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American International Health Alliance
Background on Kommersant Article
June 1, 2007

A May 30 article, “Russia Warily Eyes Human Samples,” appeared in the Russian newspaper, Kommersant, reporting a ban on shipment of all human biological samples out of the country.

The article was written in relationship to the recent prohibition by the Russian Federal Customs Service of the export of all human medical biological materials and its impact on the pharmaceutical industry and clinical research trials.  Most of the article focused on the impact of the export ban and the questionable basis for its application.  Justification of the export ban was alleged in the article to be an outgrowth of a recent FSB report about use of Russian biological samples by a number of large medical centers in the West for development of “genetically engineered biological weapons for use against the Russian population.”

The list of international organizations allegedly involved in this work, according to a source who claimed to have seen the FSB report, included the American International Health Alliance (AIHA), the Harvard School of Public Health and the Swedish International Development Agency (SIDA). (See article in English at: http://www.kommersant.com/p769777/
r_527Human_medical_biological_materials_export.

The full text is included below.)  Included within the article was a denial by both SIDA and AIHA that we had any involvement in the purported activities.

Given the nature of our capacity building programs in the Russian Federation and other countries in the region, the article and the misrepresentation of AIHA as being involved in medical research, clinical trials, and related export of biological materials came as a complete surprise. In addition to the immediate denial that was included in the Kommersant article, we quickly checked with our US partners to determine if any activities within our programs might have taken place that could have been even remotely characterized as being medical research related or involving the movement of biological samples.  Based upon the immediate and thorough response that we received, we are assured that our categorical denial is correct.

Late this afternoon, AIHA issued a press statement to the Russian press from its Moscow regional office to respond to the Kommersant article. AIHA has emphatically stated that its US healthcare professionals and institutions that currently work (or have worked) in the Russian Federation under the auspices of our programs do not conduct medical research or clinical trials of any kind, nor are we involved in the related transport of human biological materials. (See press statement attached.)

Since the May 30 article, follow-up stories in other news outlets, such as the Moscow Times, have focused their reporting on the use of biological specimens for pharmaceutical companies conducting clinical trials in Russia and for patients in need of analysis at foreign clinics, and the disruption of bone marrow transplants and other services relying upon analysis of tissue samples outside of Russia.  There have been no further references to AIHA.  We hope that our statement will fully reassure our Russian partners of our continued commitment to improving their capacity to address the complex health issues facing the people of Russia in a manner that is in full accordance with the laws, regulations, and guidelines of the Russian Government.  

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
<http://www.kommersant.ru/> , the decision by the FTS was prompted by a report submitted to Vladimir Putin <http://www.kremlin.ru/eng/> by the FSB <http://www.fsb.ru/> 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
<http://www.kommersant.ru/> yesterday that two courier firms, DHL <http://www.dhl.com/> 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 <http://www.sheremetyevo-airport.ru/> 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 <http://www.minzdrav-rf.ru/> ."
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 - 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 <http://www.fsb.ru/> 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 <http://www.kremlin.ru/eng/> 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 - hematology, oncology, morphology, molecular biology. Joint research is essential in many fields - 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 - for example, no more than ten people - 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

PRESS STATEMENT

Contacts:
Kubataev, Arsen
Regional Director
AIHA Russia
Tel. (7-495) 250-3072
a.kubataev@aiha.ru



WASHINGTON, DC and MOSCOW, RUSSIA, June 1, 2007 — In response to a May 30 article in Kommersant, “Russia Warily Eyes Human Samples,” the American International Health Alliance (AIHA) would like to set the record straight: We do not conduct medical research or clinical trials of any kind, nor are we involved in the related transport of human biological materials.

AIHA’s mission is to develop healthcare partnerships through peer-to-peer relations between US healthcare professionals and institutions and their counterparts in the Russian Federation and other nations. AIHA works closely with Russian healthcare institutions and health professionals to address critical health issues facing the Russian people. Our programs involve exchanging information, conducting skills-based training, translating and adapting international standard guidelines and educational materials, organizing workshops and study tours, and providing technical assistance to strengthen healthcare capacity.

During the past 15 years, AIHA has worked closely with the Russian Ministry of Health and Social Welfare to ensure that our activities are supportive of the needs of the Russian people and in full accordance with the laws and regulations of the Russian Federation.

With funding from our donors, including the United States Agency for International Development (USAID), the Global Fund for AIDS, Tuberculosis and Malaria, and the World Health Organization (WHO), AIHA has been engaged with many institutions within the Russian Federation, primarily with Oblast level hospitals and clinics, but also a number of leading hospitals and medical schools in St. Petersburg and Moscow. Among AIHA program accomplishments have been improved nursing skills, breast cancer and hypertension screening, neonatal resuscitation information and training centers, infection control protocols, and diabetes disease management. Working closely with the Ministry of Health and Social Welfare and key Oblasts, current AIHA programs are helping Russian healthcare providers address HIV/AIDS prevention, care, and treatment.

In view of the nature of our programs, the allegation in Kommersant is factually untrue. AIHA has reviewed all of its US healthcare professionals and institutions that currently work (or have worked) in the Russian Federation under the auspices of our programs and they are not using AIHA funding to conduct medical research, clinical trials, or the related shipment of biological materials from the Russian Federation. We look to Kommersant to publish a prominent correction to its May 30 story.

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