REVIEW OF NASA’S Longitudinal Study OF Astronaut Health

David E. Longnecker, Frederick J. Manning, and Melvin H. Worth, Jr., Editors

Committee on the Longitudinal Study of Astronaut Health

Board on Health Sciences Policy

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Review of Nasa’s Longitudinal Study of Astronaut Health REVIEW OF NASA’S Longitudinal Study OF Astronaut Health David E. Longnecker, Frederick J. Manning, and Melvin H. Worth, Jr., Editors Committee on the Longitudinal Study of Astronaut Health Board on Health Sciences Policy INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Review of Nasa’s Longitudinal Study of Astronaut Health 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 committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract/Grant No. NASW-03031 between the National Academy of Sciences and the National Aeronautics and Space Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the Institute of Medicine Committee on the Longitudinal Survey of Astronaut Health and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-09148-9 (Book) International Standard Book Number 0-309-53016-4 (PDF) 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); http://www.nap.edu. Copyright 2004 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 Museen in Berlin.

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Review of Nasa’s Longitudinal Study of Astronaut Health “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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Review of Nasa’s Longitudinal Study of Astronaut Health 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. 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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Review of Nasa’s Longitudinal Study of Astronaut Health COMMITTEE ON THE LONGITUDINAL STUDY OF ASTRONAUT HEALTH DAVID E. LONGNECKER (Chair), Senior Vice President and Corporate Chief Medical Officer and Robert D. Dripps Professor of Anesthesia, University of Pennsylvania Health System, Philadelphia, Pennsylvania ALFRED F. CONNORS, JR., Charles H. Rammelkamp Professor of Medicine, Case Western Reserve University, and Chair, Department of Medicine, MetroHealth Medical Center, Cleveland, Ohio ROY L. DEHART, Director, Vanderbilt Center for Occupational and Environmental Medicine, Nashville, Tennessee R. J. MICHAEL FRY, Retired Head of Cancer Section, Oak Ridge National Laboratory, Indianapolis, Indiana DANIEL R. MASYS, Director of Biomedical Informatics and Professor of Medicine, University of California, San Diego VAN C. MOW, Stanley Dicker Professor of Biomedical Engineering and Orthopaedic Bioengineering, and Chair, Department of Biomedical Engineering, Columbia University, New York, New York TOM S. NEUMAN, Professor of Clinical Medicine and Associate Director, Emergency Medical Services, San Diego Medical Center, University of California, San Diego THOMAS F. OLTMANNS, Edgar James Swift Professor of Arts and Sciences, Department of Psychology, Washington University, St. Louis, Missouri RUSSELL B. RAYMAN, Executive Director, Aerospace Medical Association, Arlington, Virginia WALTER ROBINSON, Associate Professor of Pediatrics and Medical Ethics, Division of Medical Ethics, Harvard Medical School, Boston, Massachusetts ELAINE RON, Senior Investigator, Radiation Epidemiology Branch, National Cancer Institute, National Institutes of Health, Rockville, Maryland CAROL SCOTT-CONNER, Chair, Department of Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa M. RHEA SEDDON, Assistant Chief Medical Officer, Vanderbilt Medical Group, Vanderbilt University Medical Center, Nashville, Tennessee DEBORAH ZUCKER, Assistant Professor of Medicine, Tufts University and Clinical Investigator, Division of Clinical Care Research, New England Medical Center, Boston, Massachusetts Study Staff FREDERICK J. MANNING, Study Director NATASHA S. DICKSON, Senior Project Assistant BENJAMIN HAMLIN, Research Assistant

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Review of Nasa’s Longitudinal Study of Astronaut Health Institute of Medicine Staff ANDREW POPE, Director, Board on Health Sciences Policy MELVIN H. WORTH, JR., Scholar-in-Residence TROY PRINCE, Administrative Assistant, Board on Health Sciences Policy CARLOS GABRIEL, Financial Associate

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Review of Nasa’s Longitudinal Study of Astronaut Health INDEPENDENT REPORT 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 contents of 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 participation in the review of this report: John R. Ball, American Society for Clinical Pathology John Boice, International Epidemiology Institute F. Andrew Gaffney, Vanderbilt University Thomas A. Louis, Johns Hopkins University Jay H. Lubin, National Institutes of Health Jonathan D. Moreno, University of Virginia Deborah J. Wear-Finkle, Maine Cognitive Therapy Center 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 ROBERT M. EPSTEIN, Harold Carron Professor of Anesthesiology Emeritus at the University of Virginia, appointed by the Institute of Medicine, 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 authoring committee and the institution.

