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International Centers as a Basis for Controlling Infectious Disease and Countering Bioterrorism

Lev S. Sandakhchiev,* Sergey V. Netesov, Raisa A. Martynyuk

Vector State Research Center for Virology and Biotechnology

Russian Federation Ministry of Health


The task of our panel is to examine the role of international collaboration in countering terrorism. In my presentation, I would like to address the need for international cooperation in combating bioterrorism.

During the past decade, policy makers and military and civilian experts have shown more and more interest in the bioterrorism issue. Much discussion and analysis has centered on possible biological agents of viral or bacterial etiology, scenarios of how to prevent and respond to the use of these agents, and epidemic response capabilities in terms of the availability of competent personnel and diagnostic and therapeutic products.

As a rule, the scenarios of bioterrorism incidents are far from optimistic in terms of both human casualties and costs associated with containing the direct consequences of such actions, not to mention the resulting economic breakdown in the region affected and the lasting psychological effect on the population.1

Terrorism is now a growth industry, and the possibility of a chemical or bioterrorist attack is increasingly defined as “not if, but when.” However, even the United States, which has longstanding experience in infectious disease control worldwide, developed its response plan, Biological and Chemical Terrorism: Strategic Plan for Preparedness and Response, only in the year 2000.2 This plan, which involves coordinated response to and elimination of such events by more than 10 agencies, is focused on five major areas:

  • Preparedness and prevention,

  • Detection and surveillance,

*

Deceased.



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International Centers as a Basis for Controlling Infectious Disease and Countering Bioterrorism Lev S. Sandakhchiev, * Sergey V. Netesov, Raisa A. Martynyuk Vector State Research Center for Virology and Biotechnology Russian Federation Ministry of Health The task of our panel is to examine the role of international collaboration in countering terrorism. In my presentation, I would like to address the need for international cooperation in combating bioterrorism. During the past decade, policy makers and military and civilian experts have shown more and more interest in the bioterrorism issue. Much discussion and analysis has centered on possible biological agents of viral or bacterial etiology, scenarios of how to prevent and respond to the use of these agents, and epidemic response capabilities in terms of the availability of competent personnel and diagnostic and therapeutic products. As a rule, the scenarios of bioterrorism incidents are far from optimistic in terms of both human casualties and costs associated with containing the direct consequences of such actions, not to mention the resulting economic breakdown in the region affected and the lasting psychological effect on the population. 1 Terrorism is now a growth industry, and the possibility of a chemical or bioterrorist attack is increasingly defined as “not if, but when.” However, even the United States, which has longstanding experience in infectious disease con- trol worldwide, developed its response plan, Biological and Chemical Terror- ism: Strategic Plan for Preparedness and Response, only in the year 2000.2 This plan, which involves coordinated response to and elimination of such events by more than 10 agencies, is focused on five major areas: • Preparedness and prevention, • Detection and surveillance, * Presenting * Deceased. author. Any comments should be sent to lev@Vector.nsc.ru. 1

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2 RUSSIAN VIEWS ON COUNTERING TERRORISM • Diagnosis and characterization of biological and chemical agents, • Response, and • Communication. Included in all of these areas are proposals for personnel training as well as investigation of and total preparedness for detection and elimination of consequences of possible attacks using chemical or biological agents in all states and cities. The key point is to design a multilevel laboratory network to efficiently warn public health authorities at the community, state, district, and city levels if biological and chemical agents are detected. This plan is aimed at significantly reengineering the existing infrastructure for infectious disease response and control. I would like to especially emphasize certain features that differentiate bio- terrorism from other kinds of terrorism.3 Explosive substances are fairly wide- spread and not very diverse. Chemical agents that could be used for terrorist purposes are well studied as potential chemical weapons, and detection proce- dures have been developed for many of them, along with measures for the treat- ment and decontamination of those affected. In case of biological agents, howev- er, it is an absolutely different situation. In nature, there are a great variety of viruses, bacteria, and fungi that cause diseases in humans, animals, or plants. Experts estimate that currently we are aware of far less than one percent of existing viruses and several percent of microbes. Nature is continuously creating new pathogens, the so-called emerging infections, and this potential is simply inexhaustible. During the last 20 years alone, scientists have discovered more than 30 new infectious agents (e.g., HIV, Marburg, and Ebola viruses) against which neither cures nor preventive drugs are yet available. As a result of their ability to change, known diseases such as influenza, tuberculosis, malaria, and some others can relatively easily overcome conven- tional immunization and drug-based approaches to prevention and therapy. Humankind has been fighting a biological war against microbes since its emergence, and even now infectious diseases account for almost 30 percent of worldwide mortality. Although experts on biological weapons and bioterrorism often operate with a limited list of several dozen infectious agents, we should not underestimate the possible terrorist use of any of the diverse pathogens existing in nature. Thus, the task of establishing a global system of surveillance for possible natural or artificial outbreaks is far more difficult than for chemical agents or explosives. It is important to realize that biological agents act over time and have a latent period during which the carrier of infection may find herself or himself in another city or even another country, where the outbreak of disease may be actually identified. It may take much time to prove the bioterrorist use of micro- organisms since it will require a comprehensive epidemiological analysis (e.g., investigation of all stages involved in the manufacture and distribution of food-

