Advocacy, Ethics, & PP

A Small Dose of Toxicology NAHMMA – Advocacy.PP 9/22/05

Advocacy, Ethics, & PP

Advocacy, Ethics, and the Precautionary Principle

NAHMMA's 2005 ConferenceSeptember 18-23, 2005Tacoma, Washington

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


NW Public Health

See: http://healthlinks.washington.edu/nwcphp/nph/

nwph

Public Health and the Precautionary

Principle

By Steven G. Gilbert


Child Health


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)


• 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


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


“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


The challenge

To develop an individual and societal ethical framework for

decision making that supports the long term maintenance of a globally

sustainable ecology

Ecological Bioethics


Socially responsible white guys?


"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


• Statistical

• Model

• Fundamental

Types of Uncertainty


• Easiest to examine & reduce

• Not knowing the exact value of a variable (inter and intra subject variance)

• Sample size

Statistical Uncertainty

Reducing Variability


• Not fully understanding the relations between variables (mechanism of action)

• Which variables are most important (high dose vs low dose)

Model or System Uncertainty


• Not knowing the right questions to ask

• Most sensitive end point

• “we don’t know what we don’t know”

Fundamental Uncertainty


Lead In Homes


Lead in Families


"Lead makes the mind give way."

Ancient Awareness

GreekDioscerides - 2nd BC


Lead Based Paint Products


Lead Based Paint

1887 - US medical authorities diagnose childhood lead poisoning

1904 - Child lead poisoning linked to lead-based paints

1909 - France, Belgium and Austria ban white-lead interior paint

1914- Pediatric lead-paint poisoning death from eating crib paint is described

1921 - National Lead Company admits lead is a poison

1922 - League of Nations bans white-lead interior paint; US declines to adopt

1943- Report concludes eating lead paint chips causes physical and neurological disorders, behavior, learning and intelligence problems in children

1971- Lead-Based Paint Poisoning Prevention Act passed


Lead Industry Advertisements

http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm

History of Lead Industry Advertisements (LINK)

http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm


Agency Blood Lead Levels

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CDC1960

CDC1973

CDC1975

CDC1985

WHO1986

EPA1986

CDC1990

CDC2006?

Agency and Year

Acceptable Childhood Blood Lead Levels


California Suing Major Retailers Over Lead in Jewelry Allegations

California is suing 13 major retailers alleging they broke state law by not warning customers that some of their jewelry contains lead. Private lawsuits containing similar allegations have been filed against a further 11 retailers.

Named in the state's suit were Macy's, Target, Wal-Mart, Kmart, J.C. Penney, Mervyn's, Nordstrom, Ross, Sears, Express, Claire's, Toys "R" Us and Burlington Coat Factory, along with some of their affiliates and parent companies, according to The San Jose Mercury News. (June 24, 2004)

Lead in Jewelry


Lead in Jewelry

http://www.leadinspector.com/


Children & Candy & Lead

Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)


WA State Guidelines

The Washington State Department of Health advises consumers not to eat candy from Mexico or southeast Asia that contains tamarind or chili powder.(http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)

California also has documented lead in candy.See the Orange County Register series on lead in candy: http://www.ocregister.com/investigations/2004/lead/index.shtml


Lead in WA Candy

Lead in Candy (Washington State)

0

50

100

150

200

250

300

350

400

450

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

Sample Number

To

tal L

ead

(m

cg)

Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)


Lead in Pottery – Action Levels

US Food and Drug Administration (FDA) action levels for the lead content of the leachate:

• Cups, mugs, and pitchers: 0.5 ppm• Large hollowware (serving dishes): 1 ppm• Small hollowware (bowls): 2 ppm• Plates, saucers, and other flatware: 3 ppm


Lead in WA Pottery

Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)

Pottery Lead Levels (WA & Oregon)

0.1

1

10

100

1000

10000

1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52

Sample Number

Lea

d (

pp

m)


Pottery with Lead

Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)


Lead & Lunchboxes

The Center for Environmental Health (CEH) http://www.cehca.org/lunchboxes.htm


Lead In Ethnic Remedies

Remedy Use Lead Content

Azarcon (Mexico)

Digestive problems

76-86%

Greta (Mexico)

Digestive problems

4-90%

Surma (India)

Cosmetic to improve eye sight

23-26%

Tibet Improve slow development

1-3%


Policy Implications

Drinking water in Seattle Schools


Children in WA State

Blood Lead No. %(mcg/dL)0-1 9,569 55.32-4 6,431 37.25-9 1,103 6.410-19 167 1.020+ 26 0.15

Children 0-6 tested in 2002-2004WA State DOH


Children with >10 mcg/dL

In 1999 and 2000, 2.2% of children 1-5 year age had lead levels that were above 10 mcg/dL.

