Jeffrey Koplan
Jeffrey Koplan, CDC's strategic plan for bioterrorism
preparedness and response, 116(2) Public Health Reports S9(8)
(March-April, 2001)
The Department of Health and Human Services (DHHS) has played a critical
lead role over the past two years in fostering activities associated
with the medical and public health response to bioterrorism. Based on a
charge from Secretary Donna Shalala in 1998, the Centers for Disease
Control and Prevention (CDC) is leading public health efforts to
strengthen the nation's capacity to detect and respond to a bioterrorist
event.
As a result of our efforts, federal, state, and local communities are
improving their public health capacities to respond to these types of
emergencies. For many of us in public health, developing plans and
capacities to respond to acts of bioterrorism is an extension of our
long-standing roles and responsibilities. These are stated in the CDC
Mission Statement: to promote health and quality of life by preventing
and controlling disease, injury, and disability, and the Bioterrorism
Mission: to lead the public health effort in enhancing readiness to
detect and respond to bioterrorism.
CDC's infectious diseases control efforts are summarized below: *
Initially formed to address malaria control in 1946;
* Established the Epidemic Intelligence Service in 1951;
* Participated in global smallpox eradication and other immunization
programs;
* Estimated 800-1,000+ field investigations/year since late 1990s;
* New diseases: Legionnaire's
Disease, toxic shock syndrome, Lyme disease, HIV, hantavirus pulmonary
syndrome, West Nile, etc.
* Today: focus on emerging infections and bioterrorism.
Over the past 50 years, CDC has seen a decline in the incidence of
some infectious diseases and an increase in some, whereas others
continue to present on a more unpredictable basis (i.e., hantavirus).
Outbreak identification, investigation, and control have been an
integral part of what we do for more than 50 years. We estimate that 800
to 1,000 field investigations have occurred every. year since the late
1990s. Today, however, we have a new focus on emerging infectious
diseases and bioterrorism.
CDC PLANS TO ADDRESS THE CHALLENGE
So what are we doing at CDC to address this challenge? We have
developed a strategic plan, reflecting broad-based input, for
implementing complementary and coordinated improvements in bioterrorism-related
preparedness at the federal, state, and local levels. This strategy
reflects input received through consultations with many private and
public organizations, including the Association of State and Territorial
Health Officials, National Association of County and City Health
Officials, Association of Public Health Laboratories, Council of State
and Territorial Epidemiologists, American Society for Microbiology,
Association of Professionals in
Infection Control and Epidemiology (APIC), Infectious Diseases Society
of America (IDSA), Center for Civilian Biodefense Studies at Johns
Hopkins University, Society of Healthcare Epidemiologists of America (SHEA),
National Association of Public Health Veterinarians (NAPHV), National
Association of Medical Examiners (NAME), Association of State Veterinary
Laboratory Directors (ASVLD), American Hospital Association (AHA),
American College of Emergency Physicians (ACEP), American Public Health
Association (APHA), as well as a number of others.
The strategic plan for bioterrorism preparedness and response
includes: * Enhanced capacity for detection, diagnosis, and management
of disease outbreaks;
* Improved characterization and identification of causative
pathogens, toxins, or selected chemical exposures;
* Strengthened public health response capacities to control and
contain such emergencies;
* Information technology infrastructure to rapidly transfer data and
information needed to prepare for and respond to these events.
The priority is to ensure that we have the appropriate level of
preparedness and response capacities at the local and state levels of
the public and private health care system. Because this is where the
first signs of a bioterrorist event will be observed, it only makes
sense that this is where we place
our first lines of defense. However, preparing communities to address
the dangers of bioterrorism is a major challenge to public and private
health care systems. A critical step in meeting these challenges is to
reexamine the core public health infrastructure in the United States
(e.g., disease surveillance, training, health communications, and
laboratory capacity). Enhancing core public health infrastructure will
enable public health agencies and primary health care providers, who are
on the front lines of response, to detect and respond rapidly when an
incident occurs. Additionally, enhancing the core public health
infrastructure will provide the added benefit of strengthening the
overall capacity for identifying and controlling emerging infectious
diseases, injuries, and other emergencies as they occur.