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 HIGH IMPACT TERRORISM stuffs, in the case of food poisoning). The well-known case of the terrorist use of Salmonella in a salad bar in Oregon in 1984 resulted in sickening more than 700 individuals. However, it was initially regarded as a natural outbreak, and only one year later it was proven that Salmonella had been used by religious cult extremists to prevent voting in Oregon. By the way, the U.S. public learned about that case many years after it occurred. Therefore, it is medical personnel that are the first to have to deal with biological incidents, and it is public health capabilities that determine the pre- paredness of a country, region, or city for timely detection and elimination of consequences of the use of biological agents. For this reason, financial and orga- nizational efforts should be focused on civilian rather than military agencies. The nation must be prepared to deal with the detection and elimination of consequences of outbreaks caused by any biological agent, including both con- ventional and exotic species of microorganisms. The existing systems for nation- wide epidemiological surveillance and control of infectious diseases should be capable of identifying, containing, and eliminating an infectious disease out- break regardless of whether it is the result of the natural manifestation of a pathogen or its deliberate use. All these features require that international collaboration be established in order to set up a system of efficient alert and response. This issue was specifical- ly addressed at the May 2001 54th World Health Assembly in the report by the Secretariat entitled “Global Health Security—Epidemic Alert and Response.” It was noted that in 1995 the World Health Assembly adopted resolutions WHA48.13 on new, emerging, and reemerging infectious diseases and WHA48.7 on the revision and updating of the International Health Regulations. The World Health Organization (WHO) totally realized the need for enhancing epidemio- logical and laboratory surveillance at the national level as “the main defense against the international spread of communicable diseases.” Increased population movements (through tourism or migration or as a re- sult of natural or technologic disasters or conflicts), growth in international trade in food and biological products, social and environmental changes associated with urbanization, and changes in food processing technologies, food distribu- tion networks, and consumer habits determine the likelihood that an infectious disease will emerge in a given country and so create a real threat to the remain- ing countries worldwide. The Secretariat pointed out the increased possibility of the intentional use of infectious disease agents and emphasized that natural epidemics and those due to the deliberate use of biological agents may manifest themselves in the same manner. The Secretariat also noted that the need for international cooperation on this issue appears far more important now than when this idea was discussed at the first International Sanitary Conference in 1851. Such cooperation has been maintained by WHO since its establishment in 1948. In 1997, WHO established a special system to seek, collect, and verify in-

