Thomas R. Insel, M.D.Thomas R. Insel, M.D.Director, NIMH/NIH/DHHSDirector, NIMH/NIH/DHHS

The National Institute of Mental HealthThe National Institute of Mental Health and the and the

American Recovery and Reinvestment ActAmerican Recovery and Reinvestment Act

July 10, 2009

NIMH MissionTo transform the understanding and treatment of mental illnesses

through basic and clinical research, paving the way for

prevention, recovery, and cure.

Source: WHO World Health Report 2002

0 5 10 15 20 25 30 35

Mental Illness*

Injuries, including self-inflicted

Alcohol and drug use

Malignant neoplasms (cancer)

Cardiovascular disease

Respiratory disease

Musculoskeletal disease

Sense organ disease

Digestive disease

Burden of Disease (DALYs) U.S., Canada, and Western Europe 15-44 years old

Public Health Impact:Early Mortality in Individuals with

Major Mental Illness (MMI)

0

5

10

15

20

25

30

35

Average Arizona Missouri Oklahoma RhodeIsland

Texas Utah

Ye

ars

of

Po

ten

tia

l Lif

e L

os

t

Adapted from Colton and Manderscheid, 2006, Prev Chronic Dis

• Average age at time of death : 56 years

• Increased likelihood of heart disease and suicide

Direct and indirect components of the economic burden of serious mental disorders, excluding incarceration, homelessness, comorbid conditions and early mortality. ($ in billions) 1992 2002Health Care Expenditures $62.91 $100.12Loss of earning $76.71 $193.23Disability (SSI + SSDI) $16.41 $24.34 Totals $156.0 B $317.6 B

Matching Resources with Public Health Need

Insel, Am J Psychiatry, 2008

Re-ThinkingRe-Thinking “ “Mental Illness”Mental Illness”

Mental disorders are brain disorders.

Mental disorders are developmental disorders.

Mental disorders result from complex genetic risk plus experiential factors.

oF11pACC24

mF9/10

PCCMCC

PF9/46 Par40PM6

sACC25

hth bstema-ins

amg mb-vta

hc

na-vst thal

SalienceMotivation

MoodstateSelf-awareness

insight

Cognition(attention-appraisal-action)

Interoception(drive-autonomic-circadian)

Mental Disorders are Brain DisordersResponse Pathways for Depression

CBT

PF

MF

MCC

MedsPF

P

Cg25

PCC

BS

MEDS

Br Med Bul 65:193-207, 2003Arch Gen Psych 61:34-41-2004

Source: J Giedd, NIMH

Prolonged Human Brain Development

10 15 20 25

Age

# ofCortical

Synapses

Normal Development

Based on McGlashan and Hoffman (2000)

A Developmental Brain Model for Schizophrenia

Psychosis Threshold

Possible Paths to Schizophrenia

Intervention

McCarthy et al., Nat Rev Genetics 2008

Mendeliandisease

Frequency of DNA variation in population

High

Intermediate

Modest

Low

Very rare Rare Uncommon Common

0.001 0.01 0.10

Complex Genetics of Mental Illness

Penetrance

22q11.216p11.11q21.115q13.3Disc-1

ANK3CACNA1C

HLACAM10

New technology for sequencingRepository of DNA from pts/controlsNeeded:Funds for supporting large scale effort

RareLarge effect

CommonSmall effect

NIMH Strategic Plan (4 P’s)

•Strategic Objective #1: Pathophysiology

•Strategic Objective #2: Predictive medicine

•Strategic Objective #3: Preemptive and Personalized Interventions

•Strategic Objective #4: Public Health Impact – Participatory Research

Nice roadmap but is there any gas in the car?

American Recovery and Reinvestment Act (ARRA)- Impact of Economic Stimulus on NIH

American Recovery and Reinvestment Act (ARRA)- Objectives

Stimulate the economy

Create and preserve jobs

Advance biomedical research

$10.4B to NIH

$366M to NIMH

Scientific Research Approach - NIMH

Stimulate and accelerate biomedical research with existing mechanisms (33%)– Funding additional meritorious R01s, R21s and R03s that have

been peer reviewed and approved by NIMH Council

– Administrative supplements to accelerate ongoing research

Expand science with new programs (67%)– Revisions to extant programs (“Competitive supplements”)

– New ARRA NIH-wide programs

– New ARRA IC-specific programs

NIMH ARRA Priorities• Jumpstart: the NIMH Strategic Plan (4P’s)

the NIH AIDS Res Strategic Plan

• Increase training, faculty recruitment, diversity

the Autism Research Strategic Plan

• Support beaker-ready projects w 2 year outcomes

• Process: transparent, careful, accountable

New ARRA NIH-wide Programs Challenge Grants

Grand Opportunities (“GO” Grants)

