Sunday, 22 November 2009

The Beau-jo (Lab stats) Nouveau est arrivée

[Edited twice to reformulate our own massive math errors, from
cross-references to 'Olympic' or 'Overall' statistics: we'll
accept any offers of editing on math... and to discuss Footnote 2 Ww]

On request from a correspondent, WADAwatch is thinking about 'Atypical Findings', that bear influence in WADA's 2008 Laboratory Statistics Report...

From the Laboratory Statistics Report 2008:

Atypical Finding” is defined in the World Anti-Doping Code as “a report from a laboratory or other WADA-approved entity which requires further investigation as provided by the International Standard for Laboratories or related Technical Documents prior to the determination of an Adverse Analytical Finding.” Atypical Findings may correspond to multiple measurements performed on the same Athlete, such as in longitudinal studies on testosterone.

Legally, there seems to be no justification for any inclusion of 'Atypical Findings' within that 2008 Report, for the simple reason that 'Atypical Findings' were never a part of the 2004 International Standards for Laboratories (ISL).

As the ISL 2009 and Code 2009 first took effect in January 2009, one would think two alternatives were pertinently apt: a) that WADA would include a footnote in the Lab Report cited above, which offers its reasoning for inclusion of a statistical measurements that isn't legally in force; b) that the inclusion of AF statistics would not appear before the Lab Report 2009, which of course will be issued in the fourth quarter of 2010.

But that procedural anomoly ignores the series of deeper, substantive problems that lay within the 'Definition' itself. And these go to our least favourite WADA problem, recurring regularly within its legal Documents: the language.

There is first one term that grates our senses, being this:

... a report from a laboratory or other WADA-approved entity...”

There are thousands of laboratories around the world, and there are 33 (currently) WADA-accredited laboratories. So we have no rational reason for this ambiguous drafting WADA 'carefully' chose to make official. It would have been so easy, and preferable, to write and approve the following:

... a report from any of the current WADA-accredited
or such entities as receive ad hoc or official
approval from WADA for the specific time period or event
, which...

Beware, Athletes under WADA's guidance: there's more 'judicial interpretation' en route, which is liable to expand your legal costs resulting from any CAS, NADO or Federation disciplinary procedures against you, if the Atypical Finding 'definition' is a factor in your case. We've chosen to 'bracket' the 'definition', because we spent a good part of this weekend trying to really define what 'IS' an AF.

We still don't 'know'...

The 2009 Code Definition, which you see above, incorporates the 2009 ISL 'definition': they are identical. That means, by reference from the Code, inquisitive Athletes or others (people that are bored on a Sunday afternoon?), are constrained to 'follow the breadcrumbs'. Since the wording of each 'definition' is identical, all we know is that an AF equals 'a report'... we aren't yet aware of the basis for that 'Atypical' status. The researcher seeks the Tech Docs, therefore, to elucidate the Code and ISL Definitions.

The WADA system has nine downloadable Tech Docs (two of which actually take effect in five weeks: 1 January 2010): they are all listed here. Another one, listed twice, will be superseded on 1 January, as well. The Tech Docs are listed (here) in two sets: those which mention 'Atypical' and those without mention (each set, in chronological order of first 'in force' date):

  • TD2009LDC (January 01, 2009: on laboratory documentation packages for AAF cases):

this TDC only mentions Atypical Findings in the sense that a the LDC provides a 'summary table... [with] criteria utilized to identify and/or quantitate the target substance(s) to report [an AAF or AF];

  • TD2009EPO (September 21, 2009: on harmonization of the method for the identification of recombinant erythropoietins (i.e. Epoetins) and analogues (e.g. Darbepoetin and Methoxypolyethylene glycol-epoetin beta)):

this document only mentions “... may ... be an atypical profile (shifted towards the basic area) ... additional scientific evidence may be needed to arrive at a final conclusion.” (although that continues, suggesting complementary processes to “... confirm the exogenous or endogenous origin of the finding.”).

