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  1. Advocacy, Ethics, & PP Advocacy, Ethics, and the Precautionary Principle NAHMMA's 2005 Conference September 18-23, 2005 Tacoma, Washington Steven G. Gilbert, PhD, DABT www.asmalldoseof.org LINK

  2. NW Public Health Public Health and the Precautionary Principle By Steven G. Gilbert See: http://healthlinks.washington.edu/nwcphp/nph/ nwph

  3. Child Health

  4. Doubt / Uncertainty "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public.“ 1969 an executive at Brown & Williamson owned by R. J. Reynolds Tobacco Company (Doubt Is Their Product by David Michaels in Scientific American, June 15, 2005)

  5. Convergence of Issues • Vision of Child Health • Knowledge of Reproductive and Developmental Toxicology • Policy Approach within an ethical framework • Social responsibilities • No technical solutions • Restriction of freedoms • Precautionary Principle

  6. American Academy of Pediatrics Mission and vision To attain optimal physical, mental and social health and well-being for all infants, children, adolescents and young adults. http://www.aap.org/member/memcore.htm

  7. American Academy of Pediatrics The APA goes on to state: “To this purpose, the AAP and its members dedicate their efforts and resources. The vision: 1) to advocate for infants, children, adolescents, and young adults and provide for their care; 2) to collaborate with others to assure child health; and …. http://www.aap.org/member/memcore.htm

  8. Environmental & Human Health “Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” S. Gilbert (1999)

  9. Ecological Bioethics The challenge To develop an individual and societal ethical framework for decision making that supports the long term maintenance of a globally sustainable ecology

  10. Socially responsible white guys?

  11. Sir Austin Bradford Hill "All scientific work is incomplete - whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or postpone the action that it appears to demand at a given time. " Sir Austin Bradford Hill (1965)

  12. Determining Causation • Strength of association • Consistency of findings • Biological gradient • Temporal sequence • Biologic or theoretical plausibility • Coherence with established knowledge • Specificity of association • Sir Austin Bradford Hill (1965)

  13. Types of Uncertainty • Statistical • Model • Fundamental

  14. Statistical Uncertainty Reducing Variability • Easiest to examine & reduce • Not knowing the exact value of a variable (inter and intra subject variance) • Sample size

  15. Model or System Uncertainty • Not fully understanding the relations between variables (mechanism of action) • Which variables are most important (high dose vs low dose)

  16. Fundamental Uncertainty • Not knowing the right questions to ask • Most sensitive end point • “we don’t know what we don’t know”

  17. Lead In Homes

  18. Lead in Families

  19. Ancient Awareness "Lead makes the mind give way." Greek Dioscerides - 2nd BC

  20. Lead Based Paint Products

  21. Lead Based Paint 1887 - US medical authorities diagnose childhood lead poisoning 1904 - Child lead poisoning linked to lead-based paints 1909 - France, Belgium and Austria ban white-lead interior paint 1914- Pediatric lead-paint poisoning death from eating crib paint is described 1921 - National Lead Company admits lead is a poison 1922 - League of Nations bans white-lead interior paint; US declines to adopt 1943- Report concludes eating lead paint chips causes physical and neurological disorders, behavior, learning and intelligence problems in children 1971- Lead-Based Paint Poisoning Prevention Act passed

  22. Lead Industry Advertisements History of Lead Industry Advertisements (LINK) http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm

  23. Agency Blood Lead Levels

  24. Lead in Jewelry California Suing Major Retailers Over Lead in Jewelry Allegations California is suing 13 major retailers alleging they broke state law by not warning customers that some of their jewelry contains lead. Private lawsuits containing similar allegations have been filed against a further 11 retailers. Named in the state's suit were Macy's, Target, Wal-Mart, Kmart, J.C. Penney, Mervyn's, Nordstrom, Ross, Sears, Express, Claire's, Toys "R" Us and Burlington Coat Factory, along with some of their affiliates and parent companies, according to The San Jose Mercury News. (June 24, 2004)

  25. Lead in Jewelry http://www.leadinspector.com/

  26. Children & Candy & Lead Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)

  27. WA State Guidelines The Washington State Department of Health advises consumers not to eat candy from Mexico or southeast Asia that contains tamarind or chili powder. (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm) California also has documented lead in candy. See the Orange County Register series on lead in candy: http://www.ocregister.com/investigations/2004/lead/index.shtml

