14th May 2021

Retroactive TUEs and salbutamol: how and why they occur

Twenty six TUE applications were received during the London 2012 Olympics, only slightly less than the 31 received before the start of the Games. Retroactive TUEs are particularly common for salbutamol, due to WADA’s rules only requiring a TUE if certain limits are exceeded. It has recently emerged that a post-race test on British Paralympian Sarah Storey at London 2012 required her to apply for a retroactive TUE, and Poland’s anti-doping agency is investigating.

Therapeutic Use Exemptions

A Therapeutic Use Exemption (TUE) allows an athlete to use a prohibited substance in order to treat a medical condition. In its International Standard for Therapeutic Use Exemptions (ISTUE), the World Anti-Doping Agency (WADA) outlines that athletes must apply for a TUE prior to competition, but also explains that a retroactive application is acceptable in certain circumstances (see right).

Retroactive therapeutic use exemptions (TUEs) are not unusual in sport. The below left figure illustrates that 21% of TUEs are applied for retroactively, rising to 39% for glucocorticoids. The Independent Observer (IO) Report for the London 2012 Olympics reveals that 31 TUE applications were made prior to the Games, while 26 TUE applications were received during the Games, one of which was rejected.

As they record observations made by anti-doping experts at the Games, the IO Reports do not contain figures on retroactive TUE applications, as they occur after an athlete returns a positive test for a prohibited substance. However, the Rio 2016 IO Report features a useful graph (right) which shows that TUE applications peaked from the 15-21 August. As the Games took place from 5-21 August, this illustrates that even when an application for a TUE is made, it is often at the last minute.

Sarah Storey

TUEs are in the news again because The Times reports that the Polish Anti-Doping Agency (POLADA) is investigating a ‘controversial’ retroactive TUE granted to British Paralympian Sarah Storey. Storey beat Poland’s Anna Harkowska in cycling’s C5 individual pursuit to win one of her four London 2012 Golds, but it is understood that a post race urine sample revealed salbutamol at above permitted levels. Officials from the British Paralympic Association (BPA) later applied for a retroactive TUE.

At this stage, it is important to point out that a TUE isn’t required for salbutamol (see right). Under the Prohibited List, inhaled salbutamol is permitted up to a maximum dose of 1,600mg per 24 hours, not exceeding 800mg in 12 hours. A TUE is required for use in excess of this, and athletes must explain any concentration in urine in excess of 1,000 ng/mL. 

WADA’s Prohibited List outlines that salbutamol in excess of 1,000 ng/mL in urine is considered an abnormal finding and not an adverse analytical finding (AAF – or ‘positive test’). If an athlete can establish that the abnormal result was due to permitted use, then is isn’t considered an AAF. The circumstances of Storey’s case suggest this is what may have happened.

Details of the GRU agents indicted in 2018 by the DoJ for their involvement in ‘Fancy Bears’…

Storey told Cycling Weekly she had been diagnosed with asthma as a child and was “less inclined” to use her inhaler due to the way in which TUEs have been portrayed by the media. For that, we can blame Fancy Bears, which hacked into anti-doping organisations and portrayed TUEs as legitimised cheating, in what was later proved to be a politically motivated plot by Russian intelligence agents.

Storey told The Times that she took a few puffs on her asthma inhaler after the race due to breathing difficulties and the need to speak to journalists. It is possible that she didn’t think she would need a TUE as she didn’t think her use would exceed WADA’s limits.

The BPA told the Daily Telegraph that everything was done by the book, and the International Paralympic Committee (IPC), WADA and the international cycling union (UCI) were aware of the situation. However, the newspaper reports that WADA’s Independent Observers also noticed Storey’s dilemma, and suggested that she should have to undergo a pharmacokinetic (CPKS) study to explain the AAF. This recommendation isn’t included in the published IO Report for London 2012. 

Privacy

Medical conditions are private information. WADA’s 2009 International Standard for the Protection of Privacy and Personal Information, which was in force at the time, outlines that TUEs are considered sensitive personal information that must be protected by anti-doping organisations (see right). 

“As one of our responsibilities as a governing body is to give a voice to athletes in our sport, we must raise concerns at what would appear to be a substantial breach of privacy without a substantial demonstration that this was in the public interest”, a British Cycling spokesperson told Cycling Weekly. “One of the reasons why WADA’s processes are confidential is to protect athlete well-being so we are particularly concerned by the impact stories like this could have on athletes who may under-use their medicine, and harm their health, rather than risk their private medical records becoming public in the future.”

Similar concerns were raised during Fancy Bears’ hacks into anti-doping organisations. In 2016, a spokesperson from the Office of the Privacy Commissioner in Canada told The Sports Integrity Initiative that it had contacted WADA – which is based in Canada – about the breach. 

How Storey’s private information became public knowledge has not been explained. Has a leak or a crime ocurred?

Chris Froome & salbutamol limits

Chris Froome

Parallels have been drawn between Storey’s situation and the Chris Froome case. A 7 September test at the 2017 Vuelta a España indicated salbutamol in Froome’s urine at a concentration of 2,000 ng/mL – twice WADA’s permitted limit.

Due to the specific circumstances of the Froome case, WADA accepted that a pharmacokinetic (CPKS) study would have revealed little. ‘It would be impossible to adequately recreate similar conditions to when Mr. Froome was subjected to the test, taking into account his physical condition, which included an illness, exacerbated asthmatic symptoms, dose escalation over a short period of time, dehydration and the fact that he was midway through a multi-day road cycling race’, read a statement issued at the time. It is not known if WADA came to the same conclusion regarding the recommendation that a CPKS be conducted involving Storey. 

Salbutamol and the difficulty with limits

Salbutamol is a corticosteroid used as an anti-asthma drug. Part of the reason that retroactive TUEs for corticosteroids are so frequent is because a TUE for salbutamol is only required if its presence in urine exceeds WADA’s limits. Athletes (such as Froome and Storey) and sporting organisations tend to think that won’t happen and are caught out when it does.

WADA’s statement on Froome revealed that of 41 salbutamol cases from 2013-17, only 21 resulted in a suspension. This suggests that even when salbutamol in urine exceeds WADA’s limit, is is hard to prove that an athlete exceeded the inhaled limit. This is exactly what played out in the Froome case.

Athletes who are given salbutamol within WADA’s permitted inhalation limits can still return an AAF. In 2014, John Dickinson of Kent University led a Study where athletes inhaled 1,600mg of salbutamol and exercised in a humid environment until a target weight loss of between 2% and 5% was achieved. Twenty of the 22 participants reported salbutamol concentrations in urine at above WADA’s limit of 1,000 ng/mL and above its Decision Limit of 1,200 ng/mL. They would have returned an AAF despite being within WADA’s inhalation limit.

Scientific evidence has found that elite athletes are more prone to asthma than the general population, particularly in sports such as cycling (pollen) and swimming (chlorine). Dickinson also found that 70% of the British Swimming squad suffered from asthma, and that elite athletes suffered from Exercise Induced Asthma (EIA), which is different from the general asthma suffered by between 8% and 10% of the general population. 

So it would appear that there is a genuine medical need for salbutamol in elite sport. As it is designed to open up the medium and large airways in the lungs, it is not hard to see how it could offer an advantage in a sport where oxygen uptake is key, such as cycling. 

However, there has been scientific debate about salbutamol’s effects on aerobic capacity in non-asthmatics. As such, drawing the line between genuine medical need (i.e. not using salbutamol would disadvantage the athlete) and performance enhancement (the athlete gets a boost beyond their ordinary physiology) remains problematic, as Storey’s case appears to once again highlight.

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