D.A. Henderson, M.D.

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Testimony
Before the Committee on Science
United States House of Representatives

The Science of Bioterrorism: HHS Preparedness

Statement of
D.A. Henderson, M.D.
Director,
Office of Public Health Preparedness
Department of Health and Human Services

For Release on Delivery
Expected at 10:00 am
on Wednesday, December 5, 2001

Mr. Chairman and Members of the Committee, thank you for inviting me here today. The Department of Health and Human Services (HHS) welcomes your interest in our efforts to respond to terrorist events, including uses of biological weapons against the civilian population. I am Dr. D. A. Henderson, Director of the newly created HHS Office of Public Health Preparedness, which will coordinate the Department-wide response to public health emergencies. To that end, I look forward to working with the Office of Homeland Security and our other partners at the Federal, state and local level to protect the American people from acts of terrorism.

HHS READINESS TO RESPOND TO MASS CASUALTY EVENTS

Although the Department of Defense (DOD) has developed defenses for biological warfare, there are additional concerns that need to be addressed to provide an adequate civilian defense from a bioterrorist attack. The potential list of microbial pathogens that threaten civilian populations is larger than that of classical biological warfare threats. HHS's identification of the major bioterrorism threat agents - a list developed in collaboration with experts in medicine and public health, law enforcement, and national security - is included as an Appendix to this testimony. Moreover, the populations to be protected are different from those generally involved in combat situations because the civilian community includes people of all ages and health status.

As you know, local and state governments bear much of the initial burden and responsibility for providing an effective response by medical and public health professionals to a terrorist attack on the civilian population. If the disease outbreak reaches any significant magnitude, however, local resources will be overwhelmed, and the federal government will be required to provide protective and responsive measures for the affected populations. HHS is working on a number of fronts to assist our partners at the state and local level, including local hospitals and medical practitioners, to deal with the effects of biological, chemical, and other terrorist acts.

Metropolitan Medical Response System

Since Fiscal Year 1995, for example, HHS through its Office of Emergency Preparedness (OEP) has been developing local Metropolitan Medical Response Systems (MMRS). Through contractual relationships, the MMRS uses existing emergency response systems - emergency management, medical and mental health providers, public health departments, law enforcement, fire departments, EMS and the National Guard - to provide an integrated, unified response to a mass casualty event. As of September 30, 2001, OEP has contracted with 97 municipalities to develop MMRSs. During FY 2002, we intend to invest $20 million in 25 additional cities (for a total of 122) for bioterrorism-related planning through the MMRS and to help them improve their medical response capabilities.

National Disaster Medical System (NDMS)

As HHS's action agent for responding to requests for assistance and resources, OEP also manages the National Disaster Medical System (NDMS), which was established in partnership with DOD, the Department of Veterans Affairs (VA), the Federal Emergency Management Agency (FEMA), and the Public Health Service Commissioned Corps Readiness Force. The NDMS can be called into action, depending upon the severity of the event, to assist in providing needed services to ensure the continued health and well being of disaster victims..

The National Disaster Medical System is a group of more than 7,000 volunteer health and support professionals who can be deployed anywhere in the country to assist communities in which local response systems are overwhelmed or incapacitated. Organized into 44 Disaster Medical Assistance Teams, these volunteers would provide on-site medical triage, patient care and transportation to medical facilities. Four National Medical Response Teams (NMRTs), which travel with their own caches of pharmaceuticals, have capabilities to detect illness-causing agents, decontaminate victims, provide medical care and remove victims from the scene. Three of the four NMRTs can be mobilized and deployed anywhere in the nation; the fourth is permanently stationed in the Washington, D.C. area. The NDMS also includes Disaster Mortuary Operations Response Teams that handle the disposition of the remains of victims of major disasters, as well as provide for victim identification and assistance to their families.

The Department of Veterans Affairs is one of the largest purchasers of pharmaceuticals and medical supplies in the world. Capitalizing on this buying power, HHS and VA have entered into an agreement under which the VA manages and stores specialized pharmaceutical caches for OEP's National Medical Response Teams. The VA has purchased many of the items in the pharmaceutical stockpile. The VA is also responsible for maintaining the inventory, ensuring its security, and rotating the stock to ensure that the caches are ready for deployment with the specialized National Medical Response Teams.

