Awards to pseudo - medicines

The pharmaceutical award was given to a drug with unproven efficacy – "Polyoxidonium"

Ilya Yasny, XX2 century

According to the results of the Russian Pharma Awards 2016 competition, which is held by the Doctor at Work service, the drug "Polyoxidonium" became the winner in the nomination "Immunomodulator of choice in the acute period of respiratory infection in frequently ill children". We decided to figure out what it is and how reasonable its use is.

The drug was developed in the USSR in the early 1980s, patented in 1996 and has since become a popular remedy used in In Russia and the CIS in the treatment of a wide range of inflammatory diseases. "Polyoxidonium" is a polycationic polymer, which, according to the manufacturer, has an immunomodulatory effect, has a direct effect on phagocytic cells and natural killers, and also stimulates antibody formation. By the way, the manufacturer of the drug is one of the sponsors of the competition – NPO Petrovax Pharm LLC. 

A cursory search in Pubmed – the international archive of biomedical scientific articles – yields about 60 references to the research of "Polyoxidonium", but most of them are published in Russian and in Russian-language journals. The few articles published in international journals with high citations relate to the effect of the drug on cells and do not include descriptions of animal experiments, not to mention clinical studies. The drug was originally used as an adjuvant – a substance that increases the effectiveness of vaccination due to nonspecific stimulation of innate immunity. And now "Polyoxidonium" is part of a number of Russian-made vaccines, for example, "Grippola".

Apparently, the drug does have some effect on the cells of the immune system, although the molecular mechanism of this effect is not reliably known. It is also possible that the drug works on some models of inflammation in animals. However, in order to recommend a drug for use in clinical practice, it is necessary that it undergo a number of human studies, and in accordance with a strict standard: these should be randomized controlled trials, preferably with double blindness (when neither the patient nor the doctors know which drug the subject receives – experimental or control) and multicenter. These studies should prove the safety and effectiveness of the drug, as well as provide an opportunity to study the behavior of the drug in the human body. Apparently, no such studies have been conducted with regard to "Polyoxidonium" as a means for treating infections in children. The few publications and reviews found do not allow us to conclude about the effectiveness of "Polyoxidonium" in the treatment and prevention of acute respiratory viral infections, since from the point of view of evidence-based medicine they do not meet the requirements for this kind of research: there are no pre-approved primary and secondary endpoints, there is no justification for the number of patients, as a rule, there is no blindness, etc. D. It is known from numerous examples of the history of evidence-based medicine that the effects obtained on small samples tend not to be reproduced in rigorous multicenter studies with a large number of patients. It is also impossible to rely on data obtained on cells and animals, especially in the field of immunology, and transfer them to humans without strict proof of safety and efficacy. And, worst of all, with an insufficiently studied safety profile, it is impossible to reliably predict what side effects the drug may have with prolonged use in a large number of patients.

We have to conclude that "Polyoxidonium" is another drug with unproven efficacy and high cost (the course of treatment will cost at least 1,500 rubles), and complain that doctors are so actively prescribing it, judging by the results of the survey of the Doctor at Work service. However, as far as it has been established, this drug is not included in the standards of medical care for acute respiratory viral infections and influenza, but it is included in the list of VED (Vital and essential medicines), as well as in the "Firing list of drugs" compiled with the participation of specialists from the "Society of Evidence-based Medicine Specialists". However, is it any wonder if in the Russian Federation the homeopathic "drug" "Anaferon" (another of the winners of the Russian Pharma Awards 2016) is included in the standards of flu care, which has no prerequisites for effectiveness at all, since it does not contain an active substance.

Portal "Eternal youth" http://vechnayamolodost.ru  12.12.2016