Confronting biological threats to international security: a biological hazards early warning program.

Confronting Biological Threats to International Security. A Biological Hazards Early Warning Program RAYMOND A. ZILINSKAS Center for Public Issues in Biotechnology University of Maryland Baltimore County Catonsville, Maryland 21228 INTRODUCTION

In this chapter I propose the establishment of a new technical international agency-the Biological Hazards Early Waming Program (BHP). While the impetus for the BHP comes from the need to prevent and deter biological warfare (BW),this endeavor would be part of a larger program: The BHP would be charged with investigating any unusual outbreaks of diseases to determinewhether they have a natural origin, or are instead the products of laboratory development and attributable to accident or design. The major benefit society would gain from the BHP is that it would warn of the potential of an emerging disease for causing an epidemic or pandemic earlier than is currently possible, alerting health officials throughout the world to the danger it poses, thus giving them more time to institute timely and practical measures to stem its spread. Further, a BHP alert would quickly reach biomedical scientists, prompting them to initiate research on the disease and its causative organism. Research results could, in turn, lead to more rapid development of therapeutic medicines and vaccines than has been possible in the past. In fact, the BHP probably could be justified solely on its public health benefits; that is, being given an earlier warning of a natural biological threat than is now common, governments and international organizations can implement timely control measures that will forestall much misery and save money. The program’s positive, strengthening effects on biological arms control would be a bonus. In the four sections that follow I develop the BHP concept. In the first section I clanfy the nature of the biological threats to mankind posed by infectious organisms whose etiologies are natural reservoirs, laboratories, or biological weapons. This section concludes with a description of the international law that seeks to prevent and control biological arms, and it 146

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recounts past and ongoing attempts to improve its operation. In the second section, I advance a rationale for the BHP in view of potential biological threats, construct a legal basis for the program withm the context of existing biologcal arms-control measures, and describe and discuss the BHP’s structure, operation, and funding. I end the second section by describmg an existing agency that seeks to meet biological threats where they originate, namely the U.S. Navy Medical Research and Development Command (NMRDC),and consult its history to draw lessons that are applicable to the BHP. In the third section I share some thought on how our concept of security must change before biological threats to society can be adequately met and how the BHP fits within this changed concept. Finally, I reiterate and ampllfy some points regarding the importance of the BHP in the CONCLUSION. THE NATURE OF BIOLOGICAL THREATS

Biological Threats of Natural Origin The history of medicine teaches that when an infectious disease emerges, it can cause a severe pandemic until such time that the invader and the besieged come to an immunological “accommodation,”coexisting uneasily For example, although measles and syphilis are still serious threats to human well-being, the extreme manifestations presented by victims of these diseases when they first emerged hundreds of years ago are no longer observed, nor are these diseases as deadly as in former times. While the causative agents of some emergmg diseases can be fung~, rickettsia, or viroids, most are likely to be bacteria or viruses. However, because of the probability that future emerging diseases will most often be caused by viruses, and in consideration of the difficulties inherent to preventing and treating viral diseases as well as their BW potential, viruses and viral diseases are emphasized in this chapter. Some thuty or so diseases caused by viruses have been discovered or 1). In view of the recurring dangers recopzed since World War I1 (TABLE posed by emerging viruses, the National Institute of Allergy and Infectious Diseases, the Fogarty International Center of the National Institutes of Health (NIH),and the Rockefeller University in 1989 jointly sponsored a conference to clanfy the mechanisms of viral emergence and to develop strateges for anticipating, detecting, and preventing the emergence of future viral di~eases.~Papers presented at this conference, as well as investigations by McNeill,2Vella,4and Grmek5indicate that an infectious disease may emerge through the operation of any of six mechanisms (or combinations thereof):

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TABLE 1. Some Examples of “Emergmg” Viruses virus Orthomyxoviridae (RNA, 8 segments) Influenza Bunyaviridae (RNA, 3 segments) Hontaon, Seoul, and others

Rift Valley fevef

Symptoms

Distribution

Respiratory

Worldwide ( h m China)

Hemorrhage fever with renal syndrome Fever, may also

Asia, Europe, USA

Rodent (e.g., Apodernus)

Africa

Mosquito; ungulate

Brazil, Trinidad, Panama

Midge

CaUSe

Oropouch@

Natural Host

hemorrhage Fever

Togaviridae (Alpha)

“4

O’nyong-nyoe Sindbis“

Arthritis, rash Arthritis, rash

Africa Africa, Europe, Asia,Australia

Mosquito Mosquito; bird

Flaviviridae (RNA) Yellow fevef

Fever, jaundice

hemorrhage Encephalitis Encephalitis

Africa, south America Asia, Africa, South America, Caribbean Brazil India

Mosquito; monkey Mosquito; human; monkey Mosquito; bird Tick; rodent

Fever, hemorrhage

South America

Fever, hemorrhage

South America

Calornys rnusculinus Calornys d m u s

Fever, hemorrhage

West Africa

Mastornys natalensis

Fever, hemorrhage

Africa

UnknOWn

Fever, may also CaUSe

Rociff Kyasanur ForesP Arenaviridae (RNA, 2 segments) Junin(Argentine hemorrhagic fever) Machupo (Bolivian fever, hemorrhagic fever) Lassa fever Filoviridae (RNA) Marburg, Ebola Retrwiridae (RNA + rwerse transcriptase) Human immunodeficiency V ~ N S Poxviridae (DNA) Monkeypox

AIDS, AIDS-related Worldwide complex

? Primate

Smallpox-like

Squirrel

Africa (rainforest)

NOTE.Boldface indicates viruses with greatest apparent potential for emergence in the near future. “Transmitted by arthropod vector.


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First, when people move to a new habitat, they will inevitably be exposed to microorganisms against which they have little or no immunodefensex2Many will, as a result, become infected and, depending on the pathogen’s virulence, some will contract the diseases these organisms cause. It is for this reason that armies fighting far from their home base typically suffer more casualties from diseases than from the fighting itseK6To cite a specific example, durmg the Vietnam war disease accounted for 65 percent of U.S. casualties.’ Second, a population moving from one place to another may bring with it diseases against which the indigenous population is immunologcally undefended. The introduction of smallpox and measles into the Americas by European colonizers is an example of this mechanism of emergence. More recently, monkeys imported by a U.S. medical supplier from the Phdippines caused a new viral disease among the American animal handlers.* Third, an organism may exist in a locale for some time but the fact of its existence and its pathogenic potential do not become apparent until there is a quantitative or qualitative change that upsets the equilibrium of the environment in which that organism and humans exist. For example, when hotels, hospitals and other facilities were equipped with water-distribution systems, humans came into contact with a high number of a water-borne organism they otherwise encounter only rarely and in small numbers. Thus, the existence and pathogenic potential of Legionella pneumophilu, the causative bacterium of Legonnaire’s disease, became apparent only in 1976 when 221 persons suddenly contracted pneumonia whde attending an American Legion convention in Philadelphia (34 died). The etiology of the disease involved the evaporative coolmg system that circulated air in the hotel where the convention was held and where many of its participants lodged. The organism had been able to multiply in the system’s water tower, increasmg its numbers beyond a certain critical threshold. As a result, many hotel guests were exposed to an infective dose of the organism. Subsequent investigation showed that while the organism had caused isolated cases of dlness and small epidemics in the past, these had been misdiagnosed or classifled as having unknown eti~logy.~ Other epidemics caused by Legionella have occurred after 1976 and water distribution systems are usually implicated as reservoirs for the organism. Fourth, the vector that carries a pathogen may expand its geographic range. For example, it has been suggested that yellow fever may have spread from Africa to the Americas via this mechanism, by slave ships that carried the mosquito vector in their water stores. A current threat is Aedes dbopictus, the mosquito vector for the dengue virus. In the early 1980s some Aedes larvae were accidentally shipped form Thailand to Houston in water that had collected in automobile tires. The mosquito subsequently spread

