The Winnowing: Meier-Augenstein on Watching the Watchdogs

Wolfram Meier-Augenstein testified for Landis at the AAA hearing. He is an expert in isotope ratio spectrometry, invented a number of the techniques, and is widely published. He also sent us a short, direct responses to the topics we suggested, and this longer piece, which we have reformatted. In the cover letter, he writes:

I have attached a slightly amended version of my "who watches the watchdogs" response to the original majority panel decision; a document I stand by to this day. It focuses on the real problem here, non-fit-for-purpose procedures incompetently applied by a lab with no adequate quality control and quality assurance procedures in place. If LNDD would be assessed by a proper accreditation body (such as UKAS) to either ISO-17025 or to GLP I should like to think they would fail.

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W. Meier-Augenstein, original version 23 Sep 2007; this amended version: 20 Dec 2008.

Quis custodiet ipsos custodes?

Who watches the watchers? (Juvenal; Satire 6.346–348)

The panel's majority decision document contains misleading information, whether deliberately or merely due to ignorance I wouldn't care to speculate. However, what can be stated with certainty is the fact that standard operating procedures as for gas chromatographic peak matching as employed by LNDD are in stark contrast to every text book on gas chromatography and in contrast to articles by internationally acknowledged pioneers in the field of gas chromatography.

Instead of facing up to the fact that LNDD's methods are fundamentally flawed, the panel majority and its expert/s throw this back at the experts for the defence calling their criticism fundamentally flawed.

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On the one hand two members of the panel brand criticism on non-matching relative retention values “scientifically totally unacceptable and fundamentally flawed” because LNDD uses two GC methods on their GC/MS and GC/C-IRMS system, respectively, while on the other claiming compound peak identification was a feasible and sound thing to do despite the fact that in addition to using two different GC methods LNDD also used two completely different GC columns of different polarity and, hence separation properties thus turning visual comparison of chromatograms into something only a cynic would call a scientifically sound approach to compound peak identification.

Is it really unreasonable to demand that methods applied to two sets of experiments are set up to be as similar as possible in almost all respects (with the exception of 1 maybe 2 parameters) if from the outset the intention is the compare the results / outputs from these two experiments? In order to see cause-and-effect relationships a laboratory must be sure that their procedures (the independent variable/s) are the only variables having an effect on the dependent variable. They should do this by holding all other variables, variables that might also affect the dependent variable, constant or as consistent as possible (“Principal of Identical Treatment”).

It’s a simple and well know fact of life applicable to every measurement system: you put garbage in, you get garbage out. This applies in an almost extreme way to GC/C-IRMS because there are so many causes for garbage-in such sample matrix interference, IRMS non-linearity, compound peak overlap to name but a few.

However, before even considering these compounding factors we need, no, must know with absolute certainty which compound is represented by which peak since GC/C-IRMS has to destroy a compound by combustion into carbon dioxide (CO2) to determine the compound’s 13C isotopic composition with the degree of accuracy and precision required for natural abundance level isotope analysis.

So, if somebody would like to compare responses from two GC systems where presence of a peak is indicated by an ‘ionization’ detector (system A) while system B uses a ‘carbon’ detector for the same purpose, is it indeed “scientifically totally unacceptable and fundamentally flawed” to ask (or assume) that experimental set-ups of both GC systems are as closely matched as possible, i.e. identical GC column (i.e. identical stationary phase), identical or at least similar carrier gas flow rate, identical or similar temperature programme to ensure one can compare chromatograms even though peak heights, peak areas, and absolute retention times will be different due to the differences in detector characteristics and variations in the GC conditions, respectively?

Both scenarios have the following in common, methods used for data evaluation as well as the experimental design must be fit for purpose and the latter must match the needs of the former.

If there is a compelling reason to use different temperature programmes one has to employ more than one Internal Retention Time Standard so Linear Retention Indices (Kovats Indices) can be calculated to compare and determine peak identity. In fact to anchor N samples peaks one has to use N+1 internal retention time standards.

If one wishes to use relative retention as proxy for peak identity between two chromatographic systems, chromatographic conditions ought to be closely matched though parameters such as column length and carrier gas flow do not have to be a 100% match.

At this point, attention is drawn to the fact that in USADA’s pre-hearing brief (16 April 2007, #172285 v1; Section IV. IRMS Confirmation of Exogenous Testosterone in Sample #995474; Sub-section D. Description of the IRMS method used by LNDD), which painstakingly describes every step of the IRMS analytical procedure as carried out at LNDD, Points 53 to 58 make no mention whatsoever how target compound peaks were identified during the IRMS analyses. All target compound peaks are primarily identified through the pre-IRMS compound identification as introduced in Point 39: “39. The LNDD IRMS test consists of three main steps: sample preparation, pre-IRMS compound identification, and IRMS analysis”.

Attention is also drawn to the following quotes from the same aforementioned USADA document. “40. … Next an internal standard (5-alpha-androstanol acetate) is added for a purpose that will be explained below. 41. … The first element of compound identification is the GC "retention time (RT)" and the second one is the molecular fingerprint recorded by the MS, which fragments the molecule into ions. 42. A parameter that is even better than the retention time is the relative retention time (RRT). It relies on the internal standard that was added to each tube during sample preparation. The internal standard has its own characteristic retention time. The relative retention time of any other compound is simply (RT of other compound)/(RT of internal standard)¹. This makes comparisons of retention times easier because it normalizes them”.

In the context of the above, Points 182 to 186 in the panel’s majority decision document make for interesting reading.

Also interesting to note is the fact that LNDD does not record the δ13C-values of the internal standard during 13C isotope analysis by GC/C-IRMS. This is point that was specifically stressed by USADA’s legal team during cross of WMA. If we except this argument then this begs the question on which basis did LNDD identify the internal standard peak in chromatograms of samples LNDD claimed to be Floyd Landis’, which showed in some fractions more than 4 peaks in the immediate vicinity of the presumed internal standard with 1 or 2 peaks being as close as 15 seconds.

Why were the panel and the WADA experts not interested in this point? Answer, if one cannot even unambiguously identify one’s chosen internal standard, what confidence can one have in the results that hinge on this knowledge?

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¹Incidentally, this statement is scientifically incorrect as many a textbook on gas chromatography and GC training manuals will testify to. What follows is a verbatim quote from Shimadzu’s GC training manual; only bold emphasis and sections underscored and in italics are added. (Shimadzu’s GC manual is accessible on the Internet at:
http://www.shimadzu.com/products/lab/ms/tutorial/oh80jt0000007e8m.html
(click on “Click here for details” beneath bullet point ‘�� Identification Using LRI’; in the new window scroll through the presentation using >> and don’t forget to open the tabs on the right hand side of each screen).

“We call the length of time between injection and position of the target compound peak a retention time [tr]. On the other hand, the time difference between the peak of an unretained compound and a target compound is called the adjusted retention time [tr’]. We call the retention time of a compound that is not retained by the stationary phase the gas hold-up time [t0].

Relative Retention α (r) [IUPAC recommend using r instead of α to avoid confusion with the Separation Factor α)

Since absolute retention times are affected by many operational parameters, retention parameters less dependent on column dimension and analysis conditions may be desired. Such parameters are expressed by the relative relation of adjusted retention time between the standard sample IS and the unknown sample: relative retention and retention index.

Relative Retention α = t’rs/t’IS = (trs-t0)/(tIS-t0)

The advantageous point of relative retention is that it depends only on the ratio of distribution coefficients and the effects from some parameters, such as column length and carrier gas flow, are basically cancelled out.

However, there are some limitations for relative retention. Measurement of errors will increase for target peaks located far from the reference peak and it is hard to find a relation with a chemical structure.”

Note, that relative retention only makes allowances for different column length and different carrier gas flow in otherwise identical set-ups, i.e. identical stationary phase and identical temperature programme.

