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Thomas V. Inglesby, MD DR. INGLESBY: We're all here. Good morning. Welcome to the portion of the national symposium entitled "Containing Epidemics of Contagious Disease: Making Difficult Decisions." My name is Tom Inglesby. I am an Assistant Professor in the School of Medicine at Johns Hopkins University and a Senior Fellow at the Johns Hopkins Center for Civilian Biodefense Studies. I will serve as this morning's panel moderator. Over the next 90 minutes, this distinguished group of panelists will describe to you some of the most important factors that decisionmakers would confront in the management of an epidemic. They will bring their substantial expertise to this problem.The format will be as follows. I will make brief introductory remarks, and then prior to each of our panelist's talks I will give them a proper introduction. Let me just now say before you are Tom Glass, Mike Osterholm, David Fidler, and Laurie Garrett. But in the event people come in late, I'd like to introduce them right before they speak.
We'll hold all questions until the end, and we will try and buzz along. Unfortunately, we didn't allow Dr. Hamburg to start until late, so we probably will adjust by 15 minutes, but we'll see as we go. We'll try and stay right with this.
First slide, please. I will begin this morning's panel with a review of the TOPOFF exercise of May 2000. And the reason I think this is an appropriate start -- the reasons are three. The first is that TOPOFF provided the most comprehensive test of our medical and public health system to respond to a bioweapons attack to date. It revealed valuable lessons as to how the U.S. might deal with future epidemics. And by these measures alone, the exercise must be called a success. The second is that the issues presented by our panelists will all be very much a part of what happened at TOPOFF, and a discussion of TOPOFF might help put them in context with each other. TOPOFF has been mentioned a number of times already in this symposium, so I think this is just a moment to step back and kind of understand again what happened. And, lastly, TOPOFF will provide for us a good context for the scenario that we'll follow this morning that will begin at 10:15. My remarks are taken from an article that was written by my colleagues Rita Grossman, Tara O'Toole, and myself, and that article will be in the back. Obviously, time is brief, so it allows only presentation of major points. That article, in turn, was derived from the observations of 11 senior participating officials who either were observers, participants, or controllers in the exercise, some of whom are in this room today, and we are very grateful to them. And we also should note at the start that this exercise brought out the best in medicine and public health at the state and federal level in Denver, and many people tried very hard to do their best for days and nights on end during the exercise. Actually, this is the wrong slide carousel. Would you go to the other talk for me? This is the 10:30. Thank you. (Laughter.) DR. INGLESBY: Foreshadowing. Just to tease. Let me move on. TOPOFF -- in an effort to assess the nation's crisis and consequence management capacity under extraordinary conditions, the U.S. Congress directed the Department of Justice to conduct an exercise engaging key personnel in the response to large-scale terrorist attacks. The resulting exercise took place in May 2000 and was called TOPOFF, named for its engagement of top officials of the U.S. Government. It was the largest exercise of its kind to date -- $3 million in direct costs, much more than that in indirect costs. The exercise took place in three cities. The chemical weapons attack event took place in Portsmouth, New Hampshire; the radiological event took place in the greater D.C. area; and the bioweapons event in Denver, Colorado. The Denver component, as you all well know by now, involved the release of a covert aerosol of a plague biological weapon, and induced the response of many parts of the medical and public health system, including a number of hospitals in the Denver area, county and state health agencies, emergency management agencies, CDC, the Public Health Service, and the Office of Emergency Preparedness. This list is not inclusive but is illustrative of the size of this epidemic -- or, excuse me, the size of this exercise. Epidemics will come. Constraints of TOPOFF -- just one slide on possible limitations and understanding of what this exercise could not do. This is a very complex exercise. Part of it was certainly player driven, and it depended on the participants' responses to questions and events. And part of it, because of the complexity, needed to be predetermined before the event. So part of this was predetermined, and so it should not be seen as all of the events were derived from participants' decisions. The second limitation was that many of these eventualities in the exercise were notional, and that is to say that they occurred on paper only. And, again, this was because of the complexity and size of the exercise. Examples of this with the laboratory diagnostic testing process occurred largely on paper. Another example was the delivery of the national pharmaceutical stockpile. That was a simulated event; that did not actually take place.
And the third was the logistics of medical care at hospitals. Again, while occurred -- many of the hospital leadership were involved; again, most of the logistics were notional in that these hospitals needed to continue to do their routine care. Two issues of great importance that were not tested in TOPOFF were the public's reaction to a plague bioweapons attack and the media's reaction. Now, they were written into the script, and I think the exercisers did a good job of presenting what might have happened. But these did not occur in TOPOFF for obvious reasons.
