“Anti-doping agencies… are sometimes better placed to interpret significance of modest changes in blood values” — Michael Ashenden

When news broke last month that the U.S. Anti-Doping Agency was filing formal doping violation charges against Lance Armstrong, Johan Bruyneel, Michele Ferrari and three team staff members, one of the most damning sentences in the official 15-page charging letter was that USADA claimed it had collected blood from Armstrong in 2009 and 2010 that was “fully consistent with blood manipulation including EPO use and/or blood transfusions.”

It was troubling both for its recent time period, and for the fact that Armstrong’s blood had been monitored, during the same time period, by the UCI’s Biological Passport program — the same program that saw Italians Franco Pellizotti and Pietro Caucchioli suspended for doping for biomarker abnormalities, without ever delivering a direct positive drug test.

To find out how USADA could have found evidence of blood manipulation that the UCI either did not find, or chose not to pursue, we asked blood-doping expert Michael Ashenden.

Up until spring of this year, Ashenden, an Australian exercise physiologist specializing in blood doping, had been on the UCI’s Biological Passport panel since its inception in 2008. He resigned from his position after a clause was added to his contract dictating an eight-year confidentiality agreement, telling the BBC, “”Anti-doping exists to protect clean athletes, not the reputation of the anti-doping movement. When push comes to shove, my actions will always be in the interests of clean athletes, even if that means I ruffle feathers by highlighting some inconvenient truths. And just because I serve on their panel, it doesn’t give them the right to silence me.”

Formerly with the Australian Institute of Sport, Ashenden was involved in the development of the blood test for EPO, first used at the 2000 Sydney Olympics, and he later led the team that developed the test that uncovered blood doping by Tyler Hamilton at the Vuelta a España in 2004.

In April of 2009 Ashenden told NYVelocity.com that, based on his interpretation of Armstrong’s urine sample data collected during the 1999 Tour de France and later exposed by French newspaper L’Equipe, he had “no doubt” that Armstrong had taken EPO during the 1999 Tour.

“There is no doubt in my mind these samples contain synthetic EPO, they belong to Lance Armstrong, and there’s no conceivable way that I can see that a lab could’ve spiked them in a way that the data has presented itself,” Ashenden said in 2009. “So there is no doubt in my mind he took EPO during the ’99 Tour.”

In April 2012 Ashenden resigned from the newly created Athlete Passport Management Unit (APMU), based at the Swiss Laboratory for Doping Analyses (LAD) in Lausanne, which had recently taken over management of the Biological Passport.

Ashenden told the BBC that his new contract required him to get permission before offering personal opinions on any matter related to his role interpreting blood profiles, claiming the APMU is “trying to manage the message”.

Ashenden now serves as the director of an international research consortium known as Science and Industry Against Blood doping.

Last month Ashenden told Cyclingews.com that he felt USADA’s claim that the UCI had covered up a positive EPO test of Armstrong’s from the 2001 Tour of Switzerland could damage the UCI’s credibility.

“Whether the EPO gel in question was positive, suspicious or negative is secondary to the fact that according to multiple witnesses, Armstrong thought he had had one of his results covered up,” he said. “He can’t cover it up himself so he must have believed that he’d influenced someone to cover up his result. That points to the UCI, and infers that Armstrong believed at the time that he had the capacity to influence their actions.”

Our line of questioning for Ashenden was centered not on Armstrong’s 2001 EPO test, but rather USADA’s claim that it had evidence that Armstrong had blood doped in 2009-2010, yet the UCI Biological Passport had not caught it.

Ashenden agreed to answer, with a few conditions: All on-the-record comments would be made via email, primarily for accuracy; he be given the opportunity to “put the whole landscape down so that readers can discern for themselves rather than rely on someone’s opinion”; and that he be granted the right to review it before it was posted, to “ensure that the core message has gotten through the editorial process.”

We agreed.

Of most significance, Ashenden told us that an agency’s “tenacity to confront dopers, as well as how risk averse they are to the prospect of lengthy legal proceedings, will influence the outcome,” and that “anti-doping agencies, which in contrast to the experts are always in possession of competition schedules, are… sometimes better placed to interpret the significance of modest changes in blood values.”

Ashenden’s reply follows on the next page.

Michael Ashenden: First of all, I want to make it clear that I have not seen Armstrong’s blood values from 2009-2010 to which you refer. I did see the one year’s worth of results that he published online, but those values stopped halfway through 2009. It would seem from the charge letter that USADA have additional data collected through 2010, which to use their words is “fully consistent with blood manipulation”, in particular the use of EPO or blood transfusions.

Because I haven’t seen those results, I must talk in generalities. Therefore I’ll approach your question not in terms of the Armstrong case but instead generically to give your readers an insight into how the Biological Passport process works.

I also want to make clear that I’m going to sacrifice some accuracy in order to make the process more easily understood. So I’ll say ahead of time that any defense lawyers reading this article should not work themselves into a lather if my explanations are somewhat looser than I would use in front of an arbitration panel.

I guess the first point to make is that athletes get tested multiple times per year. Of course there is natural biological variation over that time, which means that the results bounce up and down a little bit rather than being the same value day in, day out. The size of those variations is compared against the natural biological fluctuations that we expect to see, and only if the variations are unusually large is the profile flagged as being suspicious.

