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Testimony on Bioterrorism by Margaret A. Hamburg, M.D.
Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services

Mr. Chairman and members of the Committee, thank you for the opportunity to testify today. I am accompanied by colleagues who have responsibility for implementing various parts of our anti-bioterrorism initiative: James Hughes, M.D., Director of the National Center for Infectious Diseases, Centers for Disease Control and Prevention; Robert Knouss, M.D., Director of the Office of Emergency Preparedness, Office of the Assistant Secretary for Public Health and Science; John Taylor, Esq., Senior Advisor for Regulatory Policy, Food and Drug Administration; and Anthony Fauci, M.D., Director of the National Institute for Allergy and Infectious Diseases, National Institutes of Health. The Department of Health and Human Services (DHHS) welcomes your interest in our efforts to develop effective counter-measures for possible uses of biological weapons against the civilian population.

I will outline for you the overall strategic approach that DHHS is pursuing in our anti-bioterrorism activities - emphasizing our efforts to strengthen the public health infrastructure for infectious disease surveillance related to potential bioterrorism agents and our efforts to enhance capabilities for medical and public health response should a bioterrorist attack occur. Following that, my colleagues and I will be pleased to respond to questions.

I begin by noting that bioterrorism presents a special set of challenges to our emergency preparedness systems, public health organizations, and consequence management capability. Unlike a bomb or discrete chemical exposure, a terrorist incident involving a biological agent may not be detected or even suspected until people begin to present with serious illness. This may occur at considerable and varying distance from the site of initial exposure, both in terms of onset of disease (incubation periods can vary) and geographic location (e.g., if exposure occurs in a transportation terminal, people can spread out widely before becoming ill).

With a bioterrorist event, there is also the possibility of concentric, spreading circles of communicable disease exposure, extending significantly the damage caused by the agent released. This kind of threat will also dramatically increase the level of public fear and potential for major civil disruption.

Increasing the urgency of the need for our nation to prepare for the potential threat of bioterrorism is the fact that the agents most likely to be used in this type of attack are pathogens not commonly experienced in this country or routinely dealt with by our medical system. This has a number of significant implications: (1) the population generally has little or no immunity to the pathogen and hence is more vulnerable (e.g., no longer vaccinated against smallpox); (2) medical providers generally are not familiar with the diagnosis and treatment of these disorders (which they may even fail to initially recognize); and (3) routine scientific research into the pathogenesis and treatment of certain of these disease conditions has been at very low levels compared to other agents of infection because they have not been perceived to be high priority or because they require levels of biological containment that are not available at most research centers. For these reasons, a sound strategy for addressing bioterrorism will be quite different from one that targets other types of terrorist acts.

The DHHS initiative features activities in five distinct but related areas:

• Deterrence of biological terrorism
  
  
• Surveillance for unusual outbreaks of illness
  
  
• Medical and public health response
  
  
• Development of a national pharmaceutical stockpile
  
  
• Research and development

I will comment briefly on each.

Deterrence. The Centers for Disease Control and Prevention (CDC) has the responsibility mandated by the Antiterrorism and Effective Death Penalty Act of 1996 to regulate the shipment of certain hazardous biological organisms and toxins (hereinafter called "select agents"). Organizations such as research universities, pharmaceutical manufacturers, and microbiological archives often have occasion, as part of their routine work, to send or receive samples of dangerous pathogens or toxins. DHHS regulations (42 CFR 72.6) require that all facilities sending or receiving shipments of select agents register with the CDC, maintain records of such transfers, and otherwise document their compliance. CDC's administration of the select agent rule is part of the Administration's multi-agency effort, led by the Department of Justice, to combat terrorism.

CDC also fosters safe design and secure operation of laboratories that handle select agents. This involves consultation with laboratory officials to help ensure that new, renovated, or proposed facilities meet standard guidelines for the infectious organisms that will be handled. Development of guidelines and training materials for use by laboratory personnel and provision of technical assistance to states as requested regarding their inspection programs for BSL 3 facilities also are part of CDC's responsibilities..