National Pharmaceutical Stockpile

HHS has also developed the National Pharmaceutical Stockpile Program (NPS) into a major national security asset. The purpose of the NPS is to be able to rapidly respond to a domestic biological or chemical terrorist event with antibiotics, antidotes, vaccines and medical materiel to help save lives and prevent further spread of disease resulting from the terrorist threat agent. Operated by HHS's Centers for Disease Control and Prevention (CDC), the NPS Program would provide an initial, broad-based response within 12 hours of the federal authorization to deploy, followed by a prompt and more targeted response as dictated by the specific nature of the biological or chemical agent that is used.

One of the NPS "12-hour Push Packages" was brought to operational status on September 11th. CDC delivered a 12-hour Push Package of pharmaceuticals and medical supplies by ground, vendor managed inventory by air, and a technical advisory team in New York City, all within 7 hours of the order to deploy. Three out of the four non-military aircraft in United States airspace on the night of September 11^th were carrying National Pharmaceutical Stockpile assets and personnel to New York City.

The Stockpile Program was developed as a supplementary response asset mainly to address biological and chemical terrorism. But following the events of September 11^th, the program is now being expanded for response to an all-hazards event. The Stockpile presently is able to provide a full course of anthrax post-exposure prophylaxis to more than 2 million persons. Secretary Thompson has directed that the Stockpile development be accelerated to provide increased anthrax prophylaxis capacity for 12 million persons, and CDC will reach that level of response within the next 12 months. We will also add four more push packs to the eight already located across the country, making more emergency supplies available and augmenting our existing supplies of 400 tons by another 200 tons.

But we must accelerate the production of vaccines and antibiotics and invest in essential programs to ensure the speedy and orderly distribution of antibiotics and other supplies in the event of a biological event. That is why the President has called for an additional $1.5 billion in federal funding for those areas most critical to our ability to respond to bioterrorist threats. His proposal includes include $643 million to expand the National Pharmaceutical Stockpile and $509 million to speed the development and purchase of smallpox vaccine.

Just last week, Secretary Thompson announced that Acambis Inc., with support from its subcontractor, Baxter International Inc., has been awarded a $428 million contract to produce 155 million doses of smallpox vaccine by the end of 2002. Production of the vaccine under the new contract could begin as soon as this month and, once completed, will bring the total number of vaccine doses in the nation's stockpile to 286 million by the end of next year, enough to protect every United States citizen, if needed. In light of increasing concerns regarding the possible use of biological agents such as smallpox in acts of terrorism or war, HHS is undertaking efforts to stockpile as much vaccine as needed to protect the nation in the event of an outbreak of smallpox.

CDC Surveillance and Prevention Efforts

As our nation's premier prevention agency, CDC's top priority is to protect the Nation's health. To do this, CDC focuses on building a solid public health infrastructure - at CDC, as well as at the state and local level to protect the health of all citizens. CDC has used funds provided by Congress to begin the process of improving the expertise, facilities and procedures of state and local health departments and within CDC itself related to bioterrorism. CDC has a dedicated anti-bioterrorism staff of more than 100 full-time professionals comprising expertise in epidemiology, surveillance, secure communications, and laboratory diagnostics.

Over the last three years, CDC has awarded more than $130 million in cooperative agreements to 50 states, one territory and four major metropolitan health departments to support,

(1) Preparedness planning and readiness assessment;

(2) Epidemiology and surveillance

(3) Laboratory capacity for biological or chemical agents; and

(4) The Health Alert Network (a nationwide electronic communications system).

Since September 11, almost 500 CDC staff have been sent to the field. For example, at the height of the anthrax response in the Nation's Capital, there were 85 staff in Washington, DC alone. These experts included epidemiologists, industrial hygienists involved in environmental sampling and clean up, laboratorians, communications specialists to assist with media relations, and logistics and management staff. CDC not only investigated cases that proved to be anthrax in four states and the District of Columbia, but also investigated suspicious cases in six other states. These cases proved not to be anthrax, but required CDC assistance to go through the process of ruling them out. CDC experts were needed to augment the staff of state and local health departments, who would have been severely overtaxed without our help. The Administration has requested $20 million to support additional expert epidemiology teams that can be sent to states and cities to help them respond quickly to infectious disease outbreaks and other public health risks. And let me reiterate Secretary Thompson's conviction that every state should have at least one federally funded epidemiologist who has been trained in the CDC's Epidemic Intelligence Service (EIS) training program. The President's budget will accomplish this goal.

