NIH Support for Basic and Clinical Research

Abstract

THE NOOSE AROUND THE BUDGET OF THE NATIONAL Institutes of Health (NIH) is once again tightening as its appropriations remain almost level for the third year, after the virtual doubling of its budget between 1998 and 2003. Many biomedical researchers feel profoundly threatened, and some are laying part of the blame at the feet of the director of NIH because he has developed several new trans-NIH research programs—within the NIH Roadmap for Medical Research—including ones aimed at strengthening clinical research. However, this fingerpointing is very misdirected. When, right after the Second World War, Vannevar Bush persuaded President Harry Truman to endorse a major investment of federal funds in science, a field Bush described as “the endless frontier,” the die was cast to expand the purview of what was then the National Institute of Health. The former sleepy campus, nestled on a corner of the Wilson estate in Bethesda, Md, grew exponentially and today has become a center for medical research and the underpinning of much of US academic medicine through its extramural grants programs. But some may not remember or may choose to forget that Bush strongly recommended that federal grants to universities should only support basic sciences and that the funding agency not have its own research program. Congress agreed that federal support of scientific inquiry was warranted, but the senators and representatives were besieged by patients with serious chronic diseases. The patients insisted that some of the newly invested federal funds should be devoted to their diseases. Congress, at the urging of research supporters like Mary Lasker and NIH Directors Rolla Dyer and James Shannon, rejected the Bush formula and insisted that better management and prevention of human diseases should be a strong focus of new intramural and extramural NIH programs for basic science and clinical research. The march of disease-linked NIH institutes began and led to the unique and extraordinary growth of the NIH since 1950. Ever since that fateful decision, a tug-of-war has existed between those who favor free-flowing inquiry into basic biological principles (basic science) and those who insist on practical discovery of new preventive and therapeutic tools (clinical research). No one argues, of course, that one or the other discipline should subsume 100% of the budget. The quarrel is over proportions, and the argument can become unseemly when a crisis occurs in the NIH budgeting process. In these crises, such as the current one, the adherents of one position or the other can become strident even though both types of research are mutually dependent. A very large amount of basic research carried out by scientists free of specific applied goals is absolutely required, because most basic inquiries do not lead to practical development but rather provide data that are parts of a larger framework. Until the larger system is understood, rational clinical research cannot be undertaken. Conversely, clinical research, when wisely undertaken, can and does reveal mechanisms of disease that provide vital platforms for further basic research, as well as fulfilling its central goal of improving health. The application of the “smart” drug imatinib in chronic myelogenous leukemia and gastrointestinal stromal tumor, and the imaging systems that revealed the rapid destruction of huge tumor masses by imatinib, are perfect examples. Now, basic and translational science and intense collaboration with pharmaceutical companies are needed to solve the problem of resistance to this drug, as well as to push ahead with innumerable other opportunities to accomplish major steps in preventing or treating other diseases. In 1995, Harold Varmus, then director of the NIH, became concerned that the NIH was not providing sufficient support for clinical research. He formed a panel of experienced academic leaders who accomplished 3 important goals. First, the panel defined clinical research broadly and estimated that about one third of the NIH extramural budget was devoted to clinical research. That amount seemed reasonable to the panel, considering that