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 RUSSIAN VIEWS ON COUNTERING TERRORISM formation on reported outbreaks. Based on the close cooperation of WHO Col- laborating Centers with governmental and nongovernmental agencies, the sys- tem provides information on confirmed disease outbreaks on the WHO web site (www.who.int/disease-outbreak-news) and in the WHO Weekly Epidemiological Record (www.who.int/wer). At global level, laboratory networking takes place (www.who.int/emc), focusing on such infections as hemorrhagic fevers (includ- ing Ebola virus) and poliovirus. Efforts are also devoted to preparation of data- bases such as the WHO antimicrobial resistance data bank (ARInfoBank) (www.who.int/emc/amr.html), influenza FluNet (http://oms2.b3e.jussieu.fr/flu- net/), rabies RabNet (www.who.int/emc/diseases/zoo/rabies.html), and others. WHO has called on its member states to establish partnerships to involve both civilian public health and military medical capabilities. WHO continuously draws the attention of its member states to the ultimate role of national potential in ensuring the epidemiological welfare of other coun- tries, so it plans to expand national training programs in intervention epidemiol- ogy worldwide as well as the Training in Epidemiology and Public Health Inter- ventions Network (TEPHINET). Major conclusions based on discussions of the Secretariat report were reflected in Resolution WHA54.14 entitled “Global Health Security: Epidemic Alert and Response” (http://www.who.int/wha-1998/ EB_WHA/PDF/WHA54/ea54r14.pdf). A good example that deserves serious at- tention and similar action is the establishment of the WHO Bureau in Lyon (France) as a model for using national potential to contribute to the training of personnel for countries at high epidemic risk (www.who.int/emc/lyon). At the global level, huge resources are already available to combat infec- tious diseases. Certainly, these will also be used to counter bioterrorism inci- dents.4 They include hundreds of WHO Collaborating Centers worldwide spe- cializing in certain infections; a Pan-American Health Organization (PAHO) laboratory network; the International Clinical Epidemiology Network (INCLEN); the Pasteur Institutes network; an international research centers network of the National Institutes of Health (NIH) that involves many universities across the United States; and the Centers for Disease Control and Prevention (CDC) offices in numerous countries, many of which conduct epidemiological surveillance and provide field epidemiology training for different regions. The U.S. Army and Navy have also established a specialized network of research centers in several countries. It should be noted that this particular resource is very much focused on specific tasks and, except for the Epidemiologic Intelligence Service (EIS) centers, is not oriented toward detection and identification of the entire pathogen range. As a matter of fact, to localize and contain unusual outbreaks posing a threat to global public health, WHO has set up task forces to be deployed during such outbreaks. A number of epidemics have been eliminated in this way in recent years, although this has required tremendous efforts in terms of coordination, material supply, transportation, communication activities, and so forth.

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 HIGH IMPACT TERRORISM Another approach was proposed by the outstanding epidemiologist Dr. D. A. Henderson,5 who, based on many years of experience as a leader and actual participant in the global smallpox eradication program, arrived at the conclusion that fixed-site international centers should be established in 15 regions of the world. These should include the following: • Inpatient and outpatient capabilities to deal with infectious diseases; • Research and diagnostic laboratories; • Epidemiological teams to function like the EIS to cover regions with populations of 2 million to 5 million; and • Education and training capabilities to provide training to national and international personnel. Systematic studies of a specific region make it possible to obtain invaluable databases, investigate different factors that can influence the epidemiological situation, and identify unusual cases requiring careful examination. According to Henderson, this network of regional centers should involve collaboration with such organizations as CDC, the National Institute of Allergy and Infectious Diseases (NIAID), and academic research centers. To provide stability and a legal framework, they should work closely with WHO and gov- ernment authorities in the countries where they would operate. The leader of the U.S. Emergency Interagency Working Group, Jewellyn J. Legster, evaluates Dr. Henderson’s proposal very highly, though the former be- lieves that prior to realizing this idea it is necessary to work to analyze existing regional capabilities and choose geographic regions at high epidemic risk. Such regional centers should also have research programs in epidemiology and the region’s key problems in terms of infectious diseases, diagnostic, and therapeu- tic means, as well as personnel training.5 As a follow-up to the U.S. Institute of Medicine recommendations, the WHO Department of Communicable Disease Surveillance and Response together with the International Center of Genetic Engineering and Biotechnology (ICGEB) and several nongovernmental organizations (Program for Appropriate Technolo- gy in Health [PATH], INCLEN, and TEPHINET, the so-called Alliance against Infectious Diseases) prepared a program proposal in 2000 entitled “Global Mon- itoring, Research and Training to Control Infectious Diseases.” In the initial stage of the program, 10-12 laboratories or institutes would be identified in strategically important regions at high epidemic risk and with insuf- ficient surveillance capabilities. Those laboratories should have laboratory and clinical study capabilities and a potential for conducting epidemiology work, access to air and ground transport, possibility of telecommunications installa- tion, and prospects for future expansion. Centers thus identified would have status as WHO Collaborating Centers and preferred access to WHO programs and those of Health Ministries in WHO