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throughout the southeastern United States, although it has so far not been implicated as canying the dengue virus.l0 Fifrh, the pathogen may mutate; in rare cases a mutation will increase the pathogenicity of an organism. Viruses, in particular RNA viruses, have hgher mutation rates than other types of microorganisms. An example is the Human Immunodeficiency Virus (HIV),the causative virus of AIDS, which mutates with great frequency, complicating efforts to develop a vaccine against it. Sixth, the pathogen may undergo a genetic reassortment (orrecombination). Reassortment is especially likely to happen to viruses that possess segmented genomes, such as the influenza virus. A natural recombination may occur when two dissimilar viruses infect the same cell; the result is a new viral strain. For example, western equine encephalitis virus seems to have arisen from a recombination between a Sindbis-like virus and the eastern equine encephalitis virus that took place 100-200 years ago.” Other mechanisms of emergence may exist. For example, no one knows why certain diseases that plagued society in the past arose when they did or through which mechanisms. Diseases with evocative names such as the plague of Athens, mentagra, English Sweate, and encephalitis lethargica, are likely to forever provide fodder for intuitive analysis by medical historians and harrowing settings for mystery writers. Not all disease outbreaks arise from introductions or emergence of new or newly evident pathogenic organisms. Some important advances achieved in medical practices since World War I1 have altered the immunological accommodations between various microorganisms and human hosts. Two recent trends illustrate this phenomenon. First, the wide use of antibiotics has forced many bacterial species to develop antibiotic resistance as a survival mechanism. Most antibiotic resistance genes reside on plasmids, which are extrachromosomal and can be transferred easily among different species. Widespread improper use of antibiotics has led to many bacterial species’ having developed multiple antibiotic resistance, and it is beyond our ability to predict which bacterial species will develop resistance against which antibiotics. Second, medical treatment may severely stress the host, compromising her or his ability to generate an immune response sufficient to repel the microbial invaders. Radiotherapy, chemotherapy, dialysis, and some hormone therapies have immunosuppressive effects; advancing age and chronic diseases such as diabetes also lower immune defenses. Immunocompromised hosts are susceptible to infections generally, including some that are caused by normally benign microorganisms inhabiting many niches in our everyday environment. It is usually very difficult or impossible to predict which of these organisms may present “opportunistic” pathogenicity and which immunocompromised population they will be able to infect.


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Responsibility for meeting natural biological threats rests mainly with governments. Government agencies do not as a rule spring into action until the threat has been realized-that is, an infectious disease is apparent somewhere in the world and it is spreading. At that time, national public health agencies mobilize their resources to repel the invader, by attemptto restrict the entry of potentially contaminated products and infected individuals. If the disease gains a foothold in a nation, national public health agencies attempt to limit its spread by employing methods developed on the basis of epidemiology, preventive medicine, hygiene and sanitation, and quarantine. Sometimes a well-recognized and characterized biologcal threat becomes the target for concerted international action; for example, the World Health Organization’s (WHO)past program to eliminate smallpox and its current program for controlling AIDS.

BiologiCal T h w t s Stemming from Human Activities Threats stemming from human activities can be characterized as having one of two origms. First, they may emanate from R W D undertaken in the cidian sector relating to, for example, investigatorywork on dangerous pathogens, the field testing of genetically engineered organisms, or the marketing of products that in the long run prove to cause negative side effects. The regulating and policing of civilian R & D activities, whether licit or illicit, is done by competent civilian authorities. With the exception of illicit field testing of a genetically modified organism, they will not be considered in this section. Second, R&D undertaken by military or cidian laboratories may be done for the purpose of devising biological weapons. This type of activity is the subject of further discussion here. I begn by clarlfylng the characteristics of biologcal weapon systems. A biological weapon may be a low- or hgh-technology system. A lowtechnology biologcal weapon system has two components: an easily obtainable pathogen, such as those causing anthrax, cholera, shgellosis, and typhoid fever, and a container that holds a mass of pathogens while they are being delivered to its target. An example of a low-technology biological weapon system is a sealed glass container, such as a lght bulb, filled with anthrax bacilli and spores. Low-technology systems have limited military utility, but if used by unscrupulous and well-trained saboteurs or terrorists, they can cause heavy local casualties, alarm populations, and disturb civil governanceL2One important attribute of low-technology BW systems is that they can be assembled by virtually any qualified clinical microbiologist with access to equipment routinely employed in clinics and hospitals; t h ~ s makes the task of ascertaining that no one is developing low-technology

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BW systems impossible. Therefore, outsiders are likely to remain unaware of a program to develop a low-technology BW system until its product is actually used. A hqh-technology biological weapon system also has two major components: the pathogen and the delivery vehicle. Unlike the natural pathogen anrung the low-technologysystem, the hqh-technology agent would be the end-product of a sophisticated BW program to “weaponh” a selected bacterial or viral species. A hypothetical weaponized agent will differ from its natural relative in several important respects. It will have improved ability to survive storage in a munitions package; its resistance to desiccation, extreme fluctuations in temperature, and ultraviolet radiation will be increased; and it will be engineered to become inactive or die off within a short time after release. Simultaneously, it will be more virulent (have a greater capability of infecting its target host with a debilitating or fatal illness) than the natural form. The weaponized pathogen would be optimized through the use of a high-technology delivery vehicle, or munitions, that also will be the end product of a sophisticated engineering effort. The hypothetical delivery vehicle most likely will be capable of canying a militarily sigmficant quantity of the weaponized agent, virulence intact, to the intended target, where the payload will be disseminated so as to achieve its intended objective. To be militarily useful, the BW system (i.e., the weaponized agent combined with its delivery vehicle) will have undergone extensive field tests, to the point where its operators are certain that it will work effectively, dependably, and predictably. As far as is known, these attributes have never been combined successfully in one biological weapon system to the satisfaction of military leaders.*3J4It is therefore no surprise that when the matter of biologcal arms control came to a head in the late 1960s to early 1970s, the military in several countries assessed BW to be nonessential. We can surmise that when President Richard Nixon ordered the cessation of all offensive biological warfare R&D in the United States in 1969 and the destruction of existing stacks,15the Department of Defense (DoD)was in accord with his decision. While security experts did not consider biological weapons militarily useful in 1969, advances since that time in the biosciences and bioengineering provide grounds for changing this assessment. Many analysts believe that genetic manipulation and molecular biological techniques could be employed in efforts to design, research, and develop improved BW systems consisting of weaponized common bacterial and viral species or of unique strains custom-designed for a particular weapons system.1619The changed situation may be defined as follows: By now genetic engineeringt echques are so deeply rooted and widely spread throughout the world’s research and industrial laboratories that


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their use is routine. In the industrialized countries much of the expertise that could be relevant to BW resides in university and commercial laboratories that have no connection with the defense establishment. Given these conditions, sophisticatedR&D to produce a “perfect”BW agent could theoretically be done at any of about a thousand research laboratories in industrialized countries and about 50 in the Third World.20

Illicit national programs aimed at developing a high technology BW system will be difficult to detect, as has been demonstrated by the United Nations’ (U.N.) investigations of Iraq’s nuclear, chemical, and biological weapons development programs. Before these investigations were camed out, scholars could do little more than speculate on the scope and technical competence of these programs, especially Iraq’s nuclear weapons development program. The discovery by the U.N. inspection teams of the massive effort that Iraq had undertaken to develop nuclear arms, including the constructing and equipping of large and complex facilities, came as a surprise.21Since the demands of a nuclear weapons development and manufacture program is exceptional in terms of trained personnel, extensive facilities, and specialized equipment, such a program should be more easy to detect than an illicit program devoted to BW, where the technical demands are much less conspicuous. The fact that Iraq’s nuclear weapons program remained hidden presents a clear and ominous lesson: secret armament or rearmament programs undertaken in closed societies are llkely to remain secret. An illicit national biological warfare R&D program would therefore probably remain undetected unless revealed by accident or by the use of its products in warfare. The question, then, is how does the international community best prevent such a disastrous development or, failing this, how does it protect itself from the effects of that program?

