All About Salbutamol

[Merckx index]

Re: Re:

The WADA rules do allow the athlete to use changes in the anti-doping code 'before' their effective date and can use the files published date instead, if it is to their advantage.

Where do the rules say this? I’m not arguing this isn’t the case, I just never heard of it before.

The file wasn't published before Froome gave his AAF sample to anti-doping control, so any changes in that file can't be used by Froome's legal team to reduce his measured level of salbutomol using USG changes in that technical update.

OK, I think I understand your point now. Except of course Froome can still use the rule when it goes into effect, at least according to what some researcher said in an interview. Which, when you think about it, is a little weird, and is another problem with this changing the rules in the middle of the game. Because at this point I want to ask, how long can you delay this process? Suppose Froome had tested positive at the TDF. Could he just have sat on the case till the following March? I don’t think there’s any rule in place that would have prevented him from doing this, assuming, of course, that he knew the rule change was coming.

Thinking about this outside the box terms of why such a long delay, I'm wondering if the B sample request was after the file was published. That would create a bit of a legal issue for WADA perhaps. Maybe, the A sample will actually have to be re-tested using td2018dl_v1_en.pdf and almost use the A sample to confirm the B with its USG adjustment?

Assuming it was published Oct. 30, as you seem to be saying, I would say almost certainly no. That would be more than a month after Froome knew the A sample result. Unless Froome decided from the outset to play a delaying game, I don’t see any reason to wait that long. (Or for conspiracy theorists, unless he was told about the upcoming rule change, and knew the advantage of waiting to have his B tested). FWIW, Contador had his B tested about two and a half weeks after he learned of the A. My guess is Froome had the B tested in the first or second week of October. In any case, I know if I had been in Froome’s position, I would communicate to lawyers and scientists as soon as I was informed of the A sample, but since of course I would not commit to employing any of them based only on the A, I would want to get the B result ASAP.

Edit: I did see one doping case where the letter informing the athlete of the A sample positive instructed him to decide within one week whether he wanted the B sample tested. He replied immediately, and the sample was tested twelve days after he was informed of the A test. However, he was not notified of the B result for about another two weeks, so all told, about a month passed between learning of the A and of the B. In Froome's case, if an enantiomer test was also carried out on the B sample, I suppose it could be even longer.

 

[thehog]

WADA has already stated to the BBC that Froome gets the benefit of the new rule even though the infraction occurred prior. It’s been linked like a 1000 times now.

http://www.bbc.co.uk/sport/cycling/42417297

In the past, Wada has not adjusted the salbutamol threshold in test results to account for "high urine density", which can increase when you are dehydrated.

But that is changing from 1 March 2018, and a Wada spokesperson told BBC Sport that for any case currently being adjudicated, "the most beneficial rule to the athlete would apply".

 

[samhocking]

Daniel Frieb did some investigating into that Hog and confirmed it too, but the limit to what period a new rule can backdate before the effective date, is the file/document published date. What Froome's legal team will probably aim for is to make a point that a rule has changed just a month or so after his AAF in preparation for any ban should he not be able to explain the AAF result against what were the current testing procedures at the time of the infraction perhaps. i.e. reduce the ban.

 

[King Boonen]

I think I'm following this discussion after not reading anything over the holiday and I think people might be misunderstanding what this document means.

It's not a rule change, the level of salbutamol permitted has remained the same. WADA have just acknowledged that the current method to determine concentrations is inadequate and so the decision limit must be adjusted to account for urine specific gravity over a certain value. This doesn't just apply to salbutamol, it applies to everything where there is a DL and SG would affect the concentration calculation.


While it has an effective date I think that any athlete could, very reasonably, argue that it must be used for their samples now and retroactively. I would guess the effective date is just when labs must be implementing it, but any positive test that is currently under review should fall under this new protocol.

Arguably, anyone who has previously failed a test and served a suspension in a case where a DL was used could have their sample retested under this new procedure and have their doping conviction overturned if they were found to be within the adjusted DL.


Sorry if that's been mentioned/discussed before, I'm skim-reading several pages.