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Finally, attention is drawn to the fact that the standard sample Mix Cal Acetate used in IRMS does not contain 3 of the 6 target compounds; in fact it does not contain any of the target steroids crucial to the adverse finding in this case, namely androsterone (andro), 5α-androstanediol (5alphdiol) and 5ß-pregnanediol (pdiol). In contrast, Mix Acetate, the standard sample used in GC/MS for pre-IRMS compound identification does contain all 6 target compounds plus the Internal Standard, yet Mix Cal Acetate contains the same Internal Standard as Mix Acetate (see Point 42 of the USADA pre-hearing brief)

Given all that and given how important it is to be able to identify all target compound peak as unambiguously as possible, it is surely a logical assumption to make that LNDD had a tried and tested protocol in place that enabled them to use pre-IRMS compound identification by GC/MS analysis as an anchor for the IRMS compound identification using relative retention as proxy.

However, in the light of Points 182 to 188 of the panel’s majority decision document it would appear LNDD was not doing any such thing “because the chromatographic conditions are different”; …”the thermal ramp {…} is different.” (Point 188). [This statement is not only in stark contrast with the stated benefits of relative retention as per the USADA document quoted above: “A parameter that is even better than the retention time is the relative retention time (RRT)”; because “This makes comparisons of retention times easier because it normalizes them” it all also ignores nearly 50 years of research and development that has made gas chromatography (GC) one of the most widely used techniques in analytical and separation science and resulted in insights of GC theory such as “The advantageous point of relative retention is that it depends only on the ratio of distribution coefficients and the effects from some parameters, such as column length and carrier gas flow, are basically cancelled out”.

Similarly, the majority panel is seemingly also ignorant of the fact why renowned scientists such as E Kovats, in whose honour the linear retention index has been named Kovats Index, have devised methods and equations designed for identifying compound peaks of the same compound but analysed under temperature programmed gas chromatographic conditions.

As an aside, one of the main applications of relative retention and retention indices is to compare chromatographic behaviour of compounds on two GC systems with two different detector systems. Even though the majority panel in Point 182 try to create the impression a GC/MS and a GC/C-IRMS instruments are instruments “that are not of the same type” they contradict themselves in Point 184: “With GC/C-IRMS the sample is processed first through the GC, as with GC/MS”. Exactly right, the fact the two GC systems use different detectors does not matter a jot. The only difference in GC terms is the “additional ‘plumbing’” since this adds to the ‘hold-up time’ of the GC/C-IRMS system.

Even this point is conceded and correctly applied (in parts) by the majority panel in Point 185. “The additional time added to the RT of the analyte or standard in the IRMS will always by a constant time, regardless of the individual substances or compounds being measured”. One could not think of a better definition of ‘hold-up time’², i.e. the time it takes an unretained compound to travel trough the GC system until it reaches the detector (be that be an MS or an IRMS). To drive home this point the majority panel add “an additional 1 minute” to demonstrate how this will change the relative retention time for a compound and an internal standard with GC/MS retention times of 10 min and 5 min, respectively, which in the GC/C-IRMS will now show retention times of 11 min and 6 min, respectively. So, what do they do? They build the ratio of the absolute retention times, i.e. 10 min/5 min since as per Point 184 “in the case of the MS, the GC is connected directly to the MS and it detects the substance almost instantaneously”, hence making the assumption for the sake of this example the GC/MS does not suffer from a ‘hold-up time’, i.e. ‘hold-up time’ equals 0 min. So far, so good. In the next step they proceed to build the ratio of the absolute retention times for the case of the IRMS with a ‘hold-up time’ of 1 min (affecting both compound and internal standard in the same way), i.e. 11 min/6 min. In doing so they completely ignore a fundamental principle of GC theory that states in order to calculate relative retention one builds the ratio of adjusted retention times, i.e. absolute retention time minus ‘hold-up time’, i.e. (11-1) min/(6-1) min, which uncannily is the same as 10 min/5 min.

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² Just in case, here is the official IUPAC definition of hold-up time and hold-up volume.

hold-up volume (time) (in column chromatography), V_M, t_M

The volume of the mobile phase (or the corresponding time) required to elute a component the concentration of which in the stationary phase is negligible compared to that in the mobile phase. In other words, this component is not retained at all by the stationary phase. Thus, the hold-up volume (time) is equal to the retention volume (time) of an unretained compound. The hold-up volume (time) includes any volumes contributed by the sample injector, the detector, and connectors.

t_M = V_M/F_c

In gas chromatography this term is also called the gas hold-up volume (time).

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What have we learned thus far? Relative retention is calculated by building the ratio of adjusted retention times for a given compound and the internal standard; adjusted retention time means absolute retention time minus hold-up time; fact. Relative retention is virtually impervious to changes in column length and carrier gas flow and therefore an ideal means to compare and identify compounds peaks recorded on two different GC instruments provided chromatographic conditions are identical; fact. The same objective can be achieved in cases where temperature programming (“thermal ramp”) is different by using the linear retention index method; fact. Thanks to the USADA pre-hearing brief (point 42) and the decision document (point 185) we have also learned neither LNDD nor the majority panel and its experts know how to calculate relative retention correctly.

At face value we have to accept the assertion that LNDD never intended to use relative retention to identify compound peaks in GC/C-IRMS by using the relative retention data from the pre-IRMS compound identification as anchor.

So, if that is not the way how LNDD have identified which compound peak in the IRMS analysis represents which target compound, how did they do it?

Luckily for us, the decision document provides the answer in Point 186: “the lab compares the peaks and the sequence of peaks from the GC/MS and the GC/C-IRMS to identify metabolites and the endogenous reference compounds. Specifically, to identify the substances in question, one would compare the pattern of peak heights and retention times in the GC/C-IRMS chromatograms, anchored by the internal standard with a known RT, with the pattern of peak heights and RTs in the GC/MS chromatogram obtained from the same aliquot of the sample.”

Hang on a minute. How does this work then? Didn’t the majority panel just say in Point 183 “it cannot be expected that the RTs for a GC/MS instrument will correspond with the RTs for the GC/C-IRMS instrument”??? If that is not the mother of all contradictory statements I don’t know what is.

Well, never mind and I shall not even remind you that “the thermal ramp is different” meaning “the chromatographic conditions are different”. Neither shall I keep harping on that peak heights in GC/MS are a function of ion current, which depends how easy a compound becomes ionized and how inclined the molecular ion feels to break up into fragment ions and how many, while in contrast the peak heights in 13C IRMS are proportional to the amount of carbon (in the form of CO2) entering the ion source of the IRMS, and that the peak heights between the two detectors for the same compound are not strongly correlated.

So, where were we? “Peaks and the sequence of peaks from the GC/MS and the GC/C-IRMS” are compared “to identify metabolites and the endogenous reference compounds”.

It is probably petty of me to mention again at this point that it would really help if the standard mixture used for GC/C-IRMS would contain all 6 of the target metabolites and endogenous reference compounds one is looking for instead of being 3 crucially important target compounds short! Attention is therefore drawn again to the fact that in contrast to Mix Acetate (as used for pre-IRMS compound identification by GC/MS) the Mix Cal Acetate used for IRMS analysis contains the Internal Standard and only 3 of the target steroids, i.e. Androsterone [andro], 5α-Androstandiol [5alphadiol] and 5ß-Preganediol [pdiol] are not included.

Just as well then that “the GC column is, of course, the same in both instruments” (Point 188) so there will be no problem for the lab to compare “the peaks and the sequence of peaks from the GC/MS and the GC/C-IRMS to identify metabolites and the endogenous reference compounds. Specifically, to identify the substances in question, one would compare the pattern of peak heights and retention times in the GC/C-IRMS chromatograms, anchored by the internal standard with a known RT, with the pattern of peak heights and RTs in the GC/MS chromatogram obtained from the same aliquot of the sample” (Point 186).

Even if one only intends to compare “the peaks and sequence of peaks” for their relative position in the chromatograms by essentially extrapolating from one GC[/MS] chromatogram to another GC[/C-IRMS] chromatogram, what one should not do, is to employ a different temperature programme and, in addition, GC columns of completely different polarity in both instruments!