Biological A r m s Control Society seeks to meet the potential threat of BW through two international arms-control treaties, the 1925 Geneva Protocol and the 1972 Biologrcal and Toxin Weapons Convention (BWC).The latter has largely superseded the first, although the Protocol is stdl the primary international treaty against chemical warfare (CW). The intent of the BWC is to prevent biological warfare. Its provisions and limitations have been discussed extensively, both in this volume22,w and elsewhere.” Despite the shortcomings of the BWC, the international political climate does not favor formulation of a new, improved multilateral biological arms-control treaty,24so no alternative to the BWC can be envisioned for the foreseeable future. The only remalning option is,

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then, for the international community to ensure that the BWC operates as efficiently as possible. The question of how to ensure that the BWC in fact operates at peak efficiency has absorbed the attention of security experts since the early 1980s.18ThreeReview Conferences of the BWC, held in 1981, 1986, and 1991, have attempted to strengthen the Convention. In particular, the Second Review Conference (RC2)adopted four sets of confidence-building measures to improve the operation of the Convention, enjoining signatory nations to: (1) Exchange data on hqh security containment facilities, including data on their work programs; (2) Exchange information “on all outbreaks of infectious diseases and similar occurrencescaused by toxins, that seem to deviate from the n o d pattern as regards type,development, [and]place or time of occunence. If possible, the information provided would include, as soon as it is available, data on the type of disease, approximate area affected, and number of cases”; (3) Encourage the open publication of results from bacteriological and biological research; (4) Actively promote international contacts between biological researchers, including joint projects between them.25 These confidence-building measures were improved on and added to by the Third Review Conference (RC3),which added declarations requiring signatory nations to describe past BW programs, declare ongoing biological defense programs, describe vaccine production programs, and notdy other nations of national legislation that implements the provisions of the BWC RC3 also set up detailed reporting proced~res.2~ W e it is too early to determine how nations will respond to the decisions taken by RC3, responses by governments to RC2’s decisions generally have been 1a~kadaisical.l~ In particular, most developing countries do not take part at all in these confidence-building activities, and many of the governments that do participate, do so in a perfunctory manner. For example, in the four information exchanges following RC2, no government has reported an unusual outbreak of disease to the U.N. Department of Disarmament Affairs. Yet even a cursory perusal of the issues of Weekly Epidemiologid Record (publishedby the WHO) or the CDC’s Morbidity and Mortality Weekly Report makes it clear that unusual outbreaks of diseases have occurred with distressing frequency between 1986 and 1990, as reported informally by local health workers. Why do nations fail to report diseases that by anyone’s definition “seem to deviate from the Aside from the aforementioned general failure of normal pattern . . . many nations to participate in confidence-buildingactivities, there are four likely reasons why governments neglect to report diseases: First, many countries, especially developing nations, do not have the


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resources to collect complete dormation about health and disease within their borders. The problem is compounded by lack at the local level of expertise and resources for analyzing the information that is available and for reporting information in a form that can be used by the international public health community. Second, some governments consider information about unusual outbreaks of disease that occur within their borders as state secrets. For example, former Warsaw Pact countries were notoriously secretive, unwilling to provide information about diseases, even if they directly affected neighbors. To illustrate, despite having the second largest enzootic (animal epidemic) plague area in the world, the U.S.S.R. declined to notlfy the WHO of human cases until 1989.28 Third, some governments either do not report or falslfy records to conceal the true incidence of disease outbreaks that they feel would reflect badly on the nation itself. For example, several countries that have been struck by cholera during the last two years have under-reportedthe number of afflicted citizens, possibly to avoid fnghtenmg off tourists. Fourth, some nations may indeed not have experienced unusual outbreaks of disease or recognized them as such. This is, however, not a reason to fail to provide as required by RC2. Whatever the reason for nations’ nonparticipation in confidence-buildmg measures, the end effect is the same-international trust in the BWC is not bemg enhanced; if nations continue to abstain from participation in confidence building, reliance on the treaty will continue to diminish. The weaknesses of the BWC, especially its inability to vedy that nations comply with the treaty, and the unsatisfactory response by governments to the decisions of RC2, demonstrate that the custom of dealing with biological- and toxic weapons control solely as an arms-control issue are futile. What can be done? While there is no one answer to this question, two new approaches for suppressing biological and toxin warfare may be presented. The first approach supposes that biological- and toxin-arms control is: . . . part of a wider societal problem not only having d t a r y , but also transcending scienufic, political, psychological and ethical dimensions. Consequently, the resolution of the BTW [biological and toxin warfare] problem wdl require an interdisciplinary effort, necessitatmg to a much greater degree than previously the active and direct participation of scientists, their professional organizations, and diplomats and security experts.24

T h s being the case, HedCn and I proposed that RC3 take steps to involve scientists and scientific organizations in biologcal arms-control a c t i v i t i e ~The . ~ ~ specific action that would lead to this outcome would be for the BWC signatory nations to activate the Convention’s Article X,

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whch enjoins signatory nations to cooperate in peacefully directed applied microbiology. We advised RC3 to raise the funds necessary to implement the Article and to request the International Council of Scientific Unions to devise an international scientific program that would include elements such as training, short-term exchange visits, joint research between scientists and between laboratories, and l d u n g institutes via computerized communication networks. Participating scientists would have a moral and professional obligation to report suspicious activity to their professional organization as they carry out their n o d activities of research, teaclung and training. In fact, RC3 did decide to activate Article X, but through the U.N. Secretary-General’soffice.26However, following the inauspicious example of RC2, RC3 neglected to provide the Secretary-Generalwith funds for implementing the decision.29 The countries that are already in compliance with the BWC and wish to demonstrate that fact would probably be the ones that promote the participation of scientists and their organizations in “ground-level”biological arms control activities along the lines we suggested. This idea would probably not be taken up by governments that wish to keep the BW option open. In particular, a rogue government that decides to commit to an illicit BW-development program is unlikely to permit free movement of foreign scientists, or even admit foreign technical observers. As noted above, the probability of an outsider detecting such a program would be very small. The first indication of a secret national BW program n q h t therefore be when a deliberately inflicted disease is identified and recognized for what it is. However, a suspicious disease outbreak does not constitute proof of BW: the etiology of the suspect disease has to be determined through an objective investigation, whose results should be openly published so that the international scientific community can assess the findings. This, I contend, should be done by interdisciplinary scientific response teams that can bnng their collective expertise to bear on suspicious outbreaks of diseases when and where they occur. A network of such teams, managed by international civil servants and operated under an international aegis, would constitute the BHP. The BHP, then, is the second new approach for controlling biological and toxin weapons

THE BIOLOGICAL HAZARDS EARLY WARNING PROGRAM (BHP)

Rationale and Legal Basis for the BHP The rationale for the BHP is that for reasons related to improving public health, safeguardingthe environment, and enhancing arms control, society


