REVIEW OF REPORT AND APPROACH TO
EVALUATING LONG-TERM HEALTH EFFECTS
IN ARMY TEST SUBJECTS

Committee to Review Report on Long-Term
Health Effects on Army Test Subjects

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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This activity was supported by Contract W81K04-16-D-0036, Task 0002 between the National Academy of Sciences and the Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

Digital Object Identifier: https://doi.org/10.17226/25065

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25065.

COMMITTEE TO REVIEW REPORT ON LONG-TERM HEALTH EFFECTS ON ARMY TEST SUBJECTS

Members

IVAN RUSYN (Chair), Texas A&M University, College Station

ERIN M. BELL, University of Albany, NY

GERRY R. BOSS, University of California, San Diego

JAMES E. CLEAVER, University of California, San Francisco

PAMELA J. LEIN, University of California, Davis

CATHERINE A. MCCARTY, University of Minnesota, Duluth

NU-MAY RUBY REED, California Environmental Protection Agency (retired), Davis

KENNETH R. STILL, Portland State University, Portland, OR

VASILIS VASILIOU, Yale University, New Haven, CT

Staff

SUSAN N.J. MARTEL, Senior Program Officer

TAMARA DAWSON, Program Associate

Sponsor

U.S. ARMY

BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

Members

WILLIAM H. FARLAND (Chair), Colorado State University, Fort Collins, CO

LESA AYLWARD, Summit Toxicology, LLP, Falls Church, VA

RICHARD A. BECKER, American Chemistry Council, Washington, DC

E. WILLIAM COLGLAZIER, AAAS, Washington, DC

DOMINIC M. DITORO, University of Delaware, Newark, DE

DAVID C. DORMAN, North Carolina State University, Raleigh, NC

ANNE FAIRBROTHER, Exponent, Inc., Philomath, OR

GEORGE GRAY, The George Washington University, Washington, DC

STEVEN P. HAMBURG, Environmental Defense Fund, New York, NY

ROBERT A. HIATT, University of California, San Francisco, CA

R. JEFFREY LEWIS, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ

H. SCOTT MATTHEWS, Carnegie Mellon University, Pittsburgh, PA

ROBERT PERCIASEPE, Center for Climate and Energy Solutions, Arlington, VA

R. CRAIG POSTLEWAITE, Department of Defense, Burke, VA

REZA J. RASOULPOUR, Dow AgroSciences, Indianapolis, IN

MARK A. RATNER, Northwestern University, Evanston, IL

JOAN B. ROSE, Michigan State University, East Lansing, MI

GINA M. SOLOMON, University of California, San Francisco, CA

ROBERT M. SUSSMAN, Sussman and Associates, Washington, DC

DEBORAH L. SWACKHAMER, University of Minnesota, St. Paul, MN

PETER S. THORNE, University of Iowa, Iowa City, IA

Staff

TERESA A. FRYBERGER, Director

ELLEN K. MANTUS, Scholar and Director of Risk Assessment

RAYMOND A. WASSEL, Scholar and Director of Environmental Studies

SUSAN N.J. MARTEL, Senior Program Officer for Toxicology

ELIZABETH BOYLE, Program Officer

TAMARA DAWSON, Program Associate

BERNIDEAN WILLIAMS-SMITH, Financial Associate

SUZANNE THILENIUS, Administrative Coordinator

JESSICA WOLFMAN, Senior Program Assistant

Acknowledgments

This Consensus Study Report was 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 National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 thank the following individuals for their review of this report:

Edward C. Bishop, HDR, Inc. (retired)

David C. Dorman, North Carolina State University

David R. Franz, Independent Consultant

Philip J. Landrigan, Icahn School of Medicine at Mount Sinai

Joel E. Michalek, University of Texas Health Science Center

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by David Eaton, University of Washington, and Martin Philbert, University of Michigan. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

The committee gratefully acknowledges the following individuals for their presentations to the committee during its open session: Coleen Baird, U.S. Army Public Health Center; Weihsueh Chiu, Texas A&M University; Jonathan Samet, Colorado School of Public Health; and Rick Weidman, Vietnam Veterans of America. The committee also thanks Kathleen Stratton and Roberta Wedge of the Health and Medicine Division (HMD) of the National Academies for their assistance in providing background on the methods HMD has used in past projects to evaluate the adverse effects of vaccines and to evaluate potential health hazards to veterans of the Vietnam and Gulf Wars.

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Contents

SUMMARY

1 INTRODUCTION

The Committee’s Task and Approach

Organization of the Report

References

2 EVALUATION OF THE REPORT

Performance Work Statement

Best Practices in Hazard Identification

Examples of Missed Studies and Health Effects

Findings and Recommendations

References

3 EVALUATION OF THE ARMY’S CAUSATION METHODOLOGY

Review and Adjudication Process

Causation Methodology

Documentation

Review of the IOM Recommended Approaches to Causality in the Context of Making Determinations About Providing Medical Care to Former Test Subjects

Findings and Recommendations

References

4 STRATEGY FOR EVALUATING POTENTIAL LONG-TERM HEALTH EFFECTS IN ARMY TEST SUBJECTS

Step 1: Agent Prioritization

Step 2: Problem Formulation

Step 3: Literature Search and Screening

Step 4: Data Analysis and Evidence Synthesis

Step 5: Evidence Integration

Step 6: Drawing Hazard Identification Conclusions

References

APPENDIXES

A BIOGRAPHICAL INFORMATION ON THE MEMBERS OF THE COMMITTEE TO REVIEW REPORT ON LONG-TERM HEALTH EFFECTS ON ARMY TEST SUBJECTS

B PUBLIC AGENDA FOR FIRST COMMITTEE MEETING

C DEPARTMENT OF THE ARMY MEMORANDUM OF INSTRUCTION, BENEFITS APPLICATION PANEL REVIEW AND ADJUDICATION OF APPLICATIONS FOR MEDICAL CARE

FIGURES AND TABLES

FIGURES

S-1 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances

S-2 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances

3-1 Process of reviewing epidemiological and mechanistic evidence in the IOM Vaccine Approach

4-1 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances

4-2 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances

TABLES

2-1 Examples of References Missing from the Report

2-2 Health Effects Not Evaluated in the Report