ethics & prec prin 10/31/08 a small dose of toxicology a small dose of ethics uniting science,...

Ethics & Prec Prin 10/31/08 A Small Dose of Toxicology

A Small Dose of Ethics

Uniting Science, Ethics, and Policy to Protect

Public Health

Steven G. Gilbert, PhD, DABTwww.asmalldoseof.org

www.toxipedia.org


Child Health


• 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


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


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


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


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


“Children can develop and mature in an

environment that allows them to reach and maintain their full

potential.”

Vision for Child Health

Steven G. Gilbert, 1999


“Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” Steven G. Gilbert, 1999

Human & Environmental Health


Are we ??

Are we adequately protecting our children and wild life by preventing exposures to harmful agents?


So Many Chemicals so Little Data

2863 above 1 Million pounds

78.2% no data

21.4% some data

12 or 0.4% good data

www.preventingharm.org


"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


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


ELSI

Ethical Legal / Regulatory Social Implications or Issues What is unsaid or missing? Science Values Politics


Socially responsible white guys?


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)


David Michaels

“Doubt is their product – How Industry’s Assault on Science Threatens Your Health”

2008 - Oxford

Tobacco, Chromium 6, second hand smoke ….


"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


“An ethic, ecologically, is a limitation on freedom of action in the struggle for

existence”Aldo Leopold

Limits on Freedom


“The Commons”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Technical Solutions

“It is our considered professional judgment that

this dilemma has no technical solution.”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Problems – Solutions?

Lead and kids Fetal alcohol syndrome Nuclear disarmament Bioterrorism Ocean Fisheries Persistent chemicals The Commons


Ethics

NOT about Morals

Ethics are a generalized conceptual frame work

for decision making.


Morals

Morals are an individual frame work for decision making that

includes personal values.


Biomedical Ethics

• Respect for Autonomy• Nonmaleficence

• Beneficence• Justice

Beauchamp and Childress, 1994


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)


Non-maleficence

• B&C – a norm of avoiding the causation of harm– Do no harm (the Hippocratic Oath)

– Truth telling to avoid harm


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


Justice

• B&C – a group of norms for distributing benefits, risks and cost fairly– Equal Access

– Right to medical care


“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


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


• Setting goals (Health indicators)• Taking preventive action in the face of

uncertainty• Shifting the burden of responsibility to the

proponents of an activity (Who benefits?)• Exploring a wide range of alternatives to

possibly harmful actions (Is it necessary?)• Increasing public participation in decision

making (transparency of information & environmental justice)

Central components


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


Guiyu, China 2001 Guiyu, China 2001


Accra, Ghana 2007Accra, Ghana 2007


Available from: www.ban.org

The Digital Dump:

Exporting Re-use and Abuse to Africa


Basel Basel ConventioConventionn

Adopted Adopted March March 19891989


Basel Convention and Ban stand as Landmark Agreements for Cost Internalization and Environmental Justice


Basel Ban

Adopted March 1995


Basel Convention on the Control of Transboundary Movements of

Hazardous Waste and their Disposal

March 1989, to 118 nations signingTo date, 170 countries have ratified

the treaty.Not ratified by United States


Conclusion

• We have the knowledge• We recognize our ethical

responsibility• We can be thoughtful public

health advocates• Its time for action to protect child

health


The Potential of Children


Ethics and the Precautionary Principle

Questions or Comments?


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)


1860’s - Scientific method in medicine, Gregor Mendel

1928 - Penicillin discovered – widely used WWII

1920’s - Lead in gasoline, lead in paint

1931 - 30 states had sterilization laws on books

1932 - Tuskegee syphilis study initiated

1947 - Nuremberg - The Doctors Trial

1952 - First open heart surgery & Chlorpromazine

1953 - Structure of DNA – Watson & Crick

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?

Ethics and Science


• 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

ethics & prec prin 10/31/08 a small dose of toxicology a small dose of ethics uniting science,...

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