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When science, peer review & independent experts are anything but

By Kenneth Barbalace
[Tuesday, May 22, 2007]
After my blog a couple weeks ago about who is funding climate change experts, I'm sure this title leads one to anticipate another look into the issue of corporate funded research, but alas, this week I'm looking at your tax dollars at work (whether you are in the U.S., Canada, France Germany, etc.). For the past week my routine of scouring the Internet, reading articles and papers on environmental related issues has been totally waylaid by the Floyd Landis hearings taking place in California. The mainstream media has been more than happy to lay in wait for the "soap opera moments," that not even the writers of the Sopranos could dream up. At the same time, there has been a tremendous amount of scientifically interesting information that they have not been reporting. In light of that, I'm going to push past Sopranos moments to dig at the real issues these hearing raise.

For those who somehow missed the news, last year Floyd Landis became only the third American in history to win the Tour de France, only for it to be announced a few days later that he had tested positive for drug doping. The results of the tests had been leaked to the press before even Floyd himself had been informed. Presumably, sources connected to either the World Anti-Doping Administration (WADA) or the French testing lab LNDD where the tests were conducted, were responsible for the media leak. In the ten months that have elapsed, this case has been fought in the court of public opinion, first by WADA, and news leaks to the media, and then by a very well organized public relations effort by Floyd Landis himself, which included his public release of much of the discovery evidence his legal team had received from WADA.

As part of Floyd Landis’ defense strategy, he requested that his arbitration hearings, which are normally closed affairs, be made open to the public. The request was granted and the Pepperdine University School of Law in Malibu California agreed to host the hearing because it would give their law students an unprecedented chance to sit in and watch this type of arbitration hearing. It has also been an unprecedented opportunity for the rest of us to see into the inner workings of WADA and the federally funded USADA (U.S. Anti-Doping Administration), which oversee anti-doping efforts for all sports federations represented at the International Olympics (e.g. professional cycling). It should be noted that 2/3 of USADA's funding comes from U.S. tax payers via congressional funding. In turn, some of this funding is doled out in the form of grants to scientists and testing labs that must toe the WADA/USADA party line to continue to receive their grants (which can be in excess of one million dollars).

One should not mistake these proceedings as bearing any resemblance to a normal court of law one would find in the U.S. There isn't the standard pre-hearing discovery phase where the prosecution must turn over evidence and the defense gets to depose witnesses. In fact, by WADA rules no WADA testing laboratory is actually allowed to assist the defendant in any shape form or fashion. There is no impartial judge overseeing the matter, rather there is a three person arbitration panel which is chosen from a WADA approved pool of arbiters. One arbiter is chosen by the defense, one by the prosecution (in this case USADA for WADA) and a third arbiter chosen at random. The arbiters in this case are: Richard McLaren, a Canadian Lawyer (chosen by USADA); Chris Campbell, a Boston-based lawyer (chosen by Floyd Landis); and Patrice Brunet, a Canadian lawyer who is the chair. The arbitration panel's "independent" expert is from the Rome Italy's WADA approved lab (thus, also isn't so "independent"). The director of the WADA certified UCLA testing laboratory has been sitting behind the USADA attorneys prosecuting this case providing them with assistance. There is no jury and it only takes a majority (e.g. two arbiters) to agree on any decision. Normally these proceedings are closed to the public and are nothing more than a rubber stamp of legitimacy, a wink and nod so to speak to "due process", with the verdict being a fore gone conclusion. In fact, WADA and USADA are very proud of their 100% conviction rate.

Floyd Landis's case is built upon the premise of bad science, conflicts of interest, poor quality control, and bad testing procedures. When the focus is on the science, even though most of the witnesses thus far have been for the prosecution (USADA), Floyd Landis's lawyers have done a good job of scoring points. In fact, some of the things that have come out I found to be extremely disturbing from the stance of due process and justice.

Through the testimony and cross examination that I highlight and comment on below, it has been shown that the technicians for the French testing lab LNDD were sloppy, did not diligently log their activities (including chain of custody), could not account for large lapses in what logs they did keep, deleted data, and admitted to making mistakes during their testing. We have also learned that WADA/USADA funded labs and scientists are not allowed to testify on behalf of athletes, nor provide them with any form of aid (including independent testing).

Bill Hue, who is a recreational cyclist and is a Wisconsin Circuit Court Judge, Branch 2, Jefferson County, has also been at the Floyd Landis hearings this past week observing and writing for the blog "Trust But Verify" or TBV for short (which I reference repeatedly in this post), made the following observations:

What we are seeing is something I had not anticipated coming in and that is that the science is as political as anything else in the case. USADA could pick any independent person in the world to evaluate the work of the LNDD in this case, yet they chose J. Thomas Brenna, a man who has 1.3 million reasons (that is the dollar amount of his USADA grants over the last 4 years) to make them happy.


In the same post, Bill Hue also makes the following comments:

Science: Even A Blind Squirrel Occasionally Finds A Nut

Cynthia Mongongu and Claire Frelat flat out scare me. Their work is what it is and every expert testifying for WADA believes their results to be correct, although Don Catlin would only give their chromatograms C's or C-'s. Their laboratory paper work is in order (Landis’ expert Goldberger has big problems and more experts will comment in the coming days) according to WADA experts Brenna, Ayotte, Schanzer and Catlin. But, you have people come into Court to assess the credibility of their written results; otherwise their paper results would be all that is necessary.

I saw these two women in Court. Mongongu is not credible. Her work must exceed her live testimony because it is endorsed by some very intelligent and credible witnesses. She played dumb or she is dumb. I’m not trying to be mean because she seems like a nice person who you would like to have as a friend. She trained Frelat and did so in half the time other WADA accredited labs take to similarly train technicians.

Unlike Mongongu, Frelat isn't the kind of person you would like to hang out with. She seems bratty and immature. She doesn’t seem to care much about her work. I don’t believe a word she says. Moreover, by the time she is involved in the testing, she knows exactly whose urine she is analyzing. That sort of makes me queasy. But her results have been endorsed by some very credible people. Therein lies the dilemma and the next three days will tell the tale. God forbid these two have been behind the 300% greater rate LNDD "catches" testosterone cheats because I wouldn’t trust them to do any lab work competently.


