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THE CSTE WASHINGTON REPORT
Marcia S. Mabee, MPH, PhD
Editor
11479 Waterview
Reston, VA 20190
mmabee@ix.netcom.com
703-476-8060
APRIL
27, 2000 VOLUME 4, NO. 8
EDITOR'S NOTE: A key team of public health experts coordinated by CDC, including
former CSTE President Patricia Quinlisk, released the CDC response plan for
biological and chemical terrorism last week, marking an important milestone in
the two year effort in which CSTE and other public health groups have supported
legislation to respond to bioterrorism. The plan reflects the CSTE overall
position that civilian public health experts including epidemiologists must play
a key role in any terrorism attack and that the preparations for possible
terrorism will have significant benefits in ensuring a quick response to
non-terrorist threats but potentially equally lethal spread of infectious or
other diseases in the future. Special credit is due to Dr. Quinlisk and her
colleagues at CDC for the plan which will help guide federal, state and local
preparations in the months and years ahead.
The Washington Report is distributed to CSTE members by email and is available
on the CSTE Website at http://www.cste.org/.Legislation and regulation
referenced in the report can be located at http://www.gpo.gov/
HHS SEEKS COMMENTS ON REVISED STRATEGIC PLAN -- HHS Assistant Secretary for
Planning and Evaluation Margaret Hamburg, MD will conduct a meeting May 19 in
Washington on the agency's strategic six year plan and invites comments from key
groups. The plan is available at http://aspe.hhs.gov/hhsplan. Overall goals are
to:
--Reduce the major threats to the health and productivity of all Americans
--Improve the economic and social well-being of individuals, families and
communities in the United States
--Improve access to health services and ensure the integrity of the nation's
health entitlement and safety net programs
--Improve the quality of health care and human services
--Improve the nation's public health systems
--Improve the nation's health sciences research enterprise and enhance its
productivity
CDC ISSUES BIOLOGICAL AND CHEMICAL TERRORISM RESPONSE PLAN -- CDC in the April
21 issue of MMWR (http://www2.cdc.gov/mmwr/mmwr.html) published the
recommendations of the CDC Strategic Planning Workgroup which includes former
CSTE President Patricia Quinlisk, MD, Iowa Department of Health. The
recommendations summarize intensive planning by CDC as a key participant in a
range of federal agencies planning civilian responses to possible terrorist
attacks on U.S. populations. "Evaluation of this vulnerability has focused
on the role public health will have detecting and managing the probable covert
biological terrorist incident with the realization that the U.S. local, state,
and federal infrastructure is already strained as a result of other important
public health problems. In partnership with representatives for local and state
health departments, other federal agencies, and medical and public health
professional associations, CDC has developed a strategic plan to address the
deliberate dissemination of biological or chemical agents. The plan contains
recommendations to reduce U.S. vulnerability to biological and chemical
terrorism --- preparedness planning, detection and surveillance, laboratory
analysis, emergency response, and communication systems. Training and research
are integral components for achieving these recommendations. Success of the plan
hinges on strengthening the relationships between medical and public health
professionals and on building new partnerships with emergency management, the
military, and law enforcement professionals."
Key components of the plan include:
Preparedness and Prevention -- Detection, diagnosis, and mitigation of illness
and injury caused by biological and chemical terrorism is a complex process that
involves numerous partners and activities. Meeting this challenge will require
special emergency preparedness in all cities and states. CDC will provide public
health guidelines, support, and technical assistance to local and state public
health agencies as they develop coordinated preparedness plans and response
protocols. CDC also will provide self-assessment tools for terrorism
preparedness, including performance standards, attack simulations, and other
exercises. In addition, CDC will encourage and support applied research to
develop innovative tools and strategies to prevent or mitigate illness and
injury caused by biological and chemical terrorism.
Detection and Surveillance -- Early detection is essential for ensuring a prompt
response to a biological or chemical attack, including the provision of
prophylactic medicines, chemical antidotes, or vaccines. CDC will integrate
surveillance for illness and injury resulting from biological and chemical
terrorism into the U.S. disease surveillance systems, while developing new
mechanisms for detecting, evaluating, and reporting suspicious events that might
represent covert terrorist acts. As part of this effort, CDC and state and local
health agencies will form partnerships with front-line medical personnel in
hospital emergency departments, hospital care facilities, poison control
centers, and other offices to enhance detection and reporting of unexplained
injuries and illnesses as part of routine surveillance mechanisms for biological
and chemical terrorism.
Diagnosis and Characterization of Biological and Chemical Agents-- CDC and its
partners will create a multilevel laboratory response network for bioterrorism (LRNB).
That network will link clinical labs to public health agencies in all states,
districts, territories, and selected cities and counties and to state-of-the-art
facilities that can analyze biological agents . As part of this effort, CDC will
transfer diagnostic technology to state health laboratories and others who will
perform initial testing. CDC will also create an in-house rapid-response and
advanced technology (RRAT) laboratory. This laboratory will provide
around-the-clock diagnostic confirmatory and reference support for terrorism
response teams. This network will include the regional chemical laboratories for
diagnosing human exposure to chemical agents and provide links with other
departments (e.g., the U.S. Environmental Protection Agency, which is
responsible for environmental sampling).
