On Thursday, Trump announced a budget proposal that could turn the flow of innovation that underlies new medicines to a trickle. His plan calls for a $5.8 billion cut for the National Institutes of Health, the world's biggest funder of biomedical research — nearly a fifth of its $31.7 billion discretionary budget.
“If there’s an interest in innovative medicines, it’s hard to think of a worse idea than cutting NIH,” said Joshua Sharfstein, a professor in the department of health policy and management at Johns Hopkins Bloomberg School of Public Health. “The basic discoveries that fuel clinical advancements happen because of NIH funding, so it’s like you're shutting off the start of the pipeline.”
A study in Health Affairs found that government funding of basic research underpinned almost half of all drugs approved between 1988 and 2005. The researchers found that government funding was even more critical for those drugs that underwent a priority review -- the ones often considered the most innovative.
“It's just a terrible idea. There is substantial evidence that the sources of the most important and transformative pharmaceutical innovation that we have comes from NIH-funded, publicly funded science that occurs in academic settings and government laboratories. Reducing that by 20 percent is the surest way to ensure we don’t have the cures of tomorrow,” said Aaron Kesselheim, an associate professor of medicine at Harvard Medical School.
In 2015, Kesselheim and colleagues published another study in Health Affairs that traced innovation in medicine by examining how 26 drugs came to be. The researchers selected drugs that expert doctors said had a transformative effect on medicine — including powerful treatments for conditions such as HIV and diabetes.
What they found, generally, was a pattern of innovation that depended critically on exchanges between academic labs that draw on government funding and pharmaceutical companies. A typical origin story of a drug goes like this: Academic scientists, building on ideas and insights that originated in basic, government-funded research, come up with a strategy to fight disease. Those researchers work to show a proof of concept for the approach and develop industry collaborations. Companies eventually use their expertise and resources to do the hard work of drug development, bringing the molecule through extensive testing to make sure it is safe and effective.
NIH funding is not only critical to the development of new medicines, it's also a rare area of political agreement in divided times. There is generally bipartisan support for funding biomedical research, and a surge of new funding for the NIH was one factor that helped the 21st Century Cures bill overwhelmingly pass in Congress last year. That makes some scientists confident that the proposed cuts won't ever become real.
“The importance of basic science research by the NIH is that you don’t know what you don’t know. When a pharmaceutical company engages in research and development on a product, they have a pretty good sense that this product could work. But that product originated out of a process of uncertainty, and many times it came from a direction or a set of research that no one would have predicted would have ended up there,” said Anupam Jena, associate professor of health care policy at Harvard Medical School.
The announcement, coming a day after Trump announced he wanted to make the United States the “car capital of the world again,” was ironic to Kenneth Kaitin, the director of the Tufts Center for the Study of Drug Development, who noted that the budget move risks eroding American leadership in an industry where it is unequivocally leading.
“If you want to ensure the United States is going to be way behind the rest of the world in finding cures for diseases we don’t understand the basic mechanisms of, like Alzheimer's for example, this is the way to do it,” he said.