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Radiation in Medicine: A Need for Regulatory Reform RADIATION IN MEDICINE A NEED FOR REGULATORY REFORM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission Kate-Louise D. Gottfried and Gary Penn, Editors Division of Health Care Services INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1996
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Radiation in Medicine: A Need for Regulatory Reform NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 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 the report were chosen for their special competences 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 United States Nuclear Regulatory Commission under Contract No. NRC-02-94-002. The views presented are those of the Institute of Medicine Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission and are not necessarily those of the funding organization. Library of Congress Catalog Card No. 95-72801 International Standard Book Number 0-309-05386-2 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). Copyright 1996 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.
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Radiation in Medicine: A Need for Regulatory Reform COMMITTEE FOR REVIEW AND EVALUATION OF THE MEDICAL USE PROGRAM OF THE NUCLEAR REGULATORY COMMISSION CHARLES E. PUTMAN (Chair),* James B. Duke Professor of Radiology, Professor of Medicine, Senior Vice President, Research Administration and Policy, Duke University ROBERT S. ADLER, Professor of Legal Studies, Associate Dean of Undergraduate Program, Kenan-Flagler School of Business, University of North Carolina, Chapel Hill BYRON (BILL) WILLIAM BROWN, JR.,* Professor and Chair, Department of Health Research and Policy, Stanford University JENNIFER DUNN BUCHOLTZ, Adjunct Faculty, Department of Advanced Nursing Science, University of Delaware, Associate Faculty Member, Johns Hopkins School of Nursing, Clinical Nurse Specialist in Radiation Oncology, Division of Radiation Oncology, Johns Hopkins Oncology Center, Baltimore TIMOTHY J. CONLAN, Associate Professor, Department of Public and International Affairs, George Mason University BARBARA Y. CROFT, Associate Professor of Radiology, Department of Radiology, University of Virginia SISTER ROSEMARY DONLEY,* Executive Vice President, The Catholic University of America DAVID S. GOODEN, Director, Department of Biomedical Physics, St. Francis Hospital, Tulsa, Oklahoma, Chairman, Radiation Advisory Council, Oklahoma Department of Environmental Quality WILLIAM R. HENDEE, Senior Associate Dean for Research, Vice President for Technology, Dean of Graduate School, Professor of Radiology, Radiation Oncology, Biophysics, and Bioethics, Director, Health Information Technology Center, Medical College of Wisconsin, Executive Vice President, Medical College of Wisconsin Research Foundation, Adjunct Professor of Biomedical Engineering, Marquette University DAVID E. KUHL,* Professor of Internal Medicine and Radiology, Chief, Division of Nuclear Medicine, Department of Internal Medicine, The University of Michigan Medical Center, Ann Arbor LESTER B. LAVE,* University Professor, Graduate School of Industrial Administration, Harry B. and James H. Higgins Professor of Economics and Finance, Professor of Engineering and Public Policy, Engineering School, Professor of Urban and Public Affairs, Heinz School of Public Policy, Carnegie-Mellon University THEODORE L. PHILLIPS,* Professor and Chair, Department of Radiation Oncology, University of California, San Francisco MARCIA O. STEVIC, Health Outcomes Researcher, Health Services Advisory Group, Phoenix, Arizona
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Radiation in Medicine: A Need for Regulatory Reform JOHN C. VILLFORTH, President, The Food and Drug Law Institute, Inc., Washington, D.C. J. FRANK WILSON, Professor and Chair, Department of Radiation Oncology, Medical College of Wisconsin BARRY L. ZARET, Robert W. Berliner Professor of Medicine, Professor of Diagnostic Radiology, Chief, Section of Cardiovascular Medicine, Associate Chair for Clinical Affairs, Department of Internal Medicine, Yale University School of Medicine Study Staff KATE-LOUISE D. GOTTFRIED, Study Director GARY PENN, Research Associate (from December 1994) RICHARD JULIAN, Senior Project Assistant (from December 1995) KATHLEEN N. LOHR, Director, Division of Health Care Services NINA SPRUILL, Financial Associate DON TILLER, Administrative Assistant, Division of Health Care Services A. EVERETTE JAMES, JR., Senior Program Officer (through November 1994) ERIC CAPLAN, Research Associate (through December 1994) JEANETTE HOWARD, Project Assistant (through January 1995) JULIE M. FANBURG, Project Assistant (through July 1995) NATASSJA OLSEN, Project Assistant (through November 1995) * Institute of Medicine member.
