1
Introduction

FRAMING THE DEBATE WITH REAL-TIME CONSIDERATIONS

Bioterrorism is no longer a hypothetical event. A bioterrorist attack has occurred and could occur again at any time. The recent anthrax attacks not only caused five tragic deaths but significantly altered governmental operations in Washington, D.C., and substantially impacted our mail system. Importantly, we now have a window of opportunity to examine how we responded to that initial first hit and ask what must be done to better prepare for another attack. There is much concern that if we do not focus now with a clear framework for action, we will have lost a critical opportunity to capture the often short attention span of the nation.

We cannot assume that either the public or the policy makers truly understand the threat that still looms before us. The recent anthrax attack was as close to a traditional HAZMAT type of event as a biological event could be in terms of a defined source; teams could arrive at the site, define a perimeter, and identify who needed care. However, there are many potential biological scenarios that could unfold in very different ways that would require different strategies and investments. For example, there are many imaginable scenarios in which we would not know who had been exposed, nor would we even recognize the attack until cases started appearing in health care centers and hospitals across the country.

From a political perspective, since September 11, our awareness of our vulnerability to a bioterrorist attack is much greater than it was just three years ago, when hearings began with the Health, Education, Labor, and Pension Committee on whether we were vulnerable to such an assault. Today, we are much more aware of the holes and gaps in our system. The recently introduced Bioterrorism



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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary 1 Introduction FRAMING THE DEBATE WITH REAL-TIME CONSIDERATIONS Bioterrorism is no longer a hypothetical event. A bioterrorist attack has occurred and could occur again at any time. The recent anthrax attacks not only caused five tragic deaths but significantly altered governmental operations in Washington, D.C., and substantially impacted our mail system. Importantly, we now have a window of opportunity to examine how we responded to that initial first hit and ask what must be done to better prepare for another attack. There is much concern that if we do not focus now with a clear framework for action, we will have lost a critical opportunity to capture the often short attention span of the nation. We cannot assume that either the public or the policy makers truly understand the threat that still looms before us. The recent anthrax attack was as close to a traditional HAZMAT type of event as a biological event could be in terms of a defined source; teams could arrive at the site, define a perimeter, and identify who needed care. However, there are many potential biological scenarios that could unfold in very different ways that would require different strategies and investments. For example, there are many imaginable scenarios in which we would not know who had been exposed, nor would we even recognize the attack until cases started appearing in health care centers and hospitals across the country. From a political perspective, since September 11, our awareness of our vulnerability to a bioterrorist attack is much greater than it was just three years ago, when hearings began with the Health, Education, Labor, and Pension Committee on whether we were vulnerable to such an assault. Today, we are much more aware of the holes and gaps in our system. The recently introduced Bioterrorism

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Preparedness Act of 2001 is an attempt to fill those gaps. The leadership in Congress and the President of the United States are both committed to addressing bioterrorism in an appropriate, mature, and sophisticated way. However, it is imperative that experts in the field continue to emphasize to political leaders that the problem is much more complex than simply stockpiling. We must communicate in a way that is educational but not alarmist. In order to better prepare, we must evaluate our financial support for this effort. There is not nearly enough money to strengthen across-the-board basic public health services. However, it is possible to strengthen certain components of the public health infrastructure. Thus, we need to prioritize what can and should be done. Although the military has done an extraordinarily good job over the decades of preparing and planning for biowarfare, biowarfare is very different from bioterrorism. The issue is much more complex for the civilian population. For example, the civilian population is more diverse in terms of age and health which poses unique challenges in terms of which vaccines and antibiotics are most appropriate for different populations (i.e., children, immunocompromised individuals, geriatric patients, etc.). In fact, it was suggested that we may even need to pursue an antiviral approach to treating smallpox, given the risk of vaccinia in such a diverse civilian population. In our effort to build up our biodefense arsenal, we must decide whether it is wiser to develop vaccines and therapeutics that target specific agents or a much broader spectrum of antivirals and antibiotics that can be used more generally. Unfortunately, we do not know enough about the immune system response to develop broad-spectrum agents. Does this mean that, given the increasing accessibility of the technology and knowledge needed for bioengineering drug- and vaccine-resistant microbial strains, we must continually develop more and more specific antiterrorist agents? One option is to continue research on broad-based agents, while in the meantime continuing to develop target-specific agents. It was suggested that the very small fraction of the National Institutes of Health’s (NIH) total budget that is spent on bioterrorism be reevaluated. Some of the ground-breaking scientific findings that were presented during this workshop, for example on the mechanisms of the pathogenesis of anthrax, is testament to the long-term benefits that can result from basic research. Because of limited national capabilities, especially with regard to containment conditions required for efficacy studies with aerosolized pathogens, research questions must be prioritized. We must lay out a clear research agenda and invest appropriately to pursue that agenda in order to build the knowledge base that is necessary for developing better drugs and vaccines. The scientific community must mobilize to help reduce real risks in a way that will not be overly cumbersome to legitimate science.