Thursday, October 13, 2011

USADA : International Standards Need Not Apply

It is simply astounding the amount of ignorance that exists among the representatives and senators of the United States government in relation to the World Anti Doping Agency and it's signatory(s) satellite U.S. taxpayer funded organization(s) such as the United States Anti-Doping Agency (USADA). In a rush to testing of human growth hormone (hgh) among players in the National Football League, the good representatives invited the United States Anti-Doping Agency (USADA) Corporate Executive Officer Travis T. Tygart and several World Anti-Doping Agency (WADA) officials to a tete a tete conference and demanded to know why the testing had not commenced to "protect the interest of the children from the ravages of performance enhancing use and abuse."

Forgotten in all of these assurances of the incontestability of the WADA science and test results was the athletes who, sure as twice two make four, will certainly be accused of testing above threshold for human growth hormone based upon voodoo science and a rambling disagreement on what constitutes a criteria for a positive test, and his or her name will be dragged into a media circus by the blowhard pundits on ESPN Sports Center and the "beer and brought" herd on ESPN Radio, who will quickly scatter cow pies of calumnies on the trail.

Because as the cowherd assures us, according to the bogus scientific self report questionnaire he conducted on his audience, nobody gives a crap about cycling races, but they sure do care about football.

Alright. The U.S. Congress has about as much awareness of reality as a visitor from Neptune, and they seem to forget the little guy in almost everything. They certainly forgot to invite the National Football League Players Association (NFLPA), Maurice Suh, his group of concerned scientists, and worried football players who are intelligent enough not to trust WADA, the accredited laboratories, the testing, the results, the threshold values, or USADA.

Should there be concern among the players about the behavior of USADA? Absolutely. USADA has one goal, to continue it's own existence and financing by convicting athletes of doping infractions. The ends justify the means and Travis T. Tygart is a man who is not loath to circumvent the exactness of the judicial process with subterfuge if he is losing the public relations campaign. Indeed, in the Floyd Landis arbitration case Travis T. Tygart presented an argument to the American Arbitration Association that destroyed the very foundations of WADA code and International Standards.

Background: The 2006 Floyd Landis Tour de France Alternate "B" Tests. The USADA justification for the necessity of this testing, and the Floyd Landis defense counterargument.

USADA argued that since the Stage 17 carbon isotope ratio confirmation "B" test that was required to prove the existence of precursor(s), metabolite(s), marker(s), or method(s) of a prohibited substance [synthetic testosterone] were inconclusive, and because Floyd Landis challenged the methodology of the WADA accredited laboratory LNDD who performed the Stage 17 tests, that alternate "B" testing would be required on the urine samples Floyd Landis provided during Stages 11, 15, 19, and 20 of the 2006 Tour de France. USADA argued that supplemental testing would provide supplemental evidence that Floyd Landis used synthetic testosterone during the entire race. Floyd Landis and his defense team argued that the testing would not be done in a random double blind fashion, that the people doing the testing would know the identity of his samples, and that this would motivate the testers to confirm the Stage 17 adverse analytical finding. The Floyd Landis defense team also argued that there would be no "A" sample confirmation tests since it was determined that so much of the "A" sample urine(s) had been used in previous "A" sample testosterone/epitestosterone screening tests that there remained an insufficient quantities of urine for carbon isotope ratio "A" confirmation tests of the alternate "B" test results. There was another concern: the Stage 11, 15, 19, and 20 urine samples were domiciled at the WADA accredited laboratory at UCLA where they had been shipped for storage after the French WADA accredited laboratory at Chatenay-Malabry, France had done the initial "A" testosterone/epitestosterone screening tests on Stages 11, 15, 19, and 20. Unfortunately, UCLA laboratory director Don Catlin announced that the GC/MS and GC/C/IRMS would be off line and unavailable for testing due to routine maintenance, thus there would be a need for further transport of the sample(s) to a suitable WADA accredited laboratory for carbon isotope ratio testing. Due to the unavailability of the UCLA testing facility the Floyd Landis legal team also argued that the samples would encounter additional chain-of-custody problems, problems with security of the samples, and possible contamination and degradation of the samples that could result in false positive results. After the AAA panel ruled in favor of USADA Mr. Landis was given a choice of laboratories for the additional "B" sample testing, LNDD where the original tests were conducted or at the WADA accredited laboratory in Montreal, Canada. Mr. Landis objected to the Montreal laboratory because the director Ms. Christiane Ayotte had made several inflammatory statements to the press of her conviction that the stage 17 carbon isotope reflected the presence of the precursor(s), and metabolite(s) of synthetic testosterone even before the commencement of the oral Pepperdine law school arbitration arguments, and Mr. Landis was concerned that her testing would reflect her convictions. Therefore, the remaining "B" samples were tested at Chatenay-Malabry, France.

