Isotopes for Medicine and the Life Sciences

Committee on Biomedical Isotopes

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

S. James Adelstein and Frederick J. Manning, Editors

NATIONAL ACADEMY PRESS
Washington, D.C.
1995



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Isotopes for Medicine and the Life Sciences Committee on Biomedical Isotopes Division of Health Sciences Policy INSTITUTE OF MEDICINE S. James Adelstein and Frederick J. Manning, Editors NATIONAL ACADEMY PRESS Washington, D.C. 1995

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 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 this report were chosen for their special competencies 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. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the U.S. Department of Energy (Grant No. DE-FG02-93ER61702). This support does not constitute an endorsement by the U.S. Department of Energy of the views expressed in the report. Library of Congress Catalog Card Number 94-74964 International Standard Book Number 0-309-05190-8 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, N.W. Box 285 Washington, DC 20055 Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area) B502 Copyright 1995 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin. First Printing, December 1989 Second Printing, June 1990 Third Printing, January 1991 Fourth Printing, March 1995

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COMMITTEE ON BIOMEDICAL ISOTOPES S. JAMES ADELSTEIN (Chair), Cabot Professor of Medical Biophysics, Dean for Academic Programs, Harvard Medical School, Boston, Massachusetts THOMAS F. BUDINGER, Henry Miller Professor of Medical Research, Lawrence Berkeley Laboratory, Department of Electrical Engineering and Computer Science, University of California, Berkeley, California R. EDWARD COLEMAN, Professor of Radiology and Director, Nuclear Medicine, Duke University, Durham, North Carolina DARLA DANFORD, Senior Nutrition Science Advisor, Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Washington, D.C. WILLIAM C. ECKELMAN, Chief, Positron Emission Tomography Department, National Institutes of Health, Bethesda, Maryland, JERRY A. NOLEN, JR., Director of ATLAS, Argonne National Laboratory, Argonne, Illinois LEE L. RIEDINGER, Associate Vice Chancellor for Research, University of Tennessee. Knoxville, Tennessee THOMAS J. RUTH, Director, Positron Emission Tomography Program, University of British Columbia, Vancouver, British Columbia, Canada LEE S. SCHROEDER, Senior Physicist, Lawrence Berkeley Laboratory, Berkeley, California MICHAEL J. WELCH, Professor of Radiology and Director, Division of Radiation Sciences, Mallinckrodt Institute of Radiology, Washington University Medical School, St. Louis, Missouri STEVEN W. YATES, Professor, Department of Chemistry, University of Kentucky, Lexington, Kentucky Study Staff VALERIE P. SETLOW, Division Director FREDERICK J. MANNING, Study Director JOSEPH S. CASSELLS, Senior Program Officer A. EVERETTE JAMES, Senior Program Officer SUSAN MORGAN, Project Assistant MARGO CULLEN, Project Assistant

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Preface Few members of the general public are fully aware of the extent to which the atomic age affects their everyday lives. For many, bombs and power plants are their only associations with the term. The uses and benefits of radioactive isotopes in medicine, agriculture, industry, and science are widespread, however, allowing us to perform many tasks more accurately, more simply, less expensively, and more quickly than would otherwise be possible. In many cases, biological tracers for example, there is no alternative. A recent report assessing the role of isotopes in 80 industries and 475 occupations estimated that in 1991, in the United States alone, radioactive materials were responsible for 3.7 million jobs, $257 billion in total sales, and $45 billion in tax revenues to local, state, and federal governments (See Chapter 1). This report focuses on isotopes in medicine and the life sciences, areas where their uses are particularly widespread and important in diagnosis, therapy, and research. More than 36,000 diagnostic procedures that employ radioisotopes are performed daily in the United States. Close to 100 million laboratory tests that use radioactive isotopes to measure some constituent of a biological sample are performed each year. In addition, some form of radioactivity is used to treat 150,000 to 200,000 patients each year. The U.S. Department of Energy (DOE) and its predecessors, the Atomic Energy Commission and the Energy Research and Development Agency, have been instrumental in establishing and supporting these peaceful applications of atomic energy and have succeeded in a "technology transfer" of enormous magnitude. This very success, combined with the end of the Cold War and the general pressure to cut government spending, has created what many see as a crisis in the domestic supply of isotopes. Always a secondary mission at the many DOE

