Testimony
Before the Committee
on Appropriations, Subcommittee on Labor, HHS, Education
and Related Agencies
United States Senate
Bioterrorism
Preparedness: CDC's Public Health Response to the Threat
of Smallpox
Statement of
James LeDuc, Ph.D.
Acting Director
Division of Viral and Rickettsial Diseases, National Center
for Infectious Diseases, Centers for Disease Control and
Prevention
Department of Health and Human Services
For Release
on Delivery
Expected at 9:00 am
on Friday, November 2, 2001
Good morning, Mr.
Chairman and Members of the Subcommittee. I am Dr. James
LeDuc, Acting Director, Division of Viral and Rickettsial
Diseases, National Center for Infectious Diseases (NCID),
Centers for Disease Control and Prevention (CDC). Thank
you for the invitation to update you on CDC's public health
response to the threat of smallpox. I will address specific
activities aimed at preparedness for a deliberate release
of variola virus, the pathogen responsible for smallpox.
As you are aware,
many facilities in communities around the country have
received anthrax threat letters. Most were received as
empty envelopes; some have contained powdery substances.
However, in some cases, actual anthrax exposures have
occurred. As of Wednesday, October 31, 10 cases of inhalational
anthrax and 10 cases of cutaneous anthrax have been identified
in Florida, New Jersey, New York, and Washington, DC.
This is the first bioterrorism-related anthrax attack
in the United States, and the public health ramifications
of this attack continue to evolve. In collaboration with
state and local health and law enforcement officials,
CDC and the FBI are continuing to conduct investigations
related to anthrax exposures. During this heightened surveillance,
cases of illness that may reasonably resemble symptoms
of anthrax will be thoroughly reviewed. The public health
and medical communities continue to be on a heightened
level of disease monitoring to ensure that any potential
exposure is recognized and that appropriate medical evaluations
are given. This is an example of the disease monitoring
system in action, and that system is working.
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 when needed; expanding research on disease agents
that might be released, rapid methods for identifying
biological agents, and improved treatments and vaccines;
and regulating the shipment of hazardous biological agents
or toxins.
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 was developed with input from state
and local health departments, disease experts, and partner
organizations such as the American Society for Microbiology,
the Association of Public Health Laboratories, the Council
of State and Territorial Epidemiologists, and the Infectious
Disease Society of America. It 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 is preparing our Nation's
public health infrastructure to respond to potential future
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.
- Preparedness and Prevention
CDC
is working to ensure that all levels of the public health
community - federal, state, and local - coordinate with
the medical and emergency response communities to deal
with 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, epidemiology,
and clinical features 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, DOD, and international
partners, 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 has
been developed at CDC to help further these efforts. This
laboratory will also be used to help characterize other
potential bioterrorism pathogens. A team of collaborating
scientists has screened over 700 compounds for antiviral
activity against isolates of variola (smallpox) virus
and other related orthopoxviruses and have found several
compounds which merit further evaluation in animal models.
Over 20 of the most promising compounds will be further
tested for antiviral activity in animal model systems.
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.
In addition, CDC has included the use of cidofovir in
an existing IND to allow the emergency use of this medication
in the treatment of adverse reactions to smallpox vaccination.
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
state and local 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.
We
are pursuing the development of additional smallpox vaccine
with multiple manufacturers in order to rapidly enhance
our vaccine resource capabilities 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. We have conducted potency
testing to and have confirmed that all currently existing
lots are still potent. On October 26, NIH began recruitment
for a study to test Dryvax vaccine efficacy undiluted,
at 1:5 dilution, and at 1:10 dilution. Depending on the
results of this study, CDC will ensure availability of
enough diluent to allow for the appropriate dilution of
vaccine. One study has already been completed which found
that undiluted vaccine was effective 95% of the time,
1:10 dilution was effective 70% of the time, and 1:100
was effective 20% of the time. CDC is in the process of
contracting with additional manufacturers to produce a
total of 300 million doses of vaccine by the end of next
year. The President recently signed an Executive Order
that allows HHS to provide indemnification for the smallpox
manufacturers.
