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Support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, the U.S. Agency for International Development, and the U.S. Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Department of Veterans Affairs; U.S. Department of Agriculture; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Pfizer; GlaxoSmithKline; and Wyeth-Ayerst Laboratories.
This report is based on the proceedings of a workshop that was sponsored by the Forum on Emerging Infections. It is prepared in the form of a workshop summary by and in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections. The content of those sections is based on the presentations and the discussions that took place during the workshop.
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Copyright 2002 by the National Academy of Sciences. All rights reserved.
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THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
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FORUM ON EMERGING INFECTIONS
ADEL MAHMOUD (Chair), President,
Merck Vaccines, Whitehouse Station, New Jersey
STANLEY LEMON (Vice-Chair), Dean,
School of Medicine, The University of Texas Medical Branch, Galveston, Texas
STEVEN BRICKNER, Research Advisor,
Pfizer Global Research and Development, Pfizer Inc., Groton, Connecticut
GAIL CASSELL, Vice President,
Infectious Diseases, Eli Lilly & Company, Indianapolis, Indiana
GORDON DEFRIESE, Professor of Social Medicine,
University of North Carolina, Chapel Hill, North Carolina
CEDRIC DUMONT, Medical Director,
Department of State and the Foreign Service, Washington, DC
JESSE GOODMAN, Deputy Director,
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
RENU GUPTA, Vice President and Head,
U.S. Clinical Research and Development, and
Head,
Global Cardiovascular, Metabolic, Endocrine, and G.I. Disorders, Novartis Corporation, East Hanover, New Jersey
MARGARET HAMBURG, Vice President for Biological Programs,
Nuclear Threat Initiative, Washington, DC
CAROLE HEILMAN, Director,
Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
DAVID HEYMANN, Executive Director,
Communicable Diseases, World Health Organization, Geneva, Switzerland
JAMES HUGHES, Assistant Surgeon General and Director,
National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
SAMUEL KATZ, Wilburt C. Davison Professor and Chairman Emeritus,
Duke University Medical Center, Durham, North Carolina
PATRICK KELLEY, Colonel, Director,
Department of Defense Global Emerging Infections System, Walter Reed Army Institute of Research, Silver Spring, Maryland
MARCELLE LAYTON, Assistant Commissioner,
Bureau of Communicable Diseases, New York City Department of Health, New York, New York
JOSHUA LEDERBERG,
Raymond and Beverly Sackler Foundation Scholar, The Rockefeller University, New York, New York
CARLOS LOPEZ, Research Fellow,
Research Acquisitions, Eli Lilly Research Laboratories, Indianapolis, Indiana
LYNN MARKS, Global Head of Infectious Diseases,
GlaxoSmithKline, Collegeville, Pennsylvania
STEPHEN MORSE, Director,
Center for Public Health Preparedness, Columbia University, New York, New York
MICHAEL OSTERHOLM, Director,
Center for Infectious Disease Research and Policy and Professor, School of Public Health, University of Minnesota, Minneapolis, Minnesota
GARY ROSELLE, Program Director for Infectious Diseases,
VA Central Office, Veterans Health Administration, Department of Veterans Affairs, Washington, DC
DAVID SHLAES, Vice President,
Infectious Disease Research, Wyeth, Pearl River, New York
JANET SHOEMAKER, Director,
Office of Public Affairs, American Society for Microbiology, Washington, DC
P. FREDRICK SPARLING, J. Herbert Bate Professor Emeritus of Medicine,
Microbiology, and Immunology, University of North Carolina, Chapel Hill, North Carolina
I. KAYE WACHSMUTH, Deputy Administrator,
Office of Public Health and Science, United States Department of Agriculture, Washington, DC
C. DOUGLAS WEBB, Senior Medical Director,
Bristol-Myers Squibb Company, Princeton, New Jersey
MICHAEL ZEILINGER, Infectious Disease Team Leader,
Office of Health and Nutrition, U.S. Agency for International Development, Washington, DC
Liaisons
ENRIQUETA BOND, President,
Burroughs Wellcome Fund, Research Triangle Park, North Carolina
NANCY CARTER-FOSTER, Director,
Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, DC
