Perspectives on Research
with H5N1 Avian Influenza

Scientific Inquiry, Communication, Controversy

SUMMARY OF A WORKSHOP

Karin Matchett, Anne-Marie Mazza, and Steven Kendall, Rapporteurs

Committee on Science, Technology, and Law
Policy and Global Affairs

Board on Life Sciences
Division on Earth and Life Studies

Forum on Microbial Threats
Board on Global Health

NATIONAL RESEARCH COUNCIL AND
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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Karin Matchett, Anne-Marie Mazza, and Steven Kendall, Rapporteurs Committee on Science, Technology, and Law Policy and Global Affairs Board on Life Sciences Division on Earth and Life Studies Forum on Microbial Threats Board on Global Health

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract\No. B2012-03 between the National Academy of Sciences and Alfred P. Sloan Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13:  978-0-309-26775-5 International Standard Book Number-10:  0-309-26775-7 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Room 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2013 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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 Acad- emy 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 e ­ ngineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 Sci- ences 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON THE H5N1 AVIAN FLU VIRUS: HAS THE PARADIGM CHANGED? DAVID KORN (IOM), (Co-Chair), Consultant in Pathology, Massachusetts General Hospital; Professor of Pathology, Harvard Medical School DAVID RELMAN (IOM), (Co-Chair), Thomas C. and Joan M. Merigan Professor, Departments of Medicine, and of Microbiology and Immunology, Stanford University; Chief, Infectious Disease Section, VA Palo Alto Health Care System RUTH BERKELMAN (IOM), Rollins Professor and Director Center for Public Health Preparedness and Research, Rollins School of Public Health, Emory University GAIL CASSELL (IOM), Visiting Professor, Department of Global Health and Social Medicine, Harvard Medical School; Vice President of TB Drug Discovery, Infectious Disease Research Institute STANLEY FALKOW (IOM), Robert W. and Vivian K. Cahill Professor Emeritus of Microbiology and Immunology and Medicine, Department of Microbiology and Immunology, Stanford University DAVID FIDLER, James L. Calamaras Professor of Law, Maurer School of Law, Indiana University RICHARD J. ROBERTS, Chief Scientific Officer, New England Biolabs Staff ANNE-MARIE MAZZA, Director, Committee on Science, Technology, and Law, National Research Council EILEEN CHOFFNES, Director/Scholar, Forum on Microbial Threats, Institute of Medicine JO HUSBANDS, Scholar/Senior Project Director, Board on Life Sciences, National Research Council STEVEN KENDALL, Associate Program Officer, Committee on Science, Technology, and Law, National Research Council v

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COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW DAVID KORN (IOM), (Co-Chair), Massachusetts General Hospital and Harvard Medical School RICHARD A. MESERVE (NAE), (Co-Chair), Carnegie Institution for Science and Senior Of Counsel, Covington & Burling LLP BARBARA E. BIERER, Harvard Medical School and Brigham and Women’s Hospital ELIZABETH H. BLACKBURN (NAS/IOM), University of California, San Francisco SHERWOOD BOEHLERT, U.S. House of Representatives (retired) JOHN BURRIS, Burroughs Wellcome Fund CLAUDE CANIZARES (NAS), Massachusetts Institute of Technology ARTURO CASADEVALL, Albert Einstein College of Medicine JOE S. CECIL, Federal Judicial Center ROCHELLE COOPER DREYFUSS, New York University School of Law DREW ENDY, Stanford University and The BioBricks Foundation MARCUS FELDMAN, Stanford University JEREMY FOGEL, The Federal Judicial Center ALICE P. GAST (NAE), Lehigh University JASON GRUMET, Bipartisan Policy Center BENJAMIN W. HEINEMAN, JR., Harvard Law School and Harvard Kennedy School of Government D. BROCK HORNBY, U.S. District Court, District of Maine WALLACE LOH, University of Maryland, College Park MARGARET MARSHALL, Massachusetts Supreme Judicial Court (retired) ALAN B. MORRISON, George Washington University Law School CHERRY MURRAY (NAS/NAE), Harvard University ROBERTA NESS (IOM), University of Texas School of Public Health PRABHU PINGALI (NAS), Bill and Melinda Gates Foundation HARRIET RABB, Rockefeller University DAVID RELMAN (IOM), Stanford University and VA Palo Alto Health Care System RICHARD REVESZ, New York University School of Law DAVID S. TATEL, U.S. Court of Appeals for the District of Columbia Circuit SOPHIE VANDEBROEK, Xerox Corporation Staff ANNE-MARIE MAZZA, Director STEVEN KENDALL, Associate Program Officer vi

