Larry: ISL Violation any way you look

Tuesday, Commenter "M" contributed a post arguing the Majority was correct. In the many comments to M's post, which are worth reading, Larry has added this epic, and it seems time to switch to a new conversation. -TBV


M -

So you'd like to do the legal analysis involving IRMS identification? Good! This is really very simple ...

The simple explanation

1. The ISL includes TD2003IDCR. See ISL paragraph 1.0.
2. TD2003IDCR requires each WADA lab to "establish criteria for identification of a compound." Once established, the criteria becomes part of the ISL for the lab.
3. I can find nothing in the transcripts, briefs or other publicly available material to indicate that LNDD ever established such criteria. The failure to establish such criteria is a departure from the ISL. Alternatively, the criteria established by LNDD for identification of compounds in IRMS testing failed to satisfy TD2003IDCR, and that is also a departure from the ISL.
4. Under WADA rule 3.2.1, USADA was required to prove that this departure from the ISL did not cause the adverse finding.
5. USADA failed to meet the burden of proof referred to in (4) above.

Case dismissed.

The longer explanation

My guess, M, is that you're not going to be satisfied with my simple explanation. You're going to want to see something more complicated. TBH (to be honest), I think that the simple explanation works just fine, and that any more complicated explanation requires me to make a better case for USADA than they made themselves. But I'll give it my best shot.

[MORE]


(1), (2) and (4) above are just restatements of the rules, which we've already discussed. (3) and (5) are relatively obvious findings of fact that emerge from a reading of the trial transcript. It will take two posts to fully describe these facts. We'll start with point (3) above, to show the ISL departure based on LNDD's failure to establish and follow a satisfactory set of criteria for identifying compounds. I'll turn to the burden of proof issue under (5) in a later post.

LNDD had no criteria for identifying IRMS compounds

Did LNDD have established criteria for identification of compounds as required by TD2003IDCR? I only wish that someone had asked that question directly during the trial. But there's a great deal of indirect evidence that LNDD had no such established criteria. If such criteria existed, they should have been included in LNDD's standard operating procedure (SOP). The SOP does not appear to be available to us (it would be in French anyway), but the two LNDD lab technicians (Frelat and Mongongu) both testified in detail regarding the steps they took under the SOP when they performed the IRMS analysis. How did they identify the peaks shown on the IRMS graphs for the FL samples? I can find not one word of testimony from the lab technicians on this point, not in hundreds of pages of transcript.

Let's look at the testimony of Cynthia Mongongu, beginning at page 390 of the transcript (271 of the pdf file). Ms. Mongongu was the lab technician who performed the IRMS analysis on the Stage 17 A sample (Esther Cerpolini did the GC/MS), and verified the analysis of the B sample. Her testimony was longer and more detailed than the testimony of Ms. Frelat, plus Ms. Mongongu was the more experienced and knowledgeable lab technician, so I've focused more on her testimony. This testimony is lengthy (about 105 pages) and focused almost exclusively on how she performed the IRMS analysis. From her testimony, she took the following steps:

a. She prepared the sample, following the LNDD SOP.
b. She performed the GC/MS analysis for the identification of the compounds. According to her testimony, she verified that the GC/MS instrument is operating properly, by first making certain that the MassLynx is functioning properly and the ion source is functioning properly, then she checked the instrument for leaks, and she injected a mixed acetate into the GC/MS to make certain it was operating properly. Once the instrument was verified, she injected the prepared FL A sample, in fractions, in a prescribed sequence along with fractions of blank urine samples.
c. She performed an IRMS analysis. This involves verifying that the instrument is set up to verify the CO2, and that the instrument is stable. Then the instrument is calibrated with reference to a test on the mixed cal acetate. Finally, FL's sample is injected into the IRMS.
d. She performed a data reduction process on the data, consisting of verifying the background noise, and verifying that the chromatograph peaks are correctly integrated. This is the point at which Ms. Mongongu would make manual adjustments to the data.
e. At this point the results of the test are calculated, and it was determined that FL's A sample was positive for exogenous testosterone.

Please tell me, where does Ms. Mongongu describe how she identified the IRMS peaks? She does not do so.

