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Response to: "Rescuing the NIH before it is too late" from the Deputy Director for Extramural Research
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     Abstract

    For a number of reasons, the NIH and the biomedical research community are facing a period of fiscal constraint after pronounced growth. In these difficult times, it is important that we all speak from the facts and work together to do a better job of explaining the importance of the nation's investment in biomedical research.

    I would like to take this opportunity to respond to the recent editorial (1) raising concerns about the current and future the NIH budget picture and how the NIH manages during a time of fiscal constraint. I agree that there are reasons for serious concern in the scientific community. Adjusting to the new budget realities is difficult, especially after a pronounced period of growth. For this reason, it is important that NIH leadership, grantees, and grantee institutions engage in an open dialogue about managing during tough times. We must, however, speak from the facts – not misinformation, rumor, or speculation.

    Clearly, there is great concern about the dropping success rates. In this regard, I would first point out that the drop in success rates is not due to a major shift in the balance of our investments. We continue to support basic research at relatively the same level as in the past – the percentage of basic and applied science funding at NIH was at 55% and 41% of the NIH budget, respectively, in 2005, as compared to 54% and 41% in 1998. The drop in success rate can be explained largely by the confluence of two primary factors – the large increase in both the number of applicants applying and applications received after the completion of the doubling of the NIH budget in FY 2003 and the low-growth budgets since that time. Over 8,000 more Research Project Grant (RPG) applications were received in 2005 as compared with 2003, representing a 24% increase. This increase is larger than the total increase that occurred during the preceding five years. In parallel with this rapid increase in applications, the number of applicants also increased to a similar extent, largely due to growth in capacity at institutions that benefited from the NIH doubling. This increase lowered the likelihood of success for any single application, especially in a time of low-growth budgets. However, the success rates in 2005 – 22.3% for applications and 27.6% for applicants – are in fact much higher than the low rates that have been widely quoted by a number of people in the community.

    Scientists are also worried about the health of the R01. I can assure you that we are all very well aware of the importance of the R01 as the NIH's primary vehicle for biomedical discovery. In fact, the number and average size of R01s grew significantly during the doubling – by 22% and 32%, respectively. The increased average size reflects the complexity of current science as well as the ever-increasing cost of doing high-quality research. In addition, some have suggested that the NIH has shifted its interest away from funding unsolicited R01s to targeted research. In fact, 93% of R01 funding during this period resulted from unsolicited applications – not from responses to Requests for Applications.

    NIH is also deeply concerned about the young scientist – the willingness of these young people to enter into and stay in the research pipeline is critical to the future of biomedical research. While budgetary constraints affect all investigators, new and young investigators are often the first to feel the brunt of budget cutbacks and may opt for different opportunities as they perceive their chances of receiving a grant diminishing in the face of increased competition with established investigators. Recognizing this problem, this year the NIH launched a new award mechanism – Pathway to Independence Awards – to assist young investigators in transitioning to independent careers and improving their chances of receiving an R01 more quickly. In addition, NIH leadership has budgeted to increase the number of competing RPGs in FY 2007, thereby enlarging the pool of funds for which investigators will compete.

    There has also been much discussion in the scientific community about the NIH Roadmap for Medical Research. It is important to put it into perspective. The Roadmap represented about 1% of the FY 2005 budget and will be capped at 1.7% of the budget for the foreseeable future, while budget growth is constrained. The Roadmap is not a single large project, but a number of initiatives that emerged from a series of consultations with the scientific community. The Roadmap process sought to identify the scientific community's most urgent needs – needs that could not be addressed by a single or a few institutes and that would benefit the entire biomedical research enterprise. For example, we heard that there was a need to support innovative and high-risk research, to stimulate interdisciplinary research, to stimulate the basic science of complex biological systems, and to create a better infrastructure for clinical and translational science. The NIH is implementing these recommendations through a variety of mechanisms, including Program Project Grants, R01s, centers, and contracts. Today, Roadmap projects represent 383 new awards – 56 of them to investigators new to the NIH – at 134 institutions in 33 states. Furthermore, it is worth noting that the Roadmap was well received by Congress and the Administration and served as an important part of the rationale for NIH's small increases in 2004 (up 2.9%) and 2005 (up 1.9%).

    Finally, we all agree that the NIH's role in the nation's clinical research enterprise is vital. The NIH and industry play complementary roles in improving the health of our country. As such, the nation benefits from the entire research enterprise – publicly and privately funded. However, NIH supports clinical research and trials that would not be supported by the private sector, e.g., clinical research that seeks to find the etiology of disease or mechanisms of drug action. NIH also supports clinical trials on rare disorders, natural history trials, behavioral research, prevention trials, effectiveness research, and more – research that is generally not done by other sectors. The results of NIH clinical research and trials are also made accessible to the public. The NIH's clinical research portfolio is fulfilling the goal of providing unbiased research results that will improve the length and quality of life – a magnificent return on taxpayer investment.

    The NIH is a national treasure. The strong support that the NIH received over the doubling period is due to the value placed on the NIH by the American people, Congress, and presidential administrations – past and present. But these are uncertain times for federally supported biomedical research. There are many competing national priorities that demand resources. The NIH is engaged in communicating daily with the scientific community – sharing facts, addressing problems, and working creatively on solutions. We need to work together as a community to ensure that we can capitalize on the strides we have made in understanding human health. At the same time, we as a community need to do a better job of explaining the importance of the nation's investment in biomedical research to the public, patients, and policymakers in clear, compelling, and relevant terms. The health of the biomedical research enterprise is vital to the health of the nation.

    Footnotes

    Additional information about these topics can be found at the following websites:

    NIH Extramural Financial Operations Website http://grants1.nih.gov/grants/financial/index.htm

    New Investigators Program http://grants2.nih.gov/grants/new_investigators/index.htm

    NIH Roadmap for Medical Research http://nihroadmap.nih.gov/

    References

    Marks, A.R. 2006. . Rescuing the NIH before it is too late. J. Clin. Invest. 116::844-844 doi:10.1172/JCI28364.(Norka Ruiz Bravo, PhD, De)