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NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D.

NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D. Director, National Institutes of Health. NIH Budget Facing a “Perfect Storm”.

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NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D.

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

  2. NIH Budget Facing a “Perfect Storm” • Federal Deficit, Defense and Homeland Security priority requirements, Katrina, Pandemic flu and domestic budget cuts (-2.7% for HHS) • Congressional support for Physical Sciences for competitiveness • Overall support for NIH is still strong • Biomedical research inflation in 2004 ~ 5.5%

  3. NIH Budget: Myths and Realities…

  4. Why Are Success Rates So Low? • Is NIH placing too much emphasis on translational science at the expense of basic research? • Is NIH over-investing in big projects and initiatives at the expense of investigator-initiated research? • Is it due to the Roadmap?

  5. Basic and Applied Research 60.0% 56.4% 55.8% 55.2% 55.2% 55.2% 53.9% 56.6% 52.1% 56.1% 53.0% 50.0% 43.5% 41.0% 40.8% 40.5% 41.0% 39.8% 39.2% 40.0% 40.8% 38.5% 38.4% 30.0% 20.0% 10.0% 7.0% 5.7% 5.0% 5.5% 5.2% 4.8% 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

  6. Why Are Success Rates So Low? • Is NIH placing too much emphasis on translational science at the expense of basic research? • Is NIH over-investing in big projects and initiatives at the expense of investigator-initiated research? • Is it due to the Roadmap?

  7. RFAs per $Billion PAs per $Billion Appropriations NIH is Committed to Investigator-Initiated Research 14.0 $35 12.0 $30 12.2 11.2 11.1 10.8 10.9 10.0 $25 10.8 10 8.8 8.7 8.0 $20 8.6 8 Appropriations in Billions 8.1 8.2 8.3 Number of Announcements/$Billion 7.6 8 7 6.6 6.0 $15 6.3 5.9 5.8 5.8 4.0 $10 2.0 $5 0.0 $0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 Fiscal Year

  8. Grants: Unsolicited Far Outnumber Solicited 100% 90% 80% 70% 60% Percentage of Grants Unsolicited Solicited 50% 40% 30% 20% 10% 0% 1994 1996 1998 2000 2002 2004 2006 Fiscal Year

  9. Why Are Success Rates So Low? • Is NIH placing too much emphasis on translational science at the expense of basic research? • Is NIH over-investing in big projects and initiatives at the expense of investigator-initiated research? • Is it due to the Roadmap?

  10. NIH Roadmap for Medical Research • Developed to • Increase synergy across NIH • Respond to concerns about the perceived “balkanization” of NIH (Congress, IOM report) • Developed with wide extramural input • Beyond the scope of a single Institute or Center and benefits all • Emerging areas of science • High risk/high impact research • Enabling science infrastructure

  11. NIDA and the NIH Roadmap • Co-lead on an Interdisciplinary Research Initiative • Development of innovative methodology in social and behavioral sciences research • Involved in the development of clinical trials networks • Supports the Molecular Libraries and Imaging Roadmap Initiative

  12. Roadmap in FY05: 0.8% of Total Budget FY2005 Request = $28,757M Non-Roadmap 99.2% ($28,520 Million) Roadmap 0.8% ($237 Million) Roadmap in FY06: • 1.2% of budget • 133 institutions, 33 states

  13. NIH Roadmap for Medical Research • Not a single initiative but over 345 individual awards in FY05: • 40% basic • 40% translational • 20% high risk • Creates “Incubator Space” to accelerate critical research efforts that address major cross-cutting NIH priorities • This “Incubator Space” is now a permanent part of NIH: Office of Portfolio analysis and Strategic Initiatives (OPASI) Roadmap Funding 600 1.2% - 1.7% NIH Budget 500 400 300 200 100 0 FY04 FY05 FY06 FY07 FY08 FY09

  14. NIH Director’s Pioneer Award Program • New program designed to support individuals with high-risk, potentially groundbreaking ideas • Example: Sunney Xie of Harvard University • First to show translation of a gene at the level of a single protein molecule in a live cell • His work published in Science and Nature simultaneously Nature, 440:358-362 (March 16, 2006) Science, 331:1600-1603 (March 17, 2006)

  15. What Is Really Happening?3 Fundamental Drivers • Large capacity building throughout U.S. research institutions and dramatic increase in number of tenure-track faculty • Large increase in applicants and applications occurring after 2003 • Budgets: • Appropriations below inflation after 2003 ( +3 % in ‘04, 2.2% in ‘05 and 0% in 06 ) while BRDPI in 2004 was ~ 5.5% • 4-year budget cycling phenomenon

  16. +8,359 +8,303 Comparing the % of Grant Applications Funded (or “Success Rate”) with the Number of New Applications 35% 60,000 32% 32% 30% 32% 31% 50,000 31% 30% 49,656 25% 46,501 25% 40,000 43,069 Projected 40,862 22% 20% 19% Number of Applications % Success Rate of Grants Funded 30,000 19% 34,710 15% 28,368 27,798 30,069 26,407 20,000 24,154 10% 10,000 5% 0% 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Success Rates Applications

