NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D. Director National Institutes of Health

Competition for funds from the NIH and other sponsors, intensifying year by year, now stands at an unprecedented level, and shows no sign of abating. Never before have so many established investigators faced so much uncertainty about their longevity as active scientists. Never before have so many novices faced so many disincentives to entering or continuing a research career. Dr. William F. Raub, NIH Associate Director for Research and Training, strategy paper, 1982

NIH Budget Facing a “Perfect Storm” in 2006 Federal & Trade Deficits Defense and Homeland Security needs Katrina Pandemic flu Post- Doubling effects Physical Sciences focus Biomedical research inflation- 3 to 5%

NIH Budget: Myths and Realities…

What is Driving Success Rates? Is NIH placing more emphasis on applied as opposed to basic science Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research? Is it due to the Roadmap?

Basic and Applied Research 60.0% 56.4% 55.2% 55.8% 53.9% 55.2% 55.2% 56.6% 52.1% 56.1% 53.0% 50.0% 43.5% 40.5% 41.0% 41.0% 40.8% 39.2% 39.8% 40.0% 40.8% 38.4% 38.5% 30.0% 20.0% 10.0% 7.0% 5.7% 5.5% 5.2% 4.8% 5.0% 3.7% 3.1% 3.1% 3.6% 0.0% FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 Basic Research Applied Research Other

What is Driving Success Rates? Is NIH placing too much emphasis on translational science at the expense of basic research? Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research? Is it due to the Roadmap?

What is Driving Success Rates? Is NIH placing too much emphasis on translational science at the expense of basic research? Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research? Is it due to the Roadmap?

NIH Roadmap for Medical Research FY2005 Request = $28,757M Developed to increase synergy across NIH Not a single initiative but over 345 individual awards in FY 2005: 40% basic 40% translational 20% high risk Non-Roadmap 99.2% ($28,520 Million) Roadmap 0.8% ($237 Million)

What Is Really Happening? 3 Fundamental Drivers Large capacity building throughout U.S. research institutions and increase in number of tenure-track faculty Appropriations below inflation after 2003 Increases of +3 % in ‘04, 2.2% in ‘05 and 0% in 06 Biomedical Inflation in 2004 was ~ 5% Budget cycling phenomenon BRDPI FY04 (actual) 3.5% FY05 (est.) 3.3% FY06 (est.) 3.2% FY07 (est.) 3.2%

New Grant Applications and Success Rates During and After Doubling Period 35% 60,000 49,656 30% 31% 50,000 43,069 25% +8,359 40,000 Projected 20% 22% +8,303 Number of Applications % Success Rate of Grants Funded 19% 30,000 24,154 15% 20,000 10% 10,000 5% 0% 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Success Rates Applications

As Many Applicants in Past 2 Years as During Previous 5 Years! ≈ 5334 5208 26583 - 21249 31791 - 26583 (2003) – (1999) (2005) – (2003) Period of doubling

The Budget Cycling Phenomenon: What Funds are Available in any One Year? From current year to previous year Budget Increase Uncommitted Funds From ending grants started 4-5 years ago Continuing grants Committed Funds NIH Appropriations

NIH Congressional Appropriations $30 $28.6 $28.0 $28.6 $28.6 $27.1 $25 $23.3 ? $20 $20.5 $17.8 Billions of Dollars $15 $15.6 $13.7 $10 $5 $0 FY FY FY FY FY FY FY FY FY FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 DOUBLING

The Bottom Line: Demand for Grants “Took Off” Just as NIH Budget Was “Landing!” NIH managed well despite small increases in 2004 (2.9%) and 2005 (2%) by shifting “one time” funds from 2003 to 2004 Budget cycling effect will improve demand vs supply of grants in 2007 but we need to educate public about need for sustainability in research

The Question on Everyone’s Mind: What are MY chances of being funded?

Payline Is Not Funding Cut-off Line >99% of grants under the payline are funded Payline 100 - 75 - Success Rate per application Percent R01s Funded 50 - 25 - 10 20 30 40 Percentile Score

Success Rate per Application Understates Funding Rate per Applicant 40% Applicant 35% 22.3% 27.6% 30% 25% Applications Success Rate for R01 Equivalents 20% 15% FY 2005- 22.3% success rate for applications, but 27.6% for applicants FY 2006- 19.8% for applications, but ~25% for applicants 10% 5% 0% 1995 1997 1999 2001 2003 2005 Fiscal Year Success Rate files as of May 3, 2006. Program srf_indiv_060103_rfm Individuals are determined using the pi_profile_person_id in IMPAC-II

Where Do We Go From Here? Adaptive Strategies A Vision for the Future

Strategies First: Know the facts Second: Develop adaptive strategies Protect the essential: Knowledge and Discovery Increase number of competing grants (supply/demand management) Support new investigators New Pathway to Independence Program Institutes and Centers efforts to assist new investigators Third: Convey a unified message Increase communications about positive impact of NIH at local, regional and national levels Fourth: NIH’s exciting vision for the future

Biomedical Research Has Delivered Coronary Heart Disease 500 400 300 200 100 50 55 60 65 70 75 80 85 90 95 00 Deaths per 100,000 Year ~ 514,000 Actual Deaths in 2000 ~ 1,329,000 Projected 63% decrease in Mortality ~ 1 million early deaths averted per year $2.6 trillion in economic return New, effective treatments and prevention strategies Average investment per American ~$3.70 per year 30-year investment per American: ~$110 Total The disabled spend seven times what the non-disabled do on medical care The share of people with a stroke, fracture, or other serious condition has increased over time. Rather, reduced disability is because fewer people who have these conditions become disabled. Progress in disease management, in part due to changes in treatment, may be contributing to reduction in disability Arthritis improvements: disease-modifying antirheumatic drugs Increased accessibility of nonsteroidal antiinflammatory drugs

Biomedical Research Has Delivered Cancer Millions of People 1971 1986 1990 2003 9 6 3 For the first time in recorded history, annual cancer deaths in the United States have fallen 10 million survivors Advent of early detection and screening Average investment per American ~$8.60 per year 30-year investment per American: ~$260 Total The disabled spend seven times what the non-disabled do on medical care The share of people with a stroke, fracture, or other serious condition has increased over time. Rather, reduced disability is because fewer people who have these conditions become disabled. Progress in disease management, in part due to changes in treatment, may be contributing to reduction in disability Arthritis improvements: disease-modifying antirheumatic drugs Increased accessibility of nonsteroidal antiinflammatory drugs

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