Bioethics
Bioethics and the
Precautionary Principle
The Environment and the Health of Populations
(BHLTH497)
University of Washington, Bothell
UW1-020, 2:30-4:30, November 3, 2004
Steven G.Gilbert, PhD, DABT
www.asmalldoseof.org
Bioethics & PP 11/3/04
Child Health
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Convergence of Issues
• Vision of Child Health
• Knowledge of Reproductive and
Developmental Toxicology
• Policy Approach within an
ethical framework
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•
•
•
Social responsibilities
No technical solutions
Restriction of freedoms
Precautionary Principle
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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
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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
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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
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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
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Vision for Child Health
“Children can develop
and mature in an
environment that allows
them to reach and
maintain their full
potential.”
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Vision of Environmental Health
“Conditions that ensure that all
living things have the best
opportunity to reach and maintain
their full genetic potential.”
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Susceptibility of Children
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•
•
•
•
Dose Response Issues
Higher metabolic rate
Different nutritional requirements
Rapidly dividing & migrating cells
Immature organs
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Sequence of Human Development
Central Nervous System
Heart
Ears
Eyes
Limbs
Palate
External Genetalia
1
2
Implantation
Prenatal
Death
3
4
5
6
7
8
12
16
20
38
Emryonic period
Fetal Period
Major Morphological abnormalities
Physiological and Functional
Defects
Red - most sensitive, Gray - Less
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Ancient Awareness
 Many ancient cultures had fertility goddess
 Many ancient documentation of
malformations
 Malformations rich aspect of mythology
 6500 BC – Turkey - figurine of conjoined
twins
 4000-5000 BC – Australia drawings of twins
 2000 BC - Tablet of Nineveh – describes 62
malformations and predicts the future
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Historical Awareness
 15th-16th centuries malformations caused
by the devil, mother and child killed
 1830’s - Etienne Geoffroy Saint-Hilaire
experimented with chicken eggs
 1900’s began acceptance of
malformations related to genetics
 1940’s - Josef Warkany – environmental
factors affect rat development
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Historical Events
 1941 – Human malformations linked
to rubella virus
 1960’s – Thalidomide (a sedative and
anti-nausea drug) found to cause
human malformations
 1950’s – Methylmercury recognized as
developmental toxicant
 1970’s – Alcohol related to
developmental effects – Fetal Alcohol
Syndrome (FAS)
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Case Studies
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Thalidomide
Methylmercury
Lead
Ethanol (Alcohol)
PBDEs
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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
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Fetal Effects of MeHg
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The Mercury Cycle
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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
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Lead In Homes
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Agency Blood Lead Levels
Blood Lead (ug/dl)
Acceptable Childhood Blood Lead Levels
40
35
40
30
30
25
25
20
20
15
15
10
10
5
0
CDC
1973
CDC
1975
CDC
1985
WHO
1986
EPA
1986
CDC
1990
Agency and Year
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FAS Child
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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??
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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
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Structure of PBDEs
PolyBrominated Diphenyl Ether
O
Brx
Br
y
X & Y are number of Bromine atoms
Common Penta, Octa, and Deca
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PBDEs in House Dust (ppb)
From EWG - Toxic Fire Retardants Contaminate American Homes - http://www.ewg.org/reports/inthedust/summary.php
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PBDEs in Breast Milk (ppb)
From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http://www.ewg.org/reports/mothersmilk/es.php
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Question??
Who were the most influential people
of the past century?
James Watson (L)
and Francis Crick
(R), and the model
they built of the
structure of DNA
(and Rosalind
Franklin).
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Stem Cell History
1998 - Researchers first extract stem cells from human
embryos
1999 - First Successful human transplant of insulin-making
cells from cadavers
2001 - President Bush restricts federal funding for
embryonic stem-cell research
2002 - Juvenile Diabetes Research Foundation
International creates $20 million fund-raising effort
to support stem-cell research
2003?? - California ok stem cell research
2004 - Harvard researchers grow stem cells from embryos
using private funding
2004 - Ballot measure for $3 Billion bond for stem cells
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Importance
 Disease
• Diabetes, Spinal
cord injury,
Parkinson’s
disease, heart
disease
 Genetic based
Disease
• Cystic fibrosis,
Huntington’s
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DNA – T-A C-G
Thymine (T)
Cytosine (C)
Adenine (A)
Guanine (G)
Over 3 billion base pairs, 30,000 genes
Humans are over 99.9% identical
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Parents to Children
Mother & Father both Carriers
Children?
1 – Not a carrier (25%)
2 – Carrier (50%)
1 – With CF (25%)
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Human Clones?
Are there human clones?
Yes – Identical Twins
(Time 2.19.01)
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Coning for use in Stem Cells
Cloning techniques for
creating stem cells
Therapeutic cloning
Reproductive cloning
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IVF – In Vitro Fertilization
 Available since 1986
 About 100,000 IVF kids in U.S.
 Often creates extra embryos
 U.S. - About 400,000 frozen
embryos (unregulated)
 England – 52,000 (regulated by
government)
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Genetically Modified Products
• Bent Grass – Genetically modified
to be herbicide resistant
• Corn
• Cotton
• Soy Beans
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Socially responsible white guys?
