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Twentieth-Century Legacy: The Challenge of Biological Threats to Twenty-First Century Bio-Medical Science and Society

Christopher J. Davis, O.B.E.

INTRODUCTION

Let me begin by stating that the phrase “Weapons of Mass Destruction” (WMD) is a misconception and in many ways quite confusing. It is said to have been a Soviet invention in the 1960s, coined for political purposes and to cause confusion. We are unfortunately saddled with it—unfortunately, because by no means can all chemical and biological weapons be classified as weapons of mass destruction. In fact, the entire purpose, especially of biological weapons, is to obtain an advantage without destroying anything but people (and animals of plants), however unpleasant that concept may be.

This paper offers a broad overview of the topic of bioterrorism. It attempts to cover the nature of biological weapons agents, industrial biological weapons programs, bioterrorism, bombs, and natural infections, and to offer a few examples of terrorist use of biological weapons and the kinds of lessons that can be drawn from them. It also discusses biodefense, a practical philosophy for moving forward, and the directions in which the United States is going and what some people in the United States are doing. Bioterrorism is fortunately an area where science and technology could have enormous positive impact and in which research on biodefense will also provide significant benefits for society at large in the realm of emerging and re-emerging infectious diseases for which we are currently ill-prepared.

THE NATURE OF BIOLOGICAL WEAPONS: PRACTICAL IMPLICATIONS

First, there are lethal and nonlethal agents. Plague is an example of an organism that is highly lethal. Up to 100 percent of untreated victims of the plague will die.



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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop 14 Twentieth-Century Legacy: The Challenge of Biological Threats to Twenty-First Century Bio-Medical Science and Society Christopher J. Davis, O.B.E. INTRODUCTION Let me begin by stating that the phrase “Weapons of Mass Destruction” (WMD) is a misconception and in many ways quite confusing. It is said to have been a Soviet invention in the 1960s, coined for political purposes and to cause confusion. We are unfortunately saddled with it—unfortunately, because by no means can all chemical and biological weapons be classified as weapons of mass destruction. In fact, the entire purpose, especially of biological weapons, is to obtain an advantage without destroying anything but people (and animals of plants), however unpleasant that concept may be. This paper offers a broad overview of the topic of bioterrorism. It attempts to cover the nature of biological weapons agents, industrial biological weapons programs, bioterrorism, bombs, and natural infections, and to offer a few examples of terrorist use of biological weapons and the kinds of lessons that can be drawn from them. It also discusses biodefense, a practical philosophy for moving forward, and the directions in which the United States is going and what some people in the United States are doing. Bioterrorism is fortunately an area where science and technology could have enormous positive impact and in which research on biodefense will also provide significant benefits for society at large in the realm of emerging and re-emerging infectious diseases for which we are currently ill-prepared. THE NATURE OF BIOLOGICAL WEAPONS: PRACTICAL IMPLICATIONS First, there are lethal and nonlethal agents. Plague is an example of an organism that is highly lethal. Up to 100 percent of untreated victims of the plague will die.