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requires a mechanism for discovering new infectious diseases soon after they emerge and for quickly determining their etiology. The legal basis for establishmg the BHP may be found in Article X of the BWC and in the decisions taken by RC2 and RC3. Although Article X has not been implemented, it is a legal agreement that the signatory nations of the BWC have agreed to uphold. The language of Article X encompasses the activities that would be undertaken by the proposed BHP (described below). The part of Article X relevant to the BHP reads:

. . . (the signatory nations] undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials, and scientdic and technological information for the use of bacteriological (biological)agents and toxins for peaceful purposes. Parties to the Convention in a position to do so shall also co-operate in contributmg individually or together with other states or international organizations to the further development and application of scientific discoveries in the field of bacteriology (biology)for prevention of hsease, or for other peuceful purposes. [Emphasis added.] In establishing the BHP, BWC signatory nations would de fucro implement Article X since they would cooperate with one another and with intergovernmental organizations to establish a technical agency that will employ scientfic methodology and applied microbiology for the prevention of diseases. Additional legal support for the BHP is provided by the decisions of RC2 and RC3. Perhaps most relevant is the second confidence-buildingmeasure formulated by RC2, which enjoins governments to report unusual outbreaks of diseases and provide sufficient dormation about these outbreaks so that their etiology can be determined. By agreeing to implement confidence-building measures, the signatory nations bound themselves to take a certain course of action but, as I have pointed out, most of them have failed to act on this commitment. Instituting the BHP as the international t e c h c a l agency that would be empowered to implement that particular decision of RC2 would fill the legal void that exists as a result of governments' inaction. Also relevant is RC3's forceful official statement on activatinghicle X, excerpted as follows: The Conference urges the United Nations and State Parties to take specdic measures within their competence for the promotion of the fullest international cooperation in this field through their active intervention. Such measures could include, inter aha: -transfer and exchange of dormation concerning research programmes in biosciences and greater cooperation in international public health and disease control; . . .


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-cooperation in providing information on their national epidemiological survedance and data reporting systems, and in providing assistance, on a bilateral level and/or in conjunction with WHO, regarding epidemiological surveillance,with a view to improvements in the identification and timely reporting of sgmficant outbreaks of human and animal diseases.26 The operation of the BHP would be entirely in accord with RC3’s decision since its raison d’itre will be to conduct epidemiological surveillance for the “identification and timely reportmg” of disease outbreaks.

Tbe BHP: Structure The structure of the BHP will reflect the framework for investigating infectious diseases provided by classical epidemiology. The application of epidemiology to investigation of allegations of B W has been considered in depth elsewhere,30but it is useful to review its essential aspects. The investigation of an outbreak of infectious disease has three interlocking components: field work, laboratory studies, and mathematical analysis. Field work comprises gathering data about the health event under scrutiny, using health histories of affected individuals, and the immediate biological and chemical analysis of blood, sputum, stool, urine, and other bodily effusions. Laboratory studies include the more complex analysis of physiological samples recovered by the field team, as well as of samples take from soil, water, and other material collected at the site of the outbreak. Mathematical analysis uses the data generated by field and laboratory studies to clady causal linkages between the etiology and the spread of the disease. If the data are of high quality, the analysts well trained, and advanced computer systems available, mathematical analysis may allow epidemiologists to predict both the course of a disease in a population and its future development The three interlocking components dictate a three-tiered organizational structure for the BHP.

First Tier: BHP Field Teams The first tier would consist of BHP teams working in the field. Some teams would be stationed more or less permanently in one place, where they can continuously monitor the local population and sentinel animals; others would reconnoiter selected geographic areas, examining sick persons, checking clinic and hospital records, trackmg unusual population movements, and spotting and diagnosing epizootic diseases. In order to carry out investigations efficiently, BHP field teams would need to be interdisciplinary, comprising physicians (to make physical ex-

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aminations, take patient histories, and initiate treatment), veterinarians (to examine and diagnose sick animals and to emplace and monitor sentinel animals), specialist microbiologsts (to screen for and identdy parasites, bacteria, and viruses), immunologists (to test sera for antibodies against disease agents), clinical biochemists (to analyze blood chemistries, blood gases, and electrolyte balance), hematologists (to do complete blood counts and measure coagulation activity),and histopathologists (toprocess tissue samples).In some situations, team members may have the expertise to cover multiple responsibilities, or samples may be collected for complete testing and analysis in better-equipped and better-staffed regional centers. The field teams would collect and process samples according to methods developed by the Canadian government and the U.S. A r m ~ , ~ and 23 would employ devices ranging from hand-held microscopes to transportable mass spectrometers to detect and identdy living and inanimate agents in field invesugations. Newly developed biosensors, whch exploit the ability of monoclonal antibodies, receptors, enzymes, and microorganisms to detect minute quantities of material with high selectivity, hold particular promise for BHP activities. Biosensors may also be used to detect CW agents, thanks to their ability to measure low concentrations of chemicals in the aqueous and gas phases. Second Tier: BHP Regional Centers The second tier would consist of centers located in regons where the probability of infectious diseases emergng is high. Regional centers would, accordingly, be responsible for fielding mobile teams and for supporting stationary field teams. Ideally, they would have laboratories staffed and equipped to perform the more complex studies of physiologcal and other material collected by field teams. For this purpose, they need to be staffed by well-trained scientific and technical personnel and equipped with instruments such as electron microscopes and gas chromatographs, which are important to the investigation of diseases but cannot be transported or operated in the field. When material requires specialized analysis for example, to detect and quantdy toxins, the regional center would have procedures in place for contracting out the analysis to appropriate international scientific institutions or reference centers, and for ensuring that well-preserved samples are forwarded to their destination safely and quickly. The regional centers would also be responsible for developing wideranging collaborative arrangements with international scientific institutes or reference centers with experience in exotic diseases. These arrangements should permit the BHP to bring the scientfic expertise and resources available in Western Europe, North America, and Japan to bear on the problem of detecting and analyzing disease outbreaks in remote regons.

I

a

AGENTS1

PURpmc (DIC FROM MANY

ULCERATIVE

6. NUCHAL RIGIDITY SYNDROME Leptospirosis, histoplasmosis, enterovirus infections, LCM, B. unthrucis (rare),encephalitis viruses

I 1 1 I

I

FIGURE 1. Symptom algorithm for diagnosis of biowarfare agents.

SYNDROME Sensory paresthesias and flaccid weakness, cranial nerve abnormalities

I

4. WATERY DIARRHEA SYNDROME Shlgellosis, salmonellosis, Campylobacter,EnterotolcigenicE. coli. Vibrioparahuemolyticus, legionellosis,C. dficile, Ginrdiu, Ebola, Marburg, staphylococcal, enterotoxin B

ABDOMINAL PAIN

3. DYSENTERY SYNDROME Blood & Salmonellosis mucopus Shlgellosis in stool Campylobacteriosis Hernorrhagc fever group *

4a. COPIOUSD Cholera, enterotoxigenic E . coli

-

'

'

2. HEMORRHAGIC SYNDROME GI bleedim Ihematemesis. melena.

hematoch&a], petechiae, 'echymoses, hematoma, epistaxis, uterine bleeding, gums, needle-site bleeding, hemorrhagic fever group, leptospirI esis. vellow fever. mvcotoxin Ti

II

Plague, RMSF, variola (fulminant] (rare),hemorrhagic fever group (rare),Staph., or 7. POLYARTHRALGIA OR POLYARTHRITIS SYNDROME strep., or meningococcal Chikungunya, Ross fiver, Mayaro, O'nyong-nyong sepsis (rare]