Combined for Fiscal Years 1999 and 2000, more than $275 million has
been appropriated to CDC to help ensure efforts associated with
bioterrorism preparedness and response. Apart from the stockpile and
other congressional earmarks, more than half of these monies were
awarded extramurally to support state and local bioterrorism
preparedness and response efforts. With these funds, public health
agencies have begun to develop capacities and enhance the existing
public health infrastructure in ways not possible without the infusion
of the bioterrorism monies.
Specific activities include the development and implementation of information
systems used to monitor disease trends, detect outbreaks, and improve
public health decisions, such as the National Electronic Disease
Surveillance System (NEDSS) and the Health Alert Network, which is used
to alert public health officials about emerging disease outbreaks or
potential threats; improving hospital-based disease detection systems;
enhancing staff competencies to respond to terrorist acts; and improving
public health laboratory capacities to rapidly detect and diagnose
specific bioterrorism threat agents.
ASSESSING LOCAL CAPACITY
CDC is also working with the Department of Justice to implement an
assessment tool for local public health agencies. This effort will help
local agencies understand their current emergency response capabilities
and needs. Information already obtained from this assessment is helping
local health officials identify strengths and weaknesses of their
response capacities, an important first step in developing comprehensive
plans preparedness and response. We find this effort to be extremely
important and look forward to seeing the results.
ACHIEVEMENTS
Since the inception of the bioterrorism initiative, CDC has overcome
a number of challenges, resulting in some major improvements in our
ability to respond to bioterrorism. I acknowledge Dr. Scott Lillibridge
and his colleagues in CDC's
Bioterrorism and Preparedness Program for providing leadership and
spearheading these efforts.
Laboratory
Before the inception of the bioterrorism initiative, CDC had
limitations in its in-house ability to test for five of the six
pathogens listed on its Critical Biological Agent Category A List
(plague, tularemia, botulinum toxins, smallpox, and viral hemorrhagic
fevers). In addition, CDC now has the ability to test for anthrax. These
six critical agents represent diseases that can be easily transmitted
between individuals, cause high mortality with potential for major
public health impact, possibly cause public panic and social disruption,
and require special action for public health preparedness. Rapid
identification, triage strategies, new labs, and staff provide national
capacity to respond to such events. We continue to work with state and
local partners to ensure that we develop capacities to test for other
critical agents such as Q fever, glanders, brucellosis, alphaviruses,
epsilon toxin of Clostridium perfringens, staphylococcal enterotoxin B,
Nipah virus, tickborne hemorrhagic fever viruses, and tickborne
encephalitis viruses.
At the state and local public health laboratory levels, some level of
capacity now exists in 72 public health laboratories in 50 states to
test for plague, tularemia, and anthrax. Previously, this existed only
in a few western states, and no
state had the ability to test for anthrax. Now 22 states--up from
19--have the capability to test for botulinum toxins.
Having this level of laboratory capability at the state and local
level in 81 laboratories in 50 states clearly provides an unprecedented
level of surveillance capacity. We will continue to build on this effort
in the coming year.
CDC has also established a rapid response and advanced technology
laboratory for bioterrorism that triages and initially processes samples
from suspect cases, provides 24-hour diagnostic support to bioterrorism
response teams, maintains chain of custody, and assesses new rapid
diagnostic assays that could be transferred to the national public
health laboratory network. To date, more than 600 specimens have been
logged into the rapid response and advanced technology laboratory. Each
of these specimens tells a story of a public health mobilization at the
federal, state, and local levels. Activities associated with this level
of threat assessment involve public health and law enforcement partners
evaluating threats ranging from smallpox to the anthrax hoax.
Approximately two years ago, CDC recognized the need to ensure
appropriate laboratory testing capacities for critical biological agents
in state public health laboratories. In response to this need, CDC, in
collaboration with the Association for Public Health Laboratories, Department
of Justice/Federal Bureau of Investigation, and the Department of
Defense, developed the National Laboratory Response Network (NLRN). This
secure network provides standardized diagnostic protocols and reagents
needed by state public health labs to test for plague, tularemia,
anthrax, and botulinum toxins. The NLRN also offers assistance in
locating other laboratories that have the capability to test for
specific agents on the Critical Biological Agent List. This function
helps to share information and communicate best practices. Currently,
more than 100 individuals, mostly state public health laboratory staff,
are registered as members of the network. In 2001, CDC expects the
number of users to grow.
Besides the work being done to improve the capabilities of the public
health labs, CDC is also working with the American Society for
Microbiology (ASM) to ensure the capacity of the thousands of clinical
laboratories across the country is included in the bioterrorism
laboratory effort.