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Finally, we must evaluate and strengthen the public health infrastructure to ensure that it is fully capable of rapidly delivering countermeasures in the event of another attack. Again, several priorities for action that were identified during this session of the workshop were reiterated during the roundtable discussion and are summarized in the Summary and Assessment. Several workshop participants expressed that the level of cooperative effort under such great stress and tremendous pressure during recent events has been very heartening. However, it also became clear that there is a strong need for more direction and coordination. Indeed, this has led to the recent establishment of the Office of Public Health Preparedness (OPHP) , which will coordinate Department of Human and Health Services (DHHS) efforts in bioterrorism and bioterrorism preparedness. This new office will be the primary liaison with the Office of Homeland Security, the Department of Defense (DoD), the Department of Veterans Affairs (VA), the Federal Emergency Management Agency (FEMA), intelligence, and other governmental sectors that play a role in the national security team. The goals of the office are to address a broad range of issues, from expediting smallpox vaccine production to funding hospital planning programs. THE ROLE OF RESEARCH IN COUNTERING BIOTERRORISM Anthony S. Fauci,* M.D. Director National Institute for Allergy and Infectious Diseases Civilian biodefense preparedness requires a multifaceted and comprehensive approach within DHHS, involving first and foremost the Centers for Disease Control and Prevention (CDC). Other involved agencies include NIH, which plays an important role in basic research and developing medical interventions; the Food and Drug Administration (FDA), which plays an important role in the regulatory approval of vaccines, therapeutics, and diagnostics; and the Office of Emergency Preparedness (OEP), which is responsible for mobilizing resources to coordinate state and local responses. The most likely bioterrorist agents are the Category A agents which include smallpox, anthrax, plague, botulinum toxin, tularemia, and the viral hemorrhagic fevers. Given a limited resource pool, we must prioritize what we can and should do regarding therapies, diagnostics, and prevention for each of these agents. NIH’s total bioterrorism research funding from 1998 through 2002 is shown in Figure 1-1. Although there have been considerable increases over this timeframe, as indicated in the piechart, only 0.4% of the entire NIH budget is spent *   This statement reflects the professional view of the author and should not be construed as an official position of the National Institute for Allergy and Infectious Diseases.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary on bioterrorism. This will expand substantially. As shown in Figure 1-2, most of the $93 million allotted to bioterrorism research funding in 2002 is for vaccine (53.2%) and basic (38.5%) research. The remainder goes toward diagnostics (1.3%) and antibiotic/antiviral (7.0%) research. From a medical and biomedical standpoint, the military has done an extraordinarily good job over the past decades in preparing and planning for biowarfare. However, there are several important differences between biowarfare and bioterrorism. In terms of protection, the military thinks primarily in terms of the tactical and strategic use of bioweapons against them. Protection of the civilian population is a much more complex issue, the components of which are not considered front-burner issues for the military, nor should they be. First, the civilian population is significantly more diverse than the military population in terms of age and health and, as such, poses unique challenges such as knowing which vaccinations and antibiotics should be administered to children, pregnant women, the aged, and individuals with medical conditions. Second, military preparedness emphasizes vaccine protection; however, there are many more bioterrorist agents than there are bioweapons, and it is neither feasible nor desirable to vaccinate the entire civilian population against all microbes on every list. Civilian attacks will be sudden and unexpected, requiring rapid diagnostics and antimicrobial treatments. Vaccines need to be developed for all groups of civilians, not just healthy young men and women between the ages of 18 and 40 years (i.e., the bulk of the military). This will require perfecting those vaccines that already exist and developing new vaccines. For example, DoD is collaborating with NIH to develop a recombinant protective antigen as the immunogen for a new anthrax vaccine. Other ongoing studies are addressing the development of a preventive vaccine for Ebola. Smallpox vaccine research is based on a three-pronged plan: immediate, intermediate, and long-term. For immediate use, dilutional studies are being conducted to evaluate whether diluted vaccines can be used to “stretch” the current smallpox vaccine stockpile. Preliminary results look gratifying, and it appears that the stock is in fact quite potent. For intermediate use, we are negotiating a second generation of cell culture-based vaccines. The long-term research goal is to develop a better third-generation smallpox vaccine that has fewer side effects and can be used to vaccinate everyone. The well-known toxicities of the smallpox vaccine are described in Table 1-1.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FIGURE 1-1 NIH Bioterrorism Research Funding, FY 1998–2002 FIGURE 1-2 NIH Bioterrorism Research Funding FY 2002.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary TABLE 1-1 Complications of smallpox vaccination, United States, 1968   No. of Cases Vaccination Status Estimated No. of Vaccinations Postvaccinial Encephalitis Progressive Vaccinia Eczema Vaccinatum Generalized Vaccinia Accidental Infection Other Total Primary vaccination 5,594,00 16(4) 5(2) 58 131 142 66 418 Revaccination 8,574,00 0 6(2) 8 10 7 9 40 Contacts – 0 0 60(1) 2 44 8 114 Total 14,168,000 16(4) 11(4) 126(1) 143 193 83 572   SOURCE: JAMA 1999; 281:2127.