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 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 quarter finals 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 International Tennis Federation (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.
LATVIAN 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
<GRD1R.RI>.
The drug, originally developed by scientists at the Latvian
Institute of Organic Synthesis, is not licensed by two of the
world's biggest medicines 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
license 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.
She said it is designed to treat patients with certain
cardiovascular diseases, including angina, chronic heart failure,
cardiomyopathy and other cardiovascular disorders.
Grindeks' also promotes it for people with reduced working capacity
from physical or psycho-emotional "overload", and during recovery
from cerebrovascular disorders, head injury and encephalitis. It is
not indicated for diabetes.
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 emailed statement: "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.
In an emailed reply to questions from Reuters about her medical
reasons for using the drug, Sharapova's lawyer John Haggerty said:
"While I cannot go into detail out of respect for the ITF process, I
can confirm that Ms Sharapova had abnormal EKG tests in 2006 and was
also diagnosed with asthenia (a lack of energy or strength),
decreased immunity and diabetes indicators."
"She also had a family history of heart conditions," Haggerty said.
"The Mildronate and the other medicines recommended by her doctor
treated these conditions."
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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.
"Sharapova has been a U.S. resident since early in her career, which
does bring in a question of how or why she is using a drug that is
not licensed there," said Tom Bassindale, a lecturer in forensic
science at Sheffield Hallam University.
Sharapova's agent Max Eisenbud was not available at his Miami office
and did not immediately reply to an email seeking comment.
HELPS MUSCLES COPE
Whatever its medical benefits, research suggests Mildronate may have
potential as a performance-enhancing drug for sports.
It reduces the level of a metabolite called carnetine in muscles,
and by doing that helps muscles cope better with high levels of
stress and low oxygen levels.
"Because it effects the cellular metabolism, it would increase
energy production within cells and therefore make oxygen utilization
more efficient," said Pirmohamed.
In a 2010 academic paper published in a review journal called
Seminars in Cardiovascular Medicine and cited on the Grindeks
company website, it has been shown to improve exercise tolerance in
patients with heart problems.
The World Anti-Doping Agency, which banned the drug in January after
previously having it on a "watch list", ranks it as a prohibited
metabolic modulator and cites "evidence of its use by athletes with
the intention of enhancing performance."
Grindeks says the drug could protect athletes from cell damage, but
says it would be unlikely to improve their competitive performance.
It would be "reasonable to recommend (sports people) to use
meldonium as a cell protector to avoid heart failure or muscle
damage in case of unwanted overload," the spokeswoman said.
Athletes "should not expect increase of physical capacity, but, for
sure, they will be protected against ischemic damages of cells in
case of overload."
(Additional reporting by Ben Hirschler, editing by Peter Graff and
Janet McBride)
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