 

[thehog]

Yes, it’s a change in rules. Or more specifically, an ‘addition’ to the rules.

 

[gillan1969]

sorry if I've missed it but how do we now that the value CF has will alter the result and get him off? Presumably it would need to be very concentrated i.e. he was dehydrated? Do we have any reason to make that assumption? I thought all we knew was a) its 2000 and b) the concentration was such that the rest was admissible?

 

[thehog]

sorry if I've missed it but how do we now that the value CF has will alter the result and get him off? Presumably it would need to be very concentrated i.e. he was dehydrated? Do we have any reason to make that assumption? I thought all we knew was a) its 2000 and b) the concentration was such that the rest was admissible?

No, since he new rule added by WADA, there is a distinct possibility that Froome could claim the “measurement uncertainty” is within a range <95%, to render the test inconclusive.

 

[yaco]

Think KB has perfectly summed up the last few pages - Though expect a final decision to be awhile away and we may encounter a few twists and turns - Will add if Frrome is cleared then don't expect the reasoned decision to be made available.

 

[gillan1969]

sorry if I've missed it but how do we now that the value CF has will alter the result and get him off? Presumably it would need to be very concentrated i.e. he was dehydrated? Do we have any reason to make that assumption? I thought all we knew was a) its 2000 and b) the concentration was such that the rest was admissible?

No, since he new rule added by WADA, there is a distinct possibility that Froome could claim the “measurement uncertainty” is within a range <95%, to render the test inconclusive.

cheers......but with it being 2000 does that not make that less rather than more likely?

 

[bigcog]

sorry if I've missed it but how do we now that the value CF has will alter the result and get him off? Presumably it would need to be very concentrated i.e. he was dehydrated? Do we have any reason to make that assumption? I thought all we knew was a) its 2000 and b) the concentration was such that the rest was admissible?

No, since he new rule added by WADA, there is a distinct possibility that Froome could claim the “measurement uncertainty” is within a range <95%, to render the test inconclusive.

cheers......but with it being 2000 does that not make that less rather than more likely?

MI has explained it in earlier posts. If his USG is above certain level he will get off in all likelihood. All depends on his samples USG.

 

[King Boonen]

Yes, it’s a change in rules. Or more specifically, an ‘addition’ to the rules.

No, it isn't as far as I can find. What I can find is Article 3.2.1 of the WADA code:

3.2.1 Analytical methods or decision limits approved by Wada after consultation within the relevant scientific community and which have been the subject of peer review are presumed to be scientifically valid. Any athlete or other Person seeking to rebut this presumption of scientific validity shall, as a condition precedent to any such challenge, first notify Wada of the challenge and the basis of the challenge. CaS, on its own initiative, may also inform Wada of any such challenge. At Wada’s request, the CaS panel shall appoint an appropriate scientific expert to assist the panel in its evaluation of the challenge. Within 10 days of Wada’s receipt of such notice, and Wada’s receipt of the CaS file, Wada shall also have the right to intervene as a party, appear amicus curiae or otherwise provide evidence in such proceeding.

WADA have admitted that their previous procedure was not adequate in certain cases. If a USG measurement and a DL correction based on the new procedure sees Froome fall within the new DL, WADA have basically made all the arguments he needs to challenge the AAF under this article.

 

[thehog]

Yes, it’s a change in rules. Or more specifically, an ‘addition’ to the rules.

No, it isn't as far as I can find. What I can find is Article 3.2.1 of the WADA code:

3.2.1 Analytical methods or decision limits approved by Wada after consultation within the relevant scientific community and which have been the subject of peer review are presumed to be scientifically valid. Any athlete or other Person seeking to rebut this presumption of scientific validity shall, as a condition precedent to any such challenge, first notify Wada of the challenge and the basis of the challenge. CaS, on its own initiative, may also inform Wada of any such challenge. At Wada’s request, the CaS panel shall appoint an appropriate scientific expert to assist the panel in its evaluation of the challenge. Within 10 days of Wada’s receipt of such notice, and Wada’s receipt of the CaS file, Wada shall also have the right to intervene as a party, appear amicus curiae or otherwise provide evidence in such proceeding.

