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Margaret Hamburg, MD DR. O'TOOLE: I am very happy to introduce the first speaker, Dr. Margaret Hamburg. Dr. Hamburg is Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services, where she serves as the Principal Policy Advisor to the Secretary of Health. It is in large measure through Dr. Hamburg's leadership that HHS has come to have a place at the national security table in the federal government. She has been a strong voice and a superbly informed and thoughtful advocate for medicine and public health concerns in the highest levels of government during her tenure. Dr. Hamburg's interest in catastrophic terrorism is well earned. When she was Commissioner of Health for New York City -- a position she served in for six years -- the World Trade Center was bombed, and she had several other adventures in her Commissioner position as well as other positions in government service, which are detailed in your folders. She's a graduate of Harvard College and Harvard Medical School and was trained in internal medicine at the medical school that used to be called Cornell. It gives me great pleasure to introduce to you today Margaret Hamburg. (Applause.) DR. HAMBURG: Thank you. I appreciate that very generous introduction, and I'm very pleased to be here and have been truly stimulated by the last day's presentations and discussions and look forward to the rest of what will be a very full and very interesting day. I was asked to address the topic of challenges facing public health agencies. As public health agencies prepare to counter the threats posed by biological weapons, what are their competing demands and responsibilities? What resources are available? How does this new mission fit with the profession's traditional objectives and capacities? And what, importantly, do we need to do? There are so many in this room that have important perspectives on this topic, and I suppose that I was asked to address it because of, as Tara was saying, having served both as a local health officer and now a perspective from the federal government. Also, as she noted, I do have a very real sense of the reality of terrorism. It's not a theoretical question, and I vividly remember the disruption, devastation, and death that occurred in association with the World Trade Center bombing. But I must say I can only be struck by how much worse that devastation and the associated morbidity and mortality would have been had it involved the covert release of a biological weapon. Certainly, as Health Commissioner, I did have the opportunity, as Tara indicated, to grapple with a wide range of these outbreaks and epidemics, small and routine outbreaks, and much more exotic and larger outbreaks; the threat of imported disease in an international hub like New York City, the impact of newly emergent diseases ranging from problems like cyclospora to HIV/AIDS, which I think today we tend to forget how, in some ways really novel it in fact is, it didn't exist when I started my medical training. And as a first-year student at Harvard Medical School was sort of told matter-of-factly that, really, the future of medicine was chronic disease in the era of antibiotics and vaccines. But watching this extraordinary epidemic unfold was a large motivator in taking me out of my original career path, which was academic medicine, and actually I wanted to do neuroendocrinology and somehow found myself at a podium today talking about bioterrorism. But certainly the experiences as a local health officer have been critically important to me as I've taken on a broader role in the federal efforts in addressing emerging infections and bioterrorism and the program that the Department is trying to develop, and have really come to believe that the issues that we're addressing today are among the most central for the future, both in terms of protecting and promoting the health of individuals and communities but also in terms of our nation's security and that of the world. At the outset, I think I should say that my bias is to approach these issues as a continuum of infectious disease threats, both naturally occurring and intentionally caused. Bioterrorism clearly represents the extreme end of that continuum, both in terms of its potentially catastrophic consequences for health and because of the disruption and panic that it will cause. So I want to talk this morning, in the time that remains, about some of the important challenges that addressing the problem of bioterrorism places squarely before us, and some of the key areas of unfinished business, the key areas of focus today and into the future, and address them, if I can, in a sort of balanced way that recognizes the perspectives of local, state, and federal public health agencies. Addressing these challenges will be essential for local, state, and federal efforts in trying to counter the threat of bioterrorism. But addressing these challenges will also strengthen the ability of public health agencies to meet their responsibilities to respond to naturally occurring infectious disease threats, both routine and extraordinary. I believe that the first challenge remains communicating the importance of the threat and the unique and critical roles of public health agencies in concert with the medical and scientific community. Yesterday, Richard Falkenrath said that he thought we should put the era of consciousness raising behind us and get on with the business of actually doing things. Well, I certainly agree that we must get on with the business of doing and not just talking, but we continue to need to get policymakers, legislators, and program planners to understand that the threat of bioterrorism is really different. They need to really understand it in the context of epidemic disease.