Would you want these people testing your samples for drugs? Personally, I find it suspicious that they have 300% higher testosterone rate than other WADA approved labs and at the same time is able to train their technicians in half the time.

What I see is a seriously screwed up system that abuses science and railroads athletes. These cases aren't about a search for the truth, but a desire to get a conviction at all costs and to catch all cheats even if this means also ruining the lives of a few innocent athletes along the way. To WADA, the ends justify the means, and a few innocent casualties is an acceptable price to pay to catch the cheats. To me this is very un-American. Our system of justice is based on the ideal that it is better to let ten guilty men go free than it is to wrongly convict one innocent person, yet here we are as taxpayers funding a system of prosecution that makes a complete mockery of the search for the truth.

The only solution I see to this problem is for taxpayers to stand up and demand that Congress cut off funding to USADA unless real reforms are put in place. These reforms must include:
  • American standards of justice including innocent until proven guilty and due process.
  • Testing laboratories must not confirm their own adverse findings. If one testing lab finds sample "A" to be positive then a DIFFERENT testing lab would be required to test sample "B", with two labs be randomly chosen for the "B" sample test. One lab would get dummy control samples and the real sample while the other lab only got dummy samples. No lab would know who the other testing labs are and no one would know who was testing the real sample until after testing was completed. None of the three labs in question could know who the other testing labs were and none of the labs (or at least "B" sample labs) should know for which sport the samples are from. The athletes could still have representatives present for "B" samples, but they would have to keep the athlete and sport anonymous (transporting athletes representatives to the testing location would be at WADA expense).
  • Research and enforcement arms of the anti-doping efforts must be separated. All government grants would have to go to testing labs and scientists through a channel completely independent of WADA and anti-doping enforcement agencies (e.g. USADA) with the existing agencies only paying for the actual testing they have preformed. This must be done to eliminate conflicts of interest.
  • All testing procedures and testing methods must be validated via a true scientific peer review processes.
  • All substances on the banded substance list must have been proven via true scientific peer review to either be a performance enhancing substances or masking agents.
  • Illicit leaking of test results to the press must be criminalized.
  • Doping by athletes must be criminalized with all prosecution going through the criminal justice system.
  • Athletes and their legal teams must be allowed full and normal rights of discover for criminal cases including deposing lab testing officials prior to their case.
  • Athletes must be allowed to employ individuals from testing labs not directly involved with testing their samples as expert witnesses.


Yes this would add greater costs to the prosecution of drug cheats, but the criminalization of drug cheating would create a significant disincentive to cheat and having multiple labs conduct testing using much tighter rules of testing would virtually assure no false positives eliminating the cloud of doubt that currently hangs over the system. These ideas are also intended to reduce the potential of leaks as much as possible, and to limit the sphere of suspects if they do happen as well as eliminate the possibility fingering an innocent athlete.

Falsely accusing and or convicting an athlete is immoral, because destroys an innocent person's career, reputation and life. Whatever the changes are that get adopted they must ensure that innocent people do not get accused let alone convicted.

Key testimony as of Saturday May 19th and commentary

NOTES: While the hearing did continue on Monday, my efforts to write this post have precluded my ability to review any of Monday's testimony at the time of this writing. In addition, I want to focus on USADA witnesses rather than Landis's witnesses. The segments of transcripts of testimony below come from "Trust But Verify" (TBV), which has become the single most respected clearinghouse for everything related to the Floyd Landis case, have been at the hearings working their tails off to provide running transcripts in as close to real time as is humanly possible. As the transcripts were an effort to provide running transcripts, there are typographical errors and I made the decision to correct only the barest minimum of typographical errors that affected readability. I have also provided links before each group of transcripts to their respective page on TBV. The efforts and dedication those involved with TBV have put into telling this story as completely as possible is deserving of nothing short of a Pulitzer Prize. Video recordings of testimony can also be reviewed here.

What I have found most telling and disturbing in this case has been the admissions by USADA expert witnesses (including technicians responsible for testing samples) while under cross examination, but the one defense expert witness who testified on Friday was also very enlightening.

LNDD testing technicians admits to errors, gaps in logs, deleting data and knowing who's samples they were testing
Cynthia Mongongu, one the French laboratory (LNDD) technician responsible for testing Floyd Landis's samples exposed several points of concern. The first point of concern was that Floyd Landis's legal team was not allowed to depose her in Paris, where she lives, as the arbitration panel had no authority to compel her to be deposed. In a normal legal proceeding this would be an important part of discovery especially since she did not speak fluent English, and not being able to depose her denied Floyd Landis an important part of mounting a legal defense.

Some of the importance to having been able to depose her during discover came to light during her cross examination when she admitted to deleting computer files related to the testing of Floyd Landis's samples and could not explain major gaps in logs for testing equipment and chain of custody. She also confessed to acting as the verifying scientist for "B" samples that were run to confirm the results of "A" samples that she herself had tested. In short, she tests the "A" sample then verifies the work of the technician who tests the "B" sample that is supposed to validate her work. This is a clear conflict of interest and example of circular verification. Here is an example of her cross examination testimony:

Q: next page on the log file. 14:42:01, opening sample log file, and onto next page GDG1058 a number of entries that say processing sample 1,2,3,4,5,6,7,8 you see that?
A: yes

Q: you see between the two series there's a 10 minute delay at 15:34:38 to 15:46:27. what happened to that 10 minute gap?
A: I'm not sure what that represents.

Q: there's a time gap of 10 minutes. What happened?
A: i don't know.

Q: let's go to the bottom 15:48:26, below there is an entry at 18:21:42, a 2-1/2 hour gap. what happened in that 2-1/2 hours?
A: i don't know.

Q: time entry at 19:52:43 same day. 20:17:24 the result is run, and again at 21:08:26, on the Blank F2.
A: yes.

Q: of course the data from the preceding one is gone.
A: yes.


