The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

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COMMITTEE ON SHIPBOARD HAZARD AND DEFENSE II (SHAD II)

DAVID J. TOLLERUD (Chair), Professor and Chair, Department of Environmental and Occupational Health Sciences, University of Louisville School of Public Health and Information Sciences

JOSEPH A. BOSCARINO, Senior Scientist, Center for Health Research, Geisinger Clinic, Danville, Pennsylvania

LINDA A. MCCAULEY, Professor and Dean, Nell Hodgson Woodruff School of Nursing, Emory University

THOMAS E. MCKONE, Senior Staff Scientist and Deputy Division Director, Lawrence Berkeley National Laboratory

KENNETH R. STILL, Scientific Director and Senior Toxicology and Industrial Hygiene Consultant, Occupational Toxicology Associates, Inc., Lake Oswego, Oregon, and Adjunct Assistant Professor, Portland State University, School of Community Health, College of Urban and Public Affairs, Portland, Oregon

BETH A. VIRNIG, Professor and Senior Associate Dean for Academic Affairs and Research, University of Minnesota School of Public Health

YILIANG ZHU, Professor, Department of Epidemiology and Biostatistics, College of Public Health, and Professor, Internal Medicine, Morsani College of Medicine, University of South Florida

Consultants

DANIEL H. FREEMAN, JR., Professor Emeritus of Preventive Medicine and Community Health, University of Texas Medical Branch at Galveston

CYNTHIA C. JOHNSON, Nosologist, Richmond, Virginia

ALFRED K. MBAH, Assistant Professor of Biostatistics and Epidemiology, University of South Florida

JAMES E. QUINN, Commander, U.S. Navy, Retired

IOM Staff

LOIS JOELLENBECK, Study Director

HARRIET CRAWFORD, IT Project Manager

REINE HOMAWOO, Programmer/Analyst

DWAYNE BELL, Programmer/Analyst (through June 2015)

HEATHER YOUNG, Biostatistician (through November 2014)

JANE DURCH, Senior Program Officer

JON SANDERS, Program Associate (through January 2015)

ASHLEY MAYO, Intern (Summer 2012, 2013)

JULIE WILTSHIRE, Financial Associate

FREDERICK ERDTMANN, Director, Board on the Health of Select Populations

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Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. 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:

David B. Allison, University of Alabama at Birmingham

Joel Greenhouse, Carnegie Mellon University

David G. Hoel, Exponent

Howard M. Kipen, Rutgers School of Public Health

Kenneth W. Kizer, University of California, Davis, School of Medicine and Betty Irene Moore School of Nursing

Nan M. Laird, School of Public Health, Harvard University

Raphael C. Lee, The University of Chicago

David A. Macys, Oak Harbor, Washington

Robert B. Wallace, University of Iowa College of Public Health

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Stephen E. Fienberg, Carnegie Mellon University, and George W. Rutherford, University of California, San Francisco. They were 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.

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Preface

When the secret Project Shipboard Hazard and Defense (SHAD) testing program was made public in 2000, veterans reasonably wondered what impact their involvement in the testing might have had on their health.

Following the release of the first Institute of Medicine (IOM) SHAD report in 2007, Congress requested that the IOM undertake a new epidemiological study of the potential long-term health effects of participation in the SHAD testing. Our committee, with expertise in epidemiology, occupational health, biostatistics, exposure assessment, toxicology, and Vietnam veterans’ health issues, was convened to examine this question, a role the committee took very seriously. Our careful review of published scientific literature on the agents, simulants, tracers, and decontaminants used in the tests, led us to formulate hypotheses on health effects that might be associated with exposure to six of these substances. We also undertook exploratory analyses to ensure that unanticipated associations would not be overlooked.

Our task was challenging because of the passage of time since the tests, and because many of the documents related to the tests remain classified. Our requests for declassification of additional documents were not approved. Using the limited information available in redacted reports on these tests, the committee evaluated exposure opportunities that test participants may have had.

The study faced other challenges as well. Protecting the security of the data used in the study was, of course, of high importance to the committee and to the Department of Veterans Affairs (VA). Meeting those obligations made it necessary to work within the VA information technology system, and this posed a series of requirements that significantly delayed all aspects of our data processing and analysis. These delays also limited the depth of the data analysis that could be accomplished over the life of the study. The committee was successful in performing an extensive review of the mortality data, but analysis of the morbidity data was more limited.

In the course of our efforts, the committee benefited from the help of several organizations and individuals. We are particularly grateful to the veterans of SHAD testing who gave their time and efforts to helping to orient us to our task at the start of the study. SHAD veteran Jack Alderson was tireless in providing background to the study staff and serving as a liaison to other veterans. We appreciated use of the VA Informatics and Computing Infrastructure system to host and access data; that arrangement made completion of the study possible under difficult circumstances. We are grateful for the considerable help we received from VA in using the system, particularly John Quinn, Susan Hickey, Jeffrey Scehnet, and their team. We are grateful as well to Rebecca Crawford, Gayle Lyke, Wendi Dick, Loren Erickson, Octavia Dixon, and Terry Walters who worked with us at the VA Office of Public Health. At and through the Department of Defense, we received assistance from Michael Kilpatrick, Dee Morris, Arnold Dupuy, Nathan Pawlicki, Anthony Lee, Dupont Durst, and Kenneth Gritton. We also appreciate the help of Timothy Daly, formerly of Congressman Mike Thompson’s office, and John Driscoll, of Congressman Jared Huffman’s office. We appreciated the input and extensive background materials from Rick Weidman, Bernard Edelman, and Thomas Berger of the Vietnam Veterans of America.

I am also very grateful to my fellow committee members, volunteers who have shown great commitment to the effort, giving without complaint an additional two years of their time and expertise beyond what was initially anticipated. I also thank consultants Dan Freeman, Alfred Mbah, and James

Quinn, who made important contributions of expertise and time. On behalf of the committee, I commend the expert and tireless work of the IOM staff, including study director Lois Joellenbeck; the data team of Harriet Crawford, Reine Homawoo, and Dwayne Bell; Jane Durch, Julie Wiltshire, Andrea Cohen, Greta Gorman, Jon Sanders, and Ashley Mayo. We also appreciate the assistance and support of David Butler, Director of the Medical Follow-up Agency; Frederick Erdtmann, Director of the Board on the Health of Select Populations; and Clyde Behney, Executive Director, Institute of Medicine.

David J. Tollerud, Chair

Committee on Shipboard Hazard and Defense II

Contents

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