September 17, 2006

Floyd Landis and WADA Code Article 3.2

This week I am taking a look at three recent high-profile doping cases in the United States. In each instance I'll frame the athlete's case in terms of the WADA Code (PDF) and associated anti-doping rules. Each of the cases provides a slightly different perspective on anti-doping rules in sport.

This is part 2 of the three-part series, concerning the case of road cyclist Floyd Landis. In Part 1 I discussed the case of sprinter Justin Gatlin.

Floyd Landis is an American cyclist, 2006 winner of the Tour de France. A urine sample collected during that event came back positive for an elevated T/E ratio. His specimen also showed evidence of exogenous testosterone via the carbon isotope ratio test.

Last week Landis' lawyers filed a request with USADA to have the doping charges against their client dismissed. This request is based on a claim that the tests performed on Landis' urine sample were invalid.

This is an interesting contrast to the Gatlin case I discussed in part 1. Gatlin has conceded that his positive test constitutes an anti-doping violation under Article 2.1 of the WADA Code. His defense will apparently attempt to establish "exceptional circumstances" with respect to that violation.

Landis, on the other hand — and I should repeat again that I have no inside knowledge of the athlete's case, and am basing my comments on the public statements of the various parties — appears to be concentrating on Article 3 of the WADA Code, "Proof of Doping," denying that he had a banned substance in his specimen at all.

WADA Code Article 3.2

Article 3 of the Code clearly states that anti-doping organizations (the UCI in this case) bear the burden of proving that an anti-doping rule violation has occurred. The standard of proof is described as "greater than a mere balance of probability but less than proof beyond a reasonable doubt." In general, a positive urine test by a WADA-accredited lab is assumed to meet that standard. But this assumption can be challenged by the athlete:

WADA-accredited laboratories are presumed to have conducted sample analysis and custodial procedures in accordance with the International Standard for laboratory analysis. The athlete may rebut this presumption by establishing that a departure from the International Standard occurred.

If the athlete rebuts the preceding assumption by showing that a departure from the International Standard occurred, then the anti-doping organization shall have the burden to establish that such departure did not cause the adverse analytical finding.

     —WADA Code Article 3.2.1

It appears that this clause will be the crux of Landis' defense. He and his lawyers will attempt to establish that the WADA-accredited laboratory in Ch√Ętenay-Malabry did not follow the International Standard during the analysis of his urine sample from the Tour de France. I should point out Landis, as the athlete, faces a lower standard of proof than the UCI. He only has to establish a departure from the International Standard "by a balance of probability." If he is successful, the UCI will then be called upon to demonstrate that the lab's failures did not cause Landis' positive test. If they are successful in turn, then the positive test will be treated as proof of doping in spite of the departure from the International Standard. However, putting the burden of proof back on the UCI would be a significant victory for Landis. Let's see if he's likely to succeed.

WADA Code International Standards

The WADA Code International Standard for Laboratories (PDF) contains 45 pages of requirements and rules concerning the conduct of laboratory tests. Annex C makes reference to WADA Technical Document TD2004EAAS, Reporting and Evaluation Guidance for Testosterone, Epitestosterone, T/E Ratio and Other Endogenous Steroids (PDF), which is particularly relevant to the Landis case. There are a number of areas where an athlete might choose to challenge the way that their test was conducted, and Landis' lawyers have given us some hints about where their defense is heading.

Any challenge to the science of urine tests will necessarily be quite technical, but I think we can break the argument (as laid out in the Yahoo! News article) into two main thrusts:

1. The test results do not constitute sufficient evidence of exogenous testosterone under the International Standard. In particular, Landis' appeal makes some specific technical claims about the results of the carbon isotope ratio (also called an IRMS) test performed on his A sample. The Reporting and Evaluation Guidance explains that a number of different urinary metabolites and reference steroids can be measured via IRMS. Landis' team is claiming that although one of those metabolites had a 13C/12C differential that exceeded the threshold for a positive finding, the combined test results for all metabolites were not sufficient for a positive finding.

The Reporting and Evaluation Guidance is rather vague on the interpretation of results, stating only that "the results of IRMS analysis and/or of the steroid profile measured by GC/MS [the test used to measure the T/E ratio] shall be used to draw conclusions as to whether a doping violation may have been committed." I'm not a medical expert, so it's difficult to predict whether this defense will be successful, especially since I've only seen a brief summary of one side of the argument. But I think that those who want to believe that Landis is innocent (and I am one of them) can find some reason for hope here.

