When a major, complex problem comes to light, even the most learned and experienced can find it tough to think calmly and rationally about the reasonable, constructive steps that government should take to address it. When the problem identified is as frightening and potentially devastating as a bioterrorist attack, rationality can take a backseat. In the last few years, indeed in the weeks since September 11th, countless government officials have extolled their terrorism response capabilities, only to ask Congress in the next breath for just a few million more dollars so they can better address the problem. A few million here and a few million there soon adds up to serious money. Already, the General Accounting Office and some nongovernmental researchers like myself, have issued warnings about overlapping and short-sighted terrorism preparedness programs.

The convening of this hearing is a positive sign that Congress may soon begin to exercise more rigorously its oversight functions regarding terrorism prevention and response programs. The appointment of Governor Tom Ridge as Director of the new Office of Homeland Security would seem to be a constructive step that could put improved coordination and streamlining of the federal response bureaucracy on a fast track, but that may not be the case if he is not given strong budgetary authority. An initial review of section 3(k) of the Executive Order establishing the Office of Homeland Security and the Homeland Security Council does not appear to vest sufficiently strong budgetary authority in this new office. As a matter of priority, the Office of Homeland Security and Congress must work together to tame the unwieldy federal bureaucracy and to get preparedness resources flowing to the nation’s cities and long-neglected public health system. To aid Governor Ridge in his efforts, Congress should grant him czar-like budgetary authority. Unless this occurs in tandem with a consolidation of the number of congressional oversight committees, a few years from now a great deal of money will have been spent with marginal impact on reducing the threat of terrorism and mitigating the aftereffects of an unconventional terrorist attack.

Grasping for Perspective in the Aftermath of September 11th

Despite what you might have heard in recent weeks, there are meaningful technical hurdles that stand between this nation’s citizens and the ability of terrorist groups to engage in mass casualty attacks with chemical and biological agents. Between the misleading statements that have been made about the ability of crop dusters to disperse biological agents and the recent death of a 63-year old man in Florida from inhalational anthrax, the public is understandably spooked about the whole subject of bioterrorism. Facts often get overlooked in such an atmosphere, but I will resort to them nonetheless. Crop dusters disperse materials in a 100 micron or greater particle size, which is significantly larger than what would be required for the effective dispersal of a biowarfare agent. Another fact that has been glossed over is that the sheer mechanical stresses involved in putting a wet slurry of biowarfare agent through a sprayer can kill 95 percent or more of the microorganisms, to say nothing of the sensitivity that some agents have to environmental stresses once released. In order for an aerosol spray of biological agent to infect a person, the agent must arrive in the human lung alive, in a 1 to 10 micron particle size.

As for the developing situation in Florida, the investigation is ongoing and conclusions cannot be drawn at this point. In the end, this sad situation may fit into a pattern typical of past terrorist activity with chemical and biological substances. Data compiled by the Center for Nonproliferation Studies at the Monterey Institute of International Studies show that over the past 25 years instances where subnational actors actually used a chemical or biological substance relate mostly to disgruntled workers, domestic disputes, or others with some type of vendetta against political figures or rivals. The substances of choice tended to be household, industrial chemicals and the scope of intended harm included one or a few individuals, not dispersal at public locations or in a manner where mass casualties could result. In 96 percent of these cases where terrorists used chemical or biological substances, three or fewer people were injured or killed. Difficult though it may be, one should not jump to the conclusion that what has occurred in Florida is related to the horrific events of September 11th. In the headquarters building of American Media Inc., anthrax was reportedly found on an individual’s computer keyboard, a dispersal approach that does not enable mass casualties. Should the investigation reveal that the perpetrator(s) who introduced Bacillus anthracis into this building employed a dry, microencapsulated form in the requisite microscopic particle size, then concern would be warranted. That would indicate that a subnational actor had indeed scaled technical obstacles that other terrorists had previously been unable to overcome. Greater detail about terrorist activities with chemical and biological substances can be found in Chapter 2 of Ataxia: The Chemical and Biological Terrorist Threat and the US Response, which is available on the internet at: www.stimson.org/cwc/ataxia.asp.

