LONG-TERM HEALTH EFFECTS OF PARTICIPATION IN PROJECT SHAD (SHIPBOARD HAZARD AND DEFENSE)

William F. Page, Heather A. Young, and Harriet M. Crawford, authors

with Oversight from the

Advisory Panel for the Study of Long-Term Health Effects of Participation in Project SHAD

Medical Follow-Up Agency

Board on Military and Veterans Health

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) LONG-TERM HEALTH EFFECTS OF PARTICIPATION IN PROJECT SHAD (SHIPBOARD HAZARD AND DEFENSE) William F. Page, Heather A. Young, and Harriet M. Crawford, authors with Oversight from the Advisory Panel for the Study of Long-Term Health Effects of Participation in Project SHAD Medical Follow-Up Agency Board on Military and Veterans Health INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) 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 National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the advisory panel that oversaw the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. V101(93)P-1637, T/0#26 between the National Academy of Sciences and the Department of Veterans Affairs. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-10210-0 International Standard Book Number-10: 0-309-10210-3 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 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museum in Berlin. Suggested citation: IOM (Institute of Medicine). 2007. Long-term health effects of participation in Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) THE NATIONAL ACADEMIES 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. 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 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. Charles M. Vest 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. 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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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) AUTHORS WILLIAM F. PAGE (Study Director), Epidemiologist HEATHER A. YOUNG, Statistician HARRIET M. CRAWFORD, IT Project Manager ADVISORY PANEL FOR THE STUDY OF LONG-TERM HEALTH EFFECTS OF PARTICIPATION IN PROJECT SHAD DANIEL H. FREEMAN, Jr. (Chair), Professor, University of Texas Medical Branch at Galveston, University of Texas DAN G. BLAZER, J.P. Gibbons Professor of Psychiatry, Duke University Medical Center DONALD S. BURKE, Dean, University of Pittsburgh Graduate School of Public Health LINDA D. COWAN, George Lynn Cross Research Professor, University of Oklahoma College of Public Health GREGORY C. GRAY, Professor, College of Public Health, University of Iowa PETER S. SPENCER, Professor of Neurology and Director, Center for Research on Occupational and Environmental Toxicology, Oregon Health and Science University Project Staff WILLIAM F. PAGE, Study Director HEATHER A. YOUNG, Statistician HARRIET M. CRAWFORD, IT Project Manager NOREEN STEVENSON, Research Assistant DWAYNE BELL, Programmer Analyst JIHAD DAGHMASH, Programmer Analyst JOHN LARSON, St. Louis Records Manager ROBERT MATHES, Research Associate ALVAR MATTEI, Senior Program Assistant RICK ERDTMANN, Director, Board on Military and Veterans Health/Medical Follow-Up Agency PAMELA RAMEY-MCCRAY, Administrative Assistant ANDREA COHEN, Financial Associate JAMES QUINN, Consultant

