Attempted pharmaceutical takeover: dangerous Russian immunostimulants are trying to penetrate the Ukrainian market

In 2014, Russian medicines were excluded from the State Register of Medicines of Ukraine. However, manufacturers from the aggressor country are still trying to penetrate the Ukrainian pharmaceutical market, disguised as European or Ukrainian brands (for example, Arbivir, and Imustat).

This was stated by Valentyna Chopiak, an immunologist, Doctor of Medicine, Professor, and consultant of the State Expert Center (SEC) of the Ministry of Health of Ukraine.

She recalls that until 2014, there were many Russian medicines in Ukraine, including those that were positioned as antiviral drugs for the treatment of influenza, ARVI, and other diseases.

"There was a drug called polyoxidonium, which was very popular at the time, prescribed for various diseases to improve the immune system. Now it is not available in Ukraine. But what the Russians did was to enter through Poland, and now it is supposedly a Polish drug. In general, they are now entering the European markets: for example, we found Arbidol production in Hungary and Cagocel in Austria," the professor said.

Immunostimulants or immunomodulators?

In fact, the harm from Russian drugs is not only because they are Russian, but also because they can cause immune refractoriness – an overworking of the immune system that can lead to the development of autoimmunity and the launch of immunoproliferative processes.

As Valentyna Chopiak explained, the practice of overstimulating the immune system during SARS was generally inherent in the Soviet school of immunology.

"I had a lot of arguments with these Russian manufacturers. They would come to me and ask why I didn't support their drugs, and I would say: "Guys, you have higher medical education, so why should we stimulate the immune system when we have a virus that works and stimulates it to work actively?" – the professor recalls.

Safety for the body

Unfortunately, Ukrainian antiviral drugs with immunostimulating effects can be dangerous for the immune system. The safety of medicines entering the Ukrainian market is controlled by the State Expert Center of the Ministry of Health of Ukraine. However, the current legislation does not oblige manufacturers to indicate in the instructions whether the drug can cause immune refractoriness, despite the fact that during registration, manufacturers must provide reports on the toxicity, mutagenicity, and other pharmacological properties of the drug submitted for registration. This should definitely be done in the future.

"The instructions for medicines may indicate side effects on the immune system, such as the development of urticaria or pain in joints, muscles, etc. These are clinical manifestations of an overstimulated immune system, followed by immune refractoriness ("blinding" of the immune system). As a clinical physician with 40 years of experience, I believe it is very important that this effect should be available for this category of drugs," says Valentyna Chopiak.

Unfortunately, regulatory documents do not oblige manufacturers to test their drugs for safety in terms of their effect on the immune system, so conducting such studies depends solely on the goodwill of the manufacturer, and the health and life expectancy of the person to whom the doctor prescribes the drug may depend on it.

"We mostly have studies related to the assessment of the impact on the immune system based on clinical indicators. However the studies that should have been conducted more in-depth – on the function of immune system cells – were conducted only with Novirin. The results are interesting, but they are not reflected in the instruction. Perhaps this is due to the small number of studies. Post-marketing trails were conducted with Proteflazid, which were related to the assessment of alpha-interferon synthesis. Proteflazid is an antiviral drug of plant origin that inhibits viral replication and, at the same time, to some extent, enhances the synthesis of alpha-interferon, which, in addition to its immunomodulatory effect, also has antiviral effects. It does not cause refractoriness (exhaustion) of the immune system, which is stated in the instructions for medical use of this drug. I hope that such studies will continue and that the manufacturers of all medicines with immunotropic effects will conduct appropriate studies and include information on the absence of immunotoxicity of each medicine in the instructions," emphasizes Chopiak.

According to the professor, the state should pay more attention to the issue of side effects of drugs on the human immune system, especially for immunostimulants and immunomodulators.

"After all, we have, for example, Aflubin, which, although it is a homeopathic medicine, is presented under the slogan 'stimulate your immune system'. There is also Amixin, a drug claimed to be an immunostimulant based on the active ingredient tyloron, which is a strong stimulant and affects the activity of bone marrow cells. That is, some drugs require more detailed research.

I emphasize that the issue of a refractory immune system remains very relevant because if we overstimulate the immune system, it later becomes refractory (insensitive), that is, literally "blinded" (temporarily paralyzed). This poses serious risks to the body – it excludes our immune system from the body's antiviral defense complex, which can even lead to death, can contribute to the chronicization of the viral process, and, ultimately, can accelerate the risk of oncogenesis," the professor warns.