Summary and Assessment

In the wake of September 11 and recent anthrax events, our nation’s bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. Experts from each of these communities and the Forum on Emerging Infections convened for a three-day workshop discussion—the subject of this summary—to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities.

From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework that captures the attention and understanding of policymakers and the public to garner sufficient and sustainable support for response initiatives. Such understanding would recognize that the protection of the nation’s health is essential to ensuring national and global security. There was much debate, however, on what constitutes an appropriate framework to deliver this message.

No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be filled in order to assure a rapid and effective response to another bioterrorist attack. Many priorities for action—from encouraging antibiotic and vaccine research and development to educating first responders—were identified and discussed. Throughout the workshop, there were repeated calls for partnerships, including interagency and interdepartmental partnerships in government; and public-private partnerships that could harness the considerable power and knowledge of the academic community and industry at large.



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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Summary and Assessment In the wake of September 11 and recent anthrax events, our nation’s bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. Experts from each of these communities and the Forum on Emerging Infections convened for a three-day workshop discussion—the subject of this summary—to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework that captures the attention and understanding of policymakers and the public to garner sufficient and sustainable support for response initiatives. Such understanding would recognize that the protection of the nation’s health is essential to ensuring national and global security. There was much debate, however, on what constitutes an appropriate framework to deliver this message. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be filled in order to assure a rapid and effective response to another bioterrorist attack. Many priorities for action—from encouraging antibiotic and vaccine research and development to educating first responders—were identified and discussed. Throughout the workshop, there were repeated calls for partnerships, including interagency and interdepartmental partnerships in government; and public-private partnerships that could harness the considerable power and knowledge of the academic community and industry at large.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FRAMING THE ISSUE Bioterrorism is no longer a hypothetical event. A bioterrorist attack has occurred and could occur again at any time, under any circumstances, and at a magnitude far greater than we have thus far witnessed. U.S. bioterrorism preparedness efforts have so far focused on a number of potential agents, in particular anthrax, smallpox, plague, botulinum toxin, tularemia, and viral hemorrhagic fevers. Details of each of these threats were reviewed on the first day of the workshop. Anthrax is a proven risk and of most immediate concern, although smallpox, because it is capable of person-to-person transmission, engendered an equivalent sense of urgency. However, there is a plethora of potential, credible bioterrorist agents. One workshop participant noted that the Soviet Union is known to have weaponized some 30 different biological agents, including drug-and vaccine-resistant strains. It is impossible for us as a nation to provide a specific defense against each of these many agents within a reasonable time frame: the diversity of readily available potential bioterrorist agents is great; the technology and knowledge that make it possible to bioengineer drug- and vaccine-resistant antimicrobial strains are becoming increasingly accessible; there are many crucial gaps in our countermeasures and public health response capabilities; and it was noted that one can develop a new bioweapon within only two to three years compared to the eight to ten years that it typically takes to bring a new vaccine or antimicrobial product into the market. It is possible, however, to bolster our nation’s general biodefense to a level at which we can at least minimize, if not prevent, the potentially catastrophic consequences of a large-scale bioterrorist attack. Workshop participants asked the question, how do we convince policymakers and those who allocate funds that new and substantial resources are needed at all levels, from local surge capacities for clinical care to research facilities expansion? The public health, scientific, and private industrial communities involved with bioterrorism defense must present their needs in an appropriate framework and present a vision to which the country can respond. The most powerful strategy may be to cast bioterrorism defense as a national security issue first and foremost. Indeed, it was suggested that the only way to acquire the resources needed to develop the capacity that bioterrorism defense requires is to equate these tools with other weapons defense tools. It must be made clear that the nation’s capability to respond to a bioterrorist attack is, in essence, a weapons defense system. Although most people do not know the details of how much money or research and development are required to sustain our country’s armed forces, nonetheless they are able to express the essential role of such capabilities in our national security. Several workshop participants suggested that bioterrorism defense requires the same attention and understanding.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary There was some concern though, that the priorities of a bioterrorism public health initiative not be pitted against those directed at more general control of emerging infectious diseases. In fact, bioterrorism defense is intimately tied to emerging infectious disease preparedness. The current situation was compared to the emergence of HIV/AIDS two decades ago—it is illuminating of many of the existing problems within the health care system about which we have become complacent. For some time now, it has been apparent to many that the public health infrastructure needs to be strengthened. Workshop participants recognized that now might be an opportune moment to foster better understanding of what has been in the past decade an often unheard call in the interest of public health, from increasing infectious disease surveillance to confronting antimicrobial resistance. It was proposed that an alternative strategy would be to address bioterrorism response preparedness in a coordinated fashion with broad emerging infectious disease issues. For example, propose this effort as a defense system with concurrent substantial benefits