  • TD2009MPRL (January 1, 2010: on Minimum Required Performance Levels for detection of Prohibited Substances):

the three-page document concludes with this catch-all phrase “At any time relevant anti-doping organizations may conduct any additional investigations as they deem appropriate in assessing an atypical sample.

  • TD2009NA (January 01, 2010: Harmonization of analysis and reporting of 19-norsteroids related to nandralone):

this document states: “If the Sample does meet one of the conditions discussed in sections 3.3 and 3.4 below, then it shall be reported as an Atypical Finding and both the Testing Authority and WADA shall be notified of the results as a comment in the test report.

As the following TD have no reference to the word 'atypical' they are merely listed by title:

  • TD2003IDCR (January 1, 2004: Identification criteria for qualitative assays incorporating chromatography and mass spectometry);

  • TD2004EAAS (August 13, 2004: Reporting and evaluation guidance for testosterone, epitestosterone, T/E ratio and other endogenous steroids);

  • TD2004NA (August 13, 2004: will be superseded by above 2009NA, with title change (above includes “19-norsteroids related to” ));

  • TD2009MRPL (January 01, 2009: will be superseded by above TD2009MRPL);

  • TD2009LCOC (January 01, 2009: Laboratory Internal Chain of Custody).

Now we remind our audience we're still trying to find out what 'IS' an 'Atypical Finding'.

Frankly, answering that question is only clear, if we are asked what an AF is for 19-norsteroids related to nandralone, next year. Sections 3.3 reminds us of female subject protocols, and §3.4 discusses 'unstable urine' Samples. The AF would relate to findings for women, or when the Sample shows signs of instability. So an AF in NA is related to either pregnant woman (presuming our readers actually refer to the provided TD links), or unstable urine samples. This opens a door, when someone delays or poorly packages a Urine Sample for transport, that an Athlete could be found 'Atypical', and then 'positive', if the Laboratory refuses or ignores (or never receives) evidence of bad transport.

One is absolutely left in wonder, legally, at the realization that an AF may be just what any lab director wants it to be, based on the catch-all phrase in the 2010-effective Tech Doc on Minimum Required Performance Levels: most of the other Tech Docs do not add any coherent (and consistent!) definition, which should be complete and identical to those in both the WADC or ISL. Notably, however, the TechDoc on Measurement Uncertainty leaves 'AFs' undefined.

With such a legal dilemma, procedurally and substantively, we now can turn to the 2008 Lab Statistical Report, and look at the precocious inclusion of this data.

We've written before about the 'growth industry' aspects of anti-doping control, assuring our readers that we recognize that fact's validity, and still hoping that WADA goes 'black and white' as to the control of laboratories, NADOs and/or Anti-doping Agencies. The first statistic shown, defines that growth: 'Olympic Sports testing' grew at 15.8pc, while 'non-Olympic Sports testing' grew at 46.8pc, providing an overall industry progression of 22.7pc (actual 'A Sample analyses' hit the global sum of 274,615).

Of the 202,067 Olympic Sports A Samples analyzed, there were 1,974 AAFs, yet a total of 3,715 'findings' were counted. This is claimed to be an increase of 10.1pc in findings from 2007. However, the associated footnote reminds, under the column comparing 2008 to 2007, that the AF stats are included.

However, astute researchers find that AF, per se, are not included in the 2007 Report (whether they should actually be in the 2008 report, as they were not a legally-supported item until 'in force', remains on the table). A second footnote (FN 2), also reminds us in the 2008 Statistics Report, that it shows 2003-2007 AAF numbers, which 'include findings that are defined in the 2008 Report as Atypical Findings'. This becomes so very disconcerting: could someone at WADA please inform Athletes when an AAF IS an AAF, and when an AAF is NOT an AAF? What their legal bases are, for acting as nonchalantly as they appear in this report, are not those for which a Quigley-Rule-based CAS Panel would express its admiration.

