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JAMES M. HUGHES, M.D.
NATIONAL CENTER FOR INFECTIOUS DISEASES
CENTERS FOR DISEASE CONTROL AND PREVENTION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS,
AND INTERNATIONAL RELATIONS
COMMITTEE ON GOVERNMENT REFORM
U.S. HOUSE OF REPRESENTATIVES
July 23, 2001
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am Dr. James M. Hughes,
Director, National Center for Infectious Diseases (NCID), Centers for Disease Control and
Prevention (CDC). I am accompanied by Dr. James W. LeDuc, Acting Director of NCID's
Division of Viral and Rickettsial Diseases. Thank you for the invitation to update you on CDC's
public health response to the threat of bioterrorism. I will discuss the overall goals of our
bioterrorism preparedness program, and I will briefly address specific activities aimed at
preparedness for a deliberate release of variola virus, the pathogen responsible for smallpox.
Vulnerability of the Civilian Population
In the past, an attack with a biological agent was considered very unlikely; however, now it
seems entirely possible. Many experts believe that it is no longer a matter of "if" but "when"
such an attack will occur. Unlike an explosion or a tornado, in a biological event, it is unlikely
that a single localized place or cluster of people will be identified for traditional first responder
activity. The initial responders to such a biological attack will include emergency department
and hospital staff, members of the outpatient medical community, and a wide range of response
personnel in the public health system, in conjunction with county and city health officers.
Increased vigilance and preparedness for unexplained illnesses and injuries are an essential part
of the public health effort to protect the American people against bioterrorism.
Public Health Leadership
The Department of Health and Human Services (DHHS) anti-bioterrorism efforts are focused on
improving the nation's public health surveillance network to quickly detect and identify the
biological agent that has been released; strengthening the capacities for medical response,
especially at the local level; expanding the stockpile of pharmaceuticals for use if needed;
expanding research on disease agents that might be released, rapid methods for identifying
biological agents, and improved treatments and vaccines; and preventing bioterrorism by
regulation of the shipment of hazardous biological agents or toxins. On July 10, 2001, Secretary
Thompson named CDC's Dr. Scott Lillibridge as his special advisor to lead the Department's
coordinated bioterrorism initiative.
As the Nation's disease prevention and control agency, it is CDC's responsibility on behalf of
DHHS to provide national leadership in the public health and medical communities in a
concerted effort to detect, diagnose, respond to, and prevent illnesses, including those that occur
as a result of a deliberate release of biological agents. This task is an integral part of CDC's
overall mission to monitor and protect the health of the U.S. population.
In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the 21st Century,
which describes CDC's plan for combating today's emerging diseases and preventing those of
tomorrow. It focuses on four goals, each of which has direct relevance to preparedness for
bioterrorism: disease surveillance and outbreak response; applied research to develop diagnostic
tests, drugs, vaccines, and surveillance tools; infrastructure and training; and disease prevention
and control. This plan emphasizes the need to be prepared for the unexpected - whether it is a
naturally occurring influenza pandemic or the deliberate release of smallpox by a terrorist. It is
within the context of these overall goals that CDC has begun to address preparing our Nation's
public health infrastructure to respond to acts of biological terrorism. Copies of this CDC plan
have been provided previously to the Subcommittee. In addition, CDC presented in March a
report to the Senate entitled "Public Health's Infrastructure: A Status Report." Recommendations
in this report complement the strategies outlined for emerging infectious diseases and
preparedness and response to bioterrorism. These recommendations include training of the
public health workforce, strengthening of data and communications systems, and improving the
public health systems at the state and local level.
CDC's Strategic Plan for Bioterrorism
On April 21, 2000, CDC issued a Morbidity and Mortality Weekly Report (MMWR), Biological
and Chemical Terrorism: Strategic Plan for Preparedness and Response - Recommendations of
the CDC Strategic Planning Workgroup, which outlines steps for strengthening public health and
healthcare capacity to protect the nation against these threats. This report reinforces the work
CDC has been contributing to this effort since 1998 and lays a framework from which to enhance
public health infrastructure. In keeping with the message of this report, five key focus areas have
been identified which provide the foundation for local, state, and federal planning efforts:
Preparedness and Prevention, Detection and Surveillance, Diagnosis and Characterization of
Biological and Chemical Agents, Response, and Communication. These areas capture the goals
of CDC's Bioterrorism Preparedness and Response Program for general bioterrorism
preparedness, as well as the more specific goals targeted towards preparing for the potential
intentional reintroduction of smallpox. As was highlighted in the recent Dark Winter exercise,
smallpox virus is of particular concern.
