Sen. Rand Paul, R-Ky., filed a criminal referral with the Department of Justice against Anthony Fauci for allegedly lying to Congress about the National Institutes of Health’s gain-of-function research. While we don’t desire to see Fauci imprisoned, the complaint demonstrates the severity of the NIH’s deficiencies and the need for sweeping reform.
Any honest assessment of the NIH’s pandemic performance would give it a poor grade. While NIH support for the rapid development of the Covid vaccine deserves some credit, the NIH failed in almost every other aspect of its contribution to the pandemic response.
With the recent appointment of a new NIH director to replace Francis Collins and a new National Institute of Allergy and Infectious Diseases (NIAID) director to replace Anthony Fauci, the time is now to reflect and for Congress to enact structural reforms. But what needs fixing? The most crucial priority is to remove fundamental conflicts of interest brought to light by abuses of these positions by Collins and Fauci.
Scientific Research vs. Public Health Strategy
During a pandemic emergency, there is a need for urgent scientific research and an open and robust debate on the most appropriate science-based public health policy. The former is the responsibility of the NIH, while the latter is the responsibility of the Centers for Disease Control and Prevention and state health departments. If those responsible for public health policy also hold the purse strings of research funding, most scientists will not dare to criticize the hand that feeds them, no matter how misguided the pandemic strategy.
Former NIH leaders Fauci and Collins were architects and proponents of the lockdown-focused strategy, which ultimately failed to protect Americans from the harms of the virus and imposed enormous collateral public health damage from increased chronic diseases, deteriorated mental health, and lost education. Fauci and Collins abused their positions to destroy the reputations of credible scientists who opposed lockdowns for public health reasons.
There is an implicit conflict of interest in the power possessed by NIH leaders. We can attest to this problem from personal experience after we wrote the anti-lockdown Great Barrington Declaration (along with Professor Sunetra Gupta at Oxford University). The declaration urged focused protection of high-risk, older Americans while keeping schools open and letting young people live near-normal lives. Published in October 2020, it quickly garnered the signatures of tens of thousands of medical scientists and health care professionals.
But four days after we wrote the document, Collins wrote an email to Fauci denoting the three of us as “fringe epidemiologists” and calling for a “devastating takedown.” Fauci responded with an article from Wired Magazine that falsely alleged we were calling to let the virus “rip.” They instigated a propaganda war against us, including a spate of hit pieces written by government-friendly journalists, and we faced a barrage of hate mail and death threats due to their abuse of power. Authentic scientific leadership would instead have encouraged and organized public health discussions between scientists with different views.
In early 2020, NIH officials engaged in similar takedowns of scientists who contradicted the party line that the virus emerged from a zoonotic spillover from a bat or pangolin at the Wuhan wet market. Emails exchanged among Fauci, Collins, and other NIH officials in January and February 2020 show them organizing a coverup of the idea that a lab leak from the Wuhan Insitute of Virology might have started the pandemic. Collins even gave interviews where he called the idea racist.
When the high clerisy of the NIH decreed it anathema to oppose lockdowns or discuss the lab-leak hypothesis, many scientists with alternate ideas silenced themselves. For American biomedical scientists, NIH grant awards are not merely a source of money to run experiments. They are often required for promotion and tenure in medical schools. If you want to influence other biomedical scientists’ thinking, then winning an NIH grant is often a necessary step. For this reason, NIH leaders should stick to funding science and avoid pontificating on public health policy questions, instead leaving that to the CDC and state health departments.
NIH Patent Royalty Payments
Regulations permit NIH researchers to receive royalty payments for their taxpayer-funded research, including millions of dollars for the NIH-funded Moderna vaccine. Simultaneously, the NIH issues evidence summaries that doctors use to inform patient treatments. This conflict of interest may lead the NIH to favor patented drugs over cheap, off-patent drugs that could benefit many people for a fraction of the cost.
This conflict of interest may have affected the NIH’s pandemic decision-making. If the NIH has a job during pandemics, it is to support the rapid development of treatments. In 2020, however, the NIH failed to rapidly assess cheap, repurposed drugs with high-quality randomized trials despite several promising avenues for research. While it did fund the ACTIV randomized studies, many key results, including the highly contentious ivermectin, were unavailable until late 2022 — far too late to help.
Because of this failure, early treatment options became matters of political point-scoring rather than dispassionate scientific evaluation. By contrast, U.K. scientists ran the RECOVERY randomized trial in summer 2020, which found that a cheap steroid — dexamethasone — effectively reduced mortality among hospitalized Covid patients.
Why permit intramural NIH researchers to earn patent royalties at all? Proponents argue it would be more challenging to recruit scientists to work at the NIH without it. As a public science agency, however, the purpose of the NIH is not to outcompete universities and industry. It is to promote scientific discoveries nationwide and to conduct research that the private sector would not perform because the product is a public good.
If universities and private industry are interested in funding a scientific project with patentable byproducts, let them fund the research. NIH-funded research should focus on crucial unpatentable science that the private sector would never perform.
Fundamental Reforms
These conflicts of interest have seriously threatened the quality, integrity, and social effects of NIH research. The NIH requires fundamental reform. The NIH needs stronger conflict-of-interest rules: no more patent royalties for researchers, no more NIH leaders pontificating on matters of public health policy, no more “devastating takedowns” of other scientists, and no NIH research coordination with pharmaceutical companies. Instead, the NIH should actively encourage scientific debate and conduct research that transforms biomedicine and improves public health without imposing patent restrictions.
There must be a term limit for NIH leaders, with new leadership chosen from outside the NIH. These positions are too powerful to leave in the hands of a single person for decades. It is too easy for people in such positions to think of themselves as “the science” itself, surrounded as they are by people seeking NIH favor. Relatives of NIH leaders should not run the agency’s ethics infrastructure, as occurred during the pandemic. As science needs a regular infusion of new ideas, so does scientific leadership.
During the pandemic, the NIH failed in its mission to support medical and public health research because of its abuses of power and its conflicts of interest. Congress now has an opportunity to demand reforms so that the NIH better serves the American people in the future.