  17. ≈ 8303 34710 - 26407 (2003) – (1999) Period of doubling As Many New Applications in the Last 2 years as During the Doubling 8359 43069 - 34710 (2005) – (2003)

  18. ≈ 5208 5334 26583 - 21249 31791 - 26583 (2003) – (1999) (2005) – (2003) Period of doubling As Many New Applicants in the Last 2 years as During the Doubling

  19. What Funds are Really 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

  20. NIH Congressional Appropriations $30 $28.6 $28.6 $28.6 $28.0 $27.1 $25 ? $23.3 $20 $20.5 $17.8 $15 Billions of Dollars $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

  21. Why is the Transition so Painful? • Demand for grants “took off” (2002- 2006) just as the NIH budget was ”landing” (1999-2003) • More increase in demand for grants in last 2 years than in the full 5 years of the doubling • NIH budget increases below inflation • Budget cycle effects- uncommitted pool in 2006 comes from 2001-2002 when doubling did not yet occur • 2003 commitments will become available in 2007, allowing for a 3% increase in competing grants (even with a flat budget)

  22. The Question on Everyone’s Mind:“What are my chances of being funded?” • Because number of applications per applicant has increased from 1.2 to 1.5, success rate understates funding rate • Translates to approximately 15,000 extra applications • FY 05- 22.3% success rate for applications, but 27.6% for individual applicants • FY 06- 19.8% for applications, but ~25% for individual applicants • Payline is not the funding cut-off line!

  23. Where Do We Go From Here? The Vision for the Future

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

  25. Total investment per American over the past 30 years: ~$110 Average annual investment per American ~$3.70 Coronary Heart Disease Today • 63% decrease in mortality • ~ 1 million early deaths averted per year • $2.6 trillions in economic return • New effective treatments • More effective prevention • Successfully reduced cholesterol levels in the population • New discoveries being developed by industry 500 ~ 1,329,000 Projected Deaths in 2000 400 300 Deaths per 100,000 200 ~ 514,000 Actual Deaths in 2000 100 95 50 55 60 65 70 75 80 85 90 00 Year 35 30 25 20 % population with high serum cholesterol 15 10 5 0 1976-80 1988-94 1960-62 1971-74 1999-02

  26. Total investment per American over the past 30 years: ~$260 Average annual investment per American ~$8.60 Survivorship 9 6 Millions of People 3 1971 1986 1990 2003 Cancer Today • For the first time annual cancer deaths in the United States have fallen • 10 million survivors • Early detection and screening are more effective • New targeted, minimally invasive treatments for cancer have multiplied • New discoveries make it possible for the first time to personalize cancer treatment

  27. Need to Transform Medical Research in the 21stCentury 20th Century 21st Century Treat disease when symptoms appear and normal function is lost Intervene before symptoms appear and preserve normal function for as long as possible Did not understand the molecular and cellular events that lead to disease Understanding preclinical molecular events and ability to detect patients at risk Expensive in financial and disability costs Orders of magnitude more effective

  28. Participatory The Future Paradigm: Transform Medicine from Curative to Preemptive Predictive Personalized Preemptive

  29. Curativetreatment Symptommanagement CostSavings Molecular preemption The Future Paradigm:Preempt Disease Intolerable Tolerable Disease Burden Cost Preclinical Time

  30. Transforming medicine through discovery NIH

  31. NIH Competing Funds Remain Relatively Constant Amount of NIH Extramural Awards (Excluding R&D Contracts) $25,000 Competing Noncompeting $20,000 $15,000 Dollars Awarded (Millions) $10,000 $5,000 0 1998 1999 2000 2001 2002 2003 2004 2005 Fiscal Year

  32. Predictive: End Stage Renal Disease • End Stage Renal Disease (ESRD): • $22.8 billion in U.S. public and private spending (2001) • In the past decade, the absolute number of ESRD patients more than doubled and the incidence rate doubled • More than 85,000 new cases per year • Apolipoprotein E (APOE): • Variation predicts kidney disease progression • Prediction independent of diabetes, race, lipid and non-lipid risk factors

  33. Personalize: Cancer Treatment Impact: • 100,000 women each year can make a more informed choice • 70,000 women do not have to undergo chemotherapy • Reduces routine cost of treating these patients Identified 16 informative genes Test tumor samples for mutations in these genes Predict which patients need chemotherapy

  34. Preemptive: HPV Vaccine • Human Papillomavirus (HPV) infects over 80% of 15-50 year old women and can cause cervical cancer • Prevent sexually transmitted HPV infection = prevent cervical cancer • Anti-viral vaccines are among the most cost effective public health interventions (e.g., smallpox, polio, & measles) • NIH has two vaccines currently in clinical trials

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