Verso una migliore armonizzazione del biomonitoraggio...
Transcript of Verso una migliore armonizzazione del biomonitoraggio...
Verso una migliore armonizzazione del biomonitoraggio
umano a livello Europeo: un processo step by step
Towards a more harmonized EU Human Biomonitoring:
a step by step process
Ludwine Casteleyn,MD
University of Leuven, Belgium
COPHES & DEMOCOPHES: L. Casteleyn, M. Kolossa-Gehring, K. Becker, A. Castano, M.
Esteban, J. Angerer, H. Koch, G. Schoeters, E. Den Hond, O. Sepai, K. Exley, L. E. Knudsen,
M. Horvat, L. Bloemen,, A. Joas, R. Joas, A. Katsonouri, I. Lupsa, P. Crettaz, M. Mulcahy, M.
Berglund, P. Rudnai, D. Ligocka, S. Namorado, A. Gutleb, M.Cerna, K. Halzlova, P. Biot, D.
Aerts.
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The Project LifePlus “Womenbiopop”
ISTITUTO SUPERIORE DI SANITÀ
May 20 - 21, 2013
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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THE EUROPEAN ENVIRONMENT AND HEALTH STRATEGY (COM(2003)338 final)
• - reduce disease burden
• - identify and prevent new health threat
• - strenghten EU capacity for policymaking
presents a NEW VISION on how to address environment & health in
an integrated way and puts health in the centre of environment
policy.
TWG Biomonitoring in children (1 of the 9 TWG’s)
ONCE UPON A TIME … 2003
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The European Commission‘s Environment and Health Action
Plan 2004 – 2010, Action 3
Development of a coherent approach to Human Biomonitoring
(HBM) in Europe, in close cooperation with the Member
States
more effective use of resources by shared development of
tools and strategies
more meaningful results of national surveys as the
number of study subjects involved becomes larger
• Need for translation into policy
• Need for adapted communication
strategies
2004
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• Different approaches • Results not comparable • Communication deficits • Translation to policy
lacking FRAGMENTATION
HBM IN EUROPE
BEFORE
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• Different approaches • Results not comparable • Communication deficits • Translation to policy
lacking FRAGMENTATION
HARMONISATION Comparable results Common guidelines (tested, validated ) Network of competent centers & labs
BEFORE AFTER
HBM IN EUROPE
differences in environmental exposures
national environmental health concerns
analytical capacities
political and health priorities
cultural differences
perceptions of ethics
may render a common biomonitoring survey carried out simultaneously in several European countries difficult to achieve
• a STEP-BY-STEP approach …
TWG
2004
Need for a more coordinated HBM approach
A PILOT STUDY TO
Demonstrate feasibility EU level human biomonitoring
Capacities, networks &
infrastructure
Comparable results
Use of HBM for policy
development across Europe
A STEP-BY-STEP APPROACH….
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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DECISION MAKING
EU MS with differences in
•culture
•religion
•language
•environmental health
concerns
•ethical concerns
•technical capacities
•….
• Several disiciplines
• Distinct techical language and
understanding
WHO DECIDES?
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COPHES DEMOCOPHES
FUNDING: 2 PROJECTS! 2009
• WP1: Operational EU HBM framework
• WP2: Sampling and biobanking
• WP3: Analysis and Quality assurance
• WP4: Data analysis
• WP5: Communication
• WP6: Training and capacity building
• WP7: Horizon scanning
• WP8: Support HBM programme
• WP9: Coordination and management
Implementation in 17 countries
Recruitment of 120 children/mothers
Questionnaire information
Samples
(cadmium, phthalate metabolites,
cotinine in urine; mercury in hair;
bisphenol A)
Biobanking
CONSULTATIVE FORUM: Member States, European bodies (EEA, EFSA),
Networks of Regional and Local Authorities Stakeholder: Civil Society, NGO,
Research, Industry and International Organisations (WHO)
IT’S A LONG WAY ….
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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Based on existing experiences, old/current/planned surveys
Ideas and opinions on harmonised approach
Questionnaire round June to September
2010 (NFP, PI, LABs)
Discussions with participating countries’
representatives
• Berlin (September 2010)
• Brussels (October 2010)
• Brussels (February 2011)
.