When one retreats from the hyperbole and examines the intricacies involved in executing a mass casualty attack with biowarfare agents, one is confronted with technical obstacles so high that even terrorists that have had a wealth of time, money, and technical skill, as well as a determination to acquire and use these weapons, have fallen short of their mark. Chapter 3 of Ataxia addresses this point at some length, examining the lessons that should be learned from the very terrorist group that got the hyperbole started, Aum Shinrikyo. To summarize, although the results of the cult’s 20 March 1995 sarin gas attack were tragic enough—12 dead, 54 critically and seriously injured, and several thousand more so frightened that they fled to hospitals—Aum’s large corps of scientists hit the technical hurdle likely to stymie other groups that attempt to follow in its wayward path toward a chemical weapons capability. They were unable to figure out how to make their $10 million, state-of-the-art sarin production facility work and therefore were unable to churn out the large quantities of sarin that would be needed to kill thousands. As for Aum’s germ weapons program, it was a flop from start to finish because the technical obstacles were so significant.

The Compelling Need for Disease Outbreak Readiness

No matter where one comes out in the debate about whether terrorists can pull off a biological attack that causes massive casualties, the fact of the matter is that the debate itself is moot. One need only consult public health journals to understand that it is only a matter of time before a strain of influenza as virulent as the one that swept this country in 1918 naturally resurfaces. Further confirmation of a looming public health crisis can be secured through a steady stream of reports from the World Health Organization and the National Institutes of Medicine, which describe how an increasing list of common diseases (e.g., pneumonia, tuberculosis) are becoming resistant to antibiotics. These public health watchdogs are also justifiably worried about the array of new diseases emerging as mankind ventures more frequently into previously uninhabited areas. Microbes have an astonishing capability to humble the human race: scourges such as plague, polio, and smallpox have devastated generations past. Even with everything that is in the modern medical arsenal, public health authorities will find it difficult to grapple with disease outbreaks in the future. Rapid global travel capabilities will facilitate the mushrooming of communicable diseases through population concentrations and will in turn hinder use of the traditional means of containing a contagious disease outbreak, namely quarantine.

An even grimmer picture materializes when one consults those on the forefront of health care in America. The best medical care in the world can be found in this country, but US hospitals are at present poorly prepared to handle an epidemic. To illustrate the point, US hospitals already have difficulty handling the patient loads that accompany a regular influenza season. Ambulances wait for hours in emergency department bays, unable to unload patients until bed space is available. The press of genuinely ill and worried citizens clamoring for medical attention in the midst of a plague or smallpox epidemic would so far outstrip a normal flu season that local health care systems would quickly collapse.

Ataxia, the afore-mentioned report that I released last October with my co-author, Leslie-Anne Levy, presents a series of recommendations on how to improve federal terrorism preparedness programs. Ataxia is based largely on interviews with first responders from 33 cities in 25 states conducted over a period of 1½ years, so this report is steeped in candor and the common-sense wisdom borne of experience. Drawing from this research and the feedback that continues to come my way in the aftermath of Ataxia’s publication, I would like to address a few issues critical to an effective response to a major disease outbreak, whether caused intentionally or naturally. Those issues could be listed as the ability to detect an eruption of disease promptly, the need to establish response plans among regional health care facilities that could be quickly activated, and the ability of the federal government to provide timely delivery of emergency supplies of medicine and medical manpower. Any response, however, would be thrown off track if there is not a clear agreement on lines of authority, so I will start there.

Leadership in Confronting Disease Outbreaks

How many FBI special agents or Federal Emergency Management Agency (FEMA) officials know off the top of their heads the appropriate adult and child dosages of ciprofloxacin for prophylaxis in the event of a terrorist release of anthrax? Darned few, if any. No, the FBI excels at catching criminals and FEMA at providing mid- and long-term recovery support to communities stricken with all manner of disasters. An outbreak of disease is first and foremost a public health problem, so let’s not be confused about who should be calling the shots in an epidemic¾public health officials. Yet, this simple fact is certainly not reflected in what is taking place with regard to bioterrorism preparedness, inside or outside the beltway.

