Now, a growing number of pharmaceutical companies are trying to prevent their drugs from experiencing the same fate by joining with antidoping officials to develop tests to detect the illegal use of their drugs among athletes.
Two major drug makers, Roche and GlaxoSmithKline, have begun evaluating every new drug candidate for its potential to be abused by athletes and have agreed to share information about those products with the World Anti-Doping Agency, known as WADA, which polices drug use in international sports. Several other smaller companies have provided proprietary information about specific drugs. A conference in Paris in November dedicated to the topic drew 250 participants.
The development reflects a significant shift from the days when drug makers paid little attention to how their products could be abused by athletes, said David Howman, the director general of the antidoping agency. In the past, drug makers “felt that any publicity in relation to antidoping control would be negative,” he said. “But what they discovered is the opposite happened.”
Instead of shying away from such stories, Roche and Glaxo have promoted their involvement as an example of good corporate citizenship. Last year, Glaxo went so far as to sponsor the testing laboratories for the London Games, the first time in Olympic history that an antidoping laboratory had a named corporate sponsor.
Pauline Williams, who leads the team at Glaxo that runs the antidoping initiative, said the cooperation with WADA grew out of that sponsorship. “What the London 2012 involvement led to was a real pride and willingness, and a positive attitude toward this continued engagement,” she said. Since the start of the program, the company said it has shared information about four of its projects, and development of a test for one drug is under way.
Antidoping officials have long sought information from drug companies. For instance, Amgen, which developed EPO, helped develop a test for Aranesp, another of its drugs that has been used in doping, in advance of the 2002 Salt Lake Olympics. But such arrangements were ad hoc and fairly simple, said Olivier Rabin, the antidoping agency’s science director. “It was almost more by chance when it was happening,” he said.
Relationships between antidoping officials and pharmaceutical companies have sometimes been tense. In 2006, Amgen was criticized for sponsoring the Tour of California at a time when EPO abuse was rampant among cyclists. Although the company said it had sponsored the race to raise awareness about doping, it was later revealed that the organizers had failed to test for EPO, short for erythropoietin, a synthetic hormone that, like Aranesp, stimulates the production of red blood cells.
“They were associated with some things in the past which we felt were probably inappropriate,” Mr. Howman said. “What we had to do was start the conversation from scratch, and say let’s see how we can work together.”
Steven Elliott, the Amgen scientist who invented Aranesp, said the misperceptions went both ways. He said some believed, wrongly, that biotechnology companies were developing drugs that could be misused by athletes as a way to increase sales. “There was this uneasiness about that,” said Mr. Elliott, who recently retired but continues to work as a liaison between biotechnology companies and the antidoping agency. “There had to be this realization that it was a win-win for both sides.”
Antidoping officials began to work more closely with drug makers after 2004, when Dr. Rabin heard that athletes were talking about a new version of EPO, called CERA, that was being developed by Roche, and asked the company for help.
“We were shocked when they first contacted us,” recalled Barbara Leishman, who oversees the antidoping program there. She said company scientists had not realized that athletes were following the drug’s development so closely. “This is not the sort of thing we like to hear about our compounds.”
Roche then worked with the antidoping agency to develop a blood test for the new drug, turning over proprietary compounds, called reagents, that would help officials test for their drug. Because of the complex nature of the drug, which mimics the body’s own hormones, and the development of the test, the project took years.
In 2009, blood samples from six athletes taken during the Beijing Olympics tested positive for CERA. Other drug makers took note of the media attention Roche received for the collaboration, Mr. Howman said. “Once there’s a foot in the water, then you can follow and walk right in,” he said.
Roche broadened its agreement with WADA, expanding the project to screen all of its drugs in development. Glaxo followed suit and around the same time, two major industry groups representing biotechnology and pharmaceutical companies adopted policies encouraging their members to cooperate.
Halting the abuse of new prescription drugs is only part of the antidoping picture. Athletes today are believed to use a variety of methods to gain an advantage, from transfusing their own blood to taking tiny quantities of tried-and-true doping agents. And some performance-enhancing drugs gain life in illicit laboratories, as was the case with “the clear,” the designer steroid developed in the Bay Area Laboratory Co-operative that toppled star athletes like Marion Jones.
Still, pharmaceutical companies have an important role to play given how complex new drugs have become, and how athletes are increasingly using substances that closely mimic the body’s natural processes, officials said.
“Developing detection methods to show that the substance taken in a synthetic form is different than your natural substance is more challenging,” said Matthew Fedoruk, the science director for the United States Anti-Doping Agency.
Many pharmaceutical companies already have the tools to create a doping test for their products because the Food and Drug Administration and other regulatory bodies require them to show how the drug passes through the body. During the development process, the companies design reagents to help identify the drug. Amgen and other companies, like the biotechnology company Affymax — which makes a competing anemia drug called Omontys — have given WADA some of these reagents for use in developing tests.
Still, Dr. Rabin and others said some companies needed persuading and did not return his calls. In those cases, he said, he uses peer pressure, reminding them that other companies are also participating.
“We know the progress of their drugs, and we know that at some point collaboration will naturally come,” he said. “We are a bit stubborn.”
Article source: http://www.nytimes.com/2013/02/19/business/drug-makers-increasingly-join-fight-against-doping.html?partner=rss&emc=rss