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Radiation in Medicine: A Need for Regulatory Reform Preface Three events played an important role in prompting this study: a November 1992 radiation incident in Indiana, Pennsylvania; a December 1992 week-long series of articles in the Cleveland Plain Dealer on the hazards of radiation medicine; and a May 1993 congressional hearing, chaired by Senator John Glenn, on the regulation of radiation medicine. During the summer of 1993, following these events, the U.S. Nuclear Regulatory Commission (NRC) negotiated with the Institute of Medicine (IOM) of the National Academy of Sciences to undertake an independent review and evaluation of the NRC's Medical Use Program, which oversees the regulation of reactor-generated byproduct material. The review was intended to complement an internal management review already under way within the NRC. As a result, the IOM formed the Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission, which officially commenced a two-year study on January 2, 1994. The study was conducted by a 16-member committee of experts from a broad spectrum of disciplines, including medicine (diagnostic radiology, nuclear medicine, radiation oncology, and nuclear cardiology), health physics, economics, quality of care, biostatistics, public health, nursing, law, ethics, and regulatory matters and public policy analysis. The NRC's charge to the committee specifically requested a review of the NRC's Medical Use Program, an evaluation of the program's adequacy, and recommendations for changes. Through the IOM study, the NRC sought an evaluation of whether the rules, policies, and procedures of the current regulatory framework for medical uses of byproduct material fulfill the NRC's statutory responsibilities for public health and safety. There is particular interest
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Radiation in Medicine: A Need for Regulatory Reform in regulating the medical uses of nuclear reactor-generated byproduct material not only because byproduct material is a source of ionizing radiation, which, unlike nonionizing radiation, poses health and safety risks, but also because of nuclear reactors' special history and ties to weaponry. There are, however, sources of ionizing radiation other than byproducts that are also widely used in medicine. During the course of this study, in fact, the committee realized that procedures involving byproduct material represent only one-tenth of all medical applications of ionizing radiation. In this connection, the NRC specifically requested recommendations on a uniform national approach to regulation of the entire field of ionizing radiation in medicine, including all sources, not solely byproduct material. The committee first examined the scientific foundation for the use of ionizing radiation in medicine, including the scientific debate concerning its risks. It then discussed the appropriate level and scope of regulation for using ionizing radiation in medicine. The committee strove to clarify key issues, to define potential alternatives for regulatory programs, and to achieve a consensus as to recommendations. Its deliberations and fact-finding efforts included site visits, commissioned papers, a public hearing, the convening of a technical panel, attendance at professional conferences, and several committee meetings. The result of the committee's study is this report. In it, the committee proposes a major shift in the elaborate regulatory structure that has developed over the five decades since byproducts were first used for peaceful purposes. Nearly all of the committee agreed on the findings, conclusions, and recommendations in the report. Unlike most National Research Council committees, however, this committee did not reach total unanimity on the final recommendations. The separate statement of one committee member's views is included in Appendix L. The report, which was reviewed under the procedures of the National Research Council, constitutes the committee's final statement. As chairman, I wish to express my sincere appreciation to the IOM staff, particularly Kate-Louise Gottfried, and all members of the committee, for their diligence, sensitivity, and commitment to this process. I also wish to express my gratitude to all those who assisted us in providing information during our deliberations. The recommendations that we are proposing reflect the expertise and knowledge of a diverse group of professionals. Charles E. Putman, M.D. Chair
