Check Meldonium: how took the decision to ban the drug

Production of Meldonium pharmaceutical plant in Riga

After the Russian athletes were found to use banned since the beginning of this year of Meldonium, Russian officials made statements in which he questioned the validity of the ban of the drug by the world anti-doping organization (WADA). On Thursday in interview to REN TV, the Russian foreign Minister Sergey Lavrov said that Russia is waiting for clarification of the relevant WADA, calling the ban of Meldonium “very strange, according to experts, the decision.” “Maybe WADA management had good reasons [to include Meldonium in the list of prohibited substances] that neither we nor to the scientific community and the expert community is unknown. But then these reasons need to be articulated,” said Lavrov.

American trail

WADA made Meldonium in the list of doping products at the end of September last year. The decision came into force on 1 January. Prior to that, during the year Meldonium were monitoring anti-doping Agency. In a press release regarding the recognition of the tennis player Maria Sharapova in long-term use of Meldonium indicates that this substance is included in list “due to evidence of its use by athletes with the intention of improving results.” The positive sample was taken from Sharapova at Australian Open in late January. In addition, the test gave a positive result for another nine Russian athletes. “As of 7 March we had 60 positive results”, — said the official representative of WADA Ben Nichols.

At the request of the RBC to comment on the inclusion of the drug in the representative list of the WADA has not answered, referring to the fact that all the information presented on the official website of the Agency.

The penalty and disqualification

From 30 to 50 thousand rubles.

In Duma Committee on physical culture and sport will develop a draft law on bringing athletes to administrative responsibility for drug use. The MST has supported it: according to the Deputy Minister of sports Natalia Parshikova, it’s going to be fined in the amount from 30 to 50 thousand rbl. the same is proposed to introduce fines for falsification of the results of doping control, distribution of doping drugs and aiding in proliferation. In addition to fines, the bill provides for automatic disqualification of any employee whose guilt will be proven.

Meldonium (also known as Mildronate) was developed in the 1970-ies the Institute of organic synthesis Academy of Sciences Latvian SSR and was originally used as a means to control growth of plants and stimulate growth of animals and poultry. In the 2000s, after clinical trials it was found to be effective for the prevention of coronary heart disease, improve brain blood circulation and has been used to treat abstinence syndrome in alcoholism. The drug is certified only in the countries of the former USSR, where is the free market. The evaluation of one of its creators, Latvian pharmacologist Ivar Kalvinsh, taking it up to two million people, including athletes. He “protect the athletes in case of overload, when you start to kill heart cells and muscle cells”, the scientist quoted TASS.

One of the first on the use of Meldonium athletes drew the attention of the American anti-doping Agency USADA — half a year before the incorporation of the drug in the WADA monitoring list. “Indeed, in March 2014 we received a private message about the use by athletes of Meldonium,” said RBC Ryan Madden, a spokesman for USADA. To inform details it has refused. According to USA Today, in the spring of that year, an unknown source has said that athletes from Eastern Europe are using Meldonium to improve the results.

Responsibility today

Now the law provides liability only for a trainer or a doctor for abetment to doping. PT. 6.18 the administrative code “violation of the legislation on physical culture and sport requirements on prevention of doping in sport and combat it” provides responsibility in the form disqualification from one to two years. If the same actions committed against a minor athlete, disqualified for up to three years.

Russian research

After inclusion of Meldonium in the monitoring list of WADA accredited laboratories have conducted studies of the prevalence of its use in sport and the effects that it has on athletes. Such works, in particular, were held in Germany and in Russia. The Russian study was conducted by the Federal state unitary enterprise “Antidoping center” — at that time one of the 32 laboratories in the world, possessing license to WADA testing for doping. In parallel work was started and at the German Institute of sport (DSHS) in Cologne.

In the Russian study, “Use of Meldonium (Mildronate) and emoxipin (Mexidol) Russian athletes: a study of prevalence” (RBC) was analyzed 4316 samples of Russian athletes. In 724 of these (17%) were found traces of Meldonium. On sports the highest percentage of using Meldonium was in Rugby (53%), and lowest in volleyball (4%). Among athletes, the rate was 11%.

