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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary THE THREAT OF PANDEMIC INFLUENZA Are We Ready? Workshop Summary prepared for Forum on Microbial Threats Board on Global Health Stacey L. Knobler, Alison Mack, Adel Mahmoud, Stanley M. Lemon, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by the U.S. Department of Health and Human Services’ National Institutes of Health (Contract No. N01-OD-4-2139, TO#129), Centers for Disease Control and Prevention (200-2000-00629, TO#25), and Food and Drug Administration; U.S. Agency for International Development; U.S. Department of Defense (Contract No. DAMD-17-03-P-1331), U.S. Department of State; U.S. Department of Veterans Affairs (V101(93)P-2159); U.S. Department of Agriculture; American Society for Microbiology; Aventis Pasteur; Burroughs Wellcome Fund; Pfizer; GlaxoSmithKline; and The Merck Company Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. This report is based on the proceedings of a workshop that was sponsored by the Forum on Microbial Threats. 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 Microbial Threats. The content of those sections is based on the presentations and the discussions that took place during the workshop. Library of Congress Cataloging-in-Publication Data The threat of pandemic influenza : are we ready? : workshop summary / prepared for Forum on Microbial Threats, Board on Global Health ; Stacey L. Knobler … [et al.], editors. p. ; cm. Includes bibliographical references. ISBN 0-309-09504-2 (pbk.) — ISBN 0-309-54685-0 (pdf) 1. Influenza—Epidemiology. 2. Influenza—Government policy—United States. [DNLM: 1. Influenza—prevention & control. 2. Communicable Disease Control—organization & administration. 3. Disease Outbreaks—prevention & control. 4. Influenza Vaccines. 5. Influenza, Avian—prevention & control. ] I. Knobler, Stacey. II. Institute of Medicine (U.S.). Forum on Microbial Threats. RA644.I6T48 2005 614.5′18—dc22 2005000369 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. COVER: A detailed section of a stained glass window 21 × 56″ depicting the natural history of influenza viruses and zoonotic exchange in the emergence of new strains was used to design the front cover. Based on the work done at St. Jude Children’s Research Hospital supported by American Lebanese Syrian Associated Charities (ALSAC) and the National Institute of Allergy and Infectious Diseases (NIAID). Artist: Jenny Hammond, Highgreenleycleugh, Northumberland, England.
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary FORUM ON MICROBIAL THREATS ADEL A.F. MAHMOUD (Chair), President, Merck Vaccines, Whitehouse Station, New Jersey STANLEY M. LEMON (Vice-Chair), Dean, School of Medicine, The University of Texas Medical Branch, Galveston DAVID ACHESON, Chief Medical Officer, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Rockville, Maryland RUTH L. BERKELMAN, Rollins Professor and Director, Emory University, Center for Public Health Preparedness and Research, Rollins School of Public Health, Atlanta, Georgia STEVEN J. BRICKNER, Research Advisor, Pfizer Global Research and Development, Pfizer Inc., Groton, Connecticut DENNIS CARROLL, U.S. Agency for International Development, Washington, D.C. NANCY CARTER-FOSTER, Director, Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, D.C. GAIL H. CASSELL, Vice President, Scientific Affairs, Eli Lilly & Company, Indianapolis, Indiana JESSE L. GOODMAN, Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland EDUARDO GOTUZZO, Director, Instituto de Medicina Tropical–Alexander von Humbolt, Universidad Peruana Cayetano Heredia, Lima, Peru CHRISTINE M. GRANT, Vice President, Public Policy and Government Relations, Aventis Pasteur, Swiftwater, Pennsylvania MARGARET A. HAMBURG, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, D.C. CAROLE A. HEILMAN, Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland DAVID L. HEYMANN, Executive Director, Polio Eradication, World Health Organization, Geneva, Switzerland JAMES M. HUGHES, Assistant Surgeon General and Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia GERALD T. KEUSCH, Assistant Provost for Global Health, Boston University School of Medicine, and Associate Dean for Global Health, Boston University School of Public Health, Boston, Massachusetts LONNIE KING, Dean, College of Veterinary Medicine, Michigan State University, East Lansing
