A Small Dose of Toxicology Ethics & Advocacy 3/2/05
A Small Dose of Bioethics
An Ethical Case for Advocacy and Prevention of Developmental
Disorders
Learning Disabilities Association of America
42nd International ConferenceMarch 2, 2005
Steven G. Gilbert, PhD, DABTwww.asmalldoseof.org LINK
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Child Health
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• 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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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/why_worldgoals.html
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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=0900f3ec8000e044
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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 & Advocacy 3/2/05
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 & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
“Children can develop and mature in an
environment that allows them to reach and maintain their full
potential.”
Vision for Child Health
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
“Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.”
S. Gilbert (1999)
Environmental & Human Health
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Dose Response Issues
• Higher metabolic rate
• Different nutritional requirements
• Rapidly dividing & migrating cells
• Immature organs
Susceptibility of Children
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Socially responsible white guys?
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Who Pays
Profit – Increase Revenue
Responsibility to share holders not society
Externalized costs
Children / Society Pay
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Socially Responsibility
What is social responsibility?
What are our responsibilities to society?
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
"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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
“An ethic, ecologically, is a limitation on freedom of action in the struggle for
existence”Aldo Leopold
Limits on Freedom
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
“The Commons”
The Tragedy of the CommonsBy Garrett Hardin, Science, 1968
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Technical Solutions
“It is our considered professional judgment that
this dilemma has no technical solution.”
The Tragedy of the CommonsBy Garrett Hardin, Science, 1968
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Problems – Solutions?
Lead and kids Fetal alcohol syndrome Nuclear disarmament Bioterrorism Ocean Fisheries Persistent chemicals The Commons
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Case Studies
Thalidomide Methylmercury Lead Ethanol (Alcohol) PBDEs
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Fetal Effects of MeHg
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
The Mercury Cycle
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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.
WA State Advisory
http://www.doh.wa.gov/fish/FishAdvMercury.htm
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Recent treaty on global Hg TradeEU wanted legal binding trade restrictions
U.S. voluntary only
Cost of Hg exposureBetween 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)
Hg – Current Issues
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Lead In Homes
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Agency Blood Lead Levels
40
30
25
20
15
10
0
5
10
15
20
25
30
35
40
Blo
od
Lea
d (
ug
/dl)
CDC1973
CDC1975
CDC1985
WHO1986
EPA1986
CDC1990
Agency and Year
Acceptable Childhood Blood Lead Levels
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Lead 10 to 2 mcg/dl
CDC should drop blood action level form
10 to 2 mcg/dl.
Seehttp://www.wspha.org/
wspha_winter_2005_newsletter.pdf
A Small Dose of Toxicology Ethics & Advocacy 3/2/05FAS Child
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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 & Advocacy 3/2/05
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??
CharacteristicsGrowth deficiency
Learning dysfunctionNervous systems disabilities
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• 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
Policy Approaches
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Structure of PBDEs
X & Y are number of Bromine atomsCommon Penta, Octa, and Deca
PolyBrominated Diphenyl Ether
O
BrxBry
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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 & Advocacy 3/2/05
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 & Advocacy 3/2/05
“The Commons”
The Tragedy of the CommonsBy Garrett Hardin, Science, 1968
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
"Biology combined with diverse humanistic knowledge forging a
science that sets a system of medical and environmental
priorities for acceptable survival.“Global Bioethics (1988)
Bioethics
-------- 1911 - 2001 --------
Van Rensselaer Potter
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
The challenge
To develop an individual and societal ethical framework for
decision making that supports the long term maintenance of a globally
sustainable ecology
Genomic and Ecological Bioethics
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
The challenge
“the knowledge of how to use knowledge for the social
good”
Knowledgeable Bioethics
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
"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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
“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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• 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.
Central components
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Improve decision making Promote integrated assessments Promote transparency Promote sharing of information Examine alternatives Examine uncertainties Encourage discussion among
stake holders
Purpose/Objectives
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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 Initiative
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• 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
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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.
Citizen Toxicologist
Socially Responsible Toxicologist
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Testifying
• Writing review papers
• K-12 class room teaching
• Adding expertise to community groups
• Education
• Mentoring
• Speakers Bureau
Socially Responsible Actions
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• 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
SOT - ESLI Specialty Section
http://www.toxicology.org/memberservices/specsection/specsection.html
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
The Potential of Children
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
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)
Garrett Hardin - The Tragedy of the Commons (Science, 1968)
Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)
Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, in press, 2005
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Ethics and the Precautionary Principle
Questions or Comments?
Download Presentation from www.asmalldoseof.org
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Authorship Information
For Additional Information ContactSteven G. Gilbert, PhD, DABT
E-mail: [email protected]: www.asmalldoseof.org
This presentation is supplement to “A Small Dose of Toxicology”
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Socially Responsible
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
Scientific Process
VariabilityUncertainty
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Statistical
• Model
• Fundamental
Types of Uncertainty
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Easiest to examine & reduce
• Not knowing the exact value of a variable (inter and intra subject variance)
• Sample size
Statistical Uncertainty
Reducing Variability
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Not fully understanding the relations between variables (mechanism of action)
• Which variables are most important (high dose vs low dose)
Model or System Uncertainty
A Small Dose of Toxicology Ethics & Advocacy 3/2/05
• Not knowing the right questions to ask
• Most sensitive end point
• “we don’t know what we don’t know”
Fundamental Uncertainty
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