Tour update: No 'secret molecule' in CERA

By Laura Weislo, Cyclingnews.com | Wednesday, July 23, 2008 11.52pm

Contrary to earlier reports, Italian Riccardo Riccò's positive for EPO was not the result of a "secret molecule" being added to the drug to allow anti-doping authorities to more easily detect it.  World Anti-doping Agency president John Fahey seemingly made the statement on an interview with the Australian Broadcasting Corporation on Wednesday, but the agency's spokesman said his words may have been misinterpreted.

"No marker was inserted in the substance," the WADA spokesman said. "Thanks to the fruitful cooperation of the manufacturer of this substance (Roche) and of WADA-accredited laboratories, which started in 2004, WADA received the molecule well in advance and was able to develop ways to detect it, including through the current EPO detection method."

A Roche spokesperson confirmed to Cyclingnews that the WADA president misspoke, and that there was nothing added to the drug to help its detection. However, news of a collaboration between the company and anti-doping authorities are true. "Roche has provided samples of Mircera and assay reagents to the World Anti-Doping Agency (WADA) to help ensure that WADA laboratories will be able to carry out reliable anti-doping testing."

Riccò's A sample from the Tour de France stage four time trial in Cholet came back positive for EPO, and he and his entire team pulled out of the race. The rider and his team-mate Leonardo Piepoli were subsequently fired. The scandal led team sponsor Saunier Duval to withdraw its support of the team.

It has been widely reported in the press that the molecule found in Riccò's sample was a new form of EPO known as Mircera, or CERA. The drug, which is used to treat anemia, stimulates the production of red blood cells. It is similar enough to previous versions of EPO that a patent dispute between Roche and EPO innovator Amgen has blocked the commercialization of Mircera in the United States. Amgen's patents in Europe expired two years ago, allowing Mircera to be marketed there beginning in 2007.

CERA is a recombinant version of the protein erythropoeitin, a hormone which stimulates red blood cell production in the bone marrow, just like previous incarnations of the drug. It is distinguished from previous version of the drug by being longer acting, like Aranesp, Amgen's longer-acting drug, which was found in the urine of cross country skiers in the 2002 Salt Lake City Olympic Games.

The misunderstanding about the 'secret molecule' may have arisen from descriptions of Mircera, which called it 'pegylated', meaning that it contains a molecule of polyethylene glycol, a stabilising agent.

"Mircera can be differentiated in samples from both naturally occurring erythropoietin and from all other traditional ESA products [Erythropoeisis Stimulating Agents -ed.]," a Roche spokesperson stated. "The molecule is designed to assist in advancing the management of chronic kidney disease, not detection of illegal use.

This 'pegylated' protein was rumoured to be undetectable, but cooperation between drug manufacturers and the anti-doping authorities have put detection a step ahead of the cheaters.

Mary Klem, a spokesperson for Amgen, a competitor of Roche which sponsored the Tour of California, told Cyclingnews that this kind of collaboration began with the Salt Lake City Games, where Amgen scientific director Steve Elliott helped anti-doping authorities confirm that the skiers had Aranesp in their samples.

"Amgen has - and continues to - actively support efforts to help develop effective tests to detect doping. We recently provided a scientific research grant to develop new and improved methods for EPO testing."

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