[
TOWARDS A EU CONSENSUS PROTOCOL
2011 – 2012
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3 4 2
6
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1. National protocol – Ethics
Start - Aug 2011
2. Recruitment & sampling
Sept 2011 - Feb 2012
3. Chemical analysis samples Jan - March 2012
4. Data analysis & interpretation
March - Sept 2012
5. Communication
Sept - Nov 2012
STEP BY STEP 2011 – 2012
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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IT IS FEASIBLE!
• A common approach to EU HBM was demonstrated
• For the first time comparable data for selected substances were generated
BUT
• Sufficient time is needed
• Funding framework &
• Coordinating & decision making structure are essential
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CONCLUSIONS SO FAR
• Biomarker values showed a large variability in the
population and between the countries
• Exposure of the general population in EU is well below
the current health based guidance values, very few
participants had values which were higher then the
health based guidance values.
• The biomarker levels in children were highly correlated
with the levels in their mother, especially for mercury and
cotinine.
• The information reported by the participants on their
environment and life style allowed to identify factors that
influence the biomarker levels and hence indicate a
leverage for intervention
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• Sufficient harmonization can be achieved to
successfully conduct HBM-studies on a EU scale
• Within a certain frame, adaptations in fieldwork are
possible and do not influence the quality of the common
approach
• Only strict Quality assurance and Quality control will
guarantee comparable and reliable results:
Capacity building should never compromise these strict
criteria for lab selection
• Targetted communication from the very start is key and
must include social science strategies
• Training, helpdesk and telephone conferences were
essential additional tools to guide and maintain the
harmonised approach
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CONCLUSIONS SO FAR
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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RIGHTS OF THE STUDY SUBJECT
RIGHT OF INFORMATION
whether or not the data have been obtained directly from the data subject
• that their personal data are processed and for which purpose
• the identity of the controller
• the purpose(s) of the processing
• the recipients
• the existence of the right of access to data and the right to rectify the data
• How to deal with the ‘right to know’ of the study
participants when the links with health risks, especially at
the individual level, are not well defined?
• How to feed public debate/raise awareness, without
raising unnecessary alarm?
• How to report (uncertainty) to the relevant authorities?
• How to translate results into action?
CHALLENGES FOR COMMUNICATION
WHO POPs SURVEY IN BREAST MILK
• HBM results show that breast milk contains many pollutants
• decrease of body burden mother
• anxious reactions in mothers and in general public.
• Breast-feeding offers
many advantages to
both babies and
mothers: protection for
allergies and sickness;
comfort, physical
closeness, …
Breast-feeding is considered the preferred method of feeding
babies !
Should results be communicated, at individual level, at
population level? How not to overestimate the risks and
downplay the benefits?
Before Sampling
• General Public
• Participants
• Policy & Science leads
• Health professionals
• Schools
• Etc
During sampling
• General Public
• Participants
• Media
Results
• General Public
• Participants
• Policy & Science Leads
• Health Professionals
• Schools
• Etc…
COMMUNICATON TROUGH 3 STAGES OF
THE STUDY
What is cadmium?
Cadmium is a soft, silver to white metal that is naturally present in the Earth’s crust as a mineral in combination with other elements.
Where is it found?
Cadmium can be found naturally in small quantities in the air, water and soil. Higher levels can be found in soil and water near industrial areas or hazardous waste sites. It is also found in tobacco. Most frequently, cadmium is extracted as a by-product during the production of zinc, lead or copper. Cadmium is used in batteries, paint pigments, coatings and platings.
Human Biomonitoring of Cadmium
Cadmium can be measured in both urine and blood. Long-term exposure to cadmium can be measured in urine samples. Cadmium in blood reflects more recent exposure, about 3 months. Finding a measurable amount of cadmium in blood or urine does not necessarily mean that these levels cause an adverse health effect.
Ways to reduce exposure
•Do not smoke tobacco products and limit exposure to second-hand smoke; •Properly dispose of batteries and other cadmium containing products. •Try to avoid eating foods that may contain high levels of cadmium.
How are we exposed?
Environmental exposure to cadmium occurs primarily though smoking. Non-smokers who inhale environmental tobacco smoke (also known as second-hand smoke) take up cadmium as well. The most important source of cadmium for non-smokers is from food (especially shellfish, liver, kidney, wild mushrooms and leafy green vegetables.
