The French National Anti-Doping Agency (AFLD) has been utlizing a secret new anti-doping test for a previously undetectable performance-enhancing drug during the 2008 Tour de France. Rumors about a test for Mircera started circulating when cyclist Riccardo Ricco failed his doping protocol. The World Anti-Doping Agency (WADA) quickly confirmed the rumors.
WADA gave notice to cyclists competing at the 2008 Tour de France that they were now able to detect the performance enhancing drug Mircera (methoxy polyethylene glycol-epoetin beta), a third generation version of erythropoietin (EPO) belonging to the category of drugs known as Continuous Erythropoeitin Receptor Activators (CERA).
Doping experts concerned with the fairness of the doping protocols administered by WADA-accredited labs were quick to raise questions about the new CERA doping detection methods (”Larry: New CERA test, looking at Hamilton’s HBT,” July 20).
The TdF news concerning the detection of CERA has raised a lot of questions, including legal questions. How is it that AFLD can use a “secret” test, one that is not referenced in any of the WADA rules? How can we know that the lab’s test is valid? If there are no WADA rules for the test, how can the lab determine that the results of the test are sufficient to prove an AAF?
The folks at Trust But Verify (TBV) offer an excellent primer on unaccredited WADA anti-doping methods used to detect adverse analytical findings (AAFs). TBV, citing precedent from the Tyler Hamilton case, explains why it is legal for WADA-accredited labs to use “secret” and “unaccredited” testing methods in some cases.
[I]t is not necessary for WADA to approve a lab method before the method can be used to prove an AAF.
The panel also ruled that a WADA lab CAN use an unaccredited test method to prove an AAF, so long as the lab can prove two things. First, the lab must prove that the unaccredited test method was conducted “in accordance with the scientific community’s practices and procedures.” Second, the lab must prove that it “satisfied itself as to the validity of the [unaccredited] method before using it.” If the lab can satisfy this two-pronged burden of proof, then (according to the Hamilton decision) the lab gets the benefit of the presumption under WADA Code 3.2.1. If the lab cannot satisfy this burden, then the lab method in question cannot be used, and the AAF against the athlete must be dismissed.
The reasoning in the Hamilton case was based on the panel’s assumption that sometimes WADA labs must use unaccredited test methods. New forms of doping arise all the time, but the formal lab accreditation process is relatively slow (the method at issue in the Hamilton case was not formally validated until more than a year after the lab’s finding of the Hamilton AAF). If labs are going to detect new performance-enhancing drugs (PEDs), they may have to do so with new (and thus unaccredited) test methods. But since accreditation is an important step in making sure that test methods are “fit for purpose”, the panel reasoned that the validity of unaccredited test methods must be defended by the lab and ultimately ruled upon by the arbitration panel.
This means that AFLD may still be required to scientifically validate the new CERA test in the cases of Miguel Beltran, Moises Duenas Nevado, Riccardo Ricco and any other cyclists who accused of allegedly using Mirecera during the 2008 Tour de France.
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