Thursday, May 17, 2007

Hearing - Thurs Ayotte Cross

JACOBS CROSS of AYOTTE

q: paid?
a: no

q: retainer?
a: no

q: how many hours?
a: 20-30

[MORE]


q: reading briefs?
a: 2-3 hours.

q: you are head of Montreal?
a: yes.

q: most of what you do it drug testing for sport?
a: also research.

q: most is testing?
a: yes.

q: how much of your work is funded by WADA related sports?
a: a few thousand, about 1/5 of the total.

q: in addition to drug testting, you are sometimes asked to attend b sample tests?
a: at least twice.

q: paid for that?
a: only per-diem and expenses. member of commision, volunteer?

q: ever attend a b for an athlete?
a: no.

q: would you be prohibited by code.
a: probably yes, never approached.

a: don't know if prohibited from attending, but would be prohibited from testifying for an athlete in a proceding like this?

q: because you aren't allowed to do anything to create doubt on a laboratory?
a: yes, and also other ethical problems.

q: if you saw problems in a pack, you could not testify to that, could you?
a: if I were given a pack that had problems, i would certainly find a way to inform the responsible testing authiory of that problem.

q: but you couldn't get involved as a witness.
a: correct.

q: GDC 1354 marked, 2005 article from jobboom le magazine. That's a picture of you?
a: yes.

q: fourth paragraph, please translate
a: "the fight against doping has also got a political and legal dimensions... rich american lawyers, we have to be creative, you have to be able to give the information in laymans terms." I have not written this article.

q: let me get the correct interpretation of the 2nd word "vulgariser"
a: layman.

q: i hope by rich american lawyers you aren't referring to me?
a: how much are you getting paid?

BRUNET: you do not have to answer.

q: Have you had contact with WADA about this?
a: no.

q: you have not had communication where they said it would be good for you to comment on the case to the media?
a: yes.

q: GDC 01353.01 and .02

q: but you have spoken to the media about this.


q: this is from october 2006.
a: yes.

q: had you read the LDP at that time?
a: what was available on the web?

q: booboos?
a: typos were not important.

q: not referring to chromatography?
a: correct.

q: numbering and document mistakes?
a: yes.

q: chain of custody -- you would agree that LNDD doesn't document where the bottle is at all times.
a: i was able to go through and get the information of where the bottle was and who had custody?

q: you can't do chain of custody by memory?
a: correct.

q: it's not enough to say "i remember where the bottle was"
a: the documentation says the coc is documents, and records, and testimony.

q: so gaps in custody are ok if covered by memory of 9 or 10 months ago.
a: yes, according to the technical document.

q: better to be documented?
a: yes.

q: you spoke earlier of irms issues and positivity criteria. with the injection sequence, you said it doesn't matter what order you do the injection?
a: no, the question was whether the mixcal or mix cal acetate were switched, it doesn't matter.

q: if the SOP
a: you are fully allowed to change the order, as long as it is recorded.

q: how?
a: so as long as you can see what happened, in the record of the sequence that's OK.

q: that should be in the LDP, correct?
a: its in the records, if it's not in the LDP, you can ask for it.

q: you wouldn't expect to do taht based on the memory of theoperator.
a: also in the record of the instrumentation with dates and hours.

q: do you lndd have a SOP for order of injection?
a: don't know.

q: you'd expect them to follow it?
a: they could modify as long as it recorded.

q: you have a PDZ europa?
a: we have two...

q: what software do you use?
a: I din't know, I don't operate the machione.

q: you were in the courtroom some of yesterday and tay before during mongonfu.
a: some yes.

q: did you hear here talk about matrix interference in some of the runs?
a: I'm afraid not.

q: were you present when she testified about internal standards not being quantified because of matrix interference.
a: i understand, that's what she said.

q: you can't then say all those chromatograms are perefect, can you?
a: only affects the start of the chromatogram. In the region of interest, it was OK.

q: you didn't look at internal standards at all?
a: no

q: do you think they have any relevance?
a: only to establish retention time. not involved in the delta-delta value computatoin.

q: standard has a limited use in the process?
a: yes, not involved in the determination of the delta-delta values.

q: what is the purpose?
a: used to establish the relative retention time.

q: so if there are problems with the internal standard, it doesn't matter?
a: no, because it's not used in the calculation?

q: EX 8, ISL page 33, (validation of methods) 5.4.4.2 You said 5.4.4.4.2.1 on matrix interference says only on validation do you have to establish you can deal with matrix interference?
a: no, that the process used by the lab would be capable of dealing with it. If there is a matrix interference, that is not a violation.

q: it just makes it innaccurate?
a: lost.

a: we don't get to verify the validations. we want to make sure the lab gives an accurate value.

q: in the analysis, the lab still needs to show they have specificity?
a: yes, that's why standards.

q: identificaton?
a: yes.

q: and that there is no matrix interference?
a: yes.

q: If there is matrix interference that affects the accuracy?
a: yes.

q: so these points don't talk only about validatoin, but also analysis.
a: yes.

q: you mentioned degradation would not affect irms results?
a: yes.

q: are you saying degradation cannot affect isotope ratio?
a: yes, absolutely not. We have looked for this and not found it.

q: which we are we talking about?
a: my lab and at least one publication from a lab (lost) about microbial degradation.

q: so your opinion is that no contamination can possibly affect?
a: we have not seen an affect.

q: my question was a little different, there are NO circumstances?
a: my answer if were to see a severe affect that would cause the disappearance of the analyte, and that would show, and that's not the case.