How can it affect us?
Long-term exposure to low levels of cadmium through air, water and soil can affect the kidneys and bone density. Breathing in high levels can also damage the lungs but this is more likely to occur in occupational settings rather than in the environment. High levels of cadmium can cause cancer in humans.
Cadmium
Cd
History of risk communication
• All we have to do is get the numbers right
• All we have to do is tell them the numbers
• All we have to do is explain what we mean by the numbers
• All we have to do is show them they’ve accepted similar
risks in the past
• All we have to do is show them that it’s a good deal for
them
• All we have to do is treat them nice
• All we have to do is make them partners
• All of the above
Fischhoff, B., in: Löfstedt en Frewer (1998), p. 133-148
SHARING OF DATA /SAMPLES
RE USING EXISTING DATA AND SAMPLES
Purposes Users
Re use for a new
purpose by other
users
• Go back to study subject
• Assume he/she consented
• Anonymous data or
samples
Defined e.g. in informed consent
OUTLINE
1. How it began
2. Challenges on the road
3. A EU harmonised protocol
4. First results
5. Ethics, data protection &
communication
6. Next steps
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EU infrastructure and common
approach tested in 17 European
countries
Basic data on the distribution of
specific biomarkers among
defined/selected study population
comparable at a EU scale
Step towards European reference
values
WHAT DID WE EXPECT?
✓
✓
✓
Balancing
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Quality assurance Capacity building
Rigid protocol Flexibility for
feasibity
Central statistical
analysis
National statistical
analysis
Strict
communication
rules
Taking into account
cultural differences
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TOOLS TO BE DEVELOPED
ASAP
• A decision making structure with mandated MS representatives and EU authorities.
• An advisory group of EU experts providing recommendations
• A transparent process to define EU HBM reference and health based values
• A dedicated funding for long-lasting programmes
• Legal instruments or policies that integrate capacities, competences skills, and infrastructure
AFTER THE PILOT STUDY
• At short-term
– To design the outline of a more global EU programme
• At mid-term – To collaborate with other
existing/in development surveys (EHES, INSPIRE)
• At long-term – To assure the continuity of
a EU HBM programme as a policy tool.
232 BIOMARKERS (2009) • Exposure biomarkers for:
» Metals
» Polychlorinated biphenyls, dioxins & furans
» Organochlorine pesticides
» Carbamate pesticides
» Organophosphorous pesticides
» Pyrethroid pesticides
» Herbicides
» Polycyclic aromatic hydrocarbons
» Phthalates
» Phytoestrogens
» Pest repellants
» Cotinine
» Perfluorinated chemicals
» BFRs
» VOCs
» Perchlorate
» Acrylamide www.cdc.gov/exposurereport
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ENV.2013.6.4-1 Assessing individual exposure to environmental
stressors and predicting health outcomes: paving the way for an EU-
wide assessment – FP7-ENV-2013-two-stage
…New approaches relying on the concept of the individual exposome, representing
all environmental contributors to disease received by an individual during a
lifetime, are needed to better understand the underlying mechanisms of
environment-health/disease associations. The aim of the research is to collect
new harmonised and standardised large-scale exposure data from European
populations to improve the quality and comparability of the input data
across countries, with attempts to link individual and population-based
exposure data to health data,… e.g. through a pilot European Exposure and
Health Examination Survey.
Max EU contribution EUR 12 000 000.
Expected impact: …Reduction of fragmentation of exposure data across the EU
and contribution to harmonisation and comparability of data. …
Last call of Seventh Framework Programme February 2013
• Fund research relevant parts in Horizon 2020
• Link HBM to health surveys such as EHES?
• New policy initiatives?
Thank you for listening [email protected]
Sincere thanks to the study
participants all to all partners in
DEMOCOPHES & COPHES .
COPHES is funded under the 7th framework
program of the EU (DG Research – No. 244237.
DEMOCOPHES was possible thanks to a joint
financing of 50% from the European
Commission program LIFE+ (DG Environment –
Life09 ENV/BE000410) and 50% from each
participating country.
http://www.eu-hbm.info