As all of you I think clearly understand, the paradigm is different than that for conventional terrorism or a chemical or nuclear attack. It requires different investments and different partners. I wish that we could stop giving that speech. Sometimes in meetings I feel like a broken record. I wish that I could really agree with Richard that we had succeeded in that goal, but I think that we still have considerable work to do. Until the concept of what the true nature and scope of a bioterrorist event would be is fully recognized, our nation's preparedness programs will continue to be inadequately designed. The wrong first responders will be dressed up, and we'll fail to fully build the critical infrastructure we need to detect, manage, and respond to a real bioterrorist event. The wrong research agendas will be supported, and we'll never grapple with the long-term consequence management needs that such an event would entail. Frankly, if we look at what's been developed in the context of bioterrorism preparedness, urgent public health and medical care issues have been underdeveloped and underfunded. Of the 1.3 billion currently going into counterterrorism efforts, a very small percentage is going into the support of things that should be considered as core elements of a coherent program to address needs posed by a bioterrorist threat. The framework is there, but we need to strengthen and extend such things as ensuring a robust public health infrastructure, including surveillance and lab capacity; the pharmaceutical stockpile for civilian use; innovative approaches to expanding the capacity and flexibility of the health care system in a catastrophic crisis; and an appropriate research and development agenda -- both at the basic level of genomics pathogenesis in the human immune response as well as the development of new drugs, vaccines, and detection methodologies. Also, a focus on prevention. As Amy Smithson pointed out yesterday, we are currently missing critical opportunities to support collaborative research efforts with former Soviet bioweaponeers and redirect their talents into pro-social, constructive, biomedical research activities; and I think as Richard Butler's talk last night underscored, the need for fuller engagement of public health and the biomedical community in designing constructive, positive strategies for non-proliferation of bioweapons. I do think as I reflect back on experiences of recent years that there is a greater understanding and awareness of what public health is and why it's important. I think that's been stimulated by a number of recent events. Certainly, in New York City, the resurgence of tuberculosis, and the resurgence in a more frightening form of multiple drug resistent TB, changed the debate, and I saw the mobilization of a political will to address public health concerns that really had not been present before, because for the first time the potential economic impact and social impact of epidemic disease was strongly felt by critical leaders. For example, during the height of our epidemic in New York City, the correctional officers threatened to go on strike because they believed -- and not inappropriately -- that there were risks of TB communication to them working in New York City's unfortunately vast system of prisons and jails. Well, had they gone on strike, that would have been a major disaster and political crisis for City Hall, and events like that certainly helped them mobilize their attention and concern to the public health problems involved. Similarly, the headlines "Killer TB on Subways" in the Yew York Post helped them feel that they might have some public support for putting more money into TB. But certainly that experience told us that once you could really get the issue framed in a way that was meaningful to key political leaders and policy leaders, it could mobilize the political will and ultimately the financial support to put critical programs into place. And, thankfully, in the case of TB, it wasn't a complex program. It was costly, but all things considered it wasn't that costly to put in place the kinds of appropriate measures and effective methodologies, like directly observed therapy, that allowed us in just a few years' time to dramatically turn the tide on tuberculosis and to reduce the rates of drug-resistant TB by more than 95 percent. So it really, you know, was a very important demonstration of the effectiveness of public health. West Nile I think was the most recent example of just how effective public health response can be and the broad ramifications, political and economic, if you don't address it in a very straightforward and supportive way. And, of course, bioterrorism -- bioterrorism has brought public health I think into a new place at the table and gives us an opportunity to really make enormous strides forward. So I think that the continuing first challenge, or a challenge very high on my list, is this issue of continuing the awareness about the importance of public health, and then translating that awareness into real programs.
