Two sides of Meldonium

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Russian Sportmen’s Scandal Led to Several-Fold Higher Mildronate Sales

A doping scandal is a key event for sportsmen because not all of them can restart their career after such a shame, a country whose sport borders are weakened just before international competitions and even for prohibited drugs. Banned Meldonium reported to be found in doping tests of Russian sportsmen in early March led to short-term 2-fold or even 10-fold increase in the drug sales according to various data. Recently a consumer associated the product with another scandal that had negative influence on the sales. Now the product sales will increase again sure enough.

A sharp upswing

According to Arthur Belenko, a Commercial Manager of Mitsar-N pharmaceutical company, as compared with December, 2015, sales of Mildronate (INN – Meldonium) 250 and 500 mg tablets increased by 80% and 120-130%, respectively, on February, 15 – March, 15, 2019. He ascertained that, due to peak orders, December was selected as a comparison point and ampouled Mildronate did not demonstrate sales growth.

Anatolii Tentser, Development Manager of Katren SPC ZAO, reported that on March, 7-13 the product demonstrated approximately 10-fold higher sales, as compared with a mean value before the scandal. As explained by him, the first peak of excitement has slightly reduced already. Previously Mr. Tentser reported 15-20-fold increase in Meldonium sales on March, 7-8.

The boom involved even the State Duma pharmacy booth where all the product resources were purchased on March, 16. On his Facebook Dmitrii Gudkov, a member of the Parliament, confirmed the fact: ”They really purchased all the Mildronate in the State Duma pharmacy”.

A proven scheme

Expected sales growth is based on the similar experience in a pharmaceutical market. In 2006 Olga Pylyova, a Russian biathlonist who won a silver medal in an individual race at the Olympic Games (Turin, Italy) was deprived of the reward and disqualified for 2 years because of Phenotropil (i.e., original Russian product) administration. A representative of the Olympic Committee reported to WADA (World Anti-Doping Agency) that the product was used as doping by Russian sportsmen. So, it was included in the Prohibited Medication List. ­Despite failed career of the sportswoman, the product manufactured by Valenta Pharmaceuticals OAO met its floruit demonstrating a significant sales growth (see Fig. 1-2). According to experts, the cause was popularization of its doping properties.

Mildronate scandal was started in a similar manner. USA Anti-Doping Agency (USADA) got a line on the product used as doping by Eastern European sportsmen. It was distributed within the region only. Since October 2014 Meldonium was included in WADA-controlled medication list. At the end of the same year the drug was found in 2.2% of urine tests. Moreover, all of them belonged to Eastern European sportsmen.

In early March Meldonium was detected in doping tests of Ekaterina Bobrova, a figure skater; Pavel Kulizhnikov, an ice skater; Semyon Elistratov and Ekaterina Konstantinova, short-trackers; Eduard Vorganov, a bicycle racer; Alexandr Markin, voleyball player; Eduard Latypov, a biathlonist; Alyona and Alexei Mikhaltsovs, rugby players. Mariya Sharapova, a tennis player, admitted Mildronate administration voluntarily. Considering recent political situation, the scandal scale was much greater than Phenotropil one. However, experts do not expect equally successful sales of Mildronate, mainly, due to absolutely different properties of these products.

This is not Phenotropil

According to experts, Phenotropil is a ”strong drug” dealing with CNS diseases, intoxication, neurotic conditions, depression and psychoorganic syndrome. Owing to mental stimulating effect and improved endurance, it can influence on physical achievements. According to Mehman Mamedov, Professor, Head of Cardiovascular Risk Evaluation and Management Laboratory of the State Scientific-Research Center for Preventive Medicine, Mildronate is used as a second-line cardiological and neurological drug that relieves symptoms and, in turn, improves quality of life. He pointed out that despite improved endurance, the product does not have stimulating properties. At the same time, Mildronate’s manufacturer (Grindeks, Latvia) insists that Meldonium cannot ameliorate athletic performance. Moreover, Vitalii Mutko, The Minister of Sports, called Mildronate ”a good-for-nothing thing”. Nevertheless, the substance was included in the list of drugs whose use is prohibited by WADA during and out of a competition since January 01, 2016.

It is little wonder that doping tests were focused on Russian sportsmen in particular. ­To deforce the strongest national sportsmen of a right to participate in international competitions may be a kind of sanction that enables the USA to hurt the image of Russia. So, how was the drug whose doping properties are rejected unanimously by experts included in the ”black” list? ”Sportsmen were noted using the substance to increase their performance” – replied Ben Nichols, official representative of WADA, for request of ”The Pharmaceutical Herald”. However, evidences are still absent, despite the fact that, according to the Anti-Doping Code a substance/method is proposed to be included in the List on basis of medical or other scientific data, pharmacological effect or appropriate experience indicating its ability to improve athletic results by itself or in combination with other substances. In the words of Grindeks representatives, requests elated to the Committee’s decision ground are still unanswered.

Who is at fault?

How did it happen that sportsmen continued to use the drug suspected by WADA since autumn 2014? ”On September 16, 2015 the Executive Committee of the World Anti-Doping Agency approved the List of Prohibited Substances and Methods (2016). In Autumn 2015 the Federal Medical Biological Agency informed combined team physicians and Heads of the Federal Medical Biological Agency subordinate organizations about the fact” – confirmed a representative of the institution. On December 17, 2015 Head of the Ministry of Sports of the Russian Federation signed the Order no. 1194 ”On Approval of Substances and/or Methods Prohibited for Application to Sports”. To investigate causes of positive doping tests, an internal audit is being carried out in the Federal Medical Biological Agency now. In turn, sportsmen took various stands ranging from honest confession and reported drug withdrawal long before January 01, 2019 to suspected plant of Meldonium.

Lines of fortune

Up recently Mildronate name was directly identified with a multiple-year headline court proceeding. In 2009 23 patients demonstrated side reactions to solution collected from ampoules bearing a Mildronate label; two females died. As it turned out later, these ampoules contained Lysthenon with different pharmacological properties. 5 Sotex employees were arraigned. In 2008 Grindeks AO made a contract for production of 20% of injectable Mildronate available in the Russian market with the company.  After all the twists and turns (i.e., case papers were transferred from one court to another; judges could not define gravity of punishment) accused persons received an absolute discharge due to expiration of limitation period.

Thanks to the doping scandal, a consumer considers Mildronate previously associated with a danger to be a product that helps to discover new resources of a human body. According to Artyom Vardanyan, Commercial Manager of Kalina Pharm pharmacy chain, “This is a very efficient advertisement of Mildronate. Now a great deal depends on how the matter will develop considering unfolded data on addicting properties of the drug. Then, the demand will subside”.

Be that as it may, the drumbeat of Mildronate together with Grindex declarations of an intention to work for exclusion of their product from the ”black” list adds more ammunition to the product and its manufacturer. As they say, there is nothing extra in PR.