CDC and ATSDR Remediation Support Activities

Since the intentional release of anthrax spores, one of the areas on which CDC and HHS's Agency for Toxic Substances and Disease Registry (ATSDR) have focused is the identification and cleanup of contaminated facilities. We have refined methods for environmental sampling to assess whether anthrax contamination had occurred. In buildings, that has meant sampling of air and surfaces. CDC and ATSDR have issued recommendations on how to conduct environmental sampling and how laboratories should analyze those samples. We also recommended environmental sampling strategies to characterize the extent of exposure and to guide cleanup. We issued recommendations to protect first responders, investigators, and cleanup personnel. As buildings were identified as contaminated, we provided technical input to EPA and others tasked with cleanup to determine where remediation was necessary. These recommendations have been widely disseminated to federal, state and local health and environmental agencies, and are available at CDC's bioterrorism website (www.bt.cdc.gov).

EPA has devised strategies for remediation and has gained much experience through its activities to date. Disease experts at CDC are developing strategies to prevent the spread of disease during and after bioterrorist attacks. Although there are some data on chemical disinfectants in the scientific literature, there are no historical data that indicate the best way to eliminate spores from an office building, or to disinfect a sorting machine. The ability of a disinfectant to kill an anthrax spore is dependent upon time of contact and concentration and is mitigated by the amount and composition of material through which it must penetrate to get to the spore. For many of the clean-up methods being used to kill anthrax spores, we will not know their effectiveness until we go through the process. EPA understands this and has sought help from a variety of sources, including CDC and ATSDR, to ensure that the appropriate indicators are used and that post-sampling strategies are adequate.

With regard to the effectiveness of cleaning, even our most exhaustive sampling strategies will not identify every spore. It is unlikely that any cleaning strategy will kill every spore. However, the EPA should be able to clean and re-test to the point where we all are comfortable that spores have been killed or removed from surfaces where human contact is likely to occur. A range of sampling methods and strategies should be used to ensure the safety of building occupants.

In heavily contaminated areas, such as Senator Daschle's suite and the Brentwood postal facility, fumigation is being proposed as the method of clean-up. The use of fumigants is a potential hazard for clean-up workers, those in areas adjacent to the buildings, and those that must re-occupy the building. A fumigant that is effective at killing spores is, of necessity, a highly toxic agent. The protection of workers during the fumigation process is a matter of good industrial hygiene. EPA, CDC and ATSDR are working together to ensure remediation workers are protected during the fumigation processes. EPA works with local public health agencies to ensure that people in the area but outside of the building being fumigated are notified and kept at a safe distance.

With regard to the safety of those who will re-occupy the building, it is important to determine both that the area is clear of the fumigant and that there is no health risk. Again, CDC, ATSDR, and the Occupational Safety and Health Administration (OSHA) have developed exposure limits for fumigants, and detection methods are available to determine when any residual fumigant is well below established limits. After buildings are cleaned and post-cleaning environmental sampling has been conducted, CDC and ATSDR are committed to providing technical input to the incident command and other experts to determine whether the building is ready for re-occupancy.

HHS ROLE IN VACCINE AND DRUG RESEARCH AND DEVELOPMENT

With the support of Congress, the President has implemented a government-wide emergency response package to help deal with the tragic events of September 11^th and subsequent anthrax attacks. This complements efforts already underway to prepare our nation against such heinous attacks, including threats of bioterrorism. For example, CDC, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), all within HHS, are collaborating with the DOD and other agencies to support and encourage research to address scientific issues related to bioterrorism. The capability to detect and counter bioterrorism depends to a substantial degree on the state of relevant medical science. In some cases, new vaccines, antitoxins, or innovative drug treatments need to be developed, manufactured (or produced), and/or stocked. Moreover, we need to learn more about the pathogenesis and epidemiology of the infectious diseases that do not affect the U.S. population currently. We have only limited knowledge about how artificial methods of dispersion may affect the infection rate, virulence, or impact of these biological agents. HHS's continuing, collaborative, research agenda at CDC, FDA, NIH, and with DOD, is critical to overall preparedness.

Let me briefly outline the vital role that HHS agencies, particularly the FDA and NIH, play in our Nation's research and development agenda for vaccines and other drugs.

Food and Drug Administration

Even before the events of September 11, HHS's Food and Drug Administration actively cooperated with DOD in the operation of DOD's vaccine development program and the maintenance of their stockpile program. Any vaccine or drug development, whether by a government agency or private industry, must be in accordance with FDA requirements that ensure the safety, effectiveness and manufacturing quality of the finished product. FDA provides regulatory guidance to DOD, CDC, and others regarding the studies required to develop new vaccines and drugs, as well as assistance during all phases of development. FDA also works with DOD's office that screens new and unusual ideas for development of products to treat diseases and develop diagnostic tools.