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BOARD ON LIFE SCIENCES KEITH R. YAMAMOTO (NAS/IOM), (Chair), University of California, San Francisco BONNIE L. BASSLER (NAS), Princeton University VICKI L. CHANDLER (NAS), Gordon and Betty Moore Foundation SEAN EDDY, Janelia Farm Research Campus MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation DAVID R. FRANZ, Midwest Research Institute LOUIS J. GROSS, University of Tennessee RICHARD A. JOHNSON, Global Helix LLC CATO T. LAURENCIN (NAE/IOM), University of Connecticut Health Center ALAN LESHNER (IOM), American Association for the Advancement of Science BERNARD LO (IOM), University of California, San Francisco ROBERT M. NEREM (NAE/IOM), Georgia Institute of Technology, Atlanta, Georgia CAMILLE PARMESAN, University of Texas, Austin MURIEL E. POSTON, National Science Foundation ALISON G. POWER, Cornell University MARGARET RILEY, University of Massachusetts, Amherst BRUCE W. STILLMAN (IOM), Cold Spring Harbor Laboratory CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine MARY WOOLLEY (IOM), Research!America Staff FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director JAY B. LABOV, Senior Scientist/Program Director for Biology Education KATHERINE BOWMAN, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer INDIA HOOK-BARNARD, Program Officer KEEGAN SAWYER, Program Officer BETHELHEM BANJAW, Financial Associate CARL-GUSTAV ANDERSON, Program Associate ORIN LUKE, Senior Program Assistant SAYYEDA AYESHA AHMED, Senior Program Assistant vii

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FORUM ON MICROBIAL THREATS DAVID A. RELMAN (IOM), (Chair), Stanford University and VA Palo Alto Health Care System JAMES M. HUGHES (IOM), (Vice Chair), Emory University LONNIE J. KING (IOM), (Vice Chair), Ohio State University KEVIN ANDERSON, Department of Homeland Security ENRIQUETA C. BOND (IOM), Burroughs Wellcome Fund (Emeritus) ROGER G. BREEZE, Lawrence Livermore National Laboratory PAULA R. BRYANT, Defense Threat Reduction Agency JOHN BURRIS, Burroughs Wellcome Fund ARTURO CASADEVALL, Albert Einstein College of Medicine PETER DASZAK, EcoHealth Alliance JEFFREY S. DUCHIN, Communicable Disease Epidemiology & Immunization Section for Public Health – Seattle & King County, WA JONATHAN EISEN, University of California, Davis RALPH L. ERICKSON, Walter Reed Army Institute of Research MARK B. FEINBERG, Merck & Co., Inc. JACQUELINE FLETCHER, Oklahoma State University JESSE L. GOLDMAN (IOM), Food and Drug Administration EDUARDO GOTUZZO, Instituto de Medicina Tropical – “Alexander von Humbolt” Universidad Peruana Cayetano Heredia CAROLE A. HEILMAN, National Institutes of Allergy and Infectious Diseases, National Institutes of Health DAVID L. HEYMANN (IOM), Health Protection Agency, United Kingdom ZHI HONG, GlaxoSmithKline PHIL HOSBACH, Sanofi Pasteur STEPHAN A. JOHNSTON, Biodesign Institute, Arizona State University GERALD T. KEUSCH (IOM), Boston University School of Public Health RIMA F. KHABBAZ, Centers for Disease Control and Prevention STANLEY M. LEMON, University of North Carolina, Chapel Hill EDWARD MCSWEEGAN, National Institute of Allergy and Infectious Diseases, National Institutes of Health MARK A. MILLER, Fogarty International Center, National Institutes of Health JULIE PAVLIN, Armed Forces Health Surveillance Center GEORGE POSTE, Complex Adaptive Systems Initiative, Arizona State University DAVID RIZZO, University of California, Davis GARY A. ROSELLE, Veterans Administration Headquarters, Cincinnati, OH ALAN S. RUDOLPH, Defense Threat Reduction Agency viii

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KEVIN RUSSELL, Armed Forces Health Surveillance Center JANET SHOEMAKER, American Society for Microbiology P. FREDERICK SPARLING, University of North Carolina, Chapel Hill MURRAY TROSTLE, U.S. Agency for International Development MARY E. WILSON, Harvard University Staff EILEEN R. CHOFFNES, Director/Scholar LEIGHANNE OLSEN, Program Officer KATHERINE MCCLURE, Senior Program Associate REBEKAH HUTTON, Research Associate PAMELA BERTELSON, Senior Program Assistant ix

