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Prepared Testimony of Dr. Peggy Hamburg Regarding Biological Weapons Threat

Margaret A. Hamburg, M.D.

Commissioner U.S. Food and Drug Administration

Testimony of Margaret A. Hamburg, M.D. Vice President of Biological Programs, Nuclear Threat Initiative House Government Reform Committee Subcommittee on National Security, Veterans Affairs And International Relations

Mr. Chairman and members of the Committee, thank you for the invitation to discuss the need to enhance our nation’s capacity to respond to the threat of bioweapons. Your leadership and commitment in addressing this challenge have been impressive.

I am sure that most would agree that the intentional use of a biological agent to cause widespread panic, disease and death is a frightening prospect. The recent exercise Dark Winter, just described by Dr. Hamre, certainly made this vivid for all who participated. As you have heard, there were many lessons to be learned from this exercise which so powerfully conveyed the distinctive–and sobering–features of a potential bioterrorist attack.  

For each of us around the table, the lessons learned were somewhat different, depending on our various backgrounds, experience and expectations. It was fascinating to see the differing perspectives that were brought to bear on the same fundamental sets of data and decisionpoints. At times, the old adage “what you see depends on where you sit” came to mind. Yet I think we all agreed that the exercise was indeed plausible-- even conservative-- in the framing of the scenario and the assumptions made about disease exposure, transmission and treatment. Certainly, we all left the room humbled by what we did not know and could not do, and convinced of the urgent need to better prepare our nation against this gruesome threat.

I participated in the exercise as the Secretary of Health and Human Services. The perspective I brought to the table was that of someone who served first as a local health officer (New York City Health Commissioner) and then as a federal public health official (Assistant Secretary for Planning and Evaluation, Department of Health and Human Services). In addition, as New York City’s Health Commissioner when the World Trade Center was bombed, the threat of terrorism has a grim reality for me. However, having witnessed the devastation caused by that event, I can only imagine how much worse that situation –and the associated panic, disruption, disease and death-- would have been, had it involved the covert release of a biological weapon.  

In that context, I should also state that my bias is to approach the bioweapons issue in the broader context of infectious disease threats, both naturally occurring and intentionally caused. There is a continuum. A bioterrorist attack such as that depicted in Dark Winter would certainly represent 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 would cause.

ISSUES RAISED BY DARK WINTER EXERCISE
Dark Winter raised many important issues and provided an opportunity to enhance awareness about the complexities of a bioterrorist attack. It served as a compelling illustration of just how much an attack caused by biological weapons would differ from conventional terrorism, military strikes or even attacks caused by other weapons of mass destruction.

It demonstrated how such an attack would unfold slowly-- over days, weeks, months– as an infectious disease epidemic, with the potential to cause enormous suffering and death, as well as panic, destabilization and quite possibly civil disorder. There was little doubt that this would be a true public health emergency, for which our nation is ill-prepared to respond. Moreover, it showed how a bioterrorist attack would represent a national security crisis of enormous proportions, yet many of the traditional strategies to manage such an event would not apply. For example, identification of the perpetrator, as well as avenues for possible retaliation, might not be feasible. Dark Winter also underscored the interwined legal, ethical, political and logistical difficulties that attend contagious disease containment and control.

Dark Winter further demonstrated how poorly current organizational structures and capabilities fit with the management needs and operational requirements of an effective bioterrorism response. Responding to a bioterrorist attack will require new levels of partnership between public health and medicine, law enforcement and intelligence. However, these communities have little past experience working together and vast differences in their professional cultures, missions and needs. The Dark Winter scenario also underscored the pivotal role of the media, and how a productive partnership with media will be paramount in communicating important information to the public and reducing the potential for panic.  

Another clear lesson that emerged from Dark Winter was that effective response will also require stronger working relationships across levels of government. For while national leadership, guidance and support will be essential, it must be recognized that much of the initial crisis response and subsequent consequence management will unfold on the local level. “ Onthe- ground” local providers--public health and medical professionals, emergency response personnel, law enforcement officials and government and community leaders--will provide the foundation of the response and will deal with the problem from the moment the first cases emerge until the crisis is over.

The Dark Winter scenario also brought into bold relief the fact that management of such a crisis would almost certainly occur in the context of an already strained health care system and severe limitations on certain critical resources, including shortages of vaccine, hospital beds and isolation capacity.

CHALLENGES FOR THE FUTURE
As an exercise, Dark Winter was not designed to provide answers, but rather to raise critical questions and issues about our current preparedness to address the bioterrorist threat. Certainly it achieved that goal, but how do we begin to address these critical concerns? Building on lessons learned from Dark Winter from the perspective of public health and medicine, let me emphasize several key challenges as we move forward.  

