The value of the National Institutes of Health (NIH) to both the nation’s health and economy cannot be overstated. The U.S. leads the world in biotechnology and pharmaceutical industries, both of which are dependent on NIH-funded university science. Drugs developed through NIH-funded research have improved health not just in the U.S. but also throughout the world. Further, the NIH, both indirectly through grants awarded to universities and directly through its Fulbright-Fogarty Fellowships, supports both national and international trainees.
U.S. leadership in biotech and pharmaceutics is due in part to the wisdom of Congress in passing the Bayh-Dole act in 1980. This bipartisan legislation allowed recipients of NIH grants, primarily universities, to retain intellectual property rights for discoveries made at their institutions rather than assigning them to the government. Patents based on these rights have led to the founding of startup companies and licensing to existing companies.
NIH funding contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010 to 2016. The research behind the highly effective COVID-19 mRNA vaccines was NIH-supported, as was the research leading to discovery of GLP-1, the molecule that is the basis of Wegovy, Ozempic and Zepbound.
Locally, the University of Utah’s Anticonvulsant Drug Development (ADD) Program has been at the forefront of discovery research in the area of epilepsy and other seizure disorders. Since its founding in 1975, ADD has become the longest-running NIH-funded program of its kind, a national model for how sustained research can change lives, leading to 11 new safe and effective drugs for patients with convulsive disorders.
A revolutionary long-lasting anti-HIV drug recently developed by Gilead Sciences is based on fundamental research performed by Wesley Sundquist and colleagues in the U of U’s Department of Biochemistry.
We have been concerned about the Trump administration’s proposed severe budget cuts to the NIH. Thankfully, the recent congressional continuing resolution largely restores NIH funding close to the level of the last fiscal year. This does not, however, reverse the destructive acts and intentions of the administration, Secretary of Health and Human Services Robert F. Kennedy Jr., and NIH Director Jay Bhattacharya.
NIH funding decisions have been made without any evidence of peer review or explanation. A program to use inactivated whole viruses as vaccines was funded, while at the same time, ongoing research projects on mRNA vaccines were terminated with no credible evidence to support either action.
Kennedy and Bhattacharya disbanded longstanding NIH advisory committees and replaced them or populated them with their own biased supporters. They have also fired, without cause, senior and junior investigators and reviewers.
The proposal to cut indirect costs from an average of about 50% to a uniform 15% would be devastating to all NIH-supported research. Also called Facilities and Administrative (F&A) costs, these funds are added to grants to defray institutional expenses associated with approved grants, including heating and lighting in research buildings; management of grant applications and awards; handling and disposal of radioactive materials and hazardous chemicals; review of proposals that involve human subjects; and abiding by standards for use of animals in research. Most institutions have no way to replace these funds.
An ominous proposal supported by Dr. Bhattacharya stipulates that a grant cannot be funded unless it is approved by political appointees whose role is to ensure that the grant meets the administration’s policies regardless of its scientific value.
RFK Jr., who is neither an MD nor a scientist, is disrupting highly successful NIH programs that have allowed fundamental research into how nature works to be translated into public benefits. While all large bureaucracies can and should be assessed and improved, the image of Kennedy with a chain saw encapsulates his approach to reform. The NIH is a great institution, and for the health and welfare of the nation, it should be protected. The best way to do this is for Congress to remove Kennedy as head of HHS and Bhattacharya as head of NIH.