Here is another exchange from later in her cross examination (comments in square brackets added by TBV):

Q: page GDC 1064, gap at 15:31:14 to 15:39:16. can you say what happened? these are all "processing complete" to "starting inlet method" gaps]
A: no

Q: 17:08 to 18:03, can you say?
A: no.

Q: GDC 1066 10:27 to 10:54, can you say?
A: no

Q: 11:26 commencing mix-cal acetate, 12:09 saving file , 12:22:45, commencing again. see those?
A: yes.

Q: next page 13:06, saving file, and of course the second save erased the first one, and is no longer part of the record, correct?

A: yes.

Q: why did you run mix-cal acetate again here?
A: because the first was undoubtedly not correct.

Q: did you take any contemporaneous notes of the first being not correct?
A: no.

Q: so the record of the one that was not correct no longer exists?
A: no [meaning yes?]

Q: you remember the first is not correct from memory alone?
A: if I did a second, it's because the first was not correct.

Q: in that frame, there's a timegap from 12:09 to 12:22. what happened there, if you remember?
A: no, i don't remember.

Q: GDG 1069, 8:45:21 starting acq, 8:45:26 stability raw saved.
A: yes.
Q: 8:47:35, starting acq, 8:48, saving to stability raw again.
A: yes.

OBJECTION to form of question, "did you do"

Q: do you recall rerunning the sample?
A: no

Q: 17:18 to 18:06, time gap. were you processing the sample at this time?
A: yes, that day, yes.

Q: do you recall what happened during this time period?
A: no.

Q: up the page gap 15:10 to 15:49, what happened there?
A: no.

Q: GDG 1073, 13:09 begin cal mix acetat 01, 13:53 saving 01.raw;
A: yes.

Q: 13:55, commencing again, then 13:55:43, save again same file, then 13:57, commencing analysis again, then 14:41 saving data again. See that? Erasing the data from the first two runs, correct?
A: yes.


Now it should be noted that the reusing of file names and thus causing the deleting of existing data was the result of personal habits of the lab technician and not standard protocol. The whole purpose of logs and recorded computer data is to create a detailed evidence trail for legal proceedings like this. By overwriting file names thereby deleting existing data and not meticulously logging all actions there is not a complete record of exactly what happened when. This means the word of the technician saying she did everything correctly is all that we have to go on. Detailed logs and protection of all computer data is necessary because the technician like the rest of us is human and as such occasionally makes mistakes. In fact, the next exchange proves this point:

Q: the last mix-cal acetate USADA 183, acq time 20:39, and the current time is 14:24:44, the next day. The reason to show these to you, is that the last sample fraction and the other is the last mix-cal acetate. How much time separated the mix-cal acetate from the last sample?
A: about 5 hours.

Q: so this last mix-cal acetate was run about 5 hours later?
A: yes.

Q: and there's no record what happened in those 5 hours.
A: correct.

Q: this is the sequence that was supposed to run together.
A: yes

Q: does the sequence automatically stop between the last sample and the mix-cal acetate?
A: no

Q: what happened in this 5 hours?
A: if the mix-cal acetate was injected at 20:39, it's because on the level of the sequence I must have added at that time.

Q: don't understand?
A: I remember there was some problem, and when I went to see the sequence had run properly, I saw the mix-cal had not been injected, so placed it at the end of the sequence.

Q: did you make any notes at the time to indicate you forgot to add the mix-cal acetate.
A: no.


In yet another exchange during her cross examination, it came to light that while she was validating "B" sample test results she knew that seven of the ten samples belonged to Floyd Landis:

Q: In April, when you and Claire Frelot were analyzing 10 samples, did you know that 7 of those 10 samples belonged to Mr. Landis?
A: yes.

Q: did you know which of those 10 samples were Mr. Landis'?
A: no


Clearly this is compromised objectivity and impartiality, especially given the fact that for the six to eight months Floyd Landis and his legal team had been questioning the credibility of the testing lab and the testing work done by Ms. Mongongu. Quite simply, the results of these "B" sample tests had to be positive to support her original analysis some months earlier in order to protect her reputation and the reputation of her testing lab. In fact, this was a major point of contention for Floyd Landis's legal team when they fought to have the April tests of "B" samples conducted by a different laboratory, but which was denied by two members of arbitration panel.

When it comes to drug testing, chain of custody is extremely important as it helps document who had access to samples, when, and under what conditions. Normally this chain is carefully documented from the time a sample is given by the donor through the time it was tested. Under cross examination, however, Claire Frelot is a specialist analyst chemist in IRMS and works with Cynthia Mongongu at the French drug testing laboratory LDNN, admitted that the chain of custody had not been documented. Here is a piece of her testimony:

Q: looking at this form, show me where on the form where it records the transfer of the sample to you.
A: the transfer is not written but it is written that I received the bottle.

Q: the form reads at 11:03 the aliquot occurred, right?
A: in order to do the aliquot, I have to have the bottle in my hand.

Q: where does it show where you got the bottle or the time, the transfer from op 18 to you?

DUNN (USADA Lawyer): objection. she said she had the bottle.

Q: the question was about the intra-laboratory transfer, before 11:03 and she did the aliquot. the COC [chain of custody] is about the process of the transfer of the sample through the laboratory. We now where things were done in the laboratory, but we don't know how the bottle was moved in the laboratory.
A: the transfer is not recorded (written).

Q: please look at ex 25 any document that shows intra-laboratory transfer in this process. EX 25 is the lab packet for the B sample.

YOUNG (USADA Lawyer): please be more specific about the process.

Q: the process by which the sample moves through the intra-laboratory transfers for the B sample.
A: there is no registration or entry with respect to how the sample is transferred. there are entries which pertain to who received the bottle at what time, and where.

Q: in other words, just what we have here on USADA 254, who and what was done, but nothing else.
A: yes.


How can we trust any scientific tests like these drug tests if there is not meticulous set of logs that details everything AND the technician has a habit of deleting data? Later in the cross examination Ms. Frelot showed that like Ms. Mongongu she is human and as such is fallible:

Q: 1069, blow up 8:45:20 to 8:59:20. 8:45:31 starting acq, 8:45:36, saved to sabilite1.raw.
A: yes.

