Treatment of cardiovascular diseases is one of the most pressing problems: they are responsible for more than half of all deaths. In Russia in 2001 of them killed more than 1 million. 250 thousand people. The great achievement of modern medicine is to create drugs that can not only influence the symptoms (eg, to eliminate attacks of angina), but also reduce the likelihood of severe complications (myocardial infarction, stroke, heart failure, diabetes, etc.), ie ultimately extend the life of patients. These data are, oddly enough, little known to the general public, not least because the media prefer to report "sensational discovery", which in fact are not beyond criticism. Even worse - the aggressive advertising completely untested media, usually biologically active supplements (nutritional supplements), which creates the illusion of easily curable of all cardiovascular diseases. In fact, dietary supplements do not have medicinal properties, if any, they have identified in the application, they must re-register as medicines.
On the Russian pharmaceutical market registered a huge number of drugs (much longer than in other countries, particularly in the U.S.), differ greatly in efficiency and quality. The vast majority of them - the so-called generics, that is a copy of the original drugs. The original product developed, manufactured and fully tested (from tests on animals, ending the biggest tests for patients with tracing the influence on the outcome of the disease) a major pharmaceutical company. It is produced by special technology (which, together with the very drug usually patented). These are preparations with the highest degree of proof of their effect and they are expensive. Generics are copies of the same original drug, which produce a variety of pharmaceutical companies (from very solid to anyone not known) after the expiry of the patent for the original product, and their value is significantly lower. Active ingredient in generics - the same as the original drug. And prove their equivalence to the original medicinal product in the first place on how to penetrate the active substance from tablets in the body (through the so-called bioequivalence study, which is performed on healthy volunteers, comparing their drug concentrations in blood after taking the original drug and generic) . If all drugs be considered only in terms of active substance (the so-called International Nonproprietary Names), then between the original drug and generic competition, as well as between different generics no difference. In this we often try to convince government officials responsible for drug policy. Result: in the State Duma has repeatedly discussed the draft law on the transition to extract drugs from international nonproprietary names.
However, the real clinical practice convinces us that between the original drug and generic competition, as well as between different generics sometimes there is a very big difference. The causes are many. Despite the fact that the bioequivalence data are available for many generic (but, as it turned out, not for all, very interesting, what are the criteria to register those generics for which such data are unavailable), they can not be acquainted practitioner. These data are not available in references; registering drugs bodies and releasing their firms are in no hurry to share this information (you can guess why). It often happens that even with the full original bioequivalence of generic drugs and therapeutic properties of their unequal. This is explained by the fact that the efficacy may be affected by various fillers, as well as impurities, which can either not assessed at registration, or estimated in a very limited scale. For example, clinical studies conducted in Volgograd, pointed out that the effectiveness of different generic enalapril (to date them to the Russian market for some reason, more than 50!) - One of the most popular drugs for the treatment of arterial hypertension and congestive heart failure - may differ in several . Data on the absence of equivalence of the original drug and generic published extremely rare, which is understandable.
Therefore, the doctor is very difficult to understand the enormous amount of drugs and, accordingly, no less difficult to make a choice in the appointment of treatment a particular patient. The situation is complicated by the fact that doctors, unfortunately, often do not possess sufficient knowledge of clinical pharmacology, able to suggest the right path in choosing medications. The choice doctors pressured lists of so-called "soft drugs" and often representatives of pharmaceutical companies, the unproven claim that their generic and offering the best (sometimes personal property) to give preference to him.
Speaking of lists of "soft drugs", the principles of their formation are profound mystery. When one becomes acquainted with the latest extended list of soft drugs, published June 1, 2005, a specialist raises many questions. For example, why more than 20 registered generic one of the most popular drugs used worldwide for the treatment of hypertension, the list includes only 7, and by no means the most studied and not the cheapest, and do not include those which were large relative research?
Thus, to date very urgent is to get doctors objective information about the available medications, primarily related to the effectiveness and safety of generics used. The dearth of evidence on their comparative effectiveness and safety, and sometimes a conscious omission of such data led to the appointment of inferior treatment.
However, the real clinical practice convinces us that between the original drug and generic competition, as well as between different generics sometimes there is a very big difference. The causes are many. Despite the fact that the bioequivalence data are available for many generic (but, as it turned out, not for all, very interesting, what are the criteria to register those generics for which such data are unavailable), they can not be acquainted practitioner. These data are not available in references; registering drugs bodies and releasing their firms are in no hurry to share this information (you can guess why). It often happens that even with the full original bioequivalence of generic drugs and therapeutic properties of their unequal. This is explained by the fact that the efficacy may be affected by various fillers, as well as impurities, which can either not assessed at registration, or estimated in a very limited scale. For example, clinical studies conducted in Volgograd, pointed out that the effectiveness of different generic enalapril (to date them to the Russian market for some reason, more than 50!) - One of the most popular drugs for the treatment of arterial hypertension and congestive heart failure - may differ in several . Data on the absence of equivalence of the original drug and generic published extremely rare, which is understandable.
Therefore, the doctor is very difficult to understand the enormous amount of drugs and, accordingly, no less difficult to make a choice in the appointment of treatment a particular patient. The situation is complicated by the fact that doctors, unfortunately, often do not possess sufficient knowledge of clinical pharmacology, able to suggest the right path in choosing medications. The choice doctors pressured lists of so-called "soft drugs" and often representatives of pharmaceutical companies, the unproven claim that their generic and offering the best (sometimes personal property) to give preference to him.
Speaking of lists of "soft drugs", the principles of their formation are profound mystery. When one becomes acquainted with the latest extended list of soft drugs, published June 1, 2005, a specialist raises many questions. For example, why more than 20 registered generic one of the most popular drugs used worldwide for the treatment of hypertension, the list includes only 7, and by no means the most studied and not the cheapest, and do not include those which were large relative research?
Thus, to date very urgent is to get doctors objective information about the available medications, primarily related to the effectiveness and safety of generics used. The dearth of evidence on their comparative effectiveness and safety, and sometimes a conscious omission of such data led to the appointment of inferior treatment.
Only when the doctor is thinking about how effective and safe method, he writes and what he is waiting on his appointment, and the patient in this case would require him to appoint a proven (and not the cheapest medicine), the result of treatment will be effective reduction of cardio-vascular events indeed possible by using effective drugs.
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