Sharapova's Best Defense Will be That Meldonium Doesn't Meet WADA List Criteria

Maria Sharapova has focused her defense for a positive test on an allegation that she was improperly warned by anti-doping and tennis officials. She has taken this case directly to her fans via her Facebook page. John McEnroe explains why this is unlikely to be an effective excuse, "It would be hard to believe that no one in her camp, the 25 or 30 people that work for her or Maria herself, had no idea that this happened."

A flurry of positive tests after a drug is added to the Prohibited List is not unprecedented. The New York Times reports that when methylhexaneamine was added in 2010 there were 123 positive tests that year. The principle of "strict liability" that underpins the WADA Code presents another obstacle to Sharapova winning any appeal before the ITF or Court of Arbitration for Sport, if it gets that far.

Sharapova's public appeals may sway her fans, but not much else. She does however have a much more promising strategy, along with the 100-odd others who have been caught taking Meldonium (or midronate). That is to challenge the drug's inclusion on the WADA Prohibited List in the first place. Let me explain.

To be included on the WADA Prohibited List a substance has to meet two of three criteria, as explained under the WADA Code (here in PDF), with the relevant text reproduced here in full:

• 4.3.1 A substance or method shall be considered for inclusion on the Prohibited List if WADA, in its sole discretion, determines that the substance or method meets any two of the following three criteria:
• 4.3.1.1 Medical or other scientific evidence, pharmacological effect or experience that the substance or method, alone or in combination with other substances or methods, has the potential to enhance or enhances sport performance;
• 4.3.1.2 Medical or other scientific evidence, pharmacological effect or experience that the Use of the substance or method represents an actual or potential health risk to the Athlete;
• 4.3.1.3 WADA ’s determination that the Use of the substance or method violates the spirit of sport described in the introduction to the Code.

I think a very compelling case can be made that two of these three criteria have not been met. Let's first stipulate that one criterion has been met - a violation of the "spirit of sport" is whatever WADA decides that means. But let's take a closer look at the other two criteria.

Does Meldonium enhance sports performance or pose a health risk? The drug came to the attention to WADA in 2014 via a tip from an unnamed source to the U.S. Anti-Doping Agency that "Eastern European athletes were using the drug meldonium as a performance enhancer," according to USA Today. Later in 2014, Larry Bowers, USADA's chief scientist, gave a talk on the drug at the annual USADA Science Symposium (Note: I have put a request into USADA for a copy of his presentation). Meldonium was soon thereafter placed on WADA's list of substances being monitored, which allowed them to test for the drug but not to levy sanctions.

With Meldonium on the monitoring list, the next step was a grant of $36,000 being given to Mario Thevis at the German Sports University to reassess previously taken urine samples for the presence of Meldonium, which is apparently very easy to detect (source in PDF). The grant was provided by the Partnership for Clean Competition, which funds anti-doping research. Michael Pearlmutter, executive director of the PCC explained, "Thankfully, we were able to respond to a potential situation within weeks and the results were known less than one month later." 

The study's results, published in April 2015, found that indeed the drug was being widely used by athletes - 2.2% of the reanalyzed urine samples tested positive. USADA's Bowers (also chairman of the PCC"s scientific board) explained the significance of the findings: "From an anti-doping perspective, the 2.2% rate in this study was concerning. This figure represents more than twice the overall rate of laboratory findings for a single drug than any of the substances on the Prohibited List."

But what is lacking here - and this is key for Sharapova and others - is that research has been done on the prevalence of the drug's use, but not its performance-enhancing effects. WADA may have taken a short-cut in adding the drug to the Prohibited List, because there does not appear to be any compelling, scientifc evidence of the drug's performance enhancing effects on elite athletes. 

The literature on the drug is extremely thin, but the drug does appear to enhance the sexual performance of boars.  One study of dietary supplements used by athletes (including 22 who were taking mildronate) found no health or performance effects. In contrast, a study of rats in a swimming exercise found a modest performance benefit. An abstract from the 5th Baltic Sport Conference Sports Conference (p. 59 here in PDF) suggests that mildronate does have performance enhancing effects on athletes.

The bottom line here is that the evidence of the potential or actual performance enhancing qualities of Meldonium (mildronate) or its health risks to athletes is extremely thin. That is not to say that such benefits don't exist, only that WADA has not made the case. To work effectively, anti-doping regulations need to be evidence-based and fully accountable. 

There is a precedent here. In 2000 the IOC banned the drug Actovegin after cyclists, including Lance Armstrong, were alleged to have used the substance. The IOC later reversed course and took the substance off the banned list, where it remains today. In that instance authorities jumps the gun on a substance before collecting evidence.

My advice to Sharapova and the dozens (hundreds?) of other athletes who have been caught using Meldonium would be to call out WADA for taking a shortcut in adding the drug to its list. Anti-doping effotrs cannot afford to cut corners or appeal to moralizing. If it does it will find itself detached from science and potentially abusing the rights of athletes. Whatever you might think of Sharapova and others on Meldonium, this episode provides a great opportunity to improve evidence-based anti-doping, which will better serve all athletes.