The bulk of federal funding for medical research is delivered through the National Institutes of Health (NIH). Because federal funding is coordinated through the annual discretionary budget review process, the budget for NIH varies from year to year. Small changes in the rate of funding growth lead to significant problems for individual researchers and their supporting institutions. There is no single metric that serves as a surrogate to predict the appropriations process. This article begins with a history and physical examination of NIH. Next, the authors review the internal NIH priorities that continue to drive the funding process. Finally, the authors give a brief review of the impact congressionally mandated medical research programs have had on disease-specific funding.
The bulk of federal funding for medical research is delivered through the National Institutes of Health (NIH). Other players in the field include, but are not limited to Department of Defense (DOD), the Department of Veterans Affairs (VA), the Centers for Disease Control and Prevention (CDC), the Department of Energy (DOE), and the National Science Foundation (NSF). Of the $30 billion for medical research in the 2007 budget, $28 billion were allocated to NIH. It is quite clear, therefore, that the lifeblood of medical researchers is intimately tied to the vitality of NIH.
Federal funding of medical research is coordinated through the annual discretionary budget review process. Unlike direct spending programs (entitlements such as Medicare, Medicaid, and Social Security) that have legal mandate to collect and spend funds, the annual discretionary spending review process requires prior approval by subcommittees and committees of the House and Senate, subject to final approval of the president. The net result of this process is that the budget for NIH varies from year to year. Overall, despite the organic nature of an appropriated budget, NIH has enjoyed annual growth throughout its entire history up until 2004.
When examined from the viewpoint of many years or decades, one would anticipate the budget is likely to continue its upward growth trajectory. Therefore, from this long-range perspective, the president and the legislature would rightly anticipate a robust future for the global leadership role the United States has played and continues to play in development of medical technologies and treatments. The problem lies in that small changes in the rate of funding growth lead to significant problems for individual researchers and their supporting institutions. These vicissitudes of waxing and waning funds mean ever-changing probabilities for securing peer-reviewed federal funding—a hopelessly unstable environment in which medical researchers are forced to work.
There is no single metric that serves as a surrogate to predict the appropriations process. As with any good evaluation, we will start with a good history and physical examination. The NIH has an important legislative and appropriations history. In addition to external forces, we will review the internal NIH priorities that continue to drive the funding process. Finally, we will end with a brief review of the impact congressionally mandated medical research programs have had on disease-specific funding.
A brief history of the National Institutes of Health
There are key legislative events that have occurred in the past 80 years that have shaped the current form of the NIH. While their impact may seem distant and removed from the minutia of current day-to-day practices, they amply describe the current form and role the NIH plays in medical research funding. The NIH Web page provides a detailed outline of all related legislation. The following is a synopsis of those elements that have profoundly effected funding for this governmental agency.
The NIH has its roots in the Marine Hospital Service (MHS). MHS was established in 1798 to care for sick and injured seamen. At that time, all seamen had a 20-cent per month deduction from their wages to fund the MHS. This forerunner of the Public Health Service continued unchanged until 1818 when the Navy developed its own medical service. Merchant marines remained covered under the MHS. During the 1800s, the primary authority of the MHS was monitoring for communicable disease outbreaks and initiation of quarantine as necessary.
In 1901, the first appropriation for a “hygienic laboratory” mandated “investigations of contagious and infectious diseases and matters pertaining to public health” (31 STAT. L. 1086).
In 1912, the name Public Health and Marine Hospital Service was changed to Public Health Service (PHS). This legislation broadened the PHS research program to include “diseases of man” and contributing factors such as pollution of navigable streams, and information dissemination (37 Stat. L. 309).
In 1931, the Ransdell Act reorganized, expanded, and renamed the Hygienic Laboratory as the National Institute of Health (P.L. 71-251, 46 Stat. L. 379).
In 1934, a law established the National Cancer Institute (NCI) to conduct and support research relating to the cause, diagnosis, and treatment of cancer. The law authorized the Surgeon General to make research grants in the field of cancer, provide fellowships, train personnel, and assist efforts in cancer prevention and control (P.L. 75-244, 50 Stat. L. 559).
In 1948, the National Heart Act created the National Heart Institute thus changing the name of National Institute of Health to National Institutes of Health (P.L. 80-655, 62 Stat. L. 464). With the creation of “institutes” under the umbrella of NIH, shifting political priorities and disease-specific interests came to increasingly dominate the appropriation process.