Inside of Washington’s beltway, concepts of crisis and consequence management not only linger, they predominate. With an apparent lack of budgetary authority and proposals circulating anew to have the Justice Department retain a leadership and coordination role despite the Bush administration’s earlier appointment of FEMA in this capacity, it is fair to say that Governor Ridge’s office will have difficulty presiding over the tug of war about which federal agency should lead the federal component of unconventional terrorism response. In America’s cities, counties, and states there is also a fair amount of jostling as to who exactly would have the authority to make certain decisions during an epidemic. Only a handful of states, unfortunately, have untangled the cross-cutting jurisdictions left over from more than a century of contradictory laws passed as authorities scrambled to deal with the different diseases that were sweeping the country. Prompt, decisive action could make a lifesaving difference in the midst of an outbreak, but the experience of various terrorism exercises and drills gives ample reason to believe that precious time would be squandered as local, state, and federal officials squabbled over who has the authority to do what. These circumstances beg for a clear vision and a firm hand to untangle this mess and put the people who know the most about disease control and eradication¾public health officials¾unquestionably in charge of any biological disaster, whether natural or manmade. FEMA, the FBI, the Pentagon, and other federal and local agencies should be playing support roles, not reshaping and second-guessing the directions of public health professionals as they manage the crisis and consequences of a major eruption of disease.

Addressing Problems of Disease Outbreak Detection and Overall Medical Readiness

Perhaps the first challenge facing the health care community would be figuring out that something is amiss. Many diseases present with flu-like symptoms, and the physicians and nurses who could readily recognize the finer distinctions between influenza and more exotic diseases are few in number indeed. Thus, in a spot test conducted in mid-February 2000 in Pittsburgh, Pennsylvania, only one out of 17 doctors correctly identified smallpox after hearing a case history and being shown photographs of the disease’s progression. Smallpox, it should be recalled, presents in a most visible manner, with pustules covering the body. That sixteen doctors would not correctly diagnose smallpox can be attributed to the success of public health authorities in eliminating scores of diseases in America. Subsequently, medical and nursing schools concentrated training on ailments that health care givers are more likely to see.

In another illustration of the problem, there have been far too many reports in recent weeks of physicians prescribing antibiotics for patients worried about a possible bioterrorist attack. Of all people, physicians should understand how such prescriptions could backfire, not just in adverse reactions to the antibiotics if citizens begin self-medicating their children and themselves when they come down with the sniffles, but in the lessened ability of those very drugs to help their patients in a time of true medical need.

The exotic disease recognition problems are not limited to the medical community. In the nation’s laboratories, microbiologists and other technicians who analyze the samples (e.g., blood, throat cultures) that physicians order to help them figure out what ails their patients are much more likely to have encountered exotic diseases in textbook photographs rather than under their microscopes. Thanks to the laboratory enhancement program initiated by the Centers for Disease Control and Prevention, the ability to identify out-of-the-ordinary diseases more rapidly is on the rise in several dozen laboratories across the country. However, such is not the case in the 158,000 laboratories that serve hospitals, private physicians, and health maintenance organizations are the backbone of disease detection in this nation. In conjunction with the Centers for Disease Control and Prevention and the Association of Public Health Laboratories, the American Society of Microbiology is developing protocols to assist clinical microbiology laboratories in identifying bioterrorist agents. Although the protocols have yet to be published, volume number 33 in the Cumulative Techniques and Procedures in Clinical Microbiology series addresses bioterrorism issues and is available from the American Society of Microbiology. As of yet, there is no national guideline requiring private laboratories to enhance their ability to identify such diseases, a component of the preparedness framework that should be weighed carefully by public health authorities.

To date, the domestic preparedness training program, now administered by the Justice Department, has managed to draw some medical and laboratory personnel, mostly emergency department physicians and nurses, into the classroom in the cities where training is being provided. To enhance the disease detection and treatment skills of the medical community nationwide, however, a different strategy is required. If a long-term, systemic difference is to be made in the skills of medical and laboratory personnel, then more comprehensive instruction in medical, nursing, microbiology, and other pertinent schools is required. Knowledge of exotic diseases should be required to obtain diplomas, and the topic should become a mainstay of the refresher courses offered to maintain professional credentials. Those involved in setting the curricula for pertinent schools should waste no time in heeding the long-standing warnings of the Institute of Medicine and the World Health Organization and adjusting their course offerings, requirements, and other professional activities accordingly.