“Given the rapid removal of drug from the body (24 hours. — RBC) and its high concentration in the sample collected, one can deduce that Meldonium is used as a pharmacological support of the Russian athletes”, — concluded the experts of FSUE “anti-Doping center” Timothy Sobolewski, Marina Dikunets and their then leader Grigory Rodchenkov.

A study of the anti-Doping centre was conducted from October 2014 to February 2015. The results were presented at the annual seminar of the Institute of doping analysis of the name Manfred Donica the part of the German sports Institute in Cologne (DSHS).

One of the authors of Russian studies Marina Dikunets, holding the position of acting Director of anti-Doping centre, RBC has confirmed the authenticity of the document. “Once WADA in 2014 included Mildronate in the monitoring list, our anti-doping laboratory was to provide screening for the content of any traces of the drug in the samples that came to us. The statistics that we received, based on the study of several thousand samples, testified that the drug indeed is actively used by athletes,” she says.

Dikunets said that no data about the names of the athletes, in samples which were recorded the presence of this drug. Samples collected in-competition and out-of-competition day in Russia, were brought to the laboratory representatives of the Russian national anti-doping Association — RUSADA. “Nationality and the names of the athletes on the samples are not indicated in accordance with the rules,” said Dikunets.

Without samples

Now your anti-doping Agency in Russia. Activities RUSADA and the Moscow anti-doping laboratory (FSUE “anti-Doping centre”) was suspended from 9 November 2015 decision by WADA in connection with the identified independent Commission of numerous violations. International anti-doping officials have accused the head of the laboratory Rodchenkova in the destruction of 1417 doping tests three days before the WADA test and the manipulation of the samples to hide the facts of doping Russian athletes.

Rodchenkov was immediately dismissed, and on November 16, according to Marina Dikunets, went to the USA. As later stated Vitaly Mutko, Rodchenko and his Deputy Timothy Sobolewski moved to Los Angeles.

“I have no data, where is Grigory Mikhailovich, says Dikunets. I respect this man, but after that anti-Doping center were quite difficult legacy. Now we don’t communicate”.

Now Moscow lab does not take samples for analysis and preparing documents for the restoration of the WADA accreditation. Theoretically, the ban can be lifted may 9, 2016 — six months after the suspension.

After the removal of ineligible from activity monitoring in Russia engaged in anti-doping Agency in the UK.

The analogue of doping

Russian study confirmed the widespread use of Meldonium in sports, and German is the fact that its effect is comparable to that already included in the doping list of drugs. The DSHS study, like the Russian, was completed by February 2015 and released in April, and in December was published in the journal Drug Testing and Analysis.

German scientists came to the conclusion that the effect of Meldonium on the body is comparable to the influence of the drug Trimetazidine, included on the prohibited list WADA since the beginning of 2014 because of its properties, “modulator of cardiac metabolism.” Scientists recommended that WADA ban for athletes the use of Meldonium.

One of the authors of German studies Wilhelm Sencer refused to respond to a request to RBC, referring to employment. But one of the co-authors Hans Geier told RBC that now publish the third study: it was conducted by a group of experts led by mark Stuart, a British member of the expert community BMJ in medical consulting.

According to the authors of the report DSHS, their research was partly sponsored by the Ministry of internal Affairs of Germany, part of the charity organization “Partnership for clean competition” (PCC). This organization was created with the support of the American USADA in 2008 to support fair sport. Since 2008, according to the organization, it has issued more than $11 million on research projects, of which $3.5 million only in 2014.

In the fall of 2015, the head of the PCC Michael Perlmutter welcomed the decision by WADA to include Meldonium in the list of prohibited substances, mentioning the project of the German scientists. “This shows the effectiveness of our methods of sponsorship,” added Perlmutter. Representative Madden, the USADA declined to comment on the relationship between his office and the PCC, the headquarters of both organizations are located in Colorado springs.

With the participation of Anna deriabinoi