Maria Sharapova and Meldonium – Consideration of a Positive Drug Test

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Maria Sharapova – 2012 London Olympic Games – Photo by Oliver Catlin, www.bscg.org

Before jumping to conclusions and lambasting Maria Sharapova as a deliberate doper over recent revelations, we should attempt to educate ourselves and arrive at an informed decision based on the circumstances at hand. There is much to consider when reviewing Ms. Sharapova’s recent positive drug test at the Australian Open for the drug Meldonium.

First, we start with the drug, Meldonium, also known as Mildronate. You can review the pubchem listing for mildronate if you are interested. Other synonyms for the drug include “Quaterin; 76144-81-5; Kvaterin.” The long IUPAC chemical name is 3-[(trimethylazaniumyl)amino]propanoate.

In medicine, Meldonium is used to treat cardiac conditions like angina and vascular disease. It was developed by a Latvian company Grindeks and is approved in the Russian Federation and other countries but not in the Unites States. The description on Drugs.com describes it in two therapeutic categories; “treatment of cardiac disorders” and “inhibitor of carnitine synthesis.” Drugs.com includes 11 brand names across the Russian Federation, Latvia, Georgia and Lithuania: “Cardionate, Meldonium Olainfarm, Meldonium-MIK, Mildronat, Mildronat Grindeks, Mildronats, Mildroxyn, Vazomag, Midromax, Mildronate, Milkor.” There are 189 publications to explore via PubMed if you want to want to spend the time perusing them.

It appears Ms. Sharapova tested positive for the drug in an ITF (International Tennis Federation) drug test on Jan. 26 at the Australian Open. This information comes from her own accounts and the various media summaries of her case, including one from the New York Times that includes a video of her press conference in which she disclosed the positive test results. She explains the details saying, “I was legally taking the drug for the last ten years. I was getting sick very often, I had a deficiency in magnesium. I had irregular EKG results, and I had a family history of diabetes.” She added she had used the drug since 2006 based on treatment advice from her doctor.

Meldonium was added to the World Anti-Doping Agency (WADA) Prohibited List for 2016 under the category ‘S4. Hormone and Metabolic Modulators’. Prior to 2016, Meldonium was on WADA’s monitoring program list, meaning they were watching to see if it was being abused by athletes. The notes from WADA’s 2016 Prohibited List – Summary of Major Modifications and Explanatory Notes that came out on September 16, 2015, says that “Meldonium (Mildronate) was added because of evidence of its use by athletes with the intention of enhancing performance.”

More specifically, an abstract from a publication on Meldonium in Drug Testing and Analysis from December 2015 mentions, “the anti-ischemic drug Mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of central nervous system (CNS) functions.” A good explanation on the logic and research leading WADA to prohibit of Meldonium is included in a blog from March 3, 2016, noting the positive drug tests of runners Abebe Aregawi and Endeshaw Negesse, who also recently tested positive for Meldonium.

According to a Roidadvisor.com article, “Performance-enhancing Drugs Used by Athletes That Are Surprisingly Common,” (Oct. 17, 2015),“Meldonium has generally been used by athletes in various sports for its mild stimulant-like properties.” The piece goes on to say, “Of interest to athletes is the finding that it consistently and significantly improves exercise tolerance. Some pharmaceutical companies have recently marketed it explicitly as a performance-enhancing drug. It’s also used as a ‘smart drug’ by non-athletes. Athletes have been using it for over 5 years.” Of additional concern, the article mentions other similar drugs “telmisartan (Micardis) and T3 liothyronine (Cytomel) – are currently being used by numerous elite athletes particularly in endurance sports.”

So, on the one hand there appears to be a plausible and legitimate medical reason for Ms. Sharapova to have used Meldonium. It could have simply been a mistake that she continued to use it in 2016 without realizing it had become prohibited or seeking a therapeutic-use exemption for the drug, which presumably she could have and still might receive if her account holds true. It’s possible that will be evaluated retrospectively. It would appear there was enough time to consider the potential concern as Meldonium was on the WADA monitoring program list since January 1, 2015 and notification of it being added to the Prohibited List came out more than three months before the start of the year. It is not known if the ITF provided any notification to its players in addition to the information WADA provided.

Now, the cynics will probably look at the message board information and say it appears clear that athletes have known about the doping potential of drugs like Meldonium for years now. They may conclude that Ms. Sharapova has come up with a convenient explanation of what happened after the fact. Sadly, that explanation is also plausible.

This issue is the perfect example of a primary challenge we face when confronting the need to conduct anti-doping testing to keep sport clean. All we have is the test results that indicate a positive or negative finding in a urine sample. The results do not speak to the motivations or intentions of the athlete. In situations like this one, or in cases that involve dietary supplement use, it is hard to know whether the athlete is being truthful in their explanation or if they have developed a convenient explanation for their use of the substance involved.

We will see how things conclude in this case. Given what we know about the character of Ms. Sharapova, we have to think this is accidental doping. Of course one can never be certain and the rules of strict liability still apply as they always do in the anti-doping realm, and as she herself notes in her statement. Sadly, she is now subject to a possible two years of sanctions and has had a pall pulled over the culmination of a fabulous career. Tennis will miss her and her the game. This case is the perfect illustration of the need for drug tested athletes to take it upon themselves at the end of each year to be vigilant and review changes in the WADA Prohibited List to ensure their medications and dietary supplements are compliant with the drug testing rules for the next year.

By Oliver Catlin, President, Banned Substances Control Group, www.bscg.org

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