iOn 2 July, the Union Cycliste International (UCI) announced that the anti-doping investigation against four time Tour de France winner Chris Froome had been closed, clearing him to compete in this year’s edition of ‘Le Tour’.
The World Anti-Doping Agency (WADA), followed this announcement with its own, indicating that it would not appeal the decision of the UCI. This decision comes just in time for Froome to compete in the Tour, which starts on Saturday.
In an interview published yesterday, David Lappartient commented on the fact that he had previously thought that the decision would not come before the start of the Tour de France, however the UCI received all of the documents necessary to clear the Team Sky cyclist for the competition:
“We received the final explanation from Mr Christopher Froome on the 4th of June and in line with this we received the statement from the WADA on 28th June, so we have then all the elements to close the case.“
What were the accusations?
On 7 September 2017, following Stage 18 of the Vuelta a España, Froome was subject to a test which showed salbutamol levels in his system over and above the 1,000-nanogram per millimetre limit. Under article 2.1 of the UCI UCI Cycling Regulations (the Regulations) the presence of a prohibited substance in a rider’s sample is an anti-doping rule violation (ADRV).
The UCI Cycling Regulations
Part 14 of the Regulations govern anti-doping policies and procedures within the sport. Under section 2 of the Regulations a doping violation can be any of the following:
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Presence of a Prohibited Substance or its Metabolites or Markers in a Rider’s Sample
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Use or Attempted Use by a Rider of a Prohibited Substance or a Prohibited Method
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Evading, Refusing or Failing to Submit to Sample Collection
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Whereabouts Failures (i.e. a combination of missing tests and/or filing failures)
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Tampering or Attempted Tampering with any part of Doping Control
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Possession of a Prohibited Substance or a Prohibited Method
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Trafficking or Attempted Trafficking in any Prohibited Substance or Prohibited Method
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Administration or Attempted Administration to any Rider In-Competition of any Prohibited Substance or Prohibited Method
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Complicity
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Prohibited Association
The default position is that the burden of proof in establishing an ADRV is on the UCI and the standard of proof is beyond reasonable doubt. However, if the rider (or other individual as the case may be) wishes to rebut certain assumptions, e.g. the presumption that WADA-accredited laboratories procedures in accordance with the International Standard for Laboratories, the burden of proof falls upon that rider (or other individual), and the standard is relaxed to a mere balance of probability.
Article 4.1 of the Regulations incorporate WADA’s Prohibited List ‘as published and revised from time to time’. This is the basis of the aforementioned ‘Prohibited Substance[s]’ (see below). It was formerly the case that salbutamol required a special exemption. However, since it is not a “specified substance” under 4.2.2 of the Regulations, there was no mandatory provisional suspension in this case and Froome was allowed to race in the Giro D’Italia, a race that he won making him the third person in history to win three consecutive grand tours (the others being Eddy Merckx and Bernard Hinault).
WADA Prohibited List
Salbutamol is a ‘Beta 2 Agonist’ that is used to treat asthma and can get into the blood stream by way of an inhaler. WADA publishes a yearly Prohibited List, pursuant to which salbutamol is subject to a maximum microgram limit in an athlete’s system over 24 hours. Per the provisions of the 2017 Prohibited List, any amount of salbutamol found in excess of 1000 nanograms per millimetre is not consistent with therapeutic use of the substance.
Prohibited List 2017
All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited.
Except:
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Inhaled salbutamol: maximum 1600 micrograms over 24 hours in divided doses not to exceed 800 micrograms over 12 hours starting from any dose;
The presence in urine of salbutamol in excess of 1000 ng/mL or formoterol in excess of 40 ng/mL is not consistent with therapeutic use of the substance and will be considered as an Adverse Analytical Finding (AAF) unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of a therapeutic dose (by inhalation) up to the maximum dose indicated above.
Thus, following any findings of excess levels of salbutamol, it becomes incumbent on the rider to prove, through a controlled pharmacokinetic study (CPKS), that there has not been an Adverse Analytical Finding (AAF). In this case, Froome did not conduct such a study on the basis that it was a unique set of circumstances (involving illness and infection and the treatments necessary) that led to the test result and that such circumstances could not be recreated.
Previous cases concerning salbutamol
There are two notable, historic examples in cycling that concern use of salbutamol; these involved Alessandro Petacchi in 2007 and Diego Ulissi in 2014 – both riders were subject to bans.
Petacchi was initially cleared of any violation by the Italian Cycling Federation, but the case was appealed to the CAS by the Italian Olympic Committee and he was banned from cycling for 12 months. The regulatory backdrop was slightly different in 2007, as riders required a Therapeutic Use Exemption (TUE) to use salbutamol. Although Petacchi had a TUE for salbutamol, the CAS panel found, per paragraph 44 of the decision, that “Petacchi could not only have inhaled a dose of 600 mcg of Salbutamol in accordance with his ATUE, given that his sample was found to have a Salbutamol concentration of 1352 ng/ml”. The CAS accepted that this could have been accidental, per paragraph 53 of the decision, noting that it may have been a case of “possibly, accidentally swallowing part of the medicine (rather than inhaling it).” It is noteworthy that the inhaled salbutamol exemption provision in the 2017 Prohibited List (see above), was not in the 2007 Prohibited List.
Diego Ulissi was banned for 9 months for use of the drug after testing positive during the 2014 Giro D’Italia. This case was brought by the Swiss Olympic Committee and was not appealed to the CAS. Ulissi was purported to have 1,900 nanograms per millilitre of Salbutamol in his system, but had alleged that his increased levels of the substance were due to a crash during the race.
WADA’s Acceptance of Froome’s Case
In their announcement, WADA accepted the case put forward by Froome and the decision of the UCI. WADA concluded that the sample result was not inconsistent with Froome’s claimed inhaled usage of the drug for his asthma because of:
“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 also accepted that it was not practical for Froome to undertake a CPKS in the circumstances “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).” Finally, WADA accept that the sample was not AAF.
Conclusions
Froome’s asthma and use of an inhaler are historic issues and are well known. Back in 2014 the rider was forced to respond to camera footage of him using an inhaler at the summit finish of the Critérium du Dauphiné. It should also be noted that since he was first accused, Froome has virulently protested his innocence. Unlike previous cases, there will be no appeal to the CAS, a decision that will bring Froome the closure he needs in order to focus all his attention on a record equaling fifth victory at this year’s Tour.
authored this post.