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Radiation in Medicine: A Need for Regulatory Reform Acknowledgments This report is the result of the considered deliberations of the Institute of Medicine (IOM) Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission. The conclusions and recommendations reflect the judgments of the committee. Generous support for this study was provided by the Nuclear Regulatory Commission (NRC, Contract No. NRC-02-94-002). This report is the result of extensive collective efforts among the committee members, staff, and a variety of other contributors. The committee worked diligently writing and rewriting major sections of this report. There were many other contributors to this truly collaborative process, however, and the committee wishes to express its gratitude to them. The NRC respected the IOM's autonomy and stood ready to provide whatever information or assistance was needed. Under the leadership of Patricia Rathbun, the NRC contract officer, the IOM committee and staff were briefed and provided with documents, conducted conference calls, and obtained other important information from the NRC, all in a timely manner. Robert Bernero, Carl Papierello, Myron Pollycove, Don Cool, and John Glenn, to name a few, and a number of NRC staff were eager to provide assistance in whatever way possible. Chairman Selin and Commissioners Rogers and de Planque each visited one of our committee meetings and shared their candid views and concerns with the committee. A variety of guests were also invited to our committee meetings to provide their unique perspectives on relevant study issues. Charles Meinhold, President of the National Council of Radiation Protection and Measurements, addressed the committee. Barry Siegel of the NRC's Advisory Committee on the Medical
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Radiation in Medicine: A Need for Regulatory Reform Uses of Radioisotopes (ACMUI) gave a presentation in his capacity as ACMUI Chair. Robert Alvarez, former professional staffer on the Senate Committee for Governmental Affairs, who worked closely with Senator John Glenn, provided both critical congressional and non-regulated community perspective for the committee's consideration. Representatives of the NRC, the Food and Drug Administration (FDA), and the regulated community also shared their views with the committee. Richard Bangart, Director of State Programs of the NRC, discussed the existing state program system, its strengths and weaknesses. James Lieberman, Director of the NRC's Office of Enforcement, explained the basics of the enforcement process. Stuart A. Treby, Assistant General Counsel for Rulemaking and Fuel Cycle in the Office of the NRC General Counsel, provided an important perspective on the NRC's rulemaking process and authority. Representatives from the FDA described their agency's role in areas subject to investigation by the committee. Among them were D. Bruce Burlington, Marvin Rosenstein, Richard E. Gross, and James Cheever, who gave generously of their time to meet with and answer questions from the committee. Elizabeth Jacobson, Joseph Leavitt, and Bob Eccleston also were gracious in providing information about the FDA. Practicing physicians who visited the committee and shared their experiences with the use of radionuclides included Mike Hattwick, Worth B. Daniels, Richard Rubin, Lynn Campbell, Louis Harrison, and Daniel Clarke. Dwight Glenn also provided perspective from the physicists' vantage point. Various individuals from the Conference of Radiation Control Program Directors (CRCPD), including Charles Hardin, President, and Wayne Kerr, from the Illinois State Radiation office, provided valuable input and assistance throughout the study process. Terry Devine and staff at the main CRCPD office provided basic information, data, and reference documents and were unfailingly helpful. Joel Nobel and his staff at the ECRI also generously provided data. The committee also appreciated Carol Marcus's efforts to keep it apprised of documents and information circulating throughout the nuclear medicine community. Finally, Jerome A. Halperin, of the United States Pharmacopeial Convention, Inc., provided a context for understanding the history and handling of radiopharmaceuticals. Site visits were conducted often during the study process to provide the committee with firsthand information. This activity enabled committee members who were less familiar with the day-to-day processes involved in radiation medicine to meet with professionals in a clinical setting and interact with a variety of individuals involved in this aspect of medicine. Owing to confidentiality requirements, specific individuals and institutions cannot be named, but the committee is indebted to all those who gave of their time, meeting with us and providing important insights into the existing system. During the fall of 1994, some members of the committee participated in a daylong technical panel devoted to quality management issues. Members of the technical panel who met with committee members are listed in Appendix I.