On cross-examination, Maurice Suh walked through all of these steps again with Ms. Mongongu. (see testimony beginning on page 556 of the transcript, page 421 of the pdf file) If, somehow, the work Ms. Mongongu had performed to identify the IRMS peaks was omitted in direct examination, Ms. Mongongu had the opportunity to provide this information during cross-examination. In re-examining the steps taken by Ms. Mongongu, Mr. Suh was careful to walk through these steps in sequence, making certain that no step was skipped. So, Mr. Suh started with the stability runs on the IRMS machine, and then asked Ms. Mongongu to describe each step she'd performed, in sequence, using questions structured like "After you did x, then you did y, correct?" Again, there's not a word regarding how Ms. Mongongu identified the peaks in the IRMS tests.

You can also examine the testimony of Ms. Frelat, which is shorter but substantially the same as the testimony of Ms. Mongongu.

It's worth noting that Dr. Meier-Augenstein also wondered out loud how LNDD went about identifying its IRMS peaks. On direct examination (transcript pages 1418-19), Suh asked Dr. M-A: "When you look at the document package, do you see any documents which help you identify how they decided which one of these peaks constitutes the internal standard?" Dr M-A responded "No."

The cross-examination of Dr. M-A is even more damning to USADA's position, which is surprising given that USADA appeared to INTENTIONALLY use this cross-examination to prove that LNDD had no criteria for identifying compounds. When Dr. M-A tried to argue on cross-examination that LNDD must have had SOME procedure for the identification of the IRMS internal standard peak, USADA's counsel seemed intent on proving the contrary (testimony p. 1517, pdf 1291):

"Q. And where is it in the Paris laboratory's specs that says when you use the internal standard in connection with identifying retention time in a blank urine or athlete sample that it has to be within a particular delta value spec?"

Dr. M-A eventually responded as follows (transcript p. 1518, pdf page 1292):

"A. I -- I don't know. I don't know how they do it. Because, as I would say, there's nothing in the specs, so I don't know. Is it divine intervention or they just pick one? How do they -- how do they know which peak is their internal standard? They must have -- they must have some -- some criteria to say, Oh, let's see, there's one peak at this time; there's one peak at this time; that's not the peak at this time. They're also 20 seconds apart. How do they choose which of those it is? I don't know. And you're quite correct. There's nothing in the specs that actually tell you how to do it."

At this point, USADA's counsel could have easily rebutted Dr. M-A and shown him that LNDD DID indeed have criteria for identifying the internal standard. USADA did not do so. They appeared intent on making the point that no such criteria existed at LNDD.

I don't see any other testimony relating to whether LNDD has the established criteria required by TD2003IDCR. The testimony of other witnesses (like Dr. Brenna) did not speak directly to what LNDD did or what procedures LNDD had in place to identify compounds. Instead, this testimony spoke to what are acceptable identifying techniques as a general matter. (This other testimony will become relevant in a later post, when we look at whether USADA effectively met its burden of proof under Rule 3.2.1.) You can read this other testimony, and perhaps you can point out to me whether or where these other witnesses spoke to what LNDD actually did. In any event ... the testimony of Ms. Mongongu and Ms. Frelat is the best evidence of LNDD's actual practices and policies, though the testimony of Dr. M-A cited above IS instructive.

I think my conclusion here is a fair one: if Ms. Mongongu or Ms. Frelat took ANY steps to identify the IRMS peaks, these steps were casual and not systematic. There's no evidence that Ms. Mongongu and Ms. Frelat followed anything like "identification criteria" to identify these peaks. I conclude from this that in all likelihood, LNDD had no such identification criteria. LNDD's failure to adopt identifying criteria under TD2003IDCR is a clear and obvious departure from the ISL.

If LNDD had identifying criteria, the criteria failed to meet TD2003IDCR standards

But ... let's assume I'm wrong. Let's assume that LNDD DID establish TD2003IDCR identification criteria. What might that criteria be? Before we get started on this part of the analysis, I'll issue a warning: even if we assume that the LNDD had established TD2003IDCR criteria, the evidence of what this criteria might be is skeletal and not entirely consistent. I STILL think the best evidence is that no such criteria existed. However, if there WAS such criteria ... the best evidence I can muster is that any such criteria required a relative retention time analysis.

