Showing posts with label laboratoire. Show all posts
Showing posts with label laboratoire. Show all posts

18 September 2007

PART II: WADA gonna do about Madrid in November?

Serious work product week...

Click here for Part I of this two-part post concerning the upcoming Madrid conference to revise the World Anti-doping Agency (WADA) CODE.

At ZEN central, recent, incessant work has been under way, to produce and now publish a questionnaire with a very focussed audience: the 34 World Anti-doping Agency (WADA) accredited laboratories, the current listing of which you may link to here...

After a profound immersion in the 'macro-legal' aspects of the Floyd Landis doping case, for which I've written nearly 20 separate articles here on crystelZENmud, I'm confronted with the legal dilemma that I now share with you. In Madrid, Spain, this coming November, WADA is convening its final session for the approval of drafting reforms to its controlling documents, especially the WADA CODE.

If you care about doping and sport, I'm glad you're reading this.

I care as well, that the documents that allow athletes to be prosecuted are in legal balance, with responsibilities and rights that fall on each of the incumbent parties... comprising the 570 'Signatories' as denominated in the CODE.

Signatories are the governmental, or quasi-governmental national Antidoping Agencies (eg: United States Anti-doping Agency, or USADA), the Olympic and Paralympic International Committees, the international Federations (eg: Federation Internationale de Ski (FIS)), major event Organizers (eg: Tour de France, owned by the Amaury Sport Group), etc. (WADA CODE 2003, Appendix One)

I have reviewed the latest available version of the WADA CODE, displaying proposed 'redline revisions', which (as of September 18th, 2007) you may not download until AFTER OCTOBER 17 (it's been pulled!! Why??).

This column does not discuss the proposed CODE reforms that are oriented towards the Athletes.

I am convinced, and hope to convince readers, that the upcoming session will not focus, as it should, on the most important, heretofore ignored aspect of the WADA CODE: full harmonization of laboratory procedures, and further tightening of sanctions against laboratories that do not display adherence to the scientific International Standards, or who fail proper, 'results management' procedures by allowing premature releases (or leaks) of 'A Sample' results, prior to the 'B Sample' testing/confirmation of those, to the press.

For this Questionnaire, I outlined the WADA clauses that, as currently enforced, create the perceived imbalance. The imbalance, is a lack of comprehensive control of potentially sub-standard laboratory performance. The results of WADA CODE reform, without addressing the Articles or sub-Articles that I've listed, which denote unlinked points, or untied threads that threaten this novel system's stability and improved acceptance.

Links to the survey I developed are for each page, from the previous post. You may download these for printing:

Page one
Page two
Page three
Page four
Page five
Page six

Page seven
Page eight

As an 'interested party' (under the applicable WADA definition) I hope to provide insights to ZENmud readers, and to the 34 WADA-accredited laboratories that function to serve Athletes, and to provide incentives for cleaner competition, by offering them an opportunity to rectify the imbalance that was written into the WADA CODE that became official in 2003.

The WADA CODE Articles, or sub-Articles that I find incomplete (clicking on the links will connect to the JPG content of this annexed ZENmud post: WADA QUESTIONAIRE FOR LABS, so you can sequentially track the questions raised), include the following:

INTRODUCTION (p. 1): ... The purpose of the WADA CODE, itself, is to advance the anti-doping effort through universal harmonization of core anti-doping elements. It is intended to be specific enough to achieve complete harmonization on issues where uniformity is required...


FUNDAMENTAL RATIONALE (p. 3) ... the essence of Olympism; it is how we play true. ... the following values: [.....] Respect for rules and laws. ...


WADA CODE 3.2.1 (p. 12): WADA-accredited laboratories are presumed to have conducted Sample analysis and custodial procedures in accordance with the International Standard for laboratory analysis. ...


WADA CODE 6.4 (p. 21): Standards for Sample Analysis and Reporting

Laboratories shall analyze Doping Control Samples and report results in conformity with the International Standard for laboratory analysis.