(1) Focus on the real threat/strengthen public health. I believe that a major challenge remains the need to get policymakers, legislators, and program planners to understand that the threat of bioterrorism is both real and different. Meaningful progress against this threat depends on understanding it in the context of epidemic disease. The paradigm is different than that for conventional terrorism or a chemical or nuclear attack. It requires different investments and different partners. Until bioterrorism’s true nature as an epidemic disease event is fully recognized, our nation's preparedness programs will continue to be inadequately designed: the wrong first responders will be trained and equipped; we will fail to fully build the critical infrastructure we need to detect and respond; the wrong research agendas will be developed; and we will never effectively grapple with the long-term consequence management needs that such an event would entail.

Frankly, if we look at our current preparedness efforts, necessary public health and medical care activities are underdeveloped and underfunded. Of the roughly $10 billion budget for counterterrorism efforts in FY 2001, only a very small percentage supports activities that truly can be considered as core elements of a coherent program to address the bioterrorist threat.  

(2) Build on existing strategies. Effective strategies must build on existing systems where possible, but build in flexibility. We do not want to develop an entire ancillary system for responding to the bioterrorist threat. Rather, we should strive to integrate our thinking and planning into the continuum of infectious disease threats and potential disasters that public health agencies are already charged to respond to. The last thing we want is to find ourselves trying out a plan for the very first time in the midst of a crisis. Instead, we want to find the systems that work in routine activities and then identify what we need to do to amplify or modify them to be appropriately responsive for these more acute and catastrophic situations.

(3) Support the health care system’s capacity for mass casualty care. Controlling disease and caring for the sick will require a deep engagement of the public health and medical community. There are currently many pressures on health care providers and the hospital community that limit their ability to prepare in some of the critical ways necessary for effective planning in the face of the bioterrorist threat. The enormous downsizing that has occurred, the competitive pressures to cut costs, the just-in-time pharmaceutical supplies and staffing approaches, and the limited capacity for certain specialty services such as respiratory isolation beds and burn units that may become critical in a biological or chemical terrorist attack all need to be recognized and addressed.

We must be realistic about the potential costs that would be incurred by these institutions and individuals, as well as the enormous up front investments needed if they are truly to prepare. And in many ways, if you are a health care institution today, making those preparatory investments is a high-risk undertaking. By preparing, you are also almost setting yourself up to incur a series of costs that may not be reimbursed after the crisis is over.  

We know that we must find better ways to strategically support our health care institutions, both because of the implications of a bioterrorist attack but also because of the existing demands on the system, as evidenced this past year when a routine flu season overwhelmed hospital capacity in several cities.

There is an urgent need to develop programs that target dollars for health care disaster planning and relief, including training, templates for preparedness, and efforts 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 armories, school gymnasiums and the like were taken over to provide medical care. In doing this, we need to support local and state planning efforts to assess community assets and capabilities, and we need to look at what federal supports can be brought to bear locally in a crisis.

(4) Invest in research. Today’s investment in research and development will be the foundation of tomorrow’s preparedness. A comprehensive research agenda should be developed and pursued that extends across many important research domains. For example, our capability to detect and respond to a bioterrorist attack depends largely on the state of the relevant medical science and technology. Without rapid techniques for accurate identification of pathogens and assessment of their antibiotic sensitivities, planning for the medical and public health response will be significantly compromised. Without efficacious prophylactic and treatment agents, even the best planned responses are likely to fail. Biomedical research is needed to develop new tools for rapid diagnostics, as well as improved drugs and vaccines. At an even more basic level, we must invest in research to enhance the fundamental study of genomics, disease pathogenesis and the human immune response.  

In addition to biomedical research, further research into such diverse concerns as defining appropriate personal protective gear or decontamination procedures under different circumstances will be important to our overall preparedness for a bioterrorist attack. Research to support deeper understanding of the behavioral issues and psychosocial consequences of a catastrophic event of this kind is currently very limited but should be made a high priority.

5) Understanding the public response. Another major gap in current preparedness and planning efforts involves how to engage the public, and importantly, how to most effectively work with the public in the event of a crisis. We must begin now, with investments in research to better understand how the public will react in the event of a bioterrorist attack. As a nation, we have little experience with this kind of disaster. By examining the response to natural disasters, such as fires and floods, as well as to terrorist bombings or attacks, we can glean some important insights. Yet we must also recognize that the fear of a silent, invisible killer such as an infectious agent will likely evoke a level of fear and panic substantially greater than what has occurred in response to those more “conventional” disaster scenarios. Certainly response to previous major disease epidemics—such as the outbreak of pneumonic plague in Seurat, India in 1994— suggests a level of panic and civil disruption on a far greater scale.