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laboratories, isotope production has suffered as support for the laboratories' primary missions of research in nuclear and particle physics, nuclear weapons, and nuclear power has declined. The concerns of U.S. clinicians and researchers about the continuing availability of enriched stable isotopes and radionuclides have increased sharply since 1989, and the nuclear medicine community in particular has been highly vocal in pointing out that the needs of the various users in the United States will not be met adequately in a future market controlled by one or two foreign sources. It has been strongly urged with regard to those radionuclides needed for future research, that DOE fund a new accelerator facility with isotopes as its primary mission, a National Biomedical Tracer Facility. In response to this urging and with the realization that changing national and scientific priorities would reduce the funding for the accelerator-based facilities at Los Alamos National Laboratory (Los Alamos Meson Physics Facility) and Brookhaven National Laboratory (Brookhaven Linac Isotope Producer), DOE turned to the Institute of Medicine to undertake an intensive examination of isotope production and availability, including the education and training of those who will be required to sustain the flow of radioactive and stable materials from their sources to laboratories and bedsides. This document is the report of the committee formed to examine these matters and provide recommendations for action. The committee is comprised of 11 members, who were selected for their expertise in one of the technologies crucial to the production or use of isotopes covered by this report. Nevertheless the committee included members representative of a broad spectrum of viewpoints, including basic and applied researchers in the physical and life sciences, scientific administrators from both academic and government institutions, medical practitioners, and clinical investigators. In the course of the study, the full committee met four times in 2-day meetings, and subcommittees made 1-day site visits to isotope production facilities at Brookhaven National Laboratory on Long Island, Los Alamos National Laboratory in New Mexico, Canada's Tri-University Meson Facility, and the University of Missouri Research Reactor Center. Other important sources of information for the committee were the DOE Isotope Production and Distribution Program, specifically its director at the beginning of the study, Don Erb; representatives of a major isotope purchaser, the radiopharmaceutical industry, who addressed the committee at its second meeting; the half-dozen scientists who educated the committee on the state of the art of isotope separation at that meeting; and the reports of several previous committees, at the National Academy of Sciences and elsewhere, who wrestled with related charges in recent years. As committee chair, I am acutely aware of the contributions that Institute of Medicine staff have made to the success of the study. Special thanks and acknowledgments are owed Project Assistants Susan Morgan and Margo Cullen. Susan made our meetings and travel as comfortable and convenient as possible and provided outstanding secretarial support both at the meetings and in produc-

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ing our numerous preliminary drafts. We owe Margo our profound thanks for her painstaking production of our final product. A. Everette James and Joe Cassells, Senior Program Officers, who initially conceived the project and oversaw its birth, provided sage advice from start to finish. I am particularly grateful to Study Director Rick Manning for his skilled and professional support in shepherding the committee through its difficult task. Finally, I want to acknowledge the individual and collective contributions of the committee members. They represent an admirable example of busy but unselfish professionals volunteering their limited time tending to the scientific "commons" on which we all depend. It was a special opportunity to have worked with this outstanding group. S. James Adelstein, Chair Committee on Biomedical Isotopes

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Contents     EXECUTIVE SUMMARY   1     Enriched Stable Isotopes,   2     Reactor-Produced Radionuclides,   4     Accelerator-Produced Radionuclides,   4     Public-Private Partnership Models for NBTF,   6     A National Isotope Policy,   7 1   INTRODUCTION   9     Charge to the Committee,   14     Plan of the Report,   15 2   ENRICHED STABLE ISOTOPES   19     Historical Perspective,   19     Current Applications in Medicine and Physical and Life Sciences,   20     Isotope Separation in the United States,   25     Future Supplies,   26     New and Alternative Separation Technologies,   28     Conclusions,   30     Recommendations,   31 3   REACTOR-PRODUCED RADIONUCLIDES   35     Historical Perspective,   35     Current Applications in Medicine and Physical and Life Sciences,   36     Supplies and Suppliers,   42     Conclusions,   52     Recommendations,   52

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4   ACCELERATOR-PRODUCED RADIONUCLIDES AND A NATIONAL BIOMEDICAL TRACER FACILITY   57     Historical Perspective,   57     Current Applications in Medicine and Physical and Life Sciences,   58     Supplies and Suppliers,   60     Conclusions,   75     Recommendations,   77 5   PUBLIC-PRIVATE PARTNERSHIP MODELS FOR NBTF   81     The DOE Isotope Production and Distribution Program,   82     Canada's TRIUMF,   85     Nordion and Isotopes,   86     Universities and National Laboratories in Research,   87     DOE Laboratory and University Partnerships with Commercial Ventures,   88     Possible Model for NBTF,   92     Conclusions,   93     Recommendations,   94 6   A NATIONAL ISOTOPE POLICY: PROPOSAL FOR A NEW WAY TO MANAGE THE NATION'S ISOTOPE RESOURCES   96     Conclusions,   99     Recommendations,   100     APPENDIXES         A Waste Management   103     B Legal Considerations   113     C Acronyms and Abbreviations   123     D Table of Elements   125     E Glossary   128

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Isotopes for Medicine and the Life Sciences

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