WADA CODE Article 7 (p. 22-23): Results Management

7.1 ... the Anti-doping Organization ... shall conduct a review to determine whether ... (b) there is any apparent departure from the International Standards for Testing or laboratory analysis that undermines the validity of the Adverse Analytical Finding.

7.2 Notification after Initial Review

If the initial review under Article 7.1 does not reveal ... [a] departure that undermines the validity of the Adverse Analytical Finding, the Anti-doping Organization shall promptly notify the Athlete ....


Article 8 (p.24-25): Right to a Fair Hearing

Each Anti-doping Organization with responsibility for results management shall provide a hearing process for any Person who is asserted to have committed an anti-doping rule violation... (Defined as “A natural Person or an organization or other entity.”)


Article 13 (p. 40): Appeals

[.....]

13.5 Appeals from Decisions Suspending or Revoking Laboratory Accreditation

Decisions by WADA to suspend or revoke a laboratory's WADA accreditation may only be appealed by that laboratory with the appeal being exclusively to CAS.


14.2 (p. 40-41) Public Disclosure

The identity of Athletes whose Samples have resulted in Adverse Analytical Findings ... may be publicly disclosed by the Anti-doping Organization with results management responsibility no earlier than completion of the administrative review described in Articles 7.1 and 7.2. [.....]


Given the anticipated, returned questionnaire responses, hopefully prior to mid-October, from WADA-accredited Laboratories, international Federations or other Signatories, three vital steps will have been achieved:

  • Participants to the Madrid redrafting session will be 'on notice' that the current WADA CODE lacks transparency in procedures of discipline and accountability, as to the Signatories that work together to promote a drug-free sporting world;

  • They can go on record, prior to the Madrid session, as being in favour of increased discipline and accountability concerning those WADA CODE imbalances, and;

  • They have now, the opportunity to arrive in Madrid with an 'action plan' to create a finely-tuned, and better-harmonized body of regulatory procedures that will enforce the transparency and accountability of Signatories, as they have mandated towards the Athletes whose world they serve and control.

+ + + + + + + + +

Without a conclusion for this post, we at ZEN Central await a chance to return to it, in the fall months to come: the serious cards are now on the WADA table.


What's 'table' in Spanish?

COURAGE, friends for CLEAN SPORT!!!

ç*”*”*””*ç”*”* ZENmud ”*””*ç*”*”*””*ç”


Part I : A Questionaire for WADA Signatories

Hello ZENers...


This is a special post, (click here for Part II) because what you see to your left and below, is a questionnaire, that has been developed here at ZEN Central, that is destined to the Signatories of WADA and its infamous CODE.

Note bene: this is NOT a WADA-approved questionnaire, but my own.




Each page reflects, on its right column, official text selected from the WADA CODE 2003 ("WADC 2003"), and on the left column are questions relating mostly to the legal text on that page.



I have hopes to receive some interesting feedback from the various laboratories
(Currently numbering 34), who will receive a copy of this independent survey via email.




You can click on each page to receive an A4-sized jpg, which can be printed for study, if you choose to participate.





I have set up a special email account (at some risk of being slammed by various and sundry
ne'er-do-wells, or worse), with the hopes that some readers will respond and offer commentary that can also be applied to the cause.







And what, is the cause, one may ask? Since I have begun tracing the trail laid down by WADA,
under the guidance (I hesitate to use that term) of its President, Dick Pound, through the focalized world of cycling and testing, I have discerned one or more discrepancies in the WADA CODE, which focus more on the inquisitorial aspects and less on the 'due process' aspects of justice against Athletes accused of doping.






This is not to suggest that doping Athletes should not be rendered before Justice to receive their Doom - it merely points to the facts that the other players are ignored, in a more than curious fashion.



The Questionnaire goes page by page, through the Articles that
should enforce the behaviour of Laboratories and other relevant Signatories, and I hope to have noted where the greatest lapses are to be cured, through prompt and unbiased revisions in the upcoming Madrid conference (Nov. 15 - 17, 2007), sponsored by WADA.