for the public health system, as well as microbial and biomedical science. Recent efforts to put together a bioterrorism initiative in New York City, for example, were as much helped by the threat of naturally occurring pneumonic plague as by the threat of plague being used as a biological weapon. However, the question remained for many—is it possible to convey such a textured message that includes both bioterrorism and infectious disease preparedness needs? Many present felt it best to cast the issue as one of national defense. Terrorism, by its nature, often evokes a more urgent response from the government and the public than does the emergence of other infectious disease or public health crises. It was noted that the 4 recent deaths from anthrax, but not the ongoing global AIDS crisis (which causes thousands of deaths daily), had the temporary effect of largely incapacitating the U.S. Congress and the U.S. Postal System. Several discussants observed that there is a national security component to bioterrorism response preparedness that makes it a very different issue than what they have been dealing with in public health up until this point. The question is, how do they attract the nation’s attention so that they can acquire the necessary funds and resources to prepare in the event of another bioterrorist attack? It was pointed out that past efforts to obtain resources for emerging infectious disease preparedness have been only moderately successful at best. Strategically and tactically, it was suggested that a more compelling story than that of emerging infectious disease was needed, especially during a time when there are many competing immediate national security issues also on the table. Even the story that has unfolded over the last several months has not garnered the attention and focus that this effort requires. Again, it was suggested that bioterrorism defense be put in the context of a national security emergency that requires a new level of funding and a new way of operating. Other questions raised were: In the absence of further attacks, how do we keep this issue before Congress? How do we prevent a lapse back into a false sense of security? How do we ensure the sustainability of our response to bioter-

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary rorism? If another act of terrorism occurs targeting an element other than the public’s health, how do we ensure sustained funds for a bioterrorism preparedness effort? Thus, many agreed that the time is ripe, while the events of September 11 and the subsequent anthrax attack are fresh in the public’s memory, to at least procure initial funds with which we can begin to develop the capacity that we need to defend against a future bioterrorist attack. To better assess the amount of funding that is required, it was suggested that a prioritized list be developed setting out actions that should commence now and others that can be developed over time. If the funding is spread out over a longer period of time in this manner, the amount of funding necessary for building the capacity that is needed might be more digestible for the people who appropriate these funds. In order to do this, however, several participants noted that a governing structure would need to be in place for prioritizing and implementing such a plan. Although the best framework for bioterrorism defense may be in terms of national security, there was some admonition that we not overreact. Some believed that it was important not to inflate the threat and create a challenge that cannot be met. And, whether the issue is framed solely as a national security threat or as a national security threat with concurrent benefits for the public health infrastructure, it must be stressed that in no way should efforts toward bioterrorism preparedness diminish other specific public health programs. Finally, as one workshop participant indicated, framing the issue involves more than wrapping words around it. It was noted that allotting only a small percentage of the Department of Health and Human Services (DHHS) budget for bioterrorism defense sends a strong message to the nation and Congress that the public health community does not really consider the threat to be as serious as they claim. In order to be credible, these funds need to be reallocated in a manner that sends the message that yes, this is important. FILLING THE GAPS Several presenters and participants observed that the recent anthrax attack stretched the response network to its limit. However, it was a relatively small event and, as such, has raised many questions about our capacity and resources to cope with a larger attack. Even though there has been progress toward strengthening our response capabilities in recent years, there are still many gaps that leave us vulnerable to a potentially catastrophic event. But where are the gaps, how should they be filled, and which gaps should be filled first? Prioritizing bioterrorist defense needs is, in essence, a very complex systems problem that involves many different people and groups from both the public and private sectors. As a first step toward strengthening our nation’s response capabilities, there were repeated calls throughout the workshop for partnerships within and among government, private industry, academe, the health

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary care system, and the intelligence community. The absence of multiple experts from the intelligence community and hospital care facilities in the workshop discussions did not allow robust discussion on their related issues and priorities. It was mentioned that significant amounts of untapped laboratory capacity and scientific expertise exist within the global pharmaceutical industry in particular. It was suggested that a better way to leverage that capacity be devised by recognizing that industry truly is a partner in public health and able to contribute in very substantial ways to sustainable vaccine and drug research and development. To this end, workshop participants considered how to enlist the appropriate level of industry management and government decisionmakers in the right forums to discuss what needs to be done, who will do it, and how it will be done. It was recognized that the magnitude of the problem is clearly such that no single company can take on this challenge. Industry representatives noted that if there were plans in place, however, laid out by those who know best what the priorities are from a research and intelligence standpoint, it is likely that the pharmaceutical industry would respond very positively. One possible strategy suggested by a Forum member was to build a pharma-based industrial consortium backed with government spending to drive vaccine and antimicrobial development to where the market clearly is not going to take it. As central to the effort as it is, it was pointed out that big Pharma is not the only industry in the private sector with which partnerships should be sought. The biotechnology industry is another