We need to continue to emphasize the basics at the state, local, and federal level, in terms of trained epidemiologists and infectious disease specialists, surveillance capacity, including appropriate lab capacity, enhanced information technology expertise and capabilities, and improving that important working relationship between the medical community and health departments that, as Marcie Layton showed yesterday, were so essential in identifying the West Nile outbreak and the rapid response. And that, of course, is a two-way street. Physicians and the health care providers need to know what to report and to whom, and when they report they need to find a responsive health department that gives them critical feedback that affects their ability to care for patients. It is a two-way street. And I think we also need to recognize that at every level of government there must be accountability. There's a tendency to think, let the federal government pay for this all. And certainly when I was at the local level I fell into that mode of thinking, and we spent a lot of time trying to think about ways to get more federal dollars, also how to enhance our state match for certain activities, how to get somebody else to pay for our programs. But in the final analysis, at every level of government the activities and the responsibilities of a public health agency are somewhat different, but they are critically important and we have to integrate those functions and we have to have a robust and sustainable system of funding where at every level there's a sense of accountability, that the leadership in those communities understands the importance of the activities and is committed to funding them, and understands that if they don't they are not serving the people that elected them and put their administrations into place. And that is a continuing challenge. Obviously, as Assistant Secretary for Planning and Evaluation, I have to stress the importance of comprehensive planning, planning at the local, state, and federal level. There will be no one size fits all plan that can be produced at the federal level and put on the shelves. It needs to be something that is done by localities and states in collaboration with the federal government. And, obviously, the specifics are unpredictable. It will depend both on organizational systems unique to specific states and localities and also, of course, the characteristics of the pathogen involved and the circumstances of the exposure. The challenge of planning is, of course, enhanced by the fact that bioterrorism, in particular, is a low probability but high consequence event. It's often hard to engage attention because of all of the many reasons that were discussed at yesterday afternoon's panel. And it's also going to be very hard to sustain efforts into the future. But effective strategies must build on existing systems. We don't want to develop a whole ancillary system for responding to the bioterrorist threat. We want to integrate our thinking and planning into this continuum of infectious disease threats and potential disasters. We want to not find ourselves in the situation of in a crisis trying out a plan for the very first time, but we want to try to find the systems that work in routine activities, identify what we need to do to amplify or modify them to be appropriately responsive for these more acute and catastrophic situations. For example, clearly, for many reasons, we don't want to rely on the traditional systems of surveillance. We need to be innovative and creative in our thinking about much more real-time surveillance systems that will allow us the opportunity to do that rapid detection that will lead to appropriate and effective interventions and response. And, of course, we need to constantly be integrating new technologies as they emerge into our strategies for response. Partnerships are key, and bioterrorism obviously raises new challenges. They've been discussed already to some degree, but it's hard enough when we're talking about responding to infectious disease outbreaks to get the medicine and public health community to fully work together in the ways that are so critically important. So now we're talking about working with law enforcement and the intelligence community and partners that historically we haven't worked a great with and that in some ways we're not so comfortable with. But it's clearly critical to our success, and it I think is something that many communities have demonstrated effective ways of partnering, and we need to learn from them and we need to continue to work at the state and local, as well as federal level, to make sure that these partnerships are real and enduring and not just dependent on relationships that develop between individuals. One thing that has been striking to me in my current role that really makes it hard for our department to be fully at the table in national security discussions is our inability to deal with the issue of classified documents, and our inexperience dealing in the world of security concerns. We are currently in the process of developing secure video conferencing capability, which will really allow us to have real-time communications in a crisis, or on a routine basis, with the key partners in the security community, talking about sensitive issues. But for the longest time, an enormous amount of activities went on. We were not part of those discussions. We were not at the table. And we even had a hard time obtaining a secure fax. I think as a nation we need to really think very carefully about how we classify items and the framework for security, because certainly we've had some recent experiences that tell us our systems aren't fully working. But it is clear that if we want to be true partners in this, we have to become much more sophisticated. And at the federal level in Department of Health and Human Services, it's hard enough, both having sharp enough elbows to be at the table in person as thinking and planning and discussions go forward, but this issue of being marginalized because of our inability to function in that world I think also needs to be addressed. And I imagine at the state and local level it's going to be even more critical over time. Certainly, when I was Health Commissioner, the issue of having a security