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The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine i3{ Polar Research Board Commission on Geosciences, Environment, and Resources in cooperation with Board on Health Promotion and Disease Prevention Institute of Medicine Board on Radiation Effects Research Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1996

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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 competence and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Support for this project was provided by the United States Air Force under Contract Number F41624-94-C-2003. Front: These masks were made by Alaska Natives out of all natural materials that are available in many villages in Alaska. The man was designed by Ruth RulIand and the woman was designed by Rhoda Ahgook. Copies available from National Academy Press 2101 Constitution Avenue, N.W Box 285 Washington, D.C. 20055 (800) 624-6242 (202) 624-6242 (in the Washington Metro area) B-704 . Library of Congress Catalog Card No. 95-72623 International Standard Book No. 0-309-05428-1 Copyright 1996 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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COMMITTEE ON EVALUATION OF 1950s AIR FORCE HUMAN HEALTH TESTING IN ALASKA USING RADIOACTIVE IODINE 131 CHESTER M. PIERCE, Chair, Harvard Medical School, Boston, Massachusetts DAVID BAINES, St. Maries Family Medicine Clinic, St. Maries, Idaho TNDER CHOPRA, University of California at Los Angeles, School of Medicine, loos Angeles, California NANCY M. P. KING, University of North Carolina School of Medicine, Chapel Hill, North Carolina KENNETH L. MOSSMAN, Arizona State University, Tempe, Arizona Staff CHRIS ELFRING, Polar Research Board, Study Director (after July 1995J LOREN W. SETLOW, Polar Research Board, Study Director (through July 19959 TONI GREENLEAF, Polar Research Board, Senior Project Assistant MICHAEL STOTO, Board on Health Promotion and Disease Prevention JOHN ZIMBRICK, Board on Radiation Effects Research . . . zzz

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POLAR RESEARCH BOARD DAVID L. CLARK, Chair, University of Wisconsin, Madison KNUT AAGAARD, University of Washington, Seattle JOHN B. ANDERSON, Rice University, Houston, Texas DAVID R. BAINES, St. Maries Family Medicine Clinic, St. Maries, Idaho ERNEST S. BURCH, Consultant, Camp Hill, Pennsylvania GORDON F.N. COX, Amoco Eurasia Petroleum Company, Houston, Texas ROBERT LEE DEZAFRA, State University of New York, Stony Brook BERNARD MALLET, University of Washington, Seattle DOYAL A. HARPER, Yerkes Observatory, University of Chicago, Williams Bay, Wisconsin DAVID M. MITE, Consultant, Anchorage, Alaska DIANE M. MCKNIGHT, U.S. Geological Survey, Boulder, Colorado DONAL T. MANAHAN, A. Hancock Foundation, University of Southern Californian Los Angeles WALTER C. OECHEL, San Diego State University, San Diego, California IRENE C. PEDEN, University of Washington, Seattle GLENN E. SHAW, University of Alaska, Fairbanks DONALD B. SINIFF, University of Minnesota, St. Paul, Minnesota JUNE L. SIVA, Arco Production Company, Los Angeles, California ROBERT M. WALKER, Washington University, St. Louis, Missouri Ex-Officio Members CHARLES R. BENTLEY, Alternate U.S. Delegate, Scientific Committee on Antarctic Research, International Council of Scientific Unions (SCAR/ICSU) ELLEN MOSEEY-THOMPSON, Chair, Committee on Glaciology ROBERT RUTFORD, U.S. Delegate, Scientific Committee on Antarctic Research, International Council of Scientific Unions (SCAR/ICSU) ORAN R. YOUNG, U.S. Council Member, International Arctic Science Committee (lASC) Staff CHRIS ELFRING, Acting Director TONI GREENLEAF, Project Assistant/Financial Assistant KELLY NORSINGLE, Project Assistant IV

