Maria Sharapova and Meldonium Doping

Yesterday the worlds richest sportswoman announced she had tested positive for a banned performance enhancing drug at the first ‘Grand Slam’ of the year in Australia. The drug – meldonium.

Maria Sharapova sprang to prominence as a teenager winning Wimbledon in 2004.  Since then she has rarely been ranked outside the top ten players in the world and has apparently been the worlds top earning sportswoman for the past 11 years on top.  The drug she tested positive for is new (since January 2016) onto the World Anti Doping Agency list of prohibited substances and is called meldonium or sometimes mildronate.

What is Meldonium?

Meldonium/mildronate is a drug that has been developed to treat various heart related diseases, through its ability to adjust the body’s use of energy, stimulating glucose metabolism and also helping to clear fatty build up in arteries. The graphic below shows the types of diseases that may be helped by using meldonium, taken from the very recently published journal article by Dombrova et al).

Journal link: “Pharmacological effects of meldonium: Biochemical mechanisms and biomarkers of cardiometabolic activity” by Dombrova et al, published in ‘Pharmacological Research’.

The drug has been developed in Latvia and is available there for use, presumably for the heart and diabetes treatments as shown above. My Latvian is not up to much but if anyone else can read it, the prescription details are here: Latvian Link . The drug was initially approved in early 2000’s (although details are sketchy due to my ongoing problem with Latvian language, perhaps it was 1999).

The drug is however not widely prescribed around the world. It is not recognised for therapeutic use by the US Food and Drug Administration, the ‘Medicines & Healthcare products Regulatory Agency’ (MHRA) in the UK or the European Medicines Agency. Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using the drug not licensed there. A quick search on the web allows me to buy it fairly easily, but I doubt Sharapova would be using such sites.

WADA Ban

Meldonium was monitored by WADA during 2015, to see if it was often found in urine samples from athletes.  In September 2015 WADA gave notice that it would be put onto the prohibited list from January 2016.  It has been added under the category ‘Hormone and Metabolic Modulators‘.  Since then we have had 8 (that I can find) positive tests from athletes, a cyclists, a couple of biathletes and some track and field athletes, mostly from the old Soviet bloc countries.  When deciding whether to ban a drug WADA uses the three tests: will it enhance performance; is it detrimental to the health of an athlete and is it against the ‘Spirit of Sport’?  To be banned a drug must ‘fail’ two of these three tests.. The third of these is very wooly and provokes much conversation – what is the Spirit of Sport and how to you define it? Presumably they have decided the drug is against the spirit of sport.

There have been tests on athletic performance after taking meldonium and the advantages have found to be increased endurance and also better recovery after exercise.  The websites selling the drug also suggest it can lead to decreased stress during athletic competition.  This means you may get a leaner athlete, who has more endurance, recovers from hard efforts quicker and with an increased mental focus. I can see how each of those would be beneficial for many sports, including tennis.

Testing Method

As with a lot of doping tests the main method seems to have been developed by the Cologne laboratory.  They published a method using LC-MS to detect the drug in urine samples.  The method was developed to detect the drug alongside other drugs they look for – diuretics, SARMS, stimulants and others, making a good broad screening method.  They have also developed a high resolution mass spectrometry method for specific confirmation and identification of mildronate in urine. During the year 2015 they ran ach of the samples they received through the method and found around 2 % of the samples to be positive for the drug. That is big figure, when the athletic population should be relatively healthy, although some will have diabetes perhaps. Only around 2% of samples each year are found positive for performance enhancing drugs in general. Not a huge number of these diabetic athletes will be from Latvia I would guess…

What ban will she get?

Under the WADA strict liability rules she is responsible for whatever is found in her urine sample.  This means she has committed a doping violation, whether she was prescribed the drug or not.  If she was prescribed it she could have applied for a ‘Therapeutic Use Exemption’ allowing use for health reasons.  But she hadn’t. This appears at best an over-sight from an athlete and her expensively employed entourage. The starting point for a ban for a  first time offence now starts with four years. Unless the athlete can prove that they had no intention to enhance performance. If this is proven they period of suspension can be reduced, in the case of a contaminated supplement this could be to zero ban, or in a case like this more likely to be 1-2 years.  However, no positive tests for meldonium have been prosecuted yet, so there is no precedent to go on.  She will certainly need a good lawyer and to be able to provide those back dated prescriptions/medical certificates though…

And so one drug gets banned that has been used for 10 years or more. What will be the next to spring up? The game of ‘cat and mouse’ continues….