EDWARD McSWEEGAN,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
STEPHEN OSTROFF, Associate Director for Epidemiologic Science,
National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
Staff
STACEY KNOBLER, Director,
Forum on Emerging Infections
MARJAN NAJAFI, Research Associate
LAURIE SPINELLI, Project Assistant
BOARD ON GLOBAL HEALTH
DEAN JAMISON, (Chair), Director,
Program on International Health, Education, and Environment, University of California at Los Angeles
YVES BERGEVIN, Chief,
Health Section, UNICEF, New York, New York
PATRICIA DANZON, Professor,
Health Care Systems Development, University of Pennsylvania, Philadelphia
RICHARD FEACHEM,
Institute for Global Health, UC San Francisco/UC Berkeley, San Francisco, California
NOREEN GOLDMAN, Professor,
Woodrow Wilson School of Public and International Affairs, Princeton University, Princeton, New Jersey
ARTHUR KLEINMAN, Maude and Lillian Presley Professor of Medical Anthropology/Professor of Psychiatry and Social Medicine,
Harvard Medical School, Boston, Massachusetts
ADEL MAHMOUD, President,
Merck Vaccines, Whitehouse Station, New Jersey
ALLAN ROSENFIELD, Dean,
Mailman School of Public Health, Columbia University, New York, New York
SUSAN SCRIMSHAW, Dean,
School of Public Health, University of Illinois at Chicago
JOHN WYN OWEN, Secretary,
Nuffield Trust, London, United Kingdom
GERALD KEUSCH, (Liaison), Director,
Fogarty International Center, National Institutes of Health, Bethesda, Maryland
DAVID CHALLONER, (IOM Foreign Secretary), Vice President for Health Affairs,
University of Florida, Gainesville
Staff
JUDITH BALE, Director
PATRICIA CUFF, Research Associate
STACEY KNOBLER, Study Director
MARJAN NAJAFI, Research Associate
KATHERINE OBERHOLTZER, Project Assistant
JASON PELLMAR, Project Assistant
MARK SMOLINSKI, Study Director
LAURIE SPINELLI, Project Assistant
REVIEWERS
All presenters at the workshop have reviewed and approved their respective sections of this report for accuracy. In addition, this workshop summary has been reviewed in draft form by independent reviewers chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine (IOM) in making the published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
The Forum and IOM thank the following individuals for their participation in the review process:
Roger Breeze, Agricultural Research Service, Washington, DC
Richard Johnson, The Johns Hopkins University, Baltimore, Maryland
Stuart Nightingale, U.S. Department of Health and Human Services, Washington, DC
Gerald Parker, U.S. Army Medical Research and Material Command
M. Patricia Quinlisk, Iowa State Department of Health, Des Moines, Iowa
Robert Ryder, University of North Carolina at Chapel Hill, North Carolina
The review of this report was overseen by Melvin Worth, Scholar-in-Residence, National Academy of Sciences, who was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the editors and individual authors.
Preface
The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institutes of Health. The goal of the Forum is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government* to examine and discuss scientific and policy issues that are of shared interest and that are specifically related to research and prevention, detection, and management of emerging infectious diseases. In accomplishing this task, the Forum provides the opportunity to foster the exchange of information and ideas, identify areas in need of greater attention, clarify policy issues by enhancing knowledge and identifying points of agreement, and inform decision makers about science and policy issues. The Forum seeks to illuminate issues rather than resolve them directly; hence, it does not provide advice or recommendations on any specific policy initiative pending before any agency or organization. Its strengths are the diversity of its membership and the contributions of individual members expressed throughout the activities of the Forum.
ABOUT THE WORKSHOP
In the wake of the events of September 11, already mounting concerns about bioterrorism became imminent priorities for policymakers, researchers,
public health officials, and private industry. These communities continue to grapple with ways to better understand the potential threats and ensure the country’s ability to preempt an attack or respond to the consequences.