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop Plague can be compared with tularemia, which comes in two forms. Today, the more well known form is considered a debilitating, incapacitating disease. The other form is the one originally developed as a weapon. It causes substantial mortality. Thus, the approaches to these two agents are quite different, the results they produce are quite different, and the way we must deal with them will be different. There are also transmissible and nontransmissible agents. Smallpox, which is highly transmissible, can be compared with anthrax, which is not transmissible from person to person. The significance of this is great. One individual with smallpox will infect anywhere between 10 and 50 others, creating a mushrooming problem. There are persistent and non-persistent agents. The classic Biological Weapon (BW) organism, anthrax, is persistent and hardy. Given the right conditions, it can survive in the environment for well over 100 years. Anthrax can be compared with Venezuelan equine encephalomyelitis, a virus that is nonpersistent in the environment. Of course, there are overarching classifications of living BW organisms, divided into bacteria and viruses. Brucella can be compared with Marburg virus, for instance, and there are many other examples. The big difference is whether or not vaccines and therapeutic treatment agents exist. On the whole, there are very few drugs available to treat viral diseases. This is a large hole in our defensive armamentarium. There are living and nonliving agents. Plague, for example, is a living agent. Botulinum toxin and ricin, on the other hand, are clearly nonliving chemicals. Finally, there are the even more general categories of human diseases versus animal diseases versus plant diseases. There are organisms that can attack any part of the living world that we depend upon, ranging from salmonella infections in humans, to foot-and-mouth disease in cows, and Bunt of Wheat in food crops. So, biological weapons are a family of weapons. This must be emphasized. People talk about straightforward “ballistic” weapons, but they never confuse the use of a tank with the use of a handgun. Tanks and handguns are designed to do different jobs in the hands of different kinds of people. Similarly, it is important that the same distinction be drawn in talking about biological weapons, a family of weapons that can be used in circumstances that range from individual assassinations to mass killing of civilian populations. THE LEGACY OF INDUSTRIAL OFFENSIVE BIOLOGICAL WEAPONS PROGRAMS The modern era has seen several biological weapons programs, including two, in particular, that were very large. The United States had a very large offensive biological weapons program, which it unilaterally abandoned in 1969, in the lead-up to the 1972 Biological and Toxic Weapons Convention. The Soviet Union had a truly enormous offensive biological weapons program.61 Now there are about a dozen countries that have been assessed as having, or are suspected of having, offensive biological weapons programs; without discussing details, suffice it to say that these programs and the people with the skills to run them do exist. 61 This is one of my areas of particular expertise, as I spent 10 years in British intelligence as the senior officer responsible for global biological weapons intelligence analysis.

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop Some historical background may help provide an idea of the scale of these programs. The U.S. biological weapons program was completely destroyed in a very short period of time in 1969. Contrary to popular thinking perpetuated by government propaganda, it had been a very successful and extremely large program. By 1969, for instance, the part of the U.S. Navy dedicated to biological weapons trials at sea had grown to such a size that, had it been separated and given to a third country, it would have constituted the world’s fifth largest navy. This is an extraordinary fact given the size of the navies of the major sea powers at the time. A great deal had been achieved in the program, which the leadership of the time decided, for a very complex set of political, intelligence, and other reasons, to abandon completely. For instance, Sergeant tactical missiles with biological warheads packed with spherical bomblets were ready for use in the field; it was later discovered that the Soviets had produced very similar designs. Essentially, these were bomblets containing a liquid agent. The bomblets were designed to be released from the warhead. They were designed either to detonate at a certain height or, in the Soviet case, to bounce and split open a few meters aboveground, dispersing their contents in an aerosol along the way. I could speak at length about the Soviet biological weapons program and still not exhaust the data, so large was the effort. I was fortunate to be in the right place at the right time in London in late October 1989, when Dr. Vladimir Pasechnik, a very senior official from the Soviet program, became the first BW expert to defect to the West; in this case to the United Kingdom. This allowed us to start to make serious political and diplomatic progress with this issue. What we learned, in addition to what we already knew, was that the Soviet program was both very large and extremely secret. The degree of secrecy accorded it was even greater than that for the nuclear program. The reasons for this are obvious. Not only was it a strategic weapons program, it was illegal, outlawed by an international convention to which the Soviet Union was not only a signatory but also a depository power. Indeed, the Soviet Union was one of the architects of the 1972 Biological and Toxic Weapons Convention. Their program was vast in scope, with enormous amounts of research and development and the highest political backing, and under military control ultimately, although most of the work was carried out in a front organization called Biopreparat. It was really the substitute for what countries in the West and many other countries in the world built in their biotechnology and pharmaceutical industry. The result was that the Soviet Union became the world’s best bioweapons developer, while their biopharmaceutical industry could not produce enough standard antibiotics to meet domestic requirements. It was an extraordinary enterprise that consumed the best and most talented medical and biological minds of a generation. It drew the most capable an inventive people into this field, and they did some incredible work over a period of 15 to 20 years. In a bold political move involving Prime Minister Margaret Thatcher and President George H.W. Bush, taking Soviet leaders Mikhail Gorbachev and Edward Shevardnadze to task, we addressed this problem, and were partly successful, in that at least the civilian side of the Soviet program was ‘dismantled.’ Alas, what remains of their program, or should I say the ‘core’ still lies within the confines of its origins in the Russian military establishments because of inspections impasses into which we were

