In the Anti-Doping list there are a lot of drugs that are widely used in clinical practice, including non-prescription drugs.
Professor Dmitry Sychev, Head of the Department of Clinical Pharmacology and Therapeutics of the Russian Medical Academy of Postgraduate Education, said in interview with valdaiclub.com
, that according to some experts the infamous Mildronate drug with meldonium as active substance, banned by the World Anti-Doping Agency (WADA), has modest efficiency "evidence base". He urged not to politicize the restriction of this drug use by athletes.
Meldonium was isolated in the Soviet period. According to its action the drug belongs to so-called group of metabolic agents (sometimes referred to as a group of cytoprotectors, i.e. "protecting" the cells of the body from different impacts, especially hypoxia), that affect metabolic processes, in particular energy processes in cells. "The drug, affecting the cells energy, optimizes its operation by switching from one type of oxidation to another, energetically more favorable. This occurs in muscular tissue and other cells of the human body, with no specific effect on certain organ or tissue, "- professor said.
"I emphasize that the drug is unlikely to increase an [athlete] performance, mental or physical. On the basis of its mechanism of action the drug probably could contribute to a rapid recovery from the excessive overexposures, including sports," - said the expert.
"I am more aware how the drug is used clinically on patients. According to the official instruction for the medical use, Mildronate can be used to treat cardiovascular diseases, vascular brain diseases, alcohol withdrawal syndrome, in ophthalmology. There are several small studies, which show that Mildronate may be effective for these diseases. However, it is hardly possible to recognize that the results of these studies show high levels of evidence, " - Sychev said.
"In order to register the drug in the West, it is necessary to conduct several large-scale well-designed studies with massive sampling and randomization (random distribution of patients in groups), when comparing to placebo and the drug. The studies of this drug are not so extensive, and maybe that is why Mildronate did not penetrate to western markets and has a niche only in Russia and CIS countries, as well as many other drugs of the "metabolic series", which practically do not appear in the foreign clinical recommendations by professional medical associations (for example, cardiological ones) for the treatment of certain diseases, "- Sychev said.
Currently meldonium is registered only in the Russian Federation, in some CIS countries and Ukraine. In Western countries it is not used for medical reasons. The drug is manufactured by the Latvian company Grindeks in the form of tablets and ampoules. Indications for use are the following: coronary heart disease, chronic heart failure, various disorders of cerebral circulation, retinopathy, hemophthalmia, alcohol-withdrawal syndrome, decreased mental and physical performance.
The instruction for medical use, which was approved by the Russian Ministry of Health, prescribes: "The decreased performance, physical stress (including the athletes)”. "Last changes have been made before the WADA ban. Details are on the website of the State Register of pharmaceutical products. This is the official website of the Russian Ministry of Health, which accumulates all the official drug application instructions, "- the expert said.
According to professor, frequent and pronounced specific adverse reactions to the use of Mildronate are not described in the instruction for medical use; also there are no descriptions of withdrawal symptoms or mental/physical dependence. Abrupt withdrawal of the drug does not threaten human health. "The drug does not interact with other medications, it has a short washout period - about 3-6 hours, the drug metabolizes in liver. Generally, such metabolic products are well tolerated and do not cause adverse reactions. But some pharmacists are inclined to presume: if there is no adverse reaction, the drug has no effect," the expert said.
Dmitry Sychev believes that there should be no politicization of Mildronate introduction into the WADA list of banned doping. "In fact, in the list there are a lot of drugs that are widely used in clinical practice, including non-prescription drugs. In the banned list are not only Mildronate, but beta-blockers, which are used in almost all cardiovascular diseases (for blood pressure reduction, treatment of angina and heart attacks, heart rhythm disorders, etc.), diuretics, and even some cough and cold medications. Being in the WADA list, they are produced all over the world and have recommendations regarding relative diseases treatment.