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Creative techniques can be used to develop a chimeric vaccine from an already existent vaccine. For example, genes of the West Nile virus are being inserted into an attenuated Yellow Fever virus vaccine to create a “chimeric” West Nile virus vaccine. Theoretically, this can be done with any microbe for which we have identified and cloned the appropriate genes. To this end, we are collaborating with the Department of Energy (DOE) in cloning all the important pathogenic microbes. Selected examples of dangerous pathogens whose genome we have sequenced or are in the process of sequencing include: Bacillus anthracis (Anthrax), Brucella suis (Brucellosis), Burkholderia mallei (Glanders), Clostridium perfringes (Epsilon toxin), Coxiella burnetii (Q fever), Staphylococcus aureus (Enterotoxin B), Yersinia pestis (Plague), Variola major (Smallpox), and Vibrio cholerae (Cholera). Basic research can be a tough sell, especially when people want immediate gratification. True, we need immediate gratification because of the threat of an immediate bioterrorist attack, but we also need to prepare for the long term. The extraordinary and elegant work that John Collier and his colleagues have done on the mechanisms of the pathogenesis of anthrax has revealed multiple targets for intervention and serves as an excellent example of the long-term benefits that stem from basic research. We must continue investing in these types of studies if we, as a scientific research community, are truly going to address adequately the long-term threat of bioterrorism. The goal of diagnostics research is to apply the available technologies in the development of rapid, sensitive, easy-to-use tools that can be used to identify cases in civilian settings and assist in case management. DoD has already begun to address this issue. But because molecular biology is such an important component of diagnostics, DoD needs to collaborate with agencies that are conducting relevant molecular biology research. Such collaboration also serves as a way to learn from each other’s experiences and even mistakes. There are many existing antimicrobial agents, such as cidofovir, that could be screened for their activity against potential bioterrorism agents. Cidofovir was originally developed for the treatment of cytomegalovirus (CMV) infections in HIV-infected individuals and has shown to be highly effective against a number of pox viruses in an animal model. The goal of antimicrobial research, however, is not just to identify new therapies but also to determine how they should be used in diverse populations. Pediatric populations, for example, pose a major challenge. Many drugs are not used because of their unknown or adverse effects in children. In conclusion, we have been facing emerging and re-emerging diseases throughout history (see Figure 1-3). From an infectious disease perspective, the only difference between bioterrorism and any of these other naturally occurring diseases is that bioterrorism is deliberate. Thus, if we are to appropriately address this issue in a sustained way, we must also make a sustained effort toward addressing emerging and re-emerging diseases in general.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FIGURE 1-3 Examples of Emerging and Re-Emerging Diseases.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary THE POLITICAL PERSPECTIVE OF THE BIOTERRORISM THREAT William Frist, M.D. United States Senator from Tennessee United States Congress In the public eye and public image, September 11 and the ensuing several weeks have been a benchmark for future generations. I hope that they will say that we may not have had all the answers, but at least we responded appropriately and moved forward. This challenge provides the opportunity to bring out the very best of our universities, our academies, the U.S. Congress, our nation’s government, pharmaceutical companies, the public sector, and the partnerships within and among all of these various sectors of society. Three years ago, hearings began within the Health, Education, Labor, and Pension Committee on whether we were vulnerable to a biological assault. The answer was yes, it was very clear that there was a threat and that we were highly vulnerable. The risk had risen as a result of the progression of science, the end of the Cold War, the lack of balance and counterbalance in power, the increase in terrorist activity, and many other dynamics. The question then became, when would such an event occur and in what shape and in what form? As the chair and ranking member of the Subcommittee of Public Health, I worked with Senator Kennedy to write the “Public Health Threats and Emergencies Act of 2000.” The bill had eleven co-sponsors, was passed by unanimous consent, and was signed by the President of the United States one year ago. It has provided the framework for prevention, preparedness, and consequence management that Senator Kennedy and myself are building on today. Now, since September 11, our awareness of our vulnerability to a bioterrorist attack is obviously much greater. It has been spelled out, demarcated, and underlined. We are much more aware of what the holes and gaps are in our system. We were aware of the potential holes and gaps before September 11; now, we have even more proof. We may not know the perpetrators of recent events, but there is increasing hard evidence that formal efforts are being made by many countries to acquire biological weapons. We also know that there is a religious duty among terrorists to use germs in a way that can terrorize a nation or the world. It is imperative that experts in this field continue to communicate with policymakers in a way that is educational but not alarmist. People need to be informed about what the appropriate response is at the local, state, and national levels. For example, the response across much of the country is that everything will be okay if we just make enough vaccines. This response needs to be altered to reflect the advantage of vaccines as well as the need to examine cost-effective prevention and preparedness activities. Because “public health infrastructure” is an unfamiliar concept to most political leaders, we need to figure out how to better articulate our plans for educating people in government about it.