One thinks that WADA Signatories would request finite conclusions, finite inclusions, in the official reports that are 'signed-off' by the Secretariat for publication, and we wonder how anyone would ever know if their previous
AAF was legally invalid, based on footnote text from WADA found in this report? Last point... if 'some' pre-2008 (actually pre-2009, but it's WADA in the driver's seat on this legal SNAFU) AAF actually were AF, but preceded any legal obligation to be announced as AF, does WADA have a legal and moral obligation to assign numbers (quantitative) to the assertion in FN 2? Does WADA want the world to know, or not, if Athletes were prosecuted (persecuted?) by false AAF?

It thus appears that WADA is claiming a 15pc growth in total findings, only justifiable when including the 2008 AF numbers. Overall, there were 2,956 AAF in 2008, with 5,o61 'findings'. In the 2007 Lab Report, there were 4,402 AAF. Now we presume there is a rational reason for WADA's assertion of 'growth', yet 2956/4402 presents a different ratio to this bad mathematician.

We believe, on this singular 'global' statistic, that it is more realistic to state that AAF went down, in 2008, by a factor of nearly 32pc. And if we concede WADA's inclusion of the precocious AF statistics (obviously the numbers are 5,061 – 2,956 = 2,105 AF), we find a claim of '15pc growth from 2007' that truly reflects (in the 'global' sense') odd logic: we see premature inclusion of a legally-unfounded component, provoking odd, 'new-math' conclusions. By inclusion of the legally-unfounded AF component, the stats work as WADA claims. Without AF in the equation, the reduction in AAF is obvious. And WADA should be trumpeting its efforts.

As a percentage of total testing, the 'facts' seem to prove that WADA is being effective, even though its mathematical conclusions tend to show the opposite: why is this, or where is our math analysis wrong? In 2008, AAF percentages 'overall' were 1.08pc of all A Samples. Including the AF component, we have 1.84pc. In 2007, the annual Lab Report, regarding AAF stats, offers 1.97pc (?=?). From a 2007 level of roughly 2pc, the AAF number has nearly been cut in half, and inclusion of AF renders a five percent drop. Yet FN 2 destroys any analytical comparisons, in our view.

If the 'numbers' don't lie, conclusions flock into WADAwatch's cogitative center. Are the Athletes, as is usually claimed, slipping away from Laboratory analysis due to ever-newer medications, some even not out of Phase II clinical trials (as we reported via AFLD's claim in Le Monde: see AFLD Steps Up a Notch)? Or are they 'cleaner' (but 'Atypical'??)? Wouldn't WADA want the Athletes to receive Kudos for cleaning up their sports?

Is there a justification for examining, as Pierre Bordry suggested to WADA president John Fahey, The limits of classic antidopage controls, in the face of the growing sophistication of doping activities...? We would agree, in questioning the continuous preoccupation with end users, instead of attacking the traffickers of these boutique products. If an Athlete is receiving a Phase II Clinical Trial product, which are not yet on the publicly-available market, are not yet subject to WADA-approved (or Nature-approved, or JAMA, etc., for that matter) laboratory analyses, the focus should be on the Pharmaceutical Industry, and their sports-fan research staff driving Maseratis (non?).

When a country's authorities (police, border/Customs agents) bust some smuggler with 4kilos of Afghani hashish, heroin or Peruvian cocaine, they deprive a portion of the 'end market' with a percentage of available 'stock'. The market, which in sports doping ends at the Athlete, begins 'far far away'.

So, for once in WADAwatch's existence, we could find ourselves agreeing with Monsieur Bordry, that WADA should be re-prioritizing, re-focussing a portion of its fight. And improving, or clarifying its mathematical analysis of its family's performance that equates with our vision of (minimalist at that) Reality in Statistics... which parallels our focus on the 'Beauty of Science.'

To be continued.... "And.... action!"

..........@......... WADAWATCH
one hundred percent pure

copyright 2009 Ww

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