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Radiation in Medicine: A Need for Regulatory Reform Members of this panel assisted the committee by reviewing background materials and engaging in an important discussion regarding quality management issues. Appendix H lists the organizations that prepared written testimony for the committee's public meeting in the fall of 1994 and contains summaries of responses staff received to questions posed prior to the meeting. The committee also commissioned a number of papers to assist in preparation of this report. These papers are listed in Appendix J. Regarding the writing of the report, the committee wishes to acknowledge particular contributions of the following individuals. The study director, Kate-Louise D. Gottfried, had overall responsibility for preparation of the report. With the invaluable assistance of Gary Penn, she edited the entire document. She also prepared the summary and the first drafts of Chapter 1, which were reviewed extensively by the entire committee. Chapter 2 was the collaborative effort of committee members and was synthesized by Mark Edwards in a commissioned paper. Chapter 3 is a compilation of work created from a commissioned paper by Daniel Strom, committee members, and staff. Chapter 4 was also a joint enterprise. The first draft of the section on risk of exposure to low levels of ionizing radiation was written by Ronald Kathren and revised by committee members. The section on misadministrations benefited from a commissioned paper by Naomi Alazraki and committee members. The final section of this chapter drew on a paper commissioned from Paul Slovic. Chapters 5 and 6 are products of the entire committee's conceptual process, drafted by staff and revised repeatedly based on committee input. Appendix G was written primarily by Gary Penn, with some background material prepared by Eric Caplan and assistance of IOM senior staff, and committee members. In addition, several members of the IOM's professional staff made important contributions to this report. Kathleen N. Lohr, as Director of the Division of Health Care Services, drafted the original proposal that led to this study and provided valuable guidance and editorial assistance over the duration of the project, including review and comment on several chapters. Richard A. Rettig lent his vast regulatory and study expertise in the formative stages of the report outline. Marilyn J. Field, Deputy Director of the Division of Health Care Services, also provided insights into the study process and review of Chapter 1. A number of other IOM staff worked on this study. A. Everette James, Jr., assisted in creating the committee and establishing liaison with key individuals knowledgeable about the issues. Eric Caplan, research associate, was involved in the process initially and drafted a background paper on the quality management rule. Gary Penn joined the study seven months prior to review and rapidly assimilated vast quantities of complex material. Gary was a tremendous asset to the study during a critical juncture; his contributions to the writing and editing of the report are noteworthy. His quiet concentration and ever present calm and good humor moved the process forward. Tania DeGolyer helped get the study under way. Jeanette Howard, who succeeded her, was a diligent and efficient assistant. Julie Fanburg stepped into a
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Radiation in Medicine: A Need for Regulatory Reform process solidly under way and provided excellent assistance. Natassja Olsen arrived after the last meeting, stepping efficiently into the last critical stages of report preparation. We are all grateful for her competence. Richard Julian combined his mastery of software and attention to detail converting the report into camera-ready copy. Don Tiller provided excellent emergency assistance, Nina Spruill guarded our finances, and Claudia Carl managed the essential report review process. Rick Manning, study director of an earlier report, shared information with us as did John Zimbrick of the Commission on Life Sciences. Finally, this report benefited immeasurably from the meticulous efforts of Andrea Posner, who not only copy-edited it but also provided valuable organizational structure and coherence to the report as a whole.