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Last week, we introduced a bill—the “Bioterrorism Preparedness Act of 2001”—written by Senator Kennedy and myself (see Appendix D). The bill attempts to build on the already existing framework, fill the gaps, and better prepare the nation, government, and society. It provides a framework that will keep the nation focused as we fill these gaps. It includes recommendations from the President of the United States regarding improving the National Pharmaceutical Stockpile including an authorization for a certain amount of money. However, it does not commit the money; that is a separate issue that will be playing out over the next several weeks. It addresses research and development of new vaccines and treatments. To a certain extent, it also addresses training initiatives, outreach, response capabilities, and epidemiologic capacity. It supports core capacities for our laboratories. It discusses the dual purpose of investing in preparedness for a bioterrorist attack, i.e., that this investment will spill over into basic public health needs that physicians and families deal with every day, whether it be the flu or other infections. The bill also addresses food and agricultural safety. When that letter was sent to Senator Daschle’s office, during the following four days, we witnessed an outbreak. Initially, things were under control. This despite the fact that we didn’t know much about anthrax as a bioterrorist agent. We were able to conclude that fewer than thirty people had been exposed, and antibiotics were distributed as needed. Then, when we were made aware that somebody outside of the Hart Building had possibly been exposed to anthrax spores and developed inhalational anthrax from a piece of mail, there suddenly was a chance that our postal system would be shut down, just like the airlines had been shut down and our transportation system turned on its end on September 11. More people were admitted to the hospital; more people died; and our laboratories were stressed to their limit. We saw firsthand what our response was and what it should have been. If we pull together and form partnerships, the communication and laboratory capacity problems that we witnessed can be addressed in a positive manner. I, Senator Kennedy, our leadership in Congress, and the President of the United States—we are all committed to addressing bioterrorism in an appropriate, mature, and sophisticated way. We would all like to be able to go back to our districts, families, and homes and say that we are prepared—not underprepared, but prepared—in the event of any future bioterrorist attack.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary UPDATE ON THE IMPLICATIONS OF ANTHRAX BIOTERRORISM James M. Hughes,* M.D. Assistant Surgeon General and Director National Center for Infectious Diseases Centers for Disease Control and Prevention The recent anthrax events represent an unprecedented biological attack on our nation. On October 3, the CDC received an initial report of the index case in Florida, a 63-year old male photo editor employed by American Media, Incorporated. His illness started on September 30 and was characterized by fever and an altered mental status. He was admitted on October 2 and seen by an infectious disease clinician, Dr. Larry Bush, who was very concerned about him. A lumbar puncture was performed and blood and cerebral spinal fluid (CSF) cultures sent to a local clinical laboratory. The laboratory very rapidly isolated a suspicious organism and promptly referred it to a member of the Laboratory Response Network (LRN), a branch of the state public health laboratory located in Jacksonville. The diagnosis was confirmed by the CDC on October 4. Shortly thereafter, the CDC was notified of a 38-year old woman employed by NBC and who handled mail sent to Tom Brokaw. Onset of her illness, which was characterized by a typical skin lesion, occurred on September 25. On October 12, the diagnosis was confirmed at the CDC using immunohistochemical staining. Although it was not initially clear, it rapidly became evident that the individual had handled a letter that contained a suspicious powder. To date, there have been twenty-two cases, including eighteen confirmed and five suspected. A confirmed case is defined as a clinically compatible illness confirmed either by isolation of the organism or other evidence based on two supportive laboratory tests. A suspected case is a clinically compatible illness that is either linked to a confirmed environmental exposure or supported by one supportive laboratory test. Importantly, the epidemic curve for the first two phases of the outbreak is bimodal. The first cluster cases are associated with letters mailed from Trenton, New Jersey, on September 18. A larger cluster of cases followed mailings of letters to Senator Daschle and Senator Leahy. It remains to be seen whether the last two inhalational cases represent a third wave. There have been a total of six cases in New Jersey, including four cutaneous and two inhalational. Six of those cases involved mail handlers, the seventh a bookkeeper. Fortunately, there have been no deaths. As part of the exposure assessment, more than 1,200 nasal swabs were collected, none of which were *   This statement reflects the professional view of the author and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FRAMING THE ISSUES Edward M. Eitzen, Jr.,* M.D., M.P.H. Commander, United States Army Medical Research Institute of Infectious Diseases I am very honored to be part of this opening panel today, especially considering the fact that the other panelists are all leaders in the fields of government, infectious diseases, public health, and epidemiology. I hope that I will have a few points to add to the discussion from the perspective of the Army’s biological medical defense program at the United States Army Medical Research and Materiel Command (USAMRMC) under MG John Parker, and at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The hypothetical has become real when considering biological terrorism. And although we collectively have been able to deal with the threats we have faced recently with the anthrax mail attacks, there are certainly areas where we can improve our ability to respond. I would like to outline a few personal thoughts in that regard. Laboratory Diagnostic Capacity The first area is laboratory diagnostic