In her testimony, Ms. Mongongu testified on two occasions that LNDD computed included an internal standard in its testing in order to calculate relative retention times. (testimony p. 434, pdf p. 311; testimony p. 653, pdf p. 509). Here is one quote from her testimony:

" Q. Why do you add an internal standard to the blank urine and the athlete's sample?
A. The internal standard allows us to calculate the relative retention time of the molecules analyzed.
Q. Is that to make sure that you're looking at the right peaks?
A. Absolutely, yes."

You can also look at the IRMS SOP described above. The second step under that SOP is to perform a GC/MS analysis. What would be the point of doing such an analysis? The science types can weigh in here, but in the context of an IRMS test, a GC/MS analysis would be performed to provide peaks that could be used to identify the compounds being measured in the IRMS test. I don't know why else a GC/MS test would be relevant, other than to provide retention times that could be compared in some manner to the retention times for the IRMS test.

Dr. Ayotte's testimony provides corroborating evidence. On direct examination, Dr. Ayotte testified that she understood from Ms. Mongongu's testimony that LNDD ran a 5aA internal standard test, and that this was a good practice "to determine the relative retention time of your analytes." She went on to testify that this testing is "a necessity, otherwise, you don't know what you are measuring." (testimony pages 811-12, pdf pages 652-53) Dr. Ayotte testified more than once regarding the link between the internal standard test and the determination of relative retention times (see, for example, testimony page 849, pdf page 686).

So, if LNDD DID have established TD2003IDCR identification criteria, this criteria was based on relative retention times. The next question is, what procedures were established under these criteria for comparison of relative retention times? On this question, we're stymied. As I've already stated, there's not a word of testimony on what LNDD did to identify the IRMS peaks. However, the assumption (in the majority opinion and on this forum) is that LNDD identified the IRMS peaks by comparing them visually to the peaks identified in the GC/MS test. The best explanation I can find for this technique was provided by Dr. Brenna in his cross-examination (transcript page 1971, pdf page 1702):

Brenna: You can't use relative retention times. I explained why this morning. Would you like to know what to use? I can explain it. We have the chromatograms up there.
Suh: No, that's all right.
Brenna: Okay.
Suh: Actually, no, why don't you go ahead and explain it. Go ahead.
Brenna: Well, on the GC/MS side, we see a pattern, so we can see peak heights. And so -- and we want to look at the overall pattern is what -- an intermediate-sized peak; a small peak; this is one of the strong peaks; and then a large one. And then we move over a bit, and we find a large peak, an intermediate peak, a smaller peak. And then we move to the end, and we see a large peak. And if you look, you see the same pattern here. In fact, I would -- I would say, you see a number of peaks here, a number of peaks here, a number of peaks here, and they have approximately the same -- same look from this distance. And so -- and so I probably stuck with that peak, and say, well, that peak looks -- of course, I'm already anchored on the internal standard, because I do know what that retention time is. And I then can identify that last peak, again, based on pattern, and these center peaks, based on pattern. And that's one of the ways that I would -- one of the ways that I would identify peaks, comparing them.

We have huge problems relying on this description. First, Dr. Brenna is NOT expressly describing what went on at LNDD. He's saying how HE would identify the peaks (presumably, based on the limited data he had in front of him -- he never said that this is the method he uses in his own lab). Plus, he's saying expressly that this identification method is NOT a method for measuring relative retention times. This is a problem, given that if LNDD had established IRMS "identification criteria", our best evidence is that this criteria WAS a relative retention time analysis. (Personally, I understand Dr. Brenna to say that the method he's describing is not the kind of relative retention time analysis performed by Dr. M-A; instead, it's a more relaxed and fuzzy kind of RRT analysis.) So, it's difficult to say that Dr. Brenna is describing the LNDD's identification criteria. (Again, I see this as proof that LNDD HAD no such identification criteria -- if they had such criteria, we should at least be able to figure out what the criteria was.) However, I have nothing else to go on. So ... in the absence of anything better, let's say that if LNDD had "identification criteria" as required under TD2003IDCR, this criteria was a relative retention time analysis, performed in the manner described by Dr. Brenna.

