Introduction

Chairman Greenwood and members of the Subcommittee, good morning. I am Dr. Joseph F. Waeckerle, Editor in Chief of the Annals of Emergency Medicine, the Journal of the American College of Emergency Physicians. I am a Board of Emergency Medicine certified physician, and the Chairman of the American College of Emergency Physicians’ Nuclear, Biological, and Chemical Task Force. I am here today testifying on behalf of the American College of Emergency Physicians (ACEP), which represents more than 22,000 emergency physicians and their more than one hundred million patients.

I want to thank you for the opportunity to appear before you today to discuss the readiness and capacity of the federal programs to provide needed health related services in the event of a biological terrorist attack.

The focus of the nation since September 11 has been on the tragic and senseless loss of lives caused by terrorists willing to fly air planes into buildings. I want to talk to you today about the new weapons of war that have emerged in our modern world which perhaps represent the greatest long-term threats to our national security. Preeminent among them are biological warfare agents. To date, our nation has had very little experience with threatened bioweapon use. What experience we have had has involved small, isolated events not indicative of the true potential devastation of bioagents.

The use of biologic agents as weapons of war could approximate the lethality of a nuclear explosion, can decimate a large population, and thereby destabilize a nation. It can inflict psychological and economic hardship and political unrest by attacking small populations in multiple sites over a protracted period. America’s citizens, national security and international stature are at risk should a bioweapon be used.

America’s State of Readiness

There have been numerous analyses of the escalating risks to America and the considerable deficiencies in our responses to the threat of any weapon of mass destruction much less biologic warfare. Internal reports from the Federal government (Defense Science Board, Defense Threat Reduction Agency, General Accounting Office), external assessments by august panels such as Hart-Rudman and the Gilmore commission, and private testimonies including the Smithson report and individuals before Congress repeatedly warn of the serious deficiencies in our planning and preparation. Authorities have acted on these deficiencies, but we must decisively improve much more. Careful consideration of the existing strategies and response protocols reveals major deficits that are obvious points of interdiction.

National Strategy Deficit

A comprehensive national strategy must be predicated on an in-depth analysis of threats and risks. By identifying credible threats, available assets, and resultant vulnerabilities, a cogent national strategy can be generated. To date, the approach has centered on an “all-hazards” approach. Most of our nation’s hospitals have policies to respond to hazardous materials (HAZMAT) incident, which are inadequate for responding to some chemical agents and nearly all biologic agents. Certainly, conventional weapons are and should be our main focus. Current planning has also focused on chemical weapons with many federal agencies and departments specifically addressing these threats. This is appropriate to a degree because there are currently about 850,000 facilities in the US using hazardous or extremely hazardous materials. Better preparation for possible hazardous materials incidents whether they are the result of industrial accidents or perpetrated by terrorists is beneficial to our country.

Many governments and civilian authorities rightly believe that biologic agents suitable for warfare are readily available. The dissolution of the USSR has led to the cessation of funding for their once formidable bioweapons facilities and financial hardship for the employees. As such, security is minimal and personal motivation to survive, much less profit, is utmost, so bioagents may be “on the market.” Compared with conventional weapons, research and development of bioagents are economically feasible today for many other nations as well. Research and development is now where once only a few had the capability and resources to pursue these avenues. As a result, many nations/states have aggressively and successfully pursued their own biowarfare research and development.

There is also legitimate scientific application of microbiology, which could be used to develop biologic agents. The pharmaceutical industry, beverage industry, and others pursue research in biology to benefit mankind. Because of the overlapping assets used for producing legitimate products and bioweapons, it is extremely difficult to estimate and regulate research and development activities to prevent legitimate research from falling into the wrong hands. Today, any bidder may easily procure samples of bioagents from a variety of sources both legitimate and illicit.

Even if only small samples of a bioagent are available, technologic advancements make it possible for nations or organizations to culture and harvest adequate quantities of an agent relatively inexpensively and virtually anywhere. Bioagents can also can be easily stored and transported. Dissemination, which may be most problematic in using these agents, is now more easily accomplished as well.