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary JOSHUA LEDERBERG, Raymond and Beverly Sackler Foundation Scholar, The Rockefeller University, New York, New York JOSEPH MALONE, Director, Department of Defense Global Emerging Infections System, Walter Reed Army Institute of Research, Silver Spring, Maryland LYNN MARKS, Senior Vice President of Infectious Diseases, Medicine Development Center, GlaxoSmithKline, Collegeville, Pennsylvania STEPHEN S. MORSE, Director, Center for Public Health Preparedness, Columbia University, New York, New York MICHAEL T. OSTERHOLM, Director, Center for Infectious Disease Research and Policy, and Professor, School of Public Health, University of Minnesota, Minneapolis GEORGE POSTE, Director, Arizona BioDesign Institute, Arizona State University, Tempe GARY A. ROSELLE, Program Director for Infectious Diseases, Central Office, Veterans Health Administration, Department of Veterans Affairs, Washington, D.C. JANET SHOEMAKER, Director, Office of Public Affairs, American Society for Microbiology, Washington, D.C. P. FREDRICK SPARLING, J. Herbert Bate Professor Emeritus of Medicine, Microbiology, and Immunology, University of North Carolina, Chapel Hill Liaisons YVES BERGEVIN, Department of Child and Adolescent Health and Development, World Health Organization, Geneva, Switzerland ENRIQUETA BOND, President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina EDWARD McSWEEGAN, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland Staff STACEY L. KNOBLER, Director, Forum on Microbial Threats ELIZABETH KITCHENS, Research Associate KATHERINE OBERHOLTZER, Research Assistant LAURA SIVITZ, Research Associate
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary BOARD ON GLOBAL HEALTH DEAN T. JAMISON (Chair), Senior Fellow, Fogarty International Center, National Institutes of Health, Bethesda, Maryland YVES BERGEVIN, Department of Child and Adolescent Health and Development, World Health Organization, Geneva, Switzerland DONALD BERWICK, Clinical Professor of Pediatrics and Health Care Policy, Harvard Medical School, and President and Chief Executive Officer, Institute of Healthcare Improvement, Boston, Massachusetts JO IVEY BOUFFORD, Professor, Robert F. Wagner School of Public Service, New York University, New York DAVID R. CHALLONER (IOM Foreign Secretary), Vice President for Health Affairs, Emeritus, University of Florida, Gainesville SUE GOLDIE, Associate Professor of Health Decision Science, Department of Health Policy and Management, Center for Risk Analysis, Harvard University School of Public Health, Boston, Massachusetts RICHARD GUERRANT, Thomas H. Hunter Professor of International Medicine, Director, Center for Global Health, University of Virginia School of Medicine, Charlottesville MARGARET HAMBURG, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, D.C. GERALD KEUSCH, Assistant Provost for Global Health, Boston University School of Medicine, and Associate Dean for Global Health, Boston University School of Public Health, Boston, Massachusetts JEFFREY KOPLAN, Vice President for Academic Health Affairs, Emory University, Atlanta, Georgia ADEL A.F. MAHMOUD, President, Merck Vaccines, Whitehouse Station, New Jersey MICHAEL MERSON, Anna M.R. Lauder Professor, Dean of Public Health, and Chair, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut MAMPHELA A. RAMPHELE, Managing Director, The World Bank, Washington, D.C. MARK L. ROSENBERG, Executive Director, The Task Force for Child Survival and Development, Emory University, Decatur, Georgia PHILIP RUSSELL, Professor Emeritus, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland JAIME SEPÚLVEDA AMOR, National Institute of Public Health, Mexico Staff PATRICK KELLEY, Director DIANNE STARE, Research Assistant
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary 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 the IOM thank the following individuals for their participation in the review process: Neil Ferguson, Department of Infectious Disease Epidemiology, Imperial College, London Frederick Hayden, Division of Infectious Diseases, University of Virginia Clement S. Lewin, Chiron Vaccines Arnold Monto, School of Public Health, University of Michigan, Ann Arbor Peter Palese, Department of Microbiology, Mount Sinai School of Medicine Eve Slater, Former Assistant Secretary for Health, U.S. Department of Health and Human Services
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary An additional technical review was provided by John H. Barton, George E. Osborne Professor of Law, Emeritus, Stanford Law School. The review of this report was overseen by Elena O. Nightingale, Scholar-in-Residence, IOM, 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.