WADA have admitted that their previous procedure was not adequate in certain cases. If a USG measurement and a DL correction based on the new procedure sees Froome fall within the new DL, WADA have basically made all the arguments he needs to challenge the AAF under this article.

See attached, it’s an “addition”, semantics withstanding: https://www.wada-ama.org/sites/default/files/resources/files/td2018dl_v1_en.pdf

But fully agree, WADA have made the perfect argument for Froome to receive a significantly reduced ban or none at all. All the stars have aligned at the right time

 

[70kmph]

They also amended the rules so that you can only take a 200ug dose every 2hrs
IOW you can't do the entire 800ug at once to get up to 2000, its small amounts over long periods...

 

[thehog]

Re:

They also amended the rules so that you can only take a 200ug dose every 2hrs
IOW you can't do the entire 800ug at once to get up to 2000, its small amounts over long periods...

Froome was in a small and dark room with the lights turned out. WADA opened the door and said come this way. All Froome needs to do now is walk through the door and close it behind him.

That’s the type of protection that would make Lance Armstrong blush!

 

[Merckx index]

Re:

I would call it a change in rules, extending what previously had applied only to endogenous substances to all specified substances, including exogenous ones. As I said before, look at the 2018 technical document. The key is in the placing of footnote c, such that it now applies to all substances in the table. The footnote was only appended to endogenous substances in the 2017 document.

Another thing I just noticed should be of interest to Sam. The 2018 prohibited list was published on Sept. 29. That is after Froome was notified of the A sample test, but almost certainly before the B sample result was available. The prohibited list does not contain the USG rule change, but if dates become critical, I would think Froome’s team would want to note that his AAF was not officially confirmed until after the 2018 rules were set in motion. I.e., they could argue that the USG change is part of the entire 2018 package, and that package was in force prior to his B sample test. I'm not saying that this argument would necessarily work, but if I were a lawyer and there was some advantage to making it, I certainly would try.

To my list of critical unanswered questions I add: when was Froome notified of his B sample positive?

They also amended the rules so that you can only take a 200ug dose every 2hrs
IOW you can't do the entire 800ug at once to get up to 2000, its small amounts over long periods...

No, that's not correct (if it were, Froome would be in trouble for claiming he took possibly three puffs at the end of the stage). The little chart showing salbutamol taken at various times was only meant to clarify the original rule, which is that no more than 800 ug can be taken in any twelve hour period. Some people might have interpreted that as meaning an athlete could take 800 ug, count that as occurring at the end of a 12 hour period since he took nothing in the preceding 12 hours, then immediately take another 800 ug, counting towards a new 12 hour period. WADA wants to emphasize that no more than 800 ug can be taken in any 12 hours, no matter how those 12 hours are allotted. So, e.g., if you take 800 ug all at once, you can not have taken any more of the substance in the preceding 12 hours, nor any more in the following 12 hours.

 

[70kmph]

From WADA- 2018 starting in March

Inhaled salbutamol: maximum 1600 micrograms over 24 hours;
in divided doses not to exceed 800 micrograms over 12 hours starting from any dose;

Then the little chart showing 200ug doses every 2 hrs...this was changed from 2017

 

[King Boonen]

Yes, it’s a change in rules. Or more specifically, an ‘addition’ to the rules.

No, it isn't as far as I can find. What I can find is Article 3.2.1 of the WADA code:

3.2.1 Analytical methods or decision limits approved by Wada after consultation within the relevant scientific community and which have been the subject of peer review are presumed to be scientifically valid. Any athlete or other Person seeking to rebut this presumption of scientific validity shall, as a condition precedent to any such challenge, first notify Wada of the challenge and the basis of the challenge. CaS, on its own initiative, may also inform Wada of any such challenge. At Wada’s request, the CaS panel shall appoint an appropriate scientific expert to assist the panel in its evaluation of the challenge. Within 10 days of Wada’s receipt of such notice, and Wada’s receipt of the CaS file, Wada shall also have the right to intervene as a party, appear amicus curiae or otherwise provide evidence in such proceeding.