For those individuals seeking to gain competency in this area, knowledge is readily available. Educational opportunities are offered in the formal education process including high school, college, and graduate level courses and informally through widespread availability of knowledge via the Internet. In addition, motivated researchers using advanced techniques can now build engineered pathogens that are even more suitable for biowarfare.

The list of agents that could be used in a biological attack is formidable and growing. Legitimate and nefarious researchers have scrutinized the naturally occurring agents as to what clinical and biologic effects are most requisite. Also, newly engineered bioagents are now more than ever viable threats against which the US is vulnerable because they are custom built as weapons.

The capability is there, and today’s world fosters malcontents, extremists and malicious opportunists that view the United States with hostility. These groups include nation/states, groups, and individuals – both domestic and international – that are motivated by political, social, economic, religious, or criminal intent. Nations who could not challenge the United States because of the high cost of conventional warfare now have the capability through the use of biologic weapons to challenge our dominance as the sole remaining superpower. Individuals and groups of zealots, extremists and criminals also view the recent availability of bioagents as an opportunity to wage asymmetric warfare in order to exert influence and manipulate the system for their own gain.

Some authorities have argued that moral constraints will limit the use of such particularly lethal weapons (weapons of mass destruction) especially if civilians are exposed. However, the September 11 assaults on America have shown the contrary.

The inevitable conclusion is that the availability of biowarfare agents and supporting technologic infrastructure, coupled with the fact that there are many who are motivated to do harm to the US means that America must be prepared to defend her homeland against biological agents. Denial of this threat or the excuse that this threat is too difficult to plan for is no longer tenable.

Although the probability of a bioattack is difficult to measure, the consequences are high. Biowarfare is a multidimensional problem due to the diversity of bioagents each with particular threat characteristics, plethora of vulnerable targets and varied routes of dissemination. As such, there is no typical presentation, no easily recognizable signature to allow easy detection or identification, limited treatment options and a disturbing array of sequelae. A biological attack on America will impose unparalleled demands on all aspects of our government and our societal infrastructure that must be met.

The consequences of poor preparation are not tenable. Considerations for the use of potential biological weapons are the sine qua non of future defense readiness. Biological weapons are such formidable weapons of uniqueness and complexity that a specific defense strategy is essential. The triumvirate of research, preparedness and response issues pertinent to biowarfare are central to the formulation of a robust strategic blueprint. Congress must demand a specific, comprehensive and sophisticated strategy of deterrence and defense.

Command, Control and Communication Deficits

The United States must designate and give adequate authority to a central office to coordinate the various agencies involved in emergency response. A single line of authority is traditional in the Defense Department and law enforcement for good reason. Yet the United States has a multitude of federal agencies and departments with vested interests in WMD preparation, and there is no authority structure. The result is efforts in formulate and implement a national strategy are fragmented, uncoordinated, redundant and inefficient. Unfortunately, the absence of unity not only decays the Federal effort it undermines the critical partnership between Federal authority and State and local authorities.

Communication is also a major problem in domestic preparation today. Due to the lack of an overreaching authority, there is little communication among active Federal participants in domestic preparedness. Equally disturbing, the lack of communication among the Federal families trickles down to the state and local communities. As a result, preparation for the possible use of WMD especially biological weapons without Federal assistance is not achievable for most communities in America. Our communities desperately need guidance and support but little communication results in little progress. This is an unacceptable outcome given the risks.

Until authority is mandated, centralized and implemented, turf battles, egos, pettiness and power and money struggles will preclude effective use of our dollars and prevent a collaborative and integrated preparedness process on a national level or local level. Congress should authorize and fund a centralized Federal management and oversight office.