- 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. For example, the Florida physician's
ability to recognize a suspected case of anthrax and his
awareness of his role in reporting it to the local health
department was critical to our initial recognition of
the current bioterrorist events. 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
is enhancing its national surveillance system for hospital-acquired
infections, dialysis surveillance, and healthcare worker
safety surveillance into the National Healthcare Safety
Network (NHSN). NHSN, is a web-based tool for collecting
and communicating important clinical findings with healthcare
facilities. Other partnerships with managed care and provider
groups have proved invaluable for communicating recommendations
during the recent bioterrorism response, and further activities
to improve detection of potential bioterrorist attacks
through these partners is planned.
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.
Preparing
CDC, state, and other professionals to respond to a smallpox
bioterrorist threat or incident will revolve primarily
around training three groups:
•
CDC Response Teams. CDC will begin conducting a 3-day
course this month for personnel comprising teams that
will be deployed to respond to an incident. Training will
cover technical issues regarding the disease and the vaccine,
operational issues such as isolation and quarantine, surveillance,
and communications, and an introduction to CDC's response
plan. A scenario-based exercise will be included.
•
State Health Representatives. CDC is developing a 3-4
day training course for health representatives from U.S.
states and territories who would be involved in responding
to a smallpox bioterrorist incident. The objective of
this training is that each state/territory produce a Smallpox
Response Plan that will be compatible with CDC's national
plan. Approximately 150 representatives (up to 3 from
each state/territory) will be trained.
•
Clinicians. On December 13, CDC will conduct a live satellite
broadcast titled Smallpox: What Every Clinician Should
Know. This training session is targeted toward physicians,
nurses, and others who may be called on to identify and
handle smallpox cases and to deliver smallpox vaccine.
It will cover topics such as smallpox epidemiology, diagnosis,
laboratory confirmation, vaccination, and management of
suspected cases. After the broadcast, the course will
be converted to a web-based format and self-instructional
videotapes.
Concurrent with
the satellite broadcast, a "train the trainer" session
will be held for infectious disease experts at academic
institutions and staff at national provider organizations.
The goal is to enable representatives from these groups
to disseminate smallpox response training to their peers
throughout the medical community. Followup sessions will
be held through April/May 2002.
CDC
is also producing a variety of educational materials to
be used by clinicians who may be involved in smallpox
identification, care, or vaccination. These materials
include an interactive CD-ROM that will contain technical
information and practice exercises, fact sheets, aids
to smallpox diagnosis, and a smallpox Vaccine Information
Statement.
- 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 is critical. CDC has developed
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, also in cooperation with the Association
of Public Health Laboratories (APHL) and the National
Laboratory Training Network (NLTN) have sponsored a "hands-on"
laboratory course for public health microbiologists. In
conjunction with the course, CDC produced two videos that
were distributed to the participants as well as to members
of the NLTN. The participants in this course are now using
these videos and the other materials developed by CDC
to train other laboratorians in their states. 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. 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 has formed and
trained multiple outbreak response teams that are available
for rapid deployment to assist state and local authorities
deal with outbreaks due to any potential bioterrorism
agent including smallpox. CDC is formalizing current draft
plans for the notification and mobilization of personnel
and laboratory resources in response to a bioterrorism
emergency such as smallpox, as well as overall strategies
for vaccination, and development and implementation of
other outbreak control measures such as isolation and
quarantine measures. In addition, CDC is developing national
standards to ensure that respirators used by first responders
and by other healthcare providers responding to terrorist
acts provide adequate protection against weapons of terrorism.
Hospitals
are critical in the response to bioterrorist attacks.
CDC is collaborating with various healthcare associations
and infection control societies to better prepare for
potential bioterrorist events. Various hospital-based
syndromic surveillance activities in regions affected
by anthrax exposures have provided critical information
on possible cases. Through provider-based sentinel networks,
CDC has been able to communicate with infectious disease
clinicians, infection control professionals, and other
key clinical participants in bioterrorism preparedness
and response.
