Monday, January 28, 2008

Larry's Curb Your Anticipation, Part 1:
Some General Questions

Up to the Introduction; On to part 2.

By Commenter Larry

Preliminary Questions

Why Are the WADA Rules Binding on International Cycling?

Let’s begin our discussion of anti-doping law at the most basic level. All professional cyclists are licensed by a national federation, such as USA Cycling in the U.S. The terms of a national cycling license require that the cyclist follow the anti-doping rules of the national federation, the Union Cycliste Internationale (UCI) and the World Anti-Doping Agency (WADA).

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For example, the terms of the International License available through USA Cycling include the following:

I shall submit to disciplinary measures taken against me and shall take any appeals and litigation before the authorities provided for in the regulations. I accept the Court of Arbitration for Sport (CAS) as the only competent jurisdiction of appeal in the cases provided for by the Regulations and in compliance with the terms thereof. ... I agree to submit to drug testing and to comply with and to be bound by the UCI anti-doping regulations, the World Anti-Doping Code and its International Standards to which the UCI anti-doping regulations refer as well as the anti-doping regulations of other competent instances as foreseen by the UCI Regulations, the World Anti-Doping Code, or the U.S. Anti-Doping Agency (USADA), provided such regulations comply with the World Anti-Doping Code. …. I accept these conditions regarding blood testing and agree to undergo all tests required of me.


See http://www.usacycling.org/forms/intl_license.pdf.

The primary authority in international cycling is the UCI. WADA’s authority in cycling derives from UCI’s adoption of the World Anti-Doping Code (the WADA Rules). The WADA Rules are incorporated in the UCI Cycling Regulations (UCI Rules). See UCI Rule Part 14, Introduction, at http://www.uci.ch/imgArchive/Rules/14ant-E.pdf.

Whenever possible, I will cite to both the WADA Rules and the UCI Rules in the following discussion.

A Brief Description of the WADA Rules and the UCI Rules

In an anti-doping case, the anti-doping organization (ADA) has the initial burden of establishing that an anti-doping rule violation has occurred. UCI Rules Article 16, WADA Rules Article 3.1. However, once the Anti-Doping Organization introduces evidence of an anti-doping violation from a WADA-accredited laboratory, the results are presumed correct. UCI Rules Article 18, WADA Rules Article 2.4.3. The athlete is then entitled to rebut this presumption by establishing that the lab departed from the ISL. UCI Rules Article 18, WADA Code Article 3.2.1. If the athlete is able to prove an ISL departure, then the ADA must prove that the departure did not cause the adverse analytical finding (AAF) against the athlete. Id.

The process described above sets up what we’ve called the “burden shift” or “burden flip”. The athlete has the initial burden to show an ISL departure, at which point the burden “flips” to the prosecuting ADA to show that the ISL departure did not cause the AAF. In this article, we’ll focus almost exclusively on the first part of the “flip”: we’ll be looking at what it takes to prove an ISL departure. But keep in mind that this discussion is only half of the story: the ADA may be able to meet its burden of proof even if the burden is “flipped”. Remember that in the FL case, the FL legal team was able to prove a number of departures from the ISL, but USADA was able to prove (to the satisfaction of two of the three arbitrators on the panel) that these departures did not cause the AAF against FL.

Let’s look closer at the standard of proof required to establish an AAF. Under the UCI and WADA Rules, the ADA must prove the AAF “to the comfortable satisfaction of the hearing body bearing in mind the seriousness of the allegation which is made.” According to the UCI Rules and the WADA rules, this standard of proof is greater than the mere balance of probability required to win a case in a U.S. civil court proceeding, but is less than the proof beyond a reasonable doubt required for a U.S. criminal conviction. See UCI Rules Article 16, WADA Rules Article 3.1. In the case of USADA v. Montgomery, http://www.usantidoping.org/files/active/arbitration_rulings/CAS%20Decision_Tim%20Montgomery_Dec%202005[1].pdf, the Court of Arbitration for Sport (CAS) defined "comfortable satisfaction" to impose an “extremely high” level of proof on the prosecuting ADA. In the Montgomery case, the CAS ruled that there was “little, if indeed any, difference” between the standard of proof imposed on the ADA and proof beyond a reasonable doubt. The FL legal team concluded that USADA’s burden of proof in the FL case was “very close to ‘proof beyond a reasonable doubt’", see http://ia351413.us.archive.org/1/items/Floyd_Landis_Case_Documents_14/RespondentsProposedFindingsofFact.pdf paragraph 2.4.7, and I think that this conclusion is correct.

Is An SOP Violation the Equivalent of an ISL Departure?