The next question I'll address here is: assuming the LNDD identification criteria are those described by Dr. Brenna, do they meet the requirements of TD2003IDCR. I think it's pretty obvious that they do not.

We can start with a definition of "criteria". My old Oxford-American dictionary defines "criterion" as "a standard for judgment." This is also the Wiktionary definition, more or less. So, a "criterion" is a kind of "standard". I'm not a scientist, but I think that the very essence of a scientific criterion or standard is that it allows for objective review and evaluation. A "criterion" has to be sufficiently descriptive and detailed to permit person A to determine the validity and accuracy of a judgment reached by person B. If a procedure to reach a judgment is subjective, so that two people can reasonably reach different conclusions while following the procedure, then the procedure is not a "criterion".

My definition of "criterion" is supported by a review of the procedures listed as acceptable criteria under TD2003IDCR. All of these criteria are detailed, objective and independently verifiable. There's little or no "wiggle room" under any of these criteria.

Now M, you may argue that it's difficult to create objective and scientific criteria for the visual comparison of two different graphs. It may be difficult, but it's not impossible. As an example, please take a look at WADA's own TD2007EPO, which contain objective criteria for the visual comparison of EPO results: you divide the result chart into three parts, you determine which two bands are most "intense" based on a densitometry measure, and so forth. It's an objective standard. You can use this standard to review the judgment reached by a lab that an athlete doped with EPO.

TD2007EPO is a good reference point for us to use when we look at the methodology for identifying compounds as explained by Dr. Brenna. Under the Brenna method, you identify a pattern of "large", "intermediate" and "small" peaks on each chart, and then you check to see if these two patterns are "approximately the same" from "this distance." Does the Brenna methodology come even remotely close to describing a "standard" that person A could use to check the work performed by person B? How do you distinguish a "large" peak from an "intermediate" peak? How do you determine whether two patterns are "approximately" the same? And what in the world did Dr. Brenna mean when he said that you'd compare the two patterns "from this distance"? How can you possibly use the Brenna methodology to review the judgment reached by a lab technician? You can't.

M, if you look at the Brenna methodology for identifying compounds, the methodology does not even remotely look like a criterion or a standard. As I said, I think that the best explanation of Brenna' testimony is that LNDD did not HAVE a standard for identifying IRMS compounds as required by TD2003IDCR, and that Brenna did the best he could under the circumstances to justify what LNDD did or failed to do. The only alternative to this conclusion is that the LNDD's method of identifying compounds is the one described by Brenna, and that this method fails miserably to meet the ISL requirement that labs have "criteria" in place for such identification.

Of course, we could also examine whether the Brenna methodology, which is the only description we have of the steps LNDD might have performed to identify the FL IRMS compounds, is an adequate methodology to measure the relative retention times that LNDD said it used (according to Ms. Mongongu and Dr. Ayotte) to reach its doping finding. According to the only evidence we have on how to measure RRTs, which is the testimony of Dr. M-A, the Brenna methodology is invalid. And Dr. M-A’s testimony here is supported by Dr. Brenna (as well as the majority decision), who proclaimed that it’s impossible to measure RRTs across two different GC machines. I think this is the point that tbv and others have made here: the methodology described by Dr. Brenna and endorsed by the majority decision is unsound as a matter of science. But from a legal standpoint, we can make essentially the same point, but in a simpler manner that I think is impossible to refute: whatever you might think of the scientific validity of the methodology described by Dr. Brenna (and OMJ), the methodology is not a “criterion”, and the methodology thus fails to meet the ISL requirements.


[BACK FROM MAIN BODY]

Under either alternative, we've proven a departure on the part of LNDD from the ISL, and we’ve proven that the majority decision was incorrect on this point. The next step will be to examine whether USADA effectively rebutted the presumption that this ISL departure caused the doping finding in the FL case, which is the only way left open at this point to defend FL’s doping conviction.

I'll pause at this moment for comments and to catch my breath.