Saturday, November 24, 2007

Anti-Doping Crusade Out Of Control

The Mayo case. How many more times? Laboratorie National de Depistage du Dopage (LNDD) located in Chatenay-Malabry, France, a World Anti-Doping Agency (WADA) accredited lab used for Tour de France doping testing declares Mr. Iban Mayo EPO "positive" then rushes off to holiday without bothering to follow up with a mandatory "B" confirmation test. The Union Cycliste Internationale (UCI) sends the sample off to a lab at the University of Ghent in Belge. The Ghent lab finds a "non-negative" EPO result. To be quite sure of their findings Ghent asks EPO doping experts in Australia to provide a second opinion. The Australian lab cannot be certain of the presence of EPO in the Mayo sample. The UCI decides to return the sample to the Laboratorie National de Depistage du Dopage (LNDD) for a second "B" re-test. Anne Gripper, UCI drug czarina is so confident that the "non-negative" finding is in error she declares LNDD to be the single WADA accredited lab in the world where "a positive can be found." Right on Anne! You have charted new territory in anti-doping detection by ordering a second "B" confirmation test, one done at the University of Ghent and a second done at LNDD. Why? Because two accredited WADA labs cannot replicate LNDD's findings, but LNDD will!

Well alright, we have an old pattern developing here. Floyd Landis had a similar problem. LNDD was in a hurry to finish the Landis "B" sample Carbon Isotope Ratio (IRMS) so they could go on holiday. Perhaps LNDD lab workers were in such a hurry to leave town that nobody noticed that people who worked on the "A" sample also worked on the "B" sample. Interesting because LNDD had run into problems with lab personnel working on "A" and "B" samples before. The issue was contested in a Court of Arbitration of Sport (CAS) hearing known as the Landaluce case. The Landaluce CAS decision expressly forbade the same people working on both "A" and "B" samples because of the obvious incentive of these people to replicate their own work. The case against Landaluce was dismissed. The CAS cited a blatant disregard for WADA International Standards for Laboratories (ISL) which prohibits lab personnel from working on both samples. Perhaps LNDD lab administration did not understand implications of Landaluce and possible ramifications involved in the Floyd Landis case. Or more likely due to the cloaked nature of doping arbitration hearings, presumption, and lack of scrutiny of laboratory procedures Jacques de Ceaurriz simply did not care. After all, if a Adverse Analytical Finding resulted there would probably never be any discussion of who worked on what. This fanciful notion was almost realised. Floyd Landis and his legal team had to fight tooth and nail in discovery hearings and only because of intense public pressure did USADA and Travis T. Tygart admit to the truth. Nevertheless, LNDD has now acquired a well deserved reputation of being unable to learn from their own mistakes. It is ironic that the issue of lab personnel working on both samples will be at issue in the Landis CAS appeal. Does anyone at LNDD read technical documents or CAS rulings? Do they care?

Travis T. Tygart, UCI, and WADA hated the Landaluce decision. But Tygart had too much at stake. The AAA Majority could be counted on to ignore the CAS ruling in the Landis case because in the strange world of arbitration, rules can be made up at random and precedent need not be followed. But Tygart feared that his perfect record in doping arbitration hearings was in jeopardy because of a stupid blunder by LNDD. So the simplest remedy was to end run Landaluce by convincing the North American Court of Arbitration of Sport (AAA) to allow additional "B" IRMS of Floyd Landis. The Panel agreed to the additional tests with the stipulation that no new Adverse Analytical Findings (AAF) could be filed on the results because WADA International Standards for Laboratories (ISL) prohibited them without a "A" IRMS. However, as Chris Campbell argued in his dissent, the Panel Majority could "cherry pick" evidence that would support the Stage 17 Adverse Analytical Finding. Mr. Landis wanted the testing done at UCLA, the finest WADA accredited lab in the world. The UCLA lab was run by Don Catlin an internationally respected researcher into doping detection. But Travis T. Tygart refused to allow the IRMS tests to be done at UCLA. The fear? LNDD results would not be verified by UCLA. Therefore, his argument that doping had occurred during other stages of the race would have no merit. Landaluce would be upheld, LNDD would be exposed as a lab that does not learn from mistakes, a lab that has a disregard for WADA code, a lab that produces results that cannot be replicated by any other lab. In a panic Catlin disabled the UCLA IRMS to satisfy the concerns of Tygart. The samples were shipped thousands of miles under unknown conditions to Paris. When the additional IRMS "B" tests were being conducted, LNDD and the United States Anti-Doping Agency (USADA) prevented Mr. Landis' representative Mr. Scott Davis from witnessing some IRMS lab procedures. Of course, exclusion of a rider or his representative from any sample testing is a violation of WADA code and could be construed as interfering in the anti-doping process. In fact, many observers of the Landis case still insist that Mr. Davis was excluded in order for LNDD to "dry lab" testing. This consists of reporting findings without doing any lab work. A carefully prepared LDP done in advance to confirm "doping."