The Forum on Emerging Infections was uniquely positioned through its representation of multi-sector science and policy expertise to convene a working group discussion on the next steps for responding to bioterrorism.
Much has been written and discussed over the last decade about the potential use of biological agents in warfare or in terrorist attacks. Initiatives to prevent and respond to such events have been developed and implemented within areas of federal, state, and local government. The scientific, healthcare, policy, and law enforcement communities have also created specific agendas to address these threats.
The November 27–29, 2001, workshop of the Forum explored the current scientific understanding of threatening pathogens and what measures have been put in place to better monitor, prevent, and respond to their emergence. To determine where progress has been made and where gaps remain, Forum presentations and discussions reviewed existing policies, infrastructure, and research and scientific tools.
Additionally, Forum presentations and discussions sought to identify the obstacles to preparing an optimal response, particularly as it relates to the complexities of interaction among private industry, research and public health agencies, regulatory agencies, policymakers, academic researchers, and the public.
During this three-day workshop, Forum members and invited guests explored the issues surrounding emerging opportunities for more effective collaboration as well as the scientific and programmatic needs for responding to bioterrorism.
ORGANIZATION OF WORKSHOP SUMMARY
This workshop summary report is prepared for the Forum membership in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections sponsors or the Institute of Medicine (IOM). The contents of the unattributed sections are based on the presentations and discussions that took place during the workshop.
The workshop summary is organized within chapters as a topic-by-topic description of the presentations and discussions. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and put forth some potential responses as described by the workshop participants. The Summary and Assessment chapter discusses the core messages that emerged from the speakers’ presentations and the ensuing discussions.
Although this workshop summary provides an account of the individual presentations, it also reflects an important aspect of the Forum philosophy. The
workshop functions as a dialogue among representatives from different sectors and presents their beliefs on which areas may merit further attention. However, the reader should be aware that the material presented here expresses the views and opinions of those participating in the workshop and not the deliberations of a formally constituted IOM study committee. These proceedings summarize only what participants stated in the workshop and are not intended to be an exhaustive exploration of the subject matter.
ACKNOWLEDGMENTS
The Forum on Emerging Infections and the IOM wish to express their warmest appreciation to the individuals and organizations who gave valuable time to provide information and advice to the Forum through participation in the workshop.
The Forum is indebted to the IOM staff who contributed during the course of the workshop and the production of this workshop summary. On behalf of the Forum, we gratefully acknowledge the efforts led by Stacey Knobler, director of the Forum and coeditor of this report, who dedicated much effort and time to developing this workshop’s agenda, and for her thoughtful and insightful approach and skill in translating the workshop proceedings and discussion into this workshop summary. We would also like to thank the following IOM staff and consultants for their valuable contributions to this activity: Leslie Pray, Rob Coppock, Marjan Najafi, Laurie Spinelli, Judith Bale, Mark Smolinski, Katherine Oberholtzer, Patricia Cuff, Paige Baldwin, Jennifer Otten, Clyde Behney, Bronwyn Schrecker, Sally Stanfield, Sally Groom, Michele de la Menardiere, Francesca Moghari, and Beth Gyorgy.
Finally, the Forum also thanks sponsors that supported this activity. Financial support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Department of Veterans Affairs; U.S. Department of Agriculture; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Pfizer; GlaxoSmithKline; and Wyeth-Ayerst Laboratories. The views presented in this workshop summary are those of the editors and workshop participants and are not necessarily those of the funding organizations.
Adel Mahmoud, Chair
Stanley Lemon, Vice-Chair
Forum on Emerging Infections
Contents
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SUMMARY AND ASSESSMENT |
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The Role of Research in Countering Bioterrorism, |
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The Political Perspective of the Bioterrorism Threat, |
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Update on the Implications of Anthrax Bioterrorism, |
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Framing the Issues, |
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Framing the Debate: Applying the Lessons Learned, |
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Building Capacity to Prevent and Respond to Bioterrorism, |
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Bioterrorism: Communicating an Effective Response, |
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