The year 1956 marked the first substantive investment in medical research facilities development. The Health Research Facilities Act (Title VII of the PHS act) authorized a PHS program of federal matching grants to public and nonprofit institutions for the construction of health research facilities (P.L. 84-835, 70 Stat. L. 717). With this act, the federal government became a major benefactor of hospital development by entering into the health systems construction business.
In 1960, a law amended the PHS act to authorize grants to universities, hospitals, laboratories, and other public and nonprofit institutions to strengthen their programs of research and research training health sciences (P.L. 86-798, 74 Stat. L. 1053). This act may be seen as the beginning of the modern federally funded research scientist.
In 1963 the Health Research Facilities Act of 1956 (Title VII to the PHS act) was revised to allow grants for multipurpose facilities that would provide teaching space as well as essential research space (P.L. 88-129, 77 Stat. L. 164). This program was extended in 1965 for construction of health research facilities (P.L. 89-115).
The Heart Disease, Cancer and Stroke Amendments of 1965 mandated regional cooperative programs in research, training, continuing education, and demonstration activities in patient care. The goal of integrating activities of medical schools, clinical research institutions and hospitals was to provide patients access to the latest treatment methods (P.L. 89-239).
1971, Congress passed into law the Supplemental Appropriations Bill, which included $100 million for cancer research. This appropriation was made in response to the President Nixon’s State of the Union address, in which he called for “an intensive campaign to find a cure for cancer” (P.L. 92-18). The National Cancer Act of 1971 expanded the authority of NCI and NIH to advance research related to cancer. In addition, a National Cancer Advisory Board was established, and appropriations in excess of $400 million were authorized for FY1972 (P.L. 92-218). The National Cancer Act Amendments of 1974 authorized $2.5 billion over a 3-year period to extend and improve the National Cancer Program. Included in the language of the act was the following: establishment of the President’s Biomedical Research Panel; provision for the President to appoint the director of NIH with the advice of the Senate; and requirement for peer review of NIH grant applications and contract projects (P.L. 93-352).
In 1980, the National Institute of Arthritis, Metabolism, and Digestive Diseases (NIAMDD) was renamed the National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases (NIDDK) (P.L. 96-538). The NIDDK and the NCI have been and continue to be the primary source for federal urologic research dollars.
The supplemental appropriations for FY 1983 provided funds for PHS AIDS activities. Specific line item earmarks included $9.4 million for NIH-directed AIDS research. This marked the first time the Congress directly appropriated money for AIDS research for NIH (P.L. 98-63). Through the 1980s, special interest groups gained increased traction regarding their abilities to guide and manipulate the federal appropriations process.
The budget of NIH was reduced in real terms under the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm-Rudman-Hollings). For NIH this reduction amounted to $236 million. The revised total NIH appropriation after Gramm-Rudman-Hollings became $5.3 billion, 4.3% below the original FY 1986 appropriation (P.L. 99-177).
In 1999, the grant submission process was significantly altered and streamlined. A common application was developed. In addition, the Mentored Clinical Scientist awards were developed and opened.
This select short list of pieces of legislation related to NIH is intended to highlight the transformation of the organization over the past century. What should be seen is that NIH has had its mandate shifted from a “public health” oversight organization to a research funding clearing house. The NIH has steadily been positioned to control and direct the trajectory of research endeavors in both the United States and other countries. The net effect of the transformation and the preeminence of NIH is a situation where medical researchers and many universities are intimately dependent on the stability and growth of the NIH budget.