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Preface The Forum on Microbial Threats (previously named 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 Most infectious disease experts believe that a future influenza pandemic is inevitable. Yet despite the legacy of the 1918 “Spanish flu,” which killed an estimated 20 million people,1 and the additional deaths, social 1 For more detailed estimates of the numbers of deaths caused by the 1918 influenza outbreak, see Barry’s section in Chapter 1.
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary disruption, and economic losses that resulted from pandemics in 1957 and 1968, the general public appears relatively unconcerned about the next “killer flu,” which is conservatively expected to cause between 2 and 8 million deaths. Considerably more attention has been focused on protecting the public from terrorist attacks than from the far more likely and pervasive threat of pandemic influenza. Meanwhile, the danger mounts as the world’s capacity to produce vaccines shrinks and pandemic avian H5N1 influenza—which has infected many people and killed at least 32 to date—takes hold in southeast Asia. Research has identified three essential prerequisites for the start of a pandemic: transmission of a novel viral subtype to humans; viral replication causing disease in humans; and efficient human-to-human transmission of the virus. Since 1997, the first two prerequisites have been met on four occasions; the most recent occurred early this year in Vietnam and Thailand. With H5N1 at or near endemic levels in poultry in many parts of Asia, the world stands at the verge of pandemic and is likely to remain there for years. A recent expert consultation convened by the World Health Organization concluded that “the unpredictability of influenza viruses and the speed with which transmissibility can improve mean that the time for preparedness planning is right now.” To address these urgent concerns, the Institute of Medicine’s Forum on Microbial Threats hosted a public workshop on June 16 and 17, 2004. Through invited presentations and discussions among participants, the workshop informed the Forum, the public, and policy makers of the likelihood of an influenza pandemic and explored issues critical to the preparation and protection of the global community. Topics and questions considered during the workshop’s presentations and discussions included the following: Learning from the past: pandemics and other threats to public health Global preparations against pandemic influenza Preparing the United States for pandemic influenza State and local preparation measures Strategies to prevent and control transmission in birds and other animals Biomedical approaches to preventing or controlling a pandemic Legal issues in pandemic prevention and control Improving preparedness: surveillance, prediction, and communication
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary ACKNOWLEDGMENTS The Forum on Microbial Threats and the Institute of Medicine (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 their participation in the workshop. A full list of presenters can be found in Appendix A. 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, Elizabeth Kitchens, research associate, Laura Sivitz, research associate, and Katherine Oberholtzer, research assistant, who dedicated much effort and time to developing this workshop’s agenda, and for their 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: Patrick Kelley, Alison Mack, Bronwyn Schrecker, Elena Nightingale, Eileen Choffnes, and Kate Giamis. 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 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; Aventis Pasteur; Burroughs Wellcome Fund; U.S. Agency for International Development; Pfizer; GlaxoSmithKline; and The Merck Company Foundation. 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 A.F. Mahmoud, Chair Stanley M. Lemon, Vice-Chair Forum on Microbial Threats
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary In Memoriam John R. La Montagne 1943–2004 This publication from the Forum on Microbial Threats is dedicated to the memory and legacy of John R. La Montagne, Ph.D., Deputy Director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, who unexpectedly died on November 2, 2004, en route to an international meeting on public health. As a founding member of the Forum and a continued supporter and participant in its activities, his contributions deeply enriched the national and international dialogue on emerging and reemerging infectious diseases research. In addition to his service to the Forum, John’s outstanding grasp of the science, his global perspective, and his unwavering interest and support have been of critical importance to efforts of the Institute of Medicine focusing on the Children’s Vaccine Initiative, AIDS research, and vaccines for malaria. As a quiet but tireless champion, he helped to spearhead some of the most important recent global efforts to fight infectious diseases and to improve the health of children and adults everywhere. For nearly 30 years, John’s thoughtful demeanor and even-handed approach led the way in tackling some of nature’s greatest challenges to humankind. Relevant to this workshop summary, his work at NIAID began as the Influenza Program Officer, but it grew to include key leadership roles, including the directorship of the Division of Microbiology and Infectious Diseases. His influence has been incalculable on both national and international programs related to the development of vaccines for pertussis, rotavirus, AIDS, influenza, and malaria; new drugs for tuberculosis; and, more recently, biodefense research. In all of his work, John brought the human and public health dimensions to the efforts of laboratory research. He served the nation and the world immeasurably well, and we are better for it. For the leadership, wise counsel, humor, and friendship that he shared with us and so many others, the Forum is deeply grateful. John will be greatly missed by all who knew him.