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COMMISSION ON GEOSCIENCES, ENVIRONMENT, AND RESOURCES M. GORDON WOLMAN, Chair, The Johns Hopkins University, Baltimore, Maryland PATRICK R. ATKINS, Aluminum Company of America, Pittsburgh, Pennsylvania JAMES P. BRUCE, Canadian Climate Program Board, Ottawa WILLIAM L. FISHER, University of Texas at Austin GEORGE M. HORNBERGER, University of Virginia, Charlottsville DEBRA KNOPMAN, Progressive Foundation, Washington, D.C. PERRY L. MCCARTY, Stanford University, California JUDITH E. MCDOWELL, Woods Hole Oceanographic Institution, Massachusetts S. GEORGE PHILANDER, Princeton University, New Jersey RAYMOND A. PRICE, Queen's University at Kingston, Ontario THOMAS C. SCHELLING, University of Maryland, College Park ELLEN SILBERGELD, University of Maryland Medical School, Baltimore, Maryland STEVEN M. STANLEY, The Johns Hopkins University, Baltimore, Maryland VICTORIA I. TSCHINKEL, Landers and Parsons, Tallahassee, Florida NRC Stay STEPHEN RATTIEN, Executive Director STEPHEN D. PARKER, Associate Executive Director MORGAN GOPNIK, Assistant Executive Director GREGORY SYMMES, Reports Officer JAMES E. MALLORY, Administrative Officer SANDRA S. FITZPATRICK, Administrative Associate SUSAN SHERWIN, Project Assistant v

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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 IS63, 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. Harold Liebowitz 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 makers 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 advisor to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine 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. Harold Liebowitz are chairman and vice chairman, respectively, of the National Research Council. Vl

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Preface With the end of the Cold War has come more freedom to step back and examine its legacy. In May 1993, experts and public officials met at the Arctic Contamination Conference in Anchorage, Alaska, to discuss problems relating to the post-World War II era of human occupation of the Arctic. The conference was sponsored by 14 federal agencies that participate in the Interagency Arctic Research Policy Committee, and it focused attention on radiation and chemical experunentation and contamination of the Arctic. One issue raised at the Anchorage meeting was a 1956-1957 study conducted by the U.S. Air Force s former Arctic Aeromedical Laboratory (AAL) about the role of the thyroid gland in acclimatization of humans to cold. The study used Iodinei3i (Ii3'), a radioactive medical tracer, to measure thyroid activity in 121 people-102 Alaska Natives and 19 military personnel. When the research came to light at the conference, serious questions were raised: How were the research subjects selected? Did the subjects fully understand the purpose of the research? Were they informed of the risks? To help resolve the controversy, Congress, under the leadership of Senator Frank Murkowski (A-Alaska), asked the National Research Council (NRC) and Institute of Medicine (IOM) to review the AAL thyroid function study (Public Law 103-160~. The National Research Council and Institute of Medicine (NRC/TOM) appointed the Committee for Evaluation of Air Force 1950s Human Health Testing in Alaska Using Radioactive Iodinei3i to fulfill that request. The Committee was charged to investigate whether the study was conducted in accordance with generally accepted guidelines in the 1950s for use of human participants in medical experimentation and whether the I'3' doses used were administered in accordance with radiation exposure standards of the 1950s, as well as how the dosages would compare to modern standards. The Committee was also asked to examine whether the AAL thyroid function study had followed guidelines regarding informing participants about possible risks and whether subsequent studies of the participants should have been conducted to determine whether any suffered long-term ill effects. Given that the events at issue occurred some 40 years ago, the Committee s charge was not an easy one. The Committee first met by teleconference in June 1994 and began an intensive effort to gather records and information about the research and to locate the subjects tested. One Committee member (a physician) and an NRC staff member then traveled to two rural Alaska villages in July 1994 to interview Native subjects. Immediately following those . . Vll

