Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents Medical Follow-up Agency and Board on Life Sciences Lois M. Joellenbeck, Jane S. Durch, and Leslie Z. Benet, Editors Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html 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 Na- tional Academy of Sciences, the National Academy of Engineering, and the Institute of Medi- cine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by Contract No. DAMD17-02-C-0099 between the National Academy of Sciences and the U.S. Army. The views presented in this report are those of the Institute of Medicine and National Research Council Committee on Accelerat- ing the Research, Development, and Acquisition of Medical Countermeasures Against Bio- logical Warfare Agents and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Giving full measure to countermeasures : addressing problems in the DOD program to de- velop medical countermeasures against biological warfare agents / Committee on Acceler- ating the Research, Development, and Acquisition of Medical Countermeasures against Bio- logical Warfare Agents, Medical Follow-up Agency and Board on Life Sciences ; Lois M. Joellenbeck, Jane S. Durch, and Leslie Z. Benet, editors. p. ; cm. Includes bibliographical references. ISBN 0-309-09153-5 (pbk.) 1. Biological warfare—Health aspects—United States. 2. Biological warfare—United States—Safety measures. 3. Biological weapons—Health aspects—United States. 4. Biologi- cal weapons—United States—Safety measures. 5. Medicine, Preventive—United States. 6. Antitoxins—United States. 7. Vaccines—United States. [DNLM: 1. United States. Dept. of Defense. 2. Biological Warfare—prevention & control. 3. Drug Approval. 4. Antitoxins. 5. Military Personnel. 6. United States Govern- ment Agencies. 7. Vaccines. ] I. Joellenbeck, Lois M. (Lois Mary), 1963- II. Durch, Jane. III. Benet, Leslie Z. IV. Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures against Biological Warfare Agents. UG447.8.G58 2004 358'.38—dc22 2004005890 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 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Cover credit: The upper cover photograph is from a U.S. Department of Defense news pho- tograph. [Online]. Available: http://www.defenselink.mil/photos/May1997/970422-F- 7719S-002.html. Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html The National Academy of Sciences is a private, nonprofit, self-perpetuating soci- ety of distinguished scholars engaged in scientific and engineering research, dedi- cated 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 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 gov- ernment. Functioning in accordance with general policies determined by the Acad- emy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing ser- vices to the government, the public, and the scientific and engineering communi- ties. 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 Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html COMMITTEE ON ACCELERATING THE RESEARCH, DEVELOPMENT, AND ACQUISITION OF MEDICAL COUNTERMEASURES AGAINST BIOLOGICAL WARFARE AGENTS LESLIE Z. BENET (Chair), Professor, Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco WALTER E. BRANDT, Senior Program Officer, Malaria Vaccine Initiative, Program for Appropriate Technology in Health BARRY S. COLLER, Vice President for Medical Affairs, David Rockefeller Professor of Medicine, and Head of the Laboratory of Blood and Vascular Biology, The Rockefeller University GLENNA M. CROOKS, President, Strategic Health Policy International, Inc. R. GORDON DOUGLAS, JR., Scientific Consultant JACQUES S. GANSLER, Professor and Roger C. Lipitz Chair, Center for Public Policy and Private Enterprise, School of Public Affairs, University of Maryland ANTHONY L. ITTEILAG, Independent Consultant DENNIS L. KASPER, Executive Dean for Academic Programs, William Ellery Channing Professor of Medicine, and Professor of Microbiology and Molecular Genetics, Harvard Medical School STEVEN J. KELMAN, Albert J. Weatherhead III and Richard W. Weatherhead Professor of Public Management, John F. Kennedy School of Government, Harvard University RICHARD F. KINGHAM, Partner, Covington and Burling PETER M. PALESE, Professor and Chair, Department of Microbiology, Mount Sinai School of Medicine PAUL D. PARKMAN, President, Parkman Associates RONALD J. SALDARINI, Scientific Consultant JANE E. SISK, Professor, Department of Health Policy, Mount Sinai School of Medicine ELAINE I. TUOMANEN, Professor and Chair, Department of Infectious Diseases, St. Jude Children’s Research Hospital BENJAMIN J. WEIGLER, Director, Animal Health Resources, Division of Shared Resources, Fred Hutchinson Cancer Research Center JANET WESTPHELING, Associate Professor, Department of Genetics, University of Georgia v Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html Medical Follow-up Agency Board Liaison TIMOTHY R. GERRITY, Director, Bioengineering Institute, Worcester Polytechnic Institute Consultant JAMES D. MARKS, Professor, Anesthesia and Pharmaceutical Chemistry, University of California, San Francisco Project Staff LOIS JOELLENBECK, Senior Program Officer, Medical Follow-up Agency JANE DURCH, Senior Program Officer, Medical Follow-up Agency KAREN KAZMERZAK, Research Associate, Medical Follow-up Agency (through July 2003) PHILLIP BAILEY, Senior Project Assistant, Medical Follow-up Agency Auxiliary Staff RICHARD N. MILLER, Director, Medical Follow-up Agency (to November 2003) RICK ERDTMANN, Director, Medical Follow-up Agency (since November 2003) JENNIFER KUZMA, Senior Program Officer, Board on