Adverse events associated with testosterone administration / Shehzad Basaria, Andrea D. Coviello, Thomas G. Travison, Thomas W. Storer, Wildon R. Farwell, Alan M. Jette, Richard Eder, Sharon Tennstedt, Jagadish Ulloor, Anqi Zhang, Karen Choong, Kishore M. Lakshman, Norman A. Mazer, Renee Miciek, Joanne Krasnoff, Ayan Elmi, Philip E. Knapp, Brad Brooks, Erica Appleman, Sheetal Aggarwal, Geeta Bhasin, Leif Hede-Brierley, Ashmeet Bhatia, Lauren Collins, Nathan LeBrasseur, Louis D. Fiore, Shalender Bhasin. - (New England Journal of Medicine 363 (2010) 2 (8 July); p. 109-122)

• PMID: 20592293
• PMCID: PMC3440621
• DOI: 10.1056/NEJMoa1000485

Abstract

Background: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.

Methods: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.

Results: A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.

Conclusions: In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

Related cases:
- ANAD Comitet Sancțiune 2008_05 ANAD vs Corina Dumbrӑvean
February 19, 2008
- ANAD Comisia de Apel 2008_06 Olimpic Sport Club & Corina Dumbrӑvean vs ANAD
December 12, 2008
- CAS 2009/A/1764 Olimpic Sport Club vs ANAD
October 9, 2009
- ANAD Comisia de Apel 2010_06 Corina Dumbrӑvean vs ANAD
August 10, 2010
- ANAD Comisia de Apel 2010_07 Olimpic Sport Club vs ANAD
August 10, 2010
- ANAD Comisia de Apel 2010_08 Eleodor Rosca vs ANAD
November 18, 2010
- CAS 2010/A/2220 Corina Dumbrӑvean vs ANAD
July 26, 2011

In May 2010 the Agenţia Naţională Anti-Doping (ANAD), the National Anti-Doping Agency of Romania, has reported an anti-doping rule violation against the Athlete Corina Dumbrӑvean after she attempted to tamper with her sample and refused to provide a sample for drug testing.
After notification a provisional suspension was ordered. The Athlete filed a statement in her defence and was heard for the ANAD Hearing commission.

The Athlete claimed that she was not on the location as mentioned in het whereabouts information and that she did not receive the invitation for testing. Several witnesses stated that the Athlete was not in Villa Olympic when the sample collection was conducted on 18 May 2005. The witnesses failed to identify the person presumed to undergo the doping test and the Doping Control Officers (DCO) stated they recognized the Athlete Corina Dumbrӑvean as the person who signed the invitation to provide a sample.
The Athlete sustained her claim that she was not the person who was tested by the two DCO’s on 18 May 2005. A criminologist expert testified that the person who signed the Invitation to provide a sample was not written by the Athlete Corina Dumbrӑvean.
However the National Crimonology Institute of the Romanian Ministry of Justice investigated several document with the Athlete's signature and concluded in July 2010 that the Athlete’s signature on the invitation to provide a sample on 18 May 2010 belonged to the Athlete Corina Dumbrӑvean.

The ANAD Hearing Commission considered in this case the statements and evidence and the fact that the Athlete committed a second anti-doping rule violation. In addition the IAAF has reported in March 2010 that the Athlete tested positive for the prohibited substance erythropoetin (EPO).
Therefore the ANAD Hearing Commission decides to impose a lifetime period of ineligibility on the Athlete, starting on the date of the provisional suspension, i.e. on 3 June 2010 (case 18/08.07.2010)

Related cases:

- Dutch District Court 2009 Athlete 2009005 vs KNSB and Dopingautoriteit
June 9, 2009
- KNSB 2009 KNSB Preliminary Decision Disciplinary Committee 2009005 TU1
September 8, 2009
- Dutch District Court 2010 Athlete 2009005 vs KNSB
September 30, 2009
- KNSB 2009 KNSB Preliminary Decision Disciplinary Committee 2009005 TU2
October 15, 2009
- KNSB 2009 KNSB Preliminary Decision Disciplinary Committee 2009005 TU3
December 2, 2009
- KNSB 2010 KNSB Decision Disciplinary Committee 2009005 T
March 12, 2010
- KNSB 2010 KNSB Decision Appeal Committee 2009005 B
November 26, 2010
- CAS 2010/A/2311 Stichting Anti-Doping Autoriteit Nederland (NADO) & the Koninklijke Nederlandsche Schaatsenrijders Bond (KNSB) vs W.
August 22, 2011

In February 2009 the Royal Netherlands Skating Association (KNSB) has reported an anti-doping rule violation against the minor Athlete after his A and B samples tested positive for the prohibited substance norandrosterone (Nandrolone). After notification a provisional suspension was ordered by the KNSB.