Q: then 8:47:35, starting, then 8:45:14 save to same file.
A: yes.

Q: then 8:48 starting, 8:59:07, saving to same file.
A: may I explain? in order to prepare the IRMS in the morning we fill a LN and then we verify the peak center, and when it is good, we launch the stabilization. I had forgotten to verify the peak center, when I noticed that, I verified the peak center and then to verify the center you have to open up the 22 CO2 valve, in order to do the peak center, and then you have to close the valve and I had forgotten to do that on the second one, which means I then closed the valve and then performed the stabilization.

Q: why didn't you do this when you filled nitrogen earlier?
A: because I forgot.

Q: and you remember now.
A: yes, because it caused me to waster time.


Then this exchange took place in the cross examination of Ms. Frelot:

Q: do you recall the data from the first three are gone, right?
A: they don't exist because the do not correspond because they weren't mix-cal IRMS's; I remember that morning because there was a lot of wasted time, not just 3 minutes, but more. when I put the mix-cal IRMS into the autosampler, I did not place it in the right area. And I only discovered that when the third injection was performed, then I corrected the position and then started the mix-cal IRMS again.

Q: so to make sure I understand, you began the automatic sequence, you didn't realize until the end that they were in the wrong place?
A: yes.

Q: then you stopped the process.
A: it stopped by itself.

Q: then you put three more mix-cal IRMS in the right place?
A: the injection of the mix-cal IRMS is performed from one vial only.

Q: so you put another vial in the right place and ran it again?
A: yes. i replaced the vial in the right position?

Q: why didn't you use a different file name so we'd know what happened?
A: that's the way I did it?

Q: absent your testimony here today, that is the only way we would know what happened here? there is nothing else that shows this rerunning?
A: yes.

Q: in other words, if someone were to say, the reason the mix-cal IRMS and other samples were rerun and saved with the same filename was because you saw results you did not like and saved over it, the only way we'd know that didn't happen, is your memory of what occurred that day?
A: yes.

Q: you did B sample analysis on S17 [stage 17 of the Tour de France where the test results for Floyd Landis's samples were declared positive]?
A: yes.


This is why it is so extremely important for tests like these to be documented and logged in excruciating detail; if it isn't logged, there is no way of truly knowing if it truly happened. How many other mistakes were made during these tests that have not been discovered because they weren't logged? How many other athletes have been convicted based on tests that were riddled with procedural errors and/or omissions?

Under cross examination Ms. Frelot also admitted that while conducting tests she knew they were on Floyd Landis's samples:

Q: at the time you did this B sample test, you said you did not know this was Landis' sample?
A: once the analysis was done, the name had already appeared in the press.

Q: do you remember when Mr. Landis' name appeared in the press with an AAF from LNDD?
A: no.

Q: so you're saying when you did this test, you knew that the IRMS test was being done was Landis'?
A: yes, the B, I did know that.


To ensure complete objectivity, testers should NEVER have any idea of whom the samples they are testing belong to or the gravity of the tests being preformed. In fact, WADA code requirements even require that the tester not know whose samples they are testing. Blind testing is after all a foundation of scientific investigation.

Why scrupulous documentation and testing procedures matter

The first defense witness we heard from was Dr. Goldberger who is a Professor and Director of Toxicology in the Department of Pathology, Immunology and Laboratory Medicine in the College of Medicine at the University of Florida in Gainesville. Understand that Floyd Landis's defense team can not get any WADA certified lab directors or scientists to testify because they are prohibited from doing so, which is something I will get to in a bit. However, under cross examination by USADA lawyers, Dr. Goldberger produced a letter from the WADA certified UCLA lab soliciting him to apply for their lab director position, thus validating his credentials as being on par with any WADA drug testing lab director. Remember that the current head of the UCLA lab has been assisting the USADA lawyers.

In his own words, here is why he agreed to testify on behalf of Floyd Landis:

Q: general issues first. Why is lab documentation important.
A: the material we go through on a daily basis. I have no idea what I did yesterday a year ago, a year from now. everything is documented and retained.

Q: when you were an inspector, how did you look at errors?
A: story, before we go to a laboratory, we get a data package. As an inspector, you get a feeling about what you are walking into. So those documents are very important to the inspector.

Q: in your review of the documentation here, did you notice errors that caused concern?
A: I was reluctant to become involved. I looked at some documents, late, and after my review, I saw glaring issues with how chemistry was performed, and signed on.

Q: did you also notice mislabeling and documentation.
A: yes. forensic correction policy; there should be no obliteration, so it can be read in the future.

Q: why?
A: because we're human and make mistakes.


Here is some of the transcript from Dr. Goldberger's testimony laying out some of the procedural errors he was concerned about:
Q: let's look at some of these forensic corrections. USADA 008.
A: good example. it's not readable.

Q: it may be a scanning error, but it's what we got.

Q: you understand the sample number?
A: yes.

Q: you see this other entry?
A: you can't see it on the screen.

Q: so we have a misnumbering wasn't even numbering.
A: it's a fatal flaw, how do we know we have the right sample?

Q: cause you concern?
A: tremendous. when I look at testing, it's the first thing I look at and it's incorrect.

Q: there are a number of other pages with crossed out forensic corrections, right?
A: yes.

Q: USADA 200, I counted 6.
A: there's one on column 1 3 lines down.

Q: seeing a page like this without any notations, concern?
A: yes. it's a consistent pattern. I had an employee with a 4 that started as a two; I counseled her to do an initialed strikeout.

Q: if the response is how does that affect the results?
A: it might, we might not. Its the building of problems in the package that concerns me.

Q: there are other pages?
A: more than several.

Q: what effect did the totality of these corrections give you on the reliability of these results.
A: it's unreliable.

Q: why?
A: it's your documentation. What I said about inspecting, the documents tell you the care.

Q: what is a proper chain of custody?
A: start with collection through disposal. Include all transfers, all steps, every time handled by a human it should be documented.

Q: what is the significance if there is an omission?
A: terrible. demonstrates lack of attention to documentation. I've seen it that the CoC is completed retrospectively, filling out forms in the afternoon after doing the work. That's wrong. You need to know exactly where it's at at any particular time.