With modern data collection and analysis capabilities, however, one need not rely solely on the ability of laboratories and medical personnel to pick up the telltale early signs of a disease outbreak. In a few areas in the United States, public health and emergency management officials are teaming to test concepts to get a head start on detection. The concept focuses on early signs of syndromes (e.g., flu-like illness, fever and skin rash) that might indicate the presence of diseases of concern. They are compiling historical databases to supply a baseline of normal health patterns at various times of the year, against which contemporary developments can be measured. Since people feeling ill tend to take over-the-counter medications, consult their physicians, or request emergency medical care, some areas are beginning to track the status of health in their communities via select Emergency Medical Services call types (e.g., respiratory distress, adult asthma); sales of certain medications (e.g., over-the-counter flu remedies); reports from physicians, sentinel hospitals, and coroners about select disease symptoms or unexplained deaths; or some combination of these markers. Once a metropolitan area has compiled data to understand normal patterns activity patterns at various times of the year, abnormal activity levels can be detected. For instance, when EMS calls rise above the expected rate in the fall season, public health officials and emergency managers would get the earliest possible indication that something was amiss, which would enable them to cue medical personnel and laboratories to search more diligently for what might be causing a possible disease outbreak. This concept of syndrome surveillance will be key to allowing public health officials to get the jump on prophylaxis or whatever other control measures might be in order.

Nationwide, syndrome surveillance is being done in several locations, drawing in no small part upon the path breaking work done by New York City’s Department of Public Health and Office of Emergency Management. Their efforts are summarized in box 6.7 of Ataxia, which again is available online so that policy makers and public safety and public health officials around the United States and elsewhere can have the benefit of the composite knowledge of the individuals who shared their expertise and experiences with me.

What is now called for is a more systematic approach to institutionalizing syndrome surveillance across the nation. A model for syndrome surveillance should be refined and then made available nationally, along with funds to allow metropolitan areas to conduct the necessary historical analysis and establish the computer database, communications, and other components needed to put syndrome surveillance in place. Again, the data and the computing capabilities are available, it is just a matter of harnessing them for the purposes of early disease outbreak recognition. In their own ways, the Kennedy-Frist and the Edwards-Hagel bills address these matters. Coordination of congressional action is called for so that the most readiness can be gained for taxpayers’ dollars.

The Need for Regional Hospital Planning

The next challenge facing a metropolitan area in the midst of a major disease outbreak would be contending with the flood of humanity that would seek health care services. As already noted, hospitals would be quickly overwhelmed, so it will be critical for regional health care facilities to have a pre-agreed plan that divides responsibilities and locks in arrangements to bring emergency supplies in the interim until federal assistance can arrive. In the era of managed health care, hospitals compete with each other for business and rely on just-in-time delivery of supplies, keeping an average of two or three days supplies in inventory. Since community-wide hospital planning has fallen by the wayside, precious time could be wasted if hospitals lack prior agreement as to which facilities would convert to care of infectious disease cases¾particularly important if a communicable disease is involved¾and which ones would attend to the other medical emergencies that would persist throughout an epidemic. Business competitors, in other words, must convert within hours to work as a team.

This regional hospital plan must also contend with how to handle the overflow of patients and provide prophylaxis to thousands upon thousands of people. Whether the approach involves auxiliary facilities near major hospitals, the conversion of civic or sporting arenas to impromptu hospitals, or the use of fire stations or other neighborhood facilities to conduct patient screening and prophylaxis, such a plan needs to be put in place. Other factors that regional hospital planning must address are how to tap into local reserves of medical personnel (e.g., nursing students, retired physicians), how to break down and distribute securely the national pharmaceutical stockpile, and how to enable timely delivery of emergency supplies of everything from intravenous fluids to sheets, tongue depressors, and food.

Federal Roles in Biodisaster Preparedness

Washington’s willingness to fund regional hospital planning as well as programs that institute disease syndrome surveillance nationally will be critical to biodisaster readiness. In addition, the federal government has important roles to play in the development and production of essential medicines, in the provision of medical manpower during an emergency, and in general mid- to long-term recovery disaster recovery assistance. With regard to the latter role, FEMA’s capabilities have risen steadily over the last decade and little, if anything, would need to be added to its existing capabilities and regular Stafford Act assistance activities.

Long before the current concerns about bioterrorism, I was at a loss to explain how the federal government could have known about the extent of the Soviet Union’s biowarfare program—including the production of tons of agents such as smallpox and antibiotic resistant plague and anthrax—as early as 1992 and not kicked this nation’s vaccine research, development, and production programs into a higher gear until 1997.