In our discussions on TBV, we’ve discussed instances where the lab in the FL case may have violated its own standard operating procedures (SOP) in conducting its testing. For example, we’ve discussed at length whether the lab’s machinery was set up in accordance with the lab’s SOP. See the discussion at http://trustbut.blogspot.com/2007/12/different-columns-detailed.html. If a lab violates its own SOP, is this treated under the WADA rules like an ISL departure, where the lab must prove that its SOP violation did not cause the AAF?

This issue came up in the FL case. The lab in the FL case, the LNDD, had a SOP requiring it to do a monthly check of the linearity of its Isotope Ratio Mass Spectrometer (IRMS). USADA admitted that LNDD did not make these monthly checks. The arbitrators ruled as a result that “the Lab failed to adhere to the ISL in failing to check the linearity of the IRMS instrument on a monthly basis as provided for in its ISO 17025 accreditation.” See FL decision paragraph 218 (emphasis added). Later in the decision, focusing on this same point, the arbitrators stated that “[t]he SOPs are part of the ISO 17025 accreditation”.

It’s clear from the FL decision that at least some SOP violations will be treated as ISL departures under the WADA Rules. The key appears to be whether the SOP is a part of the lab procedures that are reviewed in the ISO 17025 accreditation process. While this question is not clearly answered in the FL decision, I would argue that any violation of an SOP that can clearly be connected to a requirement under the ISL or ISO 17025 should be treated as an ISL departure. For example, the LNDD’s failure to do its monthly linearity check of its IRMS machine arguably violated ISO 17025 Rule 5.4.5.3, which requires the lab to assess linearity as part of its method validation, and ISO 17025 Rule 5.5, which governs proper maintenance of lab equipment.

Can The Athlete Challenge the Scientific Basis of an AAF?

We’ve stated on TBV that the WADA Rules prohibit an athlete from challenging the science used by a WADA lab to prove an AAF. As it turns out, this statement is not 100% correct. As we’ll see, many anti-doping cases are based on the athlete’s argument that the AAF is based on bad science.

The actual rule in this area is as follows:

  • The UCI and WADA rules establish a presumption that a WADA lab has carried out its anti-doping tests in accordance with acceptable current scientific standards. See USADA v. Bergman, http://www.usantidoping.org/files/active/arbitration_rulings/CAS%20Decision%20-%20Bergman.pdf, p. 12.

  • This presumption of validity extends into three potential areas of challenge: the scientific basis for the test, the analytical result (for example, the chromatograms on which the FL AAF was based), and the interpretation of the analytical result. Id.

  • The athlete can overcome this presumption of validity by presenting proof that the test as designed, performed or interpreted is not scientifically valid.

There are a number of anti-doping cases where the athlete has attempted to challenge the scientific basis of the AAF. For example, in USADA v. Hamilton, http://www.usantidoping.org/files/active/arbitration_rulings/AAA_CAS%20Decision%20-%20Hamilton[1].pdf, Tyler Hamilton challenged the scientific basis of his blood doping AAF, arguing that the blood doping test used to convict him was insufficiently validated, should have been based on a quantitative rather than a visual standard, and proved only that he had a “mixed red cell population” (which could be explained by circumstances other than blood doping). See Hamilton Decision p. 4. The arbitration panel in the Hamilton case rejected Hamilton’s arguments on scientific grounds, but there is no suggestion that Hamilton was precluded by the WADA Rules from raising scientific objections to the anti-doping tests.

Similarly, in the USADA v. Bergman case cited above, Bergman unsuccessfully challenged the scientific basis of the WADA lab’s interpretation of the rEPO testing used to prove Bergman’s AAF. As with the Hamilton case, the CAS rejected Bergman’s arguments on scientific grounds, and noted the presumption under the WADA and UCI rules in favor of the lab’s interpretation of Bergman’s rEPO tests. However, there is no suggestion in the Bergman case that the WADA or UCI rules barred Bergman from challenging the science behind the rEPO testing.

From the above, we learn that the WADA and UCI rules set up a presumption that all AAFs have a valid basis in science. The athlete can challenge this presumption – there is nothing in the rules preventing the athlete from challenging any aspect of the science behind an AAF. However, to my knowledge, no such challenge has succeeded to date.



Up to the Introduction; On to part 2.

7 comments:

Larry said...

Just a quick note from the author that there's been a slight glitch, and this post is coming in out of order (I think). Please give us a moment to straighten this out.

tbv@trustbut.com said...

Now fixed. This is the intended Part 1, and what was here is in part 2.

TBV

dailbob said...

Larry,

Is An SOP Violation the Equivalent of an ISL Departure?

In my world, this question would be asked: Is An SOP Violation the Equivalent of a cGMP Departure?

The answer, from the FDA's perspective, is an unequivocally yes. That's why is blows me away that this isn't always the case within the doping arena, and that the athlete isn't even entitled to this in discovery (related to my question in the other thread).

Larry said...

I'm working on the answer to your question in the other thread.

