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
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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.
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Suggested citation: Institute of Medicine (IOM). 2007. Ethical and Legal Considerations in Mitigating Pandemic Disease, Workshop Summary. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
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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
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
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.
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.
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
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:
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Understanding the Challenges of the Future by Examining the Past: Influenza/Smallpox/SARS
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Domestic, Regional, and International Preparedness Planning
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Disease Intervention Strategies—Quarantine, Containment, and Modeling
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Priority Setting for Access to Limited-Availability Health Care Resources
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
Contents
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Past as Prologue?, |
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Contemplating Pandemics: The Role of Historical Inquiry in Developing Pandemic-Mitigation Strategies for the Twenty-First Century, |
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Pandemic Influenza Preparedness: Regional Planning Efforts, |
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Preparing for Pandemic Influenza: Legal and Ethical Challenges, |
Tables, Figures, and Boxes
TABLES
SA-1 |
NVAC/ACIP Recommendations for Prioritization of Pandemic Influenza Vaccine, |
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SA-2 |
Variety of Ethical Approaches/Foci, |
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SA-3 |
Substantive Principles, |
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1-1 |
From Quarantine to International Health Regulations: A Framework for Global Health Surveillance and Response, |
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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, |
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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, |
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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, |
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3-1 |
Ethical Guidelines in Pandemic Influenza, |
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3-2 |
Selected Public Health Law-Related Issues and Needs for Effective Mandatory Social Distancing, |
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3-3 |
Selected Challenges to Legal Preparedness for Social Distancing, |
3-4 |
Daily Transmission Probabilities, x, Among Children and Adults, by Mixing Group, and Group Sizes, |
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3-5 |
Smallpox Simulation Scenarios, |
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3-6 |
Distribution of Cases Excluding Initial Cases for Surveillance and Containment with Vaccination of Close Contacts (Scenario 3), |
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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, |
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3-8 |
Scenario Results, Excluding the 500 Initial Cases, |
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3-9 |
Number of Vaccine Doses, |
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3-10 |
Surveillance and Containment for Various Delays in Case Recognition, Excluding the 500 Initial Cases, |
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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, |
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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, |
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4-1 |
CDC Determination of States’ Readiness to Receive and Distribute the Strategic National Stockpile as of October 2006, |
FIGURES
SA-1 |
Community-based interventions, |
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1-1 |
The spread of epidemics, |
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1-2 |
International spread of polio from Nigeria in 2003, |
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1-3 |
SARS epidemic curve, China, 2002-2003, |
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2-1 |
Stages of federal government response, |
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3-1 |
Ordinary smallpox natural history, |
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3-2 |
Contact dendrogram of a rapidly expanding epidemic (one index case), |
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3-3 |
The natural history of ordinary smallpox in terms of time lines, |
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3-4 |
The natural history of modified smallpox in terms of time lines, |
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3-5 |
The natural history of hemorrhagic smallpox in terms of time lines, |
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3-6 |
Structure of the populations, |
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, |
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3-8 |
The first 60 days of one stochastically simulated smallpox epidemic with 500 randomly selected initially infected people from all age groups, |
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3-9 |
Schematic diagram of the social structures represented in the model, |
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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, |
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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, |
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), |
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2-2 |
Core Legal and Ethical Issues to Be Considered and Assessed in the NIPPPs, |
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2-3 |
Achievements of PAHO’s Member States in the Development andMember States in the Development and Assessment of NIPPPs, |
ANNEX
1-1 |
History of World Health Organization (WHO) and International Cooperation in Public Health, |