Reporting and managing elevated testosterone/epitestosterone ratios--novel aspects after five years' experience

1 Nov 2010

Reporting and managing elevated testosterone / epitestosterone ratios--novel aspects after five years' experience / Ute Mareck, Hans Geyer, Gregor Fußhöller, Anne Schwenke, Nadine Haenelt, Thomas Piper, Mario Thevis, Wilhelm Schänzer. - (Drug Testing and Analysis 2 (2010) 11-12 (November) ; p. 637-642).

  • PMID: 21204295
  • DOI: 10.1002/dta.234

Abstract:

The testosterone/epitestosterone (T/E) ratio was implemented as an indirect parameter for the detection of testosterone administration with an empirically established threshold value at T/E = 6. In 2005, the T/E reporting threshold was lowered from six to four.

Between 2005 and 2009, 63 510 doping control urine samples were analyzed in the Cologne laboratory. A total of 1442 specimens (2.3%) showed a T/E > 4; 80 (5.5%) of which were tested positive by means of isotope ratio mass spectrometry (IRMS); and most of which (68) originated from strength sport disciplines.

Specimens of high T/E ratio showed a much higher probability for being confirmed to contain exogenous testosterone using IRMS analysis than samples of low T/E values.

Considering the small number of adverse analytical findings triggered by lowering the T/E reporting threshold (978 urine specimens with T/E ratios between 4 and 6 yielded only 4 (0.4%) positive IRMS findings) and the known limitations of the T/E ratio as discriminating parameter (UGT2B17 polymorphism), the currently mandatory approach shows only marginal overall efficiency.

A more effective tool for the detection of the misuse of testosterone would be the implementation of individual reference ranges. Until athlete steroidal passports are available, it is suggested to exceed the threshold level for T/E from 4 to 6 and perform obligatory IRMS analysis for specimens showing T/E > 6. Further conditions triggering IRMS analysis could be suppressed luteinizing hormone (LH) values in males and disproportionate changes of relevant parameters in individual profiles evidently not resulting from ethanol consumption.

From population- to subject-based limits of T/E ratio to detect testosterone abuse in elite sports.

7 May 2007

From population- to subject-based limits of T/E ratio to detect testosterone abuse in elite sports / Pierre-Edouard Sottasa, Christophe Saudana, Carine Schweizer, Norbert Baume, Patrice Mangin, Martial Saugy. - (Forensic Science International 174 (2008) 2-3 ( 30 January) ; p. 166-172)

  • PMID: 17485185
  • DOI: 10.1016/j.forsciint.2007.04.001

Abstract:

In elite sports, indirect testing of testosterone abuse is mainly based on the testosterone over epitestosterone (T/E) ratio. Since this marker is characterized by a small ratio of intra- to inter-individual variation, it is surprising that current anti-doping strategy uses a screening test based on a population-based limit.

From a database of more than 15,000 steroid profiles obtained from routine controls, the collection of steroids profiles of 11 elite athletes followed during 2 years, and a longitudinal study involving 17 amateur athletes, 8 of which were orally administrated testosterone undecanoate pills, we selected 12 case studies to represent the possible scenarios to which the anti-doping laboratories are confronted.

Various detection strategies at the disposal of the laboratories are employed and discussed, including isotope ratio mass spectrometry (IRMS) analysis and a Bayesian interpretation of the T/E-time profile. The weak sensitivity versus specificity relation of a population-based limit for the T/E ratio is outlined.

As a result, we propose a Bayesian screening test whose T/E threshold progressively evolves from a population basis to a subject basis as the number of individual test results increases. We found that this screening test heightens drastically the capacity to detect testosterone abuse, at no additional financial and administrative expenses for anti-doping authorities.

Performance characteristics of a carbon isotope ratio method for detecting...

22 Nov 2000

Performance characteristics of a carbon isotope ratio method for detecting doping with testosterone based on urine diols: controls and athletes with elevated testosterone / epitestosterone ratios / Rodrigo Aguilera, Thomas Edward Chapman, Borislav Starcevic, C.K. Hatton, D.H. Catlin. - (Clinical Chemistry 47 (2001) 2 (February) ; p. 292-300)

  • PMID: 11159778

Abstract

Background: Carbon isotope ratio methods are used in doping control to determine whether urinary steroids are endogenous or pharmaceutical.

