Sharapova suspension: Doping agency's unfair game of 'gotcha'?

Many professional sporting organizations, including the International Tennis Federation, rely on WADA to decide which substances deserve banishment from international sporting. WADA doesn't just include the obvious targets: bulking agents like anabolic steroids, stimulants, pain medications prior to competition or endurance enhancing procedures like blood doping. It refines its list every year in response to new research and new evidence about what athletes are taking to get an edge.

That means you'll find drugs with legitimate treatment effects on the list. For example, exercise induced asthma is a common condition in many athletes, yet WADA bans many of the kinds of beta-2 agonist drugs athletes would take to relieve that condition. WADA allows just three of the drugs from this class and only in specified dose ranges.

There are other drugs on the list, like tamoxifen and even insulin, that don't sound like drugs of abuse. But an athlete could gain an edge even from such seemingly normal medications. With insulin doping, an athlete injects insulin in order to pack more blood sugar into the muscles, boosting endurance later during competition. Weightlifting athletes can use insulin to counter the side effects of other hormones they've abused.

Even so, this doesn't mean diabetic athletes must go without their insulin. They can file for a Therapeutic Use Exemption (TUE), the process WADA relies on when an athlete needs to take a banned substance for health reasons. The athlete's doctor has to detail that aspect of their medical history and explain why their patient needs a banned drug instead of one that isn't banned.

Sharapova never had to file a TUE over the 10 years she has freely admitted to taking meldonium (also known as mildronate), as it was only recently banned. She and other athletes who take the drug have dutifully recorded it on their health forms.

So what is meldonium? Dating back to the 1970s, meldonium interferes with a step in the body's effort to burn fatty acids for energy, and thus it makes more cells seek their energy from glucose. The body needs less oxygen to burn sugars than fats. So meldonium has found a place in common medical practice in Eastern Europe and Russia, where its application is broad: boosting endurance in patients with heart damage, providing energy in states of chronic fatigue, and, some practitioners believe, staving off diabetes.

The research literature for many of these claims is actually substantial, but much of it is in Russian. Western doctors have essentially no knowledge or experience of the drug despite its popularity in its specific geographic region.

Because the literature on meldonium looks promising for various disease states, I wondered why we haven't seen efforts to bring it into the United States. Blame geopolitics; its creators lived in the USSR state of Latvia at a time when the Cold War divided Russian medicine from Western medicine.

Meldonium entered the Russian marketplace in 1984, a representative from Grindeks, the company that held its original patent, told me in an email. It wasn't until 13 years after the Soviet Union's collapse, in 2004, that Latvia joined the European Union, bringing meldonium along with it.

Grindeks marketed it as Mildronats, but it lost the patent in 2006, and now several other companies make and market the drug as well. In 2007 meldonium topped the charts as Latvia's "most exportable product," and still ranks highly among the small nation's exports.

It's an expensive process for any drug company to expand its markets by getting its products approved by additional regulatory authorities, whether the Food and Drug Administration in the United States or the European Medicines Agency in the European Union, so that's a step that only makes sense if the company making the investment is guaranteed to benefit from that increased market share.

When Sharapova stood before the cameras this week, she explained that due to low magnesium levels, abnormal EKG readings, personal test results concerning prediabetes, and a family history of diabetes, her family doctor prescribed her meldonium. A Western doctor would not look to meldonium for any of these symptoms or risk factors, in fact most of us were unaware of the drug until this week when Sharapova made it famous.

If your magnesium level is low, we would replace it, and advise eating foods that contain magnesium. Magnesium alterations could have explained an abnormal EKG, though we are unaware of exactly what her EKG showed. As for prediabetes, if I found that your fasting blood sugar is high, and that you have a family history of diabetes, I might recommend tight control of your diet and increasing your physical activity. These would have been easy recommendations for Sharapova to follow.

That said — and having now reviewed the extent of the literature on meldonium, which convincingly describes anti-diabetic effects in animal models, and offers a scientific basis for cardiovascular protection -- I am not shocked that a Russian doctor or someone practicing in that region would have recommended this drug, which is already common in their local pharmacopeia.

Nevertheless, one physician told Reuters, "This is not something I have or would ever prescribe" and a forensics professor wondered how and why the longtime U.S. resident is using a drug that is "not licensed there [in the U.S]."

True, but it's easily available online, and FDA regulations for online purchases are so laxly enforced that they might as well not exist. It's silly to pretend that this globetrotting international tennis star (and Russian citizen) is somehow bound to the treatments and clinicians available in the United States. I would be surprised if she has not received some of her medical care in Russia and the surrounding area.

As for why meldonium ended up on the banned list, anti-doping agencies found meldonium in about 2% of control samples they tested randomly, and they've noticed chatter on websites touting the drug as a performance enhancer. In fact, dozens of other athletes besides Sharapova have now tested positive, and I imagine a sizeable percentage will prove to have no plausible medical rational for taking meldonium, and instead purchased the drug hoping to gain an edge. The uptick in activity prompted them to put the drug on a monitoring list, step up their testing, and ultimately decide to place it on a banned list, beginning in January 2016.

Outside of the hype you see about the drug online, there's not much scientific support for its use as an athletic enhancer. A major academic paper published last year recommended that WADA add meldonium to the banned list and described various methods for detecting it in urine samples.

But I looked into the only two studies that paper cited for athletic performance enhancement. One, focusing on judo, appeared in 2002 in a short-lived and now defunct journal based at Tbilisi State Medical University in the Republic of Georgia. I've been unable to locate a copy so I can't assess its methodology and data. The other paper is only a brief abstract published as part of conference. It contains no original data and cites the Tbilisi judo study.

The fact is, if meldonium did improve Sharapova's athletic ability over the past decade as she won numerous major titles, we can't know by how much. Beyond that, Sharapova is very open about her history taking meldonium, and she's offered a reasonable explanation for taking it.

WADA only announced meldonium would appear on the 2016 banned list in fall 2015.

No doubt, Sharapova and her business people are guilty of poorly managing her career by neglecting to carefully review the new banned list. But Sharapova said she knew the drug only as mildronate, not meldonium, and elaborated in Facebook post to her fans about how, she said, notices about the updated list buried the drug's addition in a maze of links, dense text and a poorly designed wallet card.

But does anyone doubt that Sharapova would have stopped the drug had she known it was on the list? Does anyone believe Sharapova thought meldonium so important to her performance that she intentionally decided she'd take her chances and continue taking the drug, hoping not to get caught? Surely not.

WADA shouldn't behave as if Sharapova participated in an attempt to deceive it. And particularly for drugs like meldonium, where legitimate uses can be argued, the agency should offer a grace period for athletes taking newly banned drugs. The anti-doping agency's gotcha system, in cases like Sharapova's, cast more shadow on professional sport than is necessary.

Athletes who've been upfront about their use of a substance that's permitted up until a particular date deserve a discreet heads-up about positive results during a grace period that allows them time to rectify the situation by stopping the drug or applying for a TUE.

Furthermore, outside of the banned list, WADA allows athletes to take any drug legally approved by any state health authority anywhere. It's a big world out there, and niche drugs like meldonium circulate in corners of it out of the scope of big dog agencies like the FDA.

WADA should bind its athletes to drugs that have passed a gauntlet set up by a large agency like the FDA.

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