Russian President Vladimir Putin, right, meets with Greek President Karolos Papoulias, left, in the Kremlin on May 31, 2007.
Photo: Dmitry Azarov
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Paging Mr. President
// A Special Medical Report for Vladimir Putin
In an interview on Friday with journalists representing the countries of the G8, Russian President Vladimir Putin cast a doubtful eye on the advisability of transporting biological specimens out of the country, which was officially forbidden in a directive from the Russian Federal Customs Service on May 28 of this year. In reply to a question from Kommersant's correspondent during the interview, Mr. Putin explained that there should be regulations governing the transport of such "sensitive things," but that such regulations are not yet in place in Russia. The president also said that he does not know of any statistics concerning the medical help that the international exchange of biological specimens provides to Russians, and he requested that such statistics be provided to him. Here, Kommersant correspondents Yulia Taratuta and Alexander Voronov fulfill President Putin's request.
Russia's participation in clinical trials of new drugs is regulated by a government decree from June 16, 2005, "Concerning the Import and Export of Medicines Designated for Medical Use." The transport of biological specimens out of the country upon the request of the organizers of clinical trials (either foreign or Russian scientific institutes participating in joint studies) is mainly regulated by letters from the Russian Health Ministry from December 15, 2002 and May 15, 2004. On the basis of these documents, the Russian Health Oversight Agency (Roszdravnadzor) is authorized to give permission for biological specimens to be transported out of the country, as long as they are labeled with the protocol number of the study, the name of the research organization in Russia and of the organization that will receive the materials, an inventory of the materials that were brought into the country, the number of specimens in the shipment, and a description of the way the specimens are packaged.
Roszdravnadzor told Kommersant that last year the agency issued 791 authorizations for the transport of biological specimens out of the country within the framework of clinical trials being carried out abroad. In 2006, according to data from Roszdravnadzor, 42,241 patients participated in trials of 597 drugs, and, according to letter #01I-311/07, in the first quarter of 2007 the agency authorized the clinical trials of 136 drugs involving around 16,000 patients. For example, the Swedish company AstraZeneca AB received permission for a 31-month trial of the drug AZD6140, which "inhibits the aggregation of platelets in the blood, which may reduce the risk of clot formation…in patients with Acute Coronary Syndrome" (which includes two conditions, unstable angina and heart attack). In total, 1,065 patients being treated at 39 research institutes and hospitals across Russia are participating in the trial. One of the main participants in the study is the Educational and Scientific Medical Center of the Russian Presidential Affairs Department.
According to pharmacology researchers, the actual number of participants in clinical trials in Russia is close to 80,000, since the average length of a research study is around two years.
The Russian Health Ministry codified the requirement that new medicines have to be tested in trials involving Russian patients before they can be registered for use in the country in a decree dated May 19, 2003. The decree states that such trials are necessary to evaluate a medicine's scientific value, prove its effectiveness and safety, and gather data about possible side effects and interactions with other drugs during use.
Such clinical drug trials, conducted in accordance with the law "Concerning Pharmaceuticals," are necessary for the introduction of new drugs on the Russian market.
Pavel Tverdokhleb, a member of the presidential administration's council of experts in pharmacology, explains that the transport of biological specimens out of the country is unavoidable: the larger the number of participants in a clinical trial, the shorter the trial needs to be. "That's the reason that multinational studies involving several dozen countries exist," he said.
"There are many fields in Russian medicine in which the application of new drugs is absolutely essential, including oncology, cardiology, AIDS, organ transplants, and bronchial asthma," said Almedis pharmaceuticals company general director Natalia Kakitelashvili. "Medicines that have gone through a clinical trial are then registered [for use] in the country. Some of the medicines that go through studies become the standard of treatment, and the appearance of each new medicine offers the opportunity to extend patients' lives," she explained.
In reply to President Putin's question regarding the actual beneficiaries of clinical studies that necessitate the transport of biological specimens out of the country, Ms. Kakitelashvili offered an example from the field of oncology: "Four or five years ago, a clinical study of an anti-tumor drug called Gleevec was started, and now this drug is the standard in Russia for treating patients with chronic myeloid leukemia, a blood cancer. This is a life-saving drug, and it has helped thousands of sick people."
Mr. Tverdokhleb mentioned other examples: "Today Russia is involved in a program to help people who are ill with type-II diabetes. Three hundred and fifty people are participating in the program, and their specimens are regularly sent to Western clinics for analysis to determine [the participants'] reactions to the drugs. They have the opportunity to get well only thanks to this program. And because of the customs ban, 29 patients have been excluded from the study, even though they expected to receive a 30-day course of treatment, which is very difficult for a diabetic."
He believes believe that the case will be the same for programs that treat patients with multiple sclerosis. "This is a debilitating disease. Seven Russian scientific centers are involved in the clinical study. After their specimens were sent [abroad], all of the patients received the latest drugs. Now (after the ban) treatment for five of them has been cancelled – it wasn't possible to monitor their safety." The situation will be even worse for programs to treat breast cancer. Such programs currently involve patients at dozens of Russian medical centers: "Against the background of hundreds of patients who have been treated successfully, 20 people have been excluded from the study due to the ban on the transport of biological specimens out of the country, even though they had waited for the treatment and it was their turn. Their tumors are continuing to grow, but they cannot get quality medical help," said Mr. Tverdokhleb.
Mikhail Maschan of the hematology department at the Russian State Pediatric Clinical Hospital concurred that it is absolutely essential to send specimens to the West when treating patients. "We started doing bone-marrow transplants in Russia five years ago, and we manage to do up to 100 such transplants annually. Last year, 70 operations were done, each of which required specimens to be sent to the lone international bone-marrow donor bank, which is located in Germany. They choose donors based on an analysis of blood from Russians. These are really lives that have been saved. In addition, several times a month we sent specimens [abroad] for clinical diagnostics to confirm a patient's diagnosis."
At the interview on Friday, the idea of making a diagnosis with the aid of biological specimens drew skepticism from the president: "Where is it, this diagnosis? Show me statistics about people being given the correct diagnosis as a result of this work," demanded the president.
"Here's a last example for you," says Mr. Maschan. "There is a rare, sometimes genetic blood disease called hemophagocytic lymphohistiocytosis. Today there exist only a handful of laboratories in the world that can make the exact diagnosis. We have our first patient to be diagnosed with the disease. A year ago, we sent specimens to be analyzed in Hamburg, and now he is getting the necessary treatment. Now the mother of this child is pregnant again. We need to run an additional diagnostic test in utero on the basis of new analyses: if this isn't done – in other words, if the specimens are not sent – we will not learn whether the fetus is healthy or not. If the results of the analyses show that the fetus is healthy, we will be able to use the umbilical blood to save the first child. Mr. Maschan admitted to Kommersant that he had succeeded on Friday in getting three test tubes containing specimens across the border by carrying them in his backpack.
Meanwhile, a representative of a pharmaceuticals company told Kommersant that the company had tried to send a small specimen abroad yesterday as part of a clinical study. Customs officials, despite the fact that the company had secured permission from Roszdravnadzor, refused to allow the specimen to be sent.
Yulia Taratuta and Alexander Voronov
All the Article in Russian as of June 05, 2007
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