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop drawn and the failure of our political and military leadership to realize the importance of this issue at a time when nuclear instability was the greater concern. The story of how this happened must wait for another occasion. BIOTERRORISM, BOMBS, AND NATURAL DISEASE How does the world of bioterrorism differ from the world of terrorism that we are used to? The world of terrorism is largely one involving guns and explosive devices. How is bioterrorism similar to or different from naturally occurring infectious disease? In the biological world, what we see are delayed effects. Even the most fast-acting toxin has a small delay, and living agents have to get into the body in order to multiply. Thus, whatever we are going to observe will be observed not at the time of the event but sometime after. The assumption is that our first warning of an attack will be the occurrence of sickness in the population. Psychology plays an important role in bioterrorism. In psychological terms, infectious diseases have an enormous impact. This is especially true in the highly developed, so-called sophisticated societies of the West that regard themselves as largely invulnerable to infectious diseases. The fact that we cannot see biological weapons agents is another psychological factor. For humans the unknown is perturbing. People can understand and come to terms with bombs and bombers because they are visible. Chemical and biological weapons, on the other hand, have an undermining effect. Re-load, a term coined by Richard Danzig, a former Secretary of the U.S. Navy, means that the person who produced the 10 grams of anthrax involved in the letter attacks in the United States could, with relative ease, increase the amount produced to 5 kilograms. Depending on how it is disseminated, 5 kilograms of dry powdered agent could do a great deal of harm. Moreover, an agent such as anthrax can inflict harm quite quickly. With 5 kilograms a perpetrator can inflict harm on multiple occasions. First responders involved in a biological weapons incident are likely to be different from the first responders for most other terrorism incidents. With bioterrorism it is the people on the medical frontline—doctors and nurses—who produce the response. Indeed, they may become casualties themselves as a result of becoming involved with transmissible diseases or a persistent agent. Bioterrorism also has the potential for many casualties and deaths. Terrorist attacks to date have caused relatively few casualties and deaths, but that is just an accident of history. Potentially, people could be killed in very large numbers, especially if transmissible agents such as plague or smallpox were used. In the aftermath of a biological attack, diagnosis can be difficult and challenging, even for the most experienced physician. Everybody sees diagnosis as being straightforward, but on the whole, it is quite difficult to distinguish one agent from another on a clinical basis, particularly in the early hours of their disease development. In addition, most medical professionals are not well trained or well prepared to distinguish biowarfare diseases from other more common diseases. They may have rarely seen, or never seen, these kinds of diseases. There is also a technical aspect that is not always well appreciated. When people are exposed to large doses of a disease agent, the pattern of disease may be different from that which is seen in the natural world and