capacity. USAMRIID, along with CDC, is one of the two level D laboratories (see Appendix K: Glossary and Acronyms) in the national LRN. In that regard, since September 11th, USAMRIID has processed and analyzed over 8,200 samples for multiple threat agents including anthrax. We have run over 30,000 individual assays. Volume of samples has ranged from 20 per day to over 700 per day at peak. To say we have been running at capacity or over capacity would be an understatement. Most of our samples have been environmental as opposed to clinical. It is my perception that the nation needs considerably more diagnostic capacity, and the LRN needs to work better. The A, B, and C laboratories should be able to handle most samples, and the D laboratories should be used for confirmation and difficult or high priority analyses. If the D laboratories are going to function at this level of capacity, then significantly greater resources are needed. The average funding for USAMRIID’s level D Special Pathogens laboratories over the past 5 years has been only about $750,000 per year. Our core diagnostics research missions have been essentially put on hold during this crisis. *   This statement reflects the professional view of the author and should not be construed as an official position of the United States Army Medical Research Institute of Infectious Diseases or the U.S. Army Medical Research and Material Command.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Research Capacity More research capacity is needed. The choke point for biological defense research is the ability to perform challenge studies for efficacy with aerosolized pathogens or toxins in animal models; these studies normally require containment conditions to perform them safely. There are only a few organizations in the United States who can do this type of work, and all of them, including USAMRIID, have limited capacity. The large anthrax post-exposure antibiotic study which was performed in non-human primates (NHPs) at USAMRIID in 1990 and 1991 (and is the basis for current treatment regimens) took over 70 people to perform, took several months, cost nearly a million dollars, and was very labor intensive—all other bacteriology research essentially stopped. Laboratory space, aerobiology capability, people, funding, and time are all issues. USAMRIID’s total yearly budget is about 50 million dollars, and one half to two thirds of this goes for maintenance and upkeep, and for salaries. That doesn’t leave a lot of excess capacity. As one of the key national research assets in this area of expertise, this speaks to a national level issue in terms of research capacity. There are research questions that need to be answered in the short, middle, and long term, and a need to prioritize those questions nationally due to the limited capabilities. Security Preventing further attacks must be a high priority. Protecting air supplies of key facilities, and other assets such as subways and metro systems would seem to me to be very important when we have a perpetrator or perpetrators who have shown the capability to create a concentrated, pure preparation of aerosolizable anthrax spores. Knowledge Assets The expertise on issues surrounding terrorist use of biological agents is limited in this country, and recent events have shown that there are some gaps in our knowledge. We need to do what we can to capture and augment the expertise that we have in a defensive direction. But we have to be able to do realistic threat assessment. There are some constraints on what is considered appropriate in the context of a defensive biological program. Education and Training Education of our healthcare providers is probably the most important defensive measure we can take, so that the “astute clinician” can recognize the medical consequences of an attack early, and sound the alarm. USAMRIID has put

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary on an Office of the Army Surgeon General (OTSG) sponsored satellite distance learning course in concert with the FDA and CDC partners for the past four years, a course which has educated over 52,000 military and civilian healthcare providers at a cost of only $55 per student. I am happy to announce that on Wednesday through Friday this week, in partnership with the VA’s Emergency Management Group and U.S. Army Medical Research Institute of Chemical Diseases, we will put on the fifth course in this series from the FDA studios in Gaithersburg, MD. This program will give physicians and nurses throughout the United States the tools they need to recognize, treat, and sound the appropriate alarm if they see one of these bioterrorism related diseases. We need more education like this for our biological first responders—who are not the classical first responders (EMTs and paramedics), but rather are doctors and nurses in emergency departments and in primary care offices and settings. As we move forward and face these new threats, there are many issues we must face together. One of the very gratifying aspects to me of the last two months has been the fantastic cooperation and great working relationships with our colleagues in other federal agencies (DHHS, CDC, FBI, Environmental Protection Agency [EPA], U.S. Postal Service) and state and local agencies as well. The level of cooperative effort under great stress and tremendous pressures has been very heartening to me personally. The relationships that have been developed over the last several years as we prepared have stood us well in this time of crisis. I am confident that with this spirit of cooperative effort that we can face the biological threats of the future, and protect and defend our nation against these threats. FRAMING THE DEBATE: APPLYING THE LESSONS LEARNED Michael T. Osterholm, Ph.D., M.P.H. Director, Center for Infectious Disease Research and Policy and Professor, School of Public Health University of Minnesota Very few of us should have been surprised by what happened on September 11. We were definitely shocked by the manner in which this catastrophic terrorism event happened on our shore, but the fact that it happened should not have surprised us. Many in our society understood and recognized that it was only a matter of time before terrorists would attack our Homeland; nonetheless most were in denial that it would actually happen. Understanding this phenomenon will be important as we move forward to better understand and prepare for what lies ahead. The post-September 11 anthrax situation was the first real test of our country’s response system to a potential bioterrorism attack. Many citizens consider the post-September 11 anthrax situation just a “scare”, not an anthrax crisis.