Recruit new faculty to conduct research

Provide summer jobs for high school /

college students and teachers in science labs

AREA (R15) Grants

} Jumpstart Strategic Plans

}Create and Retain Jobs

} National effort

On average, every NIH grant supports 6 -7 part-time or full-time jobs

Challenge Grants• 2 year $500k/yr awards – submitted April 27, 2009• Received >21,000 proposals, 894 for NIMH• Reviewed June-July, Funded before 9/30/09• NIH OD committed $200M; NIMH has committed $90M

NIMH Challenge Areas:BiomarkersGenomic sequencingSchizophrenia interactomeAIDS – behavior changeComparative EffectivenessDeveloping iPS cells

Grand Opportunity Grants

• 2 year >$500K/yr awards – submitted May 24, 2009

• Received 104 proposals for NIMH ($470M)

• Reviewed June; Funded before 9/30/09

• NIMH has committed $67M

NIMH GO Grants:Genomic profiling of mental disordersNeurodevelopmental genomicsTranscriptional map of developing human brain

ARRA NIMH RFA:Research to Address the Heterogeneity

of Autism Spectrum Disorders

4 Different mechanisms to address heterogeneity of autism and focus on short-term objectives of IACC Strategic Plan

590 proposals ($500M) submitted May 12; Peer reviewed June 19; Scheduled for Council July 17

Combined commitment is $60M (NIMH, NICHD, NINDS, NIDCR, NIEHS)

Peer Review for ARRA

Rapid (initial mail reviews within 1 month)

Extensive (364 reviewers for NIMH GO and autism proposals)

Careful (Two tier review to ensure quality)

Public input (Autism review included consumers)

http://www.nih.gov/recoveryTransparency:

Accountability: http://report.nih.gov/

NIMH Signature Project #1

Reducing Suicide in the Army

Problem: Suicide rates in Army have doubled

Army asked for assistance in assessing risk and resilience in soldiers

NIMH commits ARRA funds ($10M) to collaborative effort for historic epidemiological study to follow 15,000 soldiers

Study to provide actionable information to Army

NIMH Signature Project #2

Recovery After an Initial Schizophrenic Episode (RAISE)

Problem: Schizophrenia associated with chronic disability

RAISE will test aggressive, comprehensive treatment(medication, psychosocial, rehabilitation) to optimize outcomes

RAISE developed with SSA, SAMHSA, and CMS for “hand off” from research to practice

NIMH ARRA funds ($25M) will launch project in 2009

NIMH Signature Project #3

Neurogenomics

Problem: Many leads but few genes for psychiatric illnesses (rare variants likely but difficult to detect)

New techniques permit rapid, comprehensive sequencing, including detection of rare variants

NIMH ARRA funds ($20 -30M) will support development of first comprehensive sequencing efforts

Sequencing is feasible in 2 years

NIMH Comparative Effectiveness Research

ARRA Projects:• Leveraging existing healthcare networks for CER on Mental Disorders and Autism

• Cost effectiveness of mental health interventions

• Collaboration with AHRQ CER Program

• Building ASD registries for use in Comparative Effectiveness Research

What Can We Accomplish With ARRA?

Biomedical Progress: Creating a foundation for future progress

Creating and Preserving Jobs:>50% of grant budget = personnel

Economic Stimulus:Proposals from all 50 states

NIMH ARRA obligations actual and planned for FY2009

(all mechanisms)

SummaryARRA provides an unprecedented opportunity to advance biomedical research while participating in the nation’s economic recovery

NIMH is using ARRA funds to jumpstart its strategic plan, support autism and AIDS research, and provide training and faculty positions.

Specific signature projects focus on suicide in the Army, schizophrenia, and genomics.

Demand for ARRA support high, success relatively low, but ARRA will build foundation for progress.

www.nimh.nih.govwww.nimh.nih.gov

Paving the Way for Prevention, Recovery, and Cure

Select NIMH ARRA Funds – 7/10/09Initiative Committed

fundingDue Date

Proposalsreceived

Funding Date

Expansion of payline

$60M 2008- 2010

----- 6/09

Supplements

$10M adm.$10M comp.

4/09 $205M$ 64M

6/098/09

Challenge $90M 4/09 $578M

8/09

Grand Opportunity

$67M 5/09 $470M

9/09

New faculty recruitment

$5M 5/09 $25M 9/09

Autism RFA

$30M 5/09 $500M

7/09

Army suicide & RAISE

$35M 2009 $35M 7/09

What Happens After ARRA?

Demand for research will increase:Success rate (# funded/# proposed) < 10%Many unsuccessful grants return in 2010Both unsuccessful and successful grants return in 2011

Total # ARRA proposals = 1,703Estimated success rate in 2011:

If 50% return: 13.7%If 75% return: 12.2%If 90% return: 11.5%

Required for 20% success rate: 7 -11% increase from FY10 PB