Response--A comprehensive public health response to a biological or chemical
terrorist event involves epidemiologic investigation, medical treatment and
prophylaxis for affected persons, and the initiation of disease prevention or
environmental decontamination measures. CDC will assist state and local health
agencies in developing resources and expertise for investigating unusual events
and unexplained illnesses. In the event of a confirmed terrorist attack, CDC
will coordinate with other federal agencies in accord with Presidential Decision
Directive (PDD) 39. PDD 39 designates the Federal Bureau of Investigation as the
lead agency for the crisis plan and charges the Federal Emergency Management
Agency with ensuring that the federal response management is adequate to respond
to the consequences of terrorism (8). If requested by a state health agency, CDC
will deploy response teams to investigate unexplained or suspicious illnesses or
unusual etiologic agents and provide on-site consultation regarding medical
management and disease control. To ensure the availability, procurement, and
delivery of medical supplies, devices, and equipment that might be needed to
respond to terrorist-caused illness or injury, CDC will maintain a national
pharmaceutical stockpile.
Communication Systems--U.S. preparedness to mitigate the public health
consequences of biological and chemical terrorism depends on the coordinated
activities of well-trained health-care and public health personnel throughout
the United States who have access to up-to-the minute emergency information.
Effective communication with the public through the news media will also be
essential to limit terrorists' ability to induce public panic and disrupt daily
life. During the next 5 years, CDC will work with state and local health
agencies to develop a) a state-of-the-art communication system that will support
disease surveillance; b) rapid notification and information exchange regarding
disease outbreaks that are possibly related to bioterrorism; c) dissemination of
diagnostic results and emergency health information; and d) coordination of
emergency response activities. Through this network and similar mechanisms, 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.
FDA TO DEVELOP RISK MODEL FOR TRANSFER OF ANIMAL BACTERIA TO HUMANS -- The Food
and Drug Administration April 19 (65 FR 20992-20995) called for scientific input
to its development of risk assessment of the public health impact of
streptogramin resistance in enterococcus faecium attributable to the use of
streptogramins in animals. The agency requests comments on their approach to the
RA model and requests that scientific data and information relevant to the
conduct of the RA be submitted. This model will be applied to assess the
association between the development of streptogramin (quinupristin/dalfopristin
(QD)) resistant Enterococcus faecium in humans and the use of virginiamycin in
food-producing animals. The center will attempt to use the RA model to quantify
the human health impact attributable both to direct acquisition of resistant E.
faecium from food-producing animals and to the transfer of resistance
determinants from E. faecium in food-producing animals to E. faecium in humans.
Submit written comments, scientific data, and information by June 19, 2000.
SCIENTIFIC DATA SEARCH BROADENED BY EPA FOR ENDOCRINE DISRUPTORS -- The National
Toxicology Program (NTP) April 17 (65 FR 20478-20479) is organizing a Peer
Review to evaluate whether chemicals can cause hormone-related effects at doses
lower than those typically used in the standard toxicological dose-setting
paradigm. The U.S. Environmental Protection Agency (EPA) Endocrine Disruptor
Screening Program will use the results from this peer review to assist in
determining how to identify and characterize potential low-dose effects that may
arise during endocrine disruptor screening, testing, and hazard assessment.
TheNTP is now broadening the scope of studies to be considered for this peer
review to include relevant data from unpublished studies. Submission of
unpublished studies should include an abstract of the study describing the
hypothesis being tested, experimental design [model system (cell line, species,
strain, number per group, etc.), dosing regimen, duration of treatment and
follow-up], endpoints evaluated, and results (if available). Comments by May 22,
2000.
HHS CALLS FOR COMMENTS ON PRELIMINARY FINAL COMMENTS ON GENETIC TESTING
OVERSIGHT -- The HHS Secretary's Advisory Committee on Genetic Testing (SACGT)
April 19 (65 FR 21093-21109) called for additional comments on its oversight
plans for genetic testing. The committee advises HHS on the medical, scientific,
ethical, legal, and social issues raised by the development and use of genetic
tests. The current plan answers the following questions:
--What criteria should be used to assess the benefits and risks of genetic tests
--How can the criteria for assessing the benefits and risks of genetic tests be
used to differentiate categories of tests? What are the categories, and what
kind of mechanism could be used to assign tests to the different categories?
--What process should be used to collect, evaluate, and disseminate data on
single tests or groups of tests in each category?
--What are the options for oversight of genetic tests and the advantages and
disadvantages of each option?
--What is an appropriate level of oversight for each category of genetic test?
NIH IDENTIFIES VIRAL CHANGES RESPONSIBLE FOR CHRONIC HEPATITIS C
--Scientists from the National Institutes of Health (NIH) and other institutions
have discovered a clue that begins to explain why so many patients fail to fully
recover from infection with the hepatitis C virus (HCV). Their research,
reported in the current issue of Science, points to changes in surface proteins
that enable the virus to evade the immune system. The study shows that the
ultimate outcome of an HCV infection is determined during the initial, acute
phase of disease.
Nearly 4 million Americans have been infected with the hepatitis C virus (HCV).
Of those who contract hepatitis C, 85 percent remain chronically infected,
harboring a virus that continues to replicate throughout a person's life. HCV is
a major cause of chronic liver disease and is responsible for a third of all
cases of cirrhosis and liver cancer, half of all liver transplants, and 8,000 to
10,000 deaths in this country annually.
Patrizia Farci, M.D., and Robert Purcell, M.D., of NIAID and Harvey Alter, M.D.,
of the NIH Warren Magnuson Clinical Center, led a team of scientists in a study
designed to see whether the hepatitis C virus changes during infection. Dr.
Alter had been conducting long-term studies of patients who contracted hepatitis
from blood transfusions. These individuals subsequently developed different
clinical outcomes, ranging from short-term infections to chronic disease. Some
of these patients have had hepatitis C for over 20 years. "This unique
group was critical for our study, because they had been observed continuously
since early in infection," states Dr.Farci, who splits her time between
NIAID in the United States and the University of Cagliari in Italy.
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