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Acknowledgments We would like to acknowledge the contributions of the following indi- viduals who made presentations at the workshop: Ann Arvin, Lucile Salter Packard Professor of Pediatrics (Infectious Diseases) and Microbiology and Immunology, Stanford University School of Medicine; Ruth L. Berkelman, Rollins Professor and Director Center for Public Health Preparedness and Research, Rollins School of Public Health, Emory University; Roger Brent, Member, Division of Basic Sciences and Adjunct Member, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center; Robert Cook-Deegan, Director for Genome Ethics, Law, and Policy, Institute for Genome Sciences and Policy, Duke University; Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; David Franz, United States Army Medical Research Institute for In- fectious Diseases (retired); David Heymann, Chairman, Health Protection Agency, U.K. and Head of the Centre on Global Health Security at Chatham House, London and Professor of Infectious Disease Epidemiology at the London School of Hygiene and Tropical Medicine; Gregory E. Kaebnick, Research Scholar and editor of the Hastings Center Report, The Hastings Center; Lawrence D. Kerr, Deputy Director for Global Biological Threats, National Counterproliferation Center, Office of the Director of National Intelligence; Daniel J. Kevles, Stanley Woodward Professor of History, Yale University; David Korn, Consultant in Pathology, Massachusetts Gen- ­ eral Hospital and Professor of Pathology, Harvard Medical School; Piers Millet, Deputy Head of the Implementation Support Unit for the Biological ­ eapons Convention, United Nations Office for Disarmament; Joe Palca, W ­ ­ Science Correspondent, National Public Radio; David Relman, Thomas C. ­ xi

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xii ACKNOWLEDGMENTS and Joan M. Merigan Professor, Departments of Medicine, and of Microbi- ology and Immunology, Stanford University and Chief, Infectious Disease Section, VA Palo Alto Health Care System; ­ effery K. Taubenberger, Chief J of the Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Robert G. Webster, Rose Marie Thomas Chair and Professor, Division of Virology, Department of Infectious Diseases, St. Jude Children’s Research Hospital; Carl Zimmer, Frequent Contributor, The New York Times. We would also like to thank session moderators David Baltimore, President Emeritus and Robert Andrews Millikan Professor of Biology, California Institute of Technology; Lawrence O. Gostin, University Professor in Global Health Law, Georgetown University, Faculty Director of the O’Neill Institute for National and Global Health Law, and Direc- tor of the WHO Collaborating Center on Public Health Law and Human Rights; Alice Huang, Senior Faculty Associate in Biology, California Insti- tute of Technology; and ­ arold T. ­ hapiro, President Emeritus and Profes- H S sor of Economics and Public Affairs, Princeton University. ­ This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with pro- cedures approved by the National Academies’ 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 quality and objectivity. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this re- port: Gigi Kwik Gronvall, University of Pittsburgh; David Korn, Harvard University and Massachusetts General Hospital; Robert Lamb, Northwest- ern University; Henry Metzger, National Institute of Arthritis and Musculo­ skeletal and Skin Diseases, National Institutes of Health; Peter Palese, Mount Sinai School of Medicine; David Relman, Stanford University and VA Palo Alto Health Care System; and Jeffery K. Taubenberger, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the content of the report, nor did they see the final draft before its release. The re- view of this report was overseen by Huda Akil, University of Michigan. A ­ ppointed by the National Academies, she 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 rapporteurs and the institution.

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Contents 1 INTRODUCTION 1 The H5N1 Controversy, 1 Dual-use Research, 3 2 THE QUICKENING PACE OF BIOLOGICAL RESEARCH AND CURRENT CHALLENGES IN BIOSECURITY 5 Developments in Microbiology, 5 Developments at the Intersection of Biosecurity and Science, 9 3 INFLUENZA 15 Virulence, Transmissibility, and the Importance of Mutations for Influenza A Viruses, 15 Case Studies: The 1918 Spanish Influenza Pandemic and H5N1, 19 4 SCIENTISTS AND THE SOCIAL CONTRACT 29  Transparency, Public Participation and Confidence, and the Media, 33  The Role of Corporations in Life Sciences Research, 34 5 GOVERNANCE AND OVERSIGHT 35  U.S. Policy on Dual-use Research of Concern, 36  Role of Research Institutions, 37  Implications for International Policies, 38 xiii

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6 MOVING FORWARD 45 Regulatory Paths, Gray Zones, and Avoiding Undue Burdens, 45 Dual-use Research: What’s In a Name?, 46 Risk, 47 Broad and Inclusive Participation, 47 The Need to Revamp the Education of our Next Generation of Scientists, 48 APPENDIXES A Timeline 51 B Official Statements 55 C The Two Published H5N1 Papers 81 D Workshop Agenda 101 E Workshop Attendees 103 F Biographical Information of Committee and Staff 107 BOXES AND FIGURES Boxes 2-1 Asilomar Conference on Recombinant DNA, 7 3-1 Biosafety Levels for Infectious Disease Research, 22 Figures 3-1 Diagrammatic Representation of an Influenza A Virus, 17 3-2 Influenza A Virus Host Range, 18 3-3 Descendants of the 1918 H1N1 “Spanish” Influenza Virus, 21