important resource for new technologies that could be applied in a wide variety of ways to the bioterrorism defense effort, from improved rapid diagnostics and vaccine and therapeutics development to faster information transfer. One discussant pointed out that the challenge might not be so much that we need to develop more new technologies but that we need to optimize current applications. Users need to make their needs known and partnerships formed such that the demands can be met with the available supply. It was suggested that new mechanisms and channels for strengthening all of these various partnerships be crafted. After September 11 it became apparent just how many interested companies and applicable products exist, as well as how many individual researchers are interested in the type of research that biodefense demands. But the question for some workshop participants remained, how do we coordinate all of these efforts? As one participant noted, the challenge before us is that everyone calls for coordination, but no one likes to be coordinated. In fact, this issue may require a new coordinating structure that has yet to emerge. One suggestion was that it be modeled after the Office of Scientific Research and Development that was set up during World War II and involved the efforts of some 6,000 scientists. With both federal agencies and industry actively engaged in this debate, now may be the time to move toward the establishment of such a structure. The recent establishment of the Office of Public Health Preparedness (OPHP) was described during the workshop. The office is expected to oversee

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary activities related to bioterrorism and bioterrorism preparedness within DHHS. The office will likely serve as public health’s primary liaison with the Department of Veterans Affairs (VA), Federal Emergency Management Agency (FEMA), Office of Homeland Security, the Department of Defense (DoD), and other agencies involved with bioterrorism defense, including intelligence. That such an office has been created at a very high governmental level within DHHS was acknowledged as a very important first step toward centralizing power in a constructive way. However, because there are many other departments besides DHHS involved in this effort, some workshop participants expressed concern that there is still a need for a government-wide change in the way the prevention, control, and elimination of bioterrorist attacks are approached. Several participants called for broad changes in the communication and coordination both within and among these various other federal agencies. Partnerships, coordination, and centralized leadership may be the necessary first steps. Still, the range of problems that were described and detailed throughout this workshop comprises a daunting portfolio. Several participants described the need to wrap our hands around this issue and try in some rational way to say, “There is the set of bioterrorism issues that we must address.” Because of the enormity of the problem at hand, coupled with the reality of budget constraints, we must set priorities both in terms of research and public health preparedness. Which gaps should be filled first? It was suggested that moving such an agenda forward would require attention to the following issues: Prioritize response measures. Determine how to allocate present funds and decide which components of biodefense need to be strengthened first. Invest in real-time response role-playing exercises based on probable biological attack scenarios to assist in identifying appropriate infrastructure and training needs for an optimal response. Improve and sustain the understanding of the public, policymakers, and political leaders about the risks of bioterrorism and the capacity reqired to counter the threats. Convince those who allocate resources that new and substantial resources are needed at all levels. Evaluate the components of the National Stockpile Inventories. Determine the capacity of existing assets and establish priorities for developing and procuring additional needs. Consider the development of a peer review system for screening new bioterrorism defense research ideas. Craft innovative mechanisms and channels for forming and strengthening partnerships required for an effective response. Evaluate the necessity of a legal strategy for bioterrorism response. Consider the role for and responsibilities of a civilian biodefense program.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary The many conspicuous gaps in our nation’s biodefense science and response capabilities, from the striking insufficiency of vaccines and therapeutics to local public health departments already struggling with limited resources were described by workshop participants. A number of workshop participants suggested the urgent need to prioritize actions to be taken in order to strengthen our response capabilities. The following issues were identified by different individuals as priorities for action or consideration during the presentations and roundtable and panel discussions. The three major components are vaccines and therapeutics; research needs; and response infrastructure. Response infrastructure involves communications and information, laboratory capacity, disease detection and surveillance, and local response. Additional individual priorities are identified in the authored papers that follow in subsequent chapters of this report. The ordering and statement of priorities is a reflection of the workshop agenda. It is again emphasized that this summary document reflects only the statements and opinions of individual participants expressed during the workshop and is not intended to be an exhaustive exploration of the subject matter. VACCINES AND THERAPEUTICS Vaccines and antimicrobial therapeutics are vital to bioterrorist defense. Even if the best possible public health infrastructure existed and responses were as rapid as they need be, we might still be faced with a disease that could not be countered. Participants noted that the current biodefense arsenal is sparse and very little progress has been made in recent years in the development of new products. The hurdles in vaccine discovery and production in particular were described as high for private industry to pursue. Although this may change following September 11, still the potential market is too risky to encourage the vaccine industry to make the large investments needed for the type of research, development, and manufacturing facilities that will be necessary to bolster our biodefense vaccine supply to an adequate level. Several participants proposed the need for incentives in the vaccine industry, such as expedited regulatory pathways; direct financial awards or contracts; tax credits; guaranteed liability indemnification; and partnerships in product development. One participant urgently called for clear vaccine production priorities, the development and procurement of top-priority vaccines, and the designation of somebody to be responsible for ensuring that these actions are accomplished. It was suggested that development of biodefense vaccines must be a collaborative effort. With regard to the development of several potential new vaccines and therapeutics, efficacy is an important issue that often requires the use of monkey models that can only be studied in select laboratories. Likewise, a recent independent review of DoD’s vaccine acquisition program recommended that DoD consider a collaborative approach to vaccine research and development with industry partners. The review also recommended a dedicated facility