Ir

Coxello burnetn

.Brucellosis, Rh Valley fever, Dengue, VEE,

12. JAUNDICE SYNDROME Yellow fever, leptospirosis, legonellosis (late), hemorrhagic fever group (late, rare], aflatoxin, toxins

Cough, sputum, dyspnea, chest pain and tightness, hemoptysis, eyanosis, wheezing, abnormal chest x-ray

1. PULMONARY SYNDROME

11. OLIGURIC RENAL FAILURE SYNDROME KHF Complex, yellow fever psittacosis (rare), leptospirosis, legonellosis,

Fever, chdls, ngors, malaise, headache, eye pam,

6

'f

plex mycoplasma h ormthosis (m 10%)tularerma (m 20%) VESICULAR Vanola, vancella, monkey PUSTULAR pox, mehoidosis, tularemia, lay 3-7 enterowms, glanders CRAM M-. A T- n danders -.- - .-TI-n -. -I-J-s -Melinidnsis .-.-_ - - --__ --------

8. RASH SYNDROME

9. ENCEPHALITIS or ENCEPHALOPATHY SYNDROME Neurologic or mental abnormahties Encephalitides legionellosis Argentianian hernorrhagc fever Rh Valley fever (rare] < 1% Bolivian hemorrhagic fever

ODYNOPHAGIALassa fever (exudative tonsillitis) Coxsackie, botulism, S. pyogenes DYSPHAGIA Pontiac fever (Legionella). DRYTHROAT or Mycoplasma pneumoniae, PAINFULTHROATadenovims, parainfluenza

14. RAPIDDEATH SYNDROME Toxins

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Third Tier: BHP Headquarters The third tier would be a small BHP headquarters,which would provide administrative support for program activities, perform or oversee mathematical analysis of data from field and laboratory studies, and act as a secretariat for member nations. It may be quartered with the WHO in Geneva or the U.N. Department of Disarmament Affairs in New York. The BHP’s director would report the findings of investigations to appropriate authorities. Thus, if an investigation determined that the disease in question had a natural o w , the BHP would report its findings to the U.N. Department of Disarmament Affairs, the WHO, and national public health orgarzlzations.When appropriate, the BHP would “liaise”with the latter in efforts to control the outbreak. Indications of accidental releases of microorganisms would be reported to international and national health and environmental agencies. If, on the other hand, a BHP investigation finds evidence suggesting BW, the director d notdy the U.N. Security Council president and the U.N. Secretary-General, who would then decide what political actions are necessary and appropriate.

The BHP: Operations Ideally, the operation of the BHP would be automatic and no international organ or country should be able to stymie an investigation on political grounds. Initially the BHP would focus on human diseases (seeWheelisJ4for a different perspective). Thus, when an outbreak of disease is detected, or when rumors of a possible outbreak reaches BHP staff wherever located, the BHP would respond immediately by dispatching a small scouting team to the site of the alleged outbreak. Once there, the team leader would contact the nearest regional center by radio to apprise it about the local situation. If warranted, the center would begin to assemble a full investigation team and would contact national and local authorities, requesting permission to mount the mission and askmg for whatever assistance may be required. At the same time, BHP headquarters would be contacted and apprised of events. On receiving clearance from headquarters, the inspection team would be deployed and it would follow procedures for investigating suspicious disease outbreaks according to a protocol that had been formulated beforehand by the BHP. These procedures probably would look much like the 11-step framework for the field investigation of alleged biological or chemical weapons u~e,~Oand the symptoms algorithm shown in FIGURE 1.35 Practically spealung, many difficulties could hinder the BHP’s work.

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The major hindrances will more than likely be of a political nature. Most countries probably would collaborate with the BHP and its investigations because, as is discussed below, both governments and the populace stand to benefit from the BHP’s work to ease their disease burden. However, nations cannot, of course, be compelled to cooperate wikh the BHP or its investigations. History indicates that if a government refuses to cooperate, little can or will be done by the international community. For example, Vietnam refused to admit a U.N. team to the territory it controlled when the team sought to clarlfy the etiology of “yellow rain,”36and Iraq refused to cooperate with seven U.N. investigations to clarlfy the use of CW during the Iraq-Iran war.37Nevertheless, even if a government refuses to allow the BHP access to a site or seeks to hinder an investigation in other ways, suspicious activities can stdl be investigated from the outside, using data derived from the testimony of witnesses, analysis of samples from affected individuals, and, possibly, intelligence data. Moreover, refusal to cooperate would raise suspicions about the recalcitrant government’s activities, and possibly provide the international community with political grounds for collective actions, such as trade sanctions. It should also be noted that a government may acquiesce to a request from the BHP, but a localized conflict or banditry may present dangers to investigators, preventing them from reaching the affected regon. Many t e c h c a l problems are likely to create difficulties. Sometimes a disease outbreak will occur in countries or regons lacking adequate public health and diagnostic services, so information about it takes so long to reach the BHP that the outbreak is over and its traces are old or gone. Confounding factors, such as the presence of similar endemic diseases or attendance of several diseases in the attacked host, can camouflage the orign of a specific disease. Clearly, the task of determining the etiology of a suspect disease will require both the services of investigators endowed with slull, perspicacity and, sometimes, luck, and political support for the investigation through international and national cooperative efforts. Future review conferences of the BWC would be given the task of evaluating the effectiveness of the BHP. The usual criteria for measuring the quality of this type of program relate to either process or outcome. After the BHP has investigated several disease outbreaks, its process can be reviewed to determine whether the available resources and expertise were brought to bear on the problem in the most efficacious manner. The outcome of a successful BHP effort would be that outbreaks of infectious diseases are detected, and their etiology clarified, sooner than otherwise possible. Measuring this outcome will require extensive experience and data, so evaluating the BHP on the basis of outcome would probably not be possible until the program had been operating for some years. Process and outcome evaluations of the BHP should be carried out by outside experts


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from agencies such as the WHO or the CDC’s EpidemiologicalIntelligence Service (EIS),and the findings from the review should be used to improve future BHP investigations. Assuming adequate operation and the availability of requisite resources, the international community might at some future time wish to expand the BHP’s purview. Two possibilities present themselves. First, the BHP may develop the expertise to investigate diseases that strike animals and plants. As is the case with biologcal threats to mankind, animals and plants face biologcal threats that emanate from nature or, possibly, the laboratory. The BW threat in this regard should not be neglected; terrorists or saboteurs deploying biologcal weapons could relatively easily cause enormous economic damage to a nation by infecting animals or plants important to its agriculture. Investigations of animal diseases would make it necessary for the BHP to cooperate with the International Office of Epizootics in Paris and the Food and Agricultural Organization (FAO)in Rome; the investigation of plant diseases would necessitate close liaison with the FAO. Second, the dark side of biotechnology includes not only BW, but also the illicit testmg and distribution of biologcal agents. Already certain biotechnology-derived drugs, especially human growth hormone and erythropoietin, are being abused, and demand for them has created a thriving black market for these substance^.^^ We can expect that as biotechnology is exploited more widely, and as biotechnology-based industries generate significant profits, unscrupulous operators will make illegal efforts to circumvent intellectual property laws by setting up manufacturing facilities in countries lackmg patent law and regulations. It is also possible that as the cost and complexity of environmental and health regulations in Europe, Japan and North America increase, unethical researchers or businessmen may take advantage of countries with weak or nonexistent regulatory agencies to test or produce genetically engineered products without assuring adequate safeguards. Testing under these conditions would certady be inexpensive, but might result in incalculable damage. A well-equipped and well-staffed BHP could be given the additional mission to detect and venfy these and other illicit activities.