Q: did this document reveal CoC issues?
A: yes.

Q: what about lab transfers. Is that something that is required for good lab practice?
A: yes. everything should be recorded.

Q: location at all times?
A: yes.


Dr. Goldberger's testimony also delved very deep into the procedures and reporting of the LNDD test results:

Q: specific gcms issues starting with identification of E and T. Describe proper identification techniques.
A: involves retention time and mass spec criteria, the latter has full scan mode, need lots of ions; other is selected ion monitor, as done here. Typical process is 3 unique ions, with plotting using ion rations.

Q: that is what WADA technical document requires?
A: yes, it says you must have three ions, and they must be analysed and evaluated, not thrown out the window.

Q: anything unique about steroids?
A: no. the application of MS is just like the use for Cocaine and its metabolites.

Q: on the confirmation analysis, did you review to see if it showed LNDD acquired and evaluated three ions?
A: they acquired more, but their evaluation of the data has the display of a single ion 432.

Q: lets look at USADA 0093. You understand this is the chromatogram for one of the A confirmations.
A: yes.

Q: how many ions does it show?
A: one, 432.

Q: the documentation shows they acquired others.
A: because they're operating in low resolution mode, they are acquiring 432 to 433, which may be responsible by the baseline problems in this chromatogram. So they are operating in low res mode, so it's not typical practice. That's why it's noisier than the beautiful chromatogram from Montreal.

Q: USADA 86. what is shown here.
A: The calibration data for E and T, shows they evaluated one ion; they need more because it can effect the quantification.

Q: USADA 0083, in their brief, said that they acquired the required 3 ions, and this page is proof.
A: yes. I don't know for sure, but there's no demonstration; there's only the printout. But the proof is in the paper, and we don't see the analysis.

Q: Second A, USADA 213, this shows single ion, correct?
A: yes, same low res scale.

Q: B confirmation, anything different there. USADA 277. same thing?
A: yes, this looks worse though.

Q: how?
A: the chromatography is horrible.


Later the testimony continued:

Q: which is why you need to look at more than a single peak.
A: yes. we don't know if we have T or T and some unknown compound.

Q: USADA 282, single ion, any issues?
A: looks like the last one. Problems with E and T the way it's integrated.

Q: based on this chromatogram, is the identification acceptable?
A: no.

Q: what is the significance of the fact that LNDD did not provide the chromatograms of the ions collected?
A: they have not documented the T/E result they are claiming.

Q: if you haven't adequately identified T and E you can't go forward with your analysis?
A: correct. Where cases can end up in litigation of arbitration, we have to be supportable. Minimum of 3. I know of no lab reporting quantification on a single ion in a setting like this.

Q: do other WADA labs give different documentation?
A: yes.

Q: describe.
A: UCLA gives selected ion and full scan, the best of both worlds.

GC 524

Q: is this the UCLA chromatogram?
A: yes, it has the internal standards on top, upper left; single ion; I prefer two minimum. T is in the panel below, showing 432, 433 and 209.

Q: LNDD does something different what is the effect?
A: don't know, we haven't studied they acquired 432 and 433 together, I don't know what that will do.

Q: and UCLA shows all?
A: yes.

Q: have you authored papers on this need to acquire analyses many ions?
A: yes, for years we struggle with the use of selected ion monitoring in forensic toxicology. We were comfortable, one of the first was the one was by Dr. Bowers.


Dr. Goldberger complete testimony shows how important proper documentation and control procedures are. It should also be noted that Dr. Bowers, whom Dr. Goldberger referenced in his testimony, was also in the hearing room and was assisting USADA lawyers.

As with so many things in life, if the testing lab is sloppy with the paperwork, then this is an indication that it is also probably sloppy with their testing, and at the very least their testing procedures and results can not be independently analyzed properly. For there to be certainty that an innocent athlete is not being wrongly convicted, the lab work done by the testing labs involved must be able to stand up to the scrutiny of defense experts, and this means it must be carried out to the highest of standards and documented in absolute detail. We should expect no less.

When peer reviewed research isn't

During phone testimony of Wilhelm Schnäzer, Phd who is Director of the Institute of Biochemistry of the German Sports University Cologne on Saturday May 19th, the following exchange took place between lawyers for both parties and the arbitration panel (this testimony gets confusing, so I've identified the parties, again square brackets are comments added by TBV):

Q (Young, USADA Lawyer): EX 34, WADA Progress report March 2007.

[document they snuck in by finessing rules]

Q (Young, USADA Lawyer): published in public forum?
A (Dr. Schnäzer, USADA witness): yes, data presented in March to workshop of dope analysis, presented to scientists, to be published in proceedings.

CAMPBELL (Arbiter chosen by Landis): is this the study we've been talking about? Renew objection to this study?

ONEILL (Landis attorney): inaudible

Q (Young, USADA Lawyer): is this an incomplete study?
A (Dr. Schnäzer, USADA witness): first part of a WADA study, includes all measurements, data is complete, to be published soon.

CAMPBELL (Arbiter chosen by Landis): peer reviewed?

A (Dr. Schnäzer, USADA witness): status is data is accepted by reviewers, but not sure of status through reviews. in general accepted.

Q (Young, USADA Lawyer): reviewed in workshop by the scientist? questions?
A (Dr. Schnäzer, USADA witness): study was interesting and well accepted in discussion.

CAMPBELL (Arbiter chosen by Landis): want to converse with panel.

CAMPBELL (Arbiter chosen by Landis): clarification -- is this peer reviewed?

A (Dr. Schnäzer, USADA witness): the document is in the position that it is accepted; in hands of independent reviewers, don't know outcome.

MCLAREN (Arbiter chosen by USADA): we understand, Mr. YOUNG, can you help us understand?

YOUNG (USADA Lawyer): let me summary,

[THE YOUNG RUSE -- tell the witness what to say, so he can say yes. Will Landis attorney's get to offer their own version?]

Q (Young, USADA Lawyer): that is a type of peer review?
A (Dr. Schnäzer, USADA witness): yes.

[hoots in press room.]