There is a post to follow, but I
needed to lay out this work first, so I had in place the links to it for Part II.



Int
erested parties can spread the word, and Athletes more than any, should be following this issue closely.






After all, tis they who sometimes "die" in their sporting careers, at the whim of scientific testing gone awry, through negligence, inattention or improper training.


Being one who believes that he laboratories, as well as the Athletes, should be subject to unannounced testing and visits, I am sure you agree that were improvements are necessary, they should be implemented, not swept behind a curtain; they should be codified, not left to the man pulling the levers of a Sporting world that legitimately is doing everything possible to improve the balance for cleaner, proper Sport.








If you are not of a
similar mind, I would respectfully request that you desist from antagonizing myself or others: we have lives, jobs and our precious time is worth respect.





If, again, you are not of a similar mind, please ponder why you resist the change towards a better, more objective and scientifically-neutral codified Sporting law system?



I spent many hours on this Questionnaire: the errors within are entirely my own misfortune. I apologize in advance if you find any egregious errors.














COURAGE, friends!!!


ç*”*”*””*ç”*”* ZENmud ”*””*ç*”*”*””*ç”

17 May 2007

FLOYDING FRENZY - Day 3 FLASH

ZENistas, Landistas,

Welcome...
Floyd!

Did you read the French newspapers Thursday?


ITF, the International Tennis Federation (link to French Le Monde newspaper report), WILL NOT have its drug testing performed by LNDD! They will be performed by the
International Drug Testing Management (IDTM), says Le Monde.

See also 'Our nemeses', L'EQUIPE
: this French-article touches on the 2006 process for Roland Garros doping procedures...before LNDD was hot on the FIRE of world press.

Sacré bleu!

What can be happening to the Greatest Lab on the Planet? This exceptional laboratory, which knows beyond anyone else who has doped?


Did you know that means these samples from the world's elite Tennis men and women of the world, will be transported (airplane? Pidgeon?), NOT the 18 km (or approx. 11miles) down the road to le Laboratoir National du dépistage du dopage, but to the far-away city of Montreal, some 3433 km (2,133 miles) across the Atlantic. (map courtesy of: viamichelin.com )

Sacré bleu!

These tests will be achieved in Montreal, says ITF, due to the high cost of the testing at LNDD (vraiment? / really?), while insinuations are rampant, if you read the French-language
article (translation follows - ZENmud Global Translation Services):

"Le laboratoire national de dépistage du dopage (LNDD) de Châtenay-Malabry fait-il peur à la Fédération internationale de tennis (ITF) ?"

(Trans: "Does the National Laboratory for Doping Analysis from Châtenay-Malabry frighten the International Tennis Federation?")


As we've heard in the Floyding Frenzy testimony, LNDD produces THREE times as many positives as any other WADA-accredited laboratory...

Who shouldn't be afraid when science (like a military force?) runs amok?

You all know by now, that ZENmud rarely swears on this site, but! Now we SINCERELY BELIEVE that LNDD is not only FUCKED UP, but a RIP-OFF!!!

Thanks ITF, for showing the way forward... wonder if the Tour de France is also needing to save its sponsors' money this summer?

Stand by for more fun...

ç*””*”*”*ç*””* ZENmud *””*ç*”*”*””*ç


05 April 2007

WADA do about Strict Liability...

Warning: if anyone you know is a world-class competitor, nay! A CLEAN world-class competitor...

One who follows strict performance-based eating habits, and is exceptionally dedicated to their training programs and clean medical training assistance: beware!

Even if that person is as humanly 'perfect' as possible, morally, physically, and in the performance of their sport, they would still have no guarantee that his or her sports-career will end with their accolades intact, due to one small, grave situation.

They do NOT have to dope, to be convicted of doping.

At the dining table, or through someone offering them anything to drink; the wrong purchase of over-the-counter medications or sport-diet supplements, all these 'inputs' could be damning the competitor, whether through innocent or malicious means, such as being 'doctored' by third-party intervention.