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary that would allow maximal flexibility and expandable manufacturing capability for the production of various types of vaccines. Workshop participants debated whether this would be government-owned and contractor-operated or contractorowned and contractor-operated. Discussion of other priorities related to vaccine development and production included the consideration of alternate methods of vaccine administration that would be more amenable to rapid dispersion, such as oral or inhalational vaccines; applications of genomics and high throughput technology in the identification of genomic markers for vaccine efficacy; technological applications that would improve vaccines; the use of combination vaccines; the potential applications of the new DNA vaccination technology; and, the application of military data on vaccine use to civilian populations. One participant noted that is was important to recognize the inherent differences between military and civilian bioweapons defense vaccine usage and develop a specific vaccination policy for bioweapons defense in the civilian population. Presenters stated that just as important as vaccine research and development is the research and development of new drug therapeutics. As with vaccines, there has been very little market incentive to produce these products. There was some concern that the FDA’s new delta rules—the statistical requirements for clinical trials for antibiotics—add yet another major disincentive due to the large size of clinical trials that the new rule could demand. Several participants emphasized that there has been only one new class of antibiotic developed in the past two decades, and resistance to it emerged even before it entered the commercial market. Presenters described that very little information on antivirals for potential bioterrorist agents is available, and none have thus far proven to be of clinical utility in humans. Accumulating evidence is beginning to suggest that different viruses may have common molecular targets. In light of this, one proposed strategy was to consider the development and production of family-specific antivirals, which could be tested against viral relatives in areas where disease naturally occurs. However, some participants highlighted concerns that antivirals have several disadvantages, including their toxic side effects and limited ability to reverse the effects of disease. Antitoxins are another type of therapeutic agent discussed by presenters that could be developed for the biodefense arsenal. Basic research on the anthrax toxin system has led to some exciting prospects for antitoxin targeting. The most promising are the dominant negative inhibitors (DNIs), mutant forms of the protective antigen that block translocation of the virulence factors across the plasma membrane. Currently, DNIs are in the late stages of product development. Several participants suggested that if DNIs can be proven efficacious in infected animal models, they could be produced and deployed very rapidly. There are several other approaches in much earlier stages of development.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Finally, monoclonal antibodies provide yet another possible post-exposure therapeutic. Workshop presenters described the use of recombinant monoclonal antibodies that have been implicated for several different biothreat agents, including anthrax, smallpox, and botulinum neurotoxins. One of their primary advantages is that their route through the discovery and approval process may be faster than that of any other biodefense therapeutic. Thus, with the appropriate funding, they could serve as a very important short-term biodefense measure. Again it was suggested that following September 11, the pharmaceutical and biotechnology industries have expressed a willingness to participate in the effort to build up the nation’s biodefense arsenal of vaccines and therapeutics, but it seems that the direction, authority, and incentives are lacking. Considerations suggested by workshop participants for moving these issues forward include: Initiate stakeholder dialogue. Facilitate the role of the major vaccine and drug manufacturers in the development and production of biodefense countermeasures with clear direction and effective collaboration between industry and government. Provide incentives, priorities, and leadership to ensure that antimicrobial development and production are sufficiently scaled up. Decide to what extent our research, development, and production efforts should be directed toward agent-specific countermeasures versus broad-spectrum antimicrobials that could be used to defend against a wide range of agents. Direct more effort into developing better vaccine delivery technologies (e.g., aerosolized vaccines that can be dispensed much more quickly than injectable vaccines). Improve the usability of DNA vaccination platform technology. Explore the potential applications of genomics research to vaccine development and production. Encourage the research and development of new antitoxin treatments. Explore the potential for monoclonal and polyclonal human antibodies as countermeasures to bioterrorist agents and provide incentives to encourage development. Direct more effort toward alternative antiviral therapeutics, such as immunomodulators. Consider ways to accelerate vaccine and drug FDA review and licensure without compromising the independent and rigorous assessment of product safety and effectiveness. RESEARCH NEEDS The public health response to the anthrax attack was based on decades-old data. Clearly, our knowledge base needs to be revitalized. The country must