- Preparedness and Prevention
CDC is working to ensure that all levels of the public health community - federal, state, and
local - are prepared to work in coordination with the medical and emergency response
communities to address the public health consequences of biological and chemical terrorism.
CDC is creating diagnostic and epidemiological performance standards for state and local health
departments and will help states conduct drills and exercises to assess local readiness for
bioterrorism. In addition, CDC, the National Institutes of Health (NIH), the Department of
Defense (DOD), and other agencies are supporting and encouraging research to address scientific
issues related to bioterrorism. In some cases, new vaccines, antitoxins, or innovative drug
treatments need to be developed or stocked. Moreover, we need to learn more about the
pathogenesis and epidemiology of the infectious diseases which 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.
In 1999, the Institute of Medicine released its Assessment of Future Scientific Needs for Live
Variola Virus, which formed the basis for a phased research agenda to address several scientific
issues related to smallpox. This research agenda is a collaboration between CDC, NIH, and
DOD and is being undertaken in the high-containment laboratory at CDC with the concurrence
of WHO. The research addresses: 1) the use of modern serologic and molecular diagnostic
techniques to improve diagnostic capabilities for smallpox, 2) the evaluation of antiviral
compounds for activity against the smallpox virus, and 3) further study of the pathogenesis of
smallpox by the development of an animal model that mimics human smallpox infection. To
date, genetic material from 45 different strains of smallpox virus has been extracted and is being
evaluated to determine the genetic diversity of different strains of the virus. The NIH, with CDC
and DOD collaborators, has funded a Poxvirus Bioinformatics Resource Center
(www.poxvirus.org) to facilitate the analysis of sequence data to aid the development of rapid
and specific diagnostic assays, antiviral medicines and vaccines. A dedicated sequencing and
bio-informatics laboratory also is being developed at CDC to help further these efforts. This
laboratory will also be used to help characterize other potential bioterrorism pathogens. In
addition, a team of collaborating scientists has screened over 270 antiviral compounds for
activity against smallpox virus and other related poxviruses and have found several compounds
which merit further evaluation in animal models. These compounds were evaluated initially in
cell cultures, and 27 promising candidates are being further evaluated for efficacy. The
identification of one currently licensed compound with in vitro and in vivo efficacy against the
smallpox virus has led to the development of an Investigational New Drug (IND) application by
NIH and CDC to the FDA for use of this drug, cidofovir, in an emergency situation for treating
persons who are diagnosed with smallpox. Researchers also have been funded by NIH to design
new anti-smallpox medicines and to create human monoclonal antibodies to replace the limited
supply of vaccinia immune globulin that is needed to treat vaccine complications that arise
during immunization campaigns.
The Advisory Committee for Immunization Practices (ACIP) worked with CDC to develop
updated guidelines for the use of smallpox vaccine. These guidelines were published in the
MMWR in June 2001 and serve to educate the medical and public health community regarding
the recommended routine and emergency uses and medical aspects of the vaccine as well as, the
medical aspects of smallpox itself. Several infection control and worker safety issues were also
addressed by the ACIP within the updated guidelines.
While we are pursuing the development of additional smallpox vaccine to improve our readiness
to respond to a smallpox outbreak, we are also working to ensure that the stores of vaccine that
we have in the United States currently are ready for use, including protocols for emergency
release and transportation of the vaccine.
- Detection and Surveillance
Because the initial detection of a biological terrorist attack will most likely occur at the local
level, it is essential to educate and train members of the medical community - both public and
private - who may be the first to examine and treat the victims. It is also necessary to upgrade
the surveillance systems of state and local health departments, as well as within healthcare
facilities such as hospitals, which will be relied upon to spot unusual patterns of disease
occurrence and to identify any additional cases of illness. CDC will provide terrorism-related
training to epidemiologists and laboratorians, emergency responders, emergency department
personnel and other front-line health-care providers, and health and safety personnel. CDC is
working to provide educational materials regarding potential bioterrorism agents to the medical
and public health communities on its bioterrorism website at www.bt.cdc.gov. For example, we
are preparing a video on smallpox vaccination techniques for public health personnel and
healthcare providers who may administer vaccine in an emergency situation. CDC is planning to
work with partners such as the Johns Hopkins Center for Civilian Biodefense Studies and the
Infectious Diseases Society of America to develop training and educational materials for
incorporation into medical and public health graduate and post-graduate curricula. With public
health partners, CDC is spearheading the development of the National Electronic Disease
Surveillance System, which will facilitate automated, timely electronic capture of data from the
healthcare system. CDC has also worked with organizations such as the Council of State and
Territorial Epidemiologists to ensure that suspected cases of smallpox are immediately reportable
in their jurisdictions and that clear lines of communication are in place.