Approximately 20 million children under age 5, thus about 440,000 children in the US have blood lead levels above 10 mcg/dL.

From CDC


A Small Dose of ….

Health Effects

(< 10 mcg/dL)


Needleman, NEJM, 1979


Consequences for Society

(Slide from B. Weiss)


Lead-associated Reading Deficits in U.S. Children

75

80

85

90

95

100

105

<2.5 2.5 5 7.5 10

Blood lead levels (g/dl)

Rea

ding

Sco

re

Lanphear BP, et al. Public Health Reports 2000;115:521-529. (BL’s slide)


Canfield R, et al. NEJM 2003;348:1517-1526

IQ and Blood Lead

Life time overall• Increase in 1 mcg/dl = 0.87 IQ drop• Covariates - 1 mcg/dl = 0.46 IQ drop

1 to 10 mcg/dl (bigger drop)• Increase in 1 mcg/dl = 1.37 IQ drop• Non-linear - 1 mcg/dl = 7.4 IQ drop

A Small Dose of Toxicology NAHMMA – Advocacy.PP 9/22/05Canfield R, et al. NEJM 2003;348:1517-1526. (slide from BL)

IQ and Blood Lead


The challenge

“the knowledge of how to use knowledge for the social

good”

Knowledgeable Bioethics


“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


• 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 (environmental justice)

Wingspread Conference, 1998.

Central components


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 PP working group

Seattle Initiative


• Seattle Precautionary Principle White Paper (www.asmalldoseof.org)

• Inclusion of PP in Comp Plan Environment Element

(http://www.seattle.gov/dpd/Planning/Seattle's_Comprehensive_Plan/DPD_001178.asp) Link

Result of Effort


“Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making”

Resolution Submitted to Washington State Public Health Association

WSPHA Resolution


California

San Francisco Precautionary Purchasing Ordinance - June 2005

Resolution of the Marin county board of supervisors

“A resolution to continue to incorporate the precautionary principle in county operations.” Oct 2004

Oregon

Multnomah County, OR Resolution - September 2004 New York State Legislation - April 2005 Bill A07256 “To protect public health and the environment by establishing

a precautionary policy for state and local governments in New York State.” Bill A07257 “To establish a preference for the purchase of commodities,

services, and technologies by the State of New York that minimize

potential adverse impacts on public health and the environment.”

States in the US


Agreement Respecting Canada-wide Standards for Dioxins and Furans: Steel Manufacturing Electric Arc Furnaces

Pollution Prevention Strategy“In keeping with the Precautionary Principle as set out as guidance in the Canada-wide Standards Sub-agreement, and in consideration of the CWS principles of sound science, technical feasibility and socio-economic impacts, …..”http://www.ec.gc.ca/CEPARegistry/notices/NoticeText.cfm?intNotice=159&intDocument=939

Canada and PP


REACH -- Registration, Evaluation and Authorization of Chemicals

The two most important aims are to improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.

The Commission’s White Paper on the Strategy for a future Chemicals Policy was adopted in on 13 February 2001.

A Precautionary approach

REACH-European Union


REACH -- Registration, Evaluation and Authorization of Chemicals

Initially regulate High Production Volume (HPV) chemicals - produced or imported above 1,000 metric tons.

Total world wide production of chemicals 400 million metric tons per year or $1.6 Trillion

To be introduced into European Parliament late this year.

REACH


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


• Testifying

• Writing review papers

• K-12 class room teaching

• Adding expertise to community groups

• Education

• Mentoring

• Speakers Bureau

Socially Responsible Actions


• 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 - ELSI Specialty Section

http://www.toxicology.org/memberservices/specsection/specsection.html


• 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


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, 26/4 pp 521-530, 2005.