Rapid
and secure communications are 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 (HAN). HAN is a nationwide program
to establish the communications, information, distance-learning,
and organizational infrastructure for a new level of defense
against health threats, including bioterrorism. Currently,
13 states are connected to all of their local health jurisdictions;
50 states have begun connecting to local providers as
well; and CDC is also directly connecting to groups, such
as the American Medical Association, to cast a broad net
of coverage. CDC has also established the Epidemic Information
Exchange (Epi-X), a secure, Web-based communications system
that provides information sharing capabilities to state
and local health officials. CDC also provides timely satellite
broadcast and web-broadcast training through the Public
Health Training Network. For example, on October 18, CDC
experts shared information on anthrax with physicians,
hospitals, and other healthcare providers across the country
via a satellite broadcast, Anthrax: What Every Clinician
Should Know. Part II of this program is scheduled
for this week and will present an update on clinical guidelines
and procedures for the early recognition, diagnosis, treatment,
and reporting of anthrax exposure.
Accurate
and up-to-date information helps calm public fears and
limit collateral effects of the attack. CDC communicates
with the public directly through its website on emergency
preparedness and through a public inquiry telephone and
email system, which, since the recent attacks, has responded
to hundreds of questions daily. In addition, CDC communicates
to the public by releasing daily updates to the news media,
answering inquiries from the press and providing medical
experts for interviews.
The National
Pharmaceutical Stockpile
Another
integral component of public health preparedness at CDC
has been the development of a National Pharmaceutical
Stockpile (NPS), which is 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. The NPS was mobilized
for the first time on September 11, when a 12-hour push
pack was deployed to New York City, delivering 50 tons
of medical supplies to the site of the disaster in 7 hours.
In addition, substantial quantities of VMI were delivered
to New York City within 24 hours. Components of the VMI
were deployed to various locations along the East coast
to provide adequate supplies of antibiotics as prophylaxis
to individuals who were potentially exposed to anthrax.
CDC has developed this program in collaboration with federal
and private sector partners and with input from the states.
Challenges
As
has been highlighted recently, 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. Prior to the
September 11 attack on the United States, CDC was making
substantial progress toward defining, developing, and
implementing a nationwide public health response network
to increase the capacity of public health officials at
all levels-federal, state, and local-to prepare for and
respond to deliberate attacks on the health of our citizens.
The events of September 11 were a defining moment for
all of us, and since then we have dramatically increased
our levels of preparedness and are implementing plans
to increase it even further.
CDC
has been addressing issues of detection, epidemiologic
investigation, diagnostics, and enhanced infrastructure
and communications as part of its overall bioterrorism
preparedness strategies. Based on federal, state, and
local response in the weeks following the events of September
11, and on recent training experiences, such as the National
TOPOFF event and the Dark Winter exercise--which simulated
a terrorist release of smallpox virus, CDC has learned
valuable lessons and identified gaps that exist in bioterrorism
preparedness and response at federal, state, and local
levels. CDC will continue to work with partners to address
challenges such as improving coordination among other
federal agencies during a response and understanding the
necessary relationship needed between conducting a criminal
investigation versus an epidemiologic case investigation.
These issues, as well as overall preparedness planning
at federal, state, and local levels, require additional
action to ensure that the nation is fully prepared to
respond to acts of biological and chemical terrorism.
Disease
experts at CDC are developing strategies to prevent the
spread of disease during and after bioterrorist attacks.
Specific components include (1) creating protocols for
immunizing at-risk populations; (2) isolating large numbers
of exposed individuals; (3) reducing occupational exposures;
(4) assessing methods of safeguarding food and water from
deliberate contamination; and (5) exploring ways to improve
linkages between animal and human disease surveillance
networks since threat agents that affect both humans and
animals may first be detected in animals.
Conclusion
In
conclusion, CDC is committed to working with other federal
agencies and partners as well as state and local public
health departments to ensure the health and medical care
of our citizens. We have made substantial progress to
date in enhancing the nation's capability to prepare for
and respond to a bioterrorist event, but there is much
more to be done. 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 better prepared for deliberate bioterrorist
threats, but it will also enable us 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.