- Diagnosis and Characterization of Biological and Chemical Agents
To ensure that prevention and treatment measures can be implemented quickly in the event of a
biological or chemical terrorist attack, rapid diagnosis will be critical. CDC is developing
guidelines and quality assurance standards for the safe and secure collection, storage, transport,
and processing of biologic and environmental samples. In collaboration with other federal and
non-federal partners, CDC is co-sponsoring a series of training exercises for state public health
laboratory personnel on requirements for the safe use, containment, and transport of dangerous
biological agents and toxins. CDC is also enhancing its efforts to foster the safe design and
operation of Biosafety Level 3 laboratories, which are required for handling many highly
dangerous pathogens. In addition, CDC is helping to limit access to potential terrorist agents by
continuing to administer the Select Agent Rule, Additional Requirements for Facilities
Transferring or Receiving Select Agents (42 CFR Section 72.6), which regulates shipments of
certain hazardous biological organisms and toxins. Furthermore, CDC is developing a Rapid
Toxic Screen to detect people's exposure to 150 chemical agents using blood or urine samples.
A decisive and timely response to a biological terrorist event involves a fully documented and
well rehearsed plan of detection, epidemiologic investigation, and medical treatment for affected
persons, and the initiation of disease prevention measures to minimize illness, injury and death.
CDC is addressing this by (1) assisting state and local health agencies in developing their plans
for investigating and responding to unusual events and unexplained illnesses and (2) bolstering
CDC's capacities within the overall federal bioterrorism response effort. CDC is working to
formalize current draft plans for the notification and mobilization of personnel and laboratory
resources in response to a bioterrorism emergency, as well as overall strategies for vaccination,
and development and implementation of other potential outbreak control measures such as
quarantine measures. In addition, CDC is working to develop national standards to ensure that
respirators used by first responders to terrorist acts provide adequate protection against weapons
In the event of an intentional release of a biological agent, rapid and secure communications will
be especially crucial to ensure a prompt and coordinated response. Thus, strengthening
communication among clinicians, emergency rooms, infection control practitioners, hospitals,
pharmaceutical companies, and public health personnel is of paramount importance. To this end,
CDC is making a significant investment in building the nation's public health communications
infrastructure through the Health Alert Network, a nationwide program designed to ensure
communications capacity at all local and state health departments (full Internet connectivity and
training), ensure capacity to receive distance learning offerings from CDC and others, and ensure
capacity to broadcast and receive health alerts at every level. CDC has also established the
Epidemic Information Exchange (EPI-X), a secure, Web-based communications system to
enhance bioterrorism preparedness efforts by facilitating the sharing of preliminary information
about disease outbreaks and other health events among public health officials across jurisdictions
and provide experience in the use of secure communications.
An act of terrorism is likely to cause widespread panic, and on-going communication of accurate
and up-to-date information will help calm public fears and limit collateral effects of the attack.
To assure the most effective response to an attack, CDC is working closely with other federal
agencies, including the Food and Drug Administration, NIH, DOD, Department of Justice (DOJ),
and the Federal Emergency Management Agency (FEMA).
The National Pharmaceutical Stockpile
As CDC recently reported to this Subcommittee, another integral component of public health
preparedness at CDC has been the development of a National Pharmaceutical Stockpile (NPS),
which can be mobilized in response to an episode caused by a biological or chemical agent. The
role of the CDC's NPS program is to maintain a national repository of life-saving
pharmaceuticals and medical material that can be delivered to the site or sites of a biological or
chemical terrorism event in order to reduce morbidity and mortality in a civilian population. The
NPS is a backup and means of support to state and local first responders, healthcare providers,
and public health officials. The NPS program consists of a two-tier response: (1) 12-hour push
packages, which are pre-assembled arrays of pharmaceuticals and medical supplies that can be
delivered to the scene of a terrorism event within 12 hours of the federal decision to deploy the
assets and that will make possible the treatment or prophylaxis of disease caused by a variety of
threat agents; and (2) a Vendor-Managed Inventory (VMI) that can be tailored to a specific threat
agent. Components of the VMI will arrive at the scene 24 to 36 hours after activation. CDC has
developed this program in collaboration with federal and private sector partners and with input
from the states.
