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

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

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

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.

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.”

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.

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 ….

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

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

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?

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

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

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

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

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

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)

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” Oxford Tobacco, Chromium 6, second hand smoke ….

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 Aldo Leopold

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

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

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

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

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.

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.

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

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)

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

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

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

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, Precautionary Principle

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology Additional Information  The Science and Environmental Health Network (SEHN) (  Late lessons from early warnings: the precautionary principle – European Environment Agency (free) (  Garrett Hardin - The Tragedy of the Commons (Science, 1968)  Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)

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

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

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