And, finally, notwithstanding any of these limitations, it's important to note that we think, and the majority of the people we spoke to believe that this exercise truly was a success and revealed lessons, even though it had certain limitations. And we'll present some of those lessons now. But, first, a review of the exercise. Exercise day one. A covert release of a plague aerosol had been released at the Denver Performing Arts Center on May 17th. The release was undetected, and so the exercise begins with this hypothesis on May 20th. So this is day one of the exercise. Increasing numbers of persons are seeking medical attention at the Denver area hospitals for cough and fever. By early afternoon, 500 persons with symptoms have been reported, with 25 deaths. Plague is confirmed by the state laboratory and CDC. A public health emergency is declared. Hospitals in Denver implement their emergency plans, call in staff. Their personnel begin to wear masks. Antibiotic and ventilator shortages are reported, and hospital staff begin to call in sick. The governor issues an executive order by the end of the day restricting car, bus, rail, and air travel into and out of 14 Denver metro counties, and seeks to take control of all antibiotics that can be used to prevent or treat plague.
Citizens are told to seek treatment at a medical facility if feeling ill or following any contact with a suspected case of plague. Those who are not sick are directed to stay at home. The public is told that the plague is spread from person to person. By the end of the day, 783 cases of plague have occurred; 123 persons have died. Day two of the exercise. There are reports that hospitals are now running out of antibiotics and ventilators. A Push Pack from the national pharmaceutical stockpile arrives carrying a large cache of antibiotics -- again, notionally. At a Denver airport there are substantial difficulties moving it from the airport to the places in Denver that will need those antibiotics. Plague is now being reported in other states and in England and Japan, and by the end of this day 1,800 cases of plague have occurred throughout the U.S., London, and Tokyo, and of these 389 have died. Day three. Medical care in Denver is now described as beginning to shut down. Insufficient hospital staff, beds, ventilators, and drugs, are available. The public is now advised to wear masks. Person-to-person spread of plague is occurring as determined by public health officials. The CDC advises Colorado to close state borders to limit further spread throughout the U.S. Colorado officials express concern about their ability to get food and medical supplies into the state. And by noon of the third day, there are 3,000 cases of pneumonic plague, and 795 persons have died. On the last day of the exercise, day four, there are an estimated 3,700 cases of plague, with 950 deaths, though if you'd speak to different officials there are conflicting numbers, and we believe this would be the case in reality. Some officials believe that at the end of the exercise there were more than 2,000 deaths. And at this point, the Denver TOPOFF exercise was ended. The lessons of TOPOFF. There were certainly many, and we will focus on the ones that were most striking to us, largely in the medical and public health arena. And they can be distilled into four large areas. The first are lessons in leadership and decisionmaking; the second, priorities and logistics for resources; the third are the crises at health care facilities; and the fourth are -- involve principles for disease containment. Leadership and decisionmaking. I think, as Dr. Bracken said yesterday, leadership matters, and that was clear in TOPOFF. The Colorado governor was unable to participate in this exercise, and so his committee of astute senior advisors de facto played the role of decisionmakers for the exercise. And this committee was composed of senior public health and emergency management officials, but the absence of an elected official was believed by many to have significant impact on the exercise. The absence of the legal and moral authority that an elected official had was felt to have important consequences, including perhaps the results of the most important decisions, such as how scarce resources would have been triaged, whether to impose travel resources, and other things that we will talk about momentarily. The committee we believe acted in ways that were quite professional and skilled, but, again, it is not clear if those decisions would have been reflected in the elected official. Decisionmaking processes were problematic. The governor's committee operated in -- with the community by very large conference calls. At times, as many as 50 to 100 persons were on conference calls. As you all know, if you've been on a conference call with more than two people, this is a tall order. These calls led to what was described as highly inefficient, indecisive, and significant delays in action, as you all might anticipate. Many of the participants in the calls had never worked or met each other, and at times it was not clear who was in charge of the call. The calls were literally running one into the next, taking people out of their usual roles and putting them onto the phone. There was a clear tension between the need to make the right public health decisions and the need to make decisions urgently, and this tension played out in many ways. But one observer remarked, "With thousands standing outside hospitals awaiting prophylaxis, some officials were citing papers. In this type of crisis, one needs to make decisions quickly. You don't have the luxury of time to do more research." And this is an obvious tension in public health emergencies. The last here is the coordination of emergency management. A number of different emergency operations centers were set up by state and federal law enforcement and emergency management agencies. Many of the people who participated said it was unclear to them how these emergency operations centers would interact with each other, would interact with hospitals, would interact with public health officials, and so it was not clear that this system of EOCs, as they were called and are called, was useful in this exercise. Not to say that they could not be configured in that way, but it was difficult for the people on the medical and public health side to understand that. Next order of lessons involved priorities and logistics for resources. With local sources of antibiotics depleted relatively early in this exercise, initially there was no consensus about priorities. Now, that was resolved relatively quickly when the governor's committee decided to offer antibiotic prophylaxis to EMS officials, police officers, hospital workers, and their families. The decision to treat families was intended to allow medical and emergency responders to come to work and to maintain their willingness to work with families at home protected. Decisions about priorities quickly became much more complicated as the epidemic was found to be expanding. There was disagreement on which antibiotics should be given and whether antibiotics should be given only to contacts of plague patients, or whether they should be given to the general population. What is the strategy? One observer, again, commented some experts only wanted to