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Radiation in Medicine: A Need for Regulatory Reform Contents SUMMARY 1 1 INTRODUCTION 23 Errors and Successes, Benefits and Problems of Radiation Medicine 24 The Current Regulatory System 27 The Institute of Medicine Study 30 Chapter Summary 37 2 CLINICAL APPLICATIONS OF IONIZING RADIATION 39 Measures of Patient Exposure to Ionizing Radiation 39 Diagnostic Applications of Ionizing Radiation 43 Therapeutic Applications of Ionizing Radiation 62 Chapter Summary 75 3 REGULATION AND RADIATION MEDICINE 77 Regulatory Goals 77 The Current Regulatory Framework 78 The Costs of NRC Regulation 91 Qualitative Assessments of NRC Regulations 104 Chapter Summary 108 4 RISKS OF IONIZING RADIATION IN MEDICINE 111 Risk Assessment 111
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Radiation in Medicine: A Need for Regulatory Reform Risks of Ionizing Radiation in Medical Treatment 116 Public Perception of Radiation Risk 128 Chapter Summary 136 5 ALTERNATIVE REGULATORY SYSTEMS 141 Seven Alternative Structures 143 Assessment of the Alternatives 162 Chapter Summary 167 6 FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS 169 Report Premises 170 Findings 171 Conclusions 172 Recommendations 174 Concluding Statement 179 APPENDIXES A Committee Biographies 181 B Abbreviations and Acronyms 189 C Glossary 192 D Selected Sections of the United States Code of Federal Regulations 201 E Nuclear Regulatory Commission Agreement States and Non-agreement States 244 F Regulatory Chronology 246 G History of Radiation Regulation in Medicine 249 H Public Meeting Documents 259 I Quality Management Technical Panel 281 J Commissioned Papers 283 K The Linear, No-Threshold Model 284 L Separate Statement Robert S. Adler 290 INDEX 299 TABLES AND FIGURES Tables 1.1 Ionizing Radiation in Medicine 30 2.1 Radiation in Medicine 40 2.2 Relative Frequency and Absolute Utilization Rate of Radiological Procedures in 1980 46
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Radiation in Medicine: A Need for Regulatory Reform 2.3 Total Number (in thousands) of Imaging Procedures in U.S. Hospitals, 1970–1990 47 2.4 Estimated Total Number of All Medical Imaging Procedures, 1970–1990 48 2.5 Typical Entrance Skin Air Kerma (ESK) per Procedure and Typical Effective Dose Equivalent (EDE) for Several Common Procedures 49 2.6 Properties of Radionuclides Used in Common Nuclear Medicine Procedures 54 2.7 Number of Nuclear Medicine Procedures (in thousands) by Examination Type 55 2.8 Dosage Levels for Several Nuclear Medicine Procedures 56 2.9 Selected Reactor-Produced Radionuclides and Their Biomedical Applications 58 2.10 Selected Accelerator-Produced Radionuclides and Their Biomedical Applications 60 2.11 Estimated Number of New Cancer Cases by Site in 1995 66 2.12 Number of Radiation Oncology Facilities, Number of Treatment Machines, and Patient Loads, 1975–1990 68 2.13 Some Properties of Radionuclides Commonly Used for Brachytherapy 71 2.14 Radionuclides Commonly Used for Therapeutic Nuclear Medicine 74 3.1 Legislative Authority for Licensing and Registration of Naturally Occurring and Accelerator-Produced Radioactive Material 92 3.2 Fee Schedule for Selected Materials License Categories for FY 1994 95 3.3 Fees Collected by the NRC in FY 1993, by Selected Materials License Category 97 3.4 Fines Collected by the NRC in FY 1993, by Selected Materials License Category 99 3.5 Savings Estimated from Projected Reduction at Four NRC Licensees 103 3.6 Federal Radiation Exposure Limits 106 4.1 Ordering of Perceived Risk for 30 Activities and Technologies 130 4.2 Summary of Perception and Acceptance of Risks from Diverse Sources of Radiation Exposure 132 Figures 4.1 Mean perceived risk and perceived benefit for medical and nonmedical sources of exposure to radiation and chemicals 131 4.2 Differential impact of trust-increasing and trust-decreasing events 135