iNADO Board of Directors Statement on Low-Level Clenbuterol Findings / Institute of National Anti-Doping Organisations (iNADO). - Bonn : iNADO, 2017

Previously, the German broadcaster ARD reported about the presence of the prohibited steroid Clenbuterol in the urine samples of several unnamed athletes taken at the 2008 Beijing Summer Olympic Games, and retested in 2016. WADA issued a Statement on the matter. A number of NADOs including those of iNADO Board Members contacted the World Anti-Doping Agency (WADA) for clarification and additional information.

Clenbuterol is a powerful performance enhancer with a long history of abuse in sport. Clenbuterol is used by cheating athletes to increase musculature, speed, strength and endurance without gaining weight and for its positive enhancement of breathing performance. But it is also used in meat production, especially in China, Mexico and Guatemala, and has led to inadvertent low-level adverse analytical findings in athletes who have eaten contaminated meat.

The iNADO Board of Directors thanks WADA for responding to NADO concerns and providing additional information both at the meeting of WADA’s NADO Working Group April 11 and 12, and last week during a teleconference with WADA Director General Olivier Niggli and Science Director Olivier Rabin.

It is clear that there are gaps in the World Anti-Doping Program for retesting of samples, for reporting the analytical results and for results management, including lack of detailed guidance to Anti-Doping Organisations (ADOs) on appropriate treatment of low-concentration Clenbuterol findings that may (with necessary preliminary review) be the result of contaminated meat. The NADO community is aware of the current inability of laboratories to distinguish between low-concentration Clenbuterol findings that may be the result of direct use and those that may be the result of meat contamination. (And of the ongoing work to remedy this problem.)

The current situation has resulted in inconsistent treatment of low-concentration Clenbuterol findings by ADOs. Many cases involving clenbuterol findings have gone to a hearing have led to results disqualifications and 1st ADRVs and even periods of ineligibility. For example, the case of Polish paddler Adam Seroczynski. But many other cases with similar findings have been closed without full results management and leading to no consequences at all. The current situation has also resulted in inconsistent oversight of ADOs as results management authorities (RMAs) with respect to comparable Clenbuterol findings. All NADOs would agree that low-level Clenbuterol findings should be managed according to the Code and in an open and transparent way.

Therefore, the iNADO Board urges WADA to take steps to ensure consistent treatment of low-concentration Clenbuterol findings that may indicate contamination from meat sources. These steps should include:

1.) WADA guidance to all ADOs, which should restate the problem of meat contamination in certain countries as a source of low-concentration Clenbuterol findings, and describe how such cases have been handled to date and the numbers of them.

2.) WADA updating ADOs on the ongoing research seeking to distinguish between direct use of Clenbuterol and clenbuterol sourced resulting from contaminated meat.

3.) WADA guidance to accredited laboratories on the consistent reporting of analytical results for Clenbuterol (including designating some analytical findings as “provisional analytical findings”), and about the communications they may have with RMAs in such cases.

4.) As was the case with respect to AAFs for Meldonium, WADA should give ADOs direction on a consistent approach for all ADOs to take for results management of such cases, including clearly stated circumstances in which such adverse analytical findings need not be pursued as possible ADRVs and need not go through the normal results management process, and the circumstances in which they must be pursued as possible anti-doping rule violations with full results management.

5.) That should include a definition and guidance to all ADOs on conducting “pattern analysis” to determine Clenbuterol cases to pursue or not.

6.) WADA should indicate the gaps in the current World Anti-Doping Program with respect to retesting of samples, including the results management of AAFs produced by retesting, and describe a process for filling those gaps. WADA’s stakeholders should be invited to make proposals to WADA. iNADO and its Members will be glad to participate in this effort. In the view of the iNADO Board, this should be done as a priority and cannot await the consultation and revision process leading to the 2021 Code.

7.) WADA should indicate how it intends to advise any ADO as RMA with secured stored samples on Clenbuterol retesting. This would include the IOC as the RMA in dealing with secured 2008 Beijing samples which might still be re-analysed for Clenbuterol with improved analytical techniques that in the future can distinguish between with a view direct use of Clenbuterol and Clenbuterol consumed in meat.

The iNADO Board notes that the documents prepared for the upcoming WADA Executive Committee and Foundation Board meetings refer to a forthcoming WADA paper on the subject. The iNADO Board looks forward to the paper being issued as quickly as possible for the benefit of the entire ADO community and of clean athletes.

