VeloNews | Drug maker cooperated with WADA

The World Anti-Doping Agency said Wednesday Italian rider Riccardo Riccò tested positive at the Tour de France after a secret molecule was planted in the blood booster EPO during its manufacture.

Riccò, 24, upset the big names of the sport to win two stages of this year’s Tour before he was kicked off after testing positive for EPO (erythropoietin).

Revealing the now high-tech nature of the fight against drugs in sport, WADA chief John Fahey said his organization worked with drugs giant Roche on the newest version of EPO (erythropoietin).

He said Roche had included a molecule in the third generation of EPO, called Continuous Erythropoiesis Receptor Activator (CERA) that acted as a marker in drug tests.

“In the development of that particular substance, close cooperation occurred between WADA and the pharmaceutical company Roche Pharmaceuticals so that there was a molecule placed in the substance well in advance that was always going to be able to be detected once a test was taken,” Fahey told public radio in his native Australia.

Until this year’s Tour, CERA, which is released into the body more slowly than its predecessors, had been thought to be undetectable by drug testers.

Followers of sport have been calling for markers to be placed into certain performance-enhancing drugs for years, and it appears as though it’s finally happening.

In the United States, it would be nearly impossible to insert a marker into a drug after the fact, as it would have to go through the entire testing and approval process from the FDA all over again, which is why Epogen^® and Aranesp^® (Amgen’s EPO drugs) have taken so long to become detectable; they weren’t designed with the markers already built in, so the drug-testers had to devise another way.

But Mircera^® (the brand-name for CERA) was developed with the marker already built in; a fact that surely would have been disclosed to the approvers, and obviously to WADA, but not widely spread, especially to the athletes. And what better way to catch the cheaters than to not tell them HOW you’re going to catch them.

This is the right way to catch drug cheats; not witch hunts.

Yeah, Floyd Landis likely doped. He still got screwed by a system which admits no wrong … and the system still has a lot of other problems. Now that Dick Pound is no longer pounding his dick at WADA, their organizational issues should get better. It’s too bad he’s now a part of the Court of Arbitration for Sport, but one step at a time … and we’ll clean up both the sport and the governing bodies.

From the New York Times:

Study Shows Problems With Olympic-Style Tests

Although athletes have said EPO is in widespread use, few have tested positive. Most of the athletes who have been linked to doping in recent years have been caught not through drug testing, but rather through criminal investigations. In the August 2006 issue of the journal Blood, the American lab accredited to conduct EPO testing reported only 9 positive tests out of 2,600 urine samples.

The new study may help explain why: the test simply failed.

The study, to be published Thursday in the online edition of the Journal of Applied Physiology, was conducted last summer and fall by a renowned lab in Denmark, the Copenhagen Muscle Research Center. The investigators gave eight young men EPO and collected urine samples on multiple occasions before, during and after the men were doping. The men’s urine samples were then sent to two labs accredited by the World Anti-Doping Agency, and EPO tests were requested.

The first lab found some samples positive and a few others suspicious. (A suspicious result does not bring sanctions for doping.) The lab also declared a sample positive, although the man had stopped taking the drug and it should have been gone from his urine. His previous urine sample, obtained when he was taking EPO, was negative in this lab’s test.

The second lab did not deem any urine sample positive for EPO and found only a few to be suspicious. The two labs did not agree on which samples were suspicious.

… [Investigators] realized they had an opportunity to investigate the validity of the EPO test. So, without telling the anti-doping labs what they were doing, the investigators sent the men’s urine samples for EPO testing.

One of the two labs, which the researchers refer to as Lab B in their paper, never declared a sample positive, even when the men were taking high doses of EPO every other day. Lab A was inconsistent. It found EPO during the high dose phase. But in the maintenance phase, it found EPO in only 6 of the 16 samples.

Great news, eh?

Not like “I never tested positive” meant a whole lot before, but with this news, anyone who claims not to have doped and “never testing positive” can have the “yeah, but the tests detect it every time” argument thrown back at them …

And clean athletes will never be able to prove that they haven’t doped … all winning riders are going to fall under suspicion.

“You won the race? You must have doped.”

Brief article at CanadianCyclist.com yesterday, pointed out by a Portland-based pal:

Anti-doping Tests Flawed According to Study

The current issue of The Journal of Clinical Endocrinology & Metabolism contains a study by a Swedish team that concludes current standard anti-doping tests for steriods will not catch many athletes that used the banned substances, and will provide false positives for as many as 14% of those tested.