Challenges Highlighted in Dark Winter Exercise
CDC has been addressing issues of detection, epidemiologic investigation, diagnostics, and
enhanced infrastructure and communications as part of its overall bioterrorism preparedness
strategies. The issues that emerged from the recent Dark Winter exercise reflected similar
themes that need to be addressed.
The importance of rapid diagnosis- Rapid and accurate diagnosis of biological agents
will require strong linkages between clinical and public health laboratories. In addition,
diagnostic specimens will need to be delivered promptly to CDC, where laboratorians
will provide diagnostic confirmatory and reference support.
The importance of working through the governors' offices as part of our planning and
response efforts- During the exercise this was demonstrated by Governor Keating.
During state-wide emergencies the federal government will need to work with a partner in
the state who can galvanize the multiple response communities and government sectors
that will be needed, such as the National Guard, the state health department, and the state
law enforcement communities. These in turn will need to coordinate with their local
counterparts. CDC is refining its planning efforts through grants, policy forums such as
the National Governors Association and the National Emergency Management
Association, and training activities. CDC also participates with partners such as DOJ and
FEMA in planning and implementing national drills such as the recent TOPOFF exercise.
Better targeting of limited smallpox vaccine stocks to ensure strategic use of vaccine in
persons at highest risk of infection- It was clear that pre-existing guidance regarding
strategic use would have been beneficial and would have accelerated the response at Dark
Winter. As I mentioned earlier, CDC is working on this issue and is developing guidance
for vaccination programs and planning activities.
Federal control of the smallpox vaccine at the inception of a national crisis- Currently,
the smallpox vaccine is held by the manufacturer. CDC has worked with the U.S.
Marshals Service to conduct an initial security assessment related to a future emergency
deployment of vaccine to states. CDC is currently addressing the results of this
assessment, along with other issues related to security, movement, and initial distribution
of smallpox vaccine.
The importance of early technical information on the progress of such an epidemic for
consideration by decision makers- In Dark Winter, this required the implementation of
various steps at the local, state, and federal levels to control the spread of disease. This is
a complex endeavor and may involve measures ranging from directly observed therapy to
quarantine, along with consideration as to who would enforce such measures. Because
wide-scale federal quarantine measures have not been implemented in the United States
in over 50 years, operational protocols to implement a quarantine of significant scope are
needed. CDC hosted a forum on state emergency public health legal authorities to
encourage state and local public health officers and their attorneys to examine what legal
authorities would be needed in a bioterrorism event. In addition, CDC is reviewing
foreign and interstate quarantine regulations to update them in light of modern infectious
disease and bioterrorism concerns. CDC will continue this preparation to ensure that
such measures will be implemented early in the response to an event.
Maintaining effective communications with the media and press during such an
emergency- The need for accurate and timely information during a crisis is paramount to
maintaining the trust of the community. Those responsible for leadership in such
emergencies will need to enhance their capabilities to deal with the media and get their
message to the public. It was clear from Dark Winter that large-scale epidemics will
generate intense media interest and information needs. CDC has refined its media plan
and expanded its communications staff. These personnel will continue to be intimately
involved in our planning and response efforts to epidemics.
Expanded local clinical services for victims- DHHS's Office of Emergency Preparedness
is working with the other members of the National Disaster Medical System to expand
and refine the delivery of medical services for epidemic stricken populations.
CDC will continue to work with partners to address challenges in public health preparedness,
such as those raised at Dark Winter. For example, work done by CDC staff to model the effects
of control measures such as quarantine and vaccination in a smallpox outbreak have highlighted
the importance of both public health measures in controlling such an outbreak. The importance
of both quarantine and vaccination as outbreak control measures is also supported by historical
experience with smallpox epidemics during the eradication era. These issues, as well as overall
preparedness planning at the federal level, are currently being addressed and require additional
action to ensure that the nation is fully prepared to respond to all acts of biological terrorism,
including those involving smallpox.
In conclusion, CDC has made substantial progress to date in enhancing the nation's capability to
prepare for and, if need be, respond to a bioterrorist event. The best public health strategy to
protect the health of civilians against biological terrorism is the development, organization, and
enhancement of public health prevention systems and tools. Priorities include strengthened
public health laboratory capacity, increased surveillance and outbreak investigation capacity, and
health communications, education, and training at the federal, state, and local levels. Not only
will this approach ensure that we are prepared for deliberate bioterrorist threats, but it will also
ensure that we will be able to recognize and control naturally occurring new or re-emerging
infectious diseases. A strong and flexible public health infrastructure is the best defense against
any disease outbreak.
Thank you very much for your attention. I will be happy to answer any questions you may have.
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Last revised: July 24, 2001