Possible ways the Therapeutic Use Exemptions system can be improved to prevent abuse
Published 18 October 2016 By: Luke Sayer
On 13 September 2016, a group of hackers calling themselves “Fancy Bears”, began to leak onto the Internet1 confidential athlete data relating to, among other things, “Therapeutic Use Exemptions” (TUEs – explained below) for certain drug consumption. Fancy Bears’ claimed that they obtained the data by hacking into the World Anti-Doping Agency’s (WADA) Anti-Doping Administration and Management System (ADAMS). This has been subsequently confirmed by WADA.2
While the legality of the hack cannot be condoned, the upshot is that it has thrown TUEs under the spotlight. The public seems surprised at the number of TUEs granted to athletes,3 and there is a growing suspicion in some corners that athletes may be using TUEs unscrupulously4 to take drugs that are otherwise classified as performance enhancing and banned under the WADA Code. WADA has tried to reassure the community, with the WADA TUE Expert Group releasing this statement5 on 30 September. However, questions remain about the ethical use, integrity and principles of the TUE regime.6
Accordingly this article examines the TUE regime, asking whether it is open to abuse and, if so, how it could be improved. Specifically it looks at:
- Background to TUEs
- The International Standard for Therapeutic Use Exemptions
- The application process
- Prevalence of TUEs and possible abuse of the process
- Possible reforms
- Concluding comments
BACKGROUND TO TUEs
The International Standard for Therapeutic Use Exemptions (ISTUE),7 first adopted in 2004, was created with the understanding that, due to illness or a medical condition, an athlete may require the use of medications or treatments on WADA's Prohibited List.8 A TUE is granted to an athlete under narrow, well-defined conditions contained within the ISTUE. In simple terms, the TUE enables the athlete to take necessary medication while competing in sport events, without the consequences and ramifications of committing a doping offence.
Between January 2015 and March 2016, UK athletes were granted 159 TUEs, with 12 rejected. Of these, the UK Anti-Doping Agency approved 116 and rejected six while international federations approved 43 and rejected six9. The strict criteria for one to be granted are detailed below.
The last three WADA reports indicate a rise in TUEs worldwide across all sports generally. In 2013, there were 636 approved TUEs, 897 in 2014 and 1330 in 2015. That is an increase of more than 100% in just two years10.
The International Standard for Therapeutic Use Exemptions11
The purpose of the ISTUE is to establish:
- the conditions that must be satisfied in order for a TUE to be granted;
- the responsibilities imposed on anti-doping organisations in making and communicating TUE decisions;
- the process for an athlete to apply for a TUE;
- the process for an athlete to get a TUE granted by one anti-doping organisation recognised by another anti-doping organisation;
- the process for WADA to review TUE decisions; and
- the strict confidentiality provisions that apply to the TUE process12.
An athlete may be granted a TUE if (and only if) he/she can show, on a balance of probability, that each of the following conditions in Article 4.1 of ISTUE is met (all definitions not otherwise defined hereinafter shall have the same meaning as within ISTUE):
- The Prohibited Substance or Prohibited Method in question is needed to treat an acute or chronic medical condition, such that the Athlete would experience a significant impairment to health if the Prohibited Substance or Prohibited Method were to be withheld.
- The Therapeutic Use of the Prohibited Substance or Prohibited Method is highly unlikely to produce any additional enhancement of performance beyond what might be anticipated by a return to the Athlete's normal state of health following the treatment of the acute or chronic medical condition.
- There is no reasonable Therapeutic alternative to the Use of the Prohibited Substance or Prohibited Method.
- The necessity for the Use of the Prohibited Substance or Prohibited Method is not a consequence, wholly or in part, of the prior Use (without a TUE) of the substance or method which was prohibited at the time of such Use13.
Unless one of the exceptions set out in Article 4.3 applies, e.g. emergency treatment or treatment of an acute medical condition was necessary; or due to other exceptional circumstances, there was insufficient time or opportunity for the Athlete to submit, or for the Therapeutic Use Exemption Committee (TUEC) to consider an application for the TUE prior to sample collection; the athlete must obtain a TUE prior to using or processing the Prohibited Substance or Prohibited Method in question14.