Q (Young, USADA Lawyer): then accept for pub?
A (Dr. Schnäzer, USADA witness): yes.

Q (Young, USADA Lawyer): then another level before final, and that is what is in process?
A (Dr. Schnäzer, USADA witness): yes. final acceptance is still pending.

CAMPBELL (Arbiter chosen by Landis): SUH, comment?

SUH (Landis attorney): inaudible.

YOUNG (USADA Lawyer): there are different levels of reliability of scientific evidence, it would be hard to believe that one could only rely on peer reviewed evidence, if it is otherwise reliable. We rely on opinion evidence from experts that we consider reliable. I'd be surprised if that were the case on any scientific document.

A (Dr. Schnäzer, USADA witness): that is correct.

[ Panel discusses ]

MCLAREN (Arbiter, chair): we're letting it in. two reviews are sufficient.


Yes, the attorney for the USADA managed to change the definition of "peer reviewed," and yes, even the press room picked up on this ruse. One should keep in mind that the other reviewers were in all likelihood other scientists with various WADA certified labs and are required to toe the official party line (more about this is coming). So just what was this paper about? It is a paper that apparently claims that very low doses of testosterone gel rubbed onto the skin can aid in recovery after an event. What's interesting about this is that another truly peer reviewed paper related to this subject found no such correlation, and there is precious little evidence outside of the paper admitted by the panel that supports any claims that such creams work. Of particular note are two papers on this exact issue. The first paper, which was published in 2006, is:

"Effect of multiple oral doses of androgenic anabolic steroids on endurance performance and serum indices of physical stress in healthy male subjects," which states:

None of the measured biochemical variables showed significant impact of AAS on physical stress level. Data from exercise testing on submaximal and maximal level did not reveal any performance differences between the three groups or their response to the treatment. In the present study, no effect of multiple oral doses of AAS on endurance performance or bioserum recovery markers was found.


AAS stands for "Anabolic androgenic steroids", which includes testosterone (which Landis is accused of testing positive for). The second paper on this issue, which was published in 2004, is:

"Effects of androgenic-anabolic steroids in athletes," which states:

Although AAS administration may affect erythropoiesis and blood haemoglobin concentrations, no effect on endurance performance was observed. Little data about the effects of AAS on metabolic responses during exercise training and recovery are available and, therefore, do not allow firm conclusions.


For more on this debate see: "Can You Win The Tour de France By Doping"

WADA funded labs and scientists prohibited from helping athletes

Of the most interest to the behind the scenes politics and procedures of WADA and their iron fist rule of no dissent came out during the cross examination of USADA witness Dr. Don Catlin, who until very recently was the head of the WADA accredited lab at UCLA and is a world-renowned doping expert. No longer being responsible for a WADA certified, he seemed to be very egger to speak his mind freely and apparently laced some of his testimony with sarcasm aimed at WADA. The following is part of an exchange about what it takes to maintain a WADA accreditation:

Q: anything else to keep accred.
A: goes on and on; file reports, do research, not doing certain things, and get a "good citizen" to WADA world of labs.

Q: what is a good citizen?
A: participate, and not testify against your neighbor.

Q: in order to maintain your accreditation, you may not testify against other labs?
A: it's very clear it is not permitted to testify against other labs.

Q: are you familiar with the laboratory code of ethics?
A: yes, I wrote it.

Q: how opportune.
A: the first version.

Q: Annex B, ISL, Code of ethics, 3.4 page 55.
A: yes

Q: i'm going to highlight sections. "the lab should not provide testing services in defense of an athlete", did you write that?
A: no, it seemed to have changed.

Q: [Conduct detrimental] that would cast doubt.
A: i do.

Q: is this a description of being a good citizen.
A: yes.


In another part of the cross examination Dr. Catlin disclosed how WADA had expressed displeasure with some of his testimony:

Q: you testified you received grief for testifying on the zack lund case?
A: yes.

Q: what was the source?
A: I don't think WADA was very happy.

Q: Olivier Rabin.
A: I don't think he was very happy.

Q: did he contact you before the hearing.
A: no, he was there, and they spoke to me.

Q: what did they say.
A: before the case started, it was made clear to me it was not a good idea for me to do this.

Q: who is Olivier Rabin?
A: Scientific director of WADA.

Q: review the facts of the case, you were called by USADA, it involved finestra, before Torino games.
A: yes.

Q: there was a debate whether finestra was a masking agent.
A: yes.

Q: you testimony is that is was not.
A: yeah.

Q: which was against WADA's placement of it on the banned list.
A: yes.


In another exchange under direct questioning by a USADA lawyer, Dr. Catlin gave some answers that bring into question just what constitutes a positive result:

Q: in your opinion, do you need more than one metabolite with that kind of delta to call it positive?
A: no.

Q: if the sample had been analyzed at UCLA, and gotten these results, would you report a positive.
A: positive with side letter to client (USADA) that the sample is positive to the WADA criteria, but that we have written a letter that our published criteria would call it a negative.


Keep in mind that this piece of testimony came under direct questioning by USADA, not cross examination by Landis's lawyers. What truly constitutes a positive result? What does the science say? Why does a WADA accredited lab feel it necessary to state that under their published criteria what WADA would declare as a positive they would classify as a negative. Could it really be that WADA's standards are so strict that truly innocent athletes are testing positive and being convicted as drug cheats? Are you concerned? I certainly am. Knowing that it is my tax dollars that are in part funding the drug doping inquisition, which makes a mockery of justice and a search for the truth, simply makes me sick.

Further reading
LNDD: The Chain of Custody was broken, by Roberta Barbalace our Environmental and Technical Editor

20 comments:

NOTICE: Comments are user generated feedback and do not represent the views and/or opinions of EnvironmentalChemistry.com.

tbv@trustbut.com said...

Thanks!

We gave your execellent story prominant placement. It's more reasoned and complete by itself than I can ever be.

TBV

MisterKnow-it-All said...

