NIH funding provides the core foundation for new drugs

Proposed Trump cuts would slow progress in developing new cures

HOW MANY NEW drugs come from research funded by the National Institutes of Health? That was the question posed by Illinois Sen. Dick Durbin, co-chair of the Senate’s bipartisan NIH caucus, at a recent Senate hearing about NIH funding.

The short answer: all of them.

Sen. Durbin posed his question at a hearing focused on an administration proposal to reduce the 2018 budget appropriation for the NIH by 22 percent, from $34.6 billion to $26.9 billion. He wanted to know what effect such budget cuts would have on the pipeline of new cures.

The NIH does not actually develop drugs. Biopharmaceutical companies are ultimately responsible for developing commercial products, a process that involves performing extensive research on prospective drugs, conducting clinical trials to assess each drug’s safety and effectiveness, establishing manufacturing capabilities, submitting to regulatory review, and creating networks for distribution, marketing, and support of the product in the marketplace. It’s estimated that companies invest an average of $1.4 billion for each drug that is successfully brought to market. None of this would be possible, however, without substantial investment in research through the NIH, which provides the essential foundation of scientific insight and technological invention that enables the biopharmaceutical industry to develop and commercialize new products.

In recent research at Bentley University, published in the Proceedings of the National Academy of Sciences, we explored the scale of the NIH’s contribution to the discovery and development of the 210 new drugs approved from 2010 through 2016. These 210 new drugs include many first-in-class products, such as Sovaldi (sofosbuvir) for hepatitis, Xeljanz (tofacitinib) for arthritis, Eylea (aflibercept) for macular degeneration, and Kalydeco (ivacaftor) for cystic fibrosis, which have already improved the lives of tens of thousands of patients and become blockbusters.

We identified more than 2 million published scientific papers describing the research underlying these drugs or their biological targets. Of these, 600,000 papers acknowledged research funding from the NIH, funding that totals over $100 billion since 2000. Our research also answered Sen. Durbin’s question: NIH funding contributed to every single one of the new drugs approved from 2010 to 2016.

Our research also showed that more than 90 percent of the NIH funding was associated with basic scientific research, focused on piecing together the molecular mechanisms of biology and disease, rather than applied research focused on the drug itself. The NIH traditionally prioritizes basic research, which by definition is aimed at understanding fundamental biological phenomenon, without specific applications in mind. While basic research often involves arcane studies on mice, fruit flies, worms, sea slugs, or even fungi, such work provides insights into basic mechanisms of health and disease. This knowledge represents the core foundation for the discovery and discovery and development of new drugs.

Sen. Durbin followed his question with a very interesting suggestion. “I think it’s about time that the NIH had a label that is applied to pharmaceuticals, medical devices, and other things where you can connect the dots,” he said. We agree.

For years, the “Intel Inside” label on our computers has been a reminder that the power of our apps, software, displays, and data is provided by the core processor inside the computer. Intel does not develop or market computers, but rather produces the processors that power 80 percent of the computers on the market.

So, too, the NIH does not develop or market drugs, but rather produces the basic research that leads to the discovery and development of new drugs coming to market.  Perhaps we should label new drugs with an “NIH inside” label.

Meet the Author

Fred Ledley

Guest Contributor, Bentley University
Meet the Author

Jennifer Beierlein

Guest Contributor, Bentley University
The ongoing public policy debates about government funding for scientific research must recognize the critical contribution this funding makes to the discovery and development of new drugs. The drugs that have come to market in this decade arose from research performed by tens of thousands of scientists and students working in academic institutions and government laboratories across the country, as well as an extensive network of skilled technical support, research facilities, high-technology equipment, supplies, and services. Any decrease in the funding for this research will inevitably slow the pipeline of new drugs for decades to come and delay progress in finding cures for morbid disease.

Fred Ledley, M.D. is founder and director of the Center for the Integration of Science and Industry at Bentley University. Jennifer Beierlein, PhD, is a fellow with the Center for Integration of Science and Industry at Bentley University.