Anti-doping tests look for synthetic testosterone by measuring the ratio of testsoterone to epitestosterone in urine. If the ratio exceeds four to one (4:1) then it is considered an indication of doping (extra testosterone has been administered through steriod use). It was this particular test that led to Floyd Landis being stripped of his 2006 Tour de France title, when his ratio was found to be as high as 11:1.

The study, conducted at the Karolinska Institute, showed that people vary genetically in their ability to secrete the testosterone enyzme, and therefore may not show excess ratios, despite having used steriods. Over two-thirds of people from an East Asian background showed the gene variant which would allow them to pass an anti-doping test despite using steriods.

Further, the study found a gene that can lower the level of epitestosterone in urine, leading to higher ratios and false positive results. The study says that these mistakes can be cleared by further testing.

WADA (World Anti-Doping Agency) is reviewing the results of this study, and may have to revise or augment current testing procedures.

Now … I’m not an endocrinologist, so much of what was in the published article (linked below) is beyond me, but what I got from it is that depending on this particular genetic marker, up to 40% of people without the two main alleles for this particular gene NEVER tested above the 4:1 testosterone/epitestosterone level, and the highest level reached was only 5.3:1 in the two weeks following a testosterone injection.

On the other hand, subjects with both alleles for this gene had baseline T/E ratios above the 4:1 limit, and could generate false-positives in up to 9% of test subjects in standard doping tests.

So what does this mean?

Well, in Floyd Landis’ case, if he has both genetic markers, then it’s very possible that his initial ratio of 11:1 was a true false positive. But then there’s the results of the CIR test, which did show that some of the testosterone in his system was exogenous. However, there are still enough questions about the methods of the Châtenay-Malabry lab to cast doubt on the results of that particular test.

On the other hand, riders without the particular genetic markers, could microdose with exogenous testosterone and never get caught because their T/E ratios never exceed the limits.

It is extremely important is that WADA/USADA/IOC/UCI/etc look more closely at the protocols and a) unify/standardize them across the various labs, and b) seek the truth (and justice), rather than the automatic presumption of guilt and subsequent legal battles which cast a bad light on the sport as a whole … even if this means genetic testing as part of the so-called medical passport program.

Further reading:

1. Doping by mutant athletes undetected
2. Journal of Clinical Endocrinology & Metabolism (March 11, 2008 issue)

Make your own judgments.

Boulder Report | No Confidence
Open Letter to Hein Verbruggen, Dick Pound, Pat McQuaid, John Fahey et al.:
By Joe Lindsey

Let me make this as perfectly, crystal clear as possible:

Stop.

The political back-and-forth, the mud-slinging, the lawsuits, the puerile saber-rattling nonsense that has characterized the sport of cycling, the state of anti-doping and your “leadership” of it for the past decade needs to stop now.

Be sure to click-through, and go read the rest of it.

From www.cyclingnews.com - the world centre of cycling:

Neben, others sue Hammer Nutrition over contamination
Mark Zalewski, North American Editor

American cyclist Amber Neben, along with professional triathletes Rebekah Keat and Mike Vine, filed a lawsuit in a California district court last December against Hammer Nutrition, maker of Endurolytes. The lawsuit alleges that the product contained unlisted substances that caused all three plaintiffs to produce positive doping tests, and that further resulted in subsequent doping violations and sanctions.

Court documents obtained by Cyclingnews state that each plaintiff took multiple capsules of the product Endurolytes before competing in events in which each subsequently tested positive for 19-norandrosterone, a metabolite of the banned steroid norandrostenedione found in urine. Arguing for the plaintiffs is Howard Jacobs, well known for his work with Floyd Landis’ case as well as other professional athletes involved with doping violations.

The lawsuit, which was initiated by Keat and her twin-sister Simone, states that Simone had the capsules in question independently tested by the WADA-accredited Doping Control Centre lab in Malaysia in June of 2006, all before retaining Jacobs. That lab reported to Keats that the capsules contained dehydroepiandrosterone and 4-androstenedione. Upon further examination, after repeated requests by Keat, the lab also found the samples were contaminated with norandrostenedione.