As a PhD chemist with 18+ years of analytical experience, my only conclusion is that the system of "drug control" is worthless. If the same Chain-of-Custody and analytical procedures were performed on soil or ground water samples to verify environmental contamination, these types of "protocols" and "results" would be discarded by any self-respecting chemist and/or laboratory. The French lab has consistently been at the center of analytical controversies - they are the ones who went back and "retested" Lance Armstrong's 5-year-old blood samples for EPO, using a test that was in development, and pronounced that Armstrong had doped. This lab should be shut down, and all of the management and personnel should be forever banned from analytical testing of any sort. Then on to the other WADA accrediated laboratories....

Anonymous said...

Mister-Know-it-all knows few, confusing blood and piss !!!
This guy must be closed.

Armstrong 's garbage contained a lot of PEDs in a scandal in 2000. All stories on the guys fill a book. He was able to beat Jan Ullrich when this guy was on EPO (see the recent statement about doping in T-Mobile), ...

Carlton Reid said...

TBV is right, this is a great summary.

And it doesn't even include yesterday's testimony from the IRMS expert and the WADA-panel doc. And those two bits of testimony all but blow the USADA case out of the water.

Over on BikeBiz.com I've long been arguing that LNDD was guilty of sloppy work. In fact, the coverage started last August. This case shouldn't have got this far.

Dick Pound must be hounded from office. And then WADA/USADA's cash needs to be stopped, pending a root and branch overhaul of the whole anti-doping system. Floyd has shown it's a closed-loop system that's inherently unfair to accused athletes.

Anonymous said...

Mr. Anonymous - why be a hater! 18+ yrs of experience beats your whining about Lance vs Jan, or blood vs pee. Admit it - you wish you were as successful as LA and you will go to your grave being a hater...

Jack Thurston said...

The problem is this. Most cycling fans and much of the cycling media are perfectly happy for their idols to dope. Just so long as they don't get caught.

This is why whenever a cyclist fails a test, everyone says it's the testing lab's fault.

The efficacy of EPO and blood doping is so great that for the last 10 years, since these products were introduced, it is well nigh impossible for a clean cyclist to be on competitive terms with a doped cyclist.

And we know from admissions of riders like David Millar and Richard Virenque that EPO was widespread in top level pro cycling in the late 90s and early 00s. And blood doping is prevalent now, as Operation Puerto is revealing.

So what does that leave us to conclude about the winning cyclists who don't fail the drugs tests? Simply that they're smarter than the testing agencies. At least most of the time. And unfortunately for Floyd Landis, it looks like he slipped just once and it's costing him dearly. But I don't for a moment believe he's any cleaner than any of the rest of the riders who figure at the head of the field in the Tour De France.

The tragedy is that so many cycling fans are happy with this situation. It's a misplaced loyalty verging on delusion.

Anonymous said...

The lab did not "pronounce" Armstrong positive for EPO. All urine samples from the 1999 TdF were tested. The lab had no knowledge of who the samples belonged to because only the UCI has the information that matches sample codes to athletes. It truly was blind testing.

A French newspaper was able to obtain Armstrong's doping forms from the UCI because Armstrong gave the UCI permission to release them. The link between the tested samples and Armstrong was then able to be made.

So the implication that the lab was out to "get" Armstrong is outright false.

Anonymous said...

I am sorry that I cannot provide links to the TBV summaries that back up the following assertions, but they have bearing on the editor's comments.

The head of the Montreal lab testified that if she received a packet identifying a positive drug test and saw problems with it, her action would be to call the lab that conducted the test. Apparently they would argue about it, but in a private and unknown conversation. This is an assumption, but warranted by the structure and procedurew in place.

The first lab tech to testify (I think) indicated that she had been the "verifying" person on testing done by the other lab tech, even though she had done the testing on the A. Perhaps that is acceptable, but she went on to testify that she did not necessarily observe the testing; she would review the written materials and the test results and then sign off, "verifying" that it had been done properly.

As an attorney, not a scientist, I found this flat scary.
pcrosby

Ken said...

Anonymous 5/22/2007 04:11:00 PM,

I do refer to the circular validation of test results (tester of sample A verifying test results of sample B) above under the section titled: "LNDD testing technicians admits to errors, gaps in logs, deleting data and knowing who's samples they were testing". You can see the TBV Page on this here (I will add this link to my post above).

Anonymous said...

Hm..that guy who "won" third a couple years ago whose wife was caught with cancer drugs, then Tyler Hamilton, and now Landis...

Sorry folks. Doping is systemic in cycling.

You don't think it's even remotely possible that LA would get new untestable cancer drugs from BMS?

You don't think it's a bit strange that FL comes back all those minutes in one day?

Testing, smeschting...would it help if FL drove a white Bronco?

Open your eyes to the elephant in the room.

daniel m (a/k/a Rant) said...

Ken,

Thanks for the link. Most appreciated.

- Rant

MisterKnow-it-All said...
This comment has been removed by the author.
MisterKnow-it-All said...

Anonymous-

Blood, urine, what does it matter? My point was that the laboratories entrusted to do this testing have poor quality controls, leak information that is supposed to be secret, and otherwise violate Standard Operating Procedures. Does doping occur in cycling? You bet it does, and it does in baseball, and football, and golf, and probably women's pro volleyball. This does not mean that the testing laboratories should be held to the highest standards, because if they are not, the results they spew are meaningless. Any chemist who disregards SOPs in these analytical labs are as unethical as the athletes who dope, and they deserve to be booted out of their profession the same as the athletes do.

Anonymous said...

In response to "anonymous's" claim that the Lab did not know about Lance's samples from the 1999 TdF:

You should read the Vrijman report. Vrijman is the Dutch Attor

Gregg Dickson said...

Thanks for the article! I submitted the following statement to both of my senators and my congressman. I would encourage all of you to do the same. You can look up their website and post it via a contact form here:
http://www.senate.gov/general/contact_information/senators_cfm.cfm
and
http://www.house.gov/writerep/
-----------------------------
Subject: Please cut-off funding for the USADA

Dear _______,
I am completely appalled by the outright political corruption and utter lack of scientific, procedural and due-process controls that are in place at the US Anti-Doping Agency.
Please cut off any funding for this organization until they completely reform their policies and procedures, which should include the following:
- American standards of justice including innocent until proven guilty and due process.

