Sharapova scandal: Experts left perplexed over use of drug
LONDON: The medicine Maria Sharapova says she has taken for 10 years due to a family history of heart issues and diabetes is an old drug sold in just a few Eastern European countries that can also boost exercise tolerance.
The tennis star tested positive for the banned drug meldonium, or Mildronate, in a sample taken on January 26, the day of her Australian Open quarterfinals defeat to Serena Williams.
She said her family doctor had first given her the drug 10 years ago after she frequently became sick, had irregular electrocardiogram results, a magnesium deficiency and a family history of diabetes.
The 28-year old Russian, a five- time Grand Slam champion and the highest paid woman in sports, will be provisionally suspended starting March 12, the ITF said.
For the health conditions Sharapova says she has, however, doctors say the scientific evidence for Mildronate is limited compared with many medicines widely available in Europe and the United States, where Sharapova trains, which have full regulatory backing and years of robust safety and efficacy data. CHEAP DRUG Meldonium is cheap and available over the counter without a prescription in some eastern European countries, where it is marketed as Mildronate by the Latvian pharmaceutical firm Grindeks.
The drug, originally developed by scientists at the Latvian Institute of Organic Synthesis, is not licensed by two of the world’s
biggest medi- cines regulators: the Food and Drug Administration (FDA) in the United States where Sharapova trains, and the EU’s European Medicines Agency.
A spokeswoman for Grindeks said the firm had not applied for a licence for Mildronate from either the FDA or the EMA, but said the drug is registered in Latvia, Lithuania, Russia and other countries of the former Soviet Union.
Tim Chico, a consultant cardiologist at Britain’s Sheffield University, said it was unlikely that such a young and extremely fit woman would be suffering from a serious heart condition like angina, or would be able to play top level tennis if she were.
Asked how long the drug should be given to a patient, the Grindeks spokeswoman said in an email: “Depending on the patient health condition, treatment course of meldonium preparations may vary from 4 to 6 weeks”. Such courses could be repeated two or three times in a year.
Munir Pirmohamed, a professor of molecular and clinical pharmacology at Britain’s University of Liverpool, said the crucial issue with Mildronate for him is its lack of approval from EU and U.S. regulators. “As a physician, this is not something I have, or would ever, prescribe,” he said.
Others noted it was rare for a doctor treating illness to prescribe a drug that is unavailable in the country where the patient lives.
Whatever its medical benefits, research suggests Mildronate may have potential as a performanceenhancing drug
for sports.