ETHICAL AND LEGAL CONSIDERATIONS IN MITIGATING PANDEMIC DISEASE

Workshop Summary

Stanley M. Lemon, Margaret A. Hamburg, P. Frederick Sparling, Eileen R. Choffnes, and Alison Mack, Rapporteurs

Forum on Microbial Threats

Board on Global Health

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary ETHICAL AND LEGAL CONSIDERATIONS IN MITIGATING PANDEMIC DISEASE Workshop Summary Stanley M. Lemon, Margaret A. Hamburg, P. Frederick Sparling, Eileen R. Choffnes, and Alison Mack, Rapporteurs Forum on Microbial Threats Board on Global Health INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Ethical and Legal Considerations in Mitigating Pandemic Disease: 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. This project was supported by contracts between the National Academy of Sciences and the U.S. Department of Health and Human Services: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of Defense: Global Emerging Infections Surveillance and Response System, Walter Reed Army Institute of Research, and Defense Threat Reduction Agency; U.S. Department of Veterans Affairs; U.S. Department of Homeland Security; U.S. Department of State; Lawrence Livermore National Laboratory; American Society for Microbiology; Sanofi Pasteur; Burroughs Wellcome Fund; Pfizer; GlaxoSmithKline; Infectious Diseases Society of America; 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. International Standard Book Number-13: 978-0-309-10769-3 International Standard Book Number-10: 0-309-10769-5 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 2007 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. Suggested citation: Institute of Medicine (IOM). 2007. Ethical and Legal Considerations in Mitigating Pandemic Disease, Workshop Summary. Washington, DC: The National Academies Press.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: 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. Ralph J. Cicerone 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. 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. Ralph J. Cicerone and Dr. Wm. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary FORUM ON MICROBIAL THREATS STANLEY M. LEMON (Chair), School of Medicine, University of Texas Medical Branch, Galveston MARGARET A. HAMBURG (Vice-chair), Nuclear Threat Initiative/Global Health & Security Initiative, Washington, DC P. FREDERICK SPARLING (Vice-chair), University of North Carolina, Chapel Hill DAVID W. K. ACHESON, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Rockville, Maryland RUTH L. BERKELMAN, Emory University, Center for Public Health Preparedness and Research, Rollins School of Public Health, Atlanta, Georgia ROGER G. BREEZE, Centaur Science Group, Washington, DC STEVEN J. BRICKNER, Pfizer Global Research and Development, Pfizer Inc., Groton, Connecticut ENRIQUETA C. BOND, Burroughs Wellcome Fund, Research Triangle Park, North Carolina NANCY CARTER-FOSTER, Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, DC GAIL H. CASSELL, Eli Lilly & Company, Indianapolis, Indiana BILL COLSTON, Lawrence Livermore National Laboratory, Livermore, California RALPH L. ERICKSON, Global Emerging Infections Surveillance and Response System, Department of Defense, Silver Spring, Maryland MARK B. FEINBERG, Merck Vaccine Division, Merck & Co., West Point, Pennsylvania J. PATRICK FITCH, National Biodefense Analysis and Countermeasures Center, Frederick, Maryland DARRELL R. GALLOWAY, Medical S&T Division, Defense Threat Reduction Agency, Ft. Belvoir, Virginia S. ELIZABETH GEORGE, Biological and Chemical Countermeasures Program, Department of Homeland Security, Washington, DC JESSE L. GOODMAN, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland EDUARDO GOTUZZO, Instituto de Medicina Tropical–Alexander von Humbolt, Universidad Peruana Cayetano Heredia, Lima, Peru JO HANDELSMAN, College of Agricultural and Life Sciences, University of Wisconsin, Madison CAROLE A. HEILMAN, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland DAVID L. HEYMANN, Polio Eradication, World Health Organization, Geneva, Switzerland PHIL HOSBACH, New Products and Immunization Policy, Sanofi Pasteur, Swiftwater, Pennsylvania