Here is the discussion in the AAA Floyd Landis Award.

a. Additional Sample Testing
31. On 27 December 2006, the Applicant notified the Respondent of its intention to
perform further analysis of the samples the Athlete had provided after seven
stages of the Tour other than Stage 17. In answer to this notification the
Respondent sought to prevent further analysis of the Respondent’s remaining B
samples from the Tour.
32. Written arguments in relation to this matter were received by the Panel on 5
February 2007 from the Respondent, 9 February from the Claimant and a Reply
was received from the Respondent on 13 February 2007. The oral arguments
were presented to the Panel on 22 & 23 February 2007.
33. In response to the Respondent’s numerous allegations regarding the flawed
testing methodology at the LNDD, the Claimant proposed to test the
Respondent’s remaining “B” samples to use as corroborative evidence in these
hearings. The Respondent’s position in relation to this matter was that the anti doping
rules prevented the Lab from testing these samples as there were no
accompanying “A” samples remaining and as such the “B” samples could not be
used as proof of a positive test. The Claimant argued however, that as a result of
its contract with the Respondent, the “B” samples were now the property of UCI
and they could do as they pleased with the Sample
. Furthermore, they would not
be using the results of these tests to charge the Athlete with an anti-doping rule
violation, but rather the results would serve as corroborative evidence in
response to the Respondent’s arguments methodologies at the
Lab were flawed.
34. The Respondent also submitted that the re-testing would not be blind and this
would significantly impede the process and would not allow for an unbiased
result. The Claimant in response however pointed out that the “B” sample
testing is rarely ever completely blind and the Athlete and/or his representative
would be present during this re-testing to ensure that the proper procedure and
protocol was followed. Accordingly, a compromise was reached between the
parties and it was decided that additional samples other than those of the Athlete
would be added to the “B” samples to create a blinded analysis.

Christopher Campbell dissented from this conclusion. Under the heading:

I. The LNDD failed to provide complete documentation on the Adverse Analytical Findings for the additional tests done on the B samples from stages 11,15, 19, and 20.

Mr. Campbell made the following rebuttal argument to the testimony of USADA witness Ms. Mongongu that the Floyd Landis carbon isotope ratio urine sample results of stages 11, 15, 19, and 20 were "adverse analytical findings."

Mr. Campbell argued that LNDD did not meet the minimum requirements to declare an adverse analytical finding on the additional tests because:

38. WADA Technical Document TD2003LDOC ("Documentation Package") mandates that all documentation packages provided shall contain the following information. "A" sample confirmation procedure data [and the]"B" sample confirmation data. The International Standards define a "confirmation procedure" as follows: An analytical test procedure whose purpose is to identify the presence of a specific prohibited substance in a sample. [Comment: A confirmation procedure may also indicate a quantity of prohibited substance greater than a threshold value or quantify the amount of a prohibited substance in a sample.]
39. Regarding the "A" sample confirmation the International Standards states presumptive identification from a screening procedure of a prohibited substance, or marker(s) of the use of a prohibited substance or method must be confirmed using a second aliquot(s) taken from the original "A" sample.
40. WADA code Article 6.4 titled "Standards for Sample Analyses and Reporting" Laboratories shall analyze doping control samples and report results in conformity with the International Standards for Laboratory Analysis.

It is interesting that in spite of the panel's assurances of anonymity of the samples, when the samples were shipped from UCLA to Chatenay-Malabry they were marked with a piece of tape, and a laboratory worker testified under oath that she knew of the identity of the person of whom the samples belonged to. Was there pressure from supervisors during the testing to confirm previous results?

Mr. Campbell also raises another pertinent issue:

42. Given the amount of tests done on the Stage 17 sample [four different testosterone/epitestosterone tests that resulted in three different test results: one was discarded: forever refuting the reliability of the testosterone/epitestosterone test forever] why did the LNDD run out of urine for the "A" samples in other stages?

Why indeed? Where was the "A" sample urine for the other stages? Gone from repeated testing to find a "surprising result?" On Stage 17, the test results read:
4.7:1, 5.1:1, and 11.4:1. Considering the incredible performance of Floyd Landis on stage 17 of the 2006 Tour de France the only correct value had to be the 11.4:1 result, which was promptly reported to the press.