  28. Lead in WA Candy Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)

  29. Lead in Pottery – Action Levels • US Food and Drug Administration (FDA) action levels for the lead content of the leachate: • Cups, mugs, and pitchers: 0.5 ppm • Large hollowware (serving dishes): 1 ppm • Small hollowware (bowls): 2 ppm • Plates, saucers, and other flatware: 3 ppm

  30. Lead in WA Pottery Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)

  31. Pottery with Lead Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)

  32. Lead & Lunchboxes The Center for Environmental Health (CEH) http://www.cehca.org/lunchboxes.htm

  33. Lead In Ethnic Remedies

  34. Policy Implications Drinking water in Seattle Schools

  35. Children in WA State Blood Lead No. % (mcg/dL) 0-1 9,569 55.3 2-4 6,431 37.2 5-9 1,103 6.4 10-19 167 1.0 20+ 26 0.15 Children 0-6 tested in 2002-2004 WA State DOH

  36. Children with >10 mcg/dL In 1999 and 2000, 2.2% of children 1-5 year age had lead levels that were above 10 mcg/dL. Approximately 20 million children under age 5, thus about 440,000 children in the US have blood lead levels above 10 mcg/dL. From CDC

  37. A Small Dose of …. Health Effects (< 10 mcg/dL)

  38. Needleman, NEJM, 1979

  39. Consequences for Society (Slide from B. Weiss)

  40. Lead-associated Reading Deficits in U.S. Children Reading Score Blood lead levels (g/dl) Lanphear BP, et al. Public Health Reports 2000;115:521-529. (BL’s slide)

  41. IQ and Blood Lead • Life time overall • Increase in 1 mcg/dl = 0.87 IQ drop • Covariates - 1 mcg/dl = 0.46 IQ drop • 1 to 10 mcg/dl (bigger drop) • Increase in 1 mcg/dl = 1.37 IQ drop • Non-linear - 1 mcg/dl = 7.4 IQ drop Canfield R, et al. NEJM 2003;348:1517-1526

  42. IQ and Blood Lead Canfield R, et al. NEJM 2003;348:1517-1526. (slide from BL)

  43. Knowledgeable Bioethics The challenge “the knowledge of how to use knowledge for the social good”

  44. Precautionary Principle “When an activity raises threats of harm to human health or the environment, precautionary measures should be take even if some cause and effect relationships are not fully established scientifically.” Wingspread Conference, 1998.

  45. Safety & Efficacy vs Harm • FDA regulations of Drugs (1938) • FDA regulations of Dietary Supplements (Dietary Supplement Health and Education Act of 1994 (DSHEA)) • Ephedra present an unreasonable risk of illness or injury (Dec, 2003)

  46. Central components • Taking preventive action in the face of uncertainty • Shifting the burden of proof/responsibility to the proponents of an activity • Exploring a wide range of alternatives to possibly harmful actions • Increasing public participation in decision making (environmental justice) • Wingspread Conference, 1998.

  47. Seattle Initiative • City Comprehensive Plans • Every citizen of Seattle has an equal right to a healthy and safe environment. • Seattle sees the Precautionary Principle approach as its policy framework to develop laws for a healthier and more just Seattle. • Seattle PP working group

  48. Result of Effort • Seattle Precautionary Principle White Paper (www.asmalldoseof.org) • Inclusion of PP in Comp Plan Environment Element • (http://www.seattle.gov/dpd/Planning/Seattle's_Comprehensive_Plan/DPD_001178.asp) Link

  49. WSPHA Resolution “Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making” Resolution Submitted to Washington State Public Health Association

  50. States in the US • California • San Francisco Precautionary Purchasing Ordinance - June 2005 • Resolution of the Marin county board of supervisors • “A resolution to continue to incorporate the precautionary principle in county operations.” Oct 2004 • Oregon • Multnomah County, OR Resolution - September 2004 • New York State Legislation - April 2005 • Bill A07256 “To protect public health and the environment by establishing a precautionary policy for state and local governments in New York State.” • Bill A07257 “To establish a preference for the purchase of commodities, services, and technologies by the State of New York that minimize potential adverse impacts on public health and the environment.”