WADA defends salbutamol rules in wake of Froome acquittal

Agency provides new information on defense timeline

The World Anti-Doping Agency defended its rules against accusations from Team Sky and former Tour de France winner and Sky rider Bradley Wiggins that the regulations on salbutamol are "not fit for purpose," which arose after Chris Froome was acquitted of an anti-doping rule violation despite exceeding the allowed limit by 20 per cent.

Wiggins made the comments in a podcast this week, but they echoed statements made from Froome that suggested WADA was keeping the scientific studies that helped to end his case from the public and that WADA's standards needed to be reviewed to prevent future "false positives".

"I would welcome the publication by WADA of the scientific studies they relied on both to create the current testing regime and to exonerate me," Froome said last week.

A WADA spokesperson told Cyclingnews via e-mail that there are some unpublished and ongoing studies on salbutamol and other beta-2 agonists, but they were taken into consideration in Froome's case.

"WADA is waiting for these studies to be fully completed before they are released and published. Such studies indicate that when using high inhaled doses of salbutamol, a few subjects can occasionally exceed the decision limit for salbutamol.

"This is not new information and was already included in the management process of salbutamol. The rules afford athletes exceeding the decision limit the opportunity to prove they did so while [not] taking a prohibited dose of the substance and so exonerate them from an anti-doping rule violation."

In its press release, WADA listed 11 different scientific publications from 2008 to 2012 that are in the public domain that were used to formulate its current rules, and defended the standards as being "at the correct level".

"WADA considers that the current salbutamol threshold is at a correct level considering the scientific literature published on the substance over the past 20 years," the press release read.

"Unlike most substances, given the variables that exist with salbutamol depending on conditions specific to each case, the rule is designed to afford athletes found to have exceeded the threshold with the opportunity to prove how it has occurred and justify proper therapeutic use."

Froome did just that, according to WADA, arguing that he did not exceed the allowed limit of salbutamol dose on stage 18 of the Vuelta a Espana, and that the excretion of the drug across all his Vuelta samples was highly variable.

That variability and the stress of a three-week race led WADA to conclude that the allowed pharmacokinetic study would not have been able to reproduce the conditions, and so exonerated him - much to the chagrin of many cycling fans and experts who worried that the verdict would be the end of anti-doping.

WADA countered those worries, saying that, "While the specific details of the Froome case are unique, the result the UCI arrived at is not unusual. WADA believes it was the right and fair outcome for a very complex case and that Mr Froome deserved to be treated with the same fairness as any other athlete".

No major issue with salbutamol abuse in road cycling

The decision on Froome's salbutamol case might have been an unusual one by normal WADA records, but WADA went to lengths in its press release to demonstrate that it is not unique.

The agency revealed that across all sports between 2013 and 2017, there have been 41 salbutamol cases, eight of which resulted in an acquittal, while 21 ended with athletes being suspended. The remaining athletes were given reprimands, had TUEs, or were from sports that were not signatory to the WADA code.

In the same period, there were 16 other cases across all sports that included salbutamol use along with other prohibited substances, nine of which ended in bans.

WADA stated that "there has not been a major issue with salbutamol abuse" in road cycling, giving as evidence that only four of the 57 total cases involved cycling, with three riders being given suspensions ranging from six to nine months and one rider other than Froome receiving an acquittal in this time frame.

[The case of Alessandro Petacchi was prior to the period of the WADA statistics, but the cases of Alexandr Pliuschin and Diego Ulissi's nine-month bans were in this time frame. Mountain biker Camila Nogueira was given a three-month ban for dexamethasone and salbutamol in 2015.]

The agency also clarified that the UCI was in full control of the "procedural aspects of the case" and that while not involved in the proceedings, they were "responsive throughout the UCI's results management process and provided support where appropriate".

One instance was a response to an inquiry from Froome's attorneys, who wanted clarification on the scientific basis of the salbutamol thresholds and decision limit. WADA sent its response on March 5, 2018, and again on May 15, 2018, after being denied a request to intervene at the UCI Anti-Doping Tribunal to address the challenge to the salbutamol test.

WADA states that it received Froome's explanations and evidence on June 4, 2018, promptly reviewed them with its experts before coming to its recommendations on June 28. The UCI announced its decision to clear Froome on July 2, just before the Tour de France.

"It should be noted that, until WADA received Mr. Froome's detailed explanations on 4 June, WADA considered that this case merited going through a CPKS (controlled pharmacokinetic study) and, if necessary, disciplinary proceedings at both the UCI and Court of Arbitration for Sport level.

"However, based on what was provided by UCI to WADA, and once Mr. Froome's explanations were assessed by the appropriate internal and external experts, it became clear to WADA that, in particular, the combination of his within-subject variability for salbutamol excretion, the sudden and significant increase in salbutamol dosage prior to the doping control, and the number of consecutive doping controls meant that the analytical result could not be considered inconsistent with the ingestion of a permissible dose of inhaled salbutamol.

"For the reasons mentioned above, WADA considers that accepting Mr. Froome's explanations was the appropriate course of action and is the fair outcome."

Froome is currently attempting to win his fourth straight Grand Tour and his fifth Tour de France.

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