Specific laboratory protocols developed by ASM will be promoted by
CDC to ensure standard methodologies are used in the clinical lab
setting to rule out potential bioterrorism agents. With the clinical
labs making up such a large part of our front-line defenses against
bioterrorism, we continue to focus on this important work in the months
ahead.
In 1999, more than 700 individuals received clinical laboratory
training associated with the critical biological agents. During this
year, CDC staff provided
'train-the-trainer' training to 75% of the state public health
laboratory personnel who are members of the NLRN. This training focused
on specialized testing methods to determine presumptive and confirmatory
diagnoses of five critical biological agents associated with
bioterrorism. These efforts will continue into 2001 as we strive to
improve the competencies of laboratory personnel to rule out and
identify bioterrorism threat agents.
Surveillance and Epidemiology
Critical to CDC's bioterrorism preparedness effort is early detection
of an event coupled with effective and timely response. Because the
initial response to a biological or chemical event is likely to be made
at the local level, epidemiologists at state and local health agencies
need to acquire, develop, and maintain the resources and expertise
necessary for responding to reports of rare, unusual, or unexplained
illnesses.
All 50 states, the District of Columbia, Guam, New York City,
Chicago, and Los Angeles are supported by funds for activities to
support enhancing epidemiology and surveillance capacities. These funds
are being used to hire surveillance coordinators and epidemiologists,
support rapid reporting of bioterrorism-specific diseases and unusual
epidemiological events, identify and train rapid response teams, and
improve overall emergency notification procedures.
In keeping with lessons learned
from the West Nile virus outbreak in the Northeast, some states are also
developing reporting mechanisms with medical examiners, poison control
centers, hospitals, emergency medical system units, animal health care
providers, and other nontraditional partners to enable early detection.
Working with state and local partners, CDC has also developed
disease-specific information for health care providers, emergency
first-responders, and the public that will instruct them on what to do
during an actual bioterrorism event. Working with the US Army Medical
Research Institute of Infectious Diseases (USAMRIID), CDC has trained,
via satellite, more than 15,000 health care providers, including
emergency room physicians and infectious disease practitioners. In
addition, CDC is beginning work with IDSA, APIC, and SHEA to develop
training materials targeted at these medical specialties to help them to
detect, recognize, and respond to bioterrorism. These efforts as well as
many others demonstrate the value of bioterrorism preparedness and
response activities in improving public health response infrastructure.
The West Nile encephalitis outbreak typifies how an improved public
health infrastructure is vitally needed to deal with ongoing outbreaks
of naturally occurring infectious diseases as well as bioterrorism.
These response efforts can be greatly improved by upgrading laboratory
and surveillance capacities along with added surge capacity at CDC. Each
of the surveillance activities
mentioned supports the broad theme of preparedness, enhanced response,
and integration of surveillance activities.
Research and Development
CDC, along with the National Institutes of Health (NIH), continues to
make investments in research and development associated with vaccines
related to the diseases on our Critical Biological Agent list. To better
prepare the United States against the possible use of smallpox virus,
CDC has awarded a contract with Oravax, Inc. (Cambridge, MA) to produce
smallpox vaccine. Approximately 40 million doses of vaccine will be
produced initially, with anticipated delivery of the first full-scale
production lots in 2004. The contract allows for increased production of
the vaccine should the need arise.
To address overall vaccine issues associated with bioterrorism, a
working group of representatives from DHHS (Office of Emergency
Preparedness, CDC, NIH, Food and Drug Administration), Department of
Defense/Joint Vaccine Acquisition Program, USAMRIID, and US Department
of Agriculture was formed to evaluate vaccines currently available or in
development for the following biological threat agents: Variola major,
Bacillus anthracis, Yersinia pestis, Clostridium botulinum toxins,
Francisella tularensis, filoviruses and arenaviruses, Coxiella burnetii,
Brucella species, and alphaviruses. This is a work in progress and continues
to be a major priority for us as we assess the role of vaccines in
bioterrorism preparedness.
