What are the drug laws in Russia?

  • I wouldn’t because the chances are it’s a placebo.

    More than half of the list of Russia’s blockbuster drugs have no proven effectiveness, according to the editor of “Republic” Ira Solomonova, who studied the latest report of the analytical company DSM Group, published at the end of January 2019 about the pharmaceutical market in Russia.[1]

    I spoke with a former top manager of Valenta Pharm, the second-largest pharmaceutical company in Russia, and he claimed that the company’s business strategy has always been marketing drugs with no proven effectiveness, as it’s cheap to buy its rights, manufacturing is low tech and no expenditure on scientific research is required. Invest a buck, get returns of the ten.

    In 2014, I chanced to visit the headquarters of Valenta Pharm, which I repeat is the second-largest pharmaceutical company in Russia. I expected a glass high rise, but what I saw were two three-story buildings, each roughly the size of the co-founder’s private residency, squeezed between two giant chimneys of a heating plant

    Valenta Pharm’s former headquarters in Moscow

    What about consumers?

    “They still believe in grandma’s’ natural remedies and healing power of amulets, so this is a giant step to them,” said the former top manager of Valenta Pharm.

    Through my work, I found out that many professionals treat the majority of Russians as ignorant, stupid, uneducated mass intrinsically incapable of rational and analytical thought.

    I was employed by a Valenta’s co-founder as a tutor to his children. The man with no education or background in pharmacology or chemistry purchased a Soviet vitamins-producing factory in the early 1990s with his friends.

    As the business flourished, the lives of its founders, who were still in their 40s, turned into one endless party, as they dumped day to day control of their business on “professional” managers with no oversight or a clear roadmap for its future development.

    This was clearly an imitation of Russia’s largest pharmaceutical company Pharmstandard owned by Abramovich, who’s far more interested in super-yachts and FC Chelsea than in Russia’s drug market.

    These are three examples of the blockbuster drugs from the top-10 bestseller list.

    Nearmedic Plus-manufactured Kagocel is the most popular antiviral drug in Russia

    The manufacturer’s website provides a reference to a large study carried out in 262 centers with the participation of almost 19,000 patients in Russia, Armenia, Moldova, and Georgia.

    However, this study was observational: the authors collected information on treatment in the framework of “accepted clinical practice in each country.”

    As a result, the duration of treatment with additional prescription of “Kagocel” was reduced from 8 to 7 days. This study design also does not comply with current international standards, and it is difficult to accept its results as proof of the drug’s efficacy.

    All the mentions of Cagocel in PubMed, an international database of scientific publications, are in Russian. In English-language publications, “Kagocel” is designated as a drug used in Russian practice, or as a drug that “can be effective” against viruses.

    I heard this story from my boss. The shareholders of the above-mentioned Valenta Pharm traveled to the US and bought a drug that had been disapproved by the FDA because it had failed clinical studies. The name of the drug is Ingavirin.

    Ingavirin is a Valenta Pharmaceuticals flagship drug, which made its owners, including my former employer, wealthy men. This is Russia’s second most popular antiviral agent, and like Cagocel continuously advertised on all the federal channels seemingly round the clock.

    All but one of the articles about Ingavirin that can be found on PubMed are written in Russian and, therefore, have not been published in international peer-reviewed journals. The available English-language articles describe experiments with mice and were carried out with the participation of the manufacturer.

    Most of the clinical studies were conducted in small samples and were designed so that doctors knew who was receiving the drug and who was receiving the placebo in violation of international standards for research on drug efficacy, and the same names are found among the authors.

    “There is still no evidence that it is effective. Again, there is a case of unsubstantiated pharmaceuticals. And recently a child form of the drug appeared. Studies proving the effectiveness and safety have not been published, ”said Vasily Vlasov, Doctor of Medical Sciences, Professor of the Department of Health Care Management and Economics at the Higher School of Economics, in 2015.

    Infamed’s Miramistin is Russia’s most popular antiseptic.

    According to the instructions, the drug should be used in the treatment of wounds and burns, in dentistry, urology, gynecology, as well as in the prevention of sexually transmitted diseases. Millions of moms spray their children’s sore throats with Miramistin.

    The State Register of Medicines contains records of three completed Miramistin trials initiated by the manufacturer. Of these, only one was double-blind, placebo-controlled, but the government registry website does not provide links to the results.

    There are 38 publications on Miramistin on PubMed, but not a single meta-analysis (review of several previous studies) or randomized controlled trials. They have little to say about how the drug works in real conditions in a living organism.

    Studies in which people did participate were conducted on minimal samples and without placebo control, which means that their results can be highly skewed.

    The drug may be working, but the evidence is still lacking. Most of the articles in both Russian and English were published in medical journals with a very low impact factor – less than one. For medical journals, an impact factor of about four is considered worthy, for the most authoritative Lancet, it is higher than fifty-three.

    Footnotes

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