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 RUSSIAN VIEWS ON COUNTERING TERRORISM member states. They would be coordinated by the WHO Office of the Strategic Alliance. Each center would in turn be established by taking into account the region’s specific needs and, in the initial stage, would be provided with the necessary resources to create the most advanced potential for diagnostic, clinical, and epi- demiological activities. It also would be provided with telecommunications equipment to be able to communicate with the other centers, as well as with regional, federal, and international agencies involved in infectious disease sur- veillance and response. Each center would establish regional networks to include clinics, institutes, education establishments, and others, and it would participate intensively in the region’s infectious disease programs. The regional network would involve enter- prises manufacturing specialized pharmaceutical products that, through technol- ogy transfer, would be given an opportunity to meet the region’s needs for stan- dard diagnostic tests and therapeutic products. The regional network should also involve research laboratories that develop diagnostic and therapeutic products and vaccines, as well as biosafety research laboratories studying the safety of biological substances and microorganisms to humans and the environment. The program envisages that within 8-10 years, a worldwide network of re- gional centers would be up and running, and thus a long-term sustainable region- al potential for communicable disease control would be created. It is proposed that some of these centers would become centers of excellence like CDC, NI- AID, and ICGEB. The authors note that the proposed approach would represent the most reli- able way of preventing and dealing with possible future pandemics (for more information, send a message to WHO at allaid@who.int). In the above WHO Secretariat report, it was noted that possible mechanisms to support the initiatives to enhance epidemiological surveillance may be based on Article X of the 1972 Biological and Toxin Weapons (BTW) Convention. This article seeks to enhance international cooperation on the peaceful use of biological material, equipment, and technologies. Within the measures envis- aged, state parties would receive assistance in strengthening their potential in infectious disease surveillance and response, including research and develop- ment activities. Therefore, it is crucial that the above-mentioned international institutions not only provide the region’s epidemiological protection in case of natural or terrorist events using microorganisms, but also contribute to efforts in the ex- tremely difficult political task of confidence building, which is an important factor in enhancing the 1972 BTW Convention. For many years, our institute—Vector State Research Center for Virology and Biotechnology of the Russian Federation Ministry of Health—has been in- volved in combating viral infectious diseases. In recent years we have been

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 HIGH IMPACT TERRORISM discussing the prospects for reorganizing the institute into a regional center sim- ilar to those described above. The institute was established in 1974 with the task of conducting basic and applied research on extremely pathogenic viral agents such as the less-studied Marburg, Ebola, Lassa, and other viruses related to potential biological weapons (BW) agents. The research was aimed at assessing the potential threat posed by these agents and developing means for their diagnostics, prevention, and thera- py. Maximum biological containment laboratory facilities and clinical and epi- demiological capabilities were built, in addition to the standard engineering in- frastructure and a set of scientific and supporting facilities, including a laboratory animal breeding and holding facility. The total area of existing buildings and facilities amounts to 250,000 square meters. Before 1992, Vector received all of its funding from the federal budget and was just beginning to establish manufacturing activities. Access to workplaces by and communication with foreign scientists were limited. The same limitations applied to the participation of Vector scientists in international conferences and the publication of scientific papers. In 1989, it became obvious that Vector should be restructured 6 to adapt to changing economic conditions that ultimately resulted in a significant cutback of federal budget funding. A program was prepared for Vector’s long-range devel- opment, with the focus on conducting much more public health and veterinary medical research on infectious diseases such as HIV/AIDS, tick-borne encepha- litis, viral hepatitis A and B, measles, and others. This would include develop- ment of diagnostic tests, vaccines, and antivirals as well as establishment of manufacturing facilities for diagnostic, therapeutic, and prophylactic products. In 1993, Vector became a State Research Center and started to receive fed- eral budget funding to support its R&D activities through government civilian programs. The development of pharmaceutical manufacturing activities was sup- ported by government investments and credits, which allowed us to renovate and upgrade several facilities and purchase necessary equipment. Currently Vector is a scientific center consisting of six scientific research institutes and three daughter companies manufacturing a broad range of prod- ucts. We have managed to retain most of our key scientific personnel and estab- lish sustainable manufacturing activities. During recent years, Vector’s income pattern has changed dramatically. While in 1990 78 percent of funds came from the federal budget, in 2000, 77 percent of total income came from product sales. I would like to say a few words about the role of international foundations and organizations in Vector’s reorientation toward public health and agriculture- oriented programs. In 1992, the International Science and Technology Center (ISTC) was es- tablished as a nonproliferation-targeted program for the Newly Independent States (NIS). The same goal was set for the U.S. Civilian Research and Develop- ment Foundation (CRDF), which was established by the National Science Foun-