A number of academic institutions have also been funded to support
bioterrorism preparedness and response. These institutions (Johns
Hopkins University Center for Civilian Biodefense Studies,
Carnegie-Mellon Research Institute, St. Louis University School of
Public Health, University of Texas at Galveston, and UCLA School of
Public Health) are performing work associated with:
* Developing national medical and public health policies and
structures to protect civilian populations from bioterrorism
* Assessing the capability of computer-based surveillance systems to
detect naturally occurring disease outbreaks and acts of bioterrorism
* Establishing a center for research and education focused on
bioterrorism
* Conducting studies of viral hemorrhagic fevers as well as other
critical bioterrorism diseases considered to be the greatest threat to
the American people
Each of these research activities will offer insights into how best.
National Pharmaceutical Stockpile
Our strategy in addressing bioterrorist threats involves both preparedness
and response efforts. This being the case, we must not only build
effective disease surveillance and detection systems but also have a
response strategy that is clearly understood by both public health and
other emergency first-responders.
A key component of this response capacity is CDC's national
pharmaceutical stockpile (NPS). The NPS is organized into two
components.
The first includes eight identical 'push packages,' which CDC has
strategically placed at distribution centers throughout the United
States.
Each 12-hour push package, which is made up of 109 palletized air
cargo containers and takes two airplanes to deliver, is composed of
pharmaceuticals, intravenous and airway supplies, emergency medications,
bandages, and dressings. These items are necessary to enhance state and
local capacities to provide therapeutic treatment and prophylaxis of a
population affected by a biological or chemical terrorism incident.
In addition to the 12-hour push packages, CDC will use vendor-managed
inventory to provide specific quantities of antibiotics and other
medical materials to the requesting agency within 24 to 36 hours after
the federal decision to deploy. CDC, through a partnership with the
Department of Veterans Affairs, has contracted with vendors and
manufacturers to stock these additional pharmaceuticals and supplies.
State and local health agencies in collaboration with CDC are working
on strategies to address methods
of receiving and managing the medical materials that: would be deployed
from the national stockpile. This is important work because providing
the medicines to the individual in the most expeditious and effective
manner possible will improve our chances of rapidly controlling and
containing the consequences of a bioterrorist incident.
CDC Staff Support
For many years, CDC has provided assistance in the form of trained
epidemiologists and public health advisors to complement existing local
expertise to respond to naturally occurring infectious disease outbreaks
or to deal with chemical exposures. In the event of a bioterrorist
incident, CDC will, when requested, provide staff to support state and
local efforts.
However, the magnitude of the response and the fact that we may need
to deploy larger numbers of staff to varying locations around the
country require us to change our institutional model for response.
During the Top Off exercise (see below), we quickly realized that we
could exhaust our resources. The need to develop plans for training a
greater number of staff to respond to large disease outbreaks, similar
to the simulated plague outbreak in Denver, became readily apparent.
In conjunction with improving our internal response efforts, we are
also working with state and local public health agencies and other first-responders
to develop training programs focused on appropriate . We believe that
enhancing the response competencies of the key responders at the
federal, state, and local levels improves our overall chances of
combatting the consequences of a real bioterrorist event.
Information Technology
With new and ever-changing technologies, CDC is positioning itself to
ensure accurate and timely data collection and analysis, which will
improve overall public health decision-making capabilities.
CDC, working with the Defense Advanced Research Projects Agency, used
cutting-edge technology to conduct real-time syndrome surveillance at
the World Trade Organization meeting in Seattle in late 1999 as well as
the Republican and Democratic National Conventions in the summer of
2000. These experiences confirmed the importance of rapid and accurate
data-reporting systems.
Another example of CDC's use of information technology is in the
development of the NEDSS project, which will provide guidance and
funding to state and local health agencies to further the development of
sophisticated information systems for enhanced reporting of diseases and
allow greater use of disease data in detecting potential acts of
bioterrorism. To support this effort, $9.8 million was awarded to 49
state and local health agencies in
September 2000. These monies have been awarded to states to support
information technology assessment and planning activities needed to help
prepare them for future project growth and expansion. In addition, 12
states have been selected to focus on the development of specific
technologies (e.g., web browser data entry, HL7 messaging). These
projects are called element development sites. Finally, two states--New
York and Oregon--have been selected as charter sites. These two states
will be supporting the development of demonstration projects to provide
models and best practices in support of NEDSS standards and
specifications. Once these systems begin to develop, the nation will see
a significant improvement in how public health agencies collect and
analyze infectious disease data.