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary While this limited hit (i.e., in terms of infectious disease) resulted in “only” five tragic deaths, it did alter governmental operations in Washington, D.C., substantially impacted our mail system, and caused fear and panic among much of our country. Given these facts, I believe this event should really be classified as a tragic dry run. What are some of the lessons learned? Following September 11, the national media tended to congratulate the response by the emergency response personnel of New York City to the World Trade Center Towers disaster. Indeed, it was a very heroic effort. But there was a misunderstanding with regard to the conclusion that the emergency medical services of New York City were prepared to handle this situation. I would offer that this was not an adequate test of what could potentially happen during a terrorist attack involving biological agents. There were less than 4,000 people in the World Trade Center area that presented to hospitals for any type of medical treatment. If this had been a smallpox or anthrax situation resulting in tens of thousands of victims, many needing hospital beds, this same system would not have been able to respond. It does us no good to speculate as to who were the perpetrator(s) of the anthrax situation. If a foreign entity is involved, this simply supports the notion that there are groups out there that can provide and deliver this sophisticated bioterrorism material. The challenge may even be greater if the perpetrator(s) is a domestic terrorist, as it would indicate that there is greater expertise out there than many had recognized and understood. Regardless, someone has created a very powerful bullet. However, to date they have used a very ineffective gun. Remember, the gun was not the technological hurdle—the bullet was the hurdle. The reality is, no matter who the perpetrators are, the capability exists to take this already prepared material and use it in a much more effective gun. Unfortunately there are many ways that this bullet can be used much more effectively. Such use will result in catastrophic numbers of cases that will far exceed the casualties of the World Trade Center tragedy. Given this, we need to focus not on the anthrax scare, but on the potential future anthrax crisis. We have a window of opportunity to thoughtfully examine how we responded to this initial attack. How did the federal, state, and local agencies respond? What can we learn from our successes, and what can we learn from where our response was inadequate? The point is not to blame or give credit, but to review what happened and learn how we can be better prepared when the other shoe drops. It is essential that we evaluate our short and long term financial support for the public health system. I believe Americans have a very short attention span. A Lexis/Nexis search of all major English newspapers and TV news transcripts over the past few months illustrates this. From September 11 through September 14, there were only 14 news stories on public health scares or crises (see Figure 1-4). During the week of October 23 to October 30—the height of the post-September 11 anthrax events—there were 558 such stories. But last week, there

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary were only 104, and that number is dropping precipitously (see Figure 1-5). In a similar search for anthrax stories in particular, there were six from September 11 to September 16, 1,487 from October 16 to October 22, and only 146 last week, despite the new case in Connecticut. We will need to constantly remind our elected leaders and the public that it is only with ongoing and substantial resource support, that our country’s public health system will be able to rebuild and arm itself for future attacks. Our thinking now must consider longer-term threats and consequences. Nobody should be surprised next time if a biological agent is involved and consequences are much more substantial than what our nation has tragically experienced to date. FIGURE 1-4 Newspapers, TV stories, re: public health threat, scare, crisis, 7/31-11/20, 2001 and 2000. SOURCE: Lexis-Nexis Academic: Major world English language newspapers and TV transcripts.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FIGURE 1-5 Newspaper, TV stories re: Anthrax, 7/31 to 11/13, 2001 and 2000. SOURCE: Lexis-Nexis Academic: Major world English language newspapers and TV transcripts. BUILDING CAPACITY TO PREVENT AND RESPOND TO BIOTERRORISM Margaret A. Hamburg, M.D. Vice President of Biological Programs Nuclear Threat Initiative Now is the time to define an agenda and move forward toward countering the threat of bioterrorism—to focus now with a clear framework for action. Even though our nation has experienced its first lethal bioterrorism attack, we cannot assume that the public and critical policy makers truly understand the threat that still looms before us. We need to continue to clearly define the threat. The recent anthrax attack was as close to a traditional HAZMAT type of event as a biological event could be in terms of a defined source and in the sense that teams could arrive at the site, define a perimeter, and identify who needed care. But we need to emphasize that there are many potential biological scenarios that could unfold in a very different way that would require a different focus, different strategies, and different investments. In this attack, the anthrax was delivered through the mail. But there are many other modalities that would lead to an unfolding disease epidemic with an unknown source. We would not know who had been exposed, nor would we even recognize the attack until cases started to appear in health care centers and hospitals across the country. We must continue to define and