Methods: Gas chromatography-combustion-isotope ratio mass spectrometry (GC-C-IRMS) was used to determine the delta(13)C values for 5 beta-androstane-3 alpha,17 beta-diyl diacetate (5 beta A), 5 alpha-androstane-3 alpha,17 beta-diyl diacetate (5 alpha A), and 5 beta-pregnane-3 alpha,20 alpha-diyl diacetate (5 beta P) in a control group of 73 healthy males and 6 athletes with testosterone/epitestosterone ratios (T/E) >6.

Results: The within-assay precision SDs for 5 beta A, 5 alpha A, and 5 beta P were +/- 0.27 per thousand, +/- 0.38 per thousand, and +/- 0.28 per thousand, respectively. The between-assay precision SDs ranged from +/- 0.40 per thousand to +/- 0.52 per thousand. The system suitability and batch acceptance scheme is based on SDs. For the control group, the mean delta(13)C (SD) values were -25.69 per thousand (+/- 0.92 per thousand), -26.35 per thousand (+/- 0.68 per thousand), and -24.26 per thousand (+/- 0.70 per thousand), for 5 beta A, 5 alpha A, and 5 beta P, respectively. 5 beta P was greater than 5 beta A and 5 alpha A (P <0.01), and 5 beta A was greater than 5 alpha A (P <0.01). The means - 3 SD were -28.46 per thousand, -28.39 per thousand, and -26.37 per thousand for 5 beta A, 5 alpha A, and 5 beta P, respectively. The maximum difference between 5 beta P and 5 beta A was 3.2 per thousand, and the maximum 5 beta A/5 beta P was 1.13. Three athletes with chronically elevated T/Es had delta(13)C values consistent with testosterone administration and three did not.

Conclusions: This GC-C-IRMS assay of urine diols has low within- and between-assay SDs; therefore, analysis of one urine sample suffices for doping control. The means, SDs, +/-3 SDs, and ranges of delta(13)C values in a control group are established. In comparison, testosterone users have low 5 beta A and 5 alpha A, large differences between 5 beta A or 5 alpha A and 5 beta P, and high 5 beta A/5 beta P and 5 alpha A/5 beta P ratios.

WADA Prohibited List 2008

22 Sep 2007

The 2008 Prohibited List International Standard : The World Anti-Doping Code / World Anti-Doping Agency (WADA). - Montreal : WADA, 2007.

- 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 2008

WADA Prohibited List 2009

20 Sep 2008

The 2009 Prohibited List International Standard : The World Anti-Doping Code / World Anti-Doping Agency (WADA). - Montreal : WADA, 2008.

- 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 2009

WADA Prohibited List 2010

19 Sep 2009

The 2010 Prohibited List International Standard : The World Anti-Doping Code / World Anti-Doping Agency (WADA). - Montreal : WADA, 2009.

- 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 2010

CAS 2008_A_1608 IAAF vs Athletic Federation of Slovenia & Ms Helena Javornik

13 Mar 2009

CAS 2008/A/1608 International Association of Athletics Federations v/ Athletic Federation of Slovenia & Ms Helena Javornik

In April 2008 the International Association of Athletics Federations (IAAF) has reported an anti-doping rule violation against the Slovenian Athlete Helena Javornik after her A and B samples tested positive for the prohibited substance recombinant human erythropoietin (rhEPO).
However on 19 June 2008 the Athletic Federation of Slovenia (AFS) ruled that the Athlet didn’t commit an anti-doping rule violation and that the imposed provisional suspension was not valid.

Here the AFS finds that the analytical results of the Athlete’s sample did not establish the presence of a prohibited substance, since they didn’t fulfil the criteria set in the WADA Technical Document TD2007EPO.

Hereafter in July 2008 the IAAF appealed the Slovenian decision with the Court of Arbitration for Sport (CAS). The IAAF requested the Panel to set aside the AFS decision of 19 June 2008 and to impose a 2 year period of ineligibility on the Athlete.

The IAAF rejected the grounds to declare the Athlete not guilt for a doping offence and considers the AFS decision to be erroneous and procedurally unsound. The IAAF contended that the tests results were valid, in accordance with the ISL and the relevant WADA Technical Document.

The Panel investigated and considered the evidence in this case and concludes that the IAAF has established, to the comfortable satisfaction of the Panel, that the anti-doping rule violation has been committed and that the analyses of the A sample and of the B sample of the Athlete’s urine show positive results. Such results cannot be held to amount to falsely positive results.