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Scientific Process
Variability
Uncertainty
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Types of Uncertainty
• Statistical
• Model
• Fundamental
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Statistical Uncertainty
Reducing Variability
• Easiest to examine & reduce
• Not knowing the exact value
of a variable (inter and intra
subject variance)
• Sample size
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Model or System Uncertainty
• Not fully understanding the
relations between variables
(mechanism of action)
• Which variables are most
important (high dose vs low
dose)
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Fundamental Uncertainty
• Not knowing the right
questions to ask
• Most sensitive end point
• “we don’t know what we
don’t know”
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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)
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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)
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Ethics and Science
1860’s
1928
1920’s
1931
1932
1947
1952
1953
- Scientific method in medicine, Gregor Mendel
- Penicillin discovered – widely used WWII
- Lead in gasoline, lead in paint
- 30 states had sterilization laws on books
- Tuskegee syphilis study initiated
- Nuremberg - The Doctors Trial
- First open heart surgery & Chlorpromazine
- Structure of DNA – Watson & Crick
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Ethics and Science
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?
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ELSI
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Ethical
Legal / Regulatory
Social
Implications or Issues
What is unsaid or missing?
Science
Values
Politics
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“The Commons”
The Tragedy of the Commons
By Garrett Hardin, Science, 1968
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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
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Problems – Solutions?
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Lead and kids
Fetal alcohol syndrome
Nuclear disarmament
Bioterrorism
Ocean Fisheries
Persistent chemicals
The Commons
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Bentham
“the greatest good for the
greatest number”
Utilitarianism
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Good?
“We want the maximum
good per person – but
what is good?”
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Adam Smith
The Wealth of Nations - 1776
“the invisible hand”
“an individual who intends
only his own gain is led by an
invisible hand to promote …
the public interest”
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The Commons
Cattle
Farmers
Return on Investment
Return for me
Not the commons
Society suffers
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Morality?
“The morality of an act is a
function of the state of the
system at the time it is
performed”
You can pick one flower but
not the whole class
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Legislate Morality?
Prohibition – easy to make a
law banning alcohol (drugs)
but how to enforce
Who to legislate temperance
(moderation) – no drugs?
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Population?
Who makes people?
Group encourage
reproduction to increase
numbers – Ethical?
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Coercion?
How to influence
Robbing banks?
Bank as a common.
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Freedom?
Hegel –
“Freedom is the
recognition of necessity”
Restriction of Freedom?
The Managed Commons?
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Ethical Issues
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•
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•
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Use of stem cells
Cloning
Genetic engineering
Privacy
Genetic Knowledge
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Truth?
“It is not the truth that makes you
free. It is your possession of the
power to discover the truth. Our
dilemma is that we do not know
how to provide that power.”
Richard Lewontin
(New York Review of Books, Jan 7, 1997)
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Bioscience Ethics - Defined
An ethical approach to
environmental and biological
health and well-being
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Society
•
•
•
•
•
•
Individuals
Government
Corporations
All kinds of Associations
Local to Global
Givers and Receivers
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Influence
Society
Individual
Individual
Society
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Ethics
Ethics are a generalized
conceptual frame work
for decision making.
NOT about Morals
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Morals
Morals are an individual frame
work for decision making that
includes personal values.
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Biomedical Ethics
• Respect for Autonomy
• Nonmaleficence
• Beneficence
• Justice
Beauchamp and Childress, 1994
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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)
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Non-maleficence
• B&C – a norm of avoiding the
causation of harm
– Do no harm (the Hippocratic Oath)
– Truth telling to avoid harm
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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
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Justice
• B&C – a group of norms for
distributing benefits, risks
and cost fairly
– Equal Access
– Right to medical care
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Medical Ethics Evolution
• 1803 Thomas Percival – doctrine
of medical ethics – basis for
American Medical Association
first code of ethics 1947
– That nonmaleficence and beneficence
trump the patient’s (client’s) preference
and rights in any circumstance of
serious conflict
– Lack of respect of autonomy and
distributed justice
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BioScience Ethics
Respect for
Bodily Integrity
Veracity
Sustainability
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Veracity
Veracity implies an adherence
to fact and accuracy - an effort
to be precise in conveying
information.
Not Truth
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Bodily Integrity
Respect for individual’s
physical self
• Express their full genetic potential
• Implies - Respect for knowledge
about & decision making
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Sustainability
Is the action repeatable?
Can 1, 10 or 1 million pick
the flower?
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Bioscience Ethics Advantages
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•
•
•
Equal for care giver and care receiver
Shared responsibility for outcome
Simple and not paternalistic
Common grounds for discussion and
decision making
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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.
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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)
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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.
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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.
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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.
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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
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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.
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Socially Responsible Actions
• Testifying
• Writing review papers
• K-12 class room
teaching
• Adding expertise to
community groups
• Education
• Mentoring
• Speakers Bureau
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SOT - ESLI 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/specsection.html
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The Potential of Children
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Bioethics and the Precautionary Principle
Questions or Comments?
Download Presentation from
www.asmalldoseof.org
Bioethics & PP 11/3/04
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)
Bioethics & PP 11/3/04
Authorship Information
Steven G. Gilbert, PhD, DABT
Director, INND
8232 14th Ave NE Seattle, WA
Ph: 206.527.0926
Fx: 206.525.5102
E-mail: sgilbert@innd.org
www.asmalldoseof.org
Bioethics & PP 11/3/04