In April 2016 the International Federation of Rowing Associations (FISA) has reported an anti-doping rule violation against the Athlete Serhii Budko after his sample tested positive for the prohibited substance meldonium.

After notification a provisional suspension was ordered. The Athlete submitted the FISA questionnaire without a further statement in his defence and he waived his right to be heard.

In the FISA questionnaire the Athlete stated that he had used non prescribed meldonium in March 2016 because he was feeling fatique during training. The Athlete was not suffering from any other health condition at the time of the test and he did not mention the use of the substance on the Doping Control Form.

The FISA Doping Hearing Panel concludes that the Athlete has committed an anti-doping rule violation and decides to impose a 4 year period of ineligibility on the Athlete starting on the date of the provisional suspension, i.e. on 23 April 2016.

CAS 2016/A/4708 Belarus Canoe Association (BCA) & Belarusian Senior Men’s Canoe and Kayak team members v. International Canoe Federation (ICF)

The members of the Belarusian senior men’s kayak team:
- Mr. Raman Piatrushenka,
- Mr. Vitaliy Bialko,
- Mr. Aleh Yurenia,
- Mr. Pavel Miadzvedzeu,
- Mr. Vadzim Makhneu,
- Mr. Taras Valko,
- Mr. Aliaksandr Liapeshka,
- Mr. Andrei Tsarykovich,
- Mr. Ihar Baicheuski,
- Mr. Ivan Tsuranau,
- Mr. Dzmitry Khilchanka,
- Mr. Spartak Bazhkou,
- Mr. Mikita Borykau,
- Mr. Stanislau Daineka,
- Mr. Dzimtry Tratsiakou.

The members of the Belarusian senior men’s canoe team:
- Mr. Aliaksandr Bahdanovich,
- Mr. Andrei Bahdanovich,
- Mr. Dzianis Harazha,
- Mr. Dzmitry Rabchanka,
- Mr. Dzmitry Vaitsishkin,
- Mr. Artsem Kozyr,
- Mr. Maksim Piatrou,
- Mr. Hleb Saladukha,
- Mr. Dzianis Makhlai,
- Mr. Aliaksandr Vauchetski),

The Belarussian coaches:
- Mr. Uladzimir Shantarovich,
- Mr. Mikalai Banko,
- Mr. Ihar Radomski,
- Mr. Henadzi Halitski.

The Belarussian medical staff of these male teams:
- Mrs. Elena Kallaur,
- Mr. Aliaksei Roik.

• Canoe
• Doping (meldonium)
• Definition of “suspension” and “exclusion” in ICF Statutes
• Distribution of powers within the ICF with regard to decisions in anti-doping matters
• Meldonium taken before 1 January 2016
• Possession of Prohibited Substances by a coach and
• Therapeutic Use Exemption (“TUE”)
• Necessity of legal basis for sanctions

1. Absent any particular explanation in the ICF Statutes and bylaws, the term “suspension” must be understood to have the meaning generally used by many international sports federations. In such understanding “suspension” means that use of all membership rights by the respective National Federation or individual shall be prohibited for a certain period of time. “Exclusion”, as follows directly from the text of Article 42 (c) ICF Statutes, is restricted to particular rights, the participation at international competitions and ICF Competitions.

2. Before the ICF Executive Committee can take any additional disciplinary action under Article 12.3 ICF Anti-doping Rules (“ICF ADR”), the ICF Doping Control Panel has to first render a decision establishing a violation or failure by athletes or other persons affiliated with the National Federation in question fulfilling the requirements of Article 12.3 ICF ADR together with one of its Sub-Articles. In this respect it is not sufficient for the ICF to argue that the mere presence of a Prohibited Substance in an athlete’s body constitutes an anti-doping rule violation: to follow such argumentation would reverse one of the essential achievements of the WADA Code, namely the establishment of independent judicial bodies as replacement of political bodies to decide on anti-doping rule violations. Specifically, it would empty the competence of the ICF Doping Control Panel, circumventing the system of distribution of powers laid down by the ICF Statutes and the ICF ADR; put differently it would prejudge the decisions of the ICF Doping Control Panel and assign to this panel the role of merely executing decisions already taken by the ICF Executive Committee through own decisions; lastly it would deprive the individual person concerned of all procedural guarantees laid down by the WADA Code, implemented by the ICF in the ICF ADR.

