NIDA/FDA Collaborations

Wilson M. Compton, M.D., M.P.E.

Director, Division of Epidemiology, Services and Prevention Research

National Institute on Drug Abuse

National Institutes of Health

• 8.6 million smokers have at least one serious illness due to smoking

• Approximately 443,000 U.S. deaths each year from cigarette use and second hand smoke

Tobacco use is the leading preventable cause of disease and death in the U.S.

More deaths than caused by HIV, illegal drug use, alcohol use, motor

vehicle injuries, suicides, and murders combined

Adult per capita cigarette consumption, the United States, 1900–2006

Warner K E , Mendez D Nicotine Tob Res 2010;12:876-887

MTF – Lifetime Cigarette Use among Students, by Grade

0

20

40

60

80

100

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11

8th Grade 10th Grade 12th Grade

SOURCE: University of Michigan, 2011 Monitoring the Future Study

Denotes significant difference

between 2010 and 2011.

MTF – Past Month Cigarette Use, Marijuana Use, among Students, by Grade

0

10

20

30

40

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11

Marijuana-8th Marijuana-10th Marijuana-12th

Cigarettes-8th Cigarettes-10th Cigarettes-12th

SOURCE: University of Michigan, 2011 Monitoring the Future Study

Denotes significant difference

between 2010 and 2011.

NSDUH - Past Month Tobacco Use, Persons Aged 12 or Older: 2002-2010

30.4+ 29.8+ 29.2+ 29.4+ 29.6+

28.6+ 28.4 27.7 27.4

26.0+ 25.4+ 24.9+ 24.9+ 25.0+ 24.2+ 23.9+

23.3 23.0

5.4 5.4 5.7+ 5.6+ 5.6 5.4 5.3 5.3 5.2

3.3 3.3 3.0+ 3.2+ 3.3 3.2 3.5 3.4 3.5

0.8 0.7+ 0.8 0.9 0.9 0.8 0.8 0.8 0.8

0

5

10

15

20

25

30

35

2002 2003 2004 2005 2006 2007 2008 2009 2010

Tobacco Products

Cigarettes

Smokeless Tobacco Pipe Tobacco

Cigars

+ Difference between this estimate and the 2010 estimate is statistically significant at the .05 level.

Family Smoking Prevention and Tobacco Control Act (FSPTCA)

FSPTCA gave the Food and Drug Administration (FDA) the authority to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients and additives. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco-related morbidity and mortality in the long term.

Enacted June 22, 2009

The Tobacco Control Act Authorizes the FDA to:

• Require disclosure of tobacco product ingredients

• Regulate “modified risk” tobacco products

• Create standards for tobacco products

• Restrict tobacco sales, distribution, and marketing

• Require stronger health warnings on packaging and advertisements

• Conduct research to support tobacco product regulation

Tobacco Control Act - Limitations

FDA does not have the authority to:

• Set nicotine levels to zero

• Ban any class of tobacco products

• Require prescriptions for tobacco products

• Set price of tobacco products

• Regulate medications/products marketed to treat tobacco dependence

• Regulate clean indoor air policies

• Regulate tobacco growing

FDA Tobacco Control Goals

1. Prevent youth tobacco use

2. Help those who use tobacco to quit

3. Promote public understanding of contents and consequences of use of tobacco products

4. Develop science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability, and death

Key FDA Tobacco Control Accomplishments to Date

Examples of Specific Actions: 1. Banned flavored cigarettes

2. Required industry registration and submission of ingredients

3. Restricted access and marketing of cigarettes and smokeless tobacco products to youth

4. Prohibited misleading marketing terms (“Light,” “Low,” and “Mild”) for tobacco products

5. Required warning labels for smokeless tobacco products

6. Requiring graphic cigarette health warnings on cigarette packages and advertisements

• Started the Center for Tobacco Products (CTP), under the leadership of Lawrence R. Deyton, M.D., M.P.H., Director FDA-CTP

– Budget is $477 million in FY2012 and increases to $712 million per year for FY2019 and beyond

• Engaged in the development of a robust research program under the leadership of David Ashley, Ph.D., Director FDA-CTP Office of Science

Key FDA Tobacco Control Accomplishments to Date

How will FDA accomplish its extensive research goals?

NIH-FDA Tobacco Regulatory Science

Workgroup

Collaborations are key.

Especially with NIH

NIH-FDA Tobacco Regulatory Science Workgroup: Co-chairs: Lawrence (Bopper) Deyton and Tom Insel

IC Representatives

OD Robert Kaplan, Patty Mabry

FIC Xingzhu Liu

NCI Robert Croyle, Michele Bloch, Ami Bahde, Stacey Vandor

NEI Natalie Kurinij

NHGRI Colleen McBride

NHLBI William Riley

NIAAA Joanne Fertig, Ralph Hingson

NICHD Caroline Signore

NIDA Wilson Compton, Kay Wanke, Susan Weiss

IC Representatives

NIDCD Carter VanWaes

NIDCR Dave Clark

NIEHS Aubrey Miller

NIGMS Stephen Marcus

NIMH Amy Goldstein, Denise Juliano-Bult

NINDS Randall Stewart

NINR Linda Weglicki

NLM Pertti Hakkinen

NIH-FDA Tobacco Regulatory Science Workgroup: Co-chairs: Lawrence (Bopper) Deyton and Tom Insel

Supported Studies • Population Assessment of Tobacco and Health (PATH) Study

(Total $117.4 M for base plus option years) • Evaluating New Nicotine Standards for Cigarettes – P50