There are plenty of examples in the literature (and GC column application notes) showing that a change in polarity of the stationary phase can lead to such changes in compound retention (times) that compound peaks X and Y (for example RT(X)=15 min and RT(Y)=16 min on column A) will swap places, with compound Y now eluting before compound X (for example RT(X)= 18 min and RT(Y)= 17 min on column B).

Clearly the majority panel is aware of this compounding factor assuring us as they do that “the GC column is, of course, the same in both instruments” (Point 188).

According to LNDD’s documentation (USADA 0124) all samples pertaining to this case analysed on the GC/MS system were analysed using the “6890 GC Method”, which employs an AGILENT 19091s-433 column, 30 m long, internal diameter 0.25 mm and film thickness of the stationary phase of 0.25 μm. The manufacturer classifies this column as a non-polar column, stationary phases comprised of 5% phenyl, 95% methyl-polysiloxane. As equivalent columns are listed Rtx-5MS, HP-5MS and DB5-MS.

According to LNDD’s documentation (USADA 0153) all samples pertaining to this case analysed on the GC/C-IRMS system were analysed using a DB17-MS column, 30 m long, internal diameter 0.25 mm and film thickness of the stationary phase of 0.25 μm. The manufacturer classifies this column as a midpolarity column, stationary phases comprised of (50% phenyl)-methyl-polysiloxane. As equivalent columns are listed Rtx-50 and HP-50+.

What have learned here? LNDD have used two different GC columns of significantly different polarity and, hence compound selectivity; fact. There can be no argument about this since this fact is undeniably documented in the USADA discovery documents. Yet, the majority panel quite unequivocally state in their decision document in Point 188 “the column is, of course, the same in both instruments”. To put it another way, the majority panel and the WADA experts have either not bothered to examine the laboratory documentation of LNDD’s analytical procedures, or, if they have they have very conveniently wiped their memory of this particular fact. Either way, again a crucial piece of evidence that at the very least throws serious doubt on the competence of LNDD has been conveniently overlooked and been withheld from the public.

So, we are back where we started; garbage in, garbage out. LNDD have no way of knowing let alone unambiguously proving that the peaks analysed by IRMS are what they claim to be. Is it plausible their peak identification is correct? Perhaps. Can they prove it, and more to the point can they prove that closely neighbouring peaks such as etio and andro, and 5betadiol and 5alphadiol have not swapped places? They can not! If one cannot prove that the outcome of an analytical measurement pertains to one particular compound and that compound alone, the result becomes meaningless.

In conclusion, the experts for the defence have highlighted that the methods employed (and as applied) by LNDD are not fit for purpose no matter how you slice it. Yet, the panel (with exception of Christopher Campbell) saw fit to turn this on its head and say our criticism that target compound peaks have not been properly identified is scientifically totally unacceptable and fundamentally flawed.

It strikes me that in order to justify false positive findings of drug abuse by athletes we have now entered the era of science abuse by the watchdog.

To put it more bluntly, this modern day witch hunt that as in the days of the inquisition works on the presumption of guilt (until proven innocent) is a tragedy for sport and a travesty of justice.

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The Winnowing: Wolfram Meier-Augenstein

Wolfram Meier-Augenstein testified for Landis at the AAA hearing. He is an expert in isotope ratio spectrometry, invented a number of the techniques, and is widely published. He sent us some short, direct responses to the topics we suggested, and a longer piece which we'll publish separately.


On the Merits of the Landis case

The data produced by LNDD are scientifically flawed (ambiguous peak "identification"; no matrix matched positive quality control, no matrix matched negative quality control; only one parameter being used as qualifier to declare a failed test) as well as biologically / biochemically (results make no sense from a biochemical point of view regarding testosterone metabolism).

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Conduct of the Landis case?

It was a witch hunt; the accused is presumed guilty; WADA lab employees are under WADA orders not to testify against another WADA lab; the panel of 3 is comprised of 2 WADA appointees and 1 independent. At present WADA is judge, jury and executioner, which is unacceptable in any civilised society.

Wisdom, merit and effectiveness of anti-doping as currently practiced?

Anti-doping control is sadly a reality and will remain so to ensure fair competition as best as this can be achieved. However, turning the screws by lowering thresholds and tolerances below researched and published conservative thresholds and tolerances based on population statistics and the natural variability, even intra-individual variability of the human body increases the number of false positives. More innocent athletes are labelled as drug cheats for the sake of catching "all" real drug cheats. One almost suspects another motive for doing this is so WADA can continue to justify its existence (and the money spent by and on them).

What could be done in anti-doping that might work better?

Anti-doping should be more open to scrutiny; anti-doping labs should be monitored and quality controlled by organisations independent of WADA. Like any forensic service provider anti-doping labs must be open to peer assessment and participate in proficiency tests (international laboratory exercises). If 13C isotope analysis is to be used this ought to be carried out only by qualified staff on GC-IRMS/MS hybrid systems (available commercially "only" since 1995!!!), i.e. instruments that can measure 13C isotopic composition of a peak AND identify the compound causing the peak AS WELL AS probing for peak overlap with minor components under IDENTICAL analytical conditions during the SAME analysis.

Facts do not cease to exist because they are ignored.

Aldous Huxley, "Proper Studies", 1927

Dr W Meier-Augenstein, CChem, FRSC
Senior Lecturer - Stable Isotope Forensics
Centre for Anatomy & Human Identification
University of Dundee

Principal Scientist - Stable Isotopes
Stable Isotope Laboratory
SCRI
Invergowrie
Dundee, DD2 5DA
United Kingdom

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The Winnowing: Dan Rosen

Dan Rosen's Rant Your Head Off predated us by a few days, but he was smart enough to avoid being daily, and to have a wider focus. The experience led to a book. The wisdom of being sporadic helped him avoid burnout, and the wider focus lets him evade the sell-by-date that came with our narrower interests.

You Can’t Fight City Hall

There’s a certain genre of Hollywood B movies and pulp fiction novels that have the following story line:

Corrupt City Hall official makes a decision that steps on the toes of a Little Guy. One who can’t afford to fight city hall, and even if he could, it’s a fight he’s destined to lose. But despite the obstacles, through perseverance and strength of character, the Little Guy mounts his quixotic quest for justice. Along the way, more bad things happen, life gets tougher, his friends desert him, and he’s driven to the brink of destruction and despair. Undeterred, he fights on. Eventually, his luck turns and the corrupt official’s bad dealings come to light. People rally to his cause and he eventually proves the old adage, “You can’t fight City Hall” wrong.

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It’s a story line that we love. It’s a great idea to believe that you can take on the rich and powerful, have truth and justice on your side, and eventually prevail. But old sayings come from a certain amount of truth. Most people who are wronged by the powerful never get that sense of justice and satisfaction that our Little Guy does in those Hollywood movies.

In thinking about Floyd Landis’ case, it seems to me that we have been witnessing the same kind of underdog story. Unless you were a fan of professional cycling, you probably hadn’t heard Floyd’s name before July 2006. Or if you did, it was in passing. Those non-cycling fans who knew of him probably did because he’d been one of Lance Armstrong’s cadre for a few seasons during Big Tex’s remarkable seven-straight Tour victories. Lance’s feat is not likely to be repeated for a long, long time to come, and Floyd had a part in that.

Every American who’s won the Super Bowl of cycling has a story of overcoming adversity. Long-time cycling fans know Greg LeMond’s story. Almost bleeding to death after his brother-in-law accidentally shot him while they were turkey hunting the winter after winning his first of three Tour crowns. After two intervening years, he came back to win again, with perhaps the narrowest margin of victory ever. His is the original “American overcoming great obstacles to win the greatest bike race in the world” story. Virtually everyone knows Lance’s story – the comeback from a cancer that advanced and spread far enough in his body that it would probably have killed mere mortals. Like “The Terminator,” Armstrong has a steely determination to overcome all obstacles in his path. (If I were a pro cyclist, the words I’d dread hearing most would be the phrase “you’ve tested positive.” A close second would be Armstrong saying, “I’ll be back.” But that’s another story for another time.)

