Elite Olympic athletes looking for an edge, to say nothing of professional sports figures, have long had their eye on experimental performance enhancing drugs that are still in the development stage.
Such drugs are especially sought after by some athletes because no tests exist to detect them. Now companies led by GlaxoSmithKline Plc and Amgen Inc. are working with the World Anti-Doping Agency, better known as WADA, to take steps to force athletes who may be thinking about cheating to reconsider.
“It’s hard enough to develop and discover a new drug and make sure it’s safe and efficacious enough without having to worry it’s being abused,” said Steve Clarke, who runs human trials for an experimental anti-anemia drug from London-based Glaxo. “They’re cheats, but they’re still human, so there’s concern about them taking something that’s not safe.”
In a July report to drugmakers, WADA said it feared that treatments in clinical trials, which can take 10 years from discovery to approval, could be diverted from the patients who need them to athletes seeking a competitive advantage.
Athletes intent on obtaining as yet unreleased new drugs have ways to get them. An experimental drug may have multiple trials going on simultaneously with hundreds or thousands of patients. An unscrupulous athlete or doctor could divert some of the medicine from trial patients, said Andrew Emmett, managing director of science and regulatory affairs at the Biotechnology Industry Organization in Washington, or BIO.
Endurance athletes looking for a boost tend to seek anti-anemia medicines because they enhance the body’s ability to create oxygen-carrying blood cells. Along with anabolic steroids and human-growth hormones, they’re some of the most common drugs used by dopers.
In June, the U.S. Anti-Doping Agency charged Cyclist Lance Armstrong and his teammates on the U.S. Postal Team with taking anemia drugs to win races, including the Tour de France. Armstrong denied the charges saying they were “baseless” and “motivated by spite,” adding that tests on him never found evidence of such a drug. Since 2008, athletes from competitive cyclists to Olympic runners have tested positive for the drugs.
Epogen from Thousand Oaks, California-based Amgen was one of the first compounds to stimulate red blood-cell production in anemia patients using erythropoietin, a hormone released normally in response to decreased levels of oxygen in body tissues. Used properly, the injection is meant to treat highly anemic patients suffering from late-stage kidney failure. It has since been joined by other drugs in the same family of compounds, like Aranesp, also made by Amgen, and Roche Holding AG’s Mircera.
In healthy athletes, the drugs can boost their blood’s oxygen-carrying abilities beyond normal levels, helping them cycle up mountains, run faster and swim longer than competitors. Glaxo’s experimental drug would have a similar effect, could be cheaper to manufacture, and as a pill rather than an injection, wouldn’t be as difficult to take.
That’s why the company flagged the drug to WADA and is helping on test development, said Clarke, who wouldn’t name the compound or say whether accurate screening had been identified. WADA keeps such things confidential, he said.
“What we’d hope is that by publicizing the relationship with WADA, it will act as a deterrent, that people won’t use GSK’s drugs in this way,” Clarke said.
Guidelines announced July 23 by WADA, BIO, and the International Federation of Pharmaceutical Manufacturers & Associations set up the first formal process allowing drugmakers to work closely with the anti-doping authorities.
BIO’s Emmett said the companies have agreed to look in their pipelines for any drug that may help build muscle or extend endurance, paying special attention to compounds that have similar chemical structures or mechanisms of action to those already known to be used in sports doping.
When they find them, the drugmakers will alert anti-doping authorities, who will decide whether the compounds should be banned and whether tests for their presence in blood should be quickly developed.
“Most of the tests are typical ones you’d be doing during drug development, regardless,” Emmett said by telephone. “It isn’t intended to be an added burden on the drug development process. The earlier we can prepare, the better chances we have to make sure these products don’t get into the hands of athletes who shouldn’t be using them.”
Roche has already done that with its drug Mircera, also used against anemia, according to the world doping organization. In 2008, while competing in the Tour De France, Italian cyclist Riccardo Ricco was accused of having the drug in his system, after a test Roche helped develop recorded a positive result.
Glaxo’s Clarke also is an amateur cyclist, and as a fan of the sport’s professional ranks hopes to help keep them clean. In his spare time, he’s pedaled up some of the same French mountain passes used by athletes in the Tour, cycling’s most prestigious race.
“You lug your slack, sorry, body over these hills at a pitifully slow pace, and then you watch as these guys just fly up the hills,” he said. “If any sports fan thinks they’re doing that just by cheating, it takes away from the magic.”