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary communicate to people in critical decision-making positions what needs to be done with respect to the public health infrastructure and disease surveillance so that we can rapidly detect, investigate, and respond to disease outbreaks. We must recognize that the response will begin at the local level, thus we must ensure capacity at that level. This capacity must be augmented with clear plans for how state and federal resources will be mobilized to support local agencies. We need trained personnel, stronger laboratories, and better communication systems across all levels of government and in the private sector. We must invest in systems and activities that will be utilized as regularly as possible so that we are not testing new plans and strategies in the event of a crisis. We need to recognize that the bioterrorism threat is embedded in a set of infectious disease concerns for which we should also be better preparing our nation. At the same time, there are some unique preparedness programs that pertain specifically to the bioterrorism threat, for example the National Pharmaceutical Stockpile. As the nation moves forward with its plan to expand the National Pharmaceutical Stockpile, our efforts should be linked with the best possible intelligence about what the real and credible threats are. Furthermore, the stockpile must be linked to a real time distribution system. We need to make much more concrete plans with regards to how we are going to distribute the drugs, vaccination, or other interventions that would need to be rapidly mobilized in a mass casualty situation involving very large numbers of individuals. We also need to consider how to best prepare the medical care system to surge rapidly in the event of a mass casualty situation. This will involve careful advance planning, and a systematic look at regional capacities, how they can be mobilized, and how they can be augmented by state and federal resources. In order to build our knowledge base and become a better prepared nation in both the short and long term, we need to lay out a clear research agenda and invest appropriately to pursue that agenda. This involves research and development for new drugs and vaccines; improved diagnostics for human samples; improved environmental detection capability; and basic research on how these organisms cause disease and how the human immune system responds. We also need the type of systems research that will help us better understand the issues that have been vexing us so much over the past couple of months, such as environmental decontamination and personal protection. Public health has always been an important form of public safety. Now it is a critical pillar in our national security framework as well. As such, public health expertise should be an important component of the new Office of Homeland Security, and a public health official should become part of the White House national security team. Finally, we must consider prevention, of which a key element is intelligence. Recent events have led to a commitment to improve overall intelligence collection, and the scientific community must play an important role in this. Scientists are informed in critical ways, including fundamental knowledge of

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary biological threat agents and the effects they cause, knowing what information in the scientific literature could be misused or misapplied by those who want to do harm, and insights into what is going on at various laboratories around the world. As such, scientists will be crucial to building new expertise in this complex area within the intelligence community. The scientific medical community will also need to engage on the issue of improving biosecurity in terms of reducing access to dangerous pathogens. Steps have been taken in recent years through the select agent rule at the CDC and some of the new procedures implemented at so-called germ banks, such as the American Type Culture Collection. But the anthrax situation has demonstrated that we still don’t have an adequate handle on whether dangerous pathogens are secured, who is using them, and why. The scientific community needs to mobilize now to help reduce real risks in a way that will not be overly cumbersome to legitimate science. We must recognize that while advances in science and technology hold enormous promise for improving health, they also present many opportunities for misapplication or inadvertent harm. The Australian mousepox study is one example of an inadvertent finding that has laid out a road map for others to make an already dangerous pathogen more lethal. Finally, we need to recognize that there is a great deal that can be done to further secure or destroy dangerous biological materials in the former Soviet Union. We need to 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. We have an opportunity through those collaborations to address critical public health and medical issues of mutual concern and reduce the possibility of further development or spread of biological weapons. BIOTERRORISM: COMMUNICATING AN EFFECTIVE RESPONSE Scott R. Lillibridge,* M.D. Special Assistant to the Secretary for National Security and Emergency Management Office of the Secretary Department of Health and Human Services The DHHS bioterrorism preparedness began in earnest in FY 1999 with more than 155 cooperative grants from the CDC covering all fifty states for some component of laboratory science, surveillance, planning and preparedness, communications and information technology, and training. As we begin to examine lessons learned from the recent anthrax events, we can take stock of these *   This statement reflects the professional view of the author and should not be construed as an official position of the U.S. Department of Health and Human Services.