Just like the other two Americans to win the Tour, Landis overcame a pretty daunting obstacle to claim victory. Floyd had a bum hip, with necrosis and osteoarthritis so bad that he would eventually need a hip replacement – the after-effects of an injury suffered during a training accident in 2003. Landis also has the character and determination one needs to endure a great deal of pain and discomfort while performing as a top-flite pro cyclist.

There’s something about Floyd’s story that was different than the other two. Perhaps it was the background. The Mennonite roots. It’s hard to pinpoint what it is, exactly. But unlike the other his predecessors, Floyd Landis comes across as an Everyman who – through sheer force of will, grit and determination – made it to the pinnacle of his profession. I’m not quite sure why neither Greg nor Lance has that Everyman quality about them, but neither one strikes me as a guy you’d want to meet at the local pub for a brew. Not in the same way that it would be fun to hang out with the happy-go-lucky Mr. Landis. (And that’s not meant as a criticism of either.)

The euphoria of Landis’ victory and the inspiration of his example lasted but a short time before everything came crashing down. The positive anti-doping test results, leaked by none other than the head of the UCI because, as Pat McQuaid said, someone else would have leaked them, anyway. Landis, who was not used to the kind of media attention a Tour winner gets, was thoroughly unprepared for the media onslaught that came next.

McQuaid, he of the “worst-case scenario” leak, offered up some advice to Landis not long afterwards. You can’t beat City Hall, he told the 2006 Tour winner. Save your money. Serve out your suspension quietly. Cooperate with the anti-doping authorities and they won’t rip you a new one.

From the start, Landis maintained his innocence. Admitting to something he didn’t do would be abhorrent and out of character. He wanted to clear his name and restore his reputation. Perhaps it really was a quixotic quest, because once the news of his positive test results hit the fan, both his name and reputation were splattered with a type of muck which can’t easily – or ever – be washed away. Most people in his circumstances wouldn’t have had the resources to mount such a fight. Instead, they would be forced to swallow hard and accept the cruel handout that Fate dished up.

Losing the battle meant that Landis would become the first cyclist to be stripped of his Tour de France crown because of a doping violation. And he didn’t want to become that guy. (Landis, however, would not be the first maillot jaune to be disqualified. That would be Maurice Garin in 1904. Nor would he be the first cyclist who might have used testosterone on his way to victory– that honor likely belongs to Bernard Thevenet, who admitted to using testosterone in pursuit of at least one of his Tour victories in the 1970s.)

Landis would not just roll over and accept defeat. Over the last 28 months, he did everything he possibly could to right the wrong done to him. Though he didn’t succeed, he can look himself in the mirror secure in the knowledge that he did his best. He took on City Hall, but outwardly, it appears he didn’t win.

On the surface, the procedures of our current anti-doping system look fair. No doping charges are filed unless testing of a second portion of the original sample shows the same results as the original tests. In theory, this eliminates the possibility of lab errors. If the two test results don’t match, no case is filed. If doping charges are filed, the athlete has the right to appeal his or her case. And failing the initial appeal, the athlete has the right to appeal to the Court of Arbitration for Sport. Unless you dig deeper into how the actual system is structured and how it operates, it would be easy to assume that an athlete charged with a doping offense has a fair shot at proving his or her innocence – assuming he or she really is innocent.

City Hall – in this case, the World Anti-Doping Agency – has set things up differently, however. This is not your ordinary form of justice. There are limits on what evidence you’re allowed to have as an accused doper, while there are no limits on the evidence that the anti-doping agencies can produce to bolster their own cases. WADA has said that the only evidence that an accused athlete is entitled to is the material in the lab documentation package provided to the athlete. If it’s not in the materials provided, you’re not entitled to it. And yet, as the Landis case showed, the ADAs have an almost unlimited ability to bring other evidence into the hearings to prove their case. It begs the question: If this is how things work, can you beat City Hall?

In the system they’ve set up, you can’t argue that the science behind the testing is wrong. WADA deems that science is correct. What you can argue, however, is that the lab either didn’t interpret the results correctly, or they didn’t perform the tests correctly. Maybe there’s a shot at beating City Hall after all.

For the interpretation argument, you’ve got to find scientists who will explain to the satisfaction of the arbitrators why the results don’t mean what the prosecutors say they mean. That’s a classic battle of the experts, and almost always the prosecutor’s experts win. OK, then, so you can argue that the tests weren’t performed correctly. Except for one small detail: WADA says the labs don’t have to give you their standard operating procedures. Catch-22, anyone? Can you defeat City Hall?

Anti-doping appeals are heard by a panel of arbitrators, rather than by judges in a traditional court setting. Each side gets an equal amount of time to make their case. Sounds fair, doesn’t it? Except, in practice, that’s not the case. For the prosecution’s side, they merely have to prove that the results are accurate and they mean what they say they mean. For the defense, they need to overcome the huge advantage given to the prosecutors. In a complicated case, the time limitation works to the prosecutor’s advantage, because the defense needs much more time to overcome the prosecution’s advantages. Again, you can’t fight City Hall.

Landis’ case seemed simple enough. Either he used testosterone as the lab claims, or he didn’t. But to prove he didn’t involved complicated arguments over just how certain scientific instruments should be operated, how the data should be analyzed, and what the results mean.

For the prosecutors, it was enough to say, “These are the results and they mean what I say they mean.” For the defense, it was not so easy. They have to convince the arbitrators that their experts are more credible, that the experts’ knowledge of how to interpret results is more reliable, and they must do so in a way that the experts appear as disinterested observers who are merely trying to help the panel understand this incredibly complex scientific stuff.

And, of course, there’s the starting assumption of guilt. Justice systems can be built starting with the assumption of guilt or innocence, and as long as they give the defendant the opportunity to confront their accusers, challenge the prosecutors’ assumptions, and as long as the defendant is given full access to any potentially helpful evidence, the system can come to the right result more often than not. When one side is hamstrung by lack of access to such evidence, then the scales tip in favor of the other side. If the scales of justice are unbalanced, is it a fair fight?

A couple of cases have been thrown out by CAS panels on appeal, as it happens. Both Inigo Landaluce and LaTasha Jenkins managed to avoid suspensions, based on the same error in protocol. In both cases, a lab technician involved in the testing of each athlete’s A sample was also involved in the testing of the B samples, which is a clear violation of WADA’s rules. Maybe you can fight City Hall, but only if there is an egregious error by the lab.

The coup de grace in Floyd’s case was the CAS panel’s written decision. In that decision, they summarily threw out every argument Landis’ defense team made. The panel’s decision said that the scientists who served as Landis’ witnesses strayed into the territory of being advocates rather than dispassionate experts seeking to help the panel’s inquiry merely for altruistic motives. But if you’re taking the stance that the tests weren’t done correctly, or that the equipment wasn’t operated corrected, or that the data wasn’t analyzed correctly, exactly where is the line that can’t be crossed? Shouldn’t someone be allowed a vigorous defense? Or is one limited in how to strong a defense can be used to fight City Hall?

Landis’ attorneys’ behavior was so bad, according to what the CAS panel wrote, that they deserved to be sanctioned. And because some witnesses were made available by USADA so Landis’ defense team could question them, and because they weren’t called to testify (perhaps due to time constraints?), Landis’ was assessed a $100,000 penalty – ostensibly to cover USADA’s expenses. (The panel failed to note, however, that had they allowed those witnesses to be deposed ahead of time, the testimony could have been entered into the record with a minimal impact on the amount of time spent during the hearings and a minimal impact on the witnesses’ own lives.) Not only can’t you fight City Hall, but they’ll fine you if you do.

At least during the original arbitration hearings (which lasted approximately twice as long as the CAS appeal), the panel did find some points in favor of Landis’ arguments. In their decision, the original panel noted that certain problems in the lab’s conduct could, if not corrected, lead to cases being thrown out in the future. Maybe others might be able to beat City Hall in the future, even if Landis couldn’t?

The CAS panel, however, gave no credence at all to any arguments made by Landis’ defense. Except they didn’t extend his sanction further, as USADA requested.