3. The 2016 WADA Prohibited List (which entered into force on 1 January 2016) for the first time included meldonium as a prohibited substance. According to the WADA notice on meldonium concerning cases where athletes claim that the substance was taken before 1 January 2016, for samples taken on or after 1 March 2016 and showing a urinary concentration of meldonium below 1000 ng/ml, in the absence of other evidence of use of meldonium on or after 1 January 2016, a finding of no fault could be made. Accordingly, in order to establish a positive finding for meldonium for such a sample, an anti-doping organisation is obliged to demonstrate to the hearing panel’s comfortable satisfaction that the meldonium entered the body of the athlete in question after 1 January 2016.

4. Neither the WADA Code nor the ICF ADR contain an obligation for a Therapeutic Use Exemption for coaches. Therefore, a coach who is found in the possession of a Prohibited Substance but who establish to the hearing panel on a balance of probability that the Prohibited Substance was in his possession for personal medical reasons does not violate Article 2.6.2 ICF ADR prohibiting possession of a Prohibited Substance.

5. It is too late to only at a hearing in front of CAS introduce arguments related to a legal basis on which the imposition of sanctions are allowed if those arguments have not been referred to in the appealed decision. Put differently, issuing a decision first and thereafter searching for a possible legal basis does not confirm to the principle of legality.

On 12 April 2016, French Police and Customs raided the rooms and personal belongings of the male Belarusian canoe athletes at the training camp in Le Temple-sur-Lot (France). They confiscated various substances, medication, material and medical equipment, including meldonium, needles and other equipment for transfusions, Actovegin and iron supplements. The meldonium (16 capsules of Mildronate) were found in the room of Mr. Henadzi Halitski, the coach of the Belarusian women’s kayak team.

Seventeen athletes from the Belarus canoe team underwent a doping control and urine samples were taken from them. Meldonium was found in five of these samples and the French Ministry of Justice opened a criminal case against the Belarussian team. Only one sample showed a concentration above the WADA threshold and the Belarus Canoe Association (BCA) suspended the athlete from any competition.

The BCA expressed to the International Canoe Federation (ICF) its intention to support doping free sport. The BCA argued that the import of certain medicines was only a violation of customs rules and explained with evidence that the use and possession of the medication was valid. It asserted that the seized Mildranat was prescribed and used by Henadzi Halitski the coach of the Belarus’ women’s team.

Considering the results of the French raid into the training camp the ICF Executive Committee concluded that there was enough evidence and proof to issue sanctions against the athletes, coaches and entourage of the Belarus delegation.

The ICF Executive Committee decided on 15 July 2016 to impose a 1 year period of ineligibility on the Senior Men’s Canoe and Kayak teams including coaches, medical staff and entourage for all international competitions. The starting date for this sanction would be 13 July 2016.

Hereafter in July 2016 the Appellants appealed the ICF decision of 15 July 2016 with the Court of Arbitation for Sport (CAS). The BCA argued that the ICF Executive Committee was not entitled to issue the Decision and it violated the relevant Rules and procedural rights of the Athletes.

The Panel finds that the ICF Decision of 15 July 2016 to the exclusion (ban) was not restricted to officials only and disregarding two further restrictions.
Having not been provided with evidence by the ICF to its comfortable satisfaction that the BCA Athletes took meldonium after 1 January 2016, the Panel holds that there was no anti-doping rule violation committed by the athletes as to meldonium.

Besides, the ICF Executive Committee erred in the Appealed Decision in holding that meldonium was in the possession of the Belarus contingent, which, thus, committed a violation of Article 2.6.2 ICF ADR. The coach Mr. Halitski could explain to the Panel on a balance of probability and even to its comfortable satisfaction that the meldonium was in his possession for personal medical reasons. Since there is no obligation for a Therapeutic Use Exemption for coaches in place under the WADA Code and the ICF ADR, the Panel finds that Article 2.6.2 ICF ADR has not been violated by such possession.

The ICF could not establish to the comfortable satisfaction of the Panel that the transfusion equipment and medication found at the raid of the BCA’s training camp in France, as far as disclosed to the Panel, served the aims of prohibited methods. Thus, the Panel finds that no violation of Article 2.6.2 ICF ADR took place. There was no possession of prohibited methods, regardless of the question whether Article 2.6.2 ICF ADR is clear and precise enough at all because it does not determine under which conditions and from when a person has possession of a prohibited method.