The extent of the problem is illustrated by the fact that only one company is under contract to produce the anthrax vaccine, no company currently produces the plague vaccine, and it was not until recently that steps were taken to meaningfully jumpstart smallpox vaccine production. Such matters should have been promptly addressed if only to enable protection of US combat troops, not to mention producing enough vaccine to cover the responders on the domestic front lines, namely the medical personnel, firefighters, police, paramedics, public health officials, and emergency managers who would be called upon to aid US citizens in the event of a biological disaster.

As for the effort that was mounted, many nongovernmental experts have been taken aback at the structuring and relatively meager funding of the Joint Vaccine Acquisition Program. With a $322 million budget over ten years, this program aims to bring seven candidate biowarfare vaccines through the clinical trials process. Giving credit where it is due, one must acknowledge that this program as well as Defense Advanced Research Projects Agency-sponsored research into innovative medical treatments are making headway. However, the federal government must find ways to shrink the nine to fifteen year timeline that it takes to bring a new drug through clinical trials to the marketplace. Food and Drug Administration officials are already wrestling with how to adjust the clinical trials process for testing of new vaccines and additional bumps are to be expected on the road ahead.

Next, the National Institutes of Health and the pharmaceutical industry, not the Defense Department, are this country’s experts at clinical testing and production of medications. My point is not that the Defense Department should not have a role—perhaps even a lead role since the candidate vaccines originated with the US Army Medical Research Institute for Infectious Diseases—but these other important players need to be at the table if an accelerated program is to be achieved. As I noted, Governor Ridge will have his hands full, no matter which direction he turns. Moreover, close congressional oversight of this particular aspect of the nation’s biological disaster readiness is warranted.

On the chemical side of the house, by the way, the picture is similarly discouraging. The Pentagon now turns to one company for supply of the nerve agent antidote kits, known as Mark 1 kits, that the Health and Human Services Office of Emergency Preparedness has encouraged cities participating in the Metropolitan Medical Response System program to purchase. Many a city is still waiting to receive the Mark 1 kits ordered long ago, and when they do, these kits will have a considerably shorter shelf life than the kits made available to the military.

Emergency Medical Manpower Needs During a Major Disease Outbreak

Secretary of Health and Human Services Tommy Thompson stated on September 30th in an interview with “60 Minutes” that his department has “7,000 medical personnel that are ready to go” in the event of a bioterrorist attack. While that statement may be true in theory, in practice it may not hold. Somewhat lost in the late 1990s rush to soup up federal teams for hot zone rescues was the one major non-FEMA federal support capability that would clearly be needed after an infectious disease outbreak and perhaps after a chemical incident as well—medical assistance. The National Disaster Medical System was one of several improvements made to federal disaster recovery capabilities over the last decade, a time during which the federal government demonstrated that it could bring appreciable humanitarian and logistical assets to bear after natural catastrophes and conventional terrorist bombings. While these events flexed the muscles of the FEMA-led recovery system, including the deployment of Disaster Medical Assistance Teams, they did not even approach the type of monumental challenge that a full-fledged infectious disease outbreak would present. Prior to Secretary Thompson’s recent statement, officials from the Health and Human Services Department and the Pentagon have also stated that they could mobilize significant medical assets quickly.

Yet considerable skepticism exists that these two departments combined could have met the medical aid requests made from Denver after the release of plague was simulated during the mid-May 2000 TOPOFF drill, much less a call for even more help. During that hypothetical event, health care officials quickly found their medical facilities sinking under the patient load and concluded that 2,000 more medical personnel were needed on the ground within a day to prevent the flight of citizens that would have further spread the disease. Getting that number of physicians and nurses to a city and into hospitals and field treatment posts would be a tremendous logistic achievement. No one that interviewed for Ataxia, including members of the Disaster Medical Assistance Teams and other medical and public health professionals, felt that the federal government could deliver 2,000 civilian medical professionals within the required timeframe. For its part, the Pentagon has yet to articulate clearly or commit to civilians at the federal or local level just how much medical manpower it could deliver and in what timeframe.