The BHP: Funding Information about the cost of establishing and equipping of U.S. Naval Medical Research Units (NMRUs) provides ground for estimating BHP It would cost $5-10 million to set up and equip a BHP regional center comprising administrative facilities and a diagnostic laboratory, and $2-5 mdlion per year to operate such a center. On this basis, the cost for

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setting up a BHP operation consisting of a secretariat and four regional centers (in Africa, Asia, Eastern Europe, and Latin America) would be $21-42 million, with annual operating costs of $8-20 million. In addition, there will be the costs of equipping and operating field teams, which would depend on the number and staff requirements of the teams. My rough estimate is that it would cost less than $50 million to establish a barebones BHP (consistingof headquarters and four regional centers, each with two field teams), and $12-15 million per year to run it. The question of how and by whom the BHP would be funded may be problematic. On the one hand, in an era or budgetary constraints the cost of building a sophisticated international biological hazards program could be so daunting that poorer nations would refuse to support the BHPj furthermore, some governments habitually reject proposals for additional U.N. or U.N.-related organizations. Moreover, BWC signatory nations have by and large balked at funding the operation of the treaty, including attempts to activate Article X,severely hindering its operation. Conversely, nations might find the utility of the BHP so high that they will be willing to bear its costs. For one, it is beyond the means of many developing countries and small developed countries to fund and operate the sophisticated surveillance systems that the U.S. and larger industrialized countries have in order to protect themselves from biological threats and to monitor BWC compliance. For these countries the BHP would be a bargain, supplying them with the means to defend themselves from biological threats, including BW, at a low cost. My assessment is that initial funding for the BHP probably would have to come from a select group of developed nations with a history of commitment to biological arms control, such as Austria, Canada, Finland, and Sweden. The governments of these nations often have taken the lead in implementing far-reachmg, long-term international projects focusing on environmental and health issues; the BHP, or a similar organization, would certainly fit into h s category. The main task is to present them with a compelling rationale for action on the BHP and to estimate how much it would cost. After the BHP is established and has been operational for some years, its worth should be demonstrable, and it would attract support from more nations. Since establishmg and funding the BHP may be problematic, mght it not make more sense to set it up by expanding the scope of an existing international agency? The WHO, with its history of mobilizing resources to fight against infectious diseases, appears the most logical choice to lead a BHP-type program. The suggestion that on the international level the WHO should take a lead role in monitoring BW-related developments was, in fact, made already in 1968, when diplomats were formulating the BWC.a However, with one the WHO has avoided addressing

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BW issues. On a more practical level, the WHO does not field detection teams. This is not to say that it could not do so; if its member countries provided the commitment and resources, the WHO could easily create a program devoted to BW and take the steps required to set up and train field teams. The option of member nations’ assigning the WHO responsibilities akin to those that I have outlined in t h s chapter is certainly a viable one. Whether it operates under the auspices of the WHO, is established as a new international technical agency, or becomes part of a future international verification agenW2ultimately makes little difference. What is important is that an organizational unit like the BHP should be set up to meet the biological threats to mankind.

Tbe NMRDC:Meeting Biological Thmats to U.S. Security In developing an operating plan for the BHP, it is worth considenng how existing organizations responsible for biological defense operate. My research indicates that in the United States there are three agencies whose operations have s@cant relevance to the BHP: the Centers for Disease Control, particularly its Epidemiological Intelligence Service, the U.S. Navy Medical Research and Development Command, and the U.S. Army Medical Research and Development Command (AMRDC).(A fourth organization, the Biological Threat Analysis Center, which is part of the DoD‘s Armed Forces Medical Intelligence Center, also focuses on biological threats, but its activities are mostly classified.’ These agencies have recognized that national biologcal security can be acheved only if their work programs take into account medical and infectious disease developments around the world. Thus, the CDC works closely with WHO and many foreign health ministries, whde AMRDC and NMRDC interact with their counterparts from other countries. The latter two organizations focus on diseases of military interest (i.e., diseases that are indigenous to regions where the U.S. military may have to operate in the future),sponsoring both intramural R&D, mainly at the Naval Medical Research Institute (NMRI),43the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID),44 and the Walter Reed Army Institute of Research,45and extramural research in both U.S. and foreign laboratories. In addition, AMRDC has medical research units in Brazil, Germany, Kenya, Korea and Malaysia, as well as the Armed Forces Research Institute of Medical Sciences in the NMRDC has units in Egypt, Indonesia, Peru, and Philippines (see below). While each agency, be it CDC, NMRDC or AMRDC, could serve as a model for the BHP, I consider only one, or rather part of one, here. I selected the NMRDC because its structure of core and field units seem to resemble


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most the vision I have of the BHP. TABLE 2 contains the essential facts about the four U.S. Naval Medical Research Units (NMRU),which fall under the authority of the NMRDC. Each NMRU has the ability to set up and dispatch field teams to study local outbreaks of illness in collaboration with local authorities. For example, NMRU-Egypt sent field teams to Ethiopia and the Sudan to study leishmaniasis and malaria in the 1960s, while NMRU-Peru investigates malaria in the jungles of northern Peru. Perhaps more important is the roles that the NMRUs have as international health resources. Thus, NMRU-Egypt is internationally recognized as a sophisticated research facility that is unique in the region: it has a Biosafety Level 3 laboratory, and its scientists possess expertise in advanced tech-

TABLE 2. U.S. Naval Medical Research Units Institution and Location

Date Estab- Budget lished ($ million)

Staff

1946

4.6 (1990)

43 scientists; 11 1 technicians; 254 admin/support

1970 U.S. Naval Medical Research Unit No. 2 Detachment, lakarta, Indonesia (NMRUIndonesia) US. Naval Medical Re- 1983 search Institute Detachment, Lima, Peru (NMRU-Peru)

1.3 (1990)

6 scientists; 31 technicians; 36

U.S. Navy Medical Research Unit No. 3, Cairo, Egypt (NMRU-Egypt)

U.S. Naval Medical Research Unit No. 2," Manila, Philippines (NMRUPhilippines)

1979

admidsupport

1.4 (1990)

8 scientists; 21 technicians; 53

admidsupport

0.86 (1989) 99 total

Disease Areas Respiratory, d i a rrheal, febrile, rickettsial, viral, vector-borne parasitic diseases; febrile illness; oromaxillofacial infections; AIDS; S C ~ ~ S tosomiasis Malaria; filariasis; diarrheal diseases; arbovirus and retrovirus infections AIDS; bartonellosis; typhoid and paratyphoid fevers; diarrheal and arbviral diseases; brucellosis; leptospirosis; malaria Malaria; diarrheal and sexually transmitted diseases; hepatitis; Japanese encephalitis; dengue fever; AIDS

ONMRU No. 2 was headquartered in Taiwan until 1979, when it moved to Manila; because of uncertain political conditions, it is being relocated to Indonesia.