We’ll probably never find out, but perhaps Landis got some satisfaction in the settlement of the lawsuit he filed in September, which sought to vacate the CAS panel’s decision, including the $100,000 penalty. Among his lawyers’ contentions was that there were numerous conflicts of interest among the CAS panel members who heard his case and at least one of USADA’s attorneys. A system where an arbitrator can sit in judgment of a case one day, while being the judge on a different case the next, and where the roles of judge and prosecutor may be reversed from time to time, and where these individuals may interact with each other in different roles on different cases at roughly the same time hardly favors the defense. Fight City Hall? Maybe it would be better to shut up and take the sanction – even if you know you’re innocent.

No official word has been spoken about that settlement, and given that confidentiality agreements are often part of the deal, it’s unlikely that whatever Landis did receive in the bargain will come out. In fact, I wouldn’t be surprised to learn that there is a confidentiality agreement about the confidentiality agreement. As in, “I can neither confirm nor deny that I can confirm or deny the existence of any such agreement – if such an agreement exists.” Could it be that, in private at least, Landis did beat City Hall? At least a bit?

In the end, it seems to me that the biggest lessons of the Landis case are these:
1. The anti-doping system is structured to give the appearance of fighting doping, to protect entrenched interests at a higher level. As Mark Felt, the FBI official who was known as “Deep Throat,” once advised two young Washington Post reporters to do, follow the money. Where the trail leads will show you whose interests are really being protected. It more a case of “Anti-Doping Theater” than a serious effort to confront the problem in a thoughtful and rational manner.
2. The basic structure of the anti-doping system has to be changed to better reflect the possible scenarios that may be encountered and to ensure greater fairness. Slapping all first-time offenders with the same harsh punishment has failed to diminish the number of athletes who use performance-enhancing drugs, while at the same time inflicting severe punishment on cases of unintentional exposure. This is the argument I’m putting forth in the “Towards A New Anti-Doping Approach” series on my own site.
3. The expense of fighting City Hall is so great that we’re unlikely to ever see a case like Floyd Landis’ again. Not because the tests are getting better, or that only guilty people are being charged with doping offenses. The former might be possible, but the latter almost certainly isn’t. In any system of justice, some innocent people will be put on trial. It’s the nature of the game.

Floyd Landis fought the good fight. He took on City Hall. And in doing so, he made us aware of how things really work in WADA-world. In that sense, his fight was a success. But as for clearing his name and his reputation, that didn’t happen. And given the nature of the system as it currently stands, the end result was probably a foregone conclusion. In that sense, the outcome of his case seems to illustrate the old adage. Sometimes, you really can’t fight City Hall and win.

It’s time to move on, even though it might be hard to do so. There are forces Floyd’s case set into motion that will continue on, though perhaps in a different form. Because of his openness in his struggle to clear his name, people are aware of the flaws in the current anti-doping system. Some of those people are thinking about and discussing ways to make the system more effective. At some point, perhaps those thoughts and discussions will percolate upwards. And maybe, just maybe, some day the system really will change for the better.

In the coming year, we will get to see Floyd Landis racing. Rather than arguing about his case, we will be able to Monday-morning quarterback about how well he’s doing. Many of us may even get to see him race in person, rather than on television. There will, however, be people who won’t be accepting of his return. That’s a shame. He’s spent his time in purgatory. It’s time for Floyd to get on with racing and with life.

We owe a debt of thanks to Floyd for making his case public. It’s been an education. Those of us who’ve spent our time researching, reading, and arguing about his case – on both sides – have certainly earned our own personal master’s degrees in doping studies by now – even if none of us have one from a formal academic institution. That’s the power of the web, and the power of blogs., especially this one. It’s been a place where we could all go to learn and explore this particular subject in depth, to our hearts content.

Many thanks to TBV and the whole TBV crew for bringing this valuable site to life. It’s been a pleasure to be associated with you all – even the folks I disagree with. I look forward to crossing paths (and sometimes crossing swords) with everyone I’ve met here in the future. Perhaps at Rant, or the impending Rant 2.0, or perhaps at some other site.

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The Winnowing: Joe Papp

Joe Papp is an American sometime-professional cyclist who was busted for testosterone use and testified for USADA at the AAA hearing. He has openly admitted his own guilt.


When TBV invited me to share my thoughts on the puzzle that was the Landis Affair, I eagerly accepted – though weeks passed before I could finally articulate my perspective on the case.

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As I said during the arbitration hearing in Malibu last May, I didn’t – and don’t – have any ill-will towards Floyd Landis. I understood how my testimony as a witness for USADA could have been perceived by Landis and his supporters, but I took the stand to share with the world my own story, and to state for the record that testosterone, along with many other drugs that wouldn’t seem ideal choices for endurance athletes, are hungrily gobbled-up by professional cyclists and used exactly as I described.

The claim that there is no “scientific” evidence to support the use of testosterone for recovery by professional cyclists during multi-day stage races is a red herring – scientists and medical professionals are ethically-prohibited from carrying out the very research studies that would be required to support or disprove the theory that Androgel® works beyond having a placebo effect. Besides, with finite resources available to support the anti-doping movement, would that research represent the best allocation of funding in pursuit of the goal of “clean-sport?” I would rather see money spent to improve the efficiency and the integrity of the testing and reporting process, to ensure that other athletes accused of doping don’t suffer the same injustice that befell Floyd.

Yes, even though he was convicted of doping, I think that the anti-doping system failed Floyd Landis.

I don’t place the blame on USADA – an agency that treated me justly and respected the basic tenets of fairness during the adjudication of my case – but rather, with the foreign parties who violated Landis’ rights as an athlete and precipitously disclosed the results of his A-sample to the media.

Floyd was criticized for his public “wiki” defense, and I think he erred tactically in some of his statements, but if parties to the case other than Landis hadn’t violated their legal and ethical obligations of confidentiality, there would have been less questioning of the integrity of the entire testing process.

The anti-doping agencies should aggressively fight cheating in sport, but in a manner that leaves no room for conspiracy theories or the challenging of test results based on gross violations of an athlete’s privacy. The laboratories charged with analyzing samples must be held to the same standards to which accused athletes are subjected, because when a process and protocols are intentionally contravened (as in the case of LNDD’s leaking Landis’s results to the media), one can reasonably question the motivation and reliability of those who should be scrupulously neutral.

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The Winnowing: Arnie Baker

Arnie Baker MD (ret.), is a prolific author of cycling training and medical information. He was Landis' first coach in California. On hearing the accusations, he worked actively on interpreting the available information for the defense, and prepared the well known presentations and various versions of The Wiki Defense publication.

Landis’s Legacy
Exposing a Flawed Anti-Doping System

(For more complete documentation see: http://arniebakercycling.com/books/wiki.htm.)

By Arnie Baker, MD

Background

I met and started coaching Landis more than a decade ago.

During the 2006 Tour, like many others, I was glued to the television watching Landis’s Stage 17—an epic, daring, long solo breakaway; a fabulous day in cycling.

At the Tour’s end, amid doping allegations, I did not speak to the press—though my phone rang nonstop for three days, and more than 30 media outlets contacted me. Like Landis, I really had nothing to say—I did not know what the situation was. Unlike, Landis, I could keep to myself.

When I examined Landis’s document package, I was appalled at the lack of quality. I told Landis that if the standards for anti-doping laboratories were anything like the standards for medical laboratories and medial record keeping, this was not a positive test. This was a test that should be thrown out.

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Landis decided early to have an open arbitration. Athletes have the right to request an open hearing, but it had never been done before. Landis already knew that the World Anti-Doping Agency (WADA) system was a closed one, without standard checks and balances, where the writers of the rules could also be the prosecutors and the arbitrators.

Moreover, hardly anyone knew about anti-doping testing, and those who did generally worked in anti-doping laboratories and were prohibited from assisting athletes.

Early on, we decided on an approach not favored by most attorneys: We would post everything we could about the case on the internet. We would call it the Wiki Defense.

We would show what we had, and figured we might obtain some help from interested readers.

Here is one analogy of the WADA system:

Imagine you are driving your car on the freeway, and a traffic officer pulls you over.

