Bioethics and the Precautionary Principle

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Bioethics and the Precautionary Principle
Bioethics
The Environment and the Health of Populations
(BHLTH497) University of Washington, Bothell
UW1-020, 230-430, November 3, 2004 Steven
G.Gilbert, PhD, DABT www.asmalldoseof.org
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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
• 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?id0900f3ec8000e044
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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

• Dose Response Issues
• Higher metabolic rate
• Different nutritional requirements
• Rapidly dividing migrating cells
• Immature organs

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Sequence of Human Development
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
• 1830s - Etienne Geoffroy Saint-Hilaire
  experimented with chicken eggs
• 1900s began acceptance of malformations related
  to genetics
• 1940s - Josef Warkany environmental factors
  affect rat development

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Historical Events

• 1941 Human malformations linked to rubella
  virus
• 1960s Thalidomide (a sedative and anti-nausea
  drug) found to cause human malformations
• 1950s Methylmercury recognized as
  developmental toxicant
• 1970s Alcohol related to developmental effects
  Fetal Alcohol Syndrome (FAS)

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Case Studies

• 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
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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
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/inthed
ust/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, Parkinsons
  disease, heart disease
• Genetic based Disease
• Cystic fibrosis, Huntingtons

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DNA T-A C-G
Thymine (T) Adenine (A) Cytosine (C)
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 dont know what we dont 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

• 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

• 1860s - Scientific method in medicine, Gregor
  Mendel
• - Penicillin discovered widely used WWII
• 1920s - 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
60s - Thalidomide, mercury, chronic
hemodialysis, amniocentesis, informed consent,
IRBs 70s - Hastings Center founded, bioethics
defined, Tuskegee noticed, Belmont Report (3
principles), Genentech Inc. founded, awareness of
FAS, sensitivity of developing CNS 80s -
Recombinant microorganism could be patented, lead
is harmful to developing brain 90s - molecular
biology, sequencing of human genome (other
species), Jurassic Park 00s - US stem cell
research restricted 03 - Human cloned?
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ELSI

• 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?

• 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

• 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

• BC 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

• BC a norm of avoiding the causation of harm
• Do no harm (the Hippocratic Oath)
• Truth telling to avoid harm

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Beneficence

• BC 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

• BC 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
  patients (clients) 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 individuals 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

• 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 - governments 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/specsecti
on/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
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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_issu
  e_report_2001_22/en)
• Garrett Hardin - The Tragedy of the Commons
  (Science, 1968)
• Ethics and Environmental Health Mini Monograph
  - Environmental Health Perspectives (November
  2003)

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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_at_innd.org www.asmalld
oseof.org