Despite overwhelming evidence of tobacco's harmful effects and pressure from anti-smoking advocates, current surveys show that about one-quarter of all adults in the United States are smokers. This audience is the target for a wave of tobacco products and pharmaceuticals that claim to preserve tobacco pleasure while reducing its toxic effects.

Clearing the Smoke addresses the problems in evaluating whether such products actually do reduce the health risks of tobacco use. Within the context of regulating such products, the committee explores key questions:

• Does the use of such products decrease exposure to harmful substances in tobacco?
• Is decreased exposure associated with decreased harm to health?
• Are there surrogate indicators of harm that could be measured quickly enough for regulation of these products?
• What are the public health implications?

This book looks at the types of products that could reduce harm and reviews the available evidence for their impact on various forms of cancer and other major ailments. It also recommends approaches to governing these products and tracking their public health effects.

With an attitude of healthy skepticism, Clearing the Smoke will be important to health policy makers, public health officials, medical practitioners, manufacturers and marketers of "reduced-harm" tobacco products, and anyone trying to sort through product claims.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE TO ASSESS THE SCIENCE BASE FOR TOBACCO HARM REDUCTION
• Preface
• REVIEWERS
• Executive Summary
  • BACKGROUND
  • DEFINITION OF HARM REDUCTION
  • HISTORY OF EFFORTS TO REDUCE HARM FROM CIGARETTES
  • TYPES OF EXPOSURE REDUCTION PRODUCTS
  • THE COMMITTEE CHARGE AND ASSUMPTIONS
  • PRINCIPAL CONCLUSIONS
  • PRINCIPAL RECOMMENDATIONS
  • REFERENCES
• Section I. Introduction, Background, and Conclusions
  • 1. Introduction
    • HISTORY OF HARM REDUCTION
    • DEFINITIONS
    • NICOTINE
    • PHARMACEUTICAL PRODUCTS
    • REGULATORY ISSUES AND AUTHORITIES
    • COMMITTEE CHARGE AND PROCESS
    • APPLICATION OF RISK ASSESSMENT TO TOBACCO HARM REDUCTION
    • OPERATING PRECEPTS
    • REFERENCES
  • 2. Principles of Harm Reduction
    • CONCEPTUAL FRAMEWORK FOR HARM REDUCTION
    • APPLICATIONS
    • COMPARING OTHER HARM REDUCTION INTERVENTIONS TO THOSE FOR SMOKING
    • CONCLUSIONS
    • REFERENCES
  • 3. Historical Perspective and Lessons Learned
    • TOBACCO MARKETING: EARLY HEALTH CLAIMS
    • HEALTH IMPACT OF LOW-YIELD PRODUCTS
    • RISK PERCEPTION
    • POTENTIAL INFLUENCE OF PREPS ON TOBACCO USE BEHAVIORS
    • SUMMARY AND RELEVANCE TO PREPS
    • REFERENCES
  • 4. Products for Tobacco Exposure Reduction
    • TOBACCO AND TOBACCO PRODUCTS
    • PHARMACEUTICAL PRODUCTS
    • OTHER POTENTIAL HARM REDUCTION METHODS: BEHAVIORAL STRATEGIES AND TOBACCO CONTROL POLICIES
    • REGULATION OF EXPOSURE REDUCTION PRODUCTS
    • REFERENCES
  • 5. The Scientific Basis for PREP Assessment
    • TOBACCO SMOKE AND TOXICOLOGY (SEE SECTION II, CHAPTER 10)
    • EXPOSURE AND BIOMARKER ASSESSMENT IN HUMANS (SEE SECTION II, CHAPTER 11)
    • NICOTINE PHARMACOLOGY (SEE SECTION II, CHAPTER 9)
    • CANCER (SEE SECTION II, CHAPTER 12)
    • CARDIOVASCULAR DISEASE (SEE SECTION II, CHAPTER 13)
    • NONNEOPLASTIC RESPIRATORY DISEASE (SEE SECTION II, CHAPTER 14)
    • REPRODUCTIVE AND DEVELOPMENTAL EFFECTS (SEE SECTION II, CHAPTER 15)
    • OTHER HEALTH EFFECTS (SEE SECTION II, CHAPTER 16)
    • REFERENCES
  • 6. Surveillance for the Health and Behavioral Consequences of Exposure Reduction
    • EXISTING TOBACCO SURVEILLANCE SYSTEMS
    • PROPOSED SURVEILLANCE SYSTEM ENHANCEMENTS
    • ISSUES AND LIMITATIONS REGARDING SURVEILLANCE SYSTEMS FOR ASSESSING TOBACCO-RELATED HEALTH OUTCOMES
    • SUMMARY AND RECOMMENDATIONS
    • REFERENCES