Since there were not four or more violations of the ICF ADR (other than violations involving Article 2.4) committed by Athletes or other Persons affiliated with the BCA within a 12-month period in testing conducted by the ICF or Anti-Doping Organisations other than the BCA or BCA’s National Anti-Doping Organisation, the Panel finds that Article 12.3 ICF ADR, read together with Sub-Article 12.3.1 could not be applied on the BCA, based on the established facts. As a result, the Appealed Decision of the ICF Executive Committee is set aside.

In conclusion, the Panel finds that the Appealed Decision is also set aside as premature because there were no previous decisions taken by the ICF Doping Control Panel on violations of the ICF ADR by Athletes or other Persons affiliated with the BCA.

Therefore the Court of Arbitration for Sport decides on 23 January 2017:

1.) The appeal filed by the Belarus Canoe Association and the Belarusian senior men’s canoe and kayak team members against the decision rendered on 15 July 2016 by the ICF Executive Committee is upheld.
2.) The decision of the Executive Committee of the International Canoe Federation rendered on 15 July 2016 is set aside.
3.) The present award is rendered without costs, except for the Court Office fee of CHF 1,000 (one thousand Swiss francs), which has already been paid by the Belarus Canoe Association and is retained by the Court of Arbitration for Sport.
4.) (…).
5.) All other motions or prayers for relief are dismissed.

In February 2016 the International Volleyball Federation (FIVB) has reported an anti-doping rule violation against the Russian Athlete after his sample (provided on 9 January 2016) tested positive for the prohibited substance Meldonium. After notification a provisional suspension was ordere. The Athlete filed a statement in his defence and he was heard for the FIVB Disciplinary Panel.

The Athlete admitted that he had used prescribed meldonum for his heart condition until 13 December 2015 without intention to enhance his sport performance. He argued that the substance was still in his system in January 2016 and that he had no fault or negligence in this case considering the low concentration found in his sample (300 ng/mL) and in accordance with the criteria in the WADA Notice to issue a No Fault or Negligence in samples taken before 1 March 2016.

Considering the statements and the WADA Notice the Panel accepts that there is no other evidence suggesting that the Athlete had used Meldonium after 1 January 2016.

Therefore the FIVB Disciplinary Panel decides on 28 April 2016:

1.) The athlete Mr. Alexander Markin (Russia) has committed an anti-doping rule violation (presence of the prohibited substance “S4. Hormone and Metabolic Modulators (Meldonium))” according to Article 2.1 of the FIVB MADR.
2.) No period of ineligibility shall be imposed on the athlete Mr. Alexander Markin due to the determination that he had No Fault or Negligence pursuant to Article 10.4 FIVB MADR.
3.) The Russian national team’s results from the 2016 European Olympic Qualification competition stand.
4.) This decision may be appealed in accordance with the attached Notice of Appeals.

Annual banned-substance review: analytical approaches in human sports drug testing / Mario Thevis, Tiia Kuuranne, Hans Geyer, Wolhelm Schänzer. - (Drug testing and analysis 9 (2017) 1 (January) : p. 6-29)

• PMID: 27885819
• DOI: 10.1002/dta.2139

Contents:

• Introduction
• Non-approved substances
• Anabolic agents
  
  • Anabolic-androgenic steroids
  • Iitial testing procedures – multi-analyte screening methods and alternative chromatographic- mass spectrometric techniques
  • Initial testing procedures – metabolism studies and new target analytes
    • Steroid profiling
    • Alternative test methods and approaches
    • Other anabolic agents
  • Peptide hormones, growth factors and related subsances
    • Hyoxia-iducible factor stabilizers and activators
    • Growth hormone
    • Corticotrophins, insulin-like growth factor-1 (IGF-1), and other growth or releasing factors
  • Beta-2-agonists
  • Hormone and metabolic modulators
• Diuretics and other masking agents
• Stimulants
• Narcotics and glucocorticoids
• Manipulation of blood and blood components
• Chemical and physical manipulation
• Gene doping
• Conclusion
• References

 Abstract

There has been an immense amount of visibility of doping issues on the international stage over the past 12 months with the complexity of doping controls reiterated on various occasions. Hence, analytical test methods continuously being updated, expanded, and improved to provide specific, sensitive, and comprehensive test results in line with the World Anti-Doping Agency's (WADA) 2016 Prohibited List represent one of several critical cornerstones of doping controls. This enterprise necessitates expediting the (combined) exploitation of newly generated information on novel and/or superior target analytes for sports drug testing assays, drug elimination profiles, alternative test matrices, and recent advances in instrumental developments. This paper is a continuation of the series of annual banned-substance reviews appraising the literature published between October 2015 and September 2016 concerning human sports drug testing in the context of WADA's 2016 Prohibited List.