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Contents SUMMARY AND ASSESSMENT 1 1 THE STORY OF INFLUENZA 57 1918 Revisited: Lessons and Suggestions for Further Inquiry, John M. Barry 58 Chasing the Elusive 1918 Virus: Preparing for the Future by Examining the Past, Jeffery K. Taubenberger 69 Pandemic Influenza and Mortality: Past Evidence and Projections for the Future, L. Simonsen, D.R. Olson, C. Viboud, E. Heiman, R.J. Taylor, M.A. Miller, and T.A. Reichert 89 2 TODAY’S PANDEMIC THREAT: H5N1 INFLUENZA 115 Genesis of a Highly Pathogenic and Potentially Pandemic H5N1 Influenza Virus in Eastern Asia, K.S. Li, Y. Guan, J. Wang, G.J.D. Smith et al. 116 Avian Influenza Outbreak in Thailand: Current Policies, Chantanee Buranathai 127 The 2003–2004 H5N1 Avian Influenza Outbreak in Vietnam, T.D. Nguyen 130
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary 3 TOWARD PREPAREDNESS: OPPORTUNITIES AND OBSTACLES 141 WHO Consultation on Priority Public Health Interventions Before and During Influenza Pandemic Executive Summary, World Health Organization 144 Pandemic Influenza Preparedness and Response Plan, Department of Health and Human Services 154 Considerations for Pandemic Influenza Planning: A State Perspective Kathleen F. Gensheimer 168 Preparing for Pandemic Influenza: The Need for Enhanced Surveillance, Kathleen F. Gensheimer, Keiji Fukuda, Lynette Brammer, Nancy Cox, Peter A. Patriarca, and Raymond A. Strikes 172 Preparedness Opportunities and Obstacles, Philip H. Hosbach 177 Pandemic Influenza Vaccines: Obstacles and Opportunities, David Fedson 184 Statement from MedImmune, Inc., regarding Reverse Genetics Technology, MedImmune, Inc. 196 Perspectives on Antiviral Use During Pandemic Influenza, Frederick G. Hayden 197 Partnering with the Private Medical System, Gordon W. Grundy 212 4 STRATEGIES FOR CONTROLLING AVIAN INFLUENZA IN BIRDS AND MAMMALS 222 Standards and Activities of the OIE Related to Avian Influenza, Dewan Sibartie 223 U.S. Strategies for Controlling Avian Influenza in Agricultural Systems, David E. Swayne and David L. Suarez 233 Low-Pathogenicity Avian Influenza Outbreaks in Commercial Poultry in California, Carol Cardona 243 5 EMERGING TECHNICAL TOOLS 254 Control of Influenza Virus Infection by Immunity to Conserved Viral Features, Suzanne L. Epstein 255
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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Generation of Transgenic Chickens Resistant to Avian Influenza Virus, Laurence Tiley and Helen Sang 273 Molecular Diagnostics in an Insecure World, Michael L. Perdue 284 Modeling Pandemic Preparedness Scenarios: Health Economic Implications of Enhanced Pandemic Vaccine Supply, Jeroen K. Medema, York F. Zoellnerb, James Ryan, and Abraham Palachea 292 6 BEYOND THE BIOMEDICAL RESPONSE 315 The Economic Impact of Pandemic Influenza in the United States: Priorities for Intervention, Martin I. Meltzer, Nancy J. Cox, and Keiji Fukuda 316 Increasing Awareness and Uptake of Influenza Immunization, Glen Nowak 339 Strategies to Remedy Panic in a Pandemic: Lessons from Biodefense, Monica Schoch-Spana 347 Public Health Preparedness and Ethical Values in Pandemic Influenza, Lawrence O. Gostin 357 APPENDIXES A PANDEMIC INFLUENZA: ASSESSING CAPABILITIES FOR PREVENTION AND RESPONSE 373 B SELECTED BIBLIOGRAPHY 381 C THE CRITICAL PATH TO NEW MEDICAL PRODUCTS 388 D FORUM MEMBERS, SPEAKERS, AND STAFF BIOGRAPHIES 390
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