Monday, May 21, 2007

Hearing - Mon Amory

Dr. John Amory, Direct by Jacobs.

q: where employed.
a: UW Seattle.


q: what do you do:
a: physician, scientist in andrology

q: specialty?
a: testosterone replacement, and hypergonadism.

q: where edu?
a: Harvard, UCSF.

q: in andrology, awards?
a: Young (less than 45)

FAILURE ALERT! The HTML monster ate a bunch of stuff here, sorry.

...very rigorous paper in NE Journal of Medicine.

q: testosterone and endurance - papers.
a: August last year...

GDC 621. Effect of multiple oral doses on endurance performance, Baume et. al, including Saugy.

q: purpose?
a: study of trained athletes with t/placebo/exercise, treadmill performance. conclusions were that no benefit compared to placebo.

q: familiar with reviewed papers on recovery?
a: two old ones from the 80's. Neither showed any benefit.

q: Don Catlin testified that T wuld benefit recovery. Has he written papers on that?
a: unaware of data to substantiate that claim.

q: Joe Papp took bunch of stuff... and microdosing androgel, and he said androgel gave recovery benefit. Is there a benefit to recover.

BARNETT: objection mischaracterizing testimony.

q: do you have opinion if the androgel would give recovery bneefit.
a: my review of literature says no; of the list, the glutein (?) does give recovery benefit.

q: how does T affect someone psychologicall -- papers?
a: O Conner

GDC 1333

q: review?
a: 200 ng by injection, followed by questionaires -- no changes in normal; those sub-normal became less hostile and irritable.

q: show where in paper?
a: table 3, page 561.

q: explain table.
a: person and partner reported scales on aggression/anger/hostility; doesn't seem to have any affect.

q: familiar with t/e ratio and how used in anti-doping?
a: in cases I've judged for ADRBs, they've been triggered by t/e ratios.

q: what affect does T have on T in the short term?
a: changes the ratio?

q: affect of single use?
a: no, some studies of chronic and intermittant, including Cologne study.

EX 34 cologne.

q: not peer reviewed, correct?
a: correct.

q: do you now what review has been given?
a: presented in conference in the last year.

q: what does it show about t/e ratio?
a: has a marked and stable increase in t/e ratio.

q: some or all?
a: most over 4, some less than that.

q: for those who did not have it go over 4, what did it do to t/e over reference range.
a: tend to increase over their normal range?

q: how many participants?
a: 18 -- gcms, 2 checked by irms.

q: significance of cologne study looking at Landis' t/e values?

GDC 1363 2.8/ 1.3 / 2.5/ 1.5/ 1.8 / 11 / 2.5/ 1

a: what you see here, all less than 4, and the value of 11 is out of range. In the cologne study, if they went above 4, it would stay above 4.

q: low mode vs. high mode individual?
a: high mode have a t/e around 1. low mode because of low e have ratios perhaps around .1; you are either one or the other. Don't switch.

q: If the contention is that T gel was used on these occasions, and looking at the t/e ratios, does this l ook consistent.
a: if gel was used on all those dates, I'd expect a higher t/e ratio. t/e is a sensitive marker for t gel. I don't consider these results consistent with T gel use over that period?

q: what if injections some days, gel others, oral others.
a: would be surprised to see these results, but not impossible.

q: looking at actual T concentrations,
a: these are frankly low, others are low.

q: what it the significance of these numbers?
a: fairly consistent, in the low range of normal.

q: anything in the E numbers striking?
a: quite low. these are below lower range of normal. with excretion of t and e there is a circadian rhythm involved. Lowest in mid-afternoon, almost 10x lower than rest of the day -- 5pm is the time reported.

q: in the work you do with ADRBs, are you familiar with CIR tests?
a: yes. Classically used as a confirmatory test, to see if T is exogenous.

q: if exo-t used, explain metabolization.
a: complicated stuff. Metabolites used as markers for doping control.

q: do you expect relationships between them.
a: they should relate close to each other. the 5a and 5b should go toghether and in tandem.

q: are there papers to support that.
a: best is shackleton.

q: EX 40 at USADA 1241. Is there a portion to look at?
a: see fig 4 on page 383, this shows 5a and 5b fall dramatically, to about -4only later do they vary much.

q: in you opinoin, is there basis to believe that exo-T would affect one diol in a significantly way than another?
a: none in the published literature?

q: what's the maximum difference you'd expect to see?
a: very surprised to see it > 2.

q: what about cologne?
a: did do irms on two individuals over time. page 14, figs 18-21 the irms results. Fig 18 shows patient 10,
the t/e ratio is up all the time it is administered; good correlation of t/e with irms data.

q: other figures of interest?
a: fig 20 and fig 21, this is person 9 doing intermittent gel application. the irms differences are about as you'd expect, but not as sensitive as we'd like.

q: other points?
a: fig 21 A-diol vs B-diol. so there is a little difference between the A and B diols, but still moving the way you'd expect.

