WADA - Kerwin Clarke
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Transcript of WADA - Kerwin Clarke
Various Aspects of the Anti-Doping Framework
Kerwin ClarkeManager, Results Management/ Legal Affairs
23 March 2011Kinston, Jamaica
p.2p.2
Level 1
Level 2
Results ManagementWorld Anti-Doping Program
p.3p.3
Analytical Non Analytical
• Presence of a prohibited substance or method
• Use/Attempted Use
• Refusal
• Whereabouts
• Tampering
• Possession
• Traffic
• Administration
Two Types of Potential InfractionsADRVs
p.4p.4
1. The ADO shall notify in writing
a. Athlete
b. International Federation
c. WADA
2. Athlete has the right to a fair and impartial hearing
Assertion of an ADRV
p.5p.5
After notification, the panel shall:
• Initiate hearing
• Render a decision
• Submit the reasons of the decision in writing
• Inform other parties / WADA / IF / NADO
• Decisions may be appealed
Disciplinary Panel
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Assertion of an ADRV
No Sanction
Hearing
Sanction
X
X
XAppeal
Results Management Summary
Upheld
Partially Upheld
Rejected
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Presence of Substance
Tampering or attempt
Refusing
Whereabouts
Possession
Administering or attempt to
UseTrafficking
Anti-Doping Rule Violation – Article 2
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First violation of anti-doping rules (factors that influence ineligibility period)
1.Nature of violation
10.2 Standard ineligibility: 2 years
10.3 Trafficking + administration: 4 years
10.3.3 Whereabouts Violations: 1-2 years
10.4 Specified substances (reprimand – 2 years) More flexibility to reduce the sanction Athletes must prove:
How the substance entered their body That they were not intending to improve performance
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Sanctions (cont’d)
Commencement of the ineligibility period
10.9 Ineligibility period starts on the date of hearing, except in following cases:
Significant delay not attributed to the athlete Timely admission Provisional suspension
p.10p.10
Sanctions (cont’d)
Status during ineligibility
10.10 Prohibition to participate in
competitions and organized or authorized activities (including training)
Should this prohibition be violated, initial ineligibility period starts over again (10.10.2)
Athlete remains available for anti-doping testing (10.11)
Withholding of financial support (10.10.3)
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Sanctions (cont’d)
2nd Violation
1st
Violation
RS FFMT NSF St AS TRA
RS 1-4 2-4 2-4 4-6 8-10 10 - life
FFMT 1-4 4-8 4-8 6-8 10-life life
NSF 1-4 4-8 4-8 6-8 10-life life
St 2-4 6-8 6-8 8- life life life
AS 4-5 10-life 10-life life life life
TRA 8-life life life life life life
1) 10.7 Multiple Violations
2) 10.8.1 To regain eligibility, athlete must repay all prize money forfeited
p.12p.12
APPEALS
Article 13Appeals
Decisions made under the Code or rules adopted pursuant to the Code may be appealed pursuant to articles 13.2-13.4
Depending on the case, appeals can be made to relevant appeal bodies of the various National Anti-Doping Organisations or International Federations as well as to CAS.
p.13p.13
Appeals (cont’d)
Where a decision is not rendered within a reasonable deadline (set by WADA), WADA may appeal directly to CAS (Article 13.3)
(International federations may also provide for the same rules vis-à-vis their national
federations)
WADA Prohibited List 2011
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What is the List: International Standard that designates substances and methods prohibited:
• At all times• In competition• In Particular sports
Criteria: If a substance or method meets 2 of 3 of the following criteria it could be included in the List:
• Enhances performance• Poses a threat to athlete health• Violates the spirit of sport
How it is developed: through a Highly consultative process worldwide:
• Reviewed by experts from WADA’s List Committee• Approved by WADA Executive Committee• New and solely List published online by October 1• Goes into effect on January 1 of the following year
The ListInternational Standards
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An Athlete is responsible, and an Adverse Analytical Finding occurs, whenever a Prohibited Substance is found in an Athlete’s Sample regardless of if the Athlete intentionally or unintentionally
Used a Prohibited Substance or was negligent or otherwise at fault.
• Athletes should verify all substances prior to taking them
• Athletes should consult with their IF or NADO for recognised websites and databases
• Athletes should always inform doctors and pharmacists that they are an athlete and are subject to anti-doping rules
Strict Liability PrincipleProhibited List
p.17p.17
A word of wisdom…
The Prohibited List is a scientific/medical, legal and educational tool.