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary develop a bioterrorism defense research agenda in the context of current and emerging understandings of the threats. Indeed, research is crucial for developing new and effective vaccines and therapeutics. It must be determined how much effort should be addressed to developing generic antivirals or broadspectrum antibiotics versus target-specific agents. The issue is complicated by the spectra of genetic engineering and the increasing ease with which new, therapeutic-resistant strains of particular agents can be developed. Participants asked, do we become more and more specific, or do we develop an arsenal of weapons that can be used in any situation? The implications of the long-term research on anthrax lethal factor which was presented in this workshop is an excellent example of what are sometimes unforeseen beneficial applications of basic scientific research. Examples of the type of knowledge that is needed and that can be gleaned from basic research include a better understanding of microbial biology; the human body’s innate immunity; the potential applications of computational techniques and infectious disease modeling; and aerosol biology. Funding for basic scientific research, as well as for research associated with the development of new vaccines and therapeutics, must extend beyond the actual experimental work. Discussants noted that in order to accommodate the increased need for safely contained laboratory facilities, where some of this research must be conducted, laboratory capacity needs to be expanded. One possibility is the construction of new BSL-3 or BSL-4 laboratories and animal facilities in order to validate new vaccines and therapeutics. It would also be necessary to train a larger cadre of individuals who are skilled and knowledgeable about these particular infectious diseases and trained to conduct research in these highly specialized laboratories. Some participants considered it important to determine not only what science should be done but also how it should be done. Who should have access to materials, equipment and information? Do we take extreme measures such as requiring every individual who uses a centrifuge to be logged in and out by security agents? Although it was recognized that security is a very serious issue, we must be very careful that we not impose undo restrictions in the laboratory sector that could ultimately diminish scientific discovery by slowing or preventing important advances. The research needs for responding to biological threats extend well beyond the biological and medical issues at hand. It was noted that more operational systems research was needed—particularly as it relates to all of the various aspects of the public health infrastructure and how it operates. The question was asked: are the plans that are being implemented working? Presenters representing public health organizations identified a broad range of short-term applied research needs. Some suggested innovative, automated surveillance systems. Currently, many of the surveillance systems are “drop in” systems that are “dropped into” the Super Bowl or other high profile events. But

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary it is impossible to predict when or where a bioterrorist attack is going to occur. It was also noted that broad-spectrum diagnostics for both environmental and clinical detection are needed. Currently, there are reasonably good assays available for only a limited range of specific agents. As with research and development of vaccines and therapeutics, one of the major challenges to rapid and accurate detection and diagnosis is the immense diversity of microorganisms. There can be considerable variability even within a strain, let alone a species, that can greatly complicate diagnosis and detection by making it difficult to separate out the causal agent from related agents as well as other microbes that are naturally occurring in the environment. Whether basic or applied, short or long term, several participants recognized that all research could benefit from collaboration and federal incentives. Otherwise, applied research in particular tends to fall through the cracks if it is not profitable for the investigator. The following priorities were suggested by participants as important in developing a research agenda that responds to bioterrorism threats: Increase basic research on pathogenesis of disease caused by potential bioterrorist agents and on the human immune system response. Recruit, educate, and train more people in the fields of microbiology, aerosol biology, forensic epidemiology, and environmental microbiology. Consider how the scientific community can take a proactive role in helping to increase laboratory security and the safe transfer of knowledge while at the same time not restricting the advancement of science. Increase operational systems research that addresses whether preparedness plans are working. Consider the role of computational modeling in bioterrorism response preparedness efforts. Improve rapid molecular diagnostics. Improve environmental detection capability. THE RESPONSE INFRASTRUCTURE Numerous workshop participants agreed that the public health infrastructure must be strengthened in order to ensure a rapid, effective response in the event of another bioterrorist attack. But given obvious budget constraints, much concern was expressed that there is currently not enough money or human resources to strengthen public health services to an ideal capacity. It was suggested, however, that at least those specific components that warrant the most immediate attention should be reinforced. Indeed, if efforts are spread too thin and focus is lost, members of Congress and other sources of funding will ask, have you really delivered a product or has there been measurable improvement? Thus, workshop participants noted the imperative to set clear priorities. Public health

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary infrastructure issues were addressed in the workshop through four categories, the order of which is a reflection of the workshop agenda sequence: communication and information; laboratory capacity; surveillance, detection, and diagnosis; and strengthening the local response. Communication and Information The issue of communication was front and center during the recent anthrax events. Several speakers observed that the way in which we generate and communicate information is extremely important. During the course of the anthrax events, most of the communications were backdoor connections instead of dialogue in a set forum. The result was that it was very difficult for the government to provide a single credible source about what was happening. Several presenters and participants expressed the need for a better forum for health and medical communications across all levels of government as well as the academic community and private sector. It was suggested that appropriate and effective risk communication during and immediately following an attack is crucial. Bioterrorism is intended to generate panic in a population. Risk communication is an important first step toward diffusing public panic and assuaging people’s fears. Some participants emphasized that when authorities speak to the general population, it is extremely important that they provide hard, accurate information that people can actually use and which gives them a sense of their own control. Public health professionals, from the national to local levels, should be able to offer an informed perspective on pertinent issues and effectively communicate the real risks in ways which are both meaningful to and appropriate for diverse populations. Considered equally important by some