2. The urine tested was not Landis' specimen. When urine samples are collected, the vials containing the A and B samples are labeled with unique identifying numbers. Both vials are sealed, and then sealed together within another labeled container. The number on each sample ensures that the test results are properly assigned to the appropriate athlete, and are also supposed to ensure anonymity of the sample within the lab. The lab documentation would report the positive test by sample number only.

Landis' attorney, Howard Jacobs, claims that the laboratory documentation shows that the B sample that tested positive had a sample number that was not assigned to Landis.

Under the International Standard it is the clear responsibility of the anti-doping organization and the laboratory to ensure proper identification, documentation, and chain of custody of samples. This is critical to the integrity of the anti-doping effort. It will be extremely embarassing for the lab if it this error is confirmed.

More importantly for Landis, this would probably invalidate the results of the tests on the B sample. And if that happens, Landis is going to walk away from this doping charge.

But I'll have more to say on that subject in Part 3.

Bonus Topic: WADA Code Article 4.4

Although I don't expect it to be part of Landis' defense, I should also address the issue of therapeutic use. Earlier this week it was revealed that Landis' infamous positive was only one of thirteen at the 2006 Tour de France. The other twelve adverse findings were not reported as doping violations because the riders in question held Therapeutic Use Exemptions (TUEs) for the substances in question. A doctor for the French Council to Prevent and Combat Doping expressed concern about the fact that of the 105 riders tested at the 2006 Tour, 60 held TUEs for at least one banned substance:

This statistical indication leads us to think that there are a lot of still uncontrolled excesses in the peloton. It is quite troubling. Sixty percent of medical justifications on the Tour raises serious doubts and leads one to think that they could be hiding doping

Article 4.4 of the WADA Code states that "Every IF shall ensure … that a process is in place whereby athletes with documented medical conditions requiring the use of a prohibited substance or a prohibited method may request a therapeutic use exemption. … Such requests shall be evaluated in accordance with the International Standard on therapeutic use."

The International Standard for Therapeutic Use (PDF) states that a TUE will be granted "only in strict accordance with the following criteria:"

  • An athlete must face a "significant impairment to health" if the drug or treatment is withheld;
  • The therapeutic use of the drug or treatment may enhance performance only to the degree that a return to normal health would enhance performance; and
  • There must be no reasonable therapeutic alternative.

This is only a partial list of the criteria, actually, but the three points above outline the medical case that needs to be made before a TUE will be granted. Section 7 of the International Standard describes the detailed application process. The requesting athlete must provide a medical history, results of examinations or imaging studies, and statements from medical professionals. The anti-doping organization has 30 days to review the application after it is received.

For two very specific classes of banned subtances a TUE can be granted through an Abbreviated TUE Application Process. This process, described in section 8 of the International Standard, is just what it sounds like: a very simplified application for a TUE. In this case, the TUE is granted more or less automatically upon receipt of a medical notification from the athlete, stating the "name of the drug, dosage, route of administration and duration of the treatment." The process is only applicable for two categories of substances, in acknowledgement that "some substances included on the list of Prohibited Substances are used to treat medical conditions frequently encountered in the athlete population." The two substance classes are beta-2 antagonists (commonly used to treat asthma) and glucocorticosteroids (commonly used as an anti-inflammatory). Landis himself held a TUE for cortisone during the Tour de France, which he used for treatment of his hip.

At the end of the Sports Illustrated article I referred to above, the French doctor reveals that the thirteen positive tests at the 2006 Tour de France were for three classes of banned substance. One of them, of course, was anabolic steroids — we knew about one case already. Care to guess what the other two classes were?

I don't think we should to be outraged that Floyd Landis and some of his competitors hold very limited and specific exemptions required for their medical treatment. Is it surprising that more than half the riders in the peleton hold TUEs? I was surprised, yes. Is it possible that some athletes are abusing the TUE process to cheat the system? Well, it wouldn't be that hard to fake the application, really. All you would need is a cooperative doctor or two. But it would not be easy to get a TUE for the really serious stuff — AAS, HGH, EPO — under the criteria in the International Standard. If there's a doping epidemic in cycling, I think that bogus TUEs play a very small role.

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