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Shaky science casts doubt on doping results

On the eve of the 2008 Olympic Games in Beijing,  a prominent biomedical researcher is arguing that the international anti-doping system is critically flawed.
Image: Bernard Lagat
Bernard Lagat, who is expected to run both the 1,500 meters and the 5,000 meters for the U.S. in Beijing, tested positive for doping with EPO, a hormone that stimulates red blood cell production. Lagat protested his innocence, but was banned from the world championships. Subsequent tests, however, cleared him. Later, doping agency officials tacitly admitted that they had introduced the EPO test prematurely by changing the protocols. Jonathan Ferrey / Getty Images file

Just two days before the opening ceremonies of the 2008 Olympic Games in Beijing, where authorities charged with catching athletes who use performance-enhancing drugs have touted their prowess, a prominent biomedical researcher is arguing that the anti-doping system is critically flawed.

The criticisms, from Donald A. Berry, head of the Division of Quantitative Sciences at Texas’ MD Anderson Cancer Center, also come two days after President George W. Bush signed an international treaty legally committing the United States government to adopt the code of the World Anti-Doping Agency (WADA), which runs that same system.

The treaty, created by the United Nations Educational, Scientific and Cultural Organization (UNESCO), “concerns me very much,” Berry told “It is subscribing to something I regard not to be science.” The anti-doping agencies, he said, “don’t know what they are doing.”

In a commentary in the upcoming issue of the journal Nature, he argues that anti-doping agencies engage in science so “weak” it is sometimes impossible to tell whether an athlete who tests positive for a banned substance actually doped or not.

The result is a system that plays Russian roulette with reputations and careers.

“If conventional doping testing were to be submitted to a regulatory agency such as the U.S. Food and Drug Admin­istration to qualify as a diagnostic test for a disease, it would be rejected,” Berry writes.

Berry, a biostatistician, does not argue that labs fail to find what they say they find. Rather, he maintains that the results do not necessarily reveal cheats.

Testing procedures must be validated
Too much remains unknown about the real odds of test readings occurring in scenarios unrelated to doping and about “operating characteristics” — the rate of lab errors, sample handling errors, machine malfunctions, errors of interpretation, he said.

Anti-doping authorities simply haven’t done enough research in large trials and published those results for scientific criticism, he said.

“This is a black box with little people running around and we do not know what they are doing. This area needs some fresh air. It is just anti-science not only in its conduct but in its attitude,” he said.

Berry is not the first to accuse the anti-doping system of being a world unto itself. A few directors of WADA-approved labs have grumbled off the record about some of the same issues Berry raises. 

Howard Jacobs, a lawyer representing U.S swimmer Jessica Hardy, who is missing the Beijing games after testing positive for a banned stimulant called Clenbuterol during the Olympic trials, has often been uneasy with WADA criteria for guilt.

“It seems like a closed process by which they set these things up. They say if somebody is above a certain range, the chance of a false positive is one in a billion but you never see the data to support that,” he said.

Unlike, say, the Food and Drug Administration, which demands extensive testing in increasingly large populations before approving a drug or diagnostic device, WADA can introduce tests when it satisfies itself the test is ready. But that autonomy can backfire.

In 2003, for example, Bernard Lagat, who is expected to run both the 1,500 meters and the 5,000 meters for the U.S. in Beijing, tested positive for doping with EPO, a hormone that stimulates red blood cell production. Lagat protested his innocence, but was banned from the world championships. Subsequent tests, however, cleared him. Later, WADA tacitly admitted that it had introduced the EPO test prematurely by changing the protocols. 

In 2004, WADA announced it had a validated test for human growth hormone doping and would use it at the Athens summer games. But as recently as last year, WADA’s science director, Olivier Rabin, wrote in a journal article that such tests “are unsuitable to reliably assess hGH abuse in sports.” Now WADA is again claiming it has a validated test and that it will be used in Beijing.

Detection methods are rigorous, agency says
WADA spokesman Frédéric Donzé insisted that the agency understands its responsibility to protect fair play and an athlete’s rights.

“The detection methods undergo rigorous validation prior to being introduced…This reliability has been consistently confirmed by tribunals,” he said.

Testing for naturally occurring substances like EPO and HGH especially concerns Berry because the tests are enormously complex, sometimes looking not for the drug itself, but the effects of the drug on the body. Berry argues that this is the sort of complexity that requires rigorous statistical research using larger numbers of trial subjects who are administered doping drugs under competition-like conditions to tease out other possible reasons for those effects.

Some within the anti-doping system argue that’s unreasonable.

“I think that would be extraordinarily cost prohibitive,” said Matthew Slawson, director of the University of Utah’s Sports Medicine and Research Testing Laboratory, a WADA-approved lab. “It would be useful and very valuable, but very expensive.”

Also, ethics review boards might object to giving doping drugs to trial subjects, he said.

Berry brushed those objections aside.

“If we cannot as a society afford to fund that sort of effort, then we ought not to be trying to make these measurements and ruin people’s lives,” he said. “If we want to do it, then we have to do it right. Doing it in a half-assed way is not serving anybody.”

Berry’s demand for greater transparency is unrealistic, said Larry Bowers, senior managing director for the United States Anti-Doping Agency (USADA).

If testing agencies released everything, “within a month there’d be a book published on how to beat standardized testing procedures,” Bowers said. “We have a group of people trying to circumvent testing. It’s unlike any other field I can think of.”

Independent scrutiny is vital
Thomas Murray, president and CEO of the Hastings Center, a bioethics think-tank in Garrison, N.Y., sees both sides. While anti-doping agencies can’t afford to be as collegial as other science groups, he believes independent scrutiny is essential. “The whole testing operation benefits from involvement of first rate scientists and the critique scientists can give,” he said.

Those working within the testing system also point out that proven false positives are rare. They say they’re acutely aware of the consequences of a false positive, and, if anything, err on the side of caution so that there is a much greater chance of a false negative allowing a guilty athlete to escape.

But Berry believes that if, according to the UNESCO treaty, the war on doping is about to become a legal matter like the war on drugs, there is no room for error.

“When I see things I do not agree with, I sometimes pass it off, but if it affects people, it bothers me. It eats at me,” he said.

WADA often reacts defensively to criticism, but Berry said he’s up for the fight.

“Recognizing the crap I will go through, this is worth it to me. We all want to make a difference,” he said.