THE APPLICATION PROCESS
For substances prohibited In-Competition only, the Athlete should apply for a TUE at least 30 days before his/her next Competition, unless it is an emergency or exceptional situation. The relevant TUE application form to the relevant Anti-Doping Organisation must be accompanied by: (a) a statement by an appropriately qualified physician, attesting to the need for the Athlete to use the Prohibited Substance or Prohibited Method in question for therapeutic reasons; (b) a comprehensive medical history, including documentation from the original diagnosing physician(s) (where possible) and the results of all examinations, laboratory investigations and imaging studies relevant to the application.
Each National Anti-Doping Organisation, International Federation and Major Event Organisation must establish a TUEC to consider whether applications for a grant or recognition of TUEs meet the conditions set out in Article 4.1 of ISTUE.
An athlete who is not an International-Level Athlete should apply to his or her National Anti-Doping Organisation. An athlete who is an International-Level Athlete should apply to his or her International Federation. Where the athlete already has a TUE granted by his or her National Anti-Doping Organisation for the Prohibited Substance or Prohibited Method in question, if the TUE meets the criteria set out in ISTUE, then the International Federation are supposed to recognise it. Alternatively, if the International-Level Athlete does not already have a TUE he/she must apply directly to his or her International Federation for a TUE as soon as the need arises. These provisions are taken from Article 4.4 of the 2015 WADA Code15.
TUECs should include at least three physicians with experience in the care and treatment of athletes and a sound knowledge of clinical, sports and exercise medicine16. In order to ensure a level of independence of decisions, at least a majority of the members of a TUEC should have no political responsibility in the Anti-Doping Organisation that appoints them. All members of the TUEC must sign a conflict of interest and confidentiality declaration17.
The TUEC's decision must be communicated in writing to the Athlete and made available to WADA, and will specify the dosage(s), frequency, route and duration of Administration of the Prohibited Substance or Prohibited Method in question. Each TUE will have a specified duration, as decided by the TUEC, at the end of which the TUE will expire automatically. Article 4.4 of the 2015 WADA Code requires Anti-Doping Organisations to recognise TUEs granted by other Anti-Doping Organisations that satisfy the Article 4.1 conditions of ISTUE18.
For the avoidance of doubt, any TUE application shall be dealt with in accordance with the principles of strict medical confidentiality19.
PREVALENCE OF TUEs AND POSSIBLE ABUSE OF THE PROCESS
The starting point is that there is no suggestion to date that any athletes subject to the Fancy Bears’ leak have committed any offences. The leaks demonstrate that each of them was granted permission by a relevant TUEC to take specific medication by way of TUEs. However, as noted in the introduction, the leaks have prompted questions about whether there is enough oversight within the TUE process and in particular, whether or not TUEs are being used ethically, i.e. to treat a legitimate symptom in a proportionate way; as opposed to being used to try and “gain an edge” or eek out any possible advantage over the competition.
The majority of TUEs granted to American athletes in 2015 were for stimulants – normally administered to people with ADHD – which can enhance endurance and alertness. In addition, 67 American athletes were permitted to use glucocorticosteroids (normally prescribed for asthma) last year, which might allow them to train for longer. Separately, 30 other American athletes gained exemptions to use anabolic agents, which boost muscle mass.20
Larissa Maier, a postdoc at the Swiss Research Institute for Public Health and Addiction, claims that manipulating the process is fairly easy.21 In a 2012 survey of Swiss physicians, 67% said that they would prescribe stimulants to suffering patients even if there were no clear indication of a medical need. And in a 2013 study of 600 Danish athletes published in the International Journal of Drug Policy, half the respondents claimed that competitors had been awarded a TUE without a medical need. "If your first doctor is not prescribing it, you could hop to the next one and try it there," says Maier22.
Though professional athletes are assumed to be healthier than your average person, they appear to be using some substances more frequently than the general population. The most striking example is in baseball, a sport beset by doping scandals: the population of Major League Baseball players taking medication for ADHD is reportedly23 three times higher than the national average24.