In this 4# preliminary case proceeding the Athlete argued that the costs for an expert investigation under the Rules shall be borne by the KNSB due to the T/E ratio wasn't subject of the investigation.
The KNSB Appeal Committee accepted the Athlete's argument and ruled on 6 July 2010 that the costs for the expert investigation shall be borne by the KNSB.

Full Case History:

Between 2009 and 2011 a number of proceedings and appeals followed in the dispute between the Athlete, the KNSB and Dopingautoriteit about the anti-doping violation and the Athlete seeking annulment of the disciplinary proceedings and sanctions.

- On 9 June 2009 the Dutch District Court dismissed the Athlete’s objections about the validity of the sample collection and violation of his rights.
- On 8 September 2009 the KNSB ruled in the 1# Preliminary Decision about the validity of the sample collection and the validity of the test results for which a independent expert is appointed and the Dopingautoreit is ordered to provide additional information about the laboratory procedures and protocols.
- On 30 September 2009 the Dutch District Court dismissed the Athlete’s request to lift the provisional suspension.
- On 15 October 2010 the KNSB Disciplinary Committee ruled in the 2# Preliminary Decision about the possibility for lifting the provisional suspension for which a new hearing is ordered.
- On 2 December 2009 the KNSB Disciplinary Committee ruled in the 3# Preliminary Decision that the imposed provisional suspension will expire in February 2010 when the KNSB has not rendered a final decision against the Athlete.
- On 12 March 2010 the KNSB Disciplinary Committee dismissed the Athlete’s arguments about the validity of the test results and decided to impose a 1 year period of ineligibility on the Athlete and 1 year probationary period until November 2011.
- On 6 July 2010 the KNSB Appeal Committee ruled in the 4# Preliminary Decision that under the Rules the costs for an expert investigation shall be borne by the KNSB.
- On 26 November 2010 the KNSB Appeal Committee decides to annul the KNSB Disciplinary Committee decision of 12 March 2010 because of the KNSB’s refusal to provide additional documentation to verify the validity of the laboratory testing method as violation of the Athlete’s right of defence.

Hereafter the Dopingautoriteit and the KNSB appealed the decision the KNSB Appeal Committee of 26 November 2010 with the Court of Arbitration for Sport (CAS).

The CAS Panel concludes that the Athlete’s samples tested positive for the prohibited substance norandrosterone (Nandrolone) and that no departure from the ISL occurred in this case. Therefore the CAS Panel upholds the decision of the 12 March 2010 of the KNSB Disciplinary Committee and decides to set aside the decision of the KNSB Appeal Committee of 26 November 2010.

Facts
UK Anti-Doping Limited (“UKAD") charged Dan Staite ("player") for an anti-doping rule violation. Two Prohibited Substances (as defined), erythropoietin and androsta-1,4,6-triene-3,17-dione, had been found in an urine sample provided by player on March 13, 2010. A hearing in the player's absence, to determine the charge and consequences, took place on June 28, 2010. At his home he refused a blood test on 18 March 2010.

History
The player is a cyclist and is bound by the Anti-Doping Rules adopted by the British Cycling Federation (“the Rules”). He admits the offence and by mail he made clear not to attend the hearing.

Decision
The sole arbiter rules:
1. an anti-doping rule violation was committed by the player;
2. the period of ineligibility in his case is to be two years;
3. the period of ineligibility is to run from 8 a.m. on 1 May 2010 to 8 a.m. on 1 May 2012.

Appeal
Either UKAD or Mr Staite (or any of the organisations specified in Article 13.4.1 of the Rules) may appeal against this decision.