The Athlete you know could have, for example, won the Tour de France through superhuman, heroic efforts, and have that performance validated by seven different daily tests that affirm his lack of doping.

However, given any 'positive' result from a doping test, even if the source could be determined; say, peanut butter sent as a birthday present by an Alabama cousin, perhaps: that positive-testing Athlete would face the worst scandal of their young, over-achieving lifetime... Oooops: but wait!

If we were talking about the 2006 Tour de France, and its winner, Floyd Landis, weren't there eight tests?

Yes...

In one of Floyd's eight 2006 Tour de France tests, he was found to have an 'uncharacteristically low' epi-testosterone level, which had the legal effect of skewing his Testosterone/epi-Testosterone ratio, which is a violation of the World Anti-Doping Agency (WADA)-approved test, and creating a 'positive' Adverse Analytical Finding (“AAF”, in the vernacular). Announced after his impressive victory of the 21-day race, Floyd has been facing since August 2006 the associated insinuations and loss of credibility we have been forced to associate with cycling.

Flaming the fires through statements to the press, from directors of the Tour de France, Dick Pound, the WADA President (see ZENarticles here, here or here) added prejudicial bias by stating that his title would be stripped, once the test findings were upheld. Statements such as these were unethically premature, by the Tour de France people, and border on the illegal, according to the WADA Code that Dick Pound's organization drafted, accepted and implemented worldwide.

Floyd Landis' earlier career, beside Lance Armstrong, catapulted the Texan towards several of his Tour de France victories at the US Postal / Discovery Channel Team. Graduating into his rôle as leader of the Swiss team Phonak, Floyd's career had never been tainted by any previously positive testing results. The test results for Floyd's 17th stage, mentioned above, were produced from Chatenay-Malabry, the French Laboratoire National du Dépistage du Dopage (LNDD).

Beyond having his team disbanded (PHONAK had witnessed a suspicious proportion of doping cases in its short, impressive history) Floyd saw his impressive career path placed on hold, while awaiting his case's resolution, in May 2007, with a decision by the US Anti-Doping Agency (USADA), and that decision may sanction him to a career-threatening two-year suspension.

The decision to be taken will be based on the evidence presented by the Athlete, and the sporting world that 'indicted' him, via the US Cycling Federation.

Now this article has its own viewpoint, based on the author's cycling and legal experience, as well as his personal presence one hundred metres away from the finish line in Morzine, France, where Floyd raised his arms in victory, in achieving his amazing Alpine comeback.

Generations of French, and cycling fans globally, wanted to believe that how Floyd won was 'à l'eau claire', as they say... “On clean water”. The viewpoint here is that Floyd did win the Tour, and somewhere, somehow, in the poor performance of what should be near-sacred testing procedures, Floyd's urine was found 'positive'.

At this point the overarching problem that was revealed by Floyd's case, after extensive analysis of his situation, are the disparate and biased sports-doping rules implemented by WADA. It is clearly delineated in the new micro-managed WADA world, that Athletes are held to a standard far beyond that to which their accusers – the Laboratories – must adhere.

The disparity? Only Athletes are held to the legal standard of Strict liability, in the context of any AAF. The term 'strict liability' is defined in Black's Legal Dictionary as:

Liability that does not depend on actual negligence or intent to harm, but that is based on the breach of an absolute duty to make something safe.

Which leads to 'absolute duty':

Absolute duty: A duty to which no corresponding right attaches.

In layman's wording? 'Zero tolerance'.

Remember Zero Tolerance, a gift to America from the Reagan administration, which allowed DEA agents to seize Charter sailboats that may have been leased a boat by groups who smoked some joints, all without the knowledge of the lessor? When perhaps as little as a single marijuana seed or stalk was found, after the boat was returned to its owner, that innocent person could face the loss of their boat, or investment, under this legal standard of strict liability.