GDC 1363.

q: jul 20 -6.39 and -2.65. consistent with exo-t use?
a: no. difference of 4 is way out of line with studies.

q: jul 22, -4.8 and -1.67. consistent with exo-t?
a: no, doesn't look like anything we've seen -- exceeds 3.

[ problem case is 7/13 -4.62 and -4.09 ]

q: do you believe these results are accurate?
a: I don't think they can be used to confirm doping occurred. While 7/13 looks bad IRMS, it doesn't make sense T/E. There's no point where they are both positive.

q: if this t/e 11 is right, you wouldn't expect a 2.5 on jul 22?
a: no you would not expect that.

q: on the andro -11k, and e-11k, would you expect similar changes there?
a: they should parallel. these all look normal. the values on the 23 are confusing.

q: you've seen all the values from cologne. Are any of those values consistent with what we see here.
a: no.

q: if low mode, then t/e is always going to go to normal.

q: if high mode, it'll go from normal to > 4



q: how many studies have you done with urine steroids.
a: none.

q: so when it comes to urinary metabolism you rely on someone like shackleton?
a: I rely on the literature.

q: you said that you have work on USADA cases with t/e and irms?
a: around 2 or 3 of 10 cases.

q: that would be the only time in your career when you've have occasion to look at ratios?
a: yes.

q: the only occasion you've looked at irms results like 5a dna 5b.
a: yes.

q: your experience working with deficient patients is mostly blood.
a: yes.

q: depending on urine/blood the method of application affects metabolization.
a: yes. injection fast, gel, oral more steady state.

q: time after administration makes a difference?
a: yes.

q: are you aware of studies showing mixed administration?
a: some data in cologne, at different times.

q: if you were an athlete who wanted to keep t/e down, methods would be E cream.
a: yes.

q: could make it go down or stable.
a: yes. I'd expect the absolute value of T to be relatively high.

q: if you were using one or more T products, like fast acting pill, that would have a signficant effect.
a: yes.

q; if your e was fairly low, then it wouldn't take much administered to change ratio.
a: yes, it could change very markedly.

q: if you did that, you wouldn't see marked difference in absolute amount of t.
a: not if you were using E cream

[ i didn't follow this ]

q: are you aware of any studies that show that during a long event that an athlete's T drops.
a: no studies, but not surprising.

[landis, chin in hand ]

q: EX 43, USADA 804, whatever opinions you have on t and e may be affected is based on reading, not work you've done.
a: yes.

q: have you seen this study?
a: same group as the endurance study earlier.

q: you said you reviewed exhibits, did you get ours/
a: I have many binders. Can't say specifically.

[ blows up abstract ]

q: look at F1, p 367. look at individual S1, somebody after his first pill, t/e not affected in 24 hrs.
a: yes.

q: 5a and 5b drop together in 4 hrs, back to normal in 24 hrs.
a: clearly a low mode individual, baseline 0.1. This drug is used 3x day in europe.

q: so this would be a good way for an athlete to take T?
a: good for hiding, but bad for effect; you might evade detection, but get no benefit.

q: Subject 5, takes Oral T, gets a TE spike to 17.31, high mode.
a: what you'd expect.

q: 8 hrs. back to normal. 5a and 5b go together, gone in 8 hrs.
a: a great slide. t/e go up and down in almost exactly the same as the delta go down. Here they corroborate each other very well; inconsistent with what we see in Landis.

q: so this athlete could take oral T every day before bed and you wouldn't find it an after race test.
a: yes, this individual would never even screen positive.