Story behind Meldonium - from pharmacology to performance enhancement: a narrative review / Wolfgang Schobersberger, Tobias Dünnwald, Günther Gmeiner, Cornelia Blank. - (British Journal of Sports Medicine 51 (2016) 1 (July 27) : p. 22-25). - PubMed: 27465696. - DOI: 10.1136/bjsports-2016-096357

Abstract:

Recent reports from the World Anti-Doping Agency (WADA) indicate an alarming prevalence in the use of meldonium among elite athletes. Therefore, in January 2016, meldonium was added to WADA's prohibited list after being monitored since 2015. Meldonium has been shown to have beneficial effects in cardiovascular, neurological and metabolic diseases due to its anti-ischaemic and cardioprotective properties, which are ascribed mainly to its inhibition of ß-oxidation and its activation of glycolysis. Despite its widespread use, there are only a few clinical studies or clinical trials available. Meldonium is registered in most Baltic countries and is easily accessible through the internet with no serious adverse effects reported by the manufacturer so far. Among athletes, meldonium is used with the purpose of increasing recovery rate or exercise performance. The benefit of taking meldonium in view of performance enhancement in athletes is quite speculative and is discussed without sound scientific evidence. This narrative review provides a detailed overview of the drug meldonium, focusing on the main topics pharmacology and biochemical actions, clinical applications, pharmacokinetics, methods of detection and potential for performance enhancement in athletes.

Prohibited List January 2017 : The World Anti-Doping Code International Standard / World Anti-Doping Agency (WADA). - Montreal : WADA, 2016.

- The official text of the Prohibited List shall be maintained by WADA and shall be published in English and French. In the event of any conflict between the English and French versions, the English version shall prevail.
- This List shall come into effect on 1 January 2017

CAS AD 16/11 International Olympic Committee v. Misha Aloian

Related case:
CAS 2017_A_4927 Misha Aloyan vs IOC
June 16, 2017

Mr. Misha Aloian is a Russian Athlete competing in the Men’s -52kg boxing event at the Rio 2016 Olympic Games.

On 7 September 2016 the IOC has reported an anti-doping rule violation against the Athlete after his sample tested positive for the prohibited substance tuaminoheptane. After notification the Athlete filed a statement in his defence and he was heard for the CAS Anti-Doping Division in November 2016.

The Athlete argued that he bears no fault or negligence and that the amount of substance found in his body did not have a performance enhancing effect. The Athlete asserted that he had used the medication Rhinofluimucil out-of-competition on the advice of his team doctor and that the was advised inaccurately by his doctor.

On the balance of probability the Sole Arbitrator accepts the Athlete’s explanation that he used for his chronic disease a medication containing a prohibited substance on the advice of his team doctor.
However the Sole Arbitrator rules that the Athlete failed in his personal duty to ensure that no prohibited substance enerters his body.

Therefore the CAS Anti-Doping Division Sole Arbitrator decides on 8 December 2016:

1.) The Athlete is found to have committed an anti-doping rule violation pursuant to Article 2.1 of the IOC ADR.
2.) The results obtained by the Athlete in the Men’s -52kg boxing event at the Olympic Games Rio 2016, in which he finished 2nd and for which he was awarded a Silver medal, are disqualified with all consequences, including forfeiture of the medal, Olympic diploma and medallist pin.
3.) The Athlete is ordered to return the medal, the diploma and the medallist pin.
4.) The International Boxing Association is requested to modify the results of the above-mentioned event accordingly and to consider any further action within its own competence.
5.) The Russian Olympic Committee is requested to ensure full implementation of this decision and secure the return to the IOC, as soon as possible, of the medal, the medallist pin and the diploma awarded in connection with the Men’s -52kg boxing event.