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.
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 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 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.
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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
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
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
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
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
Acknowledgments
We would like to acknowledge the contributions of the following individuals 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 Infectious 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 General Hospital and Professor of Pathology, Harvard Medical School; Piers Millet, Deputy Head of the Implementation Support Unit for the Biological Weapons Convention, United Nations Office for Disarmament; Joe Palca, Science Correspondent, National Public Radio; David Relman, Thomas C.
and Joan M. Merigan Professor, Departments of Medicine, and of Microbiology and Immunology, Stanford University and Chief, Infectious Disease Section, VA Palo Alto Health Care System; Jeffery K. Taubenberger, Chief 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 Director of the WHO Collaborating Center on Public Health Law and Human Rights; Alice Huang, Senior Faculty Associate in Biology, California Institute of Technology; and Harold T. Shapiro, President Emeritus and Professor 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 procedures 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 report: Gigi Kwik Gronvall, University of Pittsburgh; David Korn, Harvard University and Massachusetts General Hospital; Robert Lamb, Northwestern University; Henry Metzger, National Institute of Arthritis and Musculoskeletal 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 review of this report was overseen by Huda Akil, University of Michigan. Appointed 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.
Contents
2 THE QUICKENING PACE OF BIOLOGICAL RESEARCH AND CURRENT CHALLENGES IN BIOSECURITY
Developments at the Intersection of Biosecurity and Science
Virulence, Transmissibility, and the Importance of Mutations for Influenza A Viruses
Case Studies: The 1918 Spanish Influenza Pandemic and H5N1
4 SCIENTISTS AND THE SOCIAL CONTRACT
Transparency, Public Participation and Confidence, and the Media
The Role of Corporations in Life Sciences Research
Regulatory Paths, Gray Zones, and Avoiding Undue Burdens
Dual-use Research: What’s In a Name?
Broad and Inclusive Participation
The Need to Revamp the Education of our Next Generation of Scientists
C The Two Published H5N1 Papers
F Biographical Information of Committee and Staff
BOXES AND FIGURES
Boxes
2-1 Asilomar Conference on Recombinant DNA
3-1 Biosafety Levels for Infectious Disease Research
Figures
3-1 Diagrammatic Representation of an Influenza A Virus