Various Aspects of the Anti-Doping Framework

Kerwin ClarkeManager, Results Management/ Legal Affairs

23 March 2011Kinston, Jamaica

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Level 1

Level 2

Results ManagementWorld Anti-Doping Program

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Analytical Non Analytical

• Presence of a prohibited substance or method

• Use/Attempted Use

• Refusal

• Whereabouts

• Tampering

• Possession

• Traffic

• Administration

Two Types of Potential InfractionsADRVs

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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

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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

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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

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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.

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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

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A word of wisdom…

The Prohibited List is a scientific/medical, legal and educational tool.

Difficult to achieve since occasionally diverging requirements

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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

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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

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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

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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

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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.

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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.

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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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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.

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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.

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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

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« 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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