A Small Dose of Bioethics

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A Small Dose of Bioethics
An Ethical Case for Advocacy and Prevention of
Developmental Disorders
Learning Disabilities Association of America 42nd
International Conference March 2, 2005 Steven G.
Gilbert, PhD, DABT www.asmalldoseof.org LINK
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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

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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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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
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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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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)
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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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Socially responsible white guys?
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Who Pays
Profit Increase Revenue Responsibility to
share holders not society Externalized
costs Children / Society Pay
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Socially Responsibility
What is social responsibility? What are our
responsibilities to society?
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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 ----------
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Limits on Freedom
An ethic, ecologically, is a limitation on
freedom of action in the struggle for
existence Aldo Leopold
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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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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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Hg Current Issues
Recent treaty on global Hg Trade EU wanted legal
binding trade restrictions U.S. voluntary
only Cost of Hg exposure Between 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)
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Lead In Homes
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Agency Blood Lead Levels
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Lead 10 to 2 mcg/dl
CDC should drop blood action level form 10 to 2
mcg/dl. See http//www.wspha.org/wspha_winter_200
5_newsletter.pdf
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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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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
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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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The Commons
The Tragedy of the Commons By Garrett Hardin,
Science, 1968
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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 --------
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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
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Knowledgeable Bioethics
The challenge the knowledge of how to use
knowledge for the social good
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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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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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Purpose/Objectives

• Improve decision making
• Promote integrated assessments
• Promote transparency
• Promote sharing of information
• Examine alternatives
• Examine uncertainties
• Encourage discussion among stake holders

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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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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

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Ethics and the Precautionary Principle
Questions or Comments?
Download Presentation from www.asmalldoseof.org
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Authorship Information
This presentation is supplement to A Small
Dose of Toxicology
For Additional Information Contact Steven G.
Gilbert, PhD, DABT E-mail smdose_at_asmalldoseof.org
Web www.asmalldoseof.org
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Socially Responsible
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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