Campbell could be considered a very perceptive man. In a secret behind-closed-door-hearing the Panel and Franceso Botre examined a critical volume of evidence. This secret volume apparently contained Lab Document Packages (LDP) of IRMS and testosterone/epitestosterone ratios (T/E), all stages, of urine samples provided by Mr. Landis. This testing was allowed because after urine samples are provided for testing technically they are considered property of the UCI. Botre, head of the WADA Rome Lab, essentially acted as a de-facto fourth Panel member clearly supportive of LNDD and WADA interests. The results of this examination led to a dismissal of all of Mr. Landis' scientific points of contention in a weirdly written Majority decision of "cherry picked" evidence hidden from public view.

How does all of this apply to Iban Mayo? Anne Gripper the UCI anti-doping czarina was not satisfied with the University of Ghent "non-negative" Iban Mayo "B" sample. No indeed. This would convince people that LNDD is incapable of doing competent lab work; an obvious point demonstrated in Landis' WIKI defense. Also a "non-negative" would invalidate the LNDD "A" EPO positive result. Therefore, no further action could be taken against Mayo, because both "A" and "B" tests must be positive in order to file an Adverse Analytical Finding (AAF). The Spanish Cycling Federation declared the Mayo case closed. The UCI decided to attempt to over ride Spanish Cycling with an additional "B" test at LNDD hoping that LNDD would confirm the "A" sample positive result. The UCI obviously wants to present this positive "B" LNDD sample to CAS in order to force Spanish Cycling to conform to a CAS ruling and ban Mayo.

Not enough? Gripper also stated the "B" sample would go on at LNDD with or without Mayo or his representative. The UCI seems to have adopted USADA fever. Is a lab permitted to do any type of lab work without scrutiny, even if the result is interfering in the anti-doping process?

The CAS needs to stop this confusion. "A" samples by one lab may be refuted by "B" tests from other labs. Does the UCI have a right to conduct additional "B" tests at WADA accredited lab "A" to refute conclusions reached at WADA accredited lab "B"? What set of "B" results are considered a valid measure? How many "B" tests may be run to reach a desired outcome? Also, since the Landis case is headed for a CAS showdown it is imperative to set guidelines as to what sort and how many "B" tests a anti-doping authority should be able to run. Should USADA be allowed to order additional "B" IRMS when no "A" IRMS were run? Should USADA be allowed to order IRMS tests when the original "A" T/E tests were in a normal range? Should IRMS be run only when the "A" test indicates a possible testosterone spike? Or should IRMS be done at random throughout Grand Tour stages? The Court of Arbitration of Sport needs to resolve these issues once and for all, and then enforce the rules without exception.

The issue of the rider and his representative attending testing as provided for in WADA code should be written in stone and followed religiously.

In the Mayo case the Spanish Cycling Federation has ruled the Mayo case closed. The UCI should agree to this decision and stop trying to undermine national sovereignty in cycling licensing decisions.

Otherwise a very long and costly legal process will ensue.

Sunday, November 18, 2007

Proficiency Tests for WADA Labs?

One intervention proposed at the WADA Madrid Conference was a rating system of WADA accredited labs based upon proficiency tests. A very good idea if the tests are to be administered at random and by an outside testing agency independent of WADA/IOC and member governments. For example, there are allegations that the French anti-doping authority AFLD paid an "independent" firm COFRAC to perform yearly accreditation audits on LNDD. Investigations into these audits have produced no paper trail. Records of COFRAC audits are not available upon request. Perhaps the Floyd Landis AFLD hearing will shed some light on whether LNDD audits were performed or not by COFRAC. Nevertheless, "conflict of interest" should be avoided at all costs by political interests in doping affairs, no matter what nationality.