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nologies such as DNA probe, polymerase chain reaction, and recombinant DNA techniques. The WHO designated NMRU-Egypt as the AIDS diagnostic reference laboratory for the Eastern Mediterranean region, and the U.S. Agency for International Development has cited its special expertise in s~histosomiasis.~~ NMRU-Peru has been designated by the Peruvian ~~ government as the national reference laboratory for HIV t e ~ t u - 4 .NMRU-Indonesia was established at the request of the Indonesian government after the U.S. Navy helped it control an epidemic of plague. Indonesian authorities have given NMRU-Indonesia free access to field sites for epidemiological and vaccine trials throughout the vast Indonesian archipelag~.~~O NMRU n e was originally based in Taiwan, but has had a long history of workmg with the Philippine government, assisting local authorities during outbreaks of cholera in 1961, dengue in 1966, and capdlariasis in 1976.%It moved to Manila in 1979, becoming NMRU-Manila (recent political uncertainties, however, have dictated its relocation in 1991 to the Indonesian facdity). On the basis of published information and a visit to NMRU-Peru, I believe the history and operation of the NMRUs provide six key lessons relevant to the proposed BHP: 1. The NMRUs have been able to continue to operate when the govemment of the host country changed, even when the new administration was very much at odds with the policies of its predecessor. New governments have a minimum accepted the NMRU’s presence, and more commonly encouraged it to stay. For example, when Egypt broke off diplomatic relations with the United States in 1967, NMRU-Egypt was the only official American presence in that country for seven years, and its work durmg this period was not hindered in a substantive way. The lesson for the BHP is that both its charter and activities must make it clear that it is a technical agency, disinterested in local or national politics. 2. NMRUs have formed cooperative research arrangements that involve host country scientists, health providers, and research institutes in their research projects. These relationships benefit both sides: local scientists and laboratories gain new skills and have access to advanced techniques and equipment, and the NMRU gets manpower, expertise and assistance in field work. In addition, NMRUs provide vital services to governments, especially ministries of health, acting as reference laboratories and sharmg epidemiologcal data collected by NMRUs’ field teams. The lesson for the BHP is that its field teams and regional centers should develop good workmg relationships with local and national health care and research institutions based on shared interests. 3. The NMRUs have been able to avoid being tarred with the BW brush, even though they are part of the DoD’s defense system against possible BW. It is likely that the wide-ranging,open relationships between

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ANNALS NEW Y O U ACADEMY OF SCIENCES

NMRUs and host-country agencies and laboratories forestall suspicions about the R&D at the Navy institutes. The lesson for the BHP is that its activities must be transparent, that is, its investigations, research, and analysis should include outsiders, and its work should be published in the open literature. (Investigationsof BW allegations may be done in camera, so long as there is adequate oversight and the intention is to publish the results eventually.) 4. NMRUs have accomplished a great deal with modest budgets. NMRU scientists have developed, for example, rapid ELISA diagnostics for cholera, enteric fevers caused by Salmonella, schistosomiasis, and group A meningocowl meningitis. The NMRUs have used modem molecular and immunological techniques to develop a wide range of other diagnostics and vaccines. The lesson for the prospective sponsors of the BHP is that as long as sufficient funds are provided to enable this agency to recruit highly trained and motivated individuals for staff positions, the BHP can be expected to make sigmficant contributions to epidemiology and field investigation of infectious diseases. 5. NMRUs have overcome many of the difficulties of carrying out field investigations and laboratory studies in developing countries. Staff members have proven adept at improvising, and have improved testing protocols, operated laboratories, and transported samples under the difficult conditions of field work. The lesson lor the BHP is that scientists and techcians from both developed and developing countries are willing to serve in the field under hardship conditions, for years if need be, as long as their work is intellectually challenging and scientifically rewarding. 6. Costs associated with setting up and operatingNMRUs may be used to estimate similar costs for the BHP, as is done above. BIOLOGICAL THREATS AND INTERNATIONAL SECURITY

The concept of security implies the right of a nation to safeguard the lives and property of its citizens. However, in view of the biological threats confronting manlund, whether man-made or natural, there are problems with t h s concept. In reference to man-made biological threats, a govemment attempting to safeguard its national security may engender a “security dilemma,” in the sense that the assurance of national security by one country may decrease the national security of another.51The security dilemma is, in a nutshell, the dilemma of any country’s biological defense program: such programs undertaken to protect the sponsoring nation’s security may nourish suspicion because it is dfficult to differentiate between development undertaken for permitted defensive purposes and illicit offensive ends. Thus, one nation’s biologcal defense program, undertaken

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to protect its security, may lead another nation to believe that its security is being subtly threatened. T h s notion can be extended.When little or nothmg is known about the biologcal R&D programs of other nations, especially those with closed societies, and when governments do not take part in BWC confidence building, unusual outbreaks of disease may engender suspicions about one of these nations’ sponsoring illicit BW activity. To illustrate, the 1979 anthrax epidemic in Sverdlovsk raised worries among Western security experts about the U.S.S.R.’s having an illicit BW program, and the unsatisfactory response made by the Soviet government only aggravated the situation, which in turn complicated international politics at the time and afterwardss2Future epidemics of uncertain etiology may lead to similar suspicions and complications. So, if their intent is hidden or unclear, national biologcal R&D programs intensify the security dilemma. In the United States, we try to allay suspicion about our biological defense program by practicing tran~parency,~~ and by taking part in the building of confidence in the BWC. Most developed countries do the same. N o d i t a r y biologcal R&D in Europe, Japan and the United States may at times gve rise to concerns regarding its safety or possible environmental effects, but because it is carried out in more or less open facilities, is overseen by institutional and national bodies, and its results are openly published, this R&D does not raise worries about BW. Conversely, the majority of the world’s governments provide little concrete information about their national R&D programs in biology and they neglect or decline to take part in confidence buildingS4Theintent of some governments’ programs is unclear; they have therefore raise misgivings among the intelligence c o m m ~ n i t yWhile . ~ ~ ~it~would ~ seem as if governments could, if they chose to, relatively easily dispel suspicions about their activities, one wonders that they do not. The security dilemma becomes even more problematic when the concept of security is assumed by a government to include the protection of its citizens from the natural threats posed by disease organisms. In this context the term “national” security becomes nearly meaningless, since infectious agents do not recognize borders. True national security vis-d-vis natural biological threats can be achieved best by meeting the threat where it originates, as has been clearly shown by the international smallpox and AIDS programs. Without international cooperation such a course of action would be impossible. The concept of national security therefore has to change because the fate of one nation’s populace in health matters is inexorably lmked with that of other nations. In a thoughtful article about the changing concept of security, Professor Helga Haftendorn developed the concept of “international security,” defining it as “the security of one state [being]closely linked to that of other

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states, at least one other state. States are interdependent in their security affairs such that the security of one is strongly affected by the actions of the other, and vice versa.”57The recognition of their mutual vulnerability often leads states to cooperatewith one another; cooperation may in turn lead to the evolution of regimes between states sharing a common interest. Wider ranging cooperation and the further evolution of regimes leads to institution building, which is a more or less formally organized arrangement for this cooperation. The concept of international security clearly offers abetter prescription than that of national security for meeting the biological threats facing mankind. Further, a certain progression of events has taken place in international health that seems analogous to that postulated by Haftendorn. Facing smallpox and AIDS,states have recognized their mutual vulnerability to biological threats and the need for international cooperation in meeting them. They have responded by instituting international cooperative actions under the auspices of WHO, leading to institution building in the form of the Global Program on AIDS.So many of the elements constituting an international program for achieving international security in the biological area are already present. Does it not now make sense to take the final steps necessary to meet the future biological threats posed by emerging diseases, threats that may be as dangerous as AIDS?To reiterate, true security for both governments and peoples comes from meeting biological threats and when and where they originate, and this requires international cooperation for the early detection, continuous monitoring and, ultimately, the suppressingof diseases. By creating the BHP, which would perform exactly these tasks, the international arms control community will achieve a greater measure of international security than now exists. CONCLUSION

Biological threats of natural origin are certain to be realized in the future, but their effects and etiology await discovery. They also have Mtional and international security implications: both in war, where endemic diseases frequently take a higher toll than weapons, and in peace, where epidemicslike AIDS can ravage the population of an entire region, stressing national health services to the limit. Society has benefitted from international efforts to confront global health threats, even when these efforts have not achieved the unequivocal success of the campaign to eradicate smallpox. 58 WHO is now leading a global effort to control AIDS,59but with an opponent so wily and a threat so insidious, it will take a long time before the campaign begins to succeed. What this campaign and its predecessors attest to, I believe, is that coordinated international political action is


