WADA WILL NOT APPEAL UCI DECISION IN CHRISTOPHER FROOME CASEJuly 11, 2018
The World Anti-Doping Agency (WADA) announces that it will not be appealing the Union Cycliste Internationale’s (UCI’s) decision not to assert an Anti-Doping Rule Violation (ADRV) in the case involving British rider Christopher Froome.
WADA’s announcement follows that of the UCI earlier today, which announced that the anti-doping proceedings involving Mr. Froome have now been closed. Based on careful consideration of the facts, the Agency accepts that the analytical result of Mr. Froome’s sample from 7 September 2017 during the Vuelta a España, which identified the prohibited substance Salbutamol at a concentration in excess of the decision limit of 1200 ng/mL(1), did not constitute an Adverse Analytical Finding (AAF).
It should be noted that the 2017 Prohibited List provides that Salbutamol is a prohibited beta-2 agonist under section S.3. However, as an exception, inhaled Salbutamol is permitted subject to a maximum dose of 1600 micrograms over 24 hours, not to exceed 800 micrograms every 12 hours. If Salbutamol is reported in a urine sample in a concentration in excess of the decision limit of 1200 ng/mL(1), the Prohibited List provides that it “is presumed not to be an intended therapeutic use of the substance and will be considered as an AAF unless the athlete proves, through a controlled pharmacokinetic study (CPKS), that the abnormal result was the consequence of the use of the therapeutic dose (by inhalation) up to the maximum dose indicated above.”
After being notified of the presumed AAF in September, Mr. Froome provided the UCI with explanations, supported by expert opinions, in order to attempt to explain that the concentration of Salbutamol found in his sample resulted from the use of inhaled Salbutamol within the permissible maximum dose of 1600 mcg/24 hours, not to exceed 800 mcg per 12 hours.
WADA’s decision follows a full and careful review of all explanations and supporting evidence submitted by Mr. Froome in the month of June (which the UCI shared with WADA), as well as thorough consultation with internal and independent external experts. On the basis of this, WADA’s position is as follows:
Based on a number of factors that are specific to the case of Mr. Froome -- including, in particular, a significant increase in dose, over a short period prior to the doping control, in connection with a documented illness; as well as, demonstrated within-subject variability in the excretion of Salbutamol -- WADA concluded that the sample result was not inconsistent with the ingestion of inhaled Salbutamol within the permitted maximum dose.
WADA recognizes that, in rare cases, athletes may exceed the decision limit concentration (of 1200 ng of Salbutamol per ml of urine) without exceeding the maximum inhaled dose. This is precisely why the Prohibited List allows for athletes that exceed the decision limit to demonstrate, typically through a controlled pharmacokinetic study (CPKS) as permitted by the Prohibited List, that the relevant concentration is compatible with a permissible, inhaled dose.
In Mr. Froome’s case, WADA accepts that a CPKS would not have been practicable as it would not have been possible to adequately recreate the unique circumstances that preceded the 7 September doping control (e.g. illness, use of medication, chronic use of Salbutamol at varying doses over the course of weeks of high intensity competition).
Therefore, having carefully reviewed Mr. Froome’s explanations and taking into account the unique circumstances of his case, WADA accepts that:
the sample result is not inconsistent with an ingestion of Salbutamol within the permitted maximum inhaled dose;
an adequate CPKS is not practicable; and
the sample may be considered not to be an AAF.
WADA believes this to be the right and fair outcome for what was a very complex case.
As defined in WADA’s International Standard for Laboratories, a:
Decision Limit is a concentration, accounting for the maximum permitted combined uncertainty, above which a WADA-accredited laboratory shall report an AAF. The threshold for Salbutamol is 1000 ng/mL and the decision limit, taking into account measurement uncertainty, is 1200 ng/mL.
Threshold Substance is an exogenous or endogenous prohibited substance, metabolite or marker of a prohibited substance which is analyzed quantitatively and for which an analytical result (concentration, ratio or score) in excess of a pre-determined Decision Limit constitutes an AAF.