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Reviewers 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 Research Council’s 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 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: Norman Breslow, School of Public Health and Community Medicine, University of Washington Carlos A. Camargo, Jr., Emergency Medicine Network Coordinating Center, Massachusetts General Hospital Robert Hoover, Epidemiology and Biostatistics Program, National Cancer Institute Matthew L. Puglisi, Business Development, Aptima, Inc. Kenneth R. Still, Occupational Toxicology Associates, Hillsboro, Oregon 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 Dr. Melvin Worth, Scholar-in-Residence, Institute of Medicine. Appointed by the Institute of Medicine, he 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 authors and the Institute of Medicine.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Preface Our study of the long-term health effects of participation in Project SHAD (Shipboard Hazard and Defense) posed a number of challenges, including difficulties in identifying all the Project SHAD participants, assembling an appropriate control group, devising and administering a suitable survey instrument, and producing a sound analysis and accompanying report. We could not have achieved the results we did without a great deal of help. Throughout this study, Institute of Medicine (IOM) staff have relied especially on the good guidance of our expert advisory panel. Its members included experts in biostatistics, epidemiology, survey research, infectious disease epidemiology, toxicology, and military veteran epidemiology. We could not have persevered through all of the difficult challenges we faced without their help and support. Nonetheless, although the expert panel provided sound guidance for which the study and this report are better, the authoring staff take full responsibility for the final product. We are also grateful especially to the military veterans who provided us with information, support, and encouragement. Without their willingness to donate their time and effort in support of this project, this study would not have been possible. William F. Page, Ph.D. Heather A. Young, Ph.D. Harriet M. Crawford, B.S.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Acknowledgments The study of the health effects of participation in Project SHAD was a large enterprise, and the list of people who deserve recognition for their contribution is enormous. Members of the Medical Follow-Up Agency (MFUA) data operations staff who worked on this study include Dwayne Bell, Jihad Daghmash, John Larson, Robert Mathes, Al Mattei, and Noreen Stephenson. Richard Miller, former Director of MFUA, provided valuable guidance for this study. The data collection efforts for the Project SHAD study involved many people outside of MFUA. We appreciate the efforts of Robert Bilgrad and staff at the National Death Index; Barbara Bauman and staff at the National Personnel Records Center in St. Louis, Missouri; the staff at the National Archives in College Park, MD (Archives II); and staff at many federal archives centers and Department of Veterans Affairs (VA) regional offices across the country, especially the VA regional office in the District of Columbia. We relied on a few consultants external to the staff for some technical work critical to the conduct of the study, including Victor Miller, James Quinn, and Ada Youk. We are particularly grateful to SRBI, Inc., who conducted the telephone interviews for our health survey, especially John Boyle, Stephen Dienstfrey, and Paul Schroeder. The MFUA staff has benefited from the vigilance and enthusiasm of many interested veterans, including Jack Alderson, Robert Bates, Jim Druckemiller, Norman LaChapelle, and John Olsen. The latter two also served on the Project SHAD Task Force, chaired by Jack Devine, of the Vietnam Veterans of America (VVA), whom we also thank for their assistance. We are especially grateful to Rick Weidman and Bernard Edelman, VVA staff, for their help and support throughout the study. The current members of the Advisory Panel for the Study of Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense)—chair Daniel H. Freeman, Jr., Dan G. Blazer, Donald S. Burke, Linda D. Cowan, Gregory C. Gray, and Peter S. Spencer—have helped to ensure the quality of the logic followed in the conduct of this study. We thank them and assume responsibility for whatever items of advice they offered that we did not take. Mark Brown and Han Kang of the VA have provided us valuable help, and Michael Kilpatrick and his staff at the Department of Defense’s Force Health Protection and Readiness Program (formerly Deployment Health) have been particularly helpful to us. We wish to single out Dee Morris and Roy Finno for their special assistance on this project.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Lara Andersen, Sue Barron, Andrea Cohen, James Jensen, Linda Kilroy, Bronwyn Schrecker, Christine Stencel and the many other staff at the Institute of Medicine and the National Academies all helped along the way. Special thanks to Medical Follow-up Agency Director, Frederick (Rick) Erdtmann, and administrative assistant, Pamela Ramey-McCray, who provided much appreciated support to the project. We—William Page, Harriet Crawford, and Heather Young Durick—thank everyone on this list (and perhaps a few whose names we have unintentionally omitted) for producing with us this report.

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Contents     Abbreviations and Acronyms   xvii     Summary   1 1   Study Rationale and Overview   3      Origin and Background,   3      References,   6 2   Investigating the Potential Health Effects from Participation in Project SHAD   7      Literature Review,   7      Public Meetings,   8      Review of Classified Material,   8      References,   9 3   An Overview of Project SHAD (Shipboard Hazard and Defense)   10      References,   10 4   Records-Based Data Sources   13      Introduction,   13      Data Sources Used to Identify Participants and Controls,   13      Data Sources Used to Locate and Follow-Up Participants and Controls,   14      References,   15 5   Participant Cohort   16      Initial Identification,   16      Outreach Effort to Identify Additional Participants,   17      Gathering Further Identifier Data from Military Records,   17

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) 6   Referent Cohort   19      General Scheme,   19      Detailed Information,   19 7   Health Survey   24      Background,   24      Content of the Health Survey,   24      Conduct of the Health Survey,   25      Using FedEx Delivery to Check the Quality of Survey Addresses,   25      Final Survey Response Rates,   27      Variation in Telephone Responses by Time,   29      Comparison of Mail Questionnaire Versus Telephone Interview Responses,   29      Department of Veterans Affairs Outpatient Visits by Participation Status and Response Status,   29      References,   31 8   Analysis Structure   33      Overview,   33      Available Data,   33      Defining Exposure Groups,   35      Methods of Analysis,   36      References,   38 9   Mortality Results   39      Vital Status Data and All-Cause Mortality,   39 10   Morbidity Results   45      Overview: Survey Response,   45      Primary Outcome Variable: SF-36,   45      Other Scaled Data,   56      Other Medical Data,   56      References,   64 11   Discussion   68      The Study’s Strengths and Weaknesses,   68      References,   72     Appendixes     A   Executive Summaries of Reports on Toxicological or Biological Agents   73 B   Questionnaire   101 C   Material Concerning Outreach Survey   119

