Tens of thousands of people who have undergone transplant organs live in Russia. Each of them is necessary to maintain the operation of the donor body, take medicines that prevent rejection. But what to do, if instead of an effective medication offer you an inefficient analog ?
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Currently, tens of thousands of people who have undergone transplantation of organs live in Russia. Each of them is necessary, to maintain the operation of the donor organ, throughout the life of the immunosuppressors – Drugs preventing rejection. They must be taken every day twice a day and the quality of these drugs depends on the life expectancy of such people. The basis of immunosuppressive therapy is two drugs – «Sandimmun Neoral» (the active substance of which is cyclosporin a), and «Sell-Sept» (Activity - Mikophenolate Mofetil). Both of these drugs are produced by well-known European pharmaceutical companies, long-known transplant doctors and are successfully used in many countries of the world.
However, in April 2008, transplanted patients in Russia first heard the name «Mayisept». The situation is as follows: from 2 half of 2008 patients with transplanted bodies, it is proposed to use the Indian drug, generic, that is, an analogue, a Swiss preparation «Sell-Sept», manufactured by company «Panacea Biotek». With drug «Sell-Sept» Russian nephrologists and transplantologists have been familiar for more than 12 years. The drug is comprehensively studied, the use, dosage, side effects. The introduction of this drug was very neat. And suddenly, it appears on the Russian market, an unknown person, anywhere, except India, Nepal and Sri Lanka (where a completely different genotype of a person) did not apply to the drug «Mayisept». Doctors have not seen this drug, do not know how, in which dosages to use this drug, which side effects it has.
The trouble is that the opinion of the doctors of officials is not interested. At the auction, which was won by the drug «Mayisept», No specialist in nephrology or transplantograft. And patients simply put before the fact when they come to the pharmacy with the recipe for the Swiss preparation will receive indian instead.
Coordinator of the professional service for rare expensive nosologies of the Formural Committee of the RAMS Professor Pavel Vorobiev believes that «from selling drug company «Panacea Biotek» will get huge profits, as it sells it to the state at an inflated price. A drug «Mayisept» Must cost 2-2.5 times cheaper than the original means, but the company has exhibited its drug at a price of only 12% below the original. It is also clear that without the introduction of reference prices for the vital medication, the further development of the country's drug segment will be accompanied by increasing corruption scandals».
Currently in the fight against «Mayisepta» The newly created interregional public organization of persons with disabilities and nephrological patients has joined «THE RIGHT TO LIVE». The press conference was held in «RIA News», performances in Ren-TV and NTV programs. Letters to the President of the Russian Federation were sent out, in the Ministry of Health, Rossdrav. From Rosšdrava, as from the organization, which was entrusted to deal with this question was received the answer that Rosserve share this concern, but in the auction, which was won by the drug Indian pharmaceutical company, was primarily the price of this drug. Although in November 2007, the head of RosSdrava, Mr. Yuri Belenkov said: «When selection of applications for participation in the auction, the quality of drugs will be taken into account. We cannot afford to experiment with such patients, they need reliable effective preparations, especially patients who have changed the transplant of organs».
In June, the International Congress of Negroologists was held in Moscow. At this congress, his participants were distributed questionnaires with one question: «Do you have experience and use of the drug «Mayisept»?». We got more than 300 questionnaires with the answer that this drug is not known how to use this drug nobody knows.
Organization «THE RIGHT TO LIVE» Requests for the countries of the European Union USA and Canada. The question was one: «Do you use the drug: «Mayisept»?» We think no need to explain what answer they received.
As for domestic transplants, their unanimous opinion expressed the leading Russian transplantologist, head of the branch of the kidney and liver of transplantology and artificial bodies, Doctor of Medical Sciences, Professor Jan Gennadevich Moysyuk:
«About this generic (preparation-copy of the chemical structure of the molecule, the content of the active substance in which differs from the original) — Mikophenolate Mofetile, produced in India, there is no scientific information according to world literature, neither by materials of transplantological congresses. I saw only one reference to the drug testing in India on a very small number of patients. Concerns of patients are not groundless, because with one of the Indian generics of the same company we had a sad work experience four years ago. The drug was not only not bioequivalent in the original drug, but also possessed significant side effects. Then we lost grafts in a number of patients.»
The situation cannot but cause anxiety and in patients and doctors. There is no one thousand patients on this drug, there are those who are treated for more than nine years, they are well adapted to it. The transfer of all patients in a massive order in one month to an unknown, not a proven drug does not correspond to neither medical nor scientific, nor human principles. I emphasize, we are talking about treatment that guarantees life. If the drug is ineffective or poorly tolerated, complications are possible, up to the loss of the transplanted organ. Patients whose transplant has long and therapy has been established, meet with a doctor once every six months, a year. Patients from regions living far from medical centers may be in a difficult situation without observation and without emergency.
Before Generic will take its place in everyday practice, he must pass tests — laboratory and then clinical. Copy can never exceed the original drug. At best, it will correspond to him. To clarify this, research is needed on groups of stable patients. Experts in the field of transplantology should be brought to a collegial decision, where and how to spend them. Then, even if the generic turns out to be at all effective, it will not harm patients, because patients will be supervised by specialists.
Only after that it will be possible to determine whether generic is rather effective and how different it differs from the original drug on the spectrum of side effects. This is a long and painstaking work, research should be held more than one month, because it is about life-lifelong preparation.
Transplantology Specific section of medicine. Here, as anywhere, the remote result is important. Achieve it depends on many factors, each of which, how small it seemed to someone, may be crucial. Medical support for patients with a transplanted organ, quality of drugs, their interaction between themselves is important. And therefore, any medicinal implementation in this area requires special caution, suspension.
To learn more about what is currently happening with the introduction of the drug to the Russian market «Mayisept» can be found on the Society of Disabled Society, nephrological patients «THE RIGHT TO LIVE»
