grand challenge #2: discover, quantify, and reduce environmental risks to health of individuals and...
TRANSCRIPT
GRAND CHALLENGE #2:
Discover, quantify, and reduce environmental risks to health of individuals and
populations
“ I know no safe depository of the ultimate powers of society but the people themselves; if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it away from them, but to inform their discretion.”
- Thomas Jefferson
Presidential/Congressional Commission on Risk Assessment and Risk Management
Risk assessment science & models
Risk-management framework
Communicating uncertainty
Peer review
Inter- and intra-agency consistency
“Bright lines”
Sensitive subpopulations
Ecologic risk assessment
Comparative risk assessment
Economic analysis
Judicial review
Objectives of Risk Assessment1. Balance risks and benefits
Drugs Pesticides
2. Set target levels of riskFood contaminantsWater pollutants
3. Set priorities for program activitiesRegulatory agenciesManufacturersEnvironmental/consumer organizations
4. Estimate residual risks and extent of risk
reduction after steps are taken to reduce risks
Major Hazardous Chemical Laws in the U.S.
EPA: Air Pollutants Clean Air Act 1970, 1977, 1990 Water Pollutants Fed WP Control Act 1972, 1977 Safe Drinking Water Safe DW Act 1974, 1996 Pesticides FIFRA 1972 Food Quality & Protection FQPA, 1996
Ocean Dumping Marine Protection Act, 1995 Toxic Chemicals TSCA 1976 Hazardous Wastes RCRA 1976 Hazardous Waste Cleanup CERCLA (Superfund) 1980,
1986
FDA: Foods, Drugs, Cosmetics FDC Acts, 1906, 1938, 1962, 1977, 1997
CEQ: Envtl Impacts NEPA, 1972
OSHA: Workplace OSH Act, 1970
CPSC: Dangerous Consumer Products CPS Act, 1972
DOT: Transport of Haz Materials THM Act, 1975-79, 1984, 1990
Framework for Regulatory Decision-Making
Epidemiology
Hazard Identification Lifetime rodent bioassays Short-term, in vitro/in vivo
tests Structure / activity
Potency (dose/response)
Risk Characterization Exposure analysis Variation in susceptibility
Information
Risk Reduction Substitution Regulation / Prohibition
Biological End-Points
Cancers
Mutations
Birth defects
Reproductive
toxicity
Immunological toxicity
Neurobehavioral toxicity
Organ-specific effects
Endocrine modulation /
disruption
Ecosystem effects
Context
Multiple sources of same agent
Multiple media/pathways of exposure
Multiple risks/effects of same agent
Multiple agents causing same effects
Public health: status / trends
Ecological health
Social, cultural, environmental justice
considerations
Move beyond one chemical, one environmental medium (air, water, soil, food), one health effect (cancer, birth defect…) at a time in risk assessment and risk management: requires comprehensive public health view
Change the Context
Data Gaps: “Toxic Ignorance”
Only 7% of high production volume
(HPV) chemicals had full set of studies
for 6 basic endpoints, while 43% of
HPV chemicals have no publicly
available studies for any of 6 basic
toxicity endpoints (EPA, 1998) Environmental Defense Fund report
“Toxic Ignorance” and OECD (SIDS)
stimulated new commitments to test
Eco-Genetics
• The interaction of environmental exposures and genetic variation
• Range of susceptibility for specific exposures
• Application of gene and protein expression methods to detect and clarify “molecular signatures” as biomarkers of exposure, early adverse effect, and susceptibility
Reducing risk by orders of magnitude is not equivalent to linear reductions
0
200
400
600
800
1000
1 x 10-3 1 x 10-4 1 x 10-5 1 x 10-6
Level of risk
Risk Commission, Final Report, 1997
GRAND CHALLENGE #3:
Drive progress toward affordable, quality health care.
Figure out what works and what doesn’t, what is safe and what is not, in personal health care and in community public health services.
Risks of Over-interpreting Epidemiological Associations
• Chemoprevention of cancers (and CVD) with beta-carotene and retinoids
Subjected to randomized large-scale prevention trials: no benefit (x7), major adverse effects (x2) with increased incidence of lung cancers and increased mortality from coronary heart disease
Stimulated new generation of lab work.
Risks of Over-interpreting Epidemiological Associations (2)
• Post-menopausal estrogens to prevent CHD, osteoporosis, and breast cancers—the Women’s Health Initiative
Stunning findings of net adverse impact Frustration and anger among women and gynecologists• Trials of high-fiber/low fat diets to prevent
polyp recurrence and colorectal CA—not supported
Positive Examples
• Folic acid: reduces neural tube closure defects (many RCTs) and is associated with lower CHD mortality (via HCy) and lower colorectal cancer incidence
• Statins: may have benefits on CHD mortality beyond cholesterol reduction
• Very low cost “polypill” (Nicholas Wald): beta-blocker, HCTZ, statin, folate, ASA
IOM SERIES ON HEALTH CARE QUALITY
• To Err is Human---Patient Safety
• The Health Care Quality Chasm—
6 attributes of quality care: safe, timely, patient-centered, effective, efficient, equitable
• Leadership by Example: The Role of Government in Enhancing Health Care Quality—policy ramifications of patient-centered care and coverage
Population-based efficacy
“The average patient seeing the average doctor for a typical condition finally has a better than average chance of benefitting from the encounter.”
---L.J. Henderson, 1913
Let’s be sure the odds are still good!
Mobilize to overcome major global health problems
High-quality, low-cost training, kudos to UP “Supercourse”Technological breakthroughs Remember our best example: the Salk vaccine from U Pitt
Gates Fdn/NIH Fdn “Grand Challenges”Varmus, Klausner, Zerhouni, et al, Science 2003;302:398-99
To Improve Childhood Vaccines: #1: Effective single-dose neonatal vaccines #2: Vaccines that do not require refrigeration #3: Needle-free delivery systemsTo Create New Vaccines: #4: Reliable model systems tests to evaluate
live attenuated vaccines #5: More effective antigens #6: Learn which immune responses are protective
To Deplete or Incapacitate Insects that Transmit Agents of Disease:
#7: Genetic strategies
#8: Chemical strategies
To Improve Nutrition to Promote Health:
#9: Optimal bioavailable nutrients in staple plant species
To Improve Drug Rx of Infectious Diseases:
#10: Drugs and delivery systems to minimize resistance
To Cure Latent and Chronic Infections #11: Therapies to cure latent infections #12: Immunological methods to cure chronic infections
To Measure Disease and Health Status Accurately & Economically #13: Technologies for quantitative assessment of health status #14: Point-of-care technologies for individuals with multiple conditions or pathogens
MUCH MORE THAN TECHNOLOGY IS REQUIRED
• Influence of income inequalities• Other causes of health disparities• Need to be alert to identify—and
demonstrate scientifically--unanticipated benefits: the story of Vitamin A in child survival, on top of blindness prevention
• Play a professional role in prevention of violence, from interpersonal to terrorism and war: UP leadership
PRINCIPLES OF COMMUNITY-BASED RESEARCH University of Washington
• Community partners should be involved from the earliest stages• Community partners should have real influence on project• Research processes and outcomes should benefit the community• Community members should be part of the analysis/interpretation• Productive partnerships should last beyond the project• Community members should be empowered to initiate projects
Building Broader Partnerships
• RWJF/WK Kellogg Fdn initiative “Turning Point, a new Century for Public Health”—state and local coalitions
• Take advantage of the Internet
Public Health INFO from CDC
Supercourse from U Pittsburgh GSPH
REMEMBER: Our Most Certain, Major Products are
People
Recognize Schools of Public Health as a national and international treasure!