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary preparedness measures and imagine what might have unfolded if this infrastructure had not been in place. Tribute should be paid to the many walks of public health, particularly to many present today who worked diligently to provide emergency services during the recent anthrax releases. Within DHHS, many accolades also go to our CDC, the Public Health Service Commissioned Corps, and other agencies within the Department that provided vital services during this act of bioterrorism. I would like to comment briefly on a few of the many lessons learned that will help shape the upcoming bioterrorism program within DHHS during the upcoming year. First, the initial event in Florida and thereafter during the emergency, the issue of communications was arguably one of the most important areas in our public health response. The way in which we generate and communicate information during an emergency is incredibly important to effectively deal with the problem at hand and to reassure the public. It was clear that the media was able to gather information from a wide range of sources. For example, test results, from laboratories that may be initially operating outside of the federal response were moved into the public consciousness and the political arena at a remarkable speed. There was often little distinction made between a false positive, a presumptive positive, and a confirmed positive test result by the media. This greatly complicated the dissemination of processed information by health officials operating at the state and local level. Clearly, in the future, our bioterrorism preparedness efforts will need to pay more attention to the infrastructure associated with health communications and information dissemination. A few common strategies for example will pay dividends in dealing with such an emergency from the public health perspective. First, having a state or local plan that provides for a single, consistent, authoritative spokesperson will be extremely important in addressing the public. Consideration for prepackaged infectious disease information, local spokespersons to disseminate a clear message, and the ability to rapidly investigate rumors will also be vital to tackling the communications issues associated with a fast developing epidemic response. With respect to the recent anthrax emergency, it was clear when public health experts took a prominent role in the national news media and began to promote their message, it had a tremendous positive effect in helping the public understand what was being done on their behalf. For example, when state and local public health professionals began talking about the meaning of specific laboratory tests, information about exposure, or the need for medical prophylaxis the media was far more supportive of the response than when conflicting information from different and sometimes dubious sources were communicated. Consequently, it is essential that our public health infrastructure have a strong communications capacity that can be activated during an emergency. This will greatly assist the public health community in providing an informed perspective on science, public health, epidemic control measures, and other pertinent response issues.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary A second issue to be learned from the recent anthrax attack is the importance of investing in laboratory infrastructure. It was very reassuring to know that the laboratory staff who confirmed the initial Florida case had been trained by CDC and were using standardized CDC reagents. Through the combined work of the Association of Public Health Laboratories (APHL), American Society of Microbiology (ASM), CDC, DoD, DOE and others, 81 such network laboratories are currently in place across the nation. From the events associated with the recent anthrax releases, it is clear that a greater investment in linking these laboratories and in ensuring vital surge capacity will be needed in the future. In addition, the distinction between laboratories of the network and other laboratories outside of the network were often unimportant to the media and some response organizations. As a consequence, proper tracking of laboratory samples from various response sites became an important issue. It was clear that expanded laboratory sample tracking and coordination of results information will continue to be very important issues for future preparedness highlighting the importance of developing systems of electronic laboratory reporting. Another aspect of laboratory readiness that was not anticipated in the scope of the current response laboratory network was the need for a large environmental sampling component and some method for redistributing work throughout the network. A third major lesson learned from recent events is the extreme importance of training front line healthcare providers, including nurses, doctors, clinicians, and infectious disease consultants in disease recognition. It was an alert clinician who initially identified many of these cases and then notified public health and law enforcement officials to trigger an investigation. Increasing our efforts to educate such providers will be extremely important to an ongoing bioterrorism preparedness effort. A fourth lesson learned is that the public health infrastructure is strategically important to the national security of the United States. Before these events, during discussions that took place in FY 1999, the belief that the public health infrastructure needed to be enhanced in key areas was not widely shared within the interagency emergency response community. However, as the current emergency unfolded, the interagency community as well as the various other sectors of government began to view the public health infrastructure as being strategically important to the national security of the United States. I hope these beliefs will continue to drive an investment into our increasingly important public health infrastructure for some time to come. Finally, recent events tested the adequacy of our stockpile and our ability to deploy it. The reality of deploying push packages and therapeutic prophylaxis into populations is very different from planning such activities in an office environment. During this response, it was apparent that stockpiling is more than simply a warehouse activity and many of our efforts to ready stocks work very well. Issues to be addressed in the future include, how much of the stockpile should be immediately ready to go, how much stock should be vendor-managed for delayed arrival, what drugs need to included, and how it should be best

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary packaged. This reinforced our notion that stockpiling and the policy that directs its deployment will be an extremely important component of an overall national bioterrorism preparedness program. In conclusion, Winston Churchill, who was involved in the dawn of chemical warfare in WWI and who also served as prime minister of England during WWII when the radiation age appeared, would probably tell us today that our investment in selected public health infrastructure and readiness for epidemics remains one of the best ways to prepare our population for the current threat of bioterrorism.