Executive Summary

The attacks of September 11 and the release of anthrax spores revealed enormous vulnerabilities in the U.S. public-health infrastructure and suggested similar vulnerabilities in the agricultural infrastructure as well. The traditional public health response—surveillance (intelligence), prevention, detection, response, recovery, and attribution—is the paradigm for the national response not only to all forms of terrorism but also to emerging infectious diseases. Thus, investments in research on bioterrorism will have enormous potential for application in the detection, prevention, and treatment of emerging infectious diseases that also are unpredictable and against which we must be prepared.

The deciphering of the human genome sequence and the complete elucidation of numerous pathogen genomes, our rapidly increasing understanding of the molecular mechanisms of pathogenesis and of immune responses, and new strategies for designing drugs and vaccines all offer unprecedented opportunities to use science to counter bioterrorist threats. But these same developments also allow science to be misused to create new agents of mass destruction. Hence the effort to confront bioterrorism must be a global one.

INTELLIGENCE, DETECTION, SURVEILLANCE, AND DIAGNOSIS

Increased awareness in the science and technology (S&T) community could reduce the inadvertent spread of knowledge that may aid terrorists, although there is a fine balance that must be achieved so as to not quash legitimate exchange of scientific information. Voluntary international and national efforts to share biotechnology information could improve security and safety in the handling, storage, and transport of sensitive biological material and equipment. Information



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Countering Bioterrorism: The Role of Science and Technology Executive Summary The attacks of September 11 and the release of anthrax spores revealed enormous vulnerabilities in the U.S. public-health infrastructure and suggested similar vulnerabilities in the agricultural infrastructure as well. The traditional public health response—surveillance (intelligence), prevention, detection, response, recovery, and attribution—is the paradigm for the national response not only to all forms of terrorism but also to emerging infectious diseases. Thus, investments in research on bioterrorism will have enormous potential for application in the detection, prevention, and treatment of emerging infectious diseases that also are unpredictable and against which we must be prepared. The deciphering of the human genome sequence and the complete elucidation of numerous pathogen genomes, our rapidly increasing understanding of the molecular mechanisms of pathogenesis and of immune responses, and new strategies for designing drugs and vaccines all offer unprecedented opportunities to use science to counter bioterrorist threats. But these same developments also allow science to be misused to create new agents of mass destruction. Hence the effort to confront bioterrorism must be a global one. INTELLIGENCE, DETECTION, SURVEILLANCE, AND DIAGNOSIS Increased awareness in the science and technology (S&T) community could reduce the inadvertent spread of knowledge that may aid terrorists, although there is a fine balance that must be achieved so as to not quash legitimate exchange of scientific information. Voluntary international and national efforts to share biotechnology information could improve security and safety in the handling, storage, and transport of sensitive biological material and equipment. Information

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Countering Bioterrorism: The Role of Science and Technology technology could help monitor international trafficking in biotechnology products. Knowledge of the genome sequences of major pathogens allows new molecular technologies to be developed for the sensitive detection of pathogens. These technologies offer enormous possibilities for surveillance of infectious agents in our environment, the identification of pathogens, and rapid and accurate diagnoses. For these new technologies to be used effectively to provide early warnings, there is a need to link information from the doctor’s office or the hospital’s emergency room to city and state departments of health, thereby enabling detection of an outbreak and a rational and effective response. These capabilities will be important both for responding to attacks on agricultural systems (animals and crops) and for protecting humans, and they will require careful evaluation and standards. There is an urgent need for an integrated system to protect our food supply from the farm to the dinner table. Recommendation 1: All agencies with responsibility for homeland security should work together to establish stronger and more meaningful working ties between the intelligence, S&T, and public health communities. Recommendation 2: Federal agencies should work cooperatively and in collaboration with industry to develop and evaluate rapid, sensitive, and specific early-detection technologies. Recommendation 3: Create a global network for detection and surveillance, making use of computerized methods for real-time reporting and analysis to rapidly detect new patterns of disease locally, nationally, and ultimately— internationally. The use of high-throughput methodologies that are being increasingly utilized in modern biological research should be an important component of this expanded and highly automated surveillance strategy. Recommendation 4: Use knowledge of complex biological patterns and high-throughput laboratory automation to classify and diagnose infections in patients in primary care settings. Recommendation 5: USDA should create an agency for control and prevention of plant disease. This agency should have the capabilities necessary to deal effectively with biothreats. PREVENTION, RESPONSE, AND RECOVERY To be able to respond to current and future biological threats, we will need to greatly expand research programs aimed at increasing our knowledge of the pathogenesis of and immune responses to biological infectious agents. The recent