TAS 2009/A/2014 Agence Mondiale Antidopage (AMA) c. ASBL Royale Ligue Vélocipédique Belge (RLVB) & Iljo Keisse

CAS 2009/A/2014 WADA vs Iljo Keisse & Royale Ligue Vélocipédique Belge (RLVB)

The Athlete Iljo Keissen is a professional Belgian cyclist with an UCI licence.

In December 2008 the UCI reported an anti-doping rule violation aginst the Athlete after his A and B samples tested positive for the prohibited substance cathine (above the WADA threshold), chlorothiazide and hydrocholothiazide. However on 2 November 2009 the RLVB Disciplinary Commission decided not to impose a sanction on the Athlete. 

In first instance the RLVB Disciplinary Commission ruled that not had been established to their satisfaction that the concentration cathine had exceeded the threshold limit. Furthermore the Commission deemed that the Athlete had demonstrated how the other substances had entered his system and that he had acted with no fault or negligence

Hereafter in December 2009 WADA appealed the RLVB decision of 2 November 2009 with the Court of Arbitration for Sport.

Preliminary the Athlete had challenged the CAS jurisdiction and claimed that his ECHR rights were violated. However Panel determines that the Athlete’s rights had not been violated and therefore that there are no grounds for suspension of the proceedings.

The Athlete asserted that the product Sinnutab Forte he had used contained pseudoephedrine and had caused the positive test result for cathine. The other substances found in his sample were the result of supplement contamination in his ZMA capsules he had used.

Following assesment of the Athlete's conduct the Panel concludes that he failed to research the ingredients of his supplements before using and failed to demonstrate that he acted not intentionally.

Therefore on 6 July 2010 the Cour of Arbitration for Sport decides to impose a 2 year period of ineligibility on the Athlete, starting on the date of the provisional suspension, i.e. 9 December 2008.

Facts
UK Anti-Doping Limited ("UKAD") charges Ben Payne ("player") for a violation of the Anti-Doping Rules. The prohibited substances, 19-norandrosterone and 19-noretiocholanolone, had been found in a urine sample provided by Mr Payne on 13 March 2010. The player indicated that he did not dispute the fact of the anti-doping rule violation but that he wished to put forward reasons why he should not be subjected to the usual 2 year suspension for such a violation. Unfortunately, the player did no more than say that he would explain to me at the hearing why this should be so. Eventually the player decides not to attend the oral hearing, but because everything was set it took place without the player.

History
The player explained that he had suffered severe facial injury during a game of hockey and, at the suggestion of a friend, had taken two substances called “Deca” and “Sustanon” in order to aid his recovery.

Conclusion
In summary the following decision has been made:
1. an anti-doping rule violation was committed by the player;
2. the period of ineligibility in his case is to be two years; and the period of ineligibility is to run from 8 a.m. on April 16, 2010 to 8 a.m. on April 16, 2012.

Appeal
Either UKAD or Mr Payne (or any of the organisations specified in Article 13.4.1 of the Rules) may appeal against this decision as set out in the preceding paragraph.

Positief na dopingcontrole door Vlaamse Overheid: 2009 / NADO Flanders. - Brussels : Flemish Government, 2010

Nederlandse tuchtrechtspraak en de toepassing van de World Anti-Doping Code / Steven Teitler, Herman Ram. - (Tijdschrift voor Sport & Recht (2010) 2 (Juli) : p. 57-70)

Nog niet zo lang geleden beschikten de tuchtcommissies over vrijwel onbeperkte bevoegdheden en mogelijkheden om dopingzaken af te handelen zoals het hen goed dunkte. Afgezien van enkele richtlijnen inzake de strafmaat voorzagen de dopingreglementen tot 2004 niet in tuchtrechtelijke voorschriften. De behandeling van een overtreding van het dopingreglement vond toen nog geheel plaats volgens de normen van het tuchtreglement, waar het dopingreglement tegenwoordig vrijwel op zichzelf staat. Veel dopingzaken kwamen toentertijd echter niet bij de tuchtcommissies terecht, vanwege het feit dat bondsbesturen die regelmatig onder de spreekwoordelijke pet hielden. In die gevallen volgde dus geen aangifte. De komst van de World Anti-Doping Code heeft voor zowel de vrijheid van de tuchtcolleges als die van bondsbesturen ingrijpende gevolgen gehad.

