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Michael Sinha and Aaron Kesselheim
Sketched scientific devices
Cutting funding for the NIH will disrupt the discovery and development of transformative drugs.

In March 2017, the Trump Administration introduced its “Budget Blueprint to Make America Great Again.” The proposal would cut $5.8 billion from the National Institutes of Health (NIH) budget, a staggering reduction in funding for basic scientific and medical research amounting to a decrease of nearly 20% from the previous year. The budget proposal would effectively nullify NIH funding increases authorized in the 21st Century Cures Act of 2016. Secretary of the Department of Health and Human Services (HHS), Dr. Tom Price, clarified in testimony to Congress that the budget reductions to NIH (which is within his Department) would largely come from reductions in overhead payments (or “indirects”) that flow directly to research or academic institutions. Dr. Price described these payments as “inefficiencies” in the HHS budget; last year they amounted to $6.4 billion.

After the clamor over the brief budget release in March, a more detailed draft was leaked a few weeks ago, proposing a similarly drastic cut of nearly $5.7 billion from NIH for Fiscal Year 2018. The budget would also do away with the separate Agency for Healthcare Research and Quality and create in its place a National Institute for Research on Safety and Quality in NIH, which could affect the agency’s budget, as well as its independence in setting research priorities moving forward.

Reducing spending inefficiencies is a reasonable goal at all levels, but several unintended consequences are likely to result from these budget proposals, which go far beyond what might be needed to address inefficiencies. First, absent overhead payments, large academic medical centers may begin to move away from NIH-funded research and toward other funding sources, both public and private, that may have differing agendas or guiding principles for supported research. Academic institutions may also respond by raising overhead payments for non-NIH funding, or by considering more of the work that might have previously come out of the overhead (computing capacity, Institutional Review Board organization, etc.) to be part of the direct costs of research. These shifts could impair ongoing research projects and limit future research outputs from talented scientists at top institutions. Research from our group has shown that many transformational drugs approved in the U.S. between 1984 and 2009 arose out of NIH-funded projects; such changes would stifle this important source of innovation and disrupt the drug development pipeline.

Absent robust funding mechanisms for public sector research institutions, fewer candidate drugs will emerge and enter the pipeline toward approval by the Food and Drug Administration (FDA). This is important in many different areas of medicine, such as the discovery of new antibiotics. In another study, our group showed that antibiotics are much more likely than any other drug to pass successfully through the various clinical trial phases prior to approval, meaning that the goal of getting more antibiotics on the market to help treat multidrug-resistant bacteria will depend on sustained funding of basic and translational research to identify potential new agents.

Fortunately, it appears that, so far, Congress has not taken up the President’s proposed budgets in this area, but instead has remained committed to current funding levels for the NIH so that the important work it supports can continue. Ensuring that there is a vibrant pipeline of transformative drugs depends on a strong public commitment to funding scientific investigation.

Michael S. Sinha, M.D., J.D., M.P.H. is a research fellow at Harvard Medical School and a postdoctoral fellow at Brigham and Women’s Hospital. He has clinical training in internal medicine and completed an M.P.H. in law and public health from Harvard T.H. Chan School of Public Health.

Aaron S. Kesselheim, M.D., J.D., M.P.H. is an Associate Professor of Medicine at Harvard Medical School and directs the Program On Regulation, Therapeutics, And Law (PORTAL), within the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine at Brigham and Women’s Hospital. He serves as a primary care physician at the Phyllis Jen Center for Primary Care.

Photo Credit: Motorama, "Set line icons of pharmaceutical industry," via Shutterstock, 25 July 2017.