A Small Dose of Bioethics

1. A Small Dose of Bioethics An Ethical Case for Advocacy and Prevention of Developmental Disorders Learning Disabilities Association of America 42nd International Conference March 2, 2005 Steven G. Gilbert, PhD, DABT www.asmalldoseof.org LINK

2. Current Bioethical Issues • Check the local news paper • Stem cells (state, national, international) • Genetically Engineered Organisms • Knowing your genes • In vetro fertilization – choosing your child's genes and characteristics • Global warming • Nanotechnology • Environmental health • Chemicals exposures – human health

3. Child Health

4. 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

5. WHO Vision for Child Health • A World Fit for Children • Promoting healthy lives • Providing quality education • Protecting against abuse, exploitation and violence • Combating HIV/AIDS. http://www.unicef.org/why/why_worldgoals.html

6. CDC Vision for Child Health “Environmental Health at CDC strives to promote health and quality of life by preventing or controlling those diseases or deaths that result from interactions between people and their environment.” http://www.cdc.gov/node.do?id=0900f3ec8000e044

7. 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

8. 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

9. Learning Disabilities Association The LDA Mission: LDA is dedicated to identifying causes and promoting prevention of learning disabilities and to enhancing the quality of life for all individuals with learning disabilities and their families by encouraging effective identification and intervention, fostering research, and protecting their rights under the law. LDA seeks to accomplish this through awareness, advocacy, empowerment, education, service and collaborative efforts. http://www.ldanatl.org/about/mission.asp

10. Vision for Child Health “Children can develop and mature in an environment that allows them to reach and maintain their full potential.”

11. 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)

12. Susceptibility of Children • Dose Response Issues • Higher metabolic rate • Different nutritional requirements • Rapidly dividing & migrating cells • Immature organs

13. Socially responsible white guys?

14. Who Pays Profit – Increase Revenue Responsibility to share holders not society Externalized costs Children / Society Pay

15. Socially Responsibility What is social responsibility? What are our responsibilities to society?

16. The First Bioethicist Aldo Leopold "A thing is right when it tends to preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise." - Aldo Leopold, 1949, A Sand County Almanac ---------- 1887 - 1948 ----------

17. Limits on Freedom “An ethic, ecologically, is a limitation on freedom of action in the struggle for existence” Aldo Leopold

18. “The Commons” The Tragedy of the Commons By Garrett Hardin, Science, 1968

19. Technical Solutions “It is our considered professional judgment that this dilemma has no technical solution.” The Tragedy of the Commons By Garrett Hardin, Science, 1968

20. Problems – Solutions? • Lead and kids • Fetal alcohol syndrome • Nuclear disarmament • Bioterrorism • Ocean Fisheries • Persistent chemicals • The Commons

21. Case Studies • Thalidomide • Methylmercury • Lead • Ethanol (Alcohol) • PBDEs

22. Thalidomide • Introduced in 1956 as sedative (sleeping pill) and to reduce nausea and vomiting during pregnancy • Withdrawn in 1961 • Discovered to be a human teratogen causing absence of limbs or limb malformations in newborns • 5000 to 7000 infants effected • Resulted in new drug testing rules

23. Fetal Effects of MeHg

24. The Mercury Cycle

25. WA State Advisory Limit the amount of canned tuna you eat, based on your bodyweight. Guidelines are: Women of childbearing age should limit the amount of canned tuna they eat to about one can per week (six ounces.) A woman who weighs less than 135 pounds should eat less than one can of tuna per week. Children under six should eat less than one half a can of tuna (three ounces) per week. Specific weekly limits for children under six range from one ounce for a twenty pound child, to three ounces for a child weighing about sixty pounds. http://www.doh.wa.gov/fish/FishAdvMercury.htm

26. Hg – Current Issues Recent treaty on global Hg Trade EU wanted legal binding trade restrictions U.S. voluntary only Cost of Hg exposure Between 316,588 and 637,233 children cord blood Hg levels greater than 5.8 mcg/L – associated with IQ loss Lost productivity $8.7 Billion $1.3 Billion related to power plant emissions (Trasande et al. EHP 2005)

27. Lead In Homes

28. Agency Blood Lead Levels

29. Lead 10 to 2 mcg/dl CDC should drop blood action level form 10 to 2 mcg/dl. See http://www.wspha.org/wspha_winter_2005_newsletter.pdf

30. FAS Child

31. FAS & FAE Most common preventable cause of adverse CNS development Fetal Alcohol Syndrome (FAS) 4,000-12,000 infants per year in US Fetal Alcohol Effect (FAE) 7,000-36,000 infants per year in US 1 to 3 infants per 1,000 world wide??

32. Fetal Alcohol Effect (FAE) Milder form of FAS 7,000-36,000 infants per year in US 1 to 3 infants per 1,000 world wide?? Characteristics Growth deficiency Learning dysfunction Nervous systems disabilities

33. Policy Approaches • 1981 - U.S. Surgeon General first advised that women should not drink alcoholic beverages during pregnancy. • 1988 - U.S. requires warning labels on all alcoholic beverages sold in the United States. • 1990 - U.S. Dietary Guidelines state that women who are pregnant or planning to become pregnant should not drink alcohol. • 1998 - 19 states require the posting of alcohol health warning signs where alcoholic beverages are sold

34. Structure of PBDEs O Bry Brx PolyBrominated Diphenyl Ether X & Y are number of Bromine atoms Common Penta, Octa, and Deca

35. PBDEs in House Dust (ppb) From EWG - Toxic Fire Retardants Contaminate American Homes - http://www.ewg.org/reports/inthedust/summary.php

36. PBDEs in Breast Milk (ppb) From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http://www.ewg.org/reports/mothersmilk/es.php

37. “The Commons” The Tragedy of the Commons By Garrett Hardin, Science, 1968

38. Bioethics Van Rensselaer Potter "Biology combined with diverse humanistic knowledge forging a science that sets a system of medical and environmental priorities for acceptable survival.“ Global Bioethics (1988) -------- 1911 - 2001 --------

39. Genomic and 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

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

41. 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)

42. 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)

43. 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.

44. 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)

45. 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 • Wingspread Conference, 1998.

46. Values of the precautionary principle 1) Respect - for the needs and rights of this and future generations as well as others who cannot speak for themselves 2) Humility - towards the natural world and our ability to understand it through science 3) Democracy - giving people a voice in matters that affect their lives 4) Responsibility - government’s public trust responsibility to manage the commonwealth for this and future generations. - Individuals’ including industry, obligation to take responsibility for their actions in the world.

47. Purpose/Objectives • Improve decision making • Promote integrated assessments • Promote transparency • Promote sharing of information • Examine alternatives • Examine uncertainties • Encourage discussion among stake holders

48. 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.

49. Knowledge - Responsibility • Children have a right to a safe, fair and healthy environment • Ethical Responsibility to share and use of knowledge • Duty to promote health and well being of children • Thoughtful public health advocate

50. Citizen Toxicologist Socially Responsible Toxicologist The citizen toxicologist is a thoughtful advocate for human and environmental health, who strives to share their scientific knowledge with the public, speaking to public interests rather than private or special interests.