WADA have admitted that their previous procedure was not adequate in certain cases. If a USG measurement and a DL correction based on the new procedure sees Froome fall within the new DL, WADA have basically made all the arguments he needs to challenge the AAF under this article.

See attached, it’s an “addition”, semantics withstanding: https://www.wada-ama.org/sites/default/files/resources/files/td2018dl_v1_en.pdf

But fully agree, WADA have made the perfect argument for Froome to receive a significantly reduced ban or none at all. All the stars have aligned at the right time

It’s a technical document that tells accredited labs this is how they now have to determine DLs for samples with high SG. I suppose you could claim it is a rule change for the labs but it changes nothing in the prohibited list and I don’t believe the code has any specifics on testing. So in reality, in terms of anything that people here would discuss in terms of rules, it isn’t a change. The amount allowed stays the same, this is just telling labs that the previous method of determining concentration was wrong for samples with higher SGs.

The timing seems strange but if the science is solid (I don’t have the references for what was reviewed) then this should be put in place.

 

[Merckx index]

From WADA- 2018 starting in March

Inhaled salbutamol: maximum 1600 micrograms over 24 hours;
in divided doses not to exceed 800 micrograms over 12 hours starting from any dose;

Then the little chart showing 200ug doses every 2 hrs...this was changed from 2017

There is nothing in that statement that says an athlete is limited to 200 ug every 2 hr, and again, if that were the case, asthmatics, who would not be allowed more than two puffs at a time, would be in an uproar. What is allowed is set out by the statement "may not exceed 800 ug in any 12 hr period". It doesn't say that parameters were revised to make it clear that one can't take more than 200 ug every two hours; two hours is not even indicated in the figure.

The reason that the term “divided doses” is used is because that’s normally the way asthmatics take the substance; they don’t get maximum benefit from taking the full 800 ug all at once. The figure illustrates an example that would be familiar to most asthmatics. But "divided doses" could just as well mean 700 ug one time and 100 ug another time, ten minutes apart. Or it could mean four 200 ug doses, taken five minutes apart. WADA no doubt hopes athletes don't take it that way. The figure might be interpreted as WADA's tacitly saying, this is the way you should be taking salbutamol. But the figure doesn't specify any time period between doses, and it shouldn't, because WADA isn't in the business of telling asthmatics how much they need and when, up to reasonable limits beyond which, as others have pointed out, someone shouldn't be racing.

The timing seems strange but if the science is solid (I don’t have the references for what was reviewed) then this should be put in place.

I think it's a reasonable change. As I noted before, Fitch has been advocating this for years. I believe the main reason there was resistance is because it could be argued that the threshold, or DL, was already so high that an athlete inhaling within the allowed limits shouldn't need any more benefit. Even with a high USG, one shouldn't have a level of 2000 ng/ml. Probably the fairest system would be to lower threshold and DL, while allowing the USG correction. But that's not going to happen.

As always, the fewer the false positives, the more false negatives.

 

[70kmph]

WADA changed the terminology

2017
• Inhaled salbutamol: maximum 1600 micrograms over
24 hours, not to exceed 800 micrograms every 12 hours;

2018
Inhaled salbutamol: maximum 1600 micrograms over 24 hours;
in divided doses not to exceed 800 micrograms over 12 hours starting from any dose;

See the 200 ug doses at the bottom

 

[topcat]

Re:

are uci/wada going to financially compensate Petachi and Ulissi or are team Sky/team GB going to pay them directly?



The timing seems strange but if the science is solid (I don’t have the references for what was reviewed) then this should be put in place.[/quote]

I think it's a reasonable change. As I noted before, Fitch has been advocating this for years. I believe the main reason there was resistance is because it could be argued that the threshold, or DL, was already so high that an athlete inhaling within the allowed limits shouldn't need any more benefit. Even with a high USG, one shouldn't have a level of 2000 ng/ml. Probably the fairest system would be to lower threshold and DL, while allowing the USG correction. But that's not going to happen.