Officer: “I’m going to write you a ticket.”
Driver: “How fast was I going?”
Officer: “I’m not going to tell you.”
Driver: “What’s the speed limit?”
Officer: “I’m not going to tell you.”
Driver: “Can I go to court and fight this?
Officer: “Yes, but you can only choose from judges that I’ve preselected. After you’re found guilty, we’ll charge you court costs.”
Driver: “Officer, I wasn’t speeding”
Officer: “Nonsense. Of course you were. You’re driving a red car. Everyone knows that people who drive red cars speed.”

For me, this was about the science, and the science fiction of the anti-doping laboratory that analyzed Landis’s sample. Here is what I found:


The Authorities Lied^*

• There was evidence of scientific misconduct/malfeasance.
• Vanishing acts: Records disappeared.
• Magical appearances: Documents missing or full of errors were “found” or “corrected” and appear to have been fabricated.
• False statements: USADA, its experts, and the lab appear to have repeatedly made false statements.

They Botched the Test

The report was so full of errors that other conclusions are impossible. For example:

• Sample numbers were wrong.
• The chain of custody was flawed.
• Quality control standards failed, and the failures were ignored.
• Files were overwritten/erased.

They Never Identified Testosterone Properly

Two types of tests were performed: The T/E (testosterone/epitestosterone) ratio test and the IRMS test.

The T/E ratio testing was non-compliant with basic science and WADA regulations and so did not meet the criteria for a positive test.

• Peaks were not identified according to minimum standards.

The IRMS (isotope ratio mass spectrometry, also called carbon isotope, synthetic, or exogenous) test results did not meet basic science or WADA criteria for a positive test.

• The lab had no Standard Operating Procedure (SOP) or validation study for peak identification.
• Peaks were not identified according to minimum standards.

The Arbitration Hearings

The arbitrations hearings went against Landis.

At the American Arbitration Association hearing, confirming Landis’s position about scientific misconduct, dissenting arbitrator Chris Campbell noted: “From the beginning, the Laboratoire National de Dépistage et du Dopage (“LNDD”) has not been trustworthy.”

It was only after the Court of Arbitration for Sport hearing that we confirmed some of the extent of the conflict of interest in the proceedings. For example, when Jan Paulsson and David Rivkin were selected to serve as arbitrators on the Landis panel, Rivkin was serving as president of a CAS panel considering the IOC’s enforcement action against Austrian cross-country skiers, proceedings in which Mr. Paulsson represented the IOC.

Summary

In my view, the test should have been thrown out.
The lab should have been sanctioned.

Landis provided us a legacy, at least two gifts:

• He gave us Stage 17.
• He opened our eyes to the conflicted, opaque, and flawed testing of the anti-doping establishment, a system in need of reform.

---

^*The evidence shows documents that appear to have been fabricated and documents and testimony that have been shown to be false. A “lie” or “fraud” implies intent. Without direct admission on the part of USADA, LNDD, or its witnesses, the determination of intent is a judgment. It is my belief and judgment, based on a review of the evidence, that there was intent to deceive.

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The Winnowing: Bruce Goldberger

Bruce Goldberger Phd, is prominent forensic toxicologist, and lab director who testified for Landis at both hearings. Prior to involvement in the Landis case, he'd been invited to apply as a candidate to replace Catlin as Director of the UCLA WADA laboratory.


As many people know, I was reluctant to get involved in the Landis case as I do not work for (and never have) an anti-doping laboratory. I have been practicing forensic toxicology for more than 25 years and much of my work has focused on novel analytical techniques and quality assurance/quality control procedures.

But, when given the opportunity to study the materials from the LNDD laboratory, I immediately agreed to work with Howard Jacobs and Maurice Suh. I was distressed by the quality and interpretation of the analytical data, chain-of-custody documentation, etc. If the Landis case was prosecuted in a U.S. Court of Law, the data would have never met the Frye and/or Daubert standards of evidence.

Also, I learned quickly that the WADA Anti-doping program was constructed to such a degree that accused athletes are greatly disadvantaged when defending themselves. For example, WADA Laboratory Directors cannot consult for an accused athlete; and defense experts like myself are criticized because of a "lack of expertise and experience". Further, the WADA IST and ISL are woefully inadequate to ensure a fair and equitable system which protects the rights of the athlete while ensuring the success of an anti-doping program.

Finally, I want to thank TBV for maintaining a blog devoted to the Floyd Landis doping allegations. It has been a valuable source of information.

Bruce Goldberger, Ph.D., DABFT

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The Winnowing: Spinopsys

Spinopsys Phil, an Australian self-described Floyd-basher, sent these regrets, and made good on his promise of mention at Cycling Central.

[Back to the Introduction]


I really appreciate you asking. First off congratulations of a fine blog and more importantly a fine example of what media might look like in the future. You've demonstrated that long form journalism in the digital age does not end with a 10,000 word article in a major magazine or newspaper but will be done a few hundred words at a time by a team of experts and amateurs contributing their knowledge. Yours will be an important historical archive for years to come.

Unfortunately I won't be able to contribute, busy as I am now as cycling content editor/producer for Australia's Tour de France broadcaster SBS at their brand spanking new cycling site Cycling Central.

Anyway, you can bet that I will be making note of the passing of TBV in a weekly piece I write for the site.

Regards,

Phil

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The Winnowing: John Amory

John Amory MD, is a leading andrologist (male hormone specialist) who testified for Landis in both hearings, arguing the metabolism of testosterone as documented in all reviewed studies does not have divergences between the adiols claimed in the test values.

Amory had served on USADA anti-doping review boards prior to the Landis case. In response to a specific question, he replied, "I would considering serving on an ADRB again, but part of me is very glad to be focusing on my clinical duties and my research (male contraception, oral testosterone development), and out of the contentious world of doping. "

[Back to the Introduction]

My thoughts about the Landis case are as follows:

1) The results of his IRMS were scientifically indeterminate. There is a nice discussion of this in the article by Berry from Nature which makes this case more eloquently than I can.

2) The criteria for positivity of the IRMS should be standardized between labs based on larger normal samples. For example, the UCLA lab requires the delta of both the 5-alpha-androstanediol and the 5-beta-androstanediol to be significantly elevated, but WADA only requires that a single metabolite be elevated. The latter approach reduces the specificity of the test, thereby increasing the risk of a false positives, which is probably what happened in this case (5-alpha abnormal, 5-beta normal).

3) Testing of the "B" sample should be performed at a centralized reference lab and the results from the B sample should corroborate the results from the "A" sample before a positive result is resulted. Using replicated results from two labs would vastly improve confidence in the results as it is unlikely both labs would be wrong in the same way, and it would defused "the lab is out to get me defense."

4) Only peer-reviewed published literature should be considered as evidence. In the Landis case, the prosecution argued that the 5-alpha/5-beta discrepancy was secondary to the use of testosterone gel by Mr. Landis.

They hypothesized that the use of the gel specifically increased 5-alpha reduced metabolites of testosterone. To support this, they referred to a very small unpublished study that administered testosterone gel in normal men by Schanzer and colleagues. However, in this study only two men had undergone IRMS testing and only one of whom had the isolated elevation in his 5-alpha metabolite. To my knowledge, this study has still not been published, despite that fact that this group has been very active in publishing in this area. Was the original hypothesis correct? Does testosterone gel use selectively increase 5-alpha metabolites? Clearly, it is preferable to use peer-reviewed published papers to try to understand this, and prevent erroneous and premature conclusions from being reached.

John K. Amory MD, MPH
Associate Professor of Medicine
Division of General Internal Medicine
University of Washington

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The Winnowing: Maurice Suh and Daniel Weiss

Maurice Suh and Daniel Weiss represented Landis at both the AAA hearing and the CAS appeal. Rather than write anew, they pointed us to a piece in the Los Angeles Daily Journal in January 2008, from before the CAS hearing. We hadn't seen it before.

