacity to measure the social costs or benefits they may entail. For example, how much risk mitigation is worth the price of shutting down churches on the holiest day of the Christian calendar and far beyond as happened in 2020? What is the proper balance of lives saved versus souls saved? The CDC has no business making such inherently political (and often unconstitutional) assessments and should be required by law to stay in its lane.
Most problematically, the CDC presented itself as a kind of “super-doctor” for the entire nation. The CDC is a public health institution, not a medical institution. According to its mission statement, the agency focuses on “disease prevention and — activities.”[2] It is not qualified to offer (and usually does not purport to offer) professional medical opinions applicable to specific patients.
From time to time, the CDC offers findings and recommendations that competent medical practitioners often will consider in arriving at a professional medical judgment for a particular patient. In this respect, CDC guidelines are analogous to guidelines from other public health associations or medical societies: They are informative, not prescriptive.
By statute or regulation, CDC guidance must be prohibited from taking on a prescriptive character. For example, never again should CDC officials be allowed to say in their official capacity that school children “should be” masked or vaccinated (through a schedule or otherwise) or prohibited from learning in a school building.
Such decisions should be left to parents and medical providers. We have learned that when CDC says what people “should” do, it readily becomes a “must” backed by severe punishments, including criminal penalties. CDC should report on the risks and effectiveness of all infectious disease-mitigation measures dispassionately and leave the “should” and “must” policy calls to politically accountable parties.
Conflicts of Interest
There was a time when the CDC could not take money from the pharmaceutical industry, but in 1992, the agency discovered a loophole in federal law that allowed it to accept pharma contributions through the nonprofit CDC Foundation. The money started flowing immediately: From 2014 through 2018, the CDC Foundation received $79.6 million from pharmaceutical corporations like Pfizer, Biogen, and Merck.[3] This practice presents a stark conflict of interest that should be banned.
Data Systems
The COVID-19 pandemic has revealed the disastrous public health consequences of the CDC’s failure to follow multiple congressional mandates to modernize its data infrastructure. Current reporting methods are burdensome for frontline medical workers, yet they result only in fragmented data that are not available in real time or usable across systems.
Congress should require HHS to prioritize the electronic collection and dissemination of robust, privacy-protected data that better leverages existing systems while reducing burdens on clinicians. HHS should also develop a system that makes critical information available to health care workers and policymakers in real time.[4]
The CDC operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA, which is responsible for post-marketing surveillance and evaluation of all other drugs and biological products. Data from these monitoring systems should be made available to researchers for independent review.
FOOD AND DRUG ADMINISTRATION (FDA)
The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices.
Vaccine Importation
Thousands of Americans of faith and conscience wish to receive various childhood vaccinations for themselves and their families but are not allowed to receive vaccines that are derived through or tested on aborted fetal cells. For example, the chickenpox, Hepatitis, and MMR vaccines in the U.S. are all linked to abortion in this way. There are ethically derived alternatives abroad that have been used safely there for decades, but the FDA makes it exceedingly difficult for Americans to import them.
In January 2021, the HHS Office for Civil Rights (OCR) and the FDA jointly announced that HHS was required by the Religious Freedom Restoration Act (RFRA)[5] to allow bulk importation by doctors of certain Japanese-made vaccines to accommodate religious needs of patients, but the Biden FDA unlawfully revoked this waiver. The FDA should restore the waiver to comply with RFRA and for the obvious public health benefits of increased childhood vaccination by families seeking ethically derived alternatives. To avoid future moral coercion of the sort experienced with the COVID-19 vaccines, the FDA and NIH should require the development of drugs and biologics that are free from moral taint and switch to cell lines that are not derived from aborted fetal cell lines or aborted baby body parts.
Conflicts of Interest
A 2018 report in Science found that more than two-thirds of FDA reviewers later ended up at the same companies whose products they had been reviewing while they were working for the government.[6] This revolving door is one mechanism by which pharmaceutical companies capture the agencies that regulate them. The FDA should impose a lengthy cooling off period for reviewers, preventing them from working for companies they regulated.
In 1997, the FDA relaxed regulations to permit broadcast drug advertisements, after which Big Pharma began routine direct-to-consumer advertising, making the United States and New Zealand the only countries where such practices are legal. Following the 1997 changes, pharma became the largest advertiser for all major media organizations. This buys considerable influence in the newsroom—whether media companies acknowledge this or not—and distorts independent reporting on public health issues. The FDA or Congress should regulate where and how paid advertising is used by pharmaceutical companies more stringently, especially on media outlets.
NATIONAL INSTITUTES OF HEALTH (NIH)
The National Institutes of Health (NIH) is the world’s largest biomedical research agency and is made up of 27 different components called Institutes and Centers. Despite its popular image as a benign science agency, NIH was responsible for paying for research in aborted baby body parts, human animal chimera experiments, and gain-of-function viral research that may have been responsible for COVID-19.