Difficult to achieve since occasionally diverging requirements
p.18p.18
List Committee
WADA List CommitteePanel of 12 scientists representing 8 countries and 3 continents chosen for their international expertise in:– Sport Medicine
– Sport Physiology
– Pharmacology
– Pharmaceutical Science
– Toxicology
– Analytical Chemistry
– Addictology
p.19p.19
List Elaboration Process
January - 1st meeting of the List CommitteeTask sharing for revision of the contents of the List, according to:– Comments received on the newly enforced List– New information about substances or doping practices
April - 2nd meeting of the List Committee–Expert Presentations (External or List Com members) –Drafting of the new List
May - end of July–Circulation of the new List to WADA’s stakeholders (governments & sport movement) for review & comment
p.20p.20
List Elaboration Process
August/early September – 3rd meeting of the List Committee–Final draft of the new List by Committee, integrating relevant comments from Stakeholders–Review of the new List by WADA’s Health, Medical & Research Committee for discussion and final recommendation
Mid-September–Circulation of the new List to WADA’s Executive Committee for discussion and approval
October 1–Publication of the new List which comes into effect on January 1 the following year
p.21p.21
Code Article 4.2.2.: All Prohibited Substances shall be Specified Substances except those in the classes of:
• Anabolic agents• Hormones • Certain Stimulants and certain Hormone Antagonists and Modulators• Prohibited Methods
• For these substances, the rules set forth in 10.5 –Elimination based on exceptional circumstances is the only basis for reducing the standard sanction
• Specified substances category provides flexibility to the athlete on a case by case basis to clearly demonstrate that he/she did not intend to enhance performance.
• Sanctions can range from a warning to 2 years depending on the circumstances of each case
Specified SubstancesProhibited List
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7.5.1 Mandatory provisional suspension after A sample AAF for prohibited substances other than specified substances
7.5.2 Optional for specified substances
Provisional Suspension
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At all times: In and Out of Competition
S0. Non approved substances• Substances not included in the List and no with no current approval (Governmental Health
agencies)
S1. Anabolic Agents• Nandrolone, Stanozolol
S2. Peptide Hormones, Growth Factors and Related Substances• EPO, hGH
S3. Beta-2 Agonists• Salbutamol, Terbutaline
S4. Hormone Antagonists and Modulators• Cyclofenil, Myostatine inhibitors
S5. Diuretics and Other Masking Agents• Probenecid, furosemide
Prohibited Substances Prohibited List
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In Competition
S6. Stimulants• Modafinil, Heptaminol
S7. Narcotics• Morphine, Pethidine
S8. Cannabinoids• Marijuana, THC
S9. Glucocorticosteroids• Prohibited when
administered by oral, intravenous or rectal routes
Prohibited Substances Prohibited List
p.25p.25
In Particular Sports
P1. Alcohol• Aeronautic, Archery, Automobile
P2. Beta-Blockers• Golf, Sailing, Shooting
Prohibited SubstancesProhibited List
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At all times: In and Out of Competition
M1. Enhancement of Oxygen Transfer• Blood doping
M2. Chemical and Physical Manipulation• Tampering, Intravenous infusions, Withdrawal
and reinfusion
M3. Gene Doping• Transfer of nucleic
acids, modified cells
Prohibited Methods Prohibited List
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New S0 section
Introductory sentence emphasizing the status of drugs with no official approval and not covered by other sections of the Prohibited List:
Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (i.e. drugs under pre-clinical or clinical development or discontinued) is prohibited at all times.
p.28p.28
S2 : Peptide Hormones & Growth Factors
• New class of ESA added: Hypoxia-inducible factor (HIF) stabilizers
• Ban on intramuscular Platelet Rich Plasma (PRP) removed: PRP no longer prohibited
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S5: Diuretics and other Masking Agents
• Desmopressin :Hemodilution effect (Blood transfusions or blood variables of the ABP)
• Last paragraph of section S5: reworded to more clearly explain the consequences of detecting an exogenous threshold substance at a sub-threshold concentration in the presence of a diuretic or other masking agent.
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M2. Chemical & Physical Manipulation
• M2: Methods that consist of sequentially withdrawing, manipulating and re-infusing whole blood into the circulation have been added to this category. (e.g. ozonotherapy)
• Rewording of Gene Doping section M3
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S6 Stimulants & S8 Cannabinoids
• Stimulants:
Methylhexaneamine transferred to specified
• Cannabinoids:
Clarified that all cannabimimetics (JWH018, JWH073, HU-210 ) are included in this section
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S3 B2 Agonists & S9 Glucocorticoids
• Beta2 Agonists– Removal of Declaration of Use
• Glucocorticosteroids:– Only Prohibited Routes listed (systemic)
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Prohibitions in Particular Sports
• Alcohol– Modern Pentathlon (IUPM) removed
• Beta Blockers:– Federation Int. Gymnastics removed
– World Darts Federation added
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Anti-Doping Going Forward: Two Key Issues
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Athlete Biological Passport
Collection of selected individual information compiled to assist in the detection of doping.
Substance itself is not detected/ Effects are.
Significant variables for substance classes are identified then monitored
Sensitivity improves as number of tests increase
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New vs. Old Paradigm
Athlete Biological Passport
Athlete becomes his/her own reference.