Further the Panel finds that no departures occurred and, in any case, that the validity of the analytical findings in the Athlete’s sample was not undermined. Also the Panel holds, in any case, that it has been demonstrated that the collection, storage and transport conditions of the Athlete’s sample did not undermine the validity of adverse analytical finding established in the Seibersdorf Lab.

Therefore the Court of Arbitration for Sport decides on 13 March 2009 that:

1.) The appeal filed by the International Association of Athletics Federations against the decision issued on 19 June 2008 by the Antidoping Commission of the Athletic Federation of Slovenia is upheld.
2.) The decision adopted on 19 June 2008 by the Antidoping Commission of the Athletic Federation of Slovenia is set aside.
3.) Ms Helena Javornik is found guilty of an anti-doping rule violation under IAAF Competition Rule 32.2(a) and is declared ineligible for a period of 2 years commencing on 11 June 2008.
4.) All other prayers for relief are dismissed.
5.) This award is pronounced without costs, except for the court office fee of CHF 500 (five hundred Swiss Francs) paid by the International Association of Athletics Federations, which is retained by the CAS.
6.) Each party shall bear its own costs.

CAS 2009_A_1805 IAAF vs RFEA & Josephine Onyia

22 Sep 2009

CAS 2009/A/1805 IAAF v. RFEA & Josephine Onyia
CAS 2009/A/1847 IAAF v. RFEA & Josephine Onyia

In September 2008 the International Association of Athletics Federations (IAAF) has reported two anti-doping rule violations against the Spanish Athlete Josephina Onyia after her A and B samples - provided on two occasions in Lausanne and in Stuttgart in September 2008 - tested positive for the prohibited substances Clenbuterol and Methylhexaneamine (dimethylpentylamine).
However on 21 January 2009 and on 12 March 2009 the Royal Spanish Athletics Federation (RFEA) concluded in both cases that the Athlete committed no anti-doping rule violation and decided to lift the ordered provisional suspension.

The RFEA contended regarding the reported presence of Clenbuterol that the found concentration was below the Minimum Required Performance Limit; the Cologne Lab did not comply with the ISL; the presence of Clenbutrol could be caused by the ingestion of contamined meat; and the Athlete did not commit any punishable intentional doping conduct.

In the matter of the reported presence of Methylhexaneamine the RFEA contended that this substance was not prohibited under the WADA 2008 Prohibited List; when listed the substance should be classified as a Specified Substance; it was unlikely she would have committed a doping violation given the probalility to be tested; no stimulants were found in her other samples provided in the same month; and the Lausanne erred to quantify the substance that was found.

Hereafter in April 2009 the IAAF appealed the two Spanish decisions with the Court of Arbitration for Sport (CAS).

The IAAF rejected the grounds to exonerate the Athlete and argued that the Cologne Lab tests results were valid and that the Lab was obliged to analyse samples in accordance with the ISL and the relevant WADA Technical Document. In the matter of the substance Methylhexaneamine the IAAF asserted that the substance was no specifically mentioned but classified in the Prohibited List as related substances under section 6. Further the Athlete failed to establish in both cases how the substance entered her system and under the IAAF Rules there was no need to prove that the violation was intentional.

The Panel finds that in each case the Athlete was shown, to the requisite standard of proof (i.e. to a standard greater than a mere balance of probability), to have a prohibited substance in her samples. In each case therefore she has been shown to have committed an anti-doping rule violation. In neither case was she able to impugn the analysis or provide evidence to show, on the balance of probabilities, how the Prohibited Substance had come to be in her samples. She was therefore not in a position to assert that she bore no, or no significant, fault or negligence for the violations. The appeals by the IAAF will therefore be allowed. The two anti-doping rule violations are to be considered as one single first anti-doping rule violation.

Therefore the Court of Arbitration for Sport decides on 22 September 2009 that:

1.) The appeals of the International Association of Athletics Federations are allowed.
2.) Ms Josephine Onyia is declared ineligible for all competition in respect of the two anti-doping rule violations for a period of two years, commencing on 22 September 2009.
However, credit is given for the periods of ineligibility already served because of the provisional suspensions totaling 316 days from 30 September 2008 to 21 January 2009 and from 4 March 2009 to 21 September 2009,
3.) Ms Josephine Onyia is disqualified from the 100m hurdles at the IAAF Golden League meeting "Athletissima" held in Lausanne on 2 September 2008 and from all subsequent events until the commencement date of the period of ineligibility with all resulting consequences, including the forfeiture of all titles, awards, medals, points and prize and appearance money.
4.) (…)