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8 RUSSIAN VIEWS ON COUNTERING TERRORISM dation in 1995, and for the Newly Independent States Industrial Partnering Pro- gram (IPP, currently known as Initiatives for Proliferation Prevention), which is operated through the U.S. Department of Energy with the involvement of the United States Industry Coalition (USIC). Collaboration with the European Union programs INTAS, Tacis, and others is opening up big opportunities. During 1995-2000, we completed 29 projects with these organizations. To- day, we have 26 active projects, including 23 ISTC-funded projects. In 1998, these projects began to play a significant role in Vector’s budget, whereas the contribution they made amounted to 30 percent of funds provided from the Rus- sian federal budget. In 2000, the funding under these programs had grown to almost twice as much as the funding provided from the Russian federal budget, and this year the amount of funding under project agreements that have been concluded is approximately $10 million. Grant funding and a transparent character of work allow us to receive our foreign colleagues and, in turn, travel ourselves to get acquainted with foreign laboratories. Vector employees have attended dozens of international conferenc- es and workshops. Hundreds of our scientists have visited their foreign counter- parts on-site. This has made it possible to create an atmosphere of openness and transparency at Vector, which is critical to science and scientists. Thanks to support provided for our scientific staff, we have been able to maintain our relationships with NIS scientists and scientists from other regions in Russia. Our employees attend international refresher courses, including English lan- guage training, patent and R&D commercialization classes, and training pro- grams in good laboratory, manufacturing, and clinical practices. These activities helped us realize that without implementing international quality standards in science and production, we could hardly hope that our R&D products would be competitive on the world market. Thanks to grant funding, our scientists are able to conduct research using up-to-date equipment and supplies as well as the latest techniques to gain world class results. I would especially like to mention the Biotechnology Engagement Program (BTEP) of the U.S. Department of Health and Human Services (DHHS). BTEP involves the study of infections such as HIV/AIDS that represent serious public health problems, field epidemiology of hemorrhagic fevers, (multi-) drug- resistant forms of tuberculosis, and research on hepatitis, measles, and variola viruses under an international program under the aegis of WHO. At Vector, we have one of the two WHO Collaborating Centers on smallpox (the other is at CDC, Atlanta), and we collaborate with WHO and our U.S. colleagues on a regular basis on this important program. The study of this infection is of special importance to current efforts to counter the bioterrorism threat. Very focused efforts are also being planned and implemented under the Defense Threat Reduction Agency (DTRA) Cooperative Threat Reduction (CTR) program with regard to bringing physical security and biological safety systems at the maximum biocontainment facilities at Vector up to the highest modern

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 HIGH IMPACT TERRORISM standards. Serious efforts are being undertaken to bring laboratory work with research animals and pharmaceutical manufacture at Vector’s daughter enter- prises up to GLP and GMP standards, respectively. We take very seriously the criticisms concerning the alleged use of U.S. government funds by Russian institutes for whatever prohibited purposes. These concerns have been voiced in the recent study prepared by the U.S. General Accounting Office and a study conducted by the Henry L. Stimson Center, and others.7 Despite the lack of evidentiary support for these statements, we should ad- mit that it could change the situation in principle if the recipient institution were operating on an international regimen ensuring confidence and transparency. For several years, we have been discussing this problem with representatives of the U.S. State Department, DTRA, DHHS, and Russian authorities, as well as with the scientific community at several international conferences.8 We are now in the process of discussing with DHHS experts a BTEP-ISTC project entitled “Develop- ment of Concept of an International Center for the Study of Emerging and Re- emerging Infectious Diseases.” This project proposes to define in greater detail the ways in which the above-mentioned approaches could be implemented. By an “International Center,” we mean an international organization estab- lished by an intergovernmental agreement, similar to those of ISTC or the Joint Institute for Nuclear Research in Dubna, the European Organization for Nuclear Research (CERN) in Switzerland, or the International Center for Genetic Engi- neering and Biotechnology in Trieste (Italy). Nonproliferation and threat reduc- tion goals can be achieved only through transparency and confidence building when the International Center is established and operated with free access to the program and results obtained, and with free access to financial information and to all facilities and all staff of the center. Continuous involvement of foreign scientists in work at this center would be a powerful instrument of confidence building. Although the process of establishing the International Center is complex and may take several years to complete, the proposed arrangement would provide for a long-term strategic collaboration, which is far less subject to political or eco- nomic fluctuations in member states. International partnership would accelerate the study of dangerous pathogens and the development of state-of-the-art public health products for diagnosis, prophylaxis, and therapy, as well as integration of our institution into the WHO international infectious disease control network proposed by the Strategic Alliance Initiative. The establishment of the proposed International Center would allow us to join our efforts to counter bioterrorism. It is, however, important to establish an appropriate regimen for the use of infectious agents and scientific results ob- tained to avoid their possible misuse for illicit purposes. I take this opportunity to emphasize the key role played by the staff of the Russian Federation Ministry of Industry, Science, and Technologies; the Russian

