Abstract
The world of doping and anti-doping in sport is an ongoing race between those who want to gain a performance advantage by using prohibited substances or methods and those who want to keep the sport clean. Sophisticated doping often involves substances that are difficult to detect, which presents both scientific and legal challenges for implementing new detection methods. This article provides an overview of legal considerations in anti-doping procedures that may apply to the use of the marker method for the detection of Human Growth Hormone. In cases where the blood markers IGF-1 and P-III-P indicate use of exogenous growth hormone, reference to positivity criteria and laboratory uncertainty measurements would assist anti-doping adjudicative bodies in concluding, to their comfortable satisfaction, that a positive test has been established. Use of established positivity criteria and laboratory uncertainty measurements place the application of the marker method for growth hormone within the existing, accepted legal framework for evaluating an Adverse Analytical Finding.
Introduction
The world of doping and anti-doping in sport is an ongoing race between those who want to gain a performance advantage by using prohibited substances and methods and those who want to keep sport clean. As anti-doping has become more sophisticated, cheaters have been driven away from the more traditional performance-enhancing substances such as steroids and stimulants toward substances that are more difficult to detect. In addition, each new advance in medical technology is examined by the cheaters as a potential means to enhance performance. Pharmaceutical human growth hormone, like erythropoietin before it, is an example of one of those substances. A method has been developed that uses increases in the measured concentration of the blood markers IGF-1 and P-III-P to identify the use of exogenous growth hormone. The purpose of this paper is to provide an overview of the legal framework by which this method would be assessed in anti-doping disciplinary proceedings.
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Section snippets
Description of the GH marker method
The GH marker method has been discussed in detail elsewhere. The premise of the method is that when an athlete administers exogenous growth hormone, the quantities of IGF-1 and P-III-P normally present in the athlete’s blood will become elevated. In studies conducted between 1996 and 1999 of samples from athletes who stated that they had not used growth hormone, the method developers determined mean values for the IGF-1 and P-III-P markers and a mean score when the values for those two markers
General legal framework applicable in anti-doping cases
The source document for anti-doping rules in Olympic sports and many other sports around the world is the World Anti-Doping Code (the “Code”). Since the adoption of the Code by the World Anti-Doping Agency (“WADA”) in 2003, the Code has been accepted by 192 countries through the Copenhagen Declaration on Anti-Doping in Sport, the political document through which governments show their intention to implement the Code, and through formal ratification of the UNESCO International Convention Against
Establishing the positivity criteria for the growth hormone marker method
The positivity criteria for the growth hormone marker method will be different than the criteria for many other types of prohibited substances in that the method does not directly identify exogenous growth hormone itself. For example, for the prohibited substance Stanozolol, which is not produced endogenously, any detectable quantity of Stanozolol results in a positive test. By contrast, growth hormone is produced naturally by the body and would be expected to be found in a blood sample. The
Correlating current analytical results with prior IGF-1 results using a different assay
We understand that the IGF-1 baseline for non-doping athletes was established using an immunoassay that is no longer available. Thus, those results must be appropriately adjusted to correspond to the results produced by the new assay for IGF-1 in order to provide apples to apples statistical comparison. The reliable evidence standard set forth in the Code should be satisfied in this regard by reanalyzing an appropriate number of the old IGF-1 samples with the new assay and then comparing the
Laboratory results and uncertainty of measurement
The laboratory’s analytic results using the HGH marker method are presumed to be accurate under the Code if the laboratory follows WADA’s International Standard for Laboratories and applicable Technical Documents (Article 3.2.1). Because a sample would only be positive if the results are above a specific numerical criteria established by WADA and would be negative below that criteria, the concept of uncertainty of measurement found in the International Standard for Laboratories must be applied.
Relationship of the GH marker method to other approaches to detect the abuse of exogenous growth hormone
Testing for the use of exogenous growth hormone using the “Isoform Method” of analysis was used during the Beijing Olympic Games in August 2008. The expected advantage of the GH marker method over the Isoform Method is a longer window of detection. The sensitivity of these two growth hormone detection methods and how they should be implemented together will obviously be an important matter for WADA to consider.
In addition, WADA and others have been actively pursuing a “passport” approach for
Conclusion
In summary, a positive test using the marker method for the detection of growth hormone should be upheld when a disciplinary tribunal finds to its comfortable satisfaction that the analytical results and conclusions drawn from those results are scientifically reliable. That comfortable satisfaction standard is particularly likely to be met if WADA establishes the positivity criteria for the method based on its evaluation of the relevant scientific data.
1
Richard R. Young is the managing partner of the Colorado Springs office of Holme Roberts & Owen LLP and co-chair of the firm’s Litigation Practice Group. He joined the firm in 1973 and has focused in the area of litigation, dispute resolution and problem solving. Sports law comprises a major part of his practice.
2
Jennifer S. Bielak and Sarah L. Horvitz are associates in the Colorado Springs office of Holme Roberts & Owen LLP and members of the Litigation Practice Group.View full text
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