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop may not necessarily be recognized. Additionally, the disease may progress much more quickly with much larger inoculums of a biological agent. In bioterrorism the pattern we see is in effect an instant epidemic. There are classic patterns for the emergence of any normal epidemic or for the emergence of a period of disease in society. Biological weapons do not follow this pattern. Obviously, the impact from an apparently small bioterrorist event can be enormous. The well-known anthrax letters incident in the United States in 2001 illustrates this. RECENT EXAMPLES OF BIOTERRORISM: LEARNING THE HARD WAY There are in fact relatively few recent examples of bioterrorism. If we look closely at historical record, there have been approximately 200 incidents involving toxic biological materials in the last 100 years. Most of them were minor attempts at disruption. Therefore, history is not a good indicator of the future. History does tell us, however, that it is time to take this threat more seriously. Accounts of these incidents reveal how society at large is learning the hard way about bioterrorism. Before the 1990s, most governments paid little or no attention to the problem of biological weapons, especially in terms of defense. There is a complex explanation for this. When I first came into the CBRN62 defense business in 1980, biological warfare was thought to be passé and defensive research and development was not accorded much priority or funding. By the time we started openly discussing the Soviet problem in the early mid-1990s, the potential impact of biological warfare had become more widely accepted, but it had produced less of an impact at the political level than you might think. It took the whole issue of the ‘Amerithrax’ attack to focus attention and resources on biological weapons, bioterrorism, and biodefense. The Cases I shall first address the Rajneeshee incident in the U.S. (Interestingly, the Rajneeshee sect moved from India to the United States in 1984. The next big incident to be examined will be the Aum Shinrikyo event in the 1990s in Japan. In 2001, of course, there was the more well-known attack with the anthrax-laden letters in the U.S. The first case study is that of the Rajneeshees, who were trying to take over political control of the area where they lived in Oregon. They had a licensed medical facility on their commune and obtained samples of salmonella bacteria quite legitimately. They grew cultures of salmonella and spread the resulting material on salad bars in 10 restaurants in a place called The Dalles. Then they sat back and waited. Many people suffered symptoms and became ill. There were an estimated 751 cases of salmonellosis. A few people were hospitalized, but fortunately no one died. The authorities, including the Center for Disease Control and Prevention (CDC), erroneously determined that the event was an ordinary outbreak of food poisoning, occasioned most probably by poor hygiene at one of the restaurants. They reached this conclusion even 62 CBRN stands for Chemical, Biological, Radiological and Nuclear weapons or events (weapon use incidents), used by the U.K. security services, U.K. emergency services and the U.S. military.

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop though all of the signs, including the pattern of disease, indicated otherwise. In fact, there are many reasons people did not recognize this incident, and, in some ways, did not want to recognize it. However, the police later investigated other activities of the Rajneeshees, and eventually several individuals confessed to the crime. Ultimately, two people were convicted and sentenced to long prison terms for their involvement in the incident. The next case, that of the Aum Shinrikyo sect, occurred in Japan in the early 1990s. The incident, in which about 12 people were killed and thousands were affected to a lesser extent by the sect’s release of Sarin nerve agent on the Tokyo subway, is well known. However, members of the sect also undertook several unsuccessful attempts to use biological agents in the years preceding the subway incident. It was precisely because of these failures that they employed Sarin in the way they did. The sect tried on a number of occasions to disseminate botulinum toxin by driving a car through the streets. These toxin attacks failed because of poor dissemination technique and possibly, as reported by the police, because the sect failed to produce active toxin from the Clostraidal culture they used. In 1993, the sect failed in an attempt to disseminate liquid anthrax from the roof of a building they owned in Tokyo. Many people had complained to the police about the terrible smell coming from the building. The police could not do much about that and did not want to interfere. The anthrax they used was eventually identified as a non-virulent animal vaccine strain; a Sterne variant. Had they used a fully virulent strain of anthrax, the result, despite their poor dissemination technique, might have been a lot different. Fortunately, as it was, no one became ill. In 1995, there was a sabotaged attempt to disseminate botulinum toxin in the Tokyo subway. The Aum Shinrikyo sect plotted to place cylinders of the material under the subway escalators. The person who was given the job, however, could not go through with it and filled the cylinders with water. As a result, the attack was foiled by one of the sect’s own members in a fit of conscience. The third example of a biological weapons attack is the anthrax letter incidents in the United States. Five letters were sent through the mail to high-profile individuals. A highly virulent strain of anthrax called Ames was used; the strain was misnamed, by the way, because it does not actually come from Ames, Iowa. In all, an estimated 10 grams of spores were used. The first person to die was an Englishman who had become a U.S. citizen many years before. He received a lethal dose of spores by merely opening a letter. Since then there has been considerable debate as to the exact quality of the agent preparation and the extent to which its aerosol characteristics changed during the course of the attacks. Suffice it to say that, since much of the crucial evidence remains sub judice, the perpetrators of this incident produced dry particulate agent with good enough aerosol characteristics to cause illness and death despite the poor dissemination method. The overall effect was widespread contamination of the environment wherever the agent was released or leaked from the letters. The implication of this was that if the perpetrators could produce a few grams and have this result, then it would not be difficult for them to produce 1 kilogram or even 10 kilograms or more, the dissemination of which would result in concomitantly dire consequences. When I was asked about identifying and finding the perpetrators, I replied with a great deal of caution, explaining that the intelligence community had always worried