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Tables and Figures TABLES 3-1   List of Project SHAD Tests, Ships, or Military Units Involved, and Agents,   11 6-1   The Process of Selecting Control Ships,   20 6-2   List of Participant and Control Units Showing Selected Characteristics,   21 7-1   Number and Percent of FedEx-Delivered Mailings by Source of Address,   26 7-2   Number and Percent of FedEx-Delivered Mailings by Mailing Group,   27 7-3   Percent Distribution of Various Demographic Characteristics by Participation Status, for All Study Subjects and for Survey Respondents,   28 7-4   Percent of Study Subjects with Social Security Number, by Analysis Group,   28 7-5   Response Proportions by Analysis Group, Participation Status, and Presence of Social Security Number,   29 7-6   Comparison of Mail Questionnaire Versus Telephone Interview Respondents for Selected Characteristics by Percentage Distribution,   30 7-7   Percent Distribution of Subjects with a VA Outpatient Visit, by Participation and Response Status, for Various Characteristics,   31 8-1   Variables Considered for Analysis and Their Sources,   34 8-2   Primary, Secondary, and Tertiary Outcome Variables,   35 8-3   SHAD Exposure Groups,   36 9-1   Vital Status and Availability of Death Data by Project SHAD Participant Status and Exposure Group,   40 9-2   Percentage of Study Subjects with SSN and BIRLS Record, by Exposure Group and Project SHAD Participation Status,   40 9-3   Proportional Hazards Analysis of Total Mortality, by Exposure Group, Including All Subjects, Regardless of Completeness of Mortality Follow-Up,   41

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) 9-4   Proportional Hazards Analysis of Total Mortality, by Exposure Group, Including Only Subjects with SSNs, Presumably with Virtually Complete Mortality Follow-Up,   42 9-5   Survival Analysis Using Proportional Hazards Regression: Cause-Specific Mortality Comparing Participants to Controls (Adjusted for Age, Race, Pay Grade, and Branch in Group B Only), Including Only Subjects with SSNs, Presumably with Virtually Complete Mortality Follow-Up,   43 9-6   Mortality Analysis Using Standardized Mortality Ratios (SMRs): Observed Number of Deaths and SMRs for Participants and Controls with SSNs for Selected Causes of Death, 1979–2004, by Analysis Group,   44 10-1   Availability of Mail Questionnaire and Telephone Interview Data by Analysis Group and Participation Status,   46 10-2   Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores, by Analysis Group and Participation Status (Sample Sizes in Parentheses), with Results of t-Test Comparisons,   46 10-3   Mean SF-36 Subscale Scores, by Analysis Group and Participation Status, with Results of t-Test Comparisons,   49 10-4   Mean SF-36 Summary Scores, by Analysis Group and Various Other Factors, with Results of F-Test Comparisons,   50 10-5   Adjusted Mean SF-36 Summary Scores, by Analysis Group, with Results of F-Test Comparisons,   52 10-6   Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores for Subjects in Group A (Standard Errors in Parentheses), by Agent, with Adjustment for Age, Race, Branch, Pay Grade, Smoking, Drinking, and Body Mass Index (Model 1) or These Factors Plus Number of Tests (Model 2),   54 10-7   Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores (Standard Errors in Parentheses) for Subjects in Group A, by “Dose” of Agent, with Adjustment for Age, Race, Pay Grade, and Branch,   55 10-8   Mean Somatization Scores, Unadjusted and Adjusted, for Participants and Controls, by Analysis Group,   56 10-9   Mean Memory and Attention Scores, Unadjusted and Adjusted, for Participants and Controls, by Analysis Group,   57 10-10   Number of Medical Conditions for Participants and Controls, with Adjusted Odds Ratios (ORs) and 95% Confidence Intervals (CIs), by Analysis Group,   57 10-11   Summary of Cancer Types by Group and Participant Status,   59 10-12   Ungrouped Medical Conditions by Analysis Group, Comparing Participants to Controls (Navy and Marine Only),   60 10-13   Reports of Other Neurodegenerative Diseases by Participant and Group Status,   64 10-14   Numbers of Symptoms by Group Comparing Participants to Controls, with Adjusted Odds Ratios (ORs),   65 10-15   Proportion of Subjects Hospitalized Since Discharge from Active Duty Comparing Participants to Controls, with Adjusted Odds Ratios (ORs),   67 10-16   Birth Defects Among Those Who Fathered a Child Comparing Participants to Controls, with Adjusted Odds Ratios (ORs),   67 FIGURES 7-1   Mean summary SF-36 scores by month of telephone interview,   30 10-1   Average SF-36 physical component scores (PCS) by study group and participation status,   47 10-2   Average SF-36 mental component scores (MCS) by study group and participation status,   48

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) Abbreviations and Acronyms BIRLS Beneficiary Identification and Records Locator Subsystem BUPERS Bureau of Personnel (Navy) DoD Department of Defense DTC Deseret Test Center ICD International Classification of Diseases IOM Institute of Medicine IRB institutional review board IRS Internal Revenue Service MCS mental component summary score of the SF-36 MFUA Medical Follow-Up Agency MSN military service number NCHS National Center for Health Statistics NDI National Death Index NHIS National Health Interview Survey NIOSH National Institute for Occupational Safety and Health NIS Neuropsychological Impairment Score OPT outpatient treatment file PCS physical component summary score of the SF-36 PTF patient treatment file SHAD Shipboard Hazard and Defense SMR standardized mortality ratio

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Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense) SSA Social Security Administration SSN Social Security number TARGET online interface to BIRLS system VA Department of Veterans Affairs VSO veterans service organization VVA Vietnam Veterans of America