The proper method would be proficiency tests without warning, much like out-of-competition tests WADA uses to try to catch athletes who are tempted to use performance enhancing drugs covertly between events. A carefully prepared calibration mix with known carbon isotope values and background markers would be presented to a lab with known "sloppy practices." Hint: LNDD. A score sheet could be devised, can the lab replicate the control Lab Document Package? Is the lab capable of making corrections that adhere to WADA code; for example, mistakes with a line through them, signed, dated, and a corrected value substituted? Summary pages without whiteout? Based upon good performance a lab would receive positive points. Of course, for every violation of WADA code, points would be subtracted.

Much like revisions of WADA code that call for suspensions of athletes who fail "A" and "B" tests, WADA labs would be placed under probation if they fail to meet a criteria of minimum test points. Inability to pass an proficiency examination would be considered failure of an "A" test, and an immediate suspension would be enforced. At this point a mandatory plan would be written by the lab focusing on "benchmarks for improvement." After several surprise inspections observing behavior of lab personnel and testing methods to ascertain overall adherence to WADA ISL and IST, the independent testing agency would recommend a further course of action. A failure by a WADA accredited lab to meet the goals of the benchmarks would be considered a "B" test failure and would result in an immediate two year suspension. Three failed proficiency tests would result in immediate revocation of accreditation as a WADA/IOC laboratory for life.

To the person who coined the intervention, thank you. Sanity in WADA labs will not be achieved under the current monopolistic regime. WADA is incapable of policing these labs and the IOC shows an inability to invest in equipment or talent needed to bring all WADA accredited labs to the same level of quality. An outside agency independent of WADA, the IOC, or any signatories is the only way to ensure a measure of control that reflects an honest assessment of WADA accredited laboratories. Oversight by a competent organization would convince more people that presumption of WADA lab results are viable. It would also enforce the notion that one WADA lab has the same ability to produce reliable and valid results as any other. Currently, as the Iban Mayo EPO results show one lab finds a positive finding (LNDD) while the same sample tested elsewhere (Ghent) found a "non-negative." WADA cannot justify a presumption when it is obvious that standards and methods among WADA accredited labs produce such contradictory results.

If WADA is serious about attracting additional funding for doping detection, they need to show the world that they are serious about reform of WADA accredited laboratory standards and performance. All is not lost or hopeless on the WADA front however. Revisions of the code are currently being considered, Dick Pound will soon be replaced. I think the era of "deny, deny, deny," by Pound of problems within his laboratories is over. John Fahey is the new president of WADA, so there is new hope for a sensible reform.

Tuesday, November 13, 2007

WADA World in Madrid

Off goes the WADA world to Madrid to revise the anti-doping code. The good old boy network wants to make sure that the pesky old "B" confirmation tests vanish from planet Earth. The "B" tests sure have made life rough, what with Tyler Hamilton keeping his cycling time trial Olympic gold medal when the lab froze his "B" blood sample. Hamilton was accused of blood doping and he tested positive on the "A" sample, but the "B" blood was useless for testing purposes. A stupid, foolish error made by a simple minded lab tech.

But WADA accredited labs make many foolish errors especially on "B" tests. Back in the day when the arbitration hearings were secret and formulaic, WADA could hide mistakes and the athlete had neither the legal expertise or monetary resources to expose or contest these errors. However, Floyd Landis changed the climate by showing the world his lab results, and he shocked the world. LNDD's lab practices would not have been accepted by a high school lab much less a lab that dealt with forensic evidence of a doping offense.

WADA has a clear goal. Return to the good old days of hiding lab mistakes, make an effort to argue with WADA hopeless, give athletes no option but to surrender, win all cases.

USADA will never be in jeporady of losing another case, the record will forever be perfect.

The WADA code will be revised not to improve WADA testing methods or to clarify WADA ISL, IST, or Technical Document requirements in order to protect athlete due process rights, or to standardize WADA labs to ensure "fair play." No the object will be to convict all athletes who test positive for a banned substance, without the evidence being contested. False positives, lab errors, sabotage, or incompetence by WADA accredited labs be damned.

Tuesday, November 6, 2007

Was the Testosterone/Epitestosterone Ratio Contrived?