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easiest to acheve in the health field because it is in every government’s political interest to cooperate with other governments, even ideological or political enemies, to reduce the disease burden of its people. While smallpox and AIDS confirm the vulnerability of all peoples to biological threats, the global campaigns to elmmate the first and control the second clearly demonstrate the necessity of governments’ cooperating to meet such threats. The emergence of AIDS, and the swath of destruction it is cutting through the world’s populations, reminds us of our mutual vulnerability to disease; a threat that will always remain because other dectious diseases are certain to emerge. As these truths become widely appreciated by leaders and legislators throughout the world, they also wdl recognize the necessity for a rapid international response to meet biological threats. The BHP would provide the mechanism for rapid response, improving society‘s ability to quickly meet and overcome biological threats. Although Operation Desert Storm accomplished its main objective-to expel Iraqis from Kuwait-it also complicated international politics, and its impact on efforts to prohibit biologcal and chemical warfare are likely to be profound. One lesson learned from Desert Storm is that in armed conflicts between a Thud World country and a developed country or countries, the former’s conventional weapons will prove largely ineffectual against the superior technologies available to the latter. Third World leaders gwen to expansionist foreign policy objectives are likely to take this lesson to heart and henceforth focus much of their efforts and resources to deploy unconventional forces (such as state-supported terrorists) and arm them with uncommon, powerful weapons, for example, weapons that can be developed secretly, work best under stealthy conditions, exert their major damage before the attacked party knows that it is under attack, and cannot be easily defended against. The candidate weapons systems that best fit this profile are those based on biological agents. If recent hstory is a guide, however, most future conflicts will not pit a superpower against a Third World country. Rather, the trend since World War I1 has been towards a series of low-intensityconflicts (LICs)between Thrd World countries or acts of transnational terrorism.” A convergence of factors such as increased trade in high-tech weapons, continued political instabilities, competition over scarce natural resources, and unrelieved population growth is likely to fuel more and more of these types of more or less organized violence. Biological weapons are particularly well suited for LICs and, particularly, for terrorism.13Because of their uncontrollable nature, however, we all are potential victims of biological weapons, whether a BW agent is released in the course of battle, during a terrorist operation, or via an accident at a hidden BW facility. The BHP would be designed to be a “trip wire” for biologcal weapons; it would give warning to the inter-

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national community that a BW device has been used and it rmght demonstrate who the responsible party was. An efficient BHP would probably also be a deterrent to BW development because if a government or subnational group became convinced that their transgression of the BWC would be certady detected, they might desist from commencing the transgressing program. We have weathered a conflict in which one of the better defensive systems was the Patriot missile. But the 21st century is almost here; a century predicted by some to become the Biological Age. This name suggests, I believe, that biotechnology will have profound, far-reachmg effects on many important human activities related to agriculture, environment, food, health, industry and leisure. Is the military sphere likely to remain untouched by future achievements in biotechnology?Certainly defense is not, since biotechnologies are already employed in R&D sponsored by the DoD related to detectors and sensors, adhesives and materials, diagnostics and vaccines, and many other applications. Is it too farfetched to postulate that biotechnologies might also be employed to improve present weapon systems and develop new ones? It would be foolish to disregard this possibility, especially so when more and more scientists and technicians become familiar with the biotechnologies, to the point where cloning is now taught to high school students. Surely some of this knowledge will somewhere, sometime be utilized by unscrupulous leaders to attempt to realize a military useful BW system. The allure of potentially controhg a true weapon of mass destruction will prove too strong to resist, past failures notwithstanding, and once again we will face an uncertain, but potentially great threat. When this happens, the Patriot will be of no use; instead we will have to defend ourselves with vaccines, gas masks, and antibiotics. The BHP is likely to become an important component of the international security system that seeks to protect mankind from efficacious biological weapons developed through the use of the advanced biotechnologies. In addition to its practical uses, the BHP is likely to add a useful public dimension to the debate on BW and biological arms control. A proposal for establishmg the BHP is certain to igmte a public debate; one that can be expected to add to the public’s, and its representatives’, understanding of BW and its management. Topics such as the improvement of the BWC will no longer be an arcane topic of discussion for security experts, but will become recognized as having important social and political facets, malung them subjects of open, wide-ranging discussion. The added importance that will be given by society to biological arms control would make it easier for scientists to participate in activities designed to enhance the BWC, since their role, rather than being that of a “policeman,”would be to help suppress BW through their normal scientific activities.

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QUESTION AND ANSWER QUESTION: Dr. Zilinskas, do you think the situation has changed in regard to private biotechnology companies getting involved with biological defense research? RAYMONDZILINSKAS: Many companies have the capability to perform biological defense research. For example, companies like Cetus and Amgen could get into this area, but they have chosen not to mostly because they do not want to go through the hassle of dealing with government bureaucracy. However, there are about 40 biological laboratories in the public and private sectors that do contract with the Department of Defense to perform some aspects of the research relating to the BDRP. Unlike the situation prior to 1969, all these activities are known, the companies are identified, and the results of the research are openly published. So this situation has changed from that of previous times, when anythmg to do with biological warfare was classified. Regarding BW-related R&D, in the 1970s, when the negotiations for the BiologicalWeapons Commission were talung place, research to develop biological weapons was strictly the business of government. Further, BW R&D took place in remarkable facilities, such as Fort Detrick or the Edgewood Arsenal. You don’t have that situation any longer because many smaller research units, if they wanted to, could apply modem biotechnology to “weaponize”agents and store them until such a time they would be “needed.” At that time, they could easily scale-up productions to fulfill military demands. This situation is certainly new, marking a big change from previous times.

Interfacing a biosurveillance portal and an international network of institutional analysts to detect biological threats.

Geological hazards: from early warning systems to public health toolkits.

Editorial: Biological Hazards in Food.

Using a Prediction Model to Manage Cyber Security Threats.

Fiber Optic Sensors For Detection of Toxic and Biological Threats.

Strengthening the US Medical Countermeasure Enterprise for Biological Threats.

Reassessing Biological Threats: Implications for Cooperative Mitigation Strategies.

Reverse zoonotic disease transmission (zooanthroponosis): a systematic review of seldom-documented human biological threats to animals.

Confronting Threats to Meaning: A New Framework for Understanding Responses to Unsettling Events.

Protecting the Nation from Health Security Threats.

Integrated biological-behavioural surveillance in pandemic-threat warning systems.

Potential biological hazards of commercially available cleansers for dentures.

[Drivers for the emergence of biological hazards in foods].

human adaptability studies among the Skolt Sami in Finland (1966-1970).

Biological weapons: international treaty made domestic law.

International society for biological and environmental repositories.

A topology visualization early warning distribution algorithm for large-scale network security incidents.

Preparedness and response to chemical and biological threats: the role of exposure science.

Exploring the potential of large vertebrates as early warning sentinels of threats to marine ecosystems, human health and wellbeing.

A Biological Safety Cabinet Certification Program: Experiences in Southeast Asia.

The role of water in microwave absorption by biological material with particular reference to microwave hazards.

Biological and environmental hazards associated with exposure to chemical warfare agents: arsenicals.

Biological monitoring of bidi rollers with respect to genotoxic hazards of occupational tobacco exposure.

The international contribution to the standardization of biological substances. I. Biological standards and the League of Nations 1921-1946.