Public Health and the Precautionary Principle. Steven G. Gilbert. NW Public Health, Spring 2005. http://healthlinks.washington.edu/nwcphp/nph/


Scientific Process

VariabilityUncertainty


• Statistical

• Model

• Fundamental

Types of Uncertainty


• Easiest to examine & reduce

• Not knowing the exact value of a variable (inter and intra subject variance)

• Sample size

Statistical Uncertainty

Reducing Variability


• Not fully understanding the relations between variables (mechanism of action)

• Which variables are most important (high dose vs low dose)

Model or System Uncertainty


• Not knowing the right questions to ask

• Most sensitive end point

• “we don’t know what we don’t know”

Fundamental Uncertainty


• Dose Response Issues

• Higher metabolic rate

• Different nutritional requirements

• Rapidly dividing & migrating cells

• Immature organs

Susceptibility of Children


Ethics and the Precautionary Principle

Questions or Comments?

Download Presentation from www.asmalldoseof.org


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”


Socially Responsible


Recycling Lead


“Conclusions: Blood lead concentrations, even those below 10 mgc/dL, are inversely

associated with children’s IQ scores at three and five years of age, and associated declines in IQ are greater at these concentrations than

at higher concentrations. These findings suggest that more U.S. children may be

adversely affected by environmental lead than previously estimated.”

Canfield et al. 2003, NEJM, 384

Canfield et al…, 2003



60

40

3025

2015

10

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10

20

30

40

50

60

Blo

od

Lea

d (

ug

/dl)

CDC1960

CDC1973

CDC1975

CDC1985

WHO1986

EPA1986

CDC1990

CDC2006?

Agency and Year



Environmental Pollutants and Disease in American Children: Estimates of

Morbidity, and Costs for Lead Poisoning, Asthma, Cancer, and Developmental

Disabilities, by Landrigan, P. et al. EHP, 110, July 2002, 721-728.

Cost of Childhood Lead

Assumptions in calculating costs

• All lead is harmful and from environment

• Blood lead of children age 5 – 2.7 ug/dl (CDC)

• 5-year old boys (1,960,200) and girls (1,869,800)

• 1 ug/dl of lead = 0.25 IQ point reduction

• Cost – boys $27.8 and girls $15.6 Billion

Total Costs $43.4 Billion


Stephen J. Rothenberg and Jesse C. Rothenberg, Testing the Dose-Response

Specification in Epidemiology: Public Health and Policy Consequences for

Lead Environ Health Perspect 113:1190-1195 (2005)

Policy Consequences of Lead

“The Centers for Disease Control and

Prevention action limit of 10 µg/dL for

children fails to protect against most

damage and economic cost

attributable to lead exposure.”


A Small Dose of ….

Regulation

(CDC Guidelines)


Current CDC Policy

Blood lead level µg/dL)b Actions

Time frame for beginning intervention

10-14 Provide caregiver lead education. Provide follow-up testing. Refer the child for social services if necessary.

Within 30 days

15-19 Above actions, plus:If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs 20-44.

Within 2 weeks

20-44 Above actions, plus:Provide coordination of care (case management).Provide clinical evaluation and care.c

Provide environmental investigation and control currentlead hazards.

Within 1 week

45-70 Above actions. Within 48 hours

70 or higher Above actions, plus hospitalize child for chelation therapy immediately.

Within 24 hours


Proposed CDC PolicyBlood lead level (µg/dL)

Actions Time frame for beginning intervention

<2 No action

2-5 Provide caregiver lead education. Provide follow-up testing. Refer the child for social services to investigate possible sources of lead exposure.

Within 30 days

5-10 Above actions, plus:If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs 10-20.

Within 2 weeks

10-20 Above actions, plus: Provide coordination of care (case management). Provide clinical evaluation and care. Provide environmental investigation and control current lead hazards.

Within 1 week

20-70 Above actions. Within 24 hours

70 or higher Above actions, plus hospitalize child for chelation therapy immediately.

Within 24 hours


Policy Implications

An Ethical and Precautionary Approach to

Protecting Our Children

Drinking water in Seattle Schools



60

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2015

10

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10

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d (

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CDC1960

CDC1973

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CDC1985

WHO1986

EPA1986

CDC1990

CDC2006?

Agency and Year



Lead 10 to 2 Campaign

Steven G. Gilbertwww.asmalldoseof.org

[email protected]

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