[Back to the Introduction]

Playing Hardball

by Maurice Suh and Daniel Weiss

Some extracts:

The phrase ``presumed innocent until proven guilty'' is not just a tag line for le­gal dramas such as ``Law and Order'' --- it is a core principle of our legal and societal fabric. The practical effect of this principle is remarkable, but one that is largely lost in doping cases. Presuming that an athlete is guilty based on the test result alone assumes that the anti­doping tests are infallible. This is not true. As seen in recent months, ac­credited laboratories do conduct tests improperly. For instance, the two European World Anti­Doping Agency­accredited laboratories that tested American sprinter LaTasha Jenkins were found to have vio­lated a clearly established test­ing standard. Anti­doping systems must take into account the fact that the laboratory results and methods are not always correct, and should place the onus, in each and every case, on the testing authority to es­tablish not only that a valid test for performance ­enhancing drugs was positive, but also that the test was performed in a scientifically reli­able manner.

and

What has been lost among the scandals, admissions and deni­als of the last several weeks [Jan 2008] is the great oppor­tunity that all sports have to craft a compre­hensive system that achieves clean com­petition without sacrificing the rights of the athlete.

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The Winnowing: Rational Head

Rational Head took long part in the scientific discussions at the Daily Peloton Forums. He, like Christiane Ayotte, found he had no time to say more.

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Thanks for the invitation.

At various times I expressed my thoughts at DPF on all the topics you listed. Unfortunately, I am going through a period when I simply don’t have much time to participate even in the DPF discussions.

Your blog was quite informative and is appreciated.

Best of luck.

RH

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The Winnowing: John Gilliland

US Air Force Major (for identification only, yada, yada) John Gilliland wrote an overlooked piece for us dealing with prosecutorial discretion. He is an Air Force judge advocate, involved in numerous drug prosecutions involving urinalysis testing.

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In a cover letter, he writes:

A bit of context for my piece: my office, which is the prosecution function for my Air Force base, just finished some litigation in which there were some defense shenanigans involving discovery material. This coming week we have a court-martial that entails a controversial discovery request. I made the decision to provide that information knowing that it isn't admissible but that the defense may work that information into the court anyway. We're still smarting from last week's fiasco, but the case this week is an apples to oranges comparison.

It's irritating when other folks don't play fair, but there's a big difference between playing unfair and playing in ways you're not used to seeing. I've seen both in the last couple of weeks, and I keenly understand the importance of understanding that difference. Justice, someone's career & freedom, and our reputation depends on the prosecutor's ability to make that distinction. You call foul against the former; you just do your job (and don't whine or mischaracterize it, a la Mr. Tygart) when confronted with the latter.

I think the best word to describe both sides in the Floyd Landis case is intransigence. So I thought it a bit odd that they actually reached a settlement concerning Landis’ recent federal court lawsuit. While the two sides will likely never kiss and make up, at least now there may be a détente as Landis regains his freedom to race at the end of January.

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The real question is whether USADA’s agreement to the settlement reflects a change in attitude, however slight. Based on what we’ve seen and heard from USADA throughout the proceeding, including this settlement, I think not.

As the governing/enforcing authority, USADA is essentially has a prosecutorial role. A prosecutor’s obligation is to seek the truth, regardless of what we see on television. Part of that obligation entails supporting an accused’s right to relevant documents, information, and to access experts. Yet USADA was consistently uncooperative on this issue, yielding on significant points only when it believed it had no choice. And the WADA rules it must follow concerning use of expert witnesses is patently contrary to the concept of fairness.

Another prosecution responsibility is to always act in a way that’s above board, both in reality and in perception. USADA’s strident attempts to prohibit Landis from publicizing information and the process - even though USADA’s rules explicitly allowed for it - clearly suggest a steadfast unwillingness by USADA to be open. This attitude points to a philosophy that is inherently contrary to fair play.

Admittedly it’s hard for a prosecutor to keep these obligations in mind when he has a perfect record to protect and when he hires private attorneys to fight this fight for him, but it’s still his obligation. In my opinion, USADA wanted to win at all costs and unhesitatingly abandoned its obligation to the truth.

Floyd Landis’ defense team, on the other hand, had every right to be unyielding. Their job, just as with every defense attorney, was to zealously represent their client. Only this defense team had to try to overcome something criminal defendants doesn’t: the presumption of guilt. So when Landis’ defense team dug in its heels and didn’t back down, it was because it was their right to do so, and they had no choice if they wanted to clear Floyd.

No reasonable person can take them to task for standing their ground.

After all the problems with the testing process that this case brought to light, we could at least hope to see a slight leveling of the playing field. Unfortunately, we haven’t. When CAS announced its decision, USADA could have sent a positive message by publicly waiving the $100,000 award, citing any number of reasons that would’ve been good for its image. But it didn’t.

It also could’ve gone public with the settlement agreement in order to demonstrate a (newfound?) dedication to fairness and openness. But it didn’t. Therefore, regardless of the settlement terms, the perception of USADA as an unyielding, unfair organization remains.

On a different note, please take the time to thank TBV, Judge Hue, and all the others for all the work they’ve done with this case over the last couple of years. The quality of work, analyses, and their dedication to a fair fight are all commendable, and are also exceedingly rare.

Best of luck to you all!

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The Winnowing: Duckstrap

Duckstrap is a consultant to pharmaceutical companies on setting up statistically useful and regulatory compliant development evaluation. He's looked at the available data along with us and heavily participated in the discussion. He too makes reference to the Berry argument.

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How does the Landis case look from the vantage of two years’ perspective? Muddy. I submit that nobody knows for sure whether Floyd took testosterone on that fateful day in July except Floyd. Not me. Not the folks from the ex-LNDD, and certainly not USADA or CAS. Or perhaps more pertinently, that nobody (again excepting Floyd) who strenuously purports to know, actually knows what they, in fact, do not know. I believe that CAS verdict was influenced by the politics of anti-doping much more than a strong scientific case; that by the time the case got to that point, the science was almost an afterthought. That is wrong in my view.

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Here are the things I am convinced of:

1) The statistics of the anti-doping testing are flawed. This is Don Berry’s argument, and, for me, it is convincing. The essence of it is this: if you believe that a relatively small fraction of riders dope with a particular agent, then the test for that agent needs to be very very specific, with a very low false positive rate. From screening to confirmatory T:E ratio to IRMS, LNDD’s procedures never came close to that standard. The new tests for CERA, where there is a specific molecular signature to the molecule allowing its distinction from endogenous EPO may approach that standard.

2) Overall, LNDD’s assay procedures and methods were inexcusably slipshod. The lack of adherence to procedures for sample custody were symptomatic of a broader scientific sloppiness that saw really bad chromatography in the screening procedure, unidentifiable peaks in the “confirmatory IRMS chromatography”, and finally, actually different chromatography conditions in the IRMS chromatography, so there was no definitive identification of the molecule(s) whose IRMS signature was measured. These are systemic, methodological issues with the assays as they were run in that lab. It does not mean that this tecnology could not produce a definitive answer, but in the hands of these hacks it did not. It doesn’t mean they didn’t get the right answer, but it also means they couldn’t know that they had—hence neither can we.

As for Floyd, whether he did or didn’t, I wish him all the best. If he did it, then he has taken us all for quite the ride, but has also paid a huge price for it. If he didn’t do it, then I believe he has done about all a person could do to exonerate himself, and appears, wisely, to have chosen to move on. It is couragous to fight the fight, but also couragous to put it behind you and get on with the business of living life. I’m glad to have played a small part in the drama, and am even more grateful to TBV for providing a forum for civil and knowledgable discourse of the subject.

Kevin Dykstra, PhD
aka “Duckstrap”

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The Winnowing: Klaas Faber

Klaas Faber is a widely published author on statistics for accreditation of chemometry measures. He's looked at the Landis case since it became public. He cites below the editorial in Nature by Donald Berry. (Our posts referencing Berry)

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Laboratories have arranged that they don't need to give the full data, in the WADA TD2003LDOC. In contrast, the Dutch Forensic Institute, for example, is obliged to give everything the defense needs, because that's arranged by law - a law that holds for governmental bodies (i.e. not for a lab that is paid by sport organizations and/or anti-doping agencies). For that reason, I was never able to have a good look at Floyd's data. And neither was the defense. During the hearings before the CAS, for example, the analyst of the laboratory was not able to reproduce the numbers that have led to the blue 'dot' in Figure 1 of Berry's Commentary in Nature! However, they were able to meet the required burden of proof ('...to the comfortable satisfaction of the hearing body...') on all occasions.