Inhoud:

1. Inleiding
2. Terugdringen rechtsongelijkheid en rechtsonzekerheid: voorgeschiedenis en instrumenten
2.1. Internationaal Olympisch Commité
2.2. WADA
2.3. Unesco
3. Gesloten systeem: bewijsvoering en sanctiestelsel
4. Auditcommissie Doping
5. Jurisprudentie sinds invoering Code (2004)
6. Bewijslast
7. Sanctiestelsel
8. Formele/procedurele eisen
9. Informatieplicht
10. Kennis & acceptatie
11. Samenvatting en conclusies
12. Consequenties/vooruitblik

Maltese Doping Cases / Claude Ramoni. – (International Sports Law Journal (2010) 3-4 : p. 178-181)

Content:
- Background facts
- Admissibility of the appeal
- Applicable Rules on the merit – FIFA or MFA regulations?
• Was the FIFA Disciplinary Code directly applicable?
• Did article 60 par. 2 of the FIFA Statutes compel the panel to apply FIFA regulations?
• Was the FIFA Disciplinary Code applicable by reference?
• Comment
- Sanctions
- Conclusion

At the end of 2007 and the beginning of 2008, three Maltese football players, Mattocks, Martin and Grech tested positive for prohibited substances and were suspended for 4 months (Mattocks), 9 months (Martin) and 12 months (Grech) by the Malta Football Association (MFA).
Both WADA and FIFA appealed all three decisions rendered by MFA. It seemed quite obvious to FIFA and WADA that the sanctions imposed by the MFA were not in line with the provisions of the then applicable FIFA Disciplinary Code (the 2007 FDC) or of the World Anti-Doping Code (WADC). FIFA and WADA therefore were of the opinion that all three sanctions imposed by MFA were too lenient.

The effect of the appeals lodged by FIFA and WADA in the cases of the Maltese players was to allow the CAS to review decisions rendered in application of national Maltese rules, which do not provide for a right of appeal by FIFA or WADA... The panel partially upheld two out of the three appeals, imposing however, sanctions which are not in line with the FDC or the WADC. This (practical) result does not seem in line with the purpose of the appeal by FIFA and WADA in doping matters as provided for under the FIFA Statutes.

The Need for WADA to Address Confidentiality Leaks in Drug Testing in Olympic Sports – The Ian Thorpe Situation / John T. Wendt. – (International Sports Law Journal (2010) 3-4 : p. 47-54)

Content:
- Introduction
- Thorpe’s Accomplishments
- Thorpe as an Anti-Doping Crusader
- Ressiot and l’Equipe
- Reactions to the Leak and Accusation
- WADA and Confidentiality
- Thorpe and Ressiot
- FINA, ASADA and Thorpe
- Thorpe Sues Ressiot and L’Equipe
- Reforms and Need for Confidentiality
- Changes to the World Anti-Doping Code
- Conclusion
- References

Ian Thorpe is an Australian successful elite level swimmers.
Thorpe has also been one of the leading opponents of doping.
He was a founding athlete-member of the World Anti-Doping
Association’s (WADA) “Athlete’s Passport” Program and was one of the first to provide blood samples to be frozen for future testing in accordance with WADA’s new testing procedures (World Anti-
Doping Code Annual Report, 2002). But, that reputation was tarnished when someone leaked confidential information to Damien Ressiot, a journalist for the French newspaper, L’Equipe, who accused Thorpe of committing a doping offense. For Ian Thorpe, there were two volatile issues − first, the truth of the allegations, and second the breach of confidentiality of his personal records.

Confidentiality is at the heart of any drug testing program. Names should not be revealed, unless it is firmly and legally established that a doping offense has been committed. A breach of confidentiality and media leaks undermine the entire system. It is essential that there is confidentiality throughout the whole process until there is a finding that an individual has in fact committed a doping offense. This comment looks at the breach of confidentiality of Ian Thorpe’s records, and the need for WADA to act to remedy the problem.