Planning Deficits

Any response to a weapon of mass destruction on American soil will first be local and community-based perhaps for an extended period of time. This means that communities must have plans that are well conceived and effectively coordinated. Although a general plan in most communities today, the local response is currently not well informed, not well financed, not well trained or drilled, and not properly integrated into the overriding federal response. Federal authorities must ensure coordinated ventures with the local communities but they must first cooperate among themselves to do so.

Furthermore, current disaster preparedness programs in US communities are often insufficient in their design in that they are generally inappropriate for specific preparation and response against biowarfare. A biological agent incident requires a vastly different response with regard to management and personnel and resources needed. The multi-agency, multi-jurisdictional character of the many uncoordinated strategies being delivered by the Federal family to the local community makes success against biowarfare a remote possibility. Congress must direct the centralized the federal management and oversight office to provide preparedness and response, education, guidance, and financial support directly to State and local communities.

Response Deficits

The cornerstone of the Nation’s response will lie in the medical and public health communities. It is critical they be actively involved in the threat-assets-risk analysis and subsequent national and local preparation efforts. They are essential to controlling disease outbreaks through appropriate and timely detection and identification, investigation and management.

Detection and Identification Deficits

The United States must establish, strengthen, and expand sophisticated surveillance systems that are integrated with the public health systems and the nation’s emergency departments. Efforts to detect bioagents in the environment before people become infected currently face significant technical obstacles. This is unfortunate because the best defense is to detect the agent prior to its infecting individuals. Likewise, the current technology has not matured to the point that rapid and reliable diagnostic testing of individuals is available. The absence of such capabilities will significantly impede timely response and appropriate management.

At present, the detection of a disease outbreak depends on alert clinicians – or human surveillance. However, most health care professionals are not trained to recognize the symptoms of most of diseases from bioweapons agents nor do they have any experience with these agents. Patients may only exhibit non-specific flu-like symptoms during the early stages of their infection, and clinicians probably would recognize an outbreak only after a number of patients presented with highly unusual symptoms or died of unusual circumstances.

The United States must improve the partnership between health care system and public health agencies. Physicians are not prone to reporting puzzling cases of illness to health officials. Moreover, few public health departments have the personnel or resources to conduct real-time disease reporting or provide expert advice.

The absence of real-time surveillance and simple, quick and reliable diagnostic testing further complicates matters. It will be difficult for clinicians to determine the location and scope of the attack. Infected individuals could move about without overt manifestations during the incubation period of infection. Depending on the agent, contagion could be spread unknowingly, further amplifying the peril. The ability to determine who is actually infected so needs treatment and who is not infected so needs only reassurance is paramount. Potentially, the “worried well” may overwhelm the health care system just as it needs to be entirely focused on the truly infected. The inability to distinguish the infected victims also does not allow appropriate disease containment.

Complicating this, most hospital and commercial labs cannot definitively identify the bioweapons pathogens of greatest concern, such anthrax or smallpox. There are also serious concerns about the capacity of laboratories to cope with increased demands, and the capacity of hospital emergency departments that are already operating at critical capacity to respond. The CDC has been working with state public health laboratories to augment their abilities and capacities and foster a national laboratory system.

Congress must support public and private research for the development of real-time alerting and tracking surveillance systems with analytical capabilities as well as rapid and reliable diagnostic tests for bioagents.

Investigation Deficits

Suspicion that a bioterrorist attack has occurred will provoke public health officials to begin an immediate investigation. Epidemiologic investigations are essential to managing outbreaks of contagious disease. However, the U.S. public health infrastructure is fragile and in much need of rebuilding as has been previously reported. State and local health departments often lack sufficient professional staff, office support and equipment, and the laboratory capacity to perform the basic public health functions much less respond to a large-scale incident.

As noted above, the absence of real-time electronic surveillance systems is a serious problem. These systems could provide information and analysis of data from key testing and monitoring sources thereby allowing up-to-date understanding of an incident. Better understanding will result in more focused and presumably more successful interventions.

Congress must ensure that the public health system be retooled with the appropriate capabilities and capacities needed for biowarfare, and be linked to emergency healthcare systems.