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary JAMES M. HUGHES, Global Infectious Diseases Program, Emory University, Atlanta, Georgia STEPHEN A. JOHNSTON, Arizona BioDesign Institute, Arizona State University, Tempe GERALD T. KEUSCH, Boston University School of Medicine and Boston University School of Public Health, Massachusetts RIMA F. KHABBAZ, National Center for Preparedness, Detection and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia LONNIE J. KING, Center for Zoonotic, Vectorborne, and Enteric Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia GEORGE W. KORCH, United States Army Medical Research Institute for Infectious Diseases, Ft. Detrick, Maryland JOSHUA LEDERBERG, The Rockefeller University, New York LYNN G. MARKS, Medicine Development Center, GlaxoSmithKline, Collegeville, Pennsylvania EDWARD McSWEEGAN, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland STEPHEN S. MORSE, Center for Public Health Preparedness, Columbia University, New York MICHAEL T. OSTERHOLM, Center for Infectious Disease Research and Policy, School of Public Health, University of Minnesota, Minneapolis GEORGE POSTE, Arizona BioDesign Institute, Arizona State University, Tempe DAVID A. RELMAN, Stanford University, Palo Alto, California GARY A. ROSELLE, Central Office, Veterans Health Administration, Department of Veterans Affairs, Washington, DC JANET SHOEMAKER, Office of Public Affairs, American Society for Microbiology, Washington, DC BRIAN J. STASKAWICZ, Department of Plant and Microbial Biology, University of California, Berkeley TERENCE TAYLOR, International Council for the Life Sciences, Washington, DC Staff EILEEN CHOFFNES, Forum Director ALLISON BRANTLEY, Sr. Program Assistant KIM LUNDBERG, Research Associate1 ALISON MACK, Science Writer KATE SKOCZDOPOLE, Research Associate 1 Until November 2006.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary BOARD ON GLOBAL HEALTH MARGARET HAMBURG (Chair), Consultant, Nuclear Threat Initiative, Washington, DC GEORGE ALLEYNE, Director Emeritus, Pan American Health Organization, Washington, DC YVES BERGEVIN, Coordinator Reproductive Health, Africa Division, United Nations Development Fund, New York, New York 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 (IOM Foreign Secretary), Professor, Robert F. Wagner School of Public Service, New York University, New York DAVID R. CHALLONER, Vice President for Health Affairs, Emeritus, University of Florida, Gainesville CIRO DE QUADROS, Albert B. Sabin Vaccine Institute, Washington, DC 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 and Director, Center for Global Health, University of Virginia School of Medicine, Charlottesville GERALD KEUSCH, Assistant Provost for Global Health, Boston University School of Medicine, and Associate Dean for Global Health, Boston University School of Public Health, Massachusetts JEFFREY KOPLAN, Vice President for Academic Health Affairs, Emory University, Atlanta, Georgia SHEILA LEATHERMAN, Research Professor, University of North Carolina School of Public Health, Chapel Hill 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 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 Staff PATRICK KELLEY, Director ALLISON BRANTLEY, Sr. Program Assistant IOM boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the reports rests with the authors and the institution.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: John C. Bailar III, University of Chicago, Illinois, Professor Emeritus David P. Fidler, Indiana University School of Law, Bloomington Campus Stephen S. Morse, Center for Public Health Preparedness, National Center for Disaster Preparedness and Columbia University Mailman School of Public Health, New York Mary E. Wilson, Department of Population and International Health, Harvard University Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Melvin Worth, Scholar-in-Residence, Institute of Medicine. Appointed by the National Research Council, he 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 authoring committee and the institution.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Preface The Forum on Emerging Infections was created by the Institute of Medicine (IOM) in 1996 in response to a request from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The purpose of the Forum is to provide structured opportunities for leaders from government, academia, and industry to meet and examine issues of shared concern regarding research, prevention, detection, and management of emerging or reemerging infectious diseases. In pursuing this task, the Forum provides a venue 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; for this reason, it does not provide advice or recommendations on any specific policy initiative pending before any agency or organization. Its value derives instead from the diversity of its membership and from the contributions that individual members make throughout the activities of the Forum. In September 2003, the Forum changed its name to the Forum on Microbial Threats. ABOUT THE WORKSHOP The failure to develop an effective plan before the occurrence of a public health emergency can have devastating consequences, as was recently demonstrated by the federal, state, and local responses to hurricanes Katrina and Rita. The National Response Plan, developed by the Department of Homeland Security in December 2004, serves as the blueprint for the coordination—such as there is—of federal agencies during any emergency. Additionally, the World