It simply boggles the mind that the AAA Majority could invalidate the Landis T/E ratios. I have a good idea what the lab was doing and I have a good idea of what the political motivation was behind contriving a "high testosterone level" or "testosterone spike" that was repeated relentlessly by the press during the year long ordeal that Floyd Landis endured in waiting for the AAA arbitrators and USADA to commence with his hearing. Fact: Floyd Landis never had a high testosterone level and he never had a testosterone spike. These facts were contrived by LNDD in order to justify IRMS testing, in the hopes of turning up a result that would initiate an Adverse Analytical Finding by USADA and the UCI. The strategy of the imaginary testosterone spike was clear, to expose Mr. Landis as a "cheat," a man who used performance enhancing substances in order to gain advantage over his competition. A second aim was to persuade a gullible public. The T/E ratio needed to be high enough as to be regarded by experts as certainly suspect 11:1. Next LNDD would "leak" the story to l'Equipe which would in turn would shock the world with a sensational scoop and headline, Tour de France winner tests positive for a high testosterone to epitestosterone ratio. Shortly after the l'Equipe story broke Pat McQuaid did confirm that a rider had tested positive during the 2006 Tour de France in an interview with a New York Times reporter. McQuaid was quoted as saying that the situation was "the worst possible scenario." Needless to say, McQuaid violated UCI disclosure policy that prohibits comments on pending doping cases until the rider has a chance to review accusatory evidence. Immediately after McQuaid's interview press wires waged a vicious attack on the credibility of Floyd Landis essentially calling him a doper and a liar. Taken by surprise by the double sucker punch of the l'Equipe article and the McQuaid interview, bewildered by the charges levied against him, without access to the evidence against him, Floyd Landis gave televised interviews where his confusion was evident. Landis noted that after the Stage 16 bonk he had drank beer and whiskey, possible contributing causes of a failed T/E ratio. News articles savaged Mr. Landis with titles like "Cycling the Excuses." Phase one of the campaign had succeeded.

Query: What possible motivation could LNDD have to resort to such unsavory practices against a honest athlete who rode such a sensational stage to salvage his Tour de France victory? The answer is probably rooted in a vendetta against another Tour champion who survived repeated assaults against his character, Lance Armstrong. Landis was to be a pawn, first of a testosterone spike manufactured by a discreditable lab and then nailed to the cross by a equally questionable carbon isotope ratio test. A deal was probably made in advance, if Landis should show determination and win the Tour, USADA and LNDD would work together to fail Mr. Landis on a dope test and then USADA would offer Mr. Landis a deal. Travis T. Tygart general counsel of USADA would make Floyd Landis an offer, if Landis would "confess" Tygart could prove that (1) Armstrong and his entourage had the method, means and opportunity to defeat doping detection methods, (2) to expose US Postal as an organization that would resort to systematic doping during the Tour de France when Armstrong reigned as Tour champion, (3) strip Armstrong as Tour champion, (4) discredit the Vrijman report.

The Vrijman investigation was a UCI response to questionable LNDD testing protocol which found positive findings of EPO present in urine samples of Lance Armstrong. Vrijman wrote a scathing report which cited intolerable problems with LNDD. (1) lack of security by LNDD which invited tampering of the samples by LNDD personnel. (2) Lack of chain-of-custody by LNDD. (3) Leaks of sample results by LNDD personnel to a tabloid paper owned by Amaury Sport Organisation, l'Equipe, in violation of WADA protocol. In conclusion Vrijman said that LNDD positive EPO samples "constituted nothing" and recommended that the UCI take no action against any rider who tested positive for EPO during the 1998 and 1999 Tour de France. Dick Pound, president of WADA called the Vrijman report "delusional." The UCI agreed with Vrijman, disregarded Pound's deranged ranting, thus no riders were punished.

The Vrijman episode sowed the seeds of bitterness between WADA and the UCI and began a turf war over who should be responsible for doping enforcement in professional cycling. The stalemate continued until the 2006 Tour de France when for inexplicable reasons Floyd Landis "bonked" on Stage 16, to be followed the next day with a media orchestrated "miracle" recovery on Stage 17. The Stage 17 recovery was no miracle, Landis rode well within his own published SRM power training limits and distanced the peloton in what most cycling experts would agree was one of the best single stage comebacks ever. However, Stage 17 would give WADA, USADA, LNDD, and the UCI an unexpected opportunity, discredit the monumental achievement with a bogus testosterone spike manufactured by LNDD to be followed up by a bogus IRMS test that would confirm the presence of synthetic testosterone in Landis' "A" and "B" samples.