- Testing laboratories must not confirm their own adverse findings. If one testing lab finds sample "A" to be positive then a DIFFERENT testing lab would be required to test sample "B", with two labs being randomly chosen for the "B" sample test. One lab would get dummy control samples and the real sample while the other lab only got dummy samples. No lab would know who the other testing labs are and no one would know who was testing the real sample until after testing was completed. None of the three labs in question could know who the other testing labs were and none of the labs (or at least "B" sample labs) should know for which sport the samples are from. The athletes could still have representatives present for "B" samples, but they would have to keep the athlete and sport anonymous (transporting athletes representatives to the testing location would be at WADA expense).

- Research and enforcement arms of the anti-doping efforts must be separated. All government grants would have to go to testing labs and scientists through a channel completely independent of WADA and anti-doping enforcement agencies (e.g. USADA) with the existing agencies only paying for the actual testing they have preformed. This must be done to eliminate conflicts of interest.

- All testing procedures and testing methods must be validated via a true scientific peer review processes.

- All substances on the banned substance list must have been proven via true scientific peer review to either be a performance enhancing substances or masking agents.

- Illicit leaking of test results to the press must be criminalized.

- Doping by athletes must be criminalized with all prosecution going through the criminal justice system.

- Athletes and their legal teams must be allowed full and normal rights of discover for criminal cases including deposing lab testing officials prior to their case.

- Athletes must be allowed to employ individuals from testing labs not directly involved with testing their samples as expert witnesses.

Sincerely,
______________

Ken (EnvironmentalChemistry.com) said...

If you would like to see the adverse analytical findings (AAF) rate of various WADA approved labs the 2006 report can be downloaded in PDF format from WADA. One thing that is interesting is that LNDD's anabolics AAF rate (2.38%) was over six times higher than UCLA's anablolics AAF rate (0.37%). This really makes one wonder why LNDD has such a dramatically higher AAF rate.

Jeff said...

From the testimony above I don't see any reason to discard the lab work. Looks like the Landis team is searching for any minute deviation from SOP.

The defense expert wants to see more qualitative ions on the raw data report? Get it for him. The testimony states that more ions were acquired by the GC/MS so that's not a real problem. It just needs to be printed from the electronic copy of the data file. Much ado about nothing.

Intra-laboratory chain-of-custody? give me a break. Who does that? I've seen tens of thousands of environmental samples analyzed and none had a intra-lab COC. The COC always ends once the sample is possessed by the lab. OK, suppose that an intra-lab COC showed the exact time the analyst possessed the samples. What difference would that make?

The worst thing the defense can find is that a few data files were over-written by newer data files? The worst-case scenario is that the analyst is lying and the reason for running the "mix-cal" three times was because it required three runs to pass calibration verification criteria. According to environmental methods that does not necessarily pose a problem. In fact it is common to require a couple runs at the beginning of a day if the instrument has been idle. Usually it takes a couple runs to get a good chromatographic baseline. I see no big deal there.

IMO the only REAL problem with the analysis is that the samples were not completely blind to the analyst. The analyst should have no idea to whom the sample belongs.

The defense attorney will nitpick about tiny procedural crap that could cast a sliver of doubt. That's how O.J got off.

Landis looks and smells like a rat in a sport that is full of them. All the top cyclists have been caught or admitted doping. Landis had A and B samples both high for T/E ratio and positive for synthetic T. You want to let him off the hook because a lawyer can find tiny non-critical errors by a lab tech? In a perfect world every custody form would be perfect, every logbook perfectly written, every piece of electronic data intact, every sample blind, etc, etc, etc. But this is real life - lets not be naive.

Davis Straub said...

Can we determine what the probability is that Floyd's test results of the A sample after the 17th stage of the 2006 Tour de France is a false positive, just from the AAF rates given above and the assumption of a random distribution of "drug cheats" across the various laboratories?"

I assume that we need to make an assumption about the percentage of "drug cheats" in the population. Perhaps it is that assumption that each person makes (on whatever basis) that determines how confident we are about the validity of Floyd's results.

Of course, the assumption would be made backwards, that is, after we have heard about all the results of the tests on other bike racers.

Thanks.

Davis Straub
http://ozreport.com
http://ozreport.com/worldrecordholder.php
http://ozreport.com/location.php
Blue Sky, Manquin, VA, USA

Jeff said...

Mr Straub,

You asked "Can we determine what the probability is that Floyd's test results of the A sample after the 17th stage of the 2006 Tour de France is a false positive"? I'll give my own reasonable estimate of the probability of a false positive, based on my ten years experience doing analytical chemistry: Less than one percent.

In the lab we do a study called a "Method Detection Limit Study", or MDL study. In this type of study we determine the minimum detectable amount of a target analyte based on the statistical evaluation of multiple repetitions of sample analysis. For example, seven replicate samples are spiked with a very low level of the target analyte. Based on the standard deviation of the sample results we can determine the minimum quantity of the target analyte that can be detected in a sample at the particular laboratory by the particular staff and equipment. The result of the MDL study allows the laboratory a 99% confidence level that a positive detection of the target analyte is present in the sample above a certain limit.

In other words if synthetic testosterone was detected by the lab at a level above the MDL, then the laboratory can say with 99% confidence that this is not a false positive. Considering two samples were tested and each result was a positive result, the likelihood of two false positives would be 0.01 X 0.01 = 0.0001 = 0.01% chance. You could raise this probability a bit to account for possible random errors by the analyst. But you could also lower the probability based on the large amount of synthetic testosterone found, which was not near the laboratory MDL. So a good approximation is about 0.01% chance that both samples were false positives (this is 1 in 10,000 chance).

The other possibility is deliberate sabotage of the sample by a member of the lab staff or any other person with access to the sample. The probability of sabotage is anyone's guess.

Davis Straub said...

What seems obvious to me is that one lab can't have an AAF rate 6 times another lab if they are both testing the same population and both are using methods, equipment, people skills, and procedures that are the same.

That is the likelihood that these differences are due to random chance is oh, say, 1/10,000. Have I got that wrong?

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