Classic Paradigm
Athletes variables measured against norms in the athlete population at large
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New vs. Old Paradigm (cont’d)
Philosophy and Key Principles of the Athlete Passport
To monitor parameters as indirect markers of doping
To benefit of knowledge coming from medical and forensic sciences
Based on the fact that all drug intake causes modifications in the body
Look at the consequences (effects), versus looking only at the substance itself (cause)
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Scope and objectives of the Passport
Scope Limitations of the typical doping control approach Based on knowledge of drug effects/ side effects in
medical practice
Objectives Identify possible doping cases to:
• Efficient fight against doping at the most sophisticated level
• Lead to intelligent targeting for traditional doping controls
• Reduce burden for clean athletes
• Use of existing anti-doping infrastructure
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GUIDELINES
There are very rigid protocols for collection, transportation and analysis of samples.
Heterogeneous factors (age, sex, sport) as well as confounding factors (altitude, training) are included in the model.
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Abnormal Profile
Natural Variation, Doping or Disease
i.e. Can this abnormal profile be explained by some known pathology?
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Bayesian Analysis or Adaptive Model
The biomarkers can be displayed graphically using a Bayesian type network to show probabilities.
The first values are based on population numbers with some personal information included (e.g. gender).
As more samples are taken, the model adapts to the new information and the athlete becomes his/her own reference point.
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NORMAL PROFILE
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Abnormal Profile
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Interpretation
Not measuring a true probability of doping but rather how the profile is different from what is expected in a clean athlete.
Monitor the production of red blood cells by the body to detect doping
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Managing the Results
Starting point Warning / expert Decision from the ADO ADO discussion with an
expert
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“No Black Box”
No ‘black box’ – Role of the expert is imperative
After the software alerts about a suspicious profile 99.9%, it goes to a panel of experts;
The experts then look at the profile, along with competition schedule and decide if this is more likely explained by a hypothesis of doping or by some known pathology.
p.47p.47
Haematological Experts
Initially anonymous. Presently part of ADO.
3 experts: normal, target, doping.
If suspicious, athlete is consulted, athlete’s explanations reviewed by the experts, if all 3 agree, then open disciplinary hearing;
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Establishing an anti-doping rule violation
Burden of the proof
Elements of proof Experts’ opinion Sporting Calendar Testimony Variations correlations Laboratories’ work
Standard of proof Article 3.1: Satisfaction of the
hearing panel
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Athlete’s Rights
Preliminary Exam (anonymous)
Preliminary consultation with the Athlete
Data receipt by the Athlete
Second exam by experts (not anonymous)
Disparity from protocols
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p.50
Typical Defense Arguments
These are usually centered around two areas: Lowering oxygen and creating new RBC; Pathological conditions that modified hydration status,
such as gastroenteritis.
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Hypoxic Explanation
Altitude training and hypoxic tents. Both of these conditions will create erythropoesis (the increased production of oxygen carrying red blood cells) similar to exogenous erythropoeitin.
However studies exist and demonstrate that the changes are not so dramatic as usually seen in an abnormal passport profile.
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Plasma Volume Shifts
Hemoglobin is measured by volume: g/dl therefore if there is a sudden increase in volume – e.g. athlete had medical condition and was required to drink large quantities of water suddenly would drive down the measured Hb level.
A sudden decrease in hydration status e.g. acute gastroenteritis could increase Hb levels.
However the body is intelligent and even when dehydrated, plasma volume is usually maintained.
p.53p.53
Other medical explanations
Gastric or other bleed. (Would need to be significant and well documented).
Hereditary medical condition (e.g. Hereditary spherocytosis).
These condition of abnormal blood cells should be easily diagnosed. The ABP
measures abnormal fluctuations more than absolutes.
p.54p.54
Challenges
Complexity
Difficulty to find experts
Costs
Training / Skills
Willingness of the ADO
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Trafficking
Increase of trafficking in doping substances
Great danger to public health in using doping substances
Advantage of the anonymous use of the Internet to promote and sell doping substances
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Effective Reaction
Enhance the exchange of operational information
Identify common targets
Establish a solid basis of knowledgeable agents of experts
Develop specialized training
Investigate on international trafficking of doping substances of doping substances
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Trafficking of doping products
Maximum Profit for minimum investment
Same Modus Operandi
Same Network
Same risks ? Not Quite
Drug trafficking
Comparison
Ref. INTERPOL
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Why such a disparity?
This offence is not a priority for many states
The production, distribution and use of doping substances are not harmoniously regulated
Consequence: international cooperation is slow.
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WADA partnership with INTERPOL
Cooperate in a common fight
Exchange of information
Sharing of expertise
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Increasing Focus
The largest performance-enhancing drug crackdown in U.S. history.
$6.5 million and 532 pounds of raw steroid powder
Grew out of operation targeting Mexican labs.
124 arrests, 56 steroid labs dismantled across US
11.4 million steroid doses seized,$6.5 million seized
Operation Raw Deal
Ref. ESPN
p.61p.61
« Target » Identification
Reveal ongoing investigations
Identification via the Internet
Identifying the suppliers of raw materials / equipment
Support of governmental agencies(undercover purchase)
Ref. INTERPOL
www.wada-ama.org
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