Monday, March 14, 2016

Maria Sharapova and Retrospective TUEs

If you're a tennis fan or someone who follows the myriad of doping issues, you've undoubtedly heard of the doping case of Maria Sharapova.  One of the issues raised by Sharapova's lawyer is that she could pursue a retroactive Theraputic Use Exemption(TUE).  A TUE is an option for athletes who have a medical condition that requires use of a substance that is also on the WADA banned list.
The following is the opinion of Dr. Ken Fitch, an Australian professor who has extensive experience with setting up the rules for TUE's within the Olympic movement. This topics relevance to all sports is the requirements that must be met to be granted a TUE in any sport. 

The following was submitted by Dr. Ken Fitch, an Australian doctor and Professor, School of Sports Science, Exercise and Health, Faculty of Life Science University of Western Australia. Dr. Fitch also wrote the rules for TUEs in 1991 for the IOC, chaired the IOC's TUE Committee for 20 years, chaired WADA's interim committee (2001-2003) that established the initial International Standard for TUE (2004) and chaired my national TUE Committee for 22 years. 

Maria Sharapova’s lawyer exploring a possible TUE to exempt a sanction
The ludicrous suggestion by Sharapova’s lawyer that she might seek a retroactive Therapeutic Use Exemption (TUE) to avoid a sanction for testing positive to meldonium demands a response.  Ignoring whether the 2016 World Anti-Doping Code and the 2015 International Standard for TUEs does or does not make a retroactive TUE a possibility in her circumstances, if anybody examines the criteria that must be met to grant a TUE, he/she would understand that no respectable TUE Committee could approve any such application.
WADA states that there are four criteria, all of which must be met to grant a TUE.
  • The drug is necessary to treat an acute or chronic medical condition and the athlete would experience a significant impairment to health if it were to be withheld

  • The therapeutic use of the prohibited drug 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

  • There is no reasonable therapeutic alternative to the use of the prohibited drug.

  • The necessity to use of the prohibited drug is not a consequence of prior use of a prohibited drug or method

Would Sharapova’s health be significantly impaired if she was denied a TUE? 
The Latvian makers of meldonium advise that it should be taken in intermittent courses of 4-6 weeks and for what period of time Sharapova administered meldonium during the past 10 years, has yet to be disclosed.  As the only acceptable medical indications are for ischemic cardiac and ischemic cerebral conditions, it is unthinkable that Sharapova has either.  Hence any claim that should she be denied the right to take meldonium would impair her health is simply fanciful.  Any TUE application must fail criterion 1. 
The second criterion was introduced because some athletes had an essential need to take a prohibited drug.  For example, an insulin dependent diabetic would die if denied insulin which has been prohibited in sport since 1998 and their daily insulin injections that are permitted with a TUE do not enhance performance.  Whether meldonium actually enhances performance in humans has yet to be demonstrated.  That WADA has advised that in less than two months since it was added to the Prohibited List, 99 athletes have tested positive for meldonium would appear to indicate that many athletes and their advisors believe that it does.  No athlete could claim that meldonium was essential to restore their health back to normal levels.  To claim that without it, a person’s health would be less than normal is surely fictitious.  Fails criterion 2
There are many drugs that have been demonstrated in scientific trials to be valuable in cardiac ischemia and the vast majority would be far superior to meldonium.  The few meldonium studies performed in humans have been on persons who recently had experienced a myocardial infarction or an acute coronary syndrome.  That the makers of meldonium recommend that it is administered only in intermittent courses in contrast to most of the widely acceptable, prescribed alternatives that are to be taken daily, is further evidence of the non-essential status of meldonium to treat cardiac ischemia.  As the drug is marketed in only 10 countries globally and Sharapova has lived in USA for much of her life where meldonium is not approved for human use, this poses further questions for the tennis player. 
Drug therapy for cerebral ischemia is generally ineffective and less frequently used than for cardiac ischemia but those patients on whom meldonium was trialled had had either a recent stroke or evidence of deteriorating brain function.  As Sharapova could not possibly demonstrate that she has either of these or indeed significant cardiac or cerebral ischemia, and if she could, alternative permitted drugs are at least as effective if not more so, she fails criterion 3. 
Hence Sharapova fails 3/3 and the fourth criterion has no relevance.

 Finally, should an unscrupulous or ignorant TUE Committee happen to grant Sharapova a retroactive or even a prospective TUE for meldonium, WADA would be certain to appeal to CAS and the decision would be or should be overturned.

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