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0 RUSSIAN VIEWS ON COUNTERING TERRORISM Federation Ministry of Health; RAO BIOPREPARAT; the Russian Academy of Sciences; the Russian Academy of Medical Sciences; the Institute of Internation- al Security of the Russian Academy of Sciences; the U.S. Department of State; ISTC; DTRA-CTR; the U.S. Department of Energy; DHHS; CDC; NIH; the U.S. National Academy of Sciences; USDA; and CRDF in the development of international collaborations at Vector. ACKNOWLEDGMENTS I wish to thank Mr. V.V. Ryabenko and Mr. A.V. Mironov for their help in editing this presentation. NOTES 1. Preston, R. 1998. The bioweaponeers. The New Yorker (March 9): 52-65. Preston, R. 1998. Bio-warfare: fiction and reality. Genetic Engineering News (March 1): 6-39. 2. Biological and Chemical Terrorism: Strategic Plan for Preparedness and Response Recom- mendations of the CDC Strategic Planning Workgroup. April 21, 2000 / 49(RR04); 1-14. 3. Committee on R&D Needs for Improving Civilian Medical Response to Chemical and Bio- logical Terrorism Incidents. Health Science Policy Program. Institute of Medicine and Board on Environmental Studies and Toxicology. Commission on Life Sciences. National Research Council. 1999. Chemical and Biological Terrorism. Research and Development to Improve Civilian Medical Response. Washington, D.C.: National Academy Press. Proceedings of the Eleventh Amaldi Conference on Problems of Global Security. 1999. (Moscow, November 18-20, 1998). Moscow: Nauka. 4. Lederberg, J., R.E. Shope, S.C. Daks, Jr., eds. 1992. Emerging Infections: Microbiological Threats to Health in the United States. Washington, D.C.: National Academy Press. 5. Morse, S.S., ed. 1993. Emerging Viruses. New York: Oxford University Press. 6. General Accounting Office. 2000. Biological Weapons: Effort to Reduce Former Soviet Threat Offers Benefits, Poses New Risks. Report [NSIAD-00-138]. 7. General Accounting Office. 2000. Biological Weapons: Effort to Reduce Former Soviet Threat Offers Benefits, Poses New Risks. Report [NSIAD-00-138]. Chemical and Biological Weapons Nonproliferation Project. 1999. Stimson Center Report No. 32. Toxic Archipelago. Preventing Proliferation from the Former Soviet Chemical and Biologi- cal Weapons Complexes. Available on-line at http://www.stimson.org. 8. Sandakhchiev, L.S., S.V. Netesov. 2001. Strengthening the BTWC through R&D restructur- ing: the case of the State Research Center of Virology and Biotechnology “Vector.” The Role of Biotechnology in Countering BTW Agents. Amsterdam: Kluwer Academic Publishers; Netesov, S.V., L.S. Sandakhchiev. 1999. The development of a network of international centers to combat infectious diseases and bioterrorism threats. ASA Newsletter 70 (February 19): 2-6; Sandakhchiev, L.S. 1998. The need for international cooperation to provide transparency and to strengthen the BTWC. In Conversion of Former BTW Facilities. E. Geissler et al., eds. Amsterdam: Kluwer Academic Publishers, pp. 149-156.