(click for larger)

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"Plots show the distribution of 167 samples of the metabolites etiocholanone and 5 -androstanediol (a, b), and androsterone and 5 -androstanediol (c, d). Panels b and d show samples the French national anti-doping laboratory (LNDD) designate to be 'positive' (red crosses) or 'negative' (green dots); the values from Landis's second sample from stage 17 is shown as a blue dot. Axes display delta notation, expressing isotopic composition of a sample relative to a reference compound." (source: Nature)


A final comment on WADA's TD2003LDOC. Note the sentence "Quantitative Data or ratio data and uncertainty estimation, if applicable.". First, ratio data makes a statistical treatment very complicated. That's my comment because anti-doping research don't use a lot of statistics and are therefore not troubled. Note, however, that it is often not even necessary to work with ratios because there is always an internal standard. The reasons to work with ratios are historical, not technical. Second, uncertainty estimation is always applicable. However, the people who drew up this document probably don't know (because of their lack of statistical insight). How to change this practice once it is fixed in documents?

There was a meeting of the Council of Europe Anti-Doping Convention technical advisory group on 11-July-2006, with minutes issued on 31-July. On p.2 (3d paragraph) you can read that researchers themselves have doubt about the IRMS method. ["Moreover, given that reservations have been expressed on the validity of the IRMS method, scientific background for its use would also be appreciated."] Compare the dates of the document and the 17th stage. Rather cynical.

T-DO (2006) 29, page 2

At the moment I am setting up a think tank that involves anti-doping experts but also for example a forensic statistician. Currently, there is not a single test for which the risk of a false positive is known. In forensic statistics one is trying for the last twenty years to have Bayes determine the weight of the evidence (likelihood ratio: likelihood of evidence given guilt vs. likelihood of evidence given innocence). It appears to be successful, at least here in the Netherlands. Don't know about other countries. What helps is that we don't have a jury. Here, one only needs to train judges and prosecutors on how to (correctly) interpret Bayes.


- Klaas

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The Winnowing: Carlton Reid

Carlton Reid is a UK-based cycling media mogul.

[Back to the Introduction]


Trust But Verify is closing, but I don't feel closure.

And if I also feel somewhat bitter and twisted, that's nothing to how Floyd Landis must have felt since the beginning of this sorry saga.

I came into this subject equipped with standard-issue, media-myopia goggles. WADA was pure, accused athletes were dirty, cheating scum.

I'm saying my goodbyes to TbV a whole lot more cynical about the anti-doping process. As TbV demonstrated, the anti-doping movement is enclosed, self-perpetuating and omnipotent. It resembles a religious cult. Leaders who brook no opposition; acolytes willing to do or die for the leadership; a central, easily-absorbed, hard-to-refute moral tenet ('you're bad, we're good'); exterior, no-strings funding; hair-trigger lynch-mob mentality; and Spanish Inquisition style jurisprudence.

Fanciful? A touch. But viewed through this prism it's now clear Landis never stood a chance. You can't attack a faith-based system with rationality or science, a faith-based system operates to its own, bendable rules.

Landis may have lost, but his fight - documented so well by TbV - opened a lot of people's eyes, mine included. Injustice is in the DNA of WADA. Without a major overhaul of how accusations can be refuted, innocent athletes will continue to be ensnared alongside guilty ones. This isn't right, it isn't fair. Welcome to WADA world.

Carlton Reid

Editor

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The Winnowing: WADAwatch

WADAWatch was started because the sometime-jurist author was taken aback by what he believes is the horrible wording of the WADA Code. It intrigued him enough to take vacation time to go to a WADA Conference for the press and meet and speak to many of the principals. His meta-legal analyses of The Code seem to us essential reading to anyone interested in rationalizing The Code. (Unfortunately, that may not include many of the current stakeholders.) One of the points he finds most troubling is the abandonment of the Quigley rule, something which seemed to have formed good guidance to CAS panels before the adoption of the WADA Code.

[Back to the Introduction]


As Trust but Verify prepares to shut down this superb Encyclopaedia Floydia, many of its readers are still awestruck at the outcome(s) of the Floyd Landis case(s): a victory fully enjoyed by 'the anti–doping movement' in arbitration, and withdrawal of his US Court case. It was late–summer 2008, when WADA president John Fahey announced WADA's contentment: the 'aggressive campaign against' that movement by Floyd Landis came to its arbitrated end.

And only two weeks ago, Landis withdrew his US Court case, leaving unexamined a vital, major scrutiny of the explicit conflicts of interest that permeate the private world of major sports legal arbitration.

The facts and evidence of Floyd's case stood for something profound: the fundamental concept that even Athletes have civil rights, and that a quasi–legal system of Jurisprudence/private arbitration that sought to retain monopoly control of those Athletes' lives, should uphold Western legal ideals in according those rights.

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The Landis Decisions offer proof that such is not to be, as long as a 'small group of insiders' is permitted to prioritize the protection of their own livelihoods, and the incestuous legal fraternity holding this monopoly power, throughout WADA, and Agencies, Labs and ADOs.

Those of us who were aghast that Dick Pound, former WADA president, might be installed as president of the Court of Arbitration for Sport, may wonder at what influence the man had had, in the CAS Decision confirming Floyd's positive Testosterone test. With the Landis Decision, CAS moved away from its prior legal basis, expressed in the famous Quigley Rule. That 15 year–old ruling called for implementation of a fair system, where 'rules are clear' and deviations from their meaning were often quashed, as we'd seen in the Landaluce case. WADAwatch believes, but certainly cannot prove, that the Landis Decision issued by CAS had some profound ex parte input from Pound: the former “Voice of WADA”, former candidate to become CAS' president. A Pyrrhic victory for the Omerta of WADA.

However, because Professeur de Ceaurriz and his LNDD lab techs, obsolete machines and tainted laboratory documentation, their pro forma COFRAC certification, the whitewashing French AFLD Ministry, vocal Dick Pound and WADA, with its 'independent expert witnesses' and institutional discrimination(s), supported by the USADA and Richard Young, who altogether (USADA and WADA) spent several millions of dollars, were fully supported by both the AAA Panel (majority), and the CAS Panel:

We do not know how, when, where and, to what degree
Floyd was ingesting Testosterone, if at all;

Thanks to Floyd Landis' legitimate, unnecessarily–expensive defense and appeal:

We do know how LNDD, USADA, WADA, AAA and CAS
confirmed theWADA Code's systemic viability
– in spite of having exposed its every
substantive and procedural flaw.

In other words: we don't know 'how Floyd was wrong', but we do know 'why WADA was right'.

Perfectly.

We may also never know, what honest inadequacies are, legally, nor what differentiates the acceptance of a WADA accredited lab having followed the concept(s) of rules (CAS Decision), rather than following the 'letter of the law'. Gone forever, are French accusations that Floyd's friends 'hacked' into the French lab's computer system (which some surmise was a way to disinform how evidence was destroyed, to erase traces of French shenanigans...), and gone, for some time, are the concepts expressly displayed in the WADA Code Fundamental Rationale.

We will never know why France was allowed to bring its renegade case against Floyd without being in violation of WADA Code Article 15.4, nor why its lab, in violation of Article 6.4, received full support throughout Floyd's disciplinary process. We will never know why USADA was not required to inform WADA of 'departures' (Article 7.1/7.2) before Floyd had to spend millions trying to prove those multiple, inexcusable LNDD failures. And the list goes on...

Someday Athletes may realize that the present system only serves to act as an Insurance Policy, protecting Event Organizers from Sponsorship withdrawal. WADAwatch hopes to aid Athletes, by simply encouraging WADA to enforce internally, the words of its Fundamental Rationale, not the least of which being: “Respect for rules and laws”.

Thanks to our friends, who made Trust but Verify THE daily Floyd site.

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