Those suspicious profiles are sent for a preliminary review by one of the experts on the sport’s Passport panel.

In my experience, the most common outcome from that preliminary review is for the expert to advise the sport that there is nothing to be concerned about. Although that might sound strange at first, in fact it’s a consequence of the preliminary statistical threshold having been set quite low. The threshold is deliberately set low with the intention that its low level will flag all of the athletes who had deviations caused by doping. However a consequence of that low level is that it will also likely flag some athletes who did not dope but whose results bumped up or down just a bit more than usual.

So in that sense, the expert serves as a safety filter to sift out the really suspicious results and to disregard the rest. Sophisticated dopers seek to game the system by masking their doping practices to a sufficient extent that they fail to raise the suspicion of the expert, who must wade through 10 or 20 profiles at a time that each might contain 30 or more separate blood results.

It is human nature that attention will tend to focus upon those profiles with the most dramatic changes, and so it is conceivable that the prioritization process could lead to profiles partway between normal and highly abnormal not being immediately acted upon.

But the suspicious profiles that are flagged get automatically shared with a wider group of experts, for second and third opinions.

So for example, one hypothetical might be a situation where two experts were convinced that the athlete had doped and that there was sufficient evidence to run a case, while the third expert agreed that the athlete had doped but was more cautious and requested that the sport carry out some more tests in order to strengthen the evidence. All three are looking at the same data set, but their opinions as to whether the case should move forward to an anti-doping rule violation varies.

A neat analogy is when law enforcement investigators are gathering evidence against a suspect. There is no rulebook that stipulates exactly how much evidence is needed before charging the suspect. Similarly for the Biological Passport, there is no rulebook that defines how abnormal the data set must be before the expert recommends that the sport pursue an anti-doping rule violation. So it’s up to the experts to satisfy themselves. Unless all three experts agree that not only had the athlete doped but also that the evidence was sufficient to sustain a sanction, they would not recommend that the athlete be charged with an anti-doping rule violation.

In fact, in that hypothetical circumstance, where one expert requested additional data, the athlete would be completely unaware that their profile had even been flagged as suspicious, even though the data themselves were consistent with the athlete having doped.

I think it is worthwhile here to pause briefly and clarify what I mean when I talk about the level of evidence. It should not be confused with statistical thresholds, which are used to define whether or not a sample has deviated by an abnormal amount from the athlete’s expected values. Those are purely statistical concepts, based on objective mathematics. Instead, what I am talking about is a subjective evaluation by the expert as to whether the data, without the benefit of any additional corroborating evidence, could conceivably support an anti-doping rule violation. Of course, if corroborating evidence were available to support the blood results, then that perceived burden would be reduced significantly.

So speaking for myself, it’s not just about whether I believe an athlete doped based on what I saw in the blood results. In my experience, the additional hurdle that a set of evidence needed to pass was not only whether I was convinced that the athlete had doped, but also whether I felt that the data were sufficiently straightforward that three independent arbitrators would also recognize the importance of the anomalies and draw the same conclusion as I had. That is a pretty significant hurdle.

Arbitrators are legal experts and fact finders, but not experts in how blood behaves when an athlete dopes. So what is patently obvious to a blood doping expert as being consistent with manipulation may be lost upon the arbitrator. No one can know ahead of time whether the arbitrators will grasp the arguments and explanations made by the expert. Therefore, running a Passport case is a risk that the anti-doping agency must take on, and it’s an unfortunate reality that the bigger and more successful the athlete, the more money and legal firepower they tend to throw against doping charges. Therefore the agency’s tenacity to confront dopers, as well as how risk averse they are to the prospect of lengthy legal proceedings, will also influence the outcome.

Subsequently, I always felt obliged to carefully consider whether the data, which is the body of evidence I am talking about here, was sufficiently straightforward, as well as of a sufficient level, to have a strong chance of withstanding that legal onslaught. It wasn’t about whether the athlete doped, but whether I thought the case could be won. In simple terms, it’s about trying to avoid putting a sport federation into a position where they lose a case by seeking to advise them how compelling the data associated with the athlete seems to be. Certainly when I was a member of the UCI’s expert panel those were the type of discussions that took place during the final deliberations before opening a case. I think that is as clear an insight as I can give as to why a profile consistent with doping might not necessarily lead to a case being opened.

A final point I would make is that a spreadsheet of data can take on a different complexion once the expert is advised of the athlete’s competition schedule.

For example, one case I worked on shifted from being a confusing mishmash of somewhat contradictory results, into what I felt was a compelling case of blood doping, only after I had seen the athlete’s competition schedule and was able to discern how modest deviations coincided with important race events.

Experts don’t get competition schedules in the first preliminary review, and as I said before, if a profile escapes attention during that initial phase it essentially falls through a crack in the process. Anti-doping agencies, which in contrast to the experts are always in possession of competition schedules, are thus sometimes better placed to interpret the significance of modest changes in blood values.

In my experience, this is particularly important as the sophistication of blood doping strategies increases, because those strategies are designed to reduce the size of variations. In other words, a profile that an expert might pass off during a preliminary review as merely being a somewhat dubious profile without the additional insight derived from competition schedules, might later crystallize into a compelling profile consistent with doping once the athlete’s race schedule had been assimilated with those blood data.