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Health Organization created a pandemic preparedness plan early last year, and the Department of Health and Human Services released a more specific pandemic influenza plan in November 2005. At the same time, some countries have created influenza contingency plans, and many states in this country are now doing the same. Local and state governments share the responsibility for protecting their citizens from disasters and for helping them recover when a disaster strikes. In some cases, a disaster is beyond the capabilities of the state and local governments to handle. The Stafford Disaster Relief and Emergency Assistance Act (1988), as amended, establishes a process for requesting and obtaining a Presidential disaster declaration, defines the type and scope of assistance available from the federal government, and sets the conditions for obtaining assistance. The Federal Emergency Management Agency (FEMA) Directorate, now part of the Department of Homeland Security, is given the task of coordinating the response. In the fall of 2005, the federal government’s response to hurricanes Katrina and Rita in support of state and local government first responders was less than optimal, despite a lead time of at least 96 hours. In the case of an infectious disease emergency—such as the pandemic spread of H5N1 avian influenza—the roles and responsibilities of local, state, and federal first responders will need to be defined in advance in order to assure an effective response that could lessen the morbidity and mortality associated with such an event. Even though governments at all levels are beginning to formulate public health emergency response plans, the critical ethical and legal issues involved in implementing these plans and communicating these plans to the public in a transparent fashion are often pushed to the side. Past public health emergencies—including influenza pandemics, biological threats and terrorism, SARS, and the ongoing HIV/AIDS crisis—have offered numerous lessons that can be applied in future infectious disease outbreaks. To examine the ethical and legal aspects of preparing for pandemic disease, the IOM’s Forum on Microbial Threats hosted a public workshop on September 19-20, 2006, in Washington, DC. The presentations and discussions of the workshop were intended to explore the existing knowledge and unanswered questions pertaining to (but not limited to) the following topics: Understanding the Challenges of the Future by Examining the Past: Influenza/Smallpox/SARS Domestic, Regional, and International Preparedness Planning Disease Intervention Strategies—Quarantine, Containment, and Modeling Priority Setting for Access to Limited-Availability Health Care Resources

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary ACKNOWLEDGMENTS The Forum on Microbial Threats and the IOM wish to express their warmest appreciation to the individuals and organizations who gave their valuable time to provide information and advice to the Forum through their participation in this workshop. A full list of presenters can be found in Appendix A. The Forum also would like to express its deepest appreciation to Dr. Mirta Roses Periago, director of the Pan American Health Organization (PAHO), for allowing the Forum to hold this workshop at the PAHO headquarters in Washington, DC. Special thanks and gratitude are also extended to the tireless efforts of Ed Harkness, Rickey Harpster, Sergio Chacon-Oportus, Freddie Aviless, Orlando Ortiz, and, Amira Nikolas without whose help this workshop would not have been possible. 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 Eileen Choffnes, director of the Forum, and Kate Skoczdopole, research associate, for dedicating much effort and time to developing this workshop’s agenda and for their thoughtful and insightful approach and skill in translating the workshop’s 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, Allison Brantley, Kim Lundberg, Lara Andersen, Kim Weingarten, Angela Mensah, Dalia Gilbert, Thelma Cox, and Robert Pool. Finally, the Forum wishes to recognize the 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, National Institute of Allergy and Infectious Diseases, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of Defense: Global Emerging Infections Surveillance and Response System, Walter Reed Army Institute of Research, and Defense Threat Reduction Agency; U.S. Department of Veterans Affairs; U.S. Department of Homeland Security; U.S. Department of State; Lawrence Livermore National Laboratory; American Society for Microbiology; Sanofi Pasteur; Burroughs Wellcome Fund; Pfizer; GlaxoSmithKline; Infectious Diseases Society of America; and the Merck Company Foundation. The views presented in this workshop summary report are those of the workshop participants and rapporteurs and are not necessarily those of the Forum on Microbial Threats or its sponsors. Stanley M. Lemon, Chair P. Frederick Sparling, Vice-chair Margaret A. Hamburg, Vice-chair Forum on Microbial Threats