But what if the Laboratory 'failed' in its work? What if a highly-technical scientific apparatus was mis-calibrated, or 'dirty', or leaked? Should not the accuser be held to the same legal standards? Should any hierarchy of laboratory technicians, their Directors and / or government ministries be allowed to dictate the outcome of events via either actual malfeasance or negligent casual operation of their testing facilities?

This is what Floyd and other Athletes face: there is no differentiation in WADA rules, between deliberate, excessively intentional 'doping', and innocent, accidental (careless or negligent) or malicious (deliberate 'poisoning' Athlete's food, or drink by adversaries or detractors) ingestion against one's proper morals. There are a sufficient number of cases already completed, that show that faith in such a presumption has 'destroyed' a good number of athletes' careers. One perfect example?

As a skier, the case of Alan Baxter is particularly sad, to this author. Alan, the first-ever British Alpine skiing Olypmic medalist, had purchased a Vicks Vapor Inhaler to counter his chronic nasal congestion, while attending the 2002 Salt Lake City events. Although sold under the identical mark as that which he usually bought in the UK (for chronic nasal congestion), its different formulation from that UK product cost him and England their first bronze medal, for his great race in the slalom!

He had never taken doping-medications, yet 'tested positive for methamphetamine'... by utilizing the wrong inhaler. This American variation contained no methamphetamine; however, one component has a similar chemical formula: no stimulative benefit, but it 'reveals' as meth under WADA-approved testing methodologies!

The fact that in the Landis case, “there is a 'there' there” (apologies to Gertrude Stein), by the one (out of eight) of his tests being positive, instantly suggested some prima facie presence of testosterone, or epi-testosterone 'doping' (or 'masking'), to the great majority of observers. Remember, however: Floyd's abnormal ratio stemmed from an ABSENCE: his epi-testosterone was very low. [NB: if this violation had occured under the previous IOC code, Floyd's solitary positive, against his seven other 2006 TdF negative results, may not have risen to the standard for declaring a positive.]

While the 'AAF result' from the French LNDD continues to damn Floyd Landis to a slow-death, through media obfuscation and repetition of often-misstated facts while attending this Spring's sport-arbitration, the legal situation with the LNDD who produced these results is not yet a significant matter: how the lab's analysis was performed could result in LNDD's actual suspension.

In the words of the WADA Code:

Code Article 3.2 Methods of Establishing Facts and Presumptions

3.2.1 WADA-accredited Laboratories are presumed to have conducted Sample analysis and custodial procedures in accordance with the International Standard for laboratory analysis. The Athlete may rebut this presumption by establishing that a departure from the International Standard occurred. If the Athlete rebuts the preceding presumption by showing that a departure from the International Standard occurred, then the Anti-Doping Organization shall have the burden to establish that such departure did not cause the Adverse Analytical Finding.

And how did WADA react to this unfortunate effect of its fight against 'doping'?


Other than its President repetitively spouting high invective, publishing prejudicial opinion pieces that violate the very essence of neutrality embodied in the WADA Code , it has done squat to rectify its imbalances that create a prison-camp mentality in the world-class world of sport.

[WADA has a late 2007 session scheduled, to re-examine the WADA Code in substantive detail.]

Yet, such is the life under 'strict liability' for the Athletes. How many more innocent victims must be, as may be Floyd, as certainly was Alan Baxter, scathingly scarred by the incriminations offered by labs and tests that are theoretically 'cutting edge', yet often-times not assured of the reliability that one presumes to be a standard, across the medical world?

Within the multilevel structure of WADA controlling documents (the Code, the International Standard for Laboratories (ISL) and the International Standard for Testing (IST)), the legal standard of 'strict liability' has only been applied to Athletes. Those entities that hold these Athletes' careers in their aliquots and Sample bottles, are known as the Signatories, and these include governmental authorities (which often include the accredited Laboratories), the International and National Sporting Federation authorities, as well as the Olympic and Paralympic authorities.