workshop participants was the sharing of information among partners who are involved in the response and investigation. Ideally, it was proposed that every individual, whether they are in health care, law enforcement, or another sector involved in the response, have real-time high-speed access to current and consistent information. To this end, several participants proposed the ongoing need to upgrade, secure, and back up the communication systems that support information systems. Finally, having a single database of information that is shared among labs was identified as another essential priority. A direct linkage and distribution of data between public health labs and the Centers for Disease Control and Prevention (CDC) in particular was suggested in order to ensure rapid dissemination of crucial information. Some specific priorities for improving public communication and information policy were identified by workshop participants. Identify a single authority with appropriate scientific expertise who can serve as the primary spokesperson for the government during a bioterrorist emergency.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Develop policies and public information tools for the appropriate use of vaccines and therapeutics as a bioweapons defense measure in civilian populations. Improve communication systems, both in terms of providing information to the public and sharing information with partners who are involved in the investigation. Develop ways to disseminate crucial information and response technology quickly. Public Health Laboratory Capacity A workshop speaker suggested that adequate response capabilities include sufficient laboratory resources for environmental detection and clinical diagnosis. As has been shown with recent events, harnessing these resources in the midst of a crisis can be very difficult. Advance planning is essential. Increased laboratory capacity is needed at all levels, including local, state, and federal. The roles of the different levels of laboratories (i.e., A, B, C, and D) that make up the Laboratory Response Network need to be clarified. For example, CDC laboratories were stretched to the limit with recent events, building a temporary level A laboratory to do ground-level screening when such work might have been delegated to other established level A facilities. Workshop speakers called for more serious consideration of the extent to which the public health laboratory response network can and should interact with other laboratory systems around the country, especially veterinary diagnostic labs and particularly the National Veterinary Services Laboratory, which is generally considered to be the CDC of the veterinary world. Several workshop participants noted a lack of regulatory oversight of products being marketed for detection as a growing concern because of the unnecessary increased laboratory workload that stems from false positives. Other laboratory capacity issues that were identified by workshop participants included specimen transport; worker safety; security; information management; and having nearby, accessible chemical expertise to help deal with cases where a white powder, for example, is not necessarily biological. To address such issues the following measures were suggested by individuals during roundtable discussions: Increase laboratory capacity, aerosol biology and non-human primate testing capability in particular. Strengthen and clarify the roles of the various components of the laboratory response network. Establish ongoing interactions with other laboratory systems, especially the veterinary diagnostic labs and most importantly the National Veterinary Service Laboratory. Evaluate laboratory security issues. Ensure adjacent chemical and biological expertise in diagnostic and detection laboratories.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Disease Detection and Surveillance Rapid detection of an outbreak is crucial to setting an appropriate response in motion, especially in the case of person-to-person transmission. It was noted that the single most important defensive measure that can be taken in this regard is to educate front line healthcare providers, including nurses, doctors, clinicians, and others who are in positions to detect an unusual signal and respond appropriately. It is they who are going to see that first rash, lesion or other symptom, and it is they who will sound the alarm. In order to train front line clinicians appropriately, one speaker described the need to consider the content of the educational materials that need to be provided as well as how to disseminate these materials. Workshop participants suggested that surveillance capacity be evaluated, strengthened, and accelerated. The need for a high-speed surveillance system that connects hospitals, emergency rooms, laboratories, and public health departments was described by several presenters. The technology is available, and there are many different types of surveillance systems currently being used. But none of these systems in and of itself is an ideal choice for broad-based application. It is likely that our best strategy will be to combine and integrate various components of each of these systems. A workshop presenter described the need for capacity to sequence microorganisms rapidly in order to identify foreign genetic elements and determine if the outbreak is naturally occurring or intentional and to identify where and when the infectious pathogen originated. Another presenter noted that although the development of rapid diagnostics is generally moving forward, new products and methods usually do not make it into public health labs because of financial and other constraints. There was a call from several participants to establish a standard protocol for specimen collection so that unidentified agents are still viable after having been transported as well the need to establish protocol for collecting samples from unusual places such as the inside of a computer. It was noted that radiation of mail poses an additional challenge to specimen collection and transport, because now diagnostic specimens cannot survive normal shipping. Consequently, alternative routes for medical diagnostic specimens will need to be established. Individual participants urged the following steps to action: Educate front line healthcare providers so that the astute laboratory clinician, nurse, or doctor who sees the first patient or wave of patients can recognize an attack early and sound the alarm. Develop a sustainable, standardized information-gathering database which is shared among labs and which the CDC can access. Develop consistency among different agencies with regards to environmental sampling; develop standardized sampling protocols. Develop a protocol for processing and transporting clinical aerosol samples to laboratories where they can be examined.