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop about attribution of such an incident or even of a large state-inspired attack. Identifying the perpetrators of any biological weapons use, if they do not confess, could be much more difficult than anticipated, and maybe even impossible, as it was proved to be with the anthrax letters. The economics of decontamination is important. There are two figures that are relevant. After the anthrax letter incidents, decontamination of the postal sorting office and the U.S. Senate office building alone cost an estimated $72 million, and this may be a conservative figure. This is a huge sum for just these two facilities. Decontamination took a large amount of time, effort, and material. The CDC itself committed significant resources, but even then the whole exercise got off to a confused and difficult start. At the height of the anthrax letters crisis, 2,000 of the CDC’s 8,500 staff were working full-time on the problem and most of the remaining personnel did some part-time work as well. All of this effort went into ameliorating the effects one very small incident, an outbreak of anthrax involving just 22 people of whom “only” five died. As yet, the person or persons responsible for the incidents remains unidentified by the authorities, although some commentators say that the perpetrator is known, but the evidence will not stand up in court. Lessons Learned What lessons should we learn from all this? When I was a young physician-in-training, we were told that “common things commonly occur.” In other words, before looking for some esoteric diagnosis, review the common causes of pathology. On the whole, this approach serves routine medicine well. Indeed, it has become the predominant pattern of thought in everyday life. It was responsible, in part, for the reaction to the Rajneeshee incident. After all, who would have thought of bioterrorism as the cause of the salmonellosis in an obscure location in the North West of the U.S.? And when they did, just how plausible would it have seemed at the time? Unfortunately, this higher degree of awareness is required if we are to operate effectively against bioterrorism threats and attacks. In medical diagnostics this is referred to as a ‘high index of suspicion.’ Without it, hoof beats will always signify horses and the zebra will be upon us before we can react. If we value our survival, we simply cannot afford for this to happen. Technique is extremely important in matters of weapons and their use. Without technique you can easily fail at simple things, as happened in the Aum Shinrikyo incident. The members of the sect could have achieved their aims, but they made some silly mistakes. Luckily for the Japanese people, they did not have quite the right knowledge and the essential technique to launch a successful bioweapons attack. Conversely, a simple idea well executed can be very effective. The Rajneeshees carried out a primitive form of attack, using a simple dissemination system, and caused significant illness in hundreds of individuals. Be it bugs or bombs, nothing in life is guaranteed; sometimes they work and sometimes they fail. Ill-informed commentators are inclined to say, “Oh, the Aum Shinrikyo sect with all their money and scientists failed, so it just goes to show how difficult it is to use bioweapons,” or alternatively that “bioweapons must be ineffective or useless as weapons and are not therefore a problem.” Alas, this is the wrong conclusion to draw from these incidents.