As always, the fewer the false positives, the more false negatives.[/quote]

 

[hazaran]

Re:

WADA changed the terminology

2017
• Inhaled salbutamol: maximum 1600 micrograms over
24 hours, not to exceed 800 micrograms every 12 hours;

2018
Inhaled salbutamol: maximum 1600 micrograms over 24 hours;
in divided doses not to exceed 800 micrograms over 12 hours starting from any dose;

See the 200 ug doses at the bottom

That is only an example that they clarified because someone could wrongly assume from it that you might take 800 mg at 11:59 and another 800 mg at 12:01.

 

[DirtyWorks]

[quote="Well you could hardly say that WADA is doing a good job

Once again, The only thing WADA does is write standards. So.... They are doing a great job.

 

[King Boonen]

Re:

The timing seems strange but if the science is solid (I don’t have the references for what was reviewed) then this should be put in place.

I think it's a reasonable change. As I noted before, Fitch has been advocating this for years. I believe the main reason there was resistance is because it could be argued that the threshold, or DL, was already so high that an athlete inhaling within the allowed limits shouldn't need any more benefit. Even with a high USG, one shouldn't have a level of 2000 ng/ml. Probably the fairest system would be to lower threshold and DL, while allowing the USG correction. But that's not going to happen.

As always, the fewer the false positives, the more false negatives.

I think so too, it certainly makes sense from an analytical standpoint and we do something very similar with the stuff we work on when required. I've not seen the calculations (I know you've done some in threads here but I haven't been able to follow everything, too fast paced) so I can't comment on the current threshold and DL, I'll take your word on that and yes, I can't see it happening.

To the bold, this isn't necessarily the case. I'm assuming they've either reviewed relevant data or done a meta analysis and plotted ROC curves etc. It's possible that this change will only affect sensitivity and specificity will remain the same, so at least in terms of the analytical part it may not result in more false negatives.

 

[Merckx index]

I finally found some information on B sample testing. This is from WADA’s International Standards for Laboratories website. I found this to be a really useful document, it provides a lot of information on how tests are conducted (in general, not for specific substances), as well as the time periods involved between various steps:

https://www.wada-ama.org/sites/default/files/resources/files/isl_june_2016.pdf

5.2.4.3.2.1 The “B” Sample analysis should occur as soon as possible and should take place no later than seven working days starting the first working day following notification of an “A” Sample Adverse Analytical Finding by the Laboratory, unless the Laboratory is informed that the Athlete has waived his/her right to the “B” confirmation analysis and therefore accepts the findings of the “A” confirmation analysis.

So if Froome was notified of the A sample positive on Wed., Sept. 20, the B sample analysis should have taken place by Sept. 29. Since he was notified of his A sample result 13 days after he gave the sample, one would think he would be notified of the B sample result by Oct. 12. (I’m assuming that B sample testing is expedited, that it takes no longer than A sample testing, since it would be important at that point to have the process completed. See below, also, that A notification is supposed to occur within ten days). The result at that point might or might not include the enantiomers test, I’m still not clear whether that test is routinely carried out on samples that exceed the DL. But my original estimate that Froome would have known that the B confirmed the A by the middle of October seems correct. By that time, he should have started assembling his legal/scientific team.

But then there is this:

5.2.4.3.2.4 For exogenous Threshold Substances, the “B” Sample results shall only confirm the “A” Sample identification for the Adverse Analytical Finding to be valid. No quantification of such Prohibited Substance shall be performed.

When I first read this, it didn’t make sense to me. How can you confirm the A sample AAF without quantifying the substance in the B sample? However, after reading the next article, which describes the procedure for endogenous substances, the point became clearer. For the A sample analysis, three aliquots of the urine are tested, and the mean of the three results is used. Apparently for the B sample in the case of exogenous substances, it’s not necessary to analyze three separate aliquots, but only one. That will give a less precise result, but one apparently considered good enough to confirm or not the A sample result.

So as I understand it, the 2000 ng/ml level was only the A sample reading. The B sample level, in theory, could have been much lower, as long as it, too, exceeded the DL. E.g., it could have been 1300 ng/ml. Not likely, but possible. However, that wouldn't initially help Froome, because that value would not be recorded. All that would be recorded is that B sample value exceeded the DL. The 2000 ng/ml level is still what Froome has to deal with.