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Improve CDC’s access to consultations with systems engineering expertise, building engineering expertise, etc., during a response. Local Response A strong public health infrastructure that can detect cases and deliver the appropriate therapeutics in a timely manner requires resources and organization at the community level. However, workshop presenters representing these organizations noted that there are many significant gaps in our local response capabilities. For example, delivering the stockpile to where it is needed is likely the least of our worries. Rather the challenge will be in distributing its contents. There is a need at both the state and local levels to identify emergency authorities and delegate responsibilities. A strong local response involves not only local public health agencies, but also hospitals, the law enforcement community, and the community at large. It was observed that there is a striking disparity in public health capacity not only among states but also among jurisdictions within states. Strengthening local and state public health agencies will require an infusion of resources, including both trained personnel and financial resources. Workshop participants emphasized that these resources should flow into an organized system. It was proposed that every state evaluate its own system, including its legal system, and implement its own plan of action for organizing and strengthening its response capabilities. A discussant added that this effort could be aided by the collection and dissemination of best practices information about what works and what does not work. A workshop discussant described that current median size of the approximately 3,000 local health departments in the U.S. is 13 employees. Thus, most local health departments are small and of limited capacity. Part of the problem is that local health departments suffer a dismal salary structure, a situation that needs to be rectified in order to attract experienced, trained professionals. Furthermore, only about 20% of the current public health workforce has any academic training in public health. This capacity needs to be strengthened. One suggestion, for example, is to implement training programs such as the competency-based curricula developed by the Columbia University School of Public Health to meet the local emergency preparedness needs of the New York City Department of Health. The Columbia University–New York City Department of Health program is one of several CDC public health preparedness centers that links academe and public health practice. Other suggestions for building greater local public health capacity include devising better volunteer management programs so that during a crisis the volunteers do not become a part of the problem rather than the solution; strengthening epidemiology and surveillance systems, which are typically sparse and lacking within local public health agencies; and improving relationships among

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary local public health departments, state health departments, and national CDC laboratories. Hospitals are already struggling with extremely limited resources and fiscal challenges. Thus the question was raised, what would they do if they suddenly have 100,000 anthrax patients or thousands of patients with botulism requiring mechanical ventilation? A speaker suggested that hospitals engage in evaluating their ability to care for mass casualties, which will require more than simply counting beds. Evaluating, revising, and implementing responsive plans should be based on probable bioterrorist attack scenarios and include the multiple components of the hospital health care system. Revised disaster plans should also ensure that the plans are not only chemical, but also biological eventappropriate. For example, patients from a biological event may be contagious and unable to be moved or require containment (unlike a response to chemical exposures). It was suggested that hospitals participate in joint planning exercises with their local and state public health agencies. Establish liaisons between CDC and state and local agencies to build a base for a cooperative effort. Encourage state and local health departments to assess their own needs and resources and to then move toward implementing these requirements. Strengthen local medical care surge capacity, including personnel, training, space, supplies, and equipment. Consider the usefulness of joint training and preparedness exercises among local public health departments and hospitals. Develop clear plans for how state and federal resources will be mobilized to support local agencies in response to a bioterrorist attack. Develop clear plans with regard to how local and community level agencies will distribute drugs, vaccinations, or other interventions that would be needed to be rapidly mobilized in a mass casualty situation. Enable the exchange of best practice information among local jurisdictions. BIOTERRORISM AS AN INTERNATIONAL ISSUE There were many references throughout the workshop to the international aspects of bioterrorism response preparedness. Many also noted that this is a very important but seemingly underdeveloped concept. Various efforts on the part of different governmental and public health agencies to discuss bioterrorism response preparedness with international partners, such as the World Health Organization were described. The need to continue these discussions and open the doors to a broader international dialogue was identified as essential by several workshop participants.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Not only is bioterrorism a potential global threat, such that a smallpox scare anywhere in the world should be considered a global public health emergency, but there is a broad range of other issues that should also be considered. These include global usage of our very limited vaccine resources; food-borne disease tracking; international surveillance (e.g., it was suggested that international surveillance officers be strategically placed in other countries; it was also suggested that we enlist the help of Department of Agriculture veterinarians in labs and embassies throughout the world); and the role of the international community in the enforcement of the biological weapons convention. The involvement of the international community in the research and development of new vaccines and therapeutics is crucial. It was suggested, for example, that we reevaluate live vaccine research that has been conducted in Russia and China. Israeli scientists are also known to have conducted animal studies of engineered experimental vaccines, but no data are available. The possibility of conducting clinical testing of new products in disease-endemic areas needs to be seriously considered. For example, it was suggested that scientific research pursue family-specific antiviral agents that could readily be tested against viral relatives in areas where the diseases naturally occur. The need to open international doors to build bridges and allow for a broader international dialogue regarding bioterrorism and civilian defense