But, you can read the rest of the Christopher Campbell dissent for yourself and draw your own conclusions.


The arbitration panel should have never agreed to allow the additional stage "B" tests without confirmation. The "B" sample tests should never have been allowed into evidence to support the existence of doping by Floyd Landis during the 2006 Tour de France because it forever lowers the bar as to what constitutes an adherence to WADA code and International Standards by WADA accredited laboratories and the USADA. And by allowing the additional tests to be submitted as evidence the AAA panel forever undermined the protections written into the WADA code and into the International Standards to protect the athlete from prosecutorial abuse.

USADA like WADA considers every step of the judicial process from sample collection to the final award in the Court of Arbitration of Sport to be variable in nature. The number of tests can be variable, the criteria that constitutes threshold is variable, the International Standards are variable, WADA technical documents can be interpreted in a variable way, the rules can be modified at a whim for every arbitration hearing, and former awards have no bearing on the case at hand.

I am tired of ringing the clarion bell: warning if this sort of behavior on the part of USADA can happen to Floyd Landis it can happen to you. I hope the National Football League Players Association considers this sort of conduct on the part of USADA and WADA before they agree to any human growth hormone testing. You must demand that International Standards and WADA code be adhered to and not subjected to a surprise "fishing expedition" by the prosecution.

Because if you test positive to a false positive and the prosecution demands unconfirmed tests from samples that you provided in other won't stand a chance.

Tuesday, October 4, 2011

Congress Ignores WADA Pitfalls

In a rush to "protect the children from performance enhancing drug use" some representatives from the United States government have met with some WADA people and with Travis T. Tygart of the United States Anti-Doping Agency to pressure the National Football League to rush through WADA testing for human growth hormone (HGH), according to the New York Times. Not included in the discussions were the National Football Players Association (NFLPA), concerned NFL players, or Maurice Suh and his scientific team concerned with resolving scientific reliability and validity claims made by WADA about their human growth hormone tests. Reviewing the past history of WADA behavior in testing and adjudication of tests for performance enhancing drug use in sport, there are a rational grounds for concern.

This discussion is not intended to be a dissertation of the complexity of the scientific issues involved in determining the presence or absence of performance enhancing substances in an athlete sample. For example, in the Floyd Landis synthetic testosterone case, there were multiplicitous issues. Serious students of the anti-doping process interested in the minutiae of the scientific issues raised by the Floyd Landis case should visit the excellent and very comprehensive Internet site trust but verify. Some of the scientific issues raised by the Floyd Landis defense are very technical and very alarming and should serve as dire warnings to all athletes never to trust WADA. In a football analogy, WADA would change the rules in the middle of the game to ensure that no matter how many yards they rushed on any given play, the result would always be a first down. For the defense, every play would result in a forth down, no matter how many yards they gained. Thus, it would be impossible for WADA to lose the game.

Accusing an athlete of doping is a very serious concern and cannot be taken lightly. The burden of proof, in the current anti-doping system, is pointed straight at the athlete. The athlete has the burden to prove that the laboratory made a mistake in the testing process to clear his or her name. The athlete must provide his or her own legal counsel, expert witnesses, the athlete must pay for any antecedal information that would support his or her contention of innocence, and if an award goes in favor of the prosecution, must pay additional legal costs. Meanwhile, anti-doping agencies are flush with legal counsel, expert witnesses, and cash. It costs nothing for USADA to refuse to provide documentation under it's control to the defense, even after oral argument and a arbitration panel order, but the cost to the athlete is exorbitant; needless delay while the defense team examines the evidence to prepare a proper argument. Travis T. Tygart refused to comply with an arbitration order to release evidence to Floyd Landis until moments before the oral arguments in at the Pepperdine law school were about to commence. In a normal constitutionally convened court of law, all of the prosecution evidence would have had to be surrendered to the defense. Prosecutorial surprises, in most cases, would be deemed inadmissible as evidence.