Consider for the moment that the lab's SOP might require it to be open at 8 a.m. If the lab doesn't open on a particular Tuesday until 8:15 a.m., how would that be an ISL departure? Even if that's the Tuesday that the lab runs the tests on FL's S17 sample.

There would have to be a connection between the SOP in question and the ISL for the SOP violation to be fairly treated as an ISL departure. I don't know anything about the cGMP, but I'm reasonably sure the cGMP would work the same way.

Good question though!

John said...

Larry, forgive my ignorance here if I've missed something key - to second dialbob's question about SOP / ISO departure(s) - I also understand that you want to pick up with this on another thread, so if you just lead me to where this picks up that will be fine.

My question is this - Is the term SOP an acutal legal term, as used in the context of accredidation? There are something like 2,000 + SOP's at my work place, and I'd guess that maybe 500 are followed to the letter each day. Having said that, there is no requirement for the company to either have SOPs, or to follow them in order for us to remain a legally operating company.

The reason that many SOPs are not followed to the letter (generally) is easily explainable by many factors - 1) only 1 person knows how to use a particular piece of software, and so for one day of the week, a certain check isn't done, 2) other processes remove the need to follow any said SOP, since that function covers it, 3) The SOP has become outdated so quickly, that there hasn't been enough time to update the SOP because everyone is still learning a new functionality, and SOME SOP should be in place until it changes... etc

My point (and question) goes back to those SOPs - a deviation or violation from an SOP does not in itself mean that work was not completed, or completed incorrectly. However, as it applies to an ISL departure, how MANY SOP violations would have to occur before ISL would say 'this lab is no longer fit to be accredited'?

It seems that Suh was taking on an awful lot, because, in essence, he was trying to 1) point out the violations, deviations from the SOPs, and 2) Show that this amount of deviation was enough to make the evidence inadmissable (and imply that the lab is not fit to be accredited.)

IS there a magic number of SOP violations, or are asking the wrong question? Since an SOP violation doesn't seem to prove that something was done incorrectly, what is necessary to prove actual mishandling occured?

Sorry this question is so long, but an answer would be great. Thanks for the reading, I'll try to get through it tonight if possible.

Larry said...

John (who formerly hailed from 3 cities?) -

I'm completely unqualified to talk about lab accreditation. That's outside the scope of my research and my article. You're raising an interesting area of inquiry when you discuss lab accreditation, but it's not one I can discuss.

You mentioned that Suh was trying to argue or imply that the LNDD was not fit to be accredited. I don't think that's what he was trying to do. The criteria for lab accreditation is not the same as the criteria involved in determining whether a lab has departed from the ISL in performing its testing of an athlete's sample. There may be a relationship between these two sets of criteria, but they're not necessarily the same. For example, a lab can lose its accreditation if it fails to perform a specified minimum number of doping tests each year, but that's not grounds for overturning an AAF.

(OK, I guess that if it turned out that the LNDD was not accredited in 2006, then perhaps the case against FL would have been dismissed. I didn't research this.)

Regarding SOP ... I'm not sure what does and does not qualify as an "actual legal term" (being in latin seems to help), but whatever an "actual legal term" might be, "SOP" is probably not one of those.

You're quite right, I suspect that there are an awful lot of SOPs out there in the real world, sitting on shelves, gathering dust. I won't comment on whether a company has to have SOPs -- that's going to depend on the nature of the company, how it is regulated, what it has agreed to do by contract, etc., etc. There's also the question of, once you have an SOP, then are you required to follow it? If you have an SOP for how to treat employees in the workplace, and you don't follow it, and you get sued by an employee, and the employee introduces the SOP in the litigation ... well, you can imagine what could happen then. But again, that kind of discussion is well outside of the scope of what I've written here.

In the context of the FL case, the SOPs we're concerned about are the ones tied into the ISL. For example, the ISL requires a lab to develop an SOP to cover chain of custody, and sets forth certain standards to cover what has to be contained in the SOP. If the lab violates its chain of custody SOP, I'd argue that this would be an ISL departure. (Sadly, the FL team was unable to see the LNDD's SOP governing chain of custody.)

There's no magic number of SOP violations that require dismissal of an AAF. One will do ... so long as you can show that the violation is an ISL departure and so long as the ADA cannot prove that the ISL departure did not cause the AAF.

I think I'm not exactly answering the question you meant to ask, so maybe you could follow up with whatever I failed to address. Thanks for the question, and for reading the opus.

John said...

larry, oui, it's me mr bostonlondontoyko, my name is changing due to starting a blog (which may never see the light of day... hmm). Acutally, you've answered my question completely - It would see the SOPs would really entail a very scrutinizing view of what is entalied in accreditdation. And yes, if the SOPs are directly tied to accreditation, than a departure from one SOP would be grounds to raise the issue. Still reading through your work, with much enthusiasm!