However, since Froome or at least some scientific advisor would have been present at the B sample test, and would have noted the result, if the level was in fact much lower, they could use it in a challenge. While I doubt very much the value would be much different from 2000 ng/ml., anything lower would be helpful as they try to explain how his value could result from inhaling within the allowed amount.

Some more relevant stuff:

5.2.6.5 Reporting of “A” Sample results should occur within ten working days of receipt of the Sample. The reporting time required for specific Competitions may be substantially less than ten days.

Froome’s sample was given on Sept. 7. Sept. 20 would have been nine working days later. And I assume the B sample notification would be just as prompt.

5.2.6.11 The Laboratory, upon request by the Testing Authority, Results Management Authority, or WADA may be asked to review data from longitudinal studies…as to whether the data supports an Adverse Analytical Finding or not.

IOW, they may have looked at Froome’s previous Vuelta samples, to see how his levels after other stages compared to this one. I think the general idea is that if the athlete has been well below the threshold on all other tests, than exceeding the threshold, particularly by a large margin, looks particularly suspicious, and is not likely to be the result of unusual metabolism.

Edit: However, UKAD Anti-doping rules, which I assume are what should govern Froome’s case, are a little different, and written in a manner that creates a lot of ambiguity. (I can’t copy and paste passages in the PDF, so will just summarize them here). A Notice of Charge is sent to the athlete (Article 7.7), apparently after the A sample tests positive, which stipulates that the athlete and UKAD must come to an agreement about the B sample testing within ten days. It’s not clear to me whether the B sample must be tested within ten days, or if the two sides only have to agree on the when and where of the test within this period. The way it’s written, it seems the latter, but this would then seem to be potentially in conflict with WADA rules, but it says on the website that WADA approved of these rules. Moreover, upon receipt of the notice of charge, the athlete can request the A and B documentation, though the B sample hasn’t yet been tested. The athlete also has ten days to request a hearing, though, again, the B sample hasn’t been tested. The way the rules read, it would seem to make more sense that the Notice of Charge is sent only after the B sample tests positive, but apparently that isn’t the case.

In any case, though, these rules do seem to make clear that Froome would have had to request a hearing by the end of September. So a date should have been set by around then, and it makes no sense at all to me that three months later there has been no hearing, nor even any sign that one is going to be held soon.

Also, according to the UKAD rules, a provisional suspension is generally imposed even if the AAF is for a specified substance like salbutamol (Article 7.9.2). UKAD can “disapply” this rule, but it doesn’t state why it would, under what specific circumstances. As written, the rules seem to imply it’s purely up to the whim of UKAD whether or not to suspend someone for salbutamol. I’ll just add that in all cases where an athlete is suspended, he can have the suspension lifted if he can demonstrate one of several circumstances, including 1) the charge not likely to be upheld; 2) the athlete has a strong case for no fault or negligence; 3) the substance resulted from contamination of some product; or 4) some other factor. None of these would seem to apply to Froome.

https://www.ukad.org.uk/resources/document/uk-anti-doping-rules

 

[sittingbison]

Great work MI, thanks

It keeps getting back to this: if Dawg could have explained away his AAF, he would have by now

It's clear he is at 2000 for the test on stage 18, longitudinally he has never (publicly) tripped the wire before in approximately 100 tests including stage 17 and 19, his urine specific gravity is normal (as far as possible given he is alien) which is in accordance with the 20C day and shorter 4 hour stage so he cannot get the 2000 reduced below 1000. He and SDB have publicly stated he took the proscribed dose, but it is impossible to get to 1000 (let alone 2000) as this arbitrary figure is set to preclude accidents, and the only possible explanation is NOT using an inhaler however all other methods are banned.

It is also clear this was never meant to go public, only doing so after Cookson lost control. UCI no longer controls the narrative. WADA will not accept a brush under the carpet. Neither the Giro nor Tour will accept another Contador "riding under a cloud" fiasco. And, despite the attempts of sycophants to suggest otherwise, cycling fans lining the routes will not accept it either.

Dawg is frakked.