After LNDD had confirmed a testosterone spike in Landis' "A" sample Tygart immediately offered Landis a deal. Help USADA to discredit Lance Armstrong, and in turn USADA would ensure that Landis would receive "the shortest suspension in history." Of course, Tygart had an ulterior motive, to become head of USADA with a stellar resume as the investigator who would succeed where all others had failed, the public destruction of Lance Armstrong as confirmed doper. Confession of past doping by newly deposed Tour "winner" Floyd Landis would be a sensational coup.

Unfortunately, much to the consternation of Tygart, WADA, USADA, and the UCI Mr. Floyd Landis declined to accept Tygart's terms and he stated that he would rather fight publicly against doping accusations made by LNDD using a WIKI defense.

In response, LNDD, WADA, and USADA launched an immediate plan of attack to counteract Mr. Landis' intention to post the Lab Document Package on the Internet for examination by GC/MS and GC/C/ IRMS experts. WADA and USADA were also worried that the public would learn of the doping enforcement code of "omerta," and of the fundamental unfairness of the doping adjudication process. An immediate vendetta by WADA and USADA was set into motion to defame Floyd Landis. The news media was treated to interviews by Dick Pound who characterized Floyd Landis as a steroid driven mad man who serviced maids along the Stage 17 course, and other defamatory statements. Tygart complained that skilled lawyers were trying to elicit sympathy for Landis by town hall meeting manipulations, commonly known as the Floyd Fairness Fund, where Floyd Landis solicited funds and pointed out flaws in LNDD's Lab Document Package to a sympathetic public. Floyd Landis at this point was winning the public relations war, people were examining LNDD's Lab Document Package, people were viewing Arnie Baker's Power Point Presentation and at one look doubters and fence sitters were convinced of Floyd Landis' innocence. Experts began to notice similarities to warnings of the Vrijman report! LNDD lab errors documented in the AAA hearing included (1) Lack of chain-of-custody.(2) The Stage 17 "B" calibration mix that Frelat injected into the IRMS was left unattended for five hours, an appalling lack of security and a invitation for sabotage.(3) Sloppy lab work. (4)Leaking of test results within minutes to the tabloid l'Equipe.(5) Destruction of hard drive mass-spectra evidence. (6)A calibration mix that lacked two metabolites including 5alphaAdiol.(7) The Stage 17 "B" calibration mix that re-processed with Masslynx tested an astonishing -3.65mils a result that would suggest that the blank contained synthetic testosterone.(8) Sample contamination, and degradation. See appendix.*(9)Numerous and persistent coding errors.(10) Untrained lab personnel,(11) Outdated software. (12)Violations of WADA International Standards for Laboratories.(13) Violations of WADA International Standards for Testing.(14) Violations of WADA technical documents. (15)Non-existant WADA required accreditation audits. (16) Mis-identification of metabolite peaks.

It is no wonder that in light of the above irregular laboratory work LNDD IRMS testing found one out of four testosterone metabolites above threshold for synthetic testosterone, 5alphaAdiol-pdiol. A very odd finding indeed when you consider that three other metabolites tested by IRMS were below the three mil threshold and this indicates no synthetic testosterone use whatsoever. Two of three metabolites that tested normal were calibrated with a calibration mix while 5alphaAdiol had no calibration what-so-ever and the -6.14mil result must be considered suspect. It is astounding that if a person wanted to commit a crime by sabotage of a lab sample and leave no trail for investigators to follow they could have not done a better job than LNDD. Missing metabolites in the calibration mix, deleted mass-spectra hard drive evidence, "overwriting" IRMS blank lab files, destruction of urine by IRMS combustion, and cover-up by LNDD administration, perfect.

