INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Adviser to the Nation to Improve Health

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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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

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.

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.

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

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

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

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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