q: so there is NO possible way degradation can affect?
a: as long as the assay profile lost...

q: so it depends on how much degradation?
a: if you have heavy signs of degradation, you may not have enough analyte to determine accurately.

q: so if the bacteria were eating the stuff, it could affect.
a: it could affect your ability to reliably measure the value.

q: so it can affect the measurement?
a: well, yes.

q: TD2004 EAS, ex 10, positivity criteria.
a: yes.

q: wada is telling the labs the minimum positivity criteria
a: measurement and reporting guidance, yes.

q: and how to do the test?
a: not really, just the reporting criteria.

q: the lab still needs to carry out validation to show it's testing can be done in accoranance with the TD?
a: yes.

q: so that WADA has validated the method doesn't relived the lab of the burden to validate their method?
a: WADA doesn't validate methods.

q: So because WADA uses 3 delta-delta as positive doesn't relieve the lab of the responsibility to validate it's method?
a: exactly.

q: after a procedure is transferred to a lab, they still need to validate they comply with the ISL and TD?
a: yes.

q: even assuming a lab does a validation of the irms, a positive is only as good as the chromatography?
a: yes.

q: good gc is essential?
a: yes.

q: you were not present when these were run.
a: no

q: you don't have personal knowledge of their sequences, or how they ran or reran controls?
a: no.

q: personal knowledge...?
a: of the LDP?

q: you know personally...
a: no.

q: you did hear the techs some of the logs provide explanations based on memory?
a: was not in the room, have not looked at the log.

q: why not?
a: i had enough reading to do.

q: if the log showed the lndd had rerum mix-cal acetates, would that be of interests?
a: i'm afraid we do this regularly.

q: you'd need a reason, wouldn't you.
a: yes. in the course of a sequence and you know something is going wrong, you should make arrangements, and then you can re-inject.

q: when you see something wrong, do you document in the pack?
a: no. If we have a problem, we'll do it over, and just overwrite the files.

[ prepared answer? ]

q: if they stopped a sequence to fix something would that concern you?
a: no.

q: you don't document?
a: no.

q: how is an independant analyst supposed to be able to look at an LDP if you aren't keeping records?
a: the purpose is to enable a competent expert to support or not support a conclusion reached by the lab. The calib standards, performance is nothing that should concern us?

a: the purpose of the pack is to support the results reached by the lab. what the lab has done before, filled the standard, change the liner, overwirte calibration or verification standars is absolutely of no relevanc.e

q: so it's proper to run things over and over to get results they want?
a: that's not what I said. I'm not talking about reinjecting athlete samples. I'm focussed on the instrument setup.

q: so you would never overwrite a file?
a: I said we did, with performance controls.

q: how would an expert evaluate.
a: we're not talking about the athlete samples. we're talking about the controls. whether the tech had problems setting up the instrument isn't relevant.

q: the purpose of the controls is to show the instrument is running correctly...
a: long answer.

q: you run a control that didn't work, you run it again, and that's ok?
a: yes. once it's in good working order, you run the samples.

q: in the middle of the sequence, you get a result you don't like, should you go back to the beginning?
a: depends on the problem. if the needle broke, you just fix it, resume the sequence.

q: what if you are in the middle of a control injection and the results look wrong?
a: depends on the control. if they ran stability, and happy, they can fix and rerun.
if they fix the next step.

lost

q: you run mix cal acetate, and don't like the result, run it again and it's ok. cause for concern?
a: depends.

ADJOURN.

2 comments:

Anonymous said...

Ayotte explained the starts and stops in the testing reasonably though Jacobs was trying to find an angle to catch her on. I’m not convinced that he did.

The technician is setting up the machine for the test. They do various activities (liner, controls, etc in the first part of the ‘sequence’) until the lab tech is happy that the machine is set right BEFORE they begin the test of the athlete’s sample which is why the data can get overwritten. They overwrite the file until the machine is ready for the actual test. Once the machine is set right, in the second part of the sequence, then they proceed with testing the athlete’s sample and write that file of data out for analysis.

I don’t see much sinister with that process. In fact, it seems that there are enough ‘adjustments’ to make to get the machine right that if one didn’t see some of this activity, it would seem more suspect.

I presume these finalized ‘settings’ or ‘readings’ on how the machine is set are recorded somewhere in the data but don’t recall hearing testimony to that effect (yet?).

Ayotte made the point that she hasn’t seen any significant biological degradation of steroids in samples (ie biological digestion of the steroids – if you will excuse that rough terminology) that would affect the irms results. Jacobs did get acknowledgement from her that if degradation existed, it would affect the results. However, they never got to where they explored what other types of degradation might exist. So Jacobs may have a window of opportunity there if he can establish other types of degradation potentially occurred though I have no idea how he might accomplish that.

Overall, I thought she did well for the USADA. It will be interesting what Jacobs comes up with in the morning after he’s had a chance to sleep on this testimony.

cleduc

pem said...

When I read that Ayotte was scheduled to testify for USADA, it raised some concerns within me that USADA may have valid results.

Obviously, I do not know Landis nor Ayotte, yet I believe both.

Landis conducted himself like a deer caught in headlights when the news first broke. Ever since, he has not done or said anything publicly that I am aware of, for me to doubt his claim of innocence.

On the other hand, from what I have researched on Ayotte, she appears to be a highly ethical person.

If Landis’ lawyers do not “catch” Ayotte contradicting herself (which I doubt they will), perhaps they should ask her if there is any possibility she may be aware of that could cause a person who did not dope, to still have these unusual results. I have awkwardly suggested this in some previous comments.