Hammer Nutrition’s response:

Response to Athlete Lawsuit

(WHITEFISH, MT) On January 23, 2008, Hammer Nutrition LTD. was served with a lawsuit filed by three athletes. The complaint alleged that a Hammer Nutrition product used by the athletes, specifically Endurolytes, was contaminated with banned substances which led to the athletes’ positive drug tests in 2002-2004.

On February 11, 2008, the plaintiffs issued a press release. It is unfortunate that the plaintiffs have decided to take their case to the court of public opinion. We trust that the media and the public will allow due process and the courts to deal with this matter before rushing to judgment. While we empathize with the challenges that these three athletes face by virtue of their positive drug tests, they are directing the blame for their situation in the wrong direction. We are certain that when all of the facts are presented in a court of law, Hammer Nutrition LTD. will be vindicated of any wrong doing.

It will be interesting to see where this one goes … it would also be nice to see Hammer put out a statement of some sort indicating that controls are in place to ensure that current manufacturing procedures do not allow any cross-contamination … my guess, however, is that their attorneys are telling them that would be tantamount to an admission that at the time the alleged contamination occurred they did NOT have any controls in place; because, of course, that’s the way that lawyers think.

Landis to appeal split decision ruling : Bike Biz

The three-man panel appointed by the US Anti Doping Authority to sit on the Floyd Landis hearing handed down a 2 to 1 decision against Landis on September 20th.

Both the majority decision and the dissent are available from the USADA website. Click on 2007. The majority decision is an 84-page PDF. The dissent is 26 pages.

The dissent by attorney Christopher Cambell, who has a long record of finding against athletes in doping hearings, was scathing of the anti-doping hearing procedures and severely critical of the Parisian drug-testing lab at the centre of the Landis case. The other two panel members were also critical of the French lab, throwing out the original screening tests, but deeming other results to be above board.

Regardless of whether or not Landis is actually guilty of doping, the fact remains that the system is fucked up, and the athletes are the ones getting screwed. Unless and until WADA and the IOC start holding their laboratories to the same high standards that a court would (at least, an American court, since I’m not as familiar with the justice systems in other nations), then there will always be questions.

Had this case been tried in a criminal court in the United States, it is very likely that Landis would have been found not guilty because there is certainly a reasonable doubt based on the inconsistencies in the lab reports. In a civil court, where preponderence of the evidence is the standard, the outcome is less clear, but on balance, if I were a juror, I would still find for Landis.

This doesn’t mean I think he is innocent; there is a vast difference between not guilty and innocent, but as Blackstone’s Formulation states, “it is better that ten guilty persons escape, than that one innocent suffer.”

If a guilty Landis ultimately manages to win his case, and forces change so that riders like Jason Sager and Bart Gillespie don’t have to deal with the bullshit they endured within the past couple of years, then it’s worth it.

Unfortunately, USADA and WADA seem to prefer Bismarck’s Complement, which states that “it is better that ten innocent men suffer, than that one guilty man escape.”

CyclingNews.com reports today:

A public fund is being set up to provide financial support for Floyd Landis’ defence, where he hopes to raise two million US dollars. Landis tested positive in the Tour de France Stage 17 for testosterone.

Michael Henson, Floyd Landis’ spokesman, told Cyclingnews about the fund, saying: “We are building the infrastructure now, including setting up an appropriate board of directors. We will have it up and running on or about the first of the year. The fund will help Floyd defend himself by paying for fees of the attorneys and experts.”

According to Henson, the fund will “support Floyd Landis against unsubstantiated doping allegations, provide the means to attain fairness for Floyd and bring justice to those responsible for misconduct in this case”.

Henson said that no date has been set for Landis’ appeal, which will be with the American Arbitration Association. If that appeal is unsuccessful, the case may eventually end up in the hands of the Court of Arbitration for Sport (CAS).

The LA Times reported that Landis will also start a separate entity, tentatively called the Athlete Fairness Organization, “to help wrongly accused athletes fight doping charges and lobby for improved protection for accused competitors.”

Now, I’m not too crazy about the idea of raising money for his defence … but if is is acquitted of doping charges, he should be able to sue for restitution

And regardless of what you think about the Landis case, whether or not you think he is guilty or innocent of doping, if he does manage to pull this off, creating an organization like the proposed Athlete Fairness Organization will hopefully be good news and a good resource for riders like Jason Sager and Bart Gillespie, both of whom are dealing with the unfairness of USADA/WADA incompetence right now.