A Small Dose of Bioethics Toxicology Human Health
A Small Dose of Bioethics Toxicology, Human Health, and The Precautionary Principle Department of Environmental and Occupational Health Sciences May 26, 2005 Steven G. Gilbert, Ph. D, DABT www. asmalldoseof. org LINK A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
A Small Dose of Toxicology See: www. asmalldoseof. org -- smdose A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
NW Public Health and the Precautionary Principle By Steven G. Gilbert See: http: //healthlinks. washington. edu/nwcphp/nph/ nwph A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Current Bioethical Issues Ø Ø Ø Ø Ø 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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Child Health A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Vision for Child Health “Children can develop and mature in an environment that allows them to reach and maintain their full potential. ” A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Socially responsible white guys? A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Socially Responsibility What is social responsibility? What are our responsibilities to society? A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 -----A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Limits on Freedom “An ethic, ecologically, is a limitation on freedom of action in the struggle for existence” Aldo Leopold A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
“The Commons” The Tragedy of the Commons By Garrett Hardin, Science, 1968 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Problems – Solutions? Ø Ø Ø Ø A Small Dose of Toxicology Lead and kids Fetal alcohol syndrome Nuclear disarmament Bioterrorism Ocean Fisheries Persistent chemicals The Commons Ethics & Prec Prin 05/26/05
Lessons Learned Ø Ø Ø A Small Dose of Toxicology Thalidomide Methylmercury Lead Ethanol (Alcohol) PBDEs Ethics & Prec Prin 05/26/05
Thalidomide Ø Introduced in 1956 as sedative (sleeping pill) and to reduce nausea and vomiting during pregnancy Ø Withdrawn in 1961 Ø Discovered to be a human teratogen causing absence of limbs or limb malformations in newborns Ø 5000 to 7000 infants effected Ø Resulted in new drug testing rules A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Fetal Effects of Me. Hg A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
The Mercury Cycle A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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/Fish. Adv. Mercury. htm A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Lead In Homes A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Agency Blood Lead Levels A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Small Dose of Toxicology FASAChild Ethics & Prec Prin 05/26/05
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? ? A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Structure of PBDEs Poly. Brominated Diphenyl Ether O Brx Bry X & Y are number of Bromine atoms Common Penta, Octa, and Deca A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
PBDEs in House Dust (ppb) From EWG - Toxic Fire Retardants Contaminate American Homes - http: //www. ewg. org/reports/inthedust/summary. php A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
PBDEs in Breast Milk (ppb) From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http: //www. ewg. org/reports/mothersmilk/es. php A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Developmental Data 2863 above 1 Million pounds 12 or 0. 4% good data 21. 4% some data 78. 2% no data www. preventingharm. org A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
The Consequences Ø Nearly 12 million children (17%) under age 18 in the US suffer from one or more developmental disabilities Ø Learning disabilities – 5 -10% of kids in public school Ø ADHD – 3 -6% of all school kids, maybe higher A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Knowledgeable Bioethics The challenge “the knowledge of how to use knowledge for the social good” A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Determining Causation 1. 2. 3. 4. 5. 6. 7. 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) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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. A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Safety & Efficacy vs Harm Ø FDA regulations of Drugs (1938) Ø FDA regulations of Dietary Supplements (Dietary Supplement Health and Education Act of 1994 (DSHEA)) Ø Ephedra present an unreasonable risk of illness or injury (Dec, 2003) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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. A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Purpose/Objectives Ø Improve decision making Ø Promote integrated assessments Ø Promote transparency Ø Promote sharing of information Ø Examine alternatives Ø Examine uncertainties Ø Encourage discussion among stake holders A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 PP working group A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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_Compr ehensive_Plan/DPD_001178. asp) Link A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
WSPHA Resolution “Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making” Resolution Submitted to Washington State Public Health Association A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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. A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Socially Responsible Actions • Testifying • Writing review papers • K-12 class room teaching • Adding expertise to community groups • Education • Mentoring • Speakers Bureau A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
SOT - ELSI Specialty Section • Forum in which to discuss the ethical implications of results from our science as well as the resulting legal and social implications. • 2005 SOT meeting – workshop on Conflict of Interest http: //www. toxicology. org/memberservices/specsection. html A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
The Potential of Children A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Additional Information Ø The Science and Environmental Health Network (SEHN) (www. sehn. org) Ø Late lessons from early warnings: the precautionary principle 1896 -2000 – European Environment Agency (free) Ø Garrett Hardin - The Tragedy of the Commons (Science, 1968) Ø Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003) Ø Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, in press, 2005 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Ethics and the Precautionary Principle Questions or Comments? Download Presentation from www. asmalldoseof. org A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Authorship Information This presentation is supplement to “A Small Dose of Toxicology” For Additional Information Contact Steven G. Gilbert, Ph. D, DABT E-mail: smdose@asmalldoseof. org Web: www. asmalldoseof. org A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Socially Responsible A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Scientific Process Variability Uncertainty A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Types of Uncertainty • Statistical • Model • Fundamental A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Statistical Uncertainty Reducing Variability • Easiest to examine & reduce • Not knowing the exact value of a variable (inter and intra subject variance) • Sample size A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Model or System Uncertainty • Not fully understanding the relations between variables (mechanism of action) • Which variables are most important (high dose vs low dose) A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Fundamental Uncertainty • Not knowing the right questions to ask • Most sensitive end point • “we don’t know what we don’t know” A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
Susceptibility of Children • • • Dose Response Issues Higher metabolic rate Different nutritional requirements Rapidly dividing & migrating cells Immature organs A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 -------A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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_worldgoals. html A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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=0900 f 3 ec 8000 e 044 A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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. A Small Dose of Toxicology Ethics & Prec Prin 05/26/05
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