Management Deficits

Personnel Deficits

The United States must train emergency healthcare personnel to recognize and treat victims of a biologic attack, as well as to report incidents. This is vital to our nation’s preparedness for a successful response to a bioagent, medical personnel and medical resources are paramount. Local civilian medical systems – both out-of-hospital and hospital – are the critical human infrastructure. These professionals will be integral in recognizing a bioagent and minimizing the devastation. As in any emergency, concerned or infected patients may come to the “ER” seeking medical help. Emergency physicians and nurses and emergency medical technicians will therefore be the “first responders.” Thee first and most critical line of defense for detection, notification, diagnosis, and treatment of a bioincident. However, this may be delayed if the treating emergency physicians and nurses do not have the clinical knowledge and high index of suspicion to recognize the features of a biologic attack and activate a response.

Emergency physicians and nurses along with other health care professionals in current preparedness programs. Emergency health care professionals need to be integrated and educated. These professionals, in turn must understand the need to become active participants in the preparedness arena. This specifically includes understanding of local disaster plans, including incident command systems and hospital disaster plans.

An overall plan must be implemented for providing, sustaining, and monitoring appropriate educational experiences for these emergency health care professionals in the field of biologic warfare. Unless this training is forthcoming, a critical link in the management of a bioincident will be missing.

To that end ACEP’s Task Force of Health Care and Emergency Services Professionals on Preparedness for Nuclear, Biological, and Chemical Incidents assessed the needs, demands, feasibility, and content of training for emergency physicians, nurses, and paramedics for nuclear/biological/chemical (NBC) terrorism. The task force recommended that training programs and materials need to be developed and incorporated into these professionals’ formative education and into their continuing education. The task force developed the core content essentials for incorporation into

Educational programs and recommended that each of the three groups be trained relative to their particular job responsibilities and anticipated levels of involvement.

It was suggested that a multidisciplinary oversight panel of content experts, educational specialists, and representatives of major professional organizations representing each of the three audience groups implement these educational strategies. The oversight panel would be tasked with the responsibility for the consistency, quality, and updating of the products developed. Additionally, the oversight group would work to establish partnerships with organizations and institutions to assist with the implementation of the recommendations discussed in this report. The multi disciplinary oversight group is an integral part in the development of each recommendation for each of the target audiences. They also formulate and manage formal plan for evaluating each educational product. To support the work of the oversight group, a national clearinghouse or repository should be established to collect relevant information, including articles, books, reports, research, instructional materials, and other media.

An important overarching strategy to support the proposed recommendations is to work with national professional organizations and associations to increase all health care professionals’ understanding of the necessity of this type of education.

Working through national professional organizations and associations, Congress must authorize an implement an overall plan for providing, sustaining, and monitoring appropriate educational experiences for emergency healthcare professionals in the field of biologic warfare.

Hospital Deficits

Unfortunately, civilian health care facilities are not, in general, integrated into a community or regional disaster response system. Hospitals tend to be autonomous, competitive institutions so most are not committed to cooperative efforts that would be needed during a community-wide disaster. Furthermore, hospitals do not possess or regularly exercise requisite communications networks.

Hospital capacity and capability are very real dilemmas today. Many American hospitals are financially frail. They have responded to financial pressures by cutting staff, reducing inventory and eliminating money-losing operations. “Just-in-time” staffing and supplies flow models now govern the number of personnel working and the resources available on a given day. These cost-cutting measures have reduced hospitals’ flexibility; they have no surge capacity in the face of sudden or sustained stress. As a result, it would not take many casualties presenting for evaluation and specialized treatment to overwhelm the hospital system of a large American city. Nowhere is this more evident than in the emergency departments where overcrowding, and lack of critical resources are the norm.

