Roche and WADA to Tour de France Athlete: Gotcha

Italian cyclist and Tour de France competitor Riccardo Ricco was caught doping with Roche's new erythropoiesis-stimulating agent (ESA) Mircera, according to numerous news reports today. An official of the World Anti-Doping Agency (WADA) reported to Bloomberg that use of the drug—a long-acting, pegylated version of epoetin beta—was made detectable because of an implanted, traceable molecule within the product. A brief scan of relevant, online FDA documents suggests that the implanted molecule is a trade secret of Roche.

In June, Danish investigators indicated that the detection of older, shorter-acting ESAs, namely recombinant human erythropoietin (rHuEpo), in urine by WADA laboratories is highly unreliable. The official WADA method is to distinguish endogenous Epo from rHuEpo on the basis of molecular charge, a technique that has been criticized for generating a high number of false positives and negatives.

To assess the reliability of current rHuEpo testing by WADA labs, the Danish investigators injected 8 healthy, nonathlete, male university students with rHuEpo, by using a boosting (5000 IU qod x 14 d) and maintenance (q weekly x 2 weeks) program. Urine samples were submitted to 2 different WADA labs for testing, with the following results.

Phase	Laboratory A	Laboratory B
Boosting	All positive	None positive
Maintenance	6/16 positive; 2 suspect	5 suspect
Posttreatment	2/24 positive; 3 suspect	None positive

The investigators also found little correlation between suspect or positive results from the 2 WADA labs and suggest that the "only strategy which provides a possible chance for obtaining a positive urine Epo test" is to perform out-of-competition testing at more than 1 WADA lab during the suspect rHuEpo boosting period. Alternatively they suggest that efforts should be focused on reliable detection, such as that evidently facilitated by Roche for Mircera.

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