1241/ USADA 1245 shackleton

q: Subject 5 of this study, the 5a and 5b behave differently.
a: i think there's a difference of 1 or more, at most 2. so actually difference only after 13 days, single data point do you get that large difference.

q: this is a single large injection. different people metabolize differently.
a: patterns are very similar. reproducible pharmokinetics.

q: would you expect 5a and 5b to behave differently dpeendingn on whether the product was administered orally or through skin.
a: apriori, I might; the one subject is hypothesized to be that way in the cologne study. That explanation is incorrect. I have give t-gel to 100s of men. We don't see that in these studies. We did see this with patches, but not gel. So that explanation doesn't make sense.

q: you've never measured how 5a and 5b react after administration of gel.
a: no. lots of data on serum testosterone and DHT.

q: do you look at E in blood?
a: yes.

q: medical purpose?
a: looked at for research.

q: USADA 122, is this the paper article you referred to?
a: yes.

q: you're quoted as saying men ordinarily produce 1E for 1T. true?
a: I don't think she understood our discussion.

q: "there are peple likt what who would like to see an American...disgraced. That's why the Coc has to be codified"
a: may have some resemblence to what I said, but certainly not this.

q: how would someone squirt something?
a: I don't think that's what happened.

NO QUESTIONS -- no, one more

q: you said earlier use of T increases RBC, so using hematocrit and hemoglobin to go up.
a: if started anemic, improve to baseline.

q: did mr. landis tell you he had a list of blood test results from UCI?
a: have not seen such a list.

[ This was something he alluded to with Catlin ]


JACOBS RE-DIRECT: FTR, I'm not clear what blood test list Mr Young is referring to.

q: NYT article, CoC documents important when doing ADRB work?
a: yes.

q: Also lab documentation.
a: yes.

q: when you got lab documentation, did you do that?
a: there are some errors

q: significant?
a: in a medical context they'd throw it out and force a retest.

q: GDC 1363, summary chart. asked about E cream as a masked t use. Are the E values here consistent with an E cream.
a: these are very low values. I can't see taking E cream to get these low values. this is my opinion only. based on no published data, it seems consistent with all values. Doesn't seem consistent with use of any use of a supplement. None are high, they are all low.

q: you were shown EX 43, USADA 807. Look at subject 1. Is the data consistent with in this case?
a: not at all.

q: why not?
a: low mode; Landis is high mode.

q: S2. consistent with Landis?
a: no. illustration why you expect t/e to go up while 5a and 5b go down.

q: S3. consistent with Landis?
a: no. none of these are even abnormal.

q: S4. consistent with Landis.
a: no. again, the two tests back each other up.

q: S5. consistent with Landis?
a: no; same reason.

q: S6?
a: once again no, same reasons.

q: S7?
a: no. same reasons. at no point is there a discrepency between the two tests.

q: Shackleton paper. Fig 4a, 4d, 4e, 4f.
a: no. the metabolites should corroborate each other. Nothing as large as the 4 seen in Landis.

q: is there any reason to believe a cyclist would metabolize T different than anyone else.
a: No.


[ landis yawns, deeply ]

cologne graphs.

q: focus on second graph, 11ha-adiol (don't knwo which person, looks like intermittent use). Week 7, what would you say the 11ha value is?
a: 4

q: week 8
a: 3.8

q: so the 5a is more than 4x bigger than the 5b?
a: yes.

a: only two individuals underwent irms, the problem with this study is that there is a endogenous compound and only one individual. This is shingling past the edge of the roof.

q: there are 2 others in the appendix.
a: p3.

q: p3 and p10 at 14 also has irms results, figure 18?

q: when you look at p9 and p3, you see you can get variations?
a: and at every point you get a t/e positive.

q: this is after gel for..
a: 6 weeks for one, and on and off for the other.

q: did you listen to Mr. Papp?
a: no.

q: would is surprise you to pass t/e screen on androgel?
a: with a lot less, maybe not; with large dose yes.


BRUNET: Scheduled to run till 5:00, Landis cross I don't expect cross less than 30 minutes?

SUH: After Landis, we will call Simon Davis, last witness, 2-3 hours.

BARNETT: may have one or two rebuttal witnesses.

SUH: Identify rebuttal witnesses?

BARNETT: Later tonight.

BRUNET: Provide within next hour.

RECESS till 9:30am


Anonymous said...

Dr Amory looks, sounds, and acts like he could use a good dose of T.

Anonymous said...