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. . . Vlll Preface field interviews, the filet Committee met in Fairbanks, Alaska, to hear from a wide range of people at a public hearing. Speakers included Native study participants, a military participant, doctors who worked at the Air Force laboratory in the 1950s, the physician that led the study (by phone from Norway), a medical historian, and representatives of state, local, and tribal government agencies. This report is the Committee's careful analysis of this information and its best judgment about the difficult issues that this research brings to light. The Committee would like to thank all those who participated in the hearing and other information-gathering activities this personal input was critical. The Committee did its best to sort through the sometimes wide-ranging testimony and to focus on the AAL thyroid function study. It was clear from the public hearing, however, that many Alaskans are concerned with issues broader than this one study questions about other experiments on Alaska Natives. Many at the public hearing expressed great frustration, and even rage, at the lack of information and explanation of what was done to them during this and other past research. Yet despite this anger, they were exceedingly generous in their willingness to help the Committee in its . . 1nvestl~at~on. _ ~, ~ While the Committee's review of the AAL thyroid research was ongoing, information about other medical studies of the 1950s was coming to light. One important effort was undertaken by the President's Advisory Committee on Human Radiation Experunents (ACHRE). ACHRE was established in 1994 to provide advice on ethical and scientific issues related to government-sponsored human radiation experiments, that is, experiments designed to understand the impacts of intentional exposure to ionizing radiation (excluding common and routine clinical practices) and experiments involving intentional environmental releases of radiation. ACHRE has raised significant questions about the conduct of such experiments (Advisory Committee on Human Radiation Experiments, 1995), and, although the use of a radioactive medical tracer presents far less risk and involves different objectives, the lessons from the ACHRE report have some bearing here. The AAL thyroid research must be seen in the context of the era when it was conducted. The methodology was not unusual and the researchers interacted with the people who served as subjects in the manner and tone that was typical of the times. The diagnostic use of {~3} was routine in medical practice across America in the 1950s. Research has not shown any link between small doses of li31 and thyroid cancer. Given these facts, why should a single study using diagnostic amounts of the tracer cause so much concern? In a June 1994 letter to the Committee, Senator Murkowski explained: "Unfortunately, the Todinei3i tests almost 40 years ago" even if they were safe, well intentioned, and conducted in accordance with the standards of the day have contributed to an atmosphere of conflict and mistrust between the indigenous peoples of the Arctic and the community of scientists and researchers who work in the Arctic. That is troubling and unfortunate, because science is critically important to Alaska and its future." He hoped an honest appraisal of the AAL thyroid function study would improve the relationship between the scientific and indigenous communities. The Committee bears full responsibility for the content and opinions presented in this document. However, we would like to acknowledge the many people who provided assistance. The Committee would like to thank the NRC staff for their support, including their diligent search for archival records and willingness to pursue cold trails for relevant information. The Committee also must thank the U.S. Air Force's Office of the Surgeon General, the Mayor of

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Preface IX the North Slope Borough and his staff, the Tanana Chiefs Conference in Fairbanks, and the Indian Health Service for their assistance in searching for and locating medical study subjects, and the U.S. Air Force for its financial support of the project. The Committee also received valuable assistance from the Oak Ridge Associated Universities Institute for Science and Education in calculating thyroid gland doses from administered Ii3i and from many others who spoke to us, reviewed our drafts, and provided other input. In addition, the Committee wishes to thank ACHRE for helping us review historical documents related to the conduct of medical research by the U.S. military in the 1950s. And, finally, I would like to thank personally the members of the Committee for their devoted participation in this activity. Although it is difficult and relatively unsatisfying to comment after the fact on what should have been done at a point some 40 years in the past, the Committee felt that this investigation into past actions is Important. Lessons from the past can lead to better research today, especially when it comes to cross-cultural studies. In addition, understanding the past can help set aright the continuing and long-term effects of a perceived betrayal of trust between the Alaska Native peoples and the incoming, dominant culture-represented in this case by the scientific community. This study and the public dialogue that occurred in the course of the study are a positive step in making complete information available and meeting modern standards of accountability . Chester Pierce, Chair Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Todinei3i

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Contents EXECUTIVE SUMMARY INTRODUCTION The Committee's Charge, 9 The AAL and The Thyroid Function Study, 1 1 Conduct of the Study: Sample Size and Distribution, 12 Conduct of the Study: Subject Selection, 14 Study Results, 20 The Committee's Methods, 21 Common Themes from the Public Session, 24 HEALTH EFFECT OF Il3l ADMINISTRATION IN HUMANS Radiological Background of the AAL Study, 27 Overview of Epidemiological Evidence regarding Radiation-Induced Thyroid Cancer, 27 Calculations of Radiation Risk, 33 Risk Estimates for the AAL Study, 36 Significance of Calculated Risks of Radiation-Induced Thyroid Cancer, 37 Radiation Guidelines for IN Usage- Then and Now, 38 The Evolution of our Understanding of Radiation Health Effects, 40 3 4 s THE ETHICS OF HUMAN SUBJECTS RESEARCH Background, 44 Conclusion, 60 CONCLUSIONS AND RECOMMENDATIONS REFERENCES x 1 8 26 43

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The AAL Thyroid Function Study 6 Xl APPENDICES A. Thyroid Function in Health and Disease 75 B. Summary of the Public Session 81 C. Thyroid Radiation Dose Estimates ll3} as Determined by the Radiation Internal Dose Information Center 87 D. Secretary of Defense Letter 88 E. Informed Consent Elements of Disclosure 92 F. Principles for the Conduct of Research in the Arctic 95 G. Biographical Sketches of Committee Members 99 H. Glossary 101 1

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