1. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology A Small Dose of Ethics Uniting Science, Ethics, and Policy to Protect Public Health Steven G. Gilbert, PhD, DABT www.asmalldoseof.org www.toxipedia.org

2. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Child Health

3. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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 Convergence of Issues

4. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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

5. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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

6. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology “Children can develop and mature in an environment that allows them to reach and maintain their full potential.” Vision for Child Health Steven G. Gilbert, 1999

9. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology “Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” Steven G. Gilbert, 1999 Human & Environmental Health

10. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Are we ?? Are we adequately protecting our children and wild life by preventing exposures to harmful agents?

11. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology So Many Chemicals so Little Data 2863 above 1 Million pounds 78.2% no data 21.4% some data 12 or 0.4% good data www.preventingharm.org

12. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology "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) Sir Austin Bradford Hill

13. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 1.Strength of association 2.Consistency of findings 3.Biological gradient 4.Temporal sequence 5.Biologic or theoretical plausibility 6.Coherence with established knowledge 7.Specificity of association Sir Austin Bradford Hill (1965) Determining Causation

14. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology ELSI  Ethical  Legal / Regulatory  Social  Implications or Issues  What is unsaid or missing?  Science  Values  Politics

15. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Socially responsible white guys?

16. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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)

17. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology David Michaels “Doubt is their product – How Industry’s Assault on Science Threatens Your Health” 2008 - Oxford Tobacco, Chromium 6, second hand smoke ….

18. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology "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 The First Bioethicist ---------- 1887 - 1948 ---------- Aldo Leopold

19. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology “An ethic, ecologically, is a limitation on freedom of action in the struggle for existence” Aldo Leopold Limits on Freedom

20. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology “The Commons” The Tragedy of the Commons By Garrett Hardin, Science, 1968

21. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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

22. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Problems – Solutions?  Lead and kids  Fetal alcohol syndrome  Nuclear disarmament  Bioterrorism  Ocean Fisheries  Persistent chemicals  The Commons

23. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Ethics NOT about Morals Ethics are a generalized conceptual frame work for decision making.

24. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Morals Morals are an individual frame work for decision making that includes personal values.

25. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Biomedical Ethics Respect for Autonomy Nonmaleficence Beneficence Justice Beauchamp and Childress, 1994

26. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Respect for Autonomy B&C – a norm of respecting the decision making capacities of autonomous persons –Support decisions of clients –No right or wrong –Optimal use of information –Education –Honesty – tell the facts –(not truth, not right or wrong)

27. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Non-maleficence B&C – a norm of avoiding the causation of harm –Do no harm (the Hippocratic Oath) –Truth telling to avoid harm

28. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Beneficence B&C – a group of norms for providing benefits and balancing benefits against risks and cost –Do good –Golden rule of Christian tradition – do unto others

29. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Justice B&C – a group of norms for distributing benefits, risks and cost fairly –Equal Access –Right to medical care

30. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology “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. Precautionary Principle

31. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology  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) Safety & Efficacy vs Harm

32. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Setting goals (Health indicators) Taking preventive action in the face of uncertainty Shifting the burden of responsibility to the proponents of an activity (Who benefits?) Exploring a wide range of alternatives to possibly harmful actions (Is it necessary?) Increasing public participation in decision making (transparency of information & environmental justice) Central components

33. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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. Values of the precautionary principle

34. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Guiyu, China 2001 Guiyu, China 2001

35. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology

36. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology

37. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Accra, Ghana 2007 Accra, Ghana 2007

38. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology

39. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Available from: www.ban.org The Digital Dump: Exporting Re-use and Abuse to Africa

40. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Basel Convention Adopted March 1989

41. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Basel Convention and Ban stand as Landmark Agreements for Cost Internalization and Environmental Justice

42. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Basel Ban Adopted March 1995

43. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Basel Convention on the Control of Transboundary Movements of Hazardous Waste and their Disposal  March 1989, to 118 nations signing  To date, 170 countries have ratified the treaty.  Not ratified by United States

44. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Conclusion We have the knowledge We recognize our ethical responsibility We can be thoughtful public health advocates Its time for action to protect child health

45. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology The Potential of Children

46. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Ethics and the Precautionary Principle Questions or Comments?

47. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Additional Information  The Science and Environmental Health Network (SEHN) (www.sehn.org)  Late lessons from early warnings: the precautionary principle 1896-2000 – European Environment Agency (free) (http://reports.eea.eu.int/environmental_issue_report_2001_22/en)  Garrett Hardin - The Tragedy of the Commons (Science, 1968)  Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)

48. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 1860’s - Scientific method in medicine, Gregor Mendel 1928 - Penicillin discovered – widely used WWII 1920’s - Lead in gasoline, lead in paint 1931 - 30 states had sterilization laws on books 1932 - Tuskegee syphilis study initiated 1947 - Nuremberg - The Doctors Trial 1952 - First open heart surgery & Chlorpromazine 1953 - Structure of DNA – Watson & Crick Ethics and Science

49. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 60’s - Thalidomide, mercury, chronic hemodialysis, amniocentesis, informed consent, IRB’s 70’s - Hastings Center founded, bioethics defined, Tuskegee noticed, Belmont Report (3 principles), Genentech Inc. founded, awareness of FAS, sensitivity of developing CNS 80’s - Recombinant microorganism could be patented, lead is harmful to developing brain 90’s - molecular biology, sequencing of human genome (other species), Jurassic Park 00’s - US stem cell research restricted 03 - Human cloned? Ethics and Science

50. Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology 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 Knowledge - Responsibility