Amory is my personal Doctor. He's a very cool guy.

Anonymous said...

3:09 do you have a testosterone problem...or is he your doping doctor?

Anonymous said...

Neither, wise ass. In addition to being an expert on PEDs, and T in particular, he has an internal medicine practice at UW. I had no idea he was this into USADA stuff, or that he usually testifies for USADA.

Anonymous said...

Jacobs is an ass; Suh is a heck of a lot more palatable.

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Anonymous said...

3:14, just curious on the basis of your statement. Not arguing one way or the other, as I haven't seen either in action in this case.

Anonymous said...

the meek sometimes do inherit the earth

Anonymous said...

he just sounds like an ass here because this whole direct examination is rehearsed.

Anonymous said...

Anon3:18, Jacobs demeanor and in particular his tone of voice are hard to take. He's arrogant, he sneers a lot, and generally seems like a little weasel. Suh is a lot more likable, and in general seems a lot less like a slimy lawyer. Suh you wouldn't mind hanging out with; in a short period of time, you'd probably want to punch Jacobs right in the face.

Anonymous said...

UW male-contraception trials

Anonymous said...

Plus he looks like George Costanza. Dr. Amory does some research on male pattern baldness, Jacobs would be an excellent test case.

Anonymous said...

Don't forget to help the TBV guys out for doing such a fine job. Be sure to click on all the google ads in the lower right.

Anonymous said...

When a lawyer asks a question, the witness answers, then says, wait, there was something else I was going to say here.....oh, yeah, I remember now, blah blah - does that make your testimony look rehearsed?

Anonymous said...

i like that this is in the dirt temporarily after so much science. fun.

Anonymous said...

everyone knows it is rehearsed....if it isn't rehearsed you look like a USADA witness.

Anonymous said...

Figure 18 looked a lot like Floyd's data. Mostly the T/E ration was low, with one big spike much much higher than the others. The IRMS data was high pretty much across the board. Sound familiar? Not sure I would point to that slide.

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Cheryl from Maryland said...

Oh, Dr. Amory is using the IRMS test results(the 5a & 5b diol)to discredit the T/E ratio of 7/20. I was wondering how they were going to deal with that issue.

Anonymous said...

Is Young looking at the witness, or is he looking at the wall/ceiling?

Anonymous said...

Young is a real pro; Landis is chewing on his hands now.

Anonymous said...

he is chewing on his hands so that he won't bust out in laughter or a smile like he has been known to do.

Anonymous said...

What is Young doing. He just shot himself firmly in the foot. He is strengthening Landis case. Firmly.

Those slides were the most damning I have seen out of any exbit and Suh/Jacobs should be ashamed they didn't present it themselves.

Anonymous said...

am dying to see the synopsis of whatever slides Anna is talking about...

Anonymous said...

Neither of Floyd's witnesses today are experienced in doping issues. That could have muted their effectiveness (there have been some glaring problems in their testimonies) but Young has done an awful job of crossing them. He's not quick on his feet at all. It seems he just reads what's prepared and that's basically it.

Anonymous said...

Anna, Suh and Jacobs may have planned for Young to cross using the slides. It can be extremely effective when an attorney for the other side shoots himself or herself in the foot like that. Don't assume it was oversight or incompetence.

Best -

Sachi Wilson

Anonymous said...


If so it was gamble and one that paid off greatly. They had younf show that in every single studied over over application method. T/E and 5a/5b were in striking unison, unlike the mess of values obtained for Floyd.

Anonymous said...

I'm following the testimony, but I've just reached a bit of a stumbling block. I understand that Landis' team is questioning the interpretation of the results of the tests... but I don't get it - is goal to say that the tests WERE done accurately, but misinterpreted, OR, that the tests were completely screwed up and innaccurate? Can someone help me here - it seems that the legal team has tried to argue both points - but they can't both be true...?

Anonymous said...

I think the testimony is so that the T/E ratio is out of whack and also BOTH metabolites are also out of whack. The LNDD says only 1 metabolite needs to be over to be an AAF. They are showing every single graph that the numbers don't add up for Floyd doping ever.

Anonymous said...

Anon 4:37,

I think they are saying that the test were both done innaccurate and misinterpreted.

James said...

The two witnesses today sounded like incredibly intelligent and competent people. The USADA lawyers seemed confused and gave the impression they knew they were out gunned.