WADA repeats tests until it gets the desirable results:

First there was the repeated testosterone/epitestosterone samples conducted by the French accredited laboratory LNDD located in Chatenay-Malabry, France. I have mentioned these tests before as an example of WADA incompetence and chicanery. As a justification for a necessity for a carbon isotope ratio test to determine the justification for the presence of synthetic testosterone in Floyd Landis, the laboratory ran three separate testosterone/epitestosterone tests to determine threshold, even though after the first sample result of 4.7:1 further tests were unnecessary. Perhaps the additional tests had an ulterior motive: press rattling sensationalism. When the 11.4:1 test result was measured, an employee of LNDD raced at full speed to the office of Amaury Sport Organization owned L'Equipe writer Damien Ressiot with the startling news. Before the ink was dry on the lab document package, news organization all over the world repeated the myth that Floyd Landis had tested positive for high levels of testosterone. And in a rush to judgment most media outlets were claiming that Floyd Landis would also test positive for synthetic testosterone as well.

WADA changes the rules on what constitutes a positive test:

There was a problem with the metabolite androstanediol in the Floyd Landis case that created a nightmare scenario for WADA. The problem centered around a generally understood criteria that for the presence of synthetic testosterone to be conclusively proven in a sample two C13 metabolites must have a three delta unit separation from C12 background endogenous metabolites to establish threshold, since synthetic testosterone is derived from C13 based supplements, stigmasterol, for example, and these supplements must be metabolized in order for it to be utilized by the body, and while being converted into energy a waste bi-product is produced, metabolite(s) of C13 based testosterone, androstanediol, 5-alpha androstanediol, and others.

Very well, the science seems quite clear and the criteria on what constituted a positive sample seemed as clear until the metabolite androstanediol did not meet the WADA established criteria for threshold. A separate tested metabolite 5-alpha androstanediol did meet the three delta unit threshold value at -6.39 delta units and was therefore not in contention. A single metabolite above threshold, however, did not meet the WADA requirement for detection of synthetic testosterone in the sample. This would require a second metabolite, androsterone, because the other two metabolites measured did not reach threshold, the delta unit separation was below three delta units. The "B" sample confirmation score for androsterone was -3.51 delta units, and at first glance one would come to the conclusion that this score was above three delta units, therefore constituting threshold. But not so, there was a catch, known as the published lab uncertainty of +/-.8 delta units, meaning that the score could be argued by the prosecution as above threshold and by the defense as below threshold, and both versions would be the correct answer.

WADA was so desperate to avoid a determination that the test was inconclusive that they changed the rules as what constitutes a positive test for synthetic testosterone by exploiting a loophole in a WADA technical document. The document stated that C13 based metabolite(s) above three delta unit threshold constitute the presence of synthetic testosterone in the sample. Therefore, the technical document did not necessarily require the presence to two metabolites above threshold.

The American Arbitration Association (AAA) Panel of Patrice Brunet and Richard McLaren agreed with the WADA single metabolite requirement over the strenuous objection of Christopher Campbell, and the Court of Arbitration of Sport (CAS) voted against Floyd Landis in a 3-0 unanimous vote. So you see, changing the criteria on what constitutes a positive test has the most desirable results: a perfect conviction rate of "doping" athletes.

Of course, it cannot be forgotten that the actual uncertainty of LNDD carbon isotope testing was not the published value of +/-.8 delta units, but actually the measured values were incorrect by a factor of twenty percent! So all the raging academic debates that occurred during the Floyd Landis hearing were moot, uncertainty had no bearing on the case, the single metabolite 5-alpha androstanediol was so far above threshold at -6.39 delta units that it could not possibly be effected by a twenty percent uncertainty in measurement, as the Court of Arbitration of Sport pointed out in the Floyd Landis award.

WADA got lucky with Floyd Landis, he doped during the 2006 Tour de France and was caught red handed. Next time with variable rules and with repeated tests to obtain a desirable result some innocent person may be the next WADA victim. With some of the lower profile athletes who do not have the financial where with all, in the form of millions of dollars in ready cash to challenge "clear laboratory results" they may have already been victimized, helpless to defend themselves. It is imperative that the NFLPA does not become another UCI and that before any HGH testing takes place that issues in technical document wording, and other issues of this nature are addressed before testing commences, to assure players that WADA is not operating with a variable playbook that changes depending upon the results of any given test, and to assure players that WADA is adhering to it's founding principal of "harmonization" and "fair play."

The United States government needs to wake up to the problems that WADA and people like Travis T. Tygart create with unfair practices that only serve to feather their caps at the expense of athletes. Congress needs to give the defense a chance to express their concerns too, in a special meeting. Congress would be shocked to learn all that Maurice Suh knows, but perhaps they simply don't care about a "fair process." There is plenty of time to test athletes for HGH. Better is to work out all of the problems in advance before another rush to L'Equipe.