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The idea of a struggle against bioterrorism could find fertile ground amongst the healthy majority of the Russian population. Their compatriots in hospitals may disagree, however.
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May 30, 2007
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Russia Warily Eyes Human Samples
// In the Name of Fighting Bioterrorism, Export of Biological Materials Prohibited
The Russian Federal Customs Service (FTS) has shut down the export from the country of all human medical biological materials, from hair to blood samples. According to information obtained by Kommersant, the decision by the FTS was prompted by a report submitted to Vladimir Putin by the FSB that focuses on bioterrorism and the alleged development by the West of "genetically engineered biological weapons." As of May 28, the export of materials for clinical research and analyses is forbidden until further notice. This move could threaten the lives of dozens of patients in the country and completely paralyze clinical research trials being conducted by Western pharmaceutical companies in Russia, a business that is estimated to be worth $100-150 million annually.
Representatives of the pharmaceutical industry told Kommersant yesterday that two courier firms, DHL and TNT Express, informed their clients yesterday that as of May 29 a decision by the FTS prohibits the sending of biological materials out of Russia. DHL referred to an "internal directive" from the FTS and suggested to clients that they contact the Russian Consumer Protection Oversight Agency (Rospotrebnadzor) for an explanation of the decree. TNT said that customs officials at Sheremetyevo Airport had begun prohibiting the export of "all kinds of human biological materials" on May 28, in accordance with an "unnumbered communiqu? from the FTS" dated May 25. Mark Jordan, the commercial director for DHL in Russia, and Maria Astanina, the coordinator of clinical medical research for TNT Express, confirmed the information for Kommersant.

Federal Customs Service head Andrei Belyaninov also confirmed the existence of the ban yesterday, but he declined to provide any further details, saying only that the ban on the export of biological materials is a consequence of a "special regime" introduced by the FTS "on the initiative of the Ministry of Health." He conjectured that the grounds for the decision may be "scandals involving the transplantation of human organs."

According to data from TNT, every day around a hundred packages of biological materials are sent abroad by Russian hospitals for clinical analyses (they comprise the majority of biomaterials sent out of Russia), meaning that the ban on the export of biological materials will affect the health of thousands of Russian patients every month. Children's Oncology Center deputy director Alexei Mashchan told Kommersant yesterday that "if this is true, it is a cannonball to the gut for us." Much of the analyses that require the export of biological samples can only be done abroad, such as the selection of bone marrow donors, which is commonly done in German clinics.

Officials in the department of Rospotrebnadzor that grants permission for clinical and preliminary trials of drugs and provides federal oversight of the pharmaceuticals industry confirmed that the department knows about the FTS decree but said that the agency is not acquainted with the text of the document. A Rospotrebnadzor representative suggested that the decision by the FTS may be motivated by the Customs Service's intention to clamp down on the market for clinical trials in Russia.

Russia is fairly extensively involved in that market: around 28,000 Russians are currently participating in such trials. Generally, these patients have agreed to be guinea pigs in studies of the clinical effects of new drugs that are being developed by pharmaceutical companies, most of which are Western. Experts in the pharmaceutical industry estimate that the clinical trial market is worth $100-150 million annually. Glaxo Smith Kline (GSK) spokesman Alexei Brevnov told Kommersant yesterday that "this decree will be a serious blow to our nation's health Ц it will set it back years. It makes conducting clinical trials in Russia much more difficult." According to Mr. Brevnov, GSK recently had an similar run-in with the Russian authorities over a pediatric vaccine trial in a private clinic in Volgograd: the local prosecutor's office sued the company, alleging that the study was illegal, and pressed criminal charges against three doctors. In Russia, clinical trials are an obligatory step in the approval of any new drug for introduction into the Russian market.

Yesterday no one from either the FTS or the Russian Ministry of Health was able to explain the precise reasons behind the ban on the export of biological materials, a move that will have grave consequences for research and clinical analyses for patients in Russian hospitals. Kommersant has learned, however, that over the last several months large medical facilities in Russia that participate in clinical research for pharmaceutical companies have been receiving visits from FSB officials interested in the names of the drugs and of the partners in the research, the length of the trials, and the sources of financing for the studies. Moreover, a Kommersant source in one of the medical centers reported that FSB officials seized numerous documents, particularly copies of financial documents and informed consent forms signed by patients participating in the trials. FSB officials explained that the raid was part of the agency's struggle against "bioterrorism," a struggle that President Vladimir Putin approved in 2004 against what has so far been a phantom enemy. A source in medical circles who is acquainted with the situation told Kommersant that the ban follows the presentation of a report by FSB head Nikolai Patrushev to President Putin in early May of this year. According to the source, the report thus characterizes the situation in the market for clinical trials: several large Western medical centers that receive shipments of biological materials from Russia are said to be involved in the development of "genetically engineered biological weapons" for use against the Russian population. The list of organizations purportedly working on the project includes the Harvard School of Public Health, the American International Health Alliance, the Environment and Natural Resources Division of the US Department of Justice, the Swedish Karolinska Institute and Agency for International Development, and the Indian Genome Institute. Kommersant's source reported that the report contains a wealth of fantastical details about the development of "ethnically oriented" biological weapons capable of rendering Russia's population sterile and even killing it off.

Sources indicate that the ban on the export of biological materials was a direct result of a government memo signed by First Deputy Prime Minister Sergei Ivanov that was circulated on May 22, 2007 to Health Minister Mikhail Zurabov, FSB chief Nikolai Patrushev, Defense Minister Anatoly Serdyukov, and Justice Minister Vladimir Ustinov. However, it has so far been impossible to determine whether that memo was linked to Mr. Patrushev's report about bioterrorism.

Russian Academy of Medical Sciences President Mikhail Davydov told Kommersant yesterday that "the practice of joint research using biological materials has existed for a long time. We're talking about research in all spheres of medicine Ц hematology, oncology, morphology, molecular biology. Joint research is essential in many fields Ц we are lagging seriously behind our Western partners. For example, the most promising [option] in genetic engineering is to participate in joint projects with US institutions. Financing in our [two] countries simply cannot be compared: for example, the budget of the American Institute for Cancer Research is $17 billion. And the exchange of biological materials goes both ways: our Western colleagues send us their samples, and we send them Russian samples." He considers the FTS ban to be a threat to the development of such research.

Rospotrebnadzor head Gennady Onishchenko, on the other hand, sees nothing objectionable about the initiative. "In any civilized country, the export and import of biological materials is appropriately regulated in the interest of biological security. In 2004, the issue of biological security was brought up by the president of Russia," he said, without bothering to explain the reason for the ban.

Most of the Western institutions accused in the report are denying any participation in medical research at all. Ilva Sahlstrand, a spokeswoman for the Swedish Agency for International Development, said that her organization does not support such research and is not involved in conducting it. The American International Health Alliance made a similar statement to Kommersant.

Yesterday officials at Rospotrebnadzor could not say how long the ban on the export of biological materials will remain in force. "If customs officials decided to beef up their regulations and introduce restrictions, that is a change of government policy. We are an executory agency, not a legislative one," said an agency official. He warned that the FTS may order that the number of patients participating in such studies be slashed. "They could tell us to impose restrictions Ц for example, no more than ten people Ц and we would do that," he said.

Yesterday companies affected by the ban were reported to be considering a public appeal to the Russian authorities regarding the situation.

Kommersant will continue to follow any further developments.

Dmitry Butrin, Yulia Taratuta, and Afanasy Sborov

All the Article in Russian as of May 30, 2007

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