CAS 2011_A_2353 IAAF vs Erik Tysse

29 Aug 2011

CAS 2011/A/2353 Erik Tysse v. Norwegian Athletics Federation (NAF) & International Association of Athletics Federations (IAAF)

Athletics (race walking)
Doping (EPO CERA)
Validity of the method to find Continuous Erythropoetin Receptor Activator (CERA) in a urine sample
Adverse analytical finding
Departure from International Standards
Violation of the European Convention for Human Rights

1. To establish a CERA doping violation, the applicable TD2009EPO (Technical Document issued by WADA) provides that the criteria of analysis has been established to ensure harmonization in the performance of the EPO test. For the detection of EPO, and in particular of EPO CERA, the isoelectrofocusing (IEF) analysis method must first meet the acceptance criteria. Once the analysis meets the acceptance criteria, TD2009EPO requires that the lab apply the identification criteria. Once the identification criteria is met and an Adverse Analytical Finding is suspected, the lab, in the confirmation phase, must perform a stability test on the sample.

2. Iron injections cannot explain an adverse analytical finding of EPO CERA where the evidence of an athlete’s experts is not supported by any reliable evidence.

3. Regarding any alleged breaches or departures in general, the IAAF Rules provides that the laboratory is presumed to have conducted the analysis in accordance with the International Standards for Testing. An athlete may of course rebut this presumption, but must do so on the balance of probabilities.

4. Even if it were applicable, there is no violation of the European Convention for Human Rights due to the fact that the No Fault and No Significant Fault provisions in both the WADA Code and the IAAF Rules protect athletes against any violation in this respect.


On 31 January 2011 the Norwegian Athletics Federation (NAF) Tribunal decided to impose a 2 year period of ineligibility on the race walker Erik Tysse after his A and B samples tested positive for the prohibited substance Methoxy polyethylene glycol-epoetin beta (CERA).

Hereafter in February 2011 the Athlete appealed the Norwegian decision with the Court of Arbitration for Sport (CAS).

The Athlete contended that the NAF Tribunal erred in confusing the quality of the tests and the interpretation of the test results and, as such, incorrectly concluded that his doping tests were positive.
Here he argued that the method used by the Rome Lab to detect CERA is unreliable nevertheless when interpreted correctly does not show the presence of CERA. Also the results from the Rome Lab do not meet the standards as set out in the WADA Technical Document in question and there were several procedural errors in the Rome Lab.

The NAF and IAAF rejected the Athlete’s arguments and asserted that a validated and reliable method for detecting rEPO and analogues and the analytical data from the Athlete’s test was correctly interpreted in accordance with the WADA Technical Document.

The Panel finds that it is established that there is CERA in the Athlete’s sample and that the Athlete’s expert’s evidence in this case is not relevant. Regarding the requirements in the WADA Technical Document, the Panel finds that the acceptance criteria, the identification criteria, and the stability criteria are met in this case. Further the Panel finds that the evidence establish that the used IEF method is both valid and has a high degree of specificity. The Panel finds that the medical records show no direct evidence that the Athlete suffers from any kidney condition.
The Panel concludes that the Athlete has failed to establish any departure on the balance of probabilities.

Therefore the Court of Arbitration for Sport decides on 29 August 2011 that:

(1) The appeal filed by the Appellant Mr Erik Tysse on 16 February 2011 is dismissed.
(2) The decision of the NAF Tribunal dated 31 January 2011 is hereby confirmed.
(3) (…)

Dopingautoriteit Annual Report 2007 (Netherlands)

1 Apr 2008

Dopingautoriteit jaarverslag 2007 / Dopingautoriteit. - Capelle aan den IJssel, 2008

This is the second Annual Report from the Anti-Doping
Authority of the Netherlands. The organisation was
established on 23 June 2006 with the merger of the
Netherlands Centre for Doping Affairs and Doping
Control Netherlands.
The merger has become more than just the sum of
the parts: the activities of both merger partners will be
recognisable in this report, but the new structure has
changed the way those activities are positioned in the
organisation and had an impact on their implementation.
In addition to the two operational departments dealing
with Prevention and Control, the Doping Authority has a
staff which serves both departments and the management.
This grouping of knowledge and expertise is one
of the added values generated by the merger.
We hope that this annual report will provide you with a
clear picture of the work our organisation has done in
the first complete reporting year of our existence.
The board of management

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