measures was proposed by several participants. For example, one speaker noted that it was extraordinarily unfortunate that initial information about what actually happened during the unintentional release of anthrax at the Soviet biological research complex in Sverdlovsk in 1979 was not readily available when officials first began to address the recent anthrax outbreak in the United States. Follow up by U.S. officials with the treating Russian physician from the 1979 event eventually proved useful in managing the recent attack. Another participant noted that recognizing and integrating the capacity of international scientists and facilities could prove enormously beneficial in maximizing resources and fostering responsible scientific research and use of dangerous pathogens. Deterrence and prevention of a biological attack is another important international issue. For example, one speaker suggested that we consider a molecular forensics laboratory where we would maintain molecular fingerprints (i.e., nucleotide sequences) of all bioterrorist agents worldwide so that the origins of samples could be identified. Making it known that we have the means to identify perpetrators could serve as a form of deterrence. Even if the perpetrators were not associated with the lab of origin, having identified the lab would at least provide a starting point for the investigation. However, other participants expressed concern that the complex molecular genealogies of these pathogens, combined with what would inevitably be an incomplete database, would make this kind of effort far too confusing. In addressing the global aspect of bioterrorism, these two issues stood out as important to many participants:

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Expand existing partnerships and develop new partnerships with former Soviet scientists who were once part of the bioweapons program but are now under- or unemployed. Develop targeted strategies related to disease surveillance and vaccine and drug development that include both the international communities resources and concerns. THE ROLE OF THE INTELLIGENCE COMMUNITY At several points during the course of the discussion, reference was made to the involvement of the intelligence community in bioterrorism preparedness. Of utmost concern: to what extent will prioritization require input from the intelligence community with regard to identifying which agents are most likely to be used in a bioterrorist attack and therefore which specific defensive measures should be strengthened? The general impression is that intelligence information could appropriately direct decision makers towards certain preventive strategies, including a targeted research agenda, against the most likely bioterrorist threats. However, it is unclear how this collaboration with the intelligence community should be initiated. Several participants argued not to wait for that information before making critical decisions about allocating resources. Some discussants observed that many people who have been privy to this kind of information would likely agree that while the information is extremely useful, it is not as useful to the public health community as one would expect. On the other hand another participant noted, if the former Soviet Union’s bioweapons program involved thirty agents and we are only dealing with a list of five or six, there is a large gap between what could happen and for what we are prepared. The question was also raised, would it be possible to clear a select group of people to access the Department of Defense’s classified library of our former offensive biological warfare program? Perhaps having the kind of firsthand knowledge that one would acquire by reading through that material would help us understand some of the threats that we face, such as an aerosolized attack. In that library there is likely a great deal of information about aerosol biology, a subject about which we have very little current knowledge. PUBLIC AWARENESS AND CIVILIAN BIODEFENSE The consequences of a bioterrorist attack extend far beyond public health. A bioterrorist event invokes terror and panic—psychological effects that also have serious economic implications. Indeed, one participant judged that one of the most successful elements of the September 11 terrorist act was the unforeseen damage to the airline, transportation, tourism, and restaurant industries. Public awareness entails more than risk communication during a crisis. It is also a critical part of the more general bioterrorist defense capacity-building

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary effort. Now that the recent anthrax release has entered a recovery stage, several workshop participants suggested that it is essential that we continue educating the public about the risks of bioterrorism. There is concern that many people do not realize how much damage a bioterrorist attack larger than what we have seen to date could inflict. In fact, we may be doing a disservice to the American public by not finding a way to educate them in a non-alarmist fashion about the serious nature of this problem. An increased public awareness may help overcome the challenge of convincing those who allocate resources that new and substantial resources are needed at all levels of capacity-building, from multi-sector collaborative vaccine production to informed local first responders. Several workshop participants expressed the belief that increased public awareness will indirectly send the message to Congress that this is a serious issue that demands immediate attention. Currently, it is unclear whether policymakers and those who are in positions to lead the effort to fill the gaps in our response capabilities have fully realized the reality of what looms ahead. It was described by one participant that a major challenge to public awareness, however, is the chance that this issue could diminish in importance if we are fortunate enough not to experience another attack in the near future. As such, it is crucial that we keep this issue in front of the nation and that we continue to develop our response to it. There was much discussion about whether public awareness could somehow be manifest as civilian biodefense and whether civilian biodefense could someday serve to empower local communities and decentralize the response to an attack. That is, on the one hand, we do everything that we need to do to strengthen the infrastructure of public health. But on the other hand, civilians could be educated about what they can do as individuals in terms of protective measures. With the awareness and proper training, civilian biodefense could become an important part of the local response. Indeed, as one workshop participant envisioned, is it not imaginable that in the far, far future we might be able to treat ourselves? Adel Mahmoud, M.D., Ph.D. Chair, Forum on Emerging Infections President, Merck Vaccines Stanley Lemon, M.D. Vice-Chair, Forum on Emerging Infections Dean of Medicine, University of Texas, Galveston