The scope of FDA's regulatory responsibility extends to both approved (licensed) products and investigational products (unlicensed products). FDA's Center for Biologics Evaluation Research (CBER) is responsible for evaluating the safety, purity, and potency of biological products such as vaccines, antitoxins and blood products. FDA's Center for Drug Evaluation and Research (CDER) is responsible for a similar regulatory process for drugs. Bio-warfare defense vaccines and drugs undergo the same FDA review process as any other vaccines or drugs.

FDA will work with potential sponsors of experimental therapies, at all stages of the product development process in order to stimulate scientific interchange and clarify FDA regulatory requirements. A sponsor of a vaccine or drug under review must also provide adequate product labeling to allow health care providers to understand the product's proper use, including its potential benefits and risks, to communicate with patients, and to safely deliver the product to the public.

When all of the clinical, chemistry, pre-approval inspection, manufacturing, labeling and other issues have been adequately resolved, FDA will approve the application. Licensing or approving a new vaccine or drug is only one stage of FDA's oversight of medical product safety. Following issuance of the license, there is continued post-marketing surveillance of the product by monitoring adverse events through the Adverse Event Reporting System. Subsequent to the issuance to the license, FDA also monitors the manufacturer's production activities through FDA inspections to determine the manufacturer's compliance with good manufacturing practices (GMP) regulations. Because of the complex manufacturing processes for most biological products, manufacturers may be required to submit samples of each licensed vaccine lot, along with manufacturing testing results, to FDA for review and permission to release the lot for distribution.

National Institutes of Health

The NIH bioterrorism research program, spearheaded by the National Institute of Allergy and Infectious Diseases (NIAID), includes both short- and long-term research targeted at the design, development, evaluation and approval of diagnostics, therapies and vaccines needed to control infections caused by microbes with potential for use as biological weapons. NIAID efforts have primarily focused on the bioterrorist threats posed by anthrax and smallpox, and many of these efforts are carried out in collaboration with other Federal agencies.

NIAID formed a Working Group on Anthrax Vaccines (WGAV) in 1998 to develop and test a new vaccine that could be used in response to a bioterrorist event. Such a vaccine must be capable of generating protective immunity against inhalation spores within a relatively short period of time after 1-2 immunizing doses. Through an Inter-Agency Agreement, NIAID is collaborating with the Department of Defense's U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) on a research plan to develop a new vaccine based on the use of recombinant protective antigen vaccine (rPA) to protect all ages of the American public, including military personnel. In preparation for Phase 1 clinical trials of rPA vaccines, NIH is working with CDC, FDA and DoD to refine standard serological tests to assess the effectiveness of anthrax vaccines. These tests would enable comparison of new rPA vaccines to the currently licensed anthrax (or AVA) vaccine. If the new vaccine is capable of generating a rapid immune response, it may provide a quick transition to protective immunity to those individuals undergoing treatment with antibiotics due to an anthrax exposure.

NIAID also has expanded the national research capacity substantially over the past few years on those bioterrorist threat agents of greatest concern. First, NIAID has solicited from the scientific community research proposals on anthrax and other bacterial pathogens, in an effort to further encourage research that may lead to better means of diagnosis, prevention, and treatment.

Second, NIAID recently awarded administrative supplements to several active research grants to further studies on how anthrax causes disease, which could expedite the development and implementation of novel, more effective therapeutic intervention strategies. NIAID also anticipates funding several new research proposals on the molecular mechanisms involved in the germination of anthrax spores in vivo; such work may provide the basis for a novel and very promising post-attack strategy, one that would be more acceptable than the widespread use of antimicrobial drugs which are not specific for anthrax and, when given to large groups of exposed individuals, may promote the development of antibiotic resistant strains of other bacteria.

Through an Inter-Agency Agreement with the Office of Naval Research, NIAID has provided funding to help complete work on sequencing the DNA of the chromosome of anthrax; additional funds were also provided by the Department of Energy for this purpose. The information derived from this genome-sequencing project should be of great value in developing rapid diagnostic tests, as well as new vaccines and antibiotics therapies against mutant strains of anthrax.