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Review of Nasa’s Longitudinal Study of Astronaut Health Preface As part of its ongoing commitment to the nation’s space program, NASA’s medical leadership asked the Institute of Medicine (IOM) to review specific aspects of the scientific basis, policies, and procedures associated with the Longitudinal Study of Astronaut Health (LSAH). NASA created the LSAH in 1992 to address a variety of issues, including both the health of astronauts during space flight and the longer-term health issues that might be associated with space flight and flight training. The IOM Committee on the LSAH held most of its deliberations at the new IOM facilities in Washington, DC, where the group pondered a variety of health care issues related to space flight, astronaut training, and subsequent astronaut health. We spent many hours developing an in-depth understanding of the LSAH, the major risk factors related to space flight and flight training, and the subsequent health of astronauts. The highlight of the committee’s experiences took place at the Kennedy Space Center (KSC) on January 15-16, 2003, when the committee met with numerous NASA scientists associated with the LSAH, all of whom were gathered at KSC for the scheduled launch of STS-107, the Columbia orbiter flight devoted to life sciences. The committee heard numerous scientific presentations on January 15, including those by the flight surgeons associated with the STS-107 Columbia crew. After an informative session of scientific presentations and deliberations, the committee was escorted to a night viewing of the launch site, and early Thursday morning, January 16, we attended the NASA prelaunch briefing and the subsequent launch of STS-107. Although there were occasional intervals of concern during the last 24 hours of the launch count-down, in general the launch cycle was almost routine; some described it as one of the smoothest launch cycles in recent years. In mid-morning, STS-107 lifted off (perhaps “leapt off” would be more accurate) the launch pad and disappeared into a gorgeous blue sky within five minutes. The flight controllers, crew, NASA administrators and staff, the throngs of visitors, and the committee were thrilled by this sight. The realities of the committee’s assignment were brought into sobering focus on the morning of February 1, when the image of

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Review of Nasa’s Longitudinal Study of Astronaut Health Columbia returning to the earth’s atmosphere suddenly became multiple images over the clear Texas skies. For me, and for many others on the committee, both the launch and the disintegration of Columbia are forever printed into our visual memories. The events of February 1 served to remind the committee of the perilous nature of space flight, and brought back memories of Challenger in 1986 and Apollo 1 in 1967. In all, the issues we address in this report are important, vital, and meaningful. However, beyond the long-term issues of thyroid function, behavioral medicine, cataracts, and cancer, all of which are addressed in this review, there remains the harsh reality that space flight is an inherently risky endeavor and space flyers are at risk both during training and in flight. Our recommendations address ways to mitigate at least some of these risks where possible or to compensate for health risks that cannot be anticipated or eliminated. Our committee dedicates this volume, and our many long hours of meetings, reading, analysis, deliberation, and writing, to Rick Husband (Commander of STS-107), William McCool (Pilot), Kalpana Chawala (Flight Engineer), David Brown, M.D. (Mission Specialist), Laurel Clark, M.D. (Mission Specialist), Michael Anderson (Payload Commander), and Ilan Ramon (Payload Specialist). Requiescant in pace. David E. Longnecker, Chair Committee on the Longitudinal Study of Astronaut Health

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Review of Nasa’s Longitudinal Study of Astronaut Health Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   9      Role of the Institute of Medicine,   10      Goals and Design of the Current LSAH,   11      Data Access Policy,   15 2   FINDINGS TO DATE   17      Peterson et al., 1993,   17      Hamm et al., 1998,   18      Hamm et al., 2000,   19      Briefings to the IOM Committee,   21 3   ISSUES WITH DESIGN AND IMPLEMENTATION OF THE CURRENT LONGITUINAL STUDY   29      Goals of the LSAH,   30      Statistical Power,   32      Composition of the Comparison Group,   33      Ascertainment Bias,   34      Participation,   35      International Partners,   36      Follow-up,   37 4   RECOMMENDATIONS FOR CHANGES IN STUDY DESIGN AND EXECUTION   39      LSAH Staff Recommendations for Change,   39      IOM Recommendations for Change,   41

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Review of Nasa’s Longitudinal Study of Astronaut Health 5   RECOMMENDATIONS FOR CHANGES IN HEALTH CARE POLICY   45      Department of Energy and Beryllium,   45      Department of Defense and Nuclear Weapons Tests,   47      Department of Veterans Affairs and Agent Orange,   49      Conclusions,   51     REFERENCES   53     APPENDIXES     A   Biographical Sketches of Committee and Staff   57 B   Variables in the LSAH Database   65 C   Health Lifestyle Questionnaire   69

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Review of Nasa’s Longitudinal Study of Astronaut Health List of Tables 1-1   Physical and Health Measures Collection Schedule - 2003 LSAH,   14 2-1   Mean (Standard Deviation) Age in Years and Body Mass Index (BMI) at Selection of LSAH Participants, 1959-1991,   20 2-2   Cause-Specific Mortality among Longitudinal Study of Astronaut Health Participants Selected from 1959 to 1991,   21 2-3   Relative Hazard Ratios and (95% Confidence Intervals) Comparing High Exposure-Group to Low Exposure Astronaut Groups for Cataract Risk at Age 60 and at Age 65,   24 2-4   Number and Type of Cancers Diagnosed in NASA Astronauts and LSAH Comparison Group Participants,   25 3-1   LSAH Research Questions and Appropriate Study Populations,   29 3-2   Minimum Detectable Relative Risk (Astronauts versus Comparisons) at Different Criteria for Statistical Significance (two-tailed α) with Power = 0.80.,   33 3-3   Percentage of Active JSC Civil Servants, Ex-JSC Civil Servants, and Ex-Astronaut LSAH Participants Appearing for Scheduled Physical Exams, 1993-2001,   35

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