Surveillance. Terrorist use of biological weapons against the civilian population is likely to be surreptitious. Absent an explosion, other immediate evidence of an attack, or notification of authorities by a perpetrator that an attack has been made (i.e., people have been exposed), the first responders will be health-care workers rather than fire or police personnel (as would be expected for a conventional emergency response scenario). The first indication that a silent attack has occurred probably will be an outbreak of some uncommon illness or an abrupt, significant increase in the incidence of commonly observed symptoms. How quickly the outbreak is detected, analyzed, understood, and addressed will determine the timeliness and effectiveness of the medical and public health response and hence the extent and severity of the impact upon the health and well-being of the affected community.

For example, most infectious agents have an incubation period measured in days or weeks. A silent release of a biological agent capable of producing a highly communicable disease, therefore, could afflict hundreds - if not thousands - of individuals over a wide geographic area during a period of several weeks before the need for a full medical and public health response could be identified and the response designed and mounted.

CDC is working to upgrade public health capability to counter bioterrorism through complementary, simultaneous improvements in the bioterrorism-related expertise, facilities, and procedures of state and local health departments and within the CDC itself. The emphasis areas are (a) preparedness planning by state and local health departments; (b) prompt reporting of cases of illness that might have been caused by terrorists; (c) epidemiological analysis of outbreaks to identify the source and mode of transmission; (d) laboratory identification and characterization of the agents causing the outbreaks; and (e) electronic communications among public health officials regarding occurrences of outbreaks and responses to them. CDC recently issued a competitive program announcement soliciting applications for cooperative-agreement awards whereby states and major metropolitan health departments can receive financial and technical assistance to effect desired improvements in one or more of the five emphasis areas. CDC will make these awards this summer.

Medical and Public Health Response. Much of the initial burden and responsibility for providing an effective response by medical and public health professionals to a terrorist attack of any kind rests with the local governments, with support from state and federal agencies. Local public health systems almost inevitably will be called on to provide protective and responsive measures for the affected populations, including:

• mass patient care -- including the establishment of auxiliary, temporary treatment facilities or procedures for the movement of overflow patients to other geographic areas for care;

• in the case of a bioterrorist event, mass immunization or prophylactic drug treatment for groups known to be exposed, groups who may have been exposed, and populations not already exposed but at risk of exposure from secondary transmission and/or the environment;

• mass fatality management to provide respectful and safe disposition of the deceased, including animals; and

• decontamination of the environment.

Presidential Decision Directive 62 designates DHHS as the lead federal agency to plan and prepare for a national response to medical emergencies arising from the terrorist use of weapons of mass destruction. Within DHHS, this responsibility rests with the Office of Emergency Preparedness (OEP) within the Office of Public Health and Science.

OEP seeks to develop complementary medical response capabilities at local and national levels. It works closely with other agencies ­ especially the relevant components of the Department of Defense (DOD), the Department of Justice, the Department of Veterans Affairs, the Federal Emergency Management Agency, and others ­ with a view toward ensuring that plans for managing the medical consequences of terrorist acts are well integrated with other emergency response systems. To date, the anti-terrorism focus across the federal government has been on the prospect of nuclear or chemical attacks. Future preparedness efforts must focus on the prospect of bioterrorism as well.

In particular, OEP contracts with local governments for the creation of Metropolitan Medical Response Systems (MMRSs) and, within these agreements, is placing new emphasis on preparedness for mass patient care and other consequences of biological terrorism. Also, OEP is working to strengthen its four National Medical Response Teams and the National Disaster Medical System overall with respect to the bioterrorism threat so that they can augment local capabilities as needed in the event of an attack. To date, OEP has contracted with 27 municipalities to develop MMRSs. Another 8 MMRSs are to be initiated this year; plans to fund 12 more with redirected Fiscal Year (FY)1999 funds have been provided to the Subcommittee (bringing the total to 47); and the budget request for FY 2000 includes $16.5 million for contracts with an additional 20 cities for MMRSs - bringing the total to 67. The long term goal is to establish MMRSs in all 120 metropolitan areas specified in The Response to Weapons of Mass Destruction Act of 1997.

National Pharmaceutical Stockpile. A release of biological, and some chemical, weapons of mass destruction will require rapid access to quantities of pharmaceutical antidotes, antibiotics and/or vaccines that will not be readily available in the locations in which they would be needed unless special stockpiles are created. Because no one can anticipate exactly where a terrorist will strike and each local government does not have the resources to create sufficient stockpiles on its own, special stockpiles must be created and maintained as a national resource.

