Insights From Trends in Biomedical Research Funding

Biomedical and health services research in academic institutions has been disadvantaged by inconsistent funding sources and amounts, including year-to-year variability, cycles of plenty and paucity, and low levels of funding in the case of health services research. The article by Dorsey and colleagues in this issue of JAMA¹ extends a 9-year analysis (1994-2003) of biomedical funding from all US sources for an additional 4 years (2003-2007).

This extension reinforces previous findings and contributes new insights. First, all-source funding increased at a compound, inflation-adjusted annual rate of 7.8% from 1994-2003 but only of 3.4% in the subsequent 4 years. Second, inflation-adjusted National Institutes of Health (NIH) funding for the 2 comparison periods declined more dramatically, from a doubling during the first 9 years, nearly all of which occurred from 1998-2003,² to a negative annual rate of 2.2%. Viewed in the context of a 30-year annual NIH extramural funding increase of 4.8%,³ these data suggest that the biomedical research community has experienced a bust-boom-bust cycling of NIH funding during these 14 years, the consequences of which may never be fully delineated. Third, the recent NIH funding decrements have undoubtedly affected academic institutions most seriously. These institutions depend heavily on federal funding for support of biomedical research (65% of total funding), 85% of which is granted by the NIH.¹ Fourth, funding from all other sources (state and local governments, private sources, industry) stayed ahead of inflation and mitigated to some extent the most recent decline of NIH funding. Comparable funding data for 2008 and 2009 are unlikely to be as robust for charitable organizations, foundations, industry, and state or local governments as the result of economy-driven shrinkage of endowments, philanthropy, business profits, and tax revenue. Indeed, industry funding in 2008 no longer compensated for declining NIH funding.¹

Variable research funding has been an obstacle for research program and research faculty development, as well as sustainability, in medical schools and biomedical research institutes. Trend analyses such as those provided by Dorsey et al should inform more effective investment decisions by public and private funders. Complementation and coordination of funding—in addition to long-range planning—involving all funders is a desirable goal, but implementation will be challenging. The injection of $10.5 billion federal dollars into research funding by the American Recovery Reinvestment Act, while welcomed by investigators, has the potential to initiate another uncoordinated and disruptive boom-bust cycle of biomedical research funding if not linked to carefully orchestrated follow-on funding.

The dollar values in the report by Dorsey et al were inflation-adjusted for the prices of research personnel, supplies, and equipment using the Biomedical Research and Development Price Index.⁴ However, to be competitive, actual annual cost increases for research in institutions also include the escalating cost of replacing research faculty, gap support for unfunded investigators, meeting the increasing expectations for regulatory oversight, updating to more expensive analytical equipment and facilities, and requirements for new support capabilities such as bioinformatics. Biomedical research cost increases beyond the Biomedical Research and Development Price Index are for the most part absorbed by institutions.

Institutional intramural funding of research generally adds up to 20% of total research costs.⁵ This key source of research funding was not included in the analysis by Dorsey et al.¹ In this context, other data reported are worrisome, namely that all-source (extramural) funding of biomedical research increased 14% during 2003-2007, while total research expenditures by colleges and universities expanded at half that rate (7.4%).¹ These rates suggest that intramural funding of research in academic settings fell behind in the mid 2000s, a situation that does not bode well for the vibrancy of academic research programs.

The data provided by the two articles on the financial anatomy of biomedical research^{1 - 2} make a strong case for more consistent, coordinated, data-driven, and sustainable decisions regarding biomedical research funding. Coordination of planning across funders would most logically be led by the NIH and include translation of recommendations to the legislative appropriations process. Expansion of public–private and other funding partnerships could reinforce coordination and perhaps lend stability to funding.

Dorsey et al¹ also note that biomedical research productivity, as defined by US Food and Drug Administration approval of new drugs, biologics, and devices, was constant over the 15 years from 1993-2008 and cite this as evidence for declining value of the increasing biomedical research investment by funders. Actually, the number of new drugs (molecular entities and biologics) has averaged 20 for the past 60 years, and, except for a transient increase in the late 1990s, there has been little variation around the average.⁶ Several reasons for stagnation of new product development have been proffered. The length and cost of the drug development process both reduce enthusiasm for necessary initial investments. It has been argued that a new model for development of therapeutic agents is needed to accomplish this goal.⁶ Financial incentives alone have not changed the rate at which products reach the market. On the other hand, many biomedical research advances are translated into medical improvements outside the realm of commercial product development.

As Dorsey et al¹ point out, broader measures are needed to adequately judge return on the substantial biomedical research investment. Ultimately, biomedical research productivity must be assessed against individual and population health. Even though an estimated 70% to 80% of total global biomedical research is sponsored by US public, private, and industry sources,¹ multiple health outcomes in the United States are lagging behind those of other countries.⁷

Findings reported in the article by Dorsey et al¹ also shed light on this incongruity. Extramural health services research funding (2003-2007) represented only 0.1% of total US health expenditures, and biomedical research funding was 45-fold greater than health services research funding. Recognizing that access to care is difficult for a substantial segment of the population, not much more than half of patients seeking medical services receive indicated care,^{8 - 9} individuals with a chronic disease as often as not do not adhere to agreed-on therapies,^{10 - 11} and health-related behaviors for much of the population do not promote good health. Health outcomes in the United States are likely to be influenced as much by improving how health services, including community-based activities, are delivered as by creating new or improved therapies.

National research policy should address not only funding of adequate, stable, and productive biomedical research but also adequate funding of research that addresses interventions designed to improve the delivery of a broad range of health services at an affordable cost. New drugs, biologics, and devices are needed to prevent and alleviate disease-related morbidity and extend the productive lives of individuals having a multitude of disorders for which there is no effective treatment.¹² Productivity of research aimed at improving these outcomes deserves ongoing emphasis. Balancing funding for investigative efforts across the entire spectrum of health care needs also deserves the highest level of attention.