  • 7. Implementation of a Science-Based Policy of Harm Reduction
    • NEXT STEPS: AN OVERVIEW
    • PRINCIPLES FOR REGULATING POTENTIAL REDUCED-EXPOSURE PRODUCTS
    • SUMMARY
    • REFERENCES
  • 8. Principal Conclusions
• Section II. Evidence for the Science Base
  • 9. Nicotine Pharmacology
    • BASIC AND HUMAN PHARMACOLOGY
    • PHARMACOKINETICS
    • PHARMACODYNAMICS
    • RESEARCH AGENDA
    • REFERENCES
  • 10. Tobacco Smoke and Toxicology
    • PHYSICAL AND CHEMICAL CHARACTERISTICS OF TOBACCO SMOKE
    • TOXICITY OF TOBACCO SMOKE
    • ASSESSMENT OF POTENTIAL EXPOSURE REDUCTION PRODUCTS
    • Reproductive and Developmental Effects
    • SYNERGISTIC EFFECTS WITH OTHER POLLUTANTS
    • MOLECULAR BIOLOGY TESTING TOOLS
    • SMOKELESS TOBACCO TOXICITY
    • GENERAL RESEARCH AGENDA AND RECOMMENDATIONS
    • REFERENCES
  • 11. Exposure and Biomarker Assessment in Humans
    • EXTERNAL EXPOSURE ASSESSMENT: THE FTC METHOD AND QUESTIONNAIRE DATA
    • BIOMARKERS OF EXPOSURE
    • BIOMARKERS ESTIMATING THE BIOLOGICALLY EFFECTIVE DOSE
    • BIOMARKERS OF POTENTIAL HARM
    • HOST SUSCEPTIBILITY
    • GENETIC PREDISPOSITIONS TO SMOKING ADDICTION
    • BIOMARKER ASSESSMENT FOR ENVIRONMENTAL TOBACCO SMOKE EXPOSURE
    • DEVELOPMENT AND VALIDATION OF BIOMARKER ASSAYS, INCLUDING QUALITY CONTROL
    • CONCLUSIONS
    • RESEARCH AGENDA
    • REFERENCES
  • 12. Cancer
    • MUTAGENESIS AND DNA DAMAGE
    • CARCINOGENESIS
    • TOBACCO MUTAGENS AND CARCINOGENS
    • SCIENTIFIC METHODS FOR ASSESSING HARM REDUCTION STRATEGIES
    • LUNG CANCER
    • OROPHARYNGEAL CANCERS
    • BLADDER CANCER
    • ENDOMETRIAL CANCER
    • ENVIRONMENTAL TOBACCO SMOKE
    • CIGAR SMOKING
    • SMOKELESS TOBACCO PRODUCTS
    • STUDIES OF NICOTINE MUTAGENICITY AND CARCINOGENICITY
    • CONCLUSIONS
    • RESEARCH AGENDA
    • SPECIAL ISSUES IN STUDY DESIGNS
    • REFERENCES
  • 13. Cardiovascular Disease
    • CORONARY HEART DISEASE
    • EXTRACARDIAC VASCULAR DISEASE
    • OTHER VARIABLES INFLUENCED BY SMOKING
    • SURROGATE MARKERS
    • CONCLUSIONS
    • Clinical Assessment of Tobacco-Related Disease
    • RESEARCH AGENDA
    • REFERENCES
  • 14. Nonneoplastic Respiratory Diseases
    • BIOMARKERS OF RESPIRATORY DISEASES
    • CHRONIC OBSTRUCTIVE PULMONARY DISEASE
    • ASTHMA
    • RESPIRATORY INFECTIONS
    • SUMMARY AND CONCLUSIONS
    • RESEARCH AGENDA
    • REFERENCES
  • 15. Reproductive and Developmental Effects
    • FERTILITY IMPAIRMENT
    • SPONTANEOUS ABORTIONS
    • PLACENTAL COMPLICATIONS
    • PRETERM DELIVERY
    • LOW BIRTHWEIGHT
    • SUDDEN INFANT DEATH SYNDROME (SIDS)
    • CONGENITAL MALFORMATIONS
    • COGNITIVE AND BEHAVIORAL DEFICITS IN CHILDHOOD
    • FETAL LUNG DEVELOPMENT
    • SMOKELESS TOBACCO
    • CONCLUSIONS
    • RECOMMENDATIONS
    • REFERENCES
  • 16. Other Health Effects
    • PEPTIC ULCERS
    • SURGICAL WOUND HEALING
    • INFLAMMATORY BOWEL DISEASE
    • RHEUMATOID ARTHRITIS
    • ORAL DISEASE
    • DEMENTIA
    • ORTHOPEDIC CONSEQUENCES
    • OCULAR DISEASE
    • DERMATOLOGIC CONDITIONS
    • DIABETES
    • RENAL DISEASE
    • SCHIZOPHRENIA
    • DEPRESSION
    • WEIGHT CHANGE
    • DRUG INTERACTIONS
    • FIRE SAFETY
    • PARKINSON'S DISEASE
    • PREECLAMPSIA
    • SUMMARY
    • RECOMMENDATIONS
    • REFERENCES
• Appendixes
  • A Presentations and Submissions
  • B Committee Biographical Sketches
  • C Time Line of Tobacco Events

Support for this project was provided by the Food and Drug Administration (FDA) prior to the March 2000 decision by the Supreme Court denying FDA comprehensive authority over tobacco products. The views presented in this report are those of the Institute of Medicine Committee to Assess the Science Base for Tobacco Harm Reduction and are not necessarily those of the funding agencies.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.