Athletes are 'only' members of WADA through their licenses to participate in their sporting Federations (such as FIS: the Federation International de Ski).

Why would WADA not subject its accredited Laboratories and other Anti-Doping Organizations to the same strict liability standards by which the athletes under this authority are judged? The following sub-Article of the WADA Code sets one applicable standard high enough...

Code Article 6 Analysis of Samples

Doping Control Samples shall be analyzed in accordance with the following principles:

[.....]
6.4 Standards for Sample Analysis and Reporting. Laboratories shall analyze Doping Control Samples and report results in conformity with the International Standard for Laboratories analysis.

And the International Standard for Laboratories (ISL), a derivative document enforced through adherence to the WADA CODE, also contains an interesting section:

5.4.5 Equipment
[.....]

5.4.5.3 General service equipment that is not used for making
measurements should be maintained by visual examination,
safety checks, and cleaning as necessary. Calibrations are only
required where the setting can significantly change the test
result. A maintenance schedule shall be established for items such as fume hoods, centrifuges, evaporators, etc, which are used in the test method.

5.4.5.4 Equipment or volumetric devices used in measuring shall have periodic performance checks along with servicing, cleaning, and repair.

5.4.5.5 Qualified subcontracted vendors may be used to service,
maintain, and repair measuring equipment.

5.4.5.6 All maintenance, service, and repair of equipment must be documented.

There is no directing language associated to this ISL, that forces WADA or its Anti-Doping Agencies (including accredited Laboratories) to operate at the same level of 'perfection' to which Athletes do. Meaning: there is no article in the WADA Code or corresponding Lab and Testing documents that creates strict liability against the Labs or their staff, for 'any deviation from the norm of perfection in testing and analysis', that allows the test results to be void for errors. In plain language: if a lab errs, or if a lab test such as Baxter's allows mis-identified chemical compounds to read as 'positive', should that Athlete face this unthinkably harsh penalty?

These problems bear review. As well, laboratories, especially the French LNDD, have notorious reputations for leaking information of a highly-confidential nature to various journals. The best example of this heinous practice falls against Lance Armstrong; the 2005 case of LNDD 'research' which was foisted off as 'proven', and that its 'bona fide' results established, that Armstrong 'was obviously doped on EPO in 1999'. There are no articles that proscribe automatic suspension of accredited laboratories that have serious problems maintaining mandatory confidentiality requirements.

It could happen, as such practice constitutes a violation of the ISL Annex B “Code of Ethics” Section 1:

1. Confidentiality

The heads of Laboratories, their delegates and Laboratory staff shall not discuss or comment to the media on individual results prior to the completion of any adjudication without consent of the organization that supplied sample to the Laboratory and the organization that is asserting the Adverse Analytical Finding in adjudication.

Why does WADA not hold its accredited laboratories to the same strict liability standards?

How could one envisage an inquisitorial system more perverse, than to have a laboratory that can produce 'innocent errors' or those based on negligence or malfeasance, or from unsatisfactory, yet approved, testing methods, while the Athlete bears all the shame, trauma and repercussions from an AAF against him or herself?

Should a Laboratory, which offers professional and amateur sport-career 'life or death' analyses to innocent Athletes, be held to any lower standard than those whom are to be judged by the results of their labwork?

There is no simple answer, other than the most naïve of responses: that no one could POSSIBLY suspect that a lab might operate, or might be directed to operate, with anything less than one hundred percent objectivity, and scientific perfection in the acquisition, storage and transport, processing, analysis of Samples and the subsequent related reporting of results: 'clean' or 'doped'...

The era of 'strict liability' for Athletes apart, and not for the Laboratories that 'indict' them, must end soon. Fairness, in the world of Sport, demands no less.

Why has WADA allowed this chasm to grow into a canyon of irresponsibility? Will a post-Pound WADA reassert the credibility destroyed by its current loud-mouth, hot-shot, Globetrotting President?


COURAGE!

ç*”*”*””*ç”*”* ZENmud ”*””*ç*”*”*””*ç