The initial focus will be on acquiring antibiotics useful in treating anthrax, plague, and tularemia; enhancing the utility of the existing supply of smallpox vaccine; and developing a cache of drugs and equipment for countering chemical attacks. Once research and development have yielded improved vaccines against anthrax and smallpox and new antiviral drugs effective against smallpox, they will be included in the stockpile.

CDC has responsibility for developing the stockpile. Fifty one (51) million dollars has been appropriated for this purpose this fiscal year, and a comparable sum is requested for FY 2000.

Research and Development. Capability to detect and counter bioterrorism depends to a substantial degree on the state of relevant medical science and technology. Without rapid techniques for accurate identification of pathogens and assessment of their antibiotic sensitivity, planning for the medical and public health response will be compromised significantly. Without efficacious prophylactic and therapeutic agents, even the best planned responses are likely to fail. The current base of science and technology is strong in some areas (e.g., certain classes of anti-bacterial drugs) and weak in others (e.g., rapid diagnostics, anti-viral drugs, and vaccines). Strong, sustained research and development in relevant scientific disciplines is the only proven way to remedy such deficiencies in knowledge and technology.

The National Institutes of Health (NIH) is reinvigorating its research related to the pathogenesis of - and host immune responses to - infectious organisms likely to be used in terrorist acts - e.g., the organisms that cause anthrax, tularemia, and plague. This research would be greatly facilitated by the acquisition of genome sequence information on these and related pathogens. The results of such genomics research - coupled with other pathological, immunological, biochemical, and microbiological information - are expected to facilitate pursuit of a variety of critical goals including the development of rapid diagnostic methods for the most likely biological weapons, the development of antiviral therapies for smallpox and Ebola virus, and the development of new vaccines for anthrax, cholera, and smallpox. NIH also will undertake an array of basic and targeted studies oriented toward development of new or improved methods to diagnose chemical exposures and determine their effects upon the nervous system.

Building upon the rapid advances of recent years in the molecular and cell biology of infectious organisms, the Department has requested $30 million in FY 2000 specifically for developing improved vaccines for the highest priority bioterrorism threats: anthrax and smallpox.

Other DHHS agencies are engaged in relevant research and development as well. CDC, as part of the surveillance initiative I described earlier, is expanding its in-house Rapid Toxic Screen project to develop methods for measuring, within 48 hours, toxicants in human blood or urine samples. The goal over the next three years is to devise methods to identify and measure 150 different toxins and to achieve an in-house analytic capacity of 200 samples per day. As new methods come on line, CDC will disseminate them to state and local laboratories as appropriate for incorporation into their analytic repertoires. Also, FDA proposes to expand its research on detection and characterization of toxins that might be used by terrorists.

Looking more generally at the entire civilian medical response to chemical and biological terrorism, DHHS contracted in May, 1997 with the National Academy of Sciences' Institute of Medicine (IOM) to provide specific recommendations for priority research and development activities to improve that response. The IOM's report, delivered this past January, examines a wide range of research and development needs - including not only the medical response areas described above but also topics such as environmental detection of chemical or biological agents, personal protective clothing and equipment, and decontamination. My colleagues and I have found this to be an excellent and helpful study; and the Office of Science and Technology within the Executive Office of the President is using the IOM report as its framework for assessing and coordinating counter-terrorism-related research and development throughout the Executive Branch.

Expedited Regulatory Review. The development of new or improved diagnostics, antibiotics, antivirals, and vaccines needed to combat bioterrorism must go hand in hand with efforts to streamline the regulatory process that new products must undergo successfully to be approved for marketing. FDA will work closely with sponsors and manufacturers to ensure effective and timely reviews of investigational new products. For example, NIH has created an Anthrax Vaccine Working Group, which brings together representatives of the NIH, FDA, and DOD to advance research and development relevant to developing a new anthrax vaccine. Also, FDA intends to accelerate the pace and increase the efficiency of its reviews by ensuring the availability of experts to guide sponsors through the regulatory process not only for new products but also for new uses of existing products.