Conflicts of Interest
NIH maintains inappropriate industry ties that create serious conflicts of interest. In 2018, it was revealed that a $100 million NIH study on the benefits of moderate drinking was funded by the beer and liquor industry.[7] More recently, the National Institute of Allergy and Infectious Diseases (NIAID), Anthony Fauci’s division of the NIH, owns half of the patent for the Moderna COVID-19 vaccine, among thousands of other pharma patents.[8] Rather than providing grants to university-based investigators to run the clinical trials on their own Moderna vaccine, the NIH conducted this research internally—a clear conflict of interest. The NIAID will earn millions from this vaccine’s revenue with several NIH employees (and their heirs) personally receiving up to $150,000 annually from Moderna vaccine sales.[9]
In May 2022, documents obtained pursuant to a FOIA request revealed that NIH Director Francis Collins, NAIAD Director Anthony Fauci, and Fauci’s Deputy Director, Clifford Lane, all received royalties from pharmaceutical companies between 2009 and 2014.[10] Nonprofit watchdog Open the Books estimates that from 2010 to 2020, third parties paid more than $350 million in royalties to NIH and its scientists, who are credited as coinventors. Most problematically, in the years when they received payments, Collins, Fauci, and Lane were NIH administrators, not researchers, with no plausible claim to be scientific co-discoverers.
Most of the world’s other advanced science countries have stricter prohibitions on such conflicts, which helps to explain why the most significant studies on COVID treatments, on natural immunity, and on vaccine efficacy have come mostly from outside the U.S.
Funding for scientific research should not be controlled by a small group of highly paid and unaccountable insiders at the NIH, many of whom stay in power for decades.
The NIH monopoly on directing research should be broken. Term limits should be imposed on top career leaders at the NIH, and Congress should consider block granting NIH’s grants budget to states to fund their own scientific research. Nothing in this system would prevent several states from partnering to co-fund large research projects that require greater resources or impact larger regions. Likewise, the establishment of funding for scientific research at the state level does not preclude more modest federal funding through the National Institutes of Health: The two models are not mutually exclusive.
The CDC and NIH Foundations, whose boards are populated with pharmaceutical company executives, need to be decommissioned. Private donations to these foundations—a majority of them from pharmaceutical companies—should not be permitted to influence government decisions about research funding or public health policy.
[1] Apoorva Mandavilli, “The C.D.C. Isn’t Publishing Large Portions of the Data It Collects,” The New York Times, updated February 22, 2022, https://www.congress.gov/117/meeting/house/114450/documents/HHRG-117- IF02-20220302-SD004.pdf (accessed March 22, 2023).
[2] U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Centers for Disease Control and Prevention (C),” https://www.cdc.gov/maso/pdf/cdcmiss.pdf (March 16, 2023).
[3] Judith Garber, “CDC ‘Disclaimers’ Hide Financial Conflicts of Interest,” Lown Institute Accountability Blog, November 6, 2019, https://lowninstitute.org/cdc-disclaimers-hide-financial-conflicts-of-interest/ (accessed February 6, 2023). See also U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “CDC Foundation Active Programs (October 1, 2014–September 30, 2015),” https://www. cdcfoundation.org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2015.pdf (accessed February 7, 2023); “CDC Active Programs (October 1, 2015–September 30, 2016),” https://www.cdcfoundation. org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2016.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2016–September 30, 2017),” https://www.cdcfoundation.org/ sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2017.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2017–September 30, 2018),” https://www.cdcfoundation.org/sites/default/ files/upload/pdf/CDCFoundation-ActivePrograms-FY2018.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2018–September 30, 2019,” https://www.cdcfoundation.org/sites/default/files/upload/ pdf/CDCFoundation-ActivePrograms-FY2019.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2029–September 30, 2020,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY20?inline (accessed February 7, 2023); and “CDC Foundation Active Programs, October 1, 2020–September 30, 2021,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY21?inline (accessed February 7, 2023).
[4] Joel White and Doug Badger, “In Order to Defeat COVID-19, the Federal Government Must Modernize Its Public Health Data,” Heritage Foundation Backgrounder No. 3527, September 3, 2020, https://www.heritage. org/sites/default/files/2020-09/BG3527_0.pdf.
[5] H.R. 1308, Religious Freedom Restoration Act of 1993, Public Law No. 103-141, 103rd Congress, November 16, 1993, https://www.congress.gov/103/statute/STATUTE-107/STATUTE-107-Pg1488.pdf (accessed March 18, 2023).
[6] Charles Piller, “Is FDA’s Revolving Door Open Too Wide?” Science, Vol. 361, No. 6397 (July 6, 2018), p. 21, https://www.science.org/doi/epdf/10.1126/science.361.6397.21 (accessed February 6, 2023).
[7] Joel Achenbach, “NIH Halts $100 Million Study of Moderate Drinking That Is Funded by Alcohol Industry,” The Washington Post, May 17, 2018, https://www.washingtonpost.com/news/to-your-health/wp/2018/05/17/nih-halts-controversial-study-of-moderate-drinking/ (accessed February 6, 2023).
[8] Alexander Tin, “Moderna Offers NIH Co-ownership of COVID Vaccine Patent amid Dispute with Government,” CBS News, November 15, 2021, Moderna offers NIH co-ownership of COVID vaccine patent amid dispute with government - CBS News (accessed February 6, 2023).
[9] Informed Consent Action Network, “NIH Officials Profiting from COVID-19 Vaccine,” June 3, 2021, https://www. NIH Officials Profiting from COVID-19 Vaccine - ICAN - Informed Consent Action Network (accessed February 6, 2023).
[10] Adam Andrzejewski, “Substack Investigation: Fauci’s Royalties and the $350 Million Royalty Payment Stream HIDDEN by NIH,” Open the Books Substack, May 9, 2022, https://openthebooks.substack. com/p/faucis-royalties-and-the-350-million?utm_source=/profile/24758236-adam-andrzejewski&utm_ medium=reader2&s=w (accessed February 6, 2023).