NIAID research on smallpox focuses on extending existing vaccine stocks to increase the number of available doses, developing new vaccines and treatments, as well as diagnostic tools to detect the disease quickly. Although a worldwide immunization program eradicated smallpox disease decades ago, small quantities of smallpox virus still exists under guarded conditions at CDC and in Russia, but several rogue nations may have samples. NIAID, in collaboration with DOD, CDC, and the Department of Energy, funds increased research to:

Develop and evaluate at least three antiviral drugs with preclinical activity against smallpox and vaccinia viruses and acceptable clinical safety;
Extend the usefulness of the currently available, older vaccine by doing human studies to see if we can "stretch" available stocks by diluting it;
Help develop a safe, sterile smallpox vaccine grown in cell cultures using modern technology;
Explore development of a vaccine that can be used in all segments of the civilian population (i.e., the immune-suppressed, pregnant mothers, etc.); and
Increase our knowledge of the genome of smallpox and related viruses.

NIAID recently launched a Phase 2 clinical trial to further evaluate the effectiveness of different strengths of vaccine in order to possibly expand the use of the limited smallpox vaccine supply; CDC and FDA have cooperated to ensure that the NIH study is carried out as expeditiously as possible.

In addition, NIAID and DOD's Defense Advanced Research Projects Agency (DARPA) have funded a collaborative effort involving those two agencies along with four academic centers, the CDC, USAMRIID, and the American Type Culture Collection that will focus on designing and implementing an "Orthopoxvirus Genomics and Bioinformatics Resource Center." This Center will conduct sequence and functional comparisons of genes to provide insights for the selection of targets for the design of antivirals and vaccines. The Center will design and maintain relational databases to store, display, annotate and query genome sequences, structural information, phenotypic data and bibliographic information. Part of the effort will include development and maintenance of a "Poxvirus Bioinformatics Resource Center" website to facilitate the availability of this data for other researchers.

Conclusion

Mr. Chairman, let me again emphasize that the Administration is taking aggressive steps to make sure that our country is well protected from bioterrorism. Moreover, the government - at all levels - is responding to bioterrorist threats, and responding well.

Contemplating bioterrorism is unpleasant, but it is imperative. Under the leadership of President Bush, Secretary Thompson, and Homeland Security Director Ridge, we are taking all the steps necessary to keep America safe in an era when biological and chemical attacks are as possible as they are unthinkable.

Thank you, Mr. Chairman, for letting me speak about this matter of critical importance. I will be happy to answer any questions which you or members of the Committee may have.

APPENDIX

CRITICAL BIOLOGICAL AGENTS

The U.S. Public Health system and primary healthcare providers must be prepared to address varied biological agents, including pathogens that are rarely seen in the United States. The critical agents are listed below in priority order:

Category A

High priority agents include organisms that pose a risk to national security because they can be easily disseminated or transmitted person-to-person; cause high mortality, with potential for major public health impact; might cause public panic and social disruption; and require special action for public health preparedness.Category A Agents:

variola major (smallpox)
Bacillus anthracis (anthrax)
Yersinia pestis (plague);
Clostridium botulinum toxin (botulism)
Francisella tularensis (tulararemia);
filoviruses,

Ebola hemorrhagic fever; and
Marburg hemorrhagic fever; and

arenaviruses,

Lassa (Lassa fever)
Junin (Argentine hemorrhagic fever) and related viruses

Category B

Second highest priority agents include those that are moderate easy to disseminate; cause moderate morbidity and low mortality; and require specific enhancements of CDC's diagnostic capacity and enhanced disease surveillance.

Category B Agents

Coxiella burnetti (Q fever)
Brucella species (brucellosis);
Burkholderia mallei (glanders)
alphaviruses,

Venezuelan encephalomyelitis,
eastern and western equine encephalomyelitis;

ricin toxin from Ricinus communis (castor beans);
epsilon toxin of Clostridium perfringens; and
Staphylococcus enterotoxin B

A subset of List B agents includes pathogens that are food or waterborne. These pathogens include but are not limited to:

Salmonella species,
Shigella dysenteriae,
Escherichia coli O157:H7
Vibrio cholerae, and
Cryptosporidium parvum.

Category C

Third highest priority agents include emerging pathogens that could be engineered for mass dissemination in the future because of availability; ease of production and dissemination; and potential for high morbidity and mortality and major health impact.

Category C Agents

Nipah virus,
hantaviruses,
tickborne hemorrhagic fever viruses
tickborne encephalitis viruses,
yellow fever, and
multidrug-resistant tuberculosis.