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Countering Bioterrorism: The Role of Science and Technology anthrax attacks revealed how little is known about many potential biological threats in terms of dose, mechanisms of disease production, drug targets, and requirements for immunity Research efforts critical to deterrence, response, and recovery—particularly decontamination and bioterrorism forensics—should be strengthened. Appropriate scientific expertise should be integrated into the government agencies with principal responsibilities for emergency response and postevent investigations. Modeling tools for analyzing the health and economic impacts of bioterrorist attacks are needed in order to anticipate and prepare for these threats. Techniques for protection of individuals and buildings should be developed, together with methods of decontamination in the event that such defenses are breached. In addition, multidisciplinary research in bioterrorism forensics is necessary to enable attribution of a weapon to its source and the identification of persons involved in a bioterrorist act. Preparedness for bioterrorist attacks should be improved by creating a public-health research system and by developing surge capacity to deal effectively with such terrorist attacks as well as with natural catastrophes. Additionally, new strategies must be developed and implemented for assuring the security, usability, and accurate documentation of existing stocks of supplies at research facilities, hospitals, veterinary facilities, and other host sites. The potential for a major infectious threat to kill and disable thousands of citizens requires a level of preparedness that we currently lack—a surge capacity to mobilize the public-health response and provide emergency care in a health system that has been somewhat downsized in an effort to cut costs. There are immediate needs and opportunities for training first responders, medical, nursing, and health professionals, and communities as a whole in how to respond to biological threats. Also needed is a well-trained, professional public-health reserve, including laboratories and health personnel, that can be mobilized. Standardized protocols for such purposes will be critically important. Recommendation 6: Agencies with relevant expertise (such as NIH, CDC, and DOD) should develop and support the development of models—taking into account a range of incubation periods, transmission dynamics, and variables of climate, population, and migration—to simulate the release of contagious and noncontagious agents. Such modeling may resolve many of the uncertainties about the effects of biological weapons. Recommendation 7: Expand investigations into the pathogenesis of infectious agents. Review the state of knowledge on the mechanisms of pathogenesis of all bioterrorist agents and of host responses to them, and initiate an action plan to conduct laboratory research using the latest molecular biology tools. This research will enhance understanding of the points at which these

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Countering Bioterrorism: The Role of Science and Technology threats are most susceptible to useful intervention and will help identify new targets for developing diagnostics, drugs, and vaccines. Recommendation 8: Develop and coordinate bioterrorism forensics capabilities. Federal agencies with missions in defense and national security should lead in establishing this new multidisciplinary, multilayered field. A comprehensive study should be performed to determine the capabilities of and needs for bioterrorism forensics, and an integrated national strategy and plan formulated. Recommendation 9: Increase research and development on therapeutics and vaccines. Support basic and clinical research to discover molecular targets in bacteria and viruses, develop broad-spectrum antivirals and antibiotics, and devise treatments that enhance or stimulate protective host responses (both innate and acquired). Similarly, continue to expand and deploy the capability to use genomics to rapidly identify engineered mutations or altered virulence factors, create a generic platform to develop a vaccine against recombinant pathogens, and employ streamlined testing and regulatory processes to assure adequate efficacy and safety while expediting delivery. Recommendation 10: Improve environmental and personal protective equipment. Agencies such as EPA, NIOSH, CDC, DOD, and DOE should perform and support research on new technologies that increase the protection factors of such equipment, and ensure uniform testing oversight to certify efficacy. Recommendation 11: Create a public health reserve system and develop surge capacity. As part of a broader planning process, create a health reserve system of health care professionals (modeled on the military reserve system), and prepare local and regional laboratories for deploying surge capacity to supplement and enhance disaster-response capabilities. Recommendation 12: Create an agricultural health reserve system and develop surge capacity. As part of a broader planning process, create a reserve system of veterinarians and plant pathologists (modeled on the military reserve system), and prepare local and regional laboratories for deploying surge capacity to supplement and enhance disaster-response capabilities. Recommendation 13: Develop protocols for public health responses to bioterrorist attack. OHS should develop a plan for achieving this objective, and HHS, through its various agencies, should support the necessary research.