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop Having lived in the U.K. through 30 years of ‘classical’ terrorism — something with which our Indian colleagues are very familiar — when the Provisional Irish Republican Army used a variety of devices on a regular basis, we learned that bombs did not always detonate properly. Sometimes they killed their perpetrators. The same is true with biological weapons. Even cruise missiles and other sophisticated weapons are not 100 percent reliable. It is unwise to tempt fate by judging our chances of survival by the failure rate of the weapon or the operator. When bioweapons work, as the anthrax letters did, whole societies change their behavior. That is exactly what we have observed in the United States. Sometimes a society “gets lucky.” Five people paid the ultimate price to wake us up to a whole series of problems and to prompt us to start to address them. USING SCIENCE AND TECHNOLOGY TO COUNTER BIOTERRORISM: DEFENSE IN BREADTH AND DEPTH From the historical perspective, bioterrorism is a low-probability, high-impact event. A little bioterror can have a big effect. That is the view we must take about how to deal with it and how much money and other resources to invest in defensive measures. The use of just 10 grams of anthrax has caused enormous changes. In the aftermath of the anthrax letters incidents, large amounts of money were spent and attitudes of the U.S. public changed completely. In events involving infectious diseases, preparation and prevention are key to managing outbreaks. If such events catch a society unprepared, even more time and money will be spent, and even more lives will be lost than if it had been thought through in advance. We do not understand a lot about what we thought we understood. There are many accepted dogmas about biological agents themselves, their effects, about the organisms and their physiology, pathology and effects: for many years people have taken them for granted. On the whole, these areas of science have been much neglected during the last 30 or 40 years. Scientists considered them to be boring and unproductive, and opted to do what they perceived as more exciting experimental work. After all, who wanted to look at the metabolism of some obscure bug that was no longer of importance to us when it was a simple matter to treat the problem with an antibiotic? Scientists want to do work that will build an interesting and productive career, and allow them to write papers, receive large grants, be at the cutting edge of research, and be respected by their peers. A few scientists continued to study infectious diseases, but it was not very popular. Society has suffered as a result, because there is much that is not understood, even about common diseases. Fortunately, and not a moment too soon, this parlous state of affairs is changing fast. What we need is biological defense in breadth and depth, and I will outline the kind of actions that must be undertaken in order to achieve this. It is important to put in place widely dispersed local (point) and stand-off bioaerosol detection in order to be able to monitor the atmosphere continually and detect aerosols of biological agents. It is a very tough technical challenge. In the United States, point detection is being attempted at 36 sites across the country, but it is far from a perfect system. It is possible to develop

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop stand-off detection—a sort of biological radar—but this is even more difficult to goal to achieve. It may be possible in the future, but right now. More practical in the short term is infectious disease tracking in real time. In other words, systems of detection and information exchange need to pick up changes in behavior in real time. Stockpiles of prophylactic and therapeutic agents, and doing research and development on new vaccines and therapeutics are also needed. Decisions about the tactics and the strategies to counter a wide range of organisms must be made, which is by no means as simple as it first appears. There is no multivalent vaccine that will cover everyone against everything with one shot and with no side effects. Since we lack such a vaccine, we need to be able to respond with therapeutic agents. In any case, even with effective, safe vaccines, we would probably not be able to vaccinate everyone throughout their life. Lifetime vaccination would probably be unacceptable to society at large, because the likelihood of an attack is considered to be quite small. Therefore, therapeutic agents are at least one avenue we should consider since they allow us to adapt to differing circumstances and may be used prophylactically or in response to obvious infection. We also need real-time diagnostics for infectious diseases. Doctors, nurses, and other medical professionals need tools that can be used when something unusual is occurring, but they do not know what it is. For example, if an odd cluster of people exhibit similar symptoms—temperature, aches and pains, cough, and so forth—medical professionals need to distinguish the cause of this pattern from the common cause of such a pattern. Some science and technology should focus on this area. There must be a robust public health system. It is well recognized that, even in the United States, this is a neglected area. Public health professionals are poorly paid and receive few thanks for their efforts. Public health care systems were built to protect us from infectious diseases in an era when people feared infectious diseases. Today, people do not fear infectious diseases, unless a resistant organism affects them or a relative, or if AIDS is an issue. In such instances, attitudes begin to change. We need trained and knowledgeable medical and nursing staff and paramedical first responders. These are the people on the frontlines, and they do not know as much as they need to about infectious diseases and biological threats. Finally, I have to emphasize the importance of planning and of thinking the unthinkable. It was very difficult to persuade people to do this before 2001. In the end, planning is the best chance that we have to save ourselves from potential catastrophe. Political awareness and public participation are fundamental motivations for planning. Ultimately, it is the citizens who pay the bills and decide how our taxes should be spent. ASSESSING NATIONAL CAPABILITIES Richard Danzig, former Secretary of the U.S. Navy, was asked to write a monograph assessing national capabilities for addressing bioterrorism. He looked at the problems and suggested some approaches and solutions, proposing a list of key topics by which to judge preparedness. Danzig asked two key questions: how can we assess how we are doing, and what is our scorecard? For example, when assessing our response to anthrax, how well prepared are we today? To cope with anthrax, smallpox, or other infectious diseases, he suggested a useful list of categories to use to evaluate our