Management of the granting process
For the readership, it is likely well understood that most medical research projects are multiyear endeavors. The net result is that approximately 80% of the NIH budget for any given year is for ongoing projects. The remainder therefore is intended to cover new projects, 50% of which are investigator-initiated research project grants (RPG). The pool of researchers competing for the limited NIH funds is a group of self-selected individuals who represent the best and the brightest among clinical and basic scientists. In the grant review process, proposals are reviewed, graded, and rank ordered based on scientific merit. What is clear is that, because of the high quality of the submissions, there becomes little difference among the top 30% to 40% of proposals. One NIH reviewer commented, “the ability to distinguish among a very small group of outstanding applications, which are the only ones that are going to get funded in the current climate, and to rank order then in any meaningful way is quite minimal.” As the threshold for funding begins to erode into the top cohort, the annual cumulative effect is a high rate of rejection and resubmission. While this competition may appear as a healthy way to elevate of the quality of the pool, quite the contrary occurs. As the probability of funding declines, it does so in an asymmetric fashion. Those least likely to be funded are the junior researchers who have limited time to garner funding. Most junior researchers will have departmental support for 2 to 3 years at which time they are expected to have secured the funding that moves them toward tenure-tract positions. Failure to obtain funding leads to an induced attrition of the younger cohort. These individuals often move toward the private sector. The alternative is to remain in a quasi postdoctoral position. Such a position means forced compromise in research agendas and thus diminished productivity; that very productivity that is necessary to ensure funding support in the future. In addition, senior-level researchers then support their junior colleagues for longer periods of time. For an institution, reduced numbers of grants translates to lower revenues. Thus the net effect is an ever-larger financial burden for research shifted from the federal government to public and private academic institutions.
In an elegant study, Korn and colleagues modeled growth patterns for NIH and their impact on medical research. The motivation for their study related to anticipated changes in appropriations following a rapid period of growth of the NIH budget between 1998 and 2003. Among the principals they prioritized were preservation of the integrity and merit of the peer-review process, maintenance of new investigators, sustaining commitments to ongoing awards, preservation of the capacity of awardee institutions, recognition of the need of contemporary biomedical science, and maintenance of the intramural NIH program. To ensure stability of these elements, the authors measured capacity at a series of appropriation growth rates. They found 8% to 9% growth led to a stable 32% success of securing funding for projects. A 4% NIH appropriation growth rate leads to a substantial deceleration of grant submissions and funding success. The authors did not model growth below 4% because “the tradeoffs and sacrifices that would have been caused… were too difficult to deal with in the model.”
Management of the granting process
For the readership, it is likely well understood that most medical research projects are multiyear endeavors. The net result is that approximately 80% of the NIH budget for any given year is for ongoing projects. The remainder therefore is intended to cover new projects, 50% of which are investigator-initiated research project grants (RPG). The pool of researchers competing for the limited NIH funds is a group of self-selected individuals who represent the best and the brightest among clinical and basic scientists. In the grant review process, proposals are reviewed, graded, and rank ordered based on scientific merit. What is clear is that, because of the high quality of the submissions, there becomes little difference among the top 30% to 40% of proposals. One NIH reviewer commented, “the ability to distinguish among a very small group of outstanding applications, which are the only ones that are going to get funded in the current climate, and to rank order then in any meaningful way is quite minimal.” As the threshold for funding begins to erode into the top cohort, the annual cumulative effect is a high rate of rejection and resubmission. While this competition may appear as a healthy way to elevate of the quality of the pool, quite the contrary occurs. As the probability of funding declines, it does so in an asymmetric fashion. Those least likely to be funded are the junior researchers who have limited time to garner funding. Most junior researchers will have departmental support for 2 to 3 years at which time they are expected to have secured the funding that moves them toward tenure-tract positions. Failure to obtain funding leads to an induced attrition of the younger cohort. These individuals often move toward the private sector. The alternative is to remain in a quasi postdoctoral position. Such a position means forced compromise in research agendas and thus diminished productivity; that very productivity that is necessary to ensure funding support in the future. In addition, senior-level researchers then support their junior colleagues for longer periods of time. For an institution, reduced numbers of grants translates to lower revenues. Thus the net effect is an ever-larger financial burden for research shifted from the federal government to public and private academic institutions.
In an elegant study, Korn and colleagues modeled growth patterns for NIH and their impact on medical research. The motivation for their study related to anticipated changes in appropriations following a rapid period of growth of the NIH budget between 1998 and 2003. Among the principals they prioritized were preservation of the integrity and merit of the peer-review process, maintenance of new investigators, sustaining commitments to ongoing awards, preservation of the capacity of awardee institutions, recognition of the need of contemporary biomedical science, and maintenance of the intramural NIH program. To ensure stability of these elements, the authors measured capacity at a series of appropriation growth rates. They found 8% to 9% growth led to a stable 32% success of securing funding for projects. A 4% NIH appropriation growth rate leads to a substantial deceleration of grant submissions and funding success. The authors did not model growth below 4% because “the tradeoffs and sacrifices that would have been caused… were too difficult to deal with in the model.”
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