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Contents     Summary and Assessment   1 1   Learning from Pandemics Past   31      Overview,   31      Past as Prologue?, David Heymann, M.D.   33      Contemplating Pandemics: The Role of Historical Inquiry in Developing Pandemic-Mitigation Strategies for the Twenty-First Century, Howard Markel, M.D., Ph.D.   44      References,   58 2   Planning for Pandemic Influenza   61      Overview,   61      Pandemic Influenza Preparedness: Regional Planning Efforts, Oscar J. Mujica, M.D., Otavio Oliva, M.D., Thais dos Santos, B.Sc., and John P. Ehrenberg, M.D.John P. Ehrenberg, M.D.   66      References,   74 3   Strategies for Disease Containment   76      Overview,   76      Preparing for Pandemic Influenza: Legal and Ethical Challenges, Lawrence O. Gostin, J.D., and Benjamin E. Berkman, J.D., M.P.H.   78

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary      Ethical and Legal Considerations in Preparing for Pandemic Influenza, James W. LeDuc, Ph.D., Drue H. Barrett, Ph.D., Anthony D. Moulton, Ph.D., Richard A. Goodman, M.D., J.D., M.P.H., Kathy Kinlaw, M.Div., and Robert J. Levine, M.D.   90      Public Health and Ethical Considerations in Planning for Quarantine, Martin Cetron, M.D., and Julius Landwirth, M.D., J.D.   99      Remarks on the Role of Modeling in Infectious Disease Mitigation and Containment, Joshua M. Epstein, Ph.D.   105      Containing a Large Bioterrorist Smallpox Attack: A Computer Simulation Approach, Ira M. Longini, Jr., Ph.D., M. Elizabeth Halloran, M.D., D.Sc., M.P.H., Azhar Nizam, M.S., Yang Yang, Shufu Xu, M.S., Donald S. Burke, M.D., Derek A. T. Cummings, Ph.D., and Joshua M. Epstein, Ph.D.   112      Individual-Based Computational Modeling of Smallpox Epidemic Control Strategies, Donald S. Burke, M.D., Joshua M. Epstein, Ph.D., Derek A. T. Cummings, Ph.D., Jon I. Parker, B.S., Kenneth C. Cline, B.S., Ramesh M. Singa, B.S., and Shubha Chakravarty, M.S.   132      References,   144 4   Ethical Issues in Pandemic Planning and Response   154      Overview,   154      Ethical Considerations in International Preparedness Planning Efforts, Alexander Morgan Capron   157      Social Justice and Pandemic Planning and Response, Ruth Faden, Ph.D., M.P.H.   177      Reducing State Variability in Health Emergency Preparedness Through Federal Standards, Enforcement, and Public Accountability: Lessons from the Environmental Field, Shelley A. Hearne, Dr.P.H.   183      Intensive Care Unit Triage During an Influenza Pandemic: The Need for Specific Clinical Guidelines, Bernard Lo, M.D., and Douglas B. White, M.D.   192      References,   198     Appendixes     A   Agenda   203 B   Acronyms   207 C   Forum Member Biographies   209