Anyone who has ever dealt with disaster response knows that how the needs of the public are handled from the very beginning is critical to the overall response. In the context of a biological event, this will no doubt be even more crucial. Managing the worried well may interfere with the ability to manage those truly sick or exposed. In fact, implementation of disease control measures may well depend on the constructive recruitment of the public to behave in certain ways, such as avoiding congregate settings or following isolation orders. In the final analysis, clear communication and appropriate engagement of the public will be the key to preventing mass chaos and enabling disease control as well as critical infrastructure operations to move forward. Correspondingly, the needs and concerns of response personnel, including health care workers, must also be addressed. Again, prior experience with serious infectious disease outbreaks tells us that when this does not occur, essential frontline responders and key workers are just as likely as the public to panic, if not flee. The mass exodus of health care workers following onset of the Ebola epidemic in Kikwit, Zaire in the mid 1990s serves witness to this point.

(7). Engage the media. The media represents a critical partner, 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 in a process of ongoing and continuing mutual communication and education. We must strive for the development of a set of working relationships grounded in trust—trust that we will provide them with information in a timely and appropriate manner, and in turn they will use that information in a responsible, professional way. No doubt there will always be tensions between the desire to get out a good story and an appreciation of the complexities, sensitivities and uncertainties inherent in such a crisis. But stonewalling the press or viewing them as the enemy is virtually guaranteed to make the situation worse. They will be an absolutely essential partner in getting out information to protect health and control disease.

(8) Clarify legal authorities. In planning for an effective response, an array of legal concerns need to be addressed. Issues include such basic ones as the 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 criteria for such a declaration? What are the authorities that still need to be established?

Other outstanding legal questions concern 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; or the ability to compel production of certain goods. Also, questions concerning emergency use of pharmaceuticals or diagnostics that are not yet approved or labeled for certain uses needs to be answered.  

These questions involve many different levels of government, many different laws and authorities, and raise many complex and intertwined ethical, political and economic issues. In a systematic and coherent way, we must address 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.  

(9) Plan, prepare and practice. Perhaps most fundamentally, Dark Winter signaled the need for more planning and preparation—across all the domains mentioned above and more. Planning can make a difference, but we cannot begin to prepare in the midst of a crisis. As Dark Winter unfolded, it was evident that a sense of desperation about what needed to be done arose, at least in part, because the country had not produced sufficient vaccine; had not prepared top officials to cope with this new type of security crisis; had not invested adequately in the planning and exercises needed to implement a coordinated response; and had not educated the American people or developed strategies to constructively engage the media to educate people about what was happening and how to protect themselves.  

Prior planning and preparation can greatly mitigate the death and suffering that would result from a bioweapons attack. As a nation, we need comprehensive, integrated planning for how we will address the threat of bioterrorism, focusing both on prevention and response. We need to define the relative roles and responsibilities of the different agencies involved, and identify the mechanisms by which the varying levels of government will interact and work together. We need true national leadership to address the bioweapons threat to our homeland. Planning efforts must be backed by the necessary resources and authority to translate planning into action. Moreover, we must practice what we plan. Preparations must be exercised, evaluated and understood by decision-makers if they are to prove useful in a time of crisis.

(10) The importance of prevention . The many intrinsic challenges involved in mounting an effective response to a bioterrorism attack--and the many casualties that will inevitably occur-- should compel us to make a greater commitment to what can be accomplished to reduce the fundamental threat of their use. Clearly, measures that will deter or prevent bioterrorism will be the most cost effective means to counter such threats to public health and social order– both in human and economic terms. Are there strategies to limit or prevent these often frightening microbes from getting into the hands of those who might misuse them, and how do we reduce the likelihood that they would be misused?

On a policy level, such prevention efforts require a global approach, including the need to find ways to meaningfully strengthen and enforce the Biological Weapons Convention, as well as international scientific cooperation to create opportunities for scientists formerly engaged in bioweapons research to redirect their often considerable talents and energy into more constructive and open research arenas. For example, a number of scientific collaborations have begun in Russia in an attempt to address this goal.

We must also strengthen and expand efforts to control access to and handling of certain dangerous pathogens, including proactive measures by the scientific community to monitor more closely the facilities and procedures involved in the use of such biological agents.

CONCLUSION
In conclusion, let me re-emphasize that a sound strategy for addressing bioterrorism will need to be quite different from those that target other types of terrorist acts. While still a relatively low probability event, the high consequence implications of bioterrorism place it in a special category that requires immediate and comprehensive action. Yet as we move forward to address this disturbing new threat, it is heartening to recognize that the investments we make to strengthen the public health infrastructure, to improve medical consequence management and to support fundamental and applied research, will also benefit our efforts to protect the health and safety of the public from naturally occurring disease.

To be effective, we will need to define new priorities, forge new partnerships, make new investments to build capacity and expertise, and support planning. We may never be truly prepared for some of the most catastrophic scenarios, but there is a great deal that can and should be done.

I look forward to working with you on these important issues and would be happy to answer any questions you may have. 

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Testimony before the House Government Reform Committee's Subcommittee on National Security, Veterans Affairs and International Relations.

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