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop progress. This list includes detection, drugs, vaccines, decontamination, interdiction, intelligence, surveillance and diagnosis, simulation, modeling, gaming, alleviation, counterproliferation, civilian preparation, and consequence management. This list is a practical tool to use to assess what needs to be addressed. National Preparedness: The U.S. Approach In 2003, John H. Marburger, senior science advisor to the President, stated that the anthrax incidents sent two unambiguous messages: our society is vulnerable to bioterrorism, and we are not prepared. He said that in the intervening 2 years since the anthrax incidents, however, important steps had been taken to protect and prepare the nation for a broader range of threats. A substantial framework has been created, clear directions have been established, and very basic things have changed. In former years, the CDC was not very involved or interested in addressing biological threats. It now has a new director and is much more involved and much more focused on the business of emerging diseases and the potential of bioterrorism and biological weapons. Similarly, the National Institutes of Health (NIH) have never had large amounts of money to do research in this area. In recent years, however, the U.S. Congress has appropriated a lot of money to NIH to act as the agent for driving forward biodefense and biomedical basic research and development. The NIH has a very big job assigned to it and the new mission will present quite a challenge to its prevailing culture. Funding is of course a crucial element. Very large figures are involved. Nearly $1 billion was appropriated for research and development on science and technology in 2004, with a large increase in funding going to the NIH for research during the coming years. It is quite difficult for the NIH to absorb this amount of money and to build new programs. It is all very well having the money, but it is a challenge to spend it sensibly and effectively. Overall, the response to bioterrorism has been organized into three broad interagency initiatives: (1) Project BioWatch, or early warning using atmospheric monitoring—36 sites are now being used in this experimental project; (2) Project BioSense, or biomedical data collection and fusion to detect pattern anomalies in human disease occurrence; (3) Project BioShield, which places more emphasis in the public health domain and covers the accelerated research, development, and procurement of medical countermeasures. Unintended Consequences A few things can happen to a society when it is threatened, as was the United States with biodefense, and U.S. reactions have caused some unpleasant things to occur. Consider, for instance, the issue of biosecurity, where measures, including registration, have been put in place to increase physical control and accountability over highly pathogenic microorganisms. This has caused great difficulty for many scientists in the U.S. who work with these organisms, and has become a challenge to the way scientific

