SII Focus 14th April 2016

Athletes face uncertainty after WADA’s meldonium clarification

Athletes and anti-doping organisations (ADOs) will face a tense few months following the World Anti-Doping Agency’s (WADA) Notice on handling meldonium cases, issued yesterday. As the Rio 2016 Olympic Games approaches, difficult questions are likely to emerge about who is responsible for athletes missing out on important sporting events – and potential Olympic selection – due to provisional suspensions due to meldonium. As reported by the Sports Integrity Initiative yesterday, WADA’s guidance will come as a huge relief to the 172 athletes that have tested positive for meldonium since the 2016 Prohibited List came into effect on 1 January. However, it may also present another issue for ADOs, who will have to revisit recent cases.

WADA has produced a potentially confusing minefield for ADOs. They will need to ascertain whether an athlete can can establish, on the basis of probabilities (to use WADA’s words), that they did not ingest meldonium after 1 January 2016. If evidence exists that the athlete did take meldonium after 1 January and the test was taken before 1 March, ADOs will need to decide whether to lift provisional suspensions if the level of meldonium in the athlete’s sample is between 1 μg/mL and 15 μg/mL, due to the lack of scientific evidence on excretion times. For the same reason, WADA advises that ADOs should not proceed with cases where the concentration of meldonium is less than 1 μg/mL, unless the test was conducted after March 1.

Maria Sharapova

Tennis star Maria Sharapova is arguably the highest profile athlete to test positive for meldonium, which she admitted in a 7 March press conference. She said that she had been taking mildronate (brand name for meldonium) since 2006 on the advice of her doctor for health issues including magnesium deficiency, an irregular heartbeat, and a family history of diabetes. Mildronate is manufactured in Latvia by Grindeks and is used in Lithuania and the Russian Federation, but is not approved by the Food and Drug Administration (FDA) for use in the United States, where Sharapova has lived since the age of seven.

Unfortunately for Sharapova, a statement issued by her sponsor, racquet manufacturer Head, appears to indicate that she did take mildronate after 1 January, so her case will proceed. ‘On this basis we conclude that although it is beyond doubt that she tested positive for the use of a WADA banned substance, the circumstantial evidence is equally beyond doubt that the continued use of meldonium after Jan 1st, 2016 in the dosages she had been recommended, which were significantly short of performance enhancing levels, was a manifest error by Maria’, read Head’s statement.

Her sample was taken on 26 January at the Australian Open, which means that the levels of meldonium reported in her sample will be crucial to her case. However, although Head’s statement claims that the dosages recommended to Sharapova are well short of being performance enhancing, WADA’s upper limit of 15 μg/mL – or 15 micrograms per millilitre – is incredibly small. It is equivalent to 0.015 grams per kilogram.

Sharapova is also likely to face questions over why she was prescribed a substance that was not approved for use by the FDA, since she has lived in the US since the age of seven. Don Catlin, Scientific Director of the Banned Substances Control Group told USA Today that he could not see any reason why Sharapova would use mildronate to treat the medical conditions she listed.

It is also questionable as to why a US based physician would prescribe a drug to a sports star which is not approved by the FDA. Forbes reports that such unapproved drugs can only be prescribed by a US physician in clinical trials, or to patients with serious medical conditions for whom there are no alternative treatments. It is understood that alternatives to mildronate are available in the US, however it is difficult to ascertain whether these would have been suitable for Sharapova without access to her medical records.

Yulia Efimova

Russian swimming star Yuliya Efimova has filed a request to the Fédération Internationale de Natation (FINA) to lift her provisional suspension so that she can take part in the Russian national championships, which start on Saturday. As reported by the Sports Integrity Initiative, Efimova has argued that the drug was not prohibited at the time she took it. FINA has yet to respond.

Georgian athletes cleared

Six Georgian athletes have been cleared, after their samples were found to contain acceptable levels of meldonium, according to local reports. Georgian freestyle wrestlers Beka Lomtadze and Avtandil Kentchadze, who took silver and bronze respectively at the European championships, have been cleared, as have athletes Beka Bujiashvili, Giorgi Meshvildishvili and Mate Sopadze.

Russian boxer loses title

Russian boxer Igor Mikhalkin has been stripped of the European Boxing Union’s (EBU) light-heavyweight title after testing positive for substance meldonium, reports the Associated Press. As reported by the Sports Integrity Initiative yesterday, Mikhalkin said that he stopped taking the drug before it was banned, after the 2016 Prohibited List came into effect on 1 January.

Insurance policy

Although many athletes have argued that they took meldonium for medical reasons, an interview with the inventor of meldonium, Ivar Kalvins, gives perhaps a more accurate insight into why 172 athletes have tested positive. Meldonium It is an anti-ischemic drug used to treat restrictions in blood supply to tissues, such as in cases of angina and heart failure. It is therefore understood to also be able to increase the supply of oxygen-carrying red blood cells to muscle tissue.

Kalvins told Forbes that meldonium ensures that the heart gets enough oxygen, even when pushed to its capacity as it often is in elite-level sport. “This is like insurance”, he said. Kalvins also said that there is no scientific evidence that meldonium enhances performance, however as reported by the Sports Integrity Initiative, only two of three criteria must be met for a substance to be included on the Prohibited List, and scientific evidence of the ability to enhance performance is just one of them.

This will come as little comfort to the Russian U18 Ice Hockey team, which found itself almost entirely replaced due to concerns that the team would test positive for meldonium. This suggests that there may be difficult questions to answer about who is culpable for such actions – is it WADA, or the ADO concerned? Only time will tell…

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