Center – PIs E. Donny & D. Hatsukami ($2.5 M in FY2011)

In Process Funding Opportunities for FY2012 • NIH Competitive Revision Applications for Research

Relevant to the FSPTCA (R01s and U01s, $20M) • Administrative Supplements to NIH-funded Program

Projects/Center Grants: Research Relevant to the FSPTCA ($40M)

NIH-FDA Tobacco Regulatory Science Workgroup Accomplishments

Future Funding Opportunities • Consideration of Funding of NIH grants relevant to FSPTCA • Other specific announcements in progress, such as…

Centers of Excellence for Research Relevant to the FSPTCA (P50) (NOT-DA-12-007)

Estimated FOA Publication: Spring 2012 Estimated Application Due Date: Fall 2012

Estimated Award Date: July 2013

NIH-FDA Tobacco Regulatory Science Workgroup Accomplishments

Population Assessment of Tobacco and Health (PATH) Study

HAVE Model

Host Tobacco User

Agent Tobacco Biomarkers

Vector Tobacco Industry

Environment Familial, Social, Cultural, Workplace, Political,

Economic, Historical, Media, Health Care System, etc.

Population Assessment of Tobacco and Health (PATH) Study

• National, longitudinal cohort study of 44,000+ users of tobacco products and those at risk for tobacco use ages 12 and older in the U.S.

• Conducted through NIDA via a contract to Westat.

• Funded by the Center for Tobacco Products, FDA.

• Results from this study will inform the impact of FDA regulatory authority over tobacco products, and help to inform future activities.

Specific Aims

• Identify trends in tobacco use, including new products;

• Monitor change in risk perceptions and other attitudes such as social acceptability and individual preferences;

• Characterize uptake/initiation, quitting, and relapse patterns;

• Collect biomarkers of tobacco use and disease processes (via urine, buccal, and whole-blood samples);

• Compare intermediate endpoints and ultimately, short- and long-term incident health outcomes and cause-specific mortality among users of different products;

• Assess critical subgroups.

Sample (as currently planned)

• Nationally representative sample, followed yearly Ages 18+: About 38,000 (~26,000 current tobacco

users; ~12,000 former/never users) Ages 12-17: About 7,000 (~1,300 current tobacco users;

~ 5,700 former & never users) • Critical subgroups

Young adults, 18-24 (~8,500) Menthol smokers (~7,600) Dual users of cigarettes/smokeless tobacco (~700) Daily smokers (~20,800) Recent quitters (~1,100)

Users of new and/or “modified risk” tobacco products Racial/ethnic minority groups

Domains (as currently planned)

• Outcomes – Tobacco Product Use including Dual Use, Switching, New

Products – Tobacco Use Behaviors including Initiation,

Cessation/Quitting, Relapse – Health Outcomes

• Mediators/Moderators – Demographics – Knowledge, Attitudes, Beliefs, and Risk Perceptions – Tobacco Addiction – Peer, Environmental, Contextual influences – Mental Health/Substance Abuse Co-morbidities

2011 2012 2013 2014 2015 2016

Deliverables * &

Data Files

Contract Award OMB

Submission

OMB Approval

Wave 1

Pilot Study

Wave 2 Wave 3 Wave 4

Study Timeline

*Deliverables include: Analytic Data File, Detailed Tables, Codebooks, and Other Reports

P50 Center: Evaluating New Nicotine Standards for Cigarettes (E. Donny, D. Hatsukami)

Product Regulation

26

Initiation Established user Health problems

addictiveness

attractiveness toxicity

Restrict or prohibit substances or formulations that facilitate

initiation

Restrict or prohibit substances that cause

addictiveness

Restrict or prohibit substances

that are harmful

How to address through product

regulation?

Means

Progression

Source: Dorothy Hatsukami

Establishing a Nicotine Threshold for Addiction

• Proposal:

– A gradual reduction of nicotine content of cigarettes over 10-15 years.

Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. (1994). N Engl J Med, 331(2), 123-125.

Cigarettes per Day

Hatsukami et al., Addiction, December 2010

Projects

• Assessment of Very Low Nicotine Content Cigarettes

• Gradual vs. Immediate Reduction in Nicotine Content

• Very Low Nicotine Content Cigarettes in Smokers with Schizophrenia

• Other Constituents and Nicotine Self-administration

Summary of NIDA Involvement in NIH/FDA Tobacco Control Collaborations

PATH Study Team – NIDA: Wilson Compton, Kevin Conway, Elizabeth

Lambert, Kay Wanke, Kathy Etz, Joni Rutter, Nahla Hilmi, Genevieve Vullo

HHS Tobacco Control Leadership Group – Chair: Howard Koh, M.D., Assistant Secretary for Health

– NIDA: Wilson Compton, Kay Wanke

NIH-FDA Tobacco Regulatory Science Workgroup – NIDA: Wilson Compton, Kay Wanke, & Susan Weiss

Next Steps

FY 2012 Funding Opportunities - NIH Competitive Revision Applications - Administrative Supplements to Program Projects/Centers - Funding of NIH grants relevant to FSPTCA

Additional Concepts - Projects Linked to PATH Study - Other NIH Efforts

FY 2013 Plans - P50 Centers for Research Relevant to the FSPTCA - Others possible

The Vision for NIDA/FDA Collaboration…

Support science to gather data that will monitor, inform,

support, and enhance tobacco control efforts.