The hackers are not the only ones raising concerns about TUEs. Canadian law professor, sports lawyer and the author of the most recent WADA investigation into Russian doping25, Richard McLaren, told BBC World Service:
"One would have to conduct investigations on specific sports as to whether or not too many TUEs are being used with respect to particular substances. That's one area that probably needs to be looked at – how frequently are [certain medicines] being used in particular sports.26"
At worst, they can be used to cover up systematic cheating: when cyclist Lance Armstrong tested positive for corticosteroids during the Tour de France in 1999, he secured a back-dated TUE certificate to avoid punishment27.
A further specific example is Sir Bradley Wiggins. The leaks detailed how Wiggins had obtained TUEs to use corticosteroid Triamcinolone between three major races,28 the 2011, the 2012 Tour de France (which he won), and the 2013 Giro d'Italia. Cortisone, possesses steroidal qualities capable of decreasing pain and increasing airflow by opening the airways during exercise, but is also a common anti-inflammatory prescribed to asthma patients29. Again, there is no suggestion that Wiggins contravened anti-doping regulations. However, the timings of the use of Triamcinolone, taken via intramuscular injection for asthma and pollen allergies, have highlighted the potential gaps in the TUE system. Inhalation of these drugs is not performance-enhancing and they can now be used without a TUE. A 40mg injection of triamcinolone is very different and though some experts claim it is not performance-enhancing, the experts by experience (bike riders who have abused it for decades) argue the opposite30. Chief Sports Writer of the Sunday Times, David Walsh, takes the view that
"Brailsford [General Manager of Team Sky] created a magnificent team that mostly played by the rules but at a critical moment played fast and loose with ethics. They behaved in a way they would not have accepted from rivals.31"
Wiggins' ex-teammate, Chris Froome said in a statement that "it is clear that the TUE system is open to abuse and I believe this is something that the UCI [cycling's governing body] and WADA needs to urgently address."32 Whilst this gives the impression that the UCI may be in denial about any abuse of TUEs that is not necessarily the case. The UCI for example has in place a "No Needle Policy" which states that in the case of a local injection of glucocorticoids, the rider must rest and is prevented from competing for 8 days (article 13.3.055 of the UCI Regulations).
An obvious question arising therefore is, could athletes pretend they have asthma (or indeed another medical condition) in order to benefit from otherwise prohibited drugs? Professor John Dickinson, of the University of Kent, a world-leading expert in respiratory issues who tested every member of the British swimming team in 2014, believes that is possible33. However, his view is that if properly assessed they should not be able to get away with it. He uses an eucapnic voluntary hyperpnoea test, which tries to induce a mild asthma response by replicating breathing rates athletes produce during exercise. By assessing an athlete's lung function he can see whether they suffer a muscle constriction around the airways and whether an inhaler will help34. Dickinson accepts that whilst most sports medicine doctors treat on the basis of making sure their athlete is healthy, some unscrupulous ones will wave through a little extra help so, say, they recover quicker. He also believes the use of oral corticosteroids (treatment used by Chris Froome during the 2014 Tour de France which he won35), which are more powerful than the drugs found in inhalers, should not be allowed, "if someone's asthma is that bad they should not be competing," he says36.
To the author, it appears there are at least three problems facing the current TUE process.
- Firstly, a possible inconsistency in the initial assessments carried out by an athlete's physician. As highlighted by Professor Dickinson above, there is the danger of unscrupulous physicians simply adhering to an athlete's request. Thereafter, the relevant TUEC is presented with medical evidence of an illness or medical condition. That is not to say the TUEC cannot dismiss the medical evidence. However, to satisfactorily do so, it would seem necessary to carry out further examinations and/or request additional information. These steps are provided for under Article 6.5 of ISTUE37. However, it is not clear how regularly this provision is utilised.
Another provision that could be utilised is the power to withdraw a TUE upon review by WADA or an appeal (Article 6.10 of ISTUE38). This power could be used it here is if there is suspicion of abuse by an athlete or an authority/physician empowered to assess athletes.