clearance and dealing with secure documents was just simply something that never came up. But in terms of some of the kinds of stuff that we're thinking about now, I think, you know, we need to really look at that and address it in a much more focused way. Controlling disease and caring for the sick will require a very full engagement of the public health and medical community. I don't have the time now to elaborate on some of the critical points that came up yesterday with respect to the pressures on providers and the hospital community that limit their ability to prepare in some of the critical ways that we need in looking to the future and the infectious disease and bioterrorist threat. But we cannot ignore them -- the enormous downsizing that has occurred, the competitive pressures to cut costs, the just-in-time pharmaceutical supplies and staffing approaches, the limited capacity for certain specialty services -- respiratory isolation beds and burn units -- that may become critical in a biological or a burns chemical terrorist crisis needs to be recognized and addressed. But we also, of course, have to understand the costs incurred to these institutions and individuals, and that there is enormous and upfront investments if they are truly to prepare. And in some ways, if you are institution, a health care institution in today's society, to both make those investments is a high-risk undertaking, but then you're also sort of setting yourself up to incur a series of costs that you don't know whether they'll be reimbursed or not after the crisis is over. So I think we have to find better ways to strategically support our health care institutions, both because of the implications of a bioterrorist attack but also because of the known threats to the system in the form of routine flu seasons that are currently overwhelming our system's capacity to respond. So we need to really think about developing programs that may target dollars for this kind of disaster, planning and relief, providing training, providing templates for preparedness, and trying to develop strategies in collaboration with other critical partners for providing ancillary hospital support in the event of a crisis, whether it's through the army field hospital model or going back to what was done in the 1918 pandemic flu, where you took over armories or school gymnasiums or whatever. But we need to really focus in on that. We really need to support local and state planning efforts to assess community assets and capabilities, and we need to look at what are the federal supports that can be brought to bear in a crisis. I've gone overtime, but I have to mention we still have an array of legal issues that are unaddressed, and we talk about that more in the next panel. But it ranges from such basic ones as the issue of declaration of emergency -- what are the existing authorities? Are they public health, or do they rest in other domains that will be relevant? What are the authorities that still need to be established? Other outstanding questions about the ability to isolate, quarantine, or detain groups or individuals; the ability to mandate treatment or mandate work; restrictions on travel and trade; the authority to seize community or private property, such as hospitals, utilities, medicines, or vehicles; the ability to compel production of certain goods. Also, the question of the use of certain pharmaceuticals or diagnostics that are not yet approved or labeled for certain uses in a crisis. All of these questions involve many different levels of government, many different laws and authorities, many complex ethical issues intertwined. And we need, in a systematic and coherent way, to look at this array of pressing issues and concerns. And not just what laws are in place or could be put in place, but then also what policies and procedures would be necessary to actually implement them.
I've got a couple of other areas I want to quickly mention, and I'm waiting for Tara to give me the hook. The media -- we absolutely have to find effective strategies for dealing with the media. It's such a critical partner, so key to our efforts in a crisis to communicate important information and reduce the potential for panic. Working with them in a crisis means working with them now, a process of ongoing and continuing education, and also the critical development of a trust relationship, so that when we provide them information, or can't provide them with information, we don't have to become defensive but can move on and address the critical issues before us.
And the final thing is the issue of limited resources. The nation has never been comfortable with issues of rationing or triage. Some of it goes on already, and we all know it. But it will be very stark in the kind of crisis that we're talking about at this meeting. There may be delays in getting drugs and vaccines on-site, or we may simply not have them. We're going to have to make hard decisions about who gets access to drugs. It may not be -- it will not be simply about maximizing the preservation of life, but it will be about maintaining critical infrastructure and supporting key workers, including health care workers. And so we're going to have to really think about whether we have a set of priority groups for the use of scarce resources, what that's going to be. Clearly, just an enormously charged, complex undertaking. We have been thinking about it in the context of pandemic flu, where we know there will be vaccine shortages. And we need to think about it in the context of bioterrorism as well. We need to bring together a broad set of stakeholders, need to involve every level of government, and we need, as a nation, to become comfortable with this situation that we'll almost certainly find ourselves in. Well, I've gone overtime. I apologize. And, clearly, I've just only touched on some of the critical challenges before us. They are complex and difficult, and we will probably never find completely acceptable or effective solutions.
But we are on a critical path. All of us are partners in that effort, and I'm very, very grateful to be part of this and to know that all of you who are here today are going to be continuing this important work forward. Thank you.
(Applause.)
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