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Countering Bioterrorism: The Role of Science and Technology Recommendation 14: Develop methods and standards for decontamination. Develop standards for levels of decontamination and certification of products to ensure safety. POLICY AND IMPLEMENTATION It is clear that development of therapeutics and vaccines will require more research on pathogenesis and protective host responses, but financial incentives, indemnification, and regulatory changes may be needed to allow the pharmaceutical industry to pursue such efforts. Because markets are very limited for vaccines and drugs for countering potential bioterrorist agents, special institutes may have to be established for carrying out research on biohazards and producing drugs and vaccines. The Department of Health and Human Services and the Food and Drug Administration (FDA) should investigate strategies—including the modification of regulatory procedures—to encourage the development of new drugs, vaccines, and devices to address bioterrorist threats. Effective preparedness for countering bioterrorism will not only require focused and sustained efforts to build the nation’s public and agricultural health infrastructures (including the training of health care professionals in detection, surveillance, prevention, and response); it will also require substantial changes in the way government-supported research is executed. Several overarching strategies are needed to provide the necessary funding for research and development (R&D), mechanisms for response, integration of efforts, and translation of findings into application. The recommendations listed below, which support and facilitate the R&D priorities outlined in this report, are offered in that spirit. Recommendation 15: Create special research organizations to build expertise in countermeasures to bioterrorism. Federal agencies must build human resources in threat-agent characteristics, pathogenic mechanisms, and responses to bioterrorism-induced disease. Protected environments that foster innovation must be developed to support a cadre of leaders, scientists, engineers, policy experts, and strategic thinkers. These designated research organizations should address both classified and unclassified issues, and special mechanisms for rapid funding should be created to support external research efforts as the needs and opportunities emerge. New mechanisms for funding high-risk, long-term, high-payoff projects should be created in NIH. Recommendation 16: Establish laboratory standards. Set up an oversight standards laboratory to evaluate diagnostic and detection tools; to ensure the availability of standard reagents for academia, industry, and government; and to develop appropriate standards on a continuing basis.

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Countering Bioterrorism: The Role of Science and Technology Recommendation 17: Facilitate vaccine and therapeutics production. Through public-private partnerships, create research, development, and manufacturing capacities to produce diagnostics, therapeutics, vaccines, and devices to counter terrorism and an oversight laboratory to evaluate, prepare, and standardize methodologies. Recommendation: 18: Allow regulatory exceptions for development of therapeutics and vaccines against bioterrorism threats. The FDA should convene a broadly based conference to consider options and plausible mechanisms for expedited approvals under specific emergency conditions. In addition, for new drugs and vaccines that cannot be tested in humans, mechanisms for indemnification in the case of adverse effects will need to be developed. The possibility of encouraging collaboration between pharmaceutical companies in this area by waiving antitrust restrictions—in specific cases justified by the national interest—must also be considered. Thus, in addition to the FDA, the Departments of Commerce, Treasury, and Justice should also be involved in these discussions. CONCLUDING REMARKS Although there are gaps in the scientific understanding of many potentially deadly biological agents and in the technological advances needed to anticipate and respond to their release, reliance on purely scientific or technological solutions would be misguided. A much more inclusive effort is needed to build a seamless system of preparedness and response—one that can exercise the best available tools to counter biological threats. This task depends first and foremost on rebuilding the public health infrastructure of the United States, which has been allowed to decay as the nation conquered some of the more common infectious and other disease challenges of the past century. The terrorist events of September and October 2001 should serve as a wake-up call to those in the position of setting science and health policies in the United States. Many of the scientific goals described in this report cannot be achieved in the absence of trained and well-equipped public health officers, educated and prepared first responders, and clear communication among leaders, the medical community, and the public. Preparedness is essential not only for countering bioterrorism but also for facing the constantly evolving threat of infectious diseases, particularly the widespread escalation of bacterial pathogens resistant to all known antibiotics. In reality, humans and the livestock and crops that sustain them are in a perpetual contest with microorganisms and the diseases that they cause—a contest that requires an armamentarium of knowledge gained from research, surveillance, and improved health practices. Humans and animals are not immune to the threat of infectious diseases just because they have been immunized or eat food

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Countering Bioterrorism: The Role of Science and Technology and drink water that is regulated and evaluated for their safety. Serious, sometimes deadly, outbreaks of infectious diseases continue to occur naturally around the world. Even when they are treatable, these diseases take their toll in pain and suffering, inconvenience, disability, lost time from work and lost wages, and cost to the health-care system and the economy. But preparing for the once unthinkable—a biological attack—should also prepare the U.S. population for the inevitable: the natural occurrence (or recurrence) of diseases that can affect all living things. Efforts that protect humans, animals, and plants from bioterrorism will also help us prevail in that neverending contest with natural threats.

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