“Hetq” conducted the following interview with Emil Gabrielyan, Director of the RoA Ministry of Health’s Center for Pharmaceuticals and Medical Technology Testing

-Mr. Gabrielyan, how are medicines licensed in Armenia and what is the process involved in their legal usage?

-Usually, the registration process for drugs takes up to five years. If, during that period, it is seen that the harm-benefit ratio of the drug or medicine in question is tilting towards the former, then the drug is not registered and is taken off the shelves. This is the standard practice used all over the world and supervision of the process doesn’t only take place here. The trial data is sent to an international center for evaluation. Drug makers are also interested in achieving positive results with new products as they wouldn’t welcome the negative publicity stemming from a poor quality product or one with unforeseen negatives consequences. I can also add that a few drugs were pulled from the market at the insistence of the producers themselves since it had been shown that the items were in fact doing more harm than good. In addition to standard trials, the drugs pass through a four stage clinical trial process. During the first stage, the drug is tested on young male volunteers to see what, if any, side effects come about. The second stage involves the drug being tested on a select group of patients; those ill with the malady for which the drug was intended. Usually, 150 individuals are involved in this stage of the research. During the third stage, trials are conducted at several centers involving thousands of patients who must come from different countries. Once having collected and examined all the trial data, the drug manufacturer must decide whether it is safe to go ahead and use the drug. As I said, this is a five year process and the drug is licensed only after it has been successfully completed.

-If we accept for argument’s sake that drugs manufactured in Armenia undergo the same rigid testing as imported drugs, then why is it that people usually complain about the quality of Armenian, not foreign, medicines?

-That’s a hard nut to crack. Maybe there’s psychological afoot here, claiming that the foreign product is best. In any event, oftentimes patients are thrown into confusion about their drug options by the very doctors treating them, and it’s because many of our physicians are poorly trained and haven’t kept up with the medical literature. It’ a sad fact of life and, in the end, it’s the patient that usually suffers. To prove my point, let me point out that when we conduct our studies we often find that a doctor has prescribed 2-3 different named drugs to the patient. The names are different but they contain the same active ingredients – in essence, they are the same drug. The drug has been manufactured by different firms under different marketing brands, but generically they are one and the same. Now, the poorly prepared physician, who hasn’t read the literature, prescribes the same drug several times to the patient and this can cause a fatal overdose. Then too, there are times when the physician tells the patient to make an effort and track down a certain imported drug when the same drug is produced her in Armenia and widely available. However, don’t get me wrong. I am not ruling out the possibility that poor quality drugs are produced in Armenia.

-In particular, patients with psychological disorders claim that when they take certain Armenian manufactured drugs like Triftalin, Diazepan and Benzonal, they become more , not less, aggressive. They claim that the Russian versions of these anti-anxiety relaxants are much more effective.

-As to the drugs mentioned, we have subjected them to rigorous examination far beyond the requirements of standard testing. In many cases a drug with the same name, e.g. aspirin, manufactured at different plants can have different reactions. What we must remember is that there are many nuances at work here as a result of the technology used in the preparation of the drug. Thus, there is an overall international standard – JMP. Even in the case of the smallest of deviations, two variations of the same drug, while looking alike externally, can have different reactions when taken. One can take effect immediately in a patient’s system while the other merely causes a weakened reaction. We also study this manifestation. We have the necessary technical equipment and, by the way, Armenia possesses the only fully laboratory in the region for this research. After all this multifaceted examination we have found no substantive difference between the drugs you mentioned and their Armenian equivalents. They are psychiatric drugs that are produced in Armenia by the “Arpimed” pharmaceutical company. Only after a second analysis of the drug Benzonal, did we find neutral elements that provide the drug rigidity and form. Certain changes were noted and we didn’t license the drug for usage. Rather, we suggested that the manufacturer make certain modifications. “Arpimed” did as we suggested and now everything is normal. I can think of no other evidence proving that Armenian drugs are of lower quality. Various problems may arise with certain patients, especially when they know they are being given Armenian made medicine rather than Russian. This, however, can be the psychological factor at work.

-But the relatives of psychologically impaired patients are also complaining. Are you saying that the same factor is present in all cases?

-These complaints can be categorized as anecdotal observations. I would really like to see dissatisfied patients come to us with the two drugs in question. We would also be interested to ascertain whether such views are subjective or objective in nature. The effects of the same drug given to patients under dissimilar conditions can also vary. I personally invite you to take part in the examination of these drugs and find out the truth in the lab itself.

-If the quality of Armenian drugs is on par with foreign imports, and their costs are relatively the same, why is it that foreign manufactured drugs never appear in the list of those used in government financed medical treatment? I ask this because oftentimes the Armenian drug can have unwelcomed side effects in the case of a specific patient.

-You should direct this question to those responsible for government financed treatment. We only deal with issues of a professional scientific nature.

-But this is an issue dealing with the medical profession. It relates to the psychological and other side factors you’ve mentioned that can negatively impact patients with psychological disorders.

-That is not our field of endeavor. We aren’t even included in that committee. We have not been given such obligations. Since I have no relevant information on the subject I would prefer not to offer any speculation.

-Mr. Gabrielyan, in your estimation, to what degree are consumers protected in Armenia when it comes to the purchase of bogus drugs, given the widespread prevalence of the problem?

-When we ascertain that a certain drug is counterfeit, we don’t advise the manufacturer of our finding. Our specialists make random purchases at drugstores and examine the product. We have uncovered a number of bogus drugs in this fashion. We immediately notify the RoA Ministry of Health, the RoA National Security Service and the World Health Organization. A few months ago we discovered such a bogus medicine being sold in our drugstores. We detected a Chinese biological additive that was being advertised on T.V. as a “wonder” male virility enhancer. We have a set rule in place that stipulates that if the item is a biological additive, the manufacturer cannot make specific medical claims. We examined the additive under the microscope and discovered that it contained double the normal dose of Viagra-like drugs. Now, if any male ingested a double dose of Viagra, he’d turn into a bull elephant but at a great risk. Even a normal dose of Viagra has been known to cause death. Imagine if someone took a double dose of the stuff? It’s mostly guys over 50 that use such virility enhancing drugs and such men are prone to suffer from a variety of cardio-vascular illnesses. Such drugs drastically lower the individual’s blood pressure. The poor guy’s heart can stop beating as a result. If we didn’t discover this, I am sure that the incidents of sudden death would have increased several fold. The stuff was being advertised as a plant extract with no deleterious side effects. This has become a convenient way for unscrupulous drug manufacturers to delude an unsuspecting public and circumvent the legal norms. Thus, we must constantly be on the alert for drugs that are potential threats to the consuming public. This battle against counterfeit drugs starts by effective monitoring of the numerous medicines being sold on the shelves of our local drugstore.

Editor’s note: During the translation of this article I went to the official website of the RoA Ministry of Health for reference material. It appears that the ministry hasn’t seen fit to offer an English version of the site – HG