Pill Maria Sharapova took is not a doping agent, says Grindeks

The pharmaceutical company manufacturing Meldonium, which led to the suspension of former world number one tennis player Maria Sharapova, wants the drug to be unbanned.

'Meldonium should not be banned'

Meldonium was on the World Anti-Doping Agency’s (Wada) list of drugs being monitored until September 2015, and on 1 January 2016 it was added to the list of banned substances.

Sharapova, a five-time grand slam champion and the highest paid woman in sports, was suspended in March after she tested positive for the banned drug the day of her Australian Open quarter finals defeat to Serena Williams.

Read: Drug taken by Maria Sharapova is popular among elite athletes

"The company will continue to use all the options and will stand up for to the exclusion of meldonium from the WADA’s Prohibited list," it said in a statement. "Grindeks has a firm conviction that meldonium should not be included in the Prohibited list."

The pharmaceutical company said it is unclear to them why the WADA banned meldonium because it never gave any explanation of this decision.

WADA criteria for banning substances

A substance is considered for inclusion on the Prohibited List if WADA determines that it meets any two of the following three criteria:

1. There is 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;

2. There is 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;

3. That the use of the substance or method violates the spirit of sport.

Meldonium is classed as an S4 substance under the WADA code, which addresses hormone and metabolic modulators.

Read: Your guide to illegal sports supplements

Metabolic modulators are a newer class of drugs that benefit patients by modulating cardiac metabolism without altering the fluid dynamics of blood flow. They increase glucose metabolism at the expense of free fatty acid metabolism, thereby enhancing efficient use of oxygen.

Grindeks maintains that meldonium cannot improve athletic performance. It explained that meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells.

"The mechanism of action of meldonium is based on limitation of carnitine biosynthesis, which leads to deceleration of fatty acid oxidation and activation of glycolysis.

Meldonium is a cytoprotective substance

"Unlike carnitine, meldonium doesn’t cause increase of muscle mass and physical properties. Meldonium decreases cellular damage from ischemia by reducing accumulation of detergent substances (acylcarnitine and acyl-coenzyme A) in the mitochondria."

This means, stated Grindeks, that meldonium reduces the ability of an organism to use fatty acids as its energy source.

"This is important in the treatment of pathologies associated with heart muscle ischemia (stenocardia, heart failure), because in these cases the heart is not getting enough oxygen and nutrients."

Consequently, the company argued, meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells.

"It means that meldonium cannot improve athletic performance, but it can stop tissue damage in the case of ischemia. That is why this therapeutic drug is not a doping agent."

Since the shock suspension of 28-year-old Sharapova, other athletes have also been caught using the banned substance, reported AFP.

Use of meldonium is widespread

Russian biathlete Eduard Latypov is the latest to be caught using the drug at an event in February. Swedish runner Abeba Aregawi also tested positive in February, while 2015 Tokyo marathon champion Endeshaw Negesse, Ukrainian biathletes Olga Abramova and Artem Tyschcenko and Russian ice dancer Ekaterina Bobrova have also been caught.

The use of meldonium – the substance taken by tennis star Maria Sharapova – is widespread with up to up to 490 athletes using it during the Baku 2015 European Games, research conducted on behalf of the European Olympic Committees found.

A study published in the British Journal of Sports Medicine found that the use of meldonium is widespread amongs top athletes.

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"This study highlights the widespread and inappropriate use and prescribing of this prescription drug in a generally healthy athlete population."

The aim of the report was to identify the prevalence of meldonium use in the 5632 athletes competing in the Baku 2015 European Games held in Azerbaijan from 12-28 June 2015, with the purpose of contributing to the surveillance of substances listed on the 2015 WADA Monitoring Programme.

The reseach was conducted on behalf of the European Olympic Committees and found that up to 490 athletes may have been taking meldonium during Baku 2015 European Games.

It revealed that 13 medallists or competition winners were taking meldonium and it was was detected in athletes competing in 15 of the 21 sports.

^Sources:

^{British Journal of Sports Medicine, Meldonium use by athletes at the Baku 2015 European Games. Adding data to Ms Maria Sharapova’s failed drug test case; http://blogs.bmj.com/bjsm/2016/03/08/meldonium-use-by-athletes-at-the-baku-2015-european-games-adding-data-to-ms-maria-sharapovas-failed-drug-test-case/}

^{Sport24, 99 positive tests for meldonium since January 1; http://www.sport24.co.za/OtherSport/International/99-positive-tests-for-meldonium-since-january-1-20160312}

^{Grindex.lv; http://www.grindeks.lv/en/products/prescription-medicine/grindeks-brand-products/mildronate}

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