administer antibiotics by textbook criteria. In a real scenario, decisions about antibiotic prophylaxis would be a political decision, not a medical decision. We don't necessarily endorse or refute any of these opinions, but I think they're important. These were senior participants in the exercise. The logistics of antibiotic distribution were difficult. Simulated components of a stockpile arrived in Denver promptly, but the distribution of antibiotics was problematic, as Dr. Copeland said yesterday. At one point, the antibiotics were being unbundled by a single individual and put into plastic baggies. Now, part of this was the exercise, but obviously when the antibiotics arrive a rigorous, robust plan needs to be in place to accept them. Antibiotics were to be distributed at a central antibiotic distribution facility. One such facility was exercised in this exercise. Exercised in this exercise. One hundred forty people an hour would have been able to get antibiotics. At this rate, if you do a couple of calculations, and you make a decision to treat most of Denver, you would imagine that hundreds of such facilities would need to be stood up quickly. In addition to that, the actual process of getting antibiotics is not as easy as it looks. No written guidelines were handed out with antibiotics. People were allowed to take their own antibiotics. There was not so much oversight about how to get antibiotics. And one official said that it appeared to him that it would require hundreds of people in a secure facility like this to actually get this job done. The next category of lessons -- crises at hospitals. Even at the outset of the epidemic, hospitals were quickly seeing far more patients than they could manage. In the beginning, two, three times normal, up to 10 times their normal volume, were showing up at hospitals; notionally, again, as hospitals needed to continue their usual functions, but 10 times on paper. Antibiotic supplies quickly became a problem, ventilators were short, as were places to put sick people. People began to have great troubles. There was one quote, "There were not enough places to put sick people, to triage people, or to manage dead bodies." Security at health care facilities would have been a major issue if this had been a real event. And a fourth category of lessons -- the need to develop disease containment strategies and principles, perhaps the most thorny of issues and the most commonly stated in the people that we spoke to. Again, initially, it was believed that there was insufficient priority put on the containment of the epidemic. Quickly people began to react to sick people, which is understandable. But as a beginning principle, it was not clear that people needed to begin immediately with the concept of, "This must be contained and ended, and our researchers must be directed to those purposes." Changing context brought changing consequences. Even early in the crisis, antibiotic prophylaxis and isolation were the principle containment measures. But as the epidemic was seen to be rapidly expanding, a series of increasingly intrusive containment measures were ordered, including travel restrictions, including directions to stay at home. One observer said they told one million people to stay in their homes. How would we have enforced this?
By the end of the exercise, people had been asked to stay in their homes for 72 hours, without discussion of how the public would have gotten food or medicine. Towards the end of the exercise, the governor's committee was -- it was proposed that state borders should be closed. There was not unanimous consensus about what should be done about that, but, again, another statement, "With state borders closed, how were we planning to feed four million people?" It was stated that a citizen might reasonably be expected to say, "The government has just told me I must stay in my home, so it now has an obligation to provide to me antibiotics and a mask to protect me." But there were certainly not enough antibiotics or masks to fulfill such an obligation. One official said that it appeared to him that sufficient legal powers were in place to take all of these measures, but the problem wasn't legal powers; the problem was deciding when and what was the right thing to do. And so, in conclusion, what is needed, or what should we do in response to the TOPOFF exercise? We could distill them down into these seven points. The first, political leadership is important in the management of a large-scale epidemic, especially one involving a bioweapons attack. Efficient decisionmaking would be critical and would not only require the leadership of elected officials, but also the sustained counsel of the proper expertise, like the committee that was set up in Colorado, to provide the expertise to the governor. The second, to make proper decisions, we will need better information sources, conduits, and analytical capacities. The information that was coming into decisionmakers at TOPOFF was fed to them by the exercise controllers. It is not clear that they would have had anywhere near the power of information that they got in this exercise to make decisions. So we need real-time information tools for epidemic management that allow officials to collect information, to analyze it rapidly, to move from paper and pencil to the information technology tools that we have available in the rest of our society. Priorities for scarce resources should be thought about and considered well ahead of time. A well-designed and managed pharmaceutical stockpile is certainly important, but equally critical is the local capability to distribute, and the decisions to -- on how to distribute scarce resources. Public health resources were certainly in high demand. And as Dr. Hamburg has said on other occasions, we must not double, triple, or quadruple count the same person during the same activity. Participants in this exercise should be praised for what they did. They worked hard to do everything they possibly could to stop this epidemic, but in reality it's clear that we would need a mechanism to augment public health resources, especially personnel, in the event of a large-scale crisis. And local public health agencies are beginning to consider that. Hospitals would need to have plans in place. Obviously, I can't add to the panel that took place yesterday. Incentives need to be set up to make hospitals able to withstand some kind of surge like we're talking about now. There is an urgent need to formulate clear, scientifically and politically clear principles for disease containment, and that will be a subject for a later this morning scenario. And, lastly, dual use systems. Let me end with this final quote. "At the end of the exercise, many issues were left unresolved. It is not clear what would have happened if it had gone on. There were ominous signs at the end of the exercise. Disease has already spread to other states and countries. Competition between cities for the national pharmaceutical stockpile had already broken out. It had all the characteristics of an epidemic out of control." So I'll leave you on that fairly sobering note, and now turn to the panelists who will provide you with great, deep knowledge of many of the areas that we just glanced quickly over.
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