Based on concerns from state epidemiologists that a system for
rapidly sharing information pertaining to outbreaks of infectious
diseases nationally did not exist, CDC has developed the Epidemic
Information Exchange Program, or Epi-X. This system provides realtime
information about ongoing disease outbreak activities (both bioterrorism
and naturally occurring), provides a link to related outbreaks and other
health events, helps health officials respond to emerging public health
incidents, and ensures notification of health officials. Epi-X is in the
process of being rolled out, and we expect a significant increase in
users in 2001.
CDC will continue to promote,
develop, and support various technologies that will enhance and enable
disease detection strategies associated with bioterrorism preparedness
and response as we move into the future.
Top Off Exercise CDC, as well as our partners at the state and local
levels, continues to learn valuable lessons as we move further into the
emergency response arena. In May 2000, CDC staff participated in a
national exercise, Top Off.
Our involvement in the exercise was significantly focused on a
simulated pneumonic plague outbreak in the Denver metropolitan area, but
we were also involved in a simulated mustard gas release in Portsmouth,
New Hampshire, and a simulated radiological incident in the Washington,
DC, area. Staff from CDC were assigned to a number of response
components. I was in Washington, DC, to brief the secretary and consult
with Surgeon General David Satcher. A command post was set up in
Atlanta, headed by Dr. Jim Hughes, director of the National Center for
Infectious Diseases. An operational component was staffed by the
National Center for Environmental Health's Emergency Preparedness and
Response Branch as well as a number of on-site field staff deployed to
two of the three exercise venues.
The exercise in Denver taught us many valuable lessons on how to plan
for and respond to outbreaks of
infectious diseases of this magnitude.
Several challenges were presented during the Top Off exercise in
Denver to include difficulties in implementing and exercising federal,
state, and local quarantine authorities, complications in the
distribution of the national pharmaceutical stockpile from the state
receiving site to local points of distribution, the complexity of
providing support for expanded health care delivery, and long-term
outbreak control strategies.
To address these challenges, CDC developed and implemented an action
plan from June to October 2000 to strengthen CDC's internal response
capacities. As a result, CDC drafted a national bioterrorism training
plan focusing on the public health work force, addressed the critical
issues associated with distribution of the stockpile once deployed to a
state location, developed a better understanding of its role in response
to an outbreak of this magnitude, and developed capacities to use
geographical information systems that did not previously exist.
CDC continues to work on issues associated with federal, state, and
local quarantine authorities, finalizing and implementing training plans
and working with other DHHS components that address the clinical needs
in health care facilities.
CDC has also committed to develop a centrally located emergency
operations center to deal with public health emergencies and enhance communications
with key response components of the US government.
Exercises such as Top Off provide invaluable experiences for CDC that
help improve our capacity to respond to events from the federal
perspective and help us understand how best to support state and local
efforts.
SUMMARY Although much has been accomplished in the past 2 years,
there is still much to do to prepare the nation to effectively counter
acts of biological terrorism and acts of chemical terrorism. We need to
strengthen capabilities of CDC, state and local health departments, key
health care providers, academic institutions, federal partners, as well
as traditional first-responders. This can only be accomplished through
provision of adequate resources, development of mutually beneficial
partnerships, enhancement of effective public health systems, research,
training, and technical support. Plans for the future will continue to
support the development of needed public health capabilities at the
state and local levels and linkages with clinical and infection control
professionals and veterinary communities, enhance emergency response
coordination within DHHS, as well as address infrastructure improvements
at CDC.
Specifically, these plans include defining core capacities needed at
the federal, state, and local levels to prepare for, detect, and respond
to acts of bioterrorism; strengthening state and local surveillance;
eveloping new algorithms and statistical methods for searching medical
databases on a real-time basis for evidence of suspicious events
impacting public health; and establishing criteria for investigating and
evaluating suspicious clusters of human or animal disease or injury.
CDC will continue to foster linkages between public health and
emergency management agencies. To support this effort, CDC is working to
partner with the National Governors Association and the National
Emergency Management Association to recognize the unique role public
health of in emergency response.
To widen the global bioterrorism preparedness and response network,
CDC will continue to strengthen collaborations with our international
partners, such as the World Health Organization and various ministries
of health. The work we do now to detect and respond to bioterrorist acts
and the partnerships that we develop will improve our ability to
minimize the consequences of such an event as well as the nation's
public health infrastructure to combat many of the day-to-day public
health issues to ensure we are all safer--healthier--people.