Quite frankly, the time has come for the Pentagon to stop being coy about what medical assets it could bring bear in a domestic emergency. Articulation of this capability, even if it needs to be done in classified forums, is necessary for sound planning on the civilian side. Furthermore, there have been no large-scale dress rehearsals to confirm whether civilian or military medical assets could muster that many medical professionals that quickly, or even over a few days. Even so, the 2,000 figure from the Denver segment of TOPOFF seems almost quaint when compared to one US city’s rough estimate that 45,000 health care providers—many of whom would have to be imported—would be required to screen and treat its denizens.

The only way to find out whether the federal government is truly up to the most important role it may have to perform after a bioterrorist attack or a natural disease outbreak is to hold a large-scale medical mobilization exercise. Despite the expense, Congress should mandate a realistic test of how much civilian and military medical assistance can be delivered, how fast. Unlike TOPOFF, where federal assets were pre-picked and pre-staged, the terms of the exercise should specify that teams deploy as notified. While the general nature and identity of the exercise location(s) would certainly be known beforehand and the timeframe of the drill agreed within a window of several months, local officials should trigger the onset of the exercise. In short, dispense with the tabletop games that allow everyone the comfort of claims of what they could do and see what a real exercise brings. A genuine and probably sobering measure of federal capabilities could be taken, and the lessons of the exercise could inform the structure of federal and local plans and programs.

Conclusions

One need not resort to hyperbole when it comes to how difficult it would be for major US cities to handle a pandemic; the truth is sobering enough. Even though the basic components of the ability to handle a disease outbreak¾hospitals, public health capabilities at the federal, state, and local levels, and a wealth of medical professionals¾are already in place, there is ample room for improvement. The pragmatic steps that the federal government should take are clear. Mr. Chairman, Members of the Committee, Washington can take the smart route to enhance biodisaster preparedness nationwide or it can continue to go about this in an expensive and inefficient way. The keys to biodisaster readiness are as follows:

The sufficiency of existing federal programs, response teams, and bureaucracies needs to be assessed and redundant and spurious ones need to be eliminated. In the interim until an assessment of the sufficiency of existing assets is made, a government-wide moratorium on any new rescue teams and bureaucracies should be declared, with the exception of the enhanced intelligence, law enforcement, and airport security measures that are being contemplated.

Defense Department programs related to the development and production of new vaccines and antibiotics need to be put on a faster track and incorporate expertise in such matters from outside the Pentagon.

The federal government should continue to revive the nation’s public health system, an endeavor that involves sending funds to the local and state levels, not keeping them inside the beltway. In addition, the federal government should fund regional hospital planning grants and additional tests of disease syndrome surveillance system, followed by plans and funds to establish such capabilities nationwide.

Appropriate steps should be taken to see that physicians, nurses, laboratory workers, and public officials benefit from training that is institutionalized in the nation’s universities and schools.

Last, but certainly not least, Washington needs to develop a plan to sustain preparedness over the long term. Drills at the local and federal levels are necessary because plans that sit on the shelf for extended periods of time are often plans that do not work well when emergencies occur.

I will wrap up with one more essential task to which each individual member of Congress must attend. Since September 11th, I have received numerous calls from offices on both sides of the Hill and both sides of the aisle, asking me to brief them on these issues and to help fashion legislation that would put Representative “X’s” or Senator “Z’s” stamp on the legislation that is taking shape. While I have responded as quickly as possible to such requests, they are in some way indicative of the problem that Washington faces if it is to craft meaningful, cost-effective preparedness programs.

With all due respect, I would point out that while the attacks of September 11th occurred in New York City and Northern Virginia, they were attacks on this nation as a whole. Those who risked their lives that day to save the lives of others were not thinking about themselves or their future, they were selflessly acting in the interests of others. Put another way: this is no time for pet projects, whether they be to benefit one’s home district constituents or a particular branch of government. This is not about job employment, it is about saving American lives. The future well-being of each American, I would contend, is equally important.

On behalf of the local public health and safety officials who have shared their experience and common sense views with me, I urge Congress to waste no time in passing legislation that brings the burgeoning federal terrorism preparedness programs and bureaucracies into line and points them in a more constructive, cost-effective direction. The key to biodisaster preparedness lies not in bigger budgets and more federal bureaucracy, but in smarter spending that enhances readiness at the local level. Even if terrorists never strike again in this country, such investments would be well worthwhile because they would improve the ability of hometown rescuers to respond to everyday emergencies.