NIH at the Crossroads: Myths, Realities and Strategies for the

FutureElias A. Zerhouni, M.D.

DirectorNational 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?

56.6%53.9% 55.2% 56.4%

52.1%

53.0%

55.2% 55.8%55.2%

56.1%

40.5%39.2%

38.4% 38.5%

39.8%

40.8%

43.5%41.0% 41.0% 40.8%

5.0%7.0%

3.7%5.7% 5.5% 5.2% 4.8%

3.6%

3.1% 3.1%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

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

Basic and Applied Research

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

Roadmap0.8%

($237 Million)

Non-Roadmap99.2%

($28,520 Million)

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

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

New Grant Applications and Success Rates During and After Doubling Period

Success Rates Applications

Projected

Num

ber of Applications

% S

ucce

ss R

ate

of G

rant

s F

unde

d

31%

19%

0%

5%

10%

15%

20%

25%

30%

35%

1998 19992000 200120022003 2004 20052006 20070

10,000

20,000

30,000

40,000

50,000

60,000

+8,303

+8,359

22%

49,656

43,069

24,154

As Many Applicants in Past 2 Years as During Previous 5 Years!

≈

26583 - 21249

(2003) – (1999)Period of doubling

5334

31791 - 26583

(2005) – (2003)

5208

The Budget Cycling Phenomenon:What Funds are Available in any One Year?

NIH Appropriations

Committed Funds

Uncommitted Funds

Budget Increase

From ending grants started 4-5 years ago

From current year to previous year

Continuing grants

NIH Congressional Appropriations B

illi

on

s o

f D

oll

ars

DOUBLING

$13.7$15.6

$17.8

$20.5

$23.3

$27.1$28.0 $28.6 $28.6 $28.6

$0

$5

$10

$15

$20

$25

$30

FY1998

FY1999

FY2000

FY2001

FY2002

FY2003

FY2004

FY2005

FY2006

FY2007

?

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

0 10 20 30 40

100

0

-

75 -

50 -

25 -

Percentile Score

Perc

ent

R01s

Funded

>99% of grants under the payline are funded

Success Rateper application

Payline

0%

5%

10%

15%

20%

25%

30%

35%

40%

1995

1997

1999

2001

2003

2005

Applicant

Applications

Succ

ess

Rate

for

R01 E

qu

ivale

nts

Fiscal Year

Success Rate files as of May 3, 2006. Program srf_indiv_060103_rfmIndividuals are determined using the pi_profile_person_id in IMPAC-II

Success Rate per Application Understates Funding Rate per

Applicant

22.3%

27.6%

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

Death

s p

er

10

0,0

00

Year

~ 514,000 ActualDeaths in 2000

~ 1,329,000 Projected

Deaths in 2000

63% decrease in Mortality

~ 1 million early deaths averted per year

$2.6 trillion in economic return

New, effective treatments and prevention strategies

30-year investmentper American:

~$110Total

Average investment

per American

~$3.70per year

Biomedical Research Has DeliveredCancer

Mill

ions

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 investmentper American

~$8.60per year

30-year investmentper American:

~$260Total

Basic Discovery Today Provides the Foundation for Tomorrow’s

Medicine

Basic Researchand

Technology Development

Translational Research

Clinical Applications

The Future Paradigm: Transform Medicine from Curative to Preemptive

PreemptivePersonalizedPredictive

Participatory

Elias A. Zerhouni, MD, Director, NIH May 4, 2006

NIHTransforming medicine through discovery