- Secondly, as part of the TUE application, it is possible that the TUEC is a National Anti-Doping Organisation as opposed to an International Federation. Whilst the ISTUE are binding for all nations, it is eminently possible that some committees may enforce them less vigilantly than they should. Ken Fitch, an expert in sports medicine who helped to create the application process says "There will always be a weak link in any system". Indeed, it was largely the fact that the Russian National Anti-Doping Agency (RUSADA) was non-compliant under the WADA Code that led to the 'Russian doping scandal' last year39. Accordingly, if there are concerns over the abuse of TUEs, stemming from a national TUEC, there needs to be an even greater emphasis by WADA on a possible offending national TUEC, when it carries out a review of a decision to grant a TUE.
- Thirdly, individual sports can take responsibility themselves. In 2007, a number of top cycling teams formed the Movement for Credible Cycling (MPCC) and one of their aims was to eliminate at least some of the ambiguity. At the time, half of the teams in the peloton signed up. They addressed the abuse of TUEs. MPCC set a higher ethical standard than that laid down by WADA. They would not allow a rider to race with a TUE. Team Sky refused to join MPCC. They said that had their reasons but did not specify. Had they signed up to MPCC, Wiggins would not have been allowed the TUEs he received in 2011, 2012 and 2013.
Other team sports could adopt a similar model. Whilst there would be no obligation to join a body similar to MPCC, it would allow for complete transparency on the basis there would be no competing athletes with the benefit of a TUE. The difficulty with this approach is that it ignores evidence that TUEs are an important part of ensuring athlete well-being. WADA's view is that the notion of precluding athletes that suffer from illnesses and conditions such as diabetes, asthma, inflammatory bowel disease, rheumatological conditions, etc. from sport cannot be given serious consideration. It would undermine a fundamental value of sport that is the right access and participation to sport and play, which has long been recognised by numerous international conventions40.
- Finally, it may be possible for WADA to be more transparent about the process. Whilst the author is not pushing for breaches of patient-doctor confidentiality, in order to mitigate the abuse of prohibited substances, WADA could create an international public database of TUE prescription statistics. Such a database would generally maintain athletes' anonymity, but would track three major factors:
- the TUEs being prescribed;
- per capita prescription across countries; and
- their use within certain sports41.
Such data should allow for appropriate measures to be taken if statistical data suggest an abuse of a particular substance, by a particular country/territory, or within a specific sport. Obvious measures would include further testing of the athletes in question and potential revisions to the availability of certain TUEs.
Whilst the issue of doping shouldn't be conflated with that of a TUE – the former is illegal while the latter is perfectly within legal boundaries – the recent leaks have raised the argument that the system is rigged in favour of athletes42. We need to be careful that a blanket accusation is not made of all athletes with TUEs. After all, it is not surprising that a child diagnosed with ADHD such a Simone Biles was introduced to gymnastics in an attempt to put such “energy” to use. It is conceivable that any system could be exploited but, in this author's opinion, the extent of the problem could be greatly reduced, or even eradicated, through better statistical observations and appropriate steps deriving from such statistics.
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- Tags: Anti-Doping Administration and Management System (ADAMS) | Athletics | Cycling | Gymnastics | International Standard for Therapeutic Use Exemptions (ISTUE) | Russian National Anti-Doping Agency (RUSADA) | Therapeutic Use Exemption Committee (TUEC) | Therapeutic Use Exemptions (TUE) | TUE Expert Group | UCI Regulations | Union Cycliste Internationale (UCI) | WADA Code 2015 | WADA Prohibited List | World Anti-Doping Agency (WADA)
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Luke is a lawyer specialising in litigation, both commercial and civil, regulatory matters, employment law and image rights with Carey Olsen, Guernsey. Luke has a wide range of experience from his five years as a qualified solicitor. Luke has a passion for sports law and is interested in most sports particularly rugby, football, athletics, and cricket. He previously represented England Students and Leicester Tigers at rugby union whilst attending the University of Nottingham.