Staffing issues are also challenging. Although many if not most, physicians and nurses hold hospital privileges at several facilities so this will be available to only one institution. Hospital staff privileges requirements and state licensing restrictions are barriers to doctors and nurses from outside the community assisting. Further complicating the local shortage, many health care professionals are committed to military duty as reservists or have volunteered to serve on medical assistance teams or at emergency operations centers.

In addition to professional staff, hospital operations depend on a wide array of skills – the absence of lab technicians, security guards, food service, or housekeeping personnel would significantly affect the efficiency and effectiveness of the whole institution. Furthermore, a significant proportion of a hospital’s staff may fail to report to work in the midst of an epidemic due to fear of a deadly, contagious bioagent.

Congress must recognize that hospitals and their emergency departments are critical components of the infrastructure of America’s biodefense system, and must take these steps necessary to fortify their ability to respond.

Medical Treatment Deficits

For almost all of the bioagents thought to represent a serious threat, the speed with which appropriate medical treatment is administered is critical, i.e. early detection. Different bioweapons agents will require different medical treatment and in some cases there are scant scientific and clinical data available to support treatment decisions. The effectiveness of existing antibiotics and vaccines to prevent or limit the severity of diseases caused by bioweapons pathogens is quite limited as well. For some bioagents, antibiotic treatment is effective but in some cases only if given before symptoms begin or become severe. In other instances, the mainstay of care is supportive which can be very labor intensive.

Currently, there are no effective vaccines for many important bioweapons agents. When available, some vaccines have undesirable features and in other cases, existing vaccine supplies are limited. Special populations, such as children, pregnant women, and immune-compromised persons may be a particular risk or have contraindications for specific therapies. The possibility of bioengineered weapons resistant to traditional therapies must also be considered.

It is clear that there is major shortfall in the readily available capacity of drugs and vaccines. It is also clear that there are many vaccines yet to be developed. This is due to the lack of existing commercial partners interested in undertaking the production, minimal excess capacity within the drug and vaccine industry even if there were interested parties, and the regulatory and technology transfer issues that need to be overcome in order to rapidly manufacture critical supplies.

In addition, there is a lack of a coherent acquisition strategy for national pharmaceutical and vaccine stockpiles. The federal government has recognized that the availability of necessary vaccines and antibiotics is a critical component of an effective bioterrorism response and has taken steps to create a National Pharmaceutical Stockpile (NPS) of medicines and supplies. However, significant logistical problems were encountered in the handling and distribution of the supplies during Operation Topoff that must be remedied.

Congress should direct the centralized federal management and oversight office to partner with private industry interested in undertaking the research, development, and production of necessary pharmaceuticals; maintaining some surge capacity. Congress should also address the regulatory and technology transfer barriers that impede rapid development and availability of critical supplies.

Conclusions

The United States homeland is vulnerable. We are a free society; our greatest right is our greatest liability. We are an inherently trusting and tolerant people so we are not overly suspicious. We are peace loving; we do not act offensively but only respond when provoked. Finally and fortunately, we have had essentially no first hand experience with any form of modern warfare waged in our country until recently

An attack against the homeland using a biological weapon would severely test us. Foremost, the ability to mitigate the consequences of a bioterrorist attack is directly tied to the deficits of the civilian medical and public health systems. The importance of limiting casualties and minimizing interference with daily life is obvious. In addition, failure to deliver adequate medical care or to execute appropriate public health measures could lead to loss of public confidence in the government's ability to protect our citizens, raise the possibility of profound, even violent, civil disorder, and possibly diminish America’s position internationally.

Americans must now commit to not allow such heinous acts to occur in our country. We must all vow to become involved. Our goal is to deter or mitigate any terrorist action against our people or our country. Federal authorities must provide the leadership, the financial investment and the organizational and logistical support requisite to develop a comprehensive national strategy, solid domestic preparedness and appropriate response plans. Health care professionals and state and community leaders must pledge dedication and involvement. Such preparation is very costly, financially, and personally. There is never enough time. But American must remain resolute, for what is the price of our freedom, of our country’s well-being, of our lives.