Odder still was LNDD results which contrasted with the blood workups of Landis done during the Tour that showed a normal level of leuitinizing hormone, a hormone that triggers the Leydig cells to produce testosterone. Testosterone is hormone that is "bottom up" or receptor driven. The hypothalamus has a "set point" for testosterone and if exogenous testosterone is applied the receptors signal the hypothalamus to order the pituitary gland to suppress the production of leuitinizing hormone in order to maintain homeostasis. After the excess exogenous testosterone has been metabolized, the feedback loop will produce leuitinizing hormone and the Leydig cells will commence to manufacture endogenous testosterone. If Floyd Landis had been doping throughout the Tour, leutinizing hormone would have been suppressed and this would have been detected by blood screening. However, Don Catlin concluded that T/LH levels were normal. There was no exogenous testosterone present in Floyd Landis' blood samples.

Most experts at this point viewed LNDD's "single metabolite" theory with suspicion. In an attempt to salvage the situation and to prevent future legal complications Tygart did some public relations work of his own. He knew that LNDD had violated another WADA standard when personnel who worked on the "A" sample also worked on the "B" sample in an attempt to duplicate their findings. He also knew that the CAS had ruled against LNDD in the Landaluze case. So in an attempt to do an end run on Landaluze he argued before the AAA panel to allow additional IRMS tests on the "B" samples Landis gave previous and after the Stage 17 samples, all of which tested normal on the T/E screen. The Panel agreed to the additional testing although they stated that no additional AAF could be filed based on the results of the IRMS results because no IRMS tests had been performed on the "A" samples. However, at the discretion of the Panel IRMS results could be used as supportive evidence of a doping violation. It was a risky gamble by USADA derided in the press as a fishing expedition. Floyd Landis had even stronger words, USADA he said was ordering additional tests in order to destroy evidence and to render the samples useless for further testing purposes. Landis also requested from USADA that the testing be done at the WADA certified laboratory UCLA, the laboratory used by USADA for doping testing purposes. Not only did Tygart refuse the UCLA request but Dick Catlin head of the UCLA lab pulled the IRMS for maintenance, so the samples had to be shipped all the way back to Paris for testing, although Landis argued that if LNDD could not do the original testing correctly how could they be trusted to perform additional tests?

The new testing became even more bizarre, Dr. Scott Davis, Mr. Landis' representative was denied access to several tests by USADA and LNDD even though this is a clear violation of WADA protocol. In spite of the lockout by USADA and LNDD of Mr. Davis, the results of the additional testing exposed several errors made by LNDD. To summarize quickly, LNDD's additional tests reached a conclusion that violates metabolite behavior and biological logic, a fact that should have rendered the illegal "B" IRMS tests invalid by the AAA Majority. A fact that was ignored by the Majority decision. Campbell in his dissent cited the lack of scientific support of LNDD's test results and argued that Floyd Landis had proved his case beyond a reasonable doubt. But, even though most rational scientific minded people considered LNDD's results as impossible, the lay public who were force fed a steady diet of WADA and USADA mis-information, including most of the main stream press, continue to insist that Floyd Landis tested positive for elevated levels of testosterone. Get a clue people, the T/E ratio was dismissed by the AAA Majority! I sincerely hope that the CAS panel will not be duped by the inarticulate, poorly reasoned and scientific hoax of a Majority decision that most experts in GC/MS and GC/C/IRMS have deplored as unsound.

Yes, in spite of such obvious errors by LNDD and the inescapable conclusion that the results are of the WADA world not the real world the Majority had to save face and bury Mr. Landis. It was a matter of revenge against a man who defended himself against unfair accusations. A man who exposed WADA, LNDD, and USADA for the corrupt power crazed monopoly they are. A man who exposed the garbage in garbage out testing methods of WADA accredited labs. A man who raised doubts as to the nature of the process that acts as prosecutor, judge, and jury against helpless athletes who can NEVER WIN. So, what have we learned from this charade? Never fight against the machine, if you are accused save whatever reputation (and money) you have left and surrender. Do not fight, you lose. But never agree to betray your friends. -Jon< id="SPELLING_ERROR_226" class="blsp-spelling-error">contamination was dealt with twice in the Floyd Landis case. First, it was ignored by the Anti-Doping Review Board when Howard Jacobs made a submission for dismissal of the case, even though the ADRB violated WADA TD2004 EAAS, which states that degraded samples cannot result in an AAF. Second, degradation of the sample was dismissed by the AAA Majority when Dr. Ayotte argued that although the LNDD Lab Document Package showed epitestosterone in the free portion of the sample, the free portion was "steroid free." (See AAA Majority decision paragraph 108.)