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Tables, Figures, and Boxes TABLES SA-1   NVAC/ACIP Recommendations for Prioritization of Pandemic Influenza Vaccine,   10 SA-2   Variety of Ethical Approaches/Foci,   20 SA-3   Substantive Principles,   21 1-1   From Quarantine to International Health Regulations: A Framework for Global Health Surveillance and Response,   36 2-1   Potential Impact of a 25 Percent Clinical Attack Rate Influenza Pandemic in Latin America and the Caribbean, by Main Health Outcome and Severity Scenario, Mid-2006,   69 2-2   Pandemic Preparedness Readiness in Latin America and the Caribbean. Current Compliance (percentage) with WHO Guidelines, by Core Components and PAHO Sub-Regions, Mid-2006,   70 2-3   Assessment of the Emergency Preparedness NIPPP Component, Including Legal and Ethical Issues, in Latin America and the Caribbean. Current Compliance (percentage) with WHO Guidelines, by Main Areas and PAHO Sub-Regions, Mid-2006,   72 3-1   Ethical Guidelines in Pandemic Influenza,   93 3-2   Selected Public Health Law-Related Issues and Needs for Effective Mandatory Social Distancing,   96 3-3   Selected Challenges to Legal Preparedness for Social Distancing,   96

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary 3-4   Daily Transmission Probabilities, x, Among Children and Adults, by Mixing Group, and Group Sizes,   151 3-5   Smallpox Simulation Scenarios,   124 3-6   Distribution of Cases Excluding Initial Cases for Surveillance and Containment with Vaccination of Close Contacts (Scenario 3),   127 3-7   Average Distribution of the Sources of Infections for Smallpox Cases with Surveillance and Containment (Scenario 3), Compared to the Distribution Observed in European Epidemics, 1950-1971,   127 3-8   Scenario Results, Excluding the 500 Initial Cases,   128 3-9   Number of Vaccine Doses,   129 3-10   Surveillance and Containment for Various Delays in Case Recognition, Excluding the 500 Initial Cases,   130 3-11   Summary of Results of Epidemic Simulation Runs Showing the Effects of “No Response” Scenarios 1 and 2 and Response Scenarios 3-10 on Epidemics Initiated by the Introduction of Ten Smallpox Cases into 6,000-Person Towns,   152 3-12   Summary of Results of Epidemic Simulation Runs Showing the Effects of “No Response” Scenarios 1 and 2 and Response Scenarios 3-10 on Epidemics Initiated by the Introduction of 500 Smallpox Cases into 50,000-Person Towns,   153 4-1   CDC Determination of States’ Readiness to Receive and Distribute the Strategic National Stockpile as of October 2006,   189 FIGURES SA-1   Community-based interventions,   15 1-1   The spread of epidemics,   35 1-2   International spread of polio from Nigeria in 2003,   36 1-3   SARS epidemic curve, China, 2002-2003,   40 2-1   Stages of federal government response,   63 3-1   Ordinary smallpox natural history,   110 3-2   Contact dendrogram of a rapidly expanding epidemic (one index case),   111 3-3   The natural history of ordinary smallpox in terms of time lines,   116 3-4   The natural history of modified smallpox in terms of time lines,   118 3-5   The natural history of hemorrhagic smallpox in terms of time lines,   119 3-6   Structure of the populations,   120

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary     3-7   A plot showing the relationship between the transmission probability x during the second day of fever from an unvaccinated case of smallpox to an exposed unvaccinated person in a mixing group and the maximum household secondary attack (SAR) rate if the person circulated in the mixing group for the entire infectious period,   125 3-8   The first 60 days of one stochastically simulated smallpox epidemic with 500 randomly selected initially infected people from all age groups,   126 3-9   Schematic diagram of the social structures represented in the model,   136 3-10   Summary sketch of the interventions and combinations of baseline conditions and interventions studied in “no response” scenarios 1 and 2 and response scenarios 3-10,   138 3-11   Number of cases of each clinical disease expression type and epidemic reproductive rate attributable to each of these clinical disease types for each epidemic generation,   142 BOXES 2-1   PAHO Strategy in Supporting Member States in the DevelopmentPAHO Strategy in Supporting Member States in the Development and Assessment of National Influenza Pandemic Preparedness Plans (NIPPPs),   68 2-2   Core Legal and Ethical Issues to Be Considered and Assessed in the NIPPPs,   71 2-3   Achievements of PAHO’s Member States in the Development andMember States in the Development and Assessment of NIPPPs,   73 ANNEX 1-1   History of World Health Organization (WHO) and International Cooperation in Public Health,   59

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