I can't wait to read the reviews of todays testimony. I think Team Landis scored some major points today.

Quote of the day goes to Dr. Meieeir-Augenstein...

q: where is it in the spec it matters if it's outside the spec?
a: they must have some criteria, how do they choose? Divine intervention? I'm amazed. You're left with the GCMS, which has mass spectra, then you get to retention time, and it doesn't match in the IRMS. How do you identify one unknown peak among 5 unknown peaks? I don't know how they do it.

I too am amazed.

Anonymous said...

I'm amazed that USADA is hanging their hat on an study with only one or two subjects, that is not yet peer reviewed. They slipped it in last week, but it has taken a bunch of hits today.

If that's the best they can do, Floyd is innocent, period.

BTW, I was kind of blown away by the "divine intervention" statement earlier. That German scientist so obviously knew his shit that it seemed at times he was questioning the USADA lawyer rather than the other way around. Brilliant!

Anonymous said...

Hopefully there was a bit more development of what "peer reviewed" means in the testimony. I still find it hard to believe that the panel was bamboozled on that.

Lots of positives in both direct and indirect. Problem for me is the whispering Italian. I wonder if Landis can request clarification of what his role will be in deliberations and if there will be a record of questions and his answers? Posing those questions might make them think twice about relying on him.

This is especially true since the panel is supposed to be made up of individuals with special knowledge of sports doping. They should not need to be "educated" by a WADA shill.

If his role has been clarified and I missed it in one of the posts I apologize; if not, can it be?

Anonymous said...

It's called posturing.

Pure BS. None of his witnesses have steroid or athletic anabolic doping/masking experience.

Sophistry, threats and empty denial is the landis defense case.

Laura Challoner, DVM said...

Well, we can all go home then. pack it up and leave. you know the answers. Talk about sophistry.

Anonymous said...

After (finally) reading Amory's testimony today, all I can say is, wow! The direct questioning was very damaging for USADA, and then Young seemed like more of a defense attorney. Amazing. I actually think the cross helped Landis.

What a one/two punch today. I hope tomorrow is as good.

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Anonymous said...

WG's despicable behavior is irrelevant to the facts of the case. (Yes, that's a period.)

Anonymous said...

With all these data gathered and discussed in Landis case, my cycling team and doctor now have a deep knowledge about how to dope with T and E without beeing screen positive.
Thanks a lot to all these experts in many different discipline ! We never had enough money before to pay all theses consulting.

I'm now quite confident with the fact that in no way any WADA labs on earth can provide enough effort to produce enough documentation on each possible metabolite of any easily chemically derived substance, with peer review, papers , medical and recovery tests and so on. It will cost many times the budget of all theses labs !

I'm specifically loving reading there's no paper available on recovery with androgel. So funny !

See you soon on the road :)

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Anonymous said...

I think there is one danger here, and I'd like to get some feedback from others about this. In looking through the testimony so far, it seems that the overall impression that arises is that there is vast differentiation in opinion as to what constitutes a 'positive' result for a test. This throws into question the whole truthfulness of the ability of labs to be able to test.

I understand why the defence is using these differing standards as part of their case, but I'm thinking about the long-term effect this will have on the issue of doping. In other words, what we're learning here is that you can't trust any lab unless you know their procedures beforehand. That isn't exactly the most optimistic and faith-inspiring message to send to the world who wants to see doping-free sports.

I'm not saying that Floyd bears the sport's historical weight on his shoulders, but if riders know that they shouldn't enter a race because this or that country has more stringent testing, then this could really change the sport. In that sense, the testimony helps Landis, but doesn't really help the public's perception of how anti-doping is managed. All the lay people (like myself) are now completely uncertain if it's possible to really prove doping or not.

Anonymous said...

If each lab has its own "standards", then there really are no standards. All the labs testing for WADA should use the exact same procedures, on the same equipment in the same way. The back up studies should be done by WADA, not each individual lab. A "standard" should be the same everywhere!

Without this type of standardization, the athletes will be competing under different rules in different countries.

Anonymous said...

Is it surprising Dr. A. hasn't seen similar results in his practice, when his practice doesn't include endurance atheletes or presumably persons who are intentionally doping? I'm not convinced his observations are that relevant, even though he's on the USADA panel. However, I'm also not sure that USADA brought out these things clearly on cross.