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop pursuits have always been conducted. Scientists who once worked with microorganisms under little scrutiny, now face Draconian penalties if they make mistakes with paperwork or physical accounting procedures. This also affects international cooperation. The United States and the United Kingdom have a history of close collaboration in this area. In both countries, even within government circles where the network of people doing research and development on “Select Agents” is small and very tight, shared projects have come under pressure because of these new rules. No one has yet solved this problem as we continue to crack a walnut. We must be very careful about how we implement protective rules without knowing the ramifications of our actions. The question of the dual-use dilemma on misuse of technology for destructive purposes was addressed by the National Academies’ Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology.63 How do we, as scientists and technologists, police ourselves against the kind of science that we think may be dangerous to our society? Can we indeed do this? When science poses danger to society, should it be confined to special sites, should the results be vetted before publication or should we abandon it altogether? These questions are very sensitive and are under debate. THE WIDER WORLD Out there is a big wide world in which some bad things are happening. The question of new and reemerging infectious diseases is now recognized as a rising global issue as well as a security threat. Infectious disease accounts for 25 percent of the deaths that occur annually worldwide. Since 1973, 20 well-known diseases have reemerged or spread geographically. More than 30 new diseases have been identified since that time. Tuberculosis (TB), malaria, and HIV/AIDS continue to surge. TB is likely to become the largest cause of death in the developing world by 2020. In the United States, the price of public complacency about infectious disease is high. Annual infectious disease rates have doubled to more than 170,000 per year since 1980, and these figures are 3 years out of date. Four million Americans are Hepatitis C carriers, Influenza kills 30,000 Americans annually, and foodborne illnesses are in the millions, with 9,000 deaths per annum. Even in the U.S. TB has made a comeback and is still increasing. Highly virulent and antimicrobial-resistant pathogens are major sources of hospital-acquired infections, killing 14,000 patients annually. Interestingly, however, it took just five anthrax deaths to change behavior towards infectious disease in the United States. A SILVER LINING Despite these challenges, let me end on a note of optimism. One high profile incident of bioterrorism caused five deaths, drove U.S. society and its leaders to re- 63 National Research Council. 2004. Biotechnology Research in an Age of Terrorism, National Academy Press, Washington, D.C.

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Science and Technology to Counter Terrorism: Proceedings of an Indo-U.S. Workshop examine the issues and focus on the problem of biowarfare and the related, but larger everyday problem of infectious disease. The complacency that is largely born of the era of antibiotics is slowly being rolled back. Already this new awareness has produced a better response to new challenges, such as Severe Acute Repertory Syndrome (SARS). Unquestionably, the CDC reacted in a much more publicly acceptable, professional, and speedy way in response to SARS when it was informed of the outbreak by the World Health Organization (WHO). The WHO, in turn, had picked up from its network what had happened when an infected Chinese gentleman moved into Vietnam with the disease. Clearly, the situation is improving, and people are less complacent. PAYING THE INSURANCE PREMIUMS Ultimately, these efforts are going to cost a lot of money, but I think this kind of expenditure is best viewed as paying insurance premiums. So, why pay insurance premiums? I believe in a defense strongly constructed in breadth and depth and openly declared. I applaud the way that the United States deals with biodefense in this respect. Its approach stands in contrast to the more secretive approach of the United Kingdom. There the view favors keeping plans secret, to be revealed only when necessary in response to an event. Actually I do not want the day of the event to come. I do not want the perpetrator to challenge my defenses. Rather, I believe it is better to show potential perpetrators what they are up against and use this as a deterrent. Regarding bioweapons, we have no means of retaliation, and possibly no means of attribution. We have not even found the person or persons who sent the anthrax letters. We would not have caught the Rajneeshees had there not been a confession, and had the Aum Shinrikyo not been so inept, we would not have found them either. Defense is the only answer for us, especially since we are not in the business of biological retaliation. If there is a deliberate attack, of course, defense pays enormous dividends. It will ameliorate effects and minimize long-term damage. The defense systems that are proposed at the moment will not give us 100 percent protection, but then again no defensive system is 100 percent effective. Unlike most other costly defensive or weapons programs, preparedness for bioterrorism will pay dividends everyday because it increases our ability to combat the growing hazards of “ordinary” infectious disease. Therefore, if we can deal with the very unpleasant and highly unlikely problem of weapons, at the same time we will help the people who have real, everyday needs for dealing with infectious diseases. By spending the money in one place, it will flow across to help in several other areas. This is an area where science and technology will almost certainly prove decisive; in increasing the capability of society to ameliorate the effect of an attack or even to prevent such an attack from taking place by raising the bar of defense so high that adversaries look for more vulnerable targets. Because of the wealth of intellectual capability that India has to offer in the fields of biotechnology, engineering, and information science, prospects are good for creating fruitful partnerships between the United States and India in this sphere of endeavor. I am not the world’s greatest optimist, but on this occasion, I think that together we have a chance to make a difference where it counts.