Advancing Nuclear Medicine Through Innovation
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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 competences and with regard for appropriate balance.
This study was supported by Contract No. DE-AM01-04PI45013, Task Order DE-AT01-06ER64218 between the National Academy of Sciences and the U.S. Department of Energy and Contract No. N01-OD-4-2139 between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
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Cover: Photo courtesy of Peter Conti, University of Southern California.
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THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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COMMITTEE ON STATE OF THE SCIENCE OF NUCLEAR MEDICINE
HEDVIG HRICAK (Chair),
Memorial Sloan-Kettering Cancer Center, New York
S. JAMES ADELSTEIN,
Harvard Medical School, Boston, Massachusetts
PETER S. CONTI,
University of Southern California, Los Angeles
JOANNA FOWLER,
Brookhaven National Laboratory, Upton, New York
JOE GRAY,
Lawrence Berkeley National Laboratory, Berkeley, California
LIN-WEN HU,
Massachusetts Institute of Technology, Cambridge
JOEL KARP,
University of Pennsylvania, Philadelphia
THOMAS LEWELLEN,
University of Washington, Seattle
ROGER MACKLIS,
Cleveland Clinic Foundation, Ohio
C. DOUGLAS MAYNARD,
Wake Forest University School of Medicine, Winston-Salem, North Carolina
THOMAS J. RUTH,
Tri-University Meson Facility, Vancouver, Canada
HEINRICH SCHELBERT,
University of California, Los Angeles
GUSTAV VON SCHULTHESS,
University Hospital of Zurich, Switzerland
MICHAEL R. ZALUTSKY,
Duke University, Durham, North Carolina
Staff
NAOKO ISHIBE, Study Director
MARILYN FIELD, Senior Program Officer
TRACEY BONNER, Program Assistant
SHAUNTEÉ WHETSTONE, Program Assistant
NUCLEAR AND RADIATION STUDIES BOARD
RICHARD A. MESERVE (Chair),
Carnegie Institution, Washington, D.C.
S. JAMES ADELSTEIN (Vice Chair),
Harvard Medical School, Boston, Massachusetts
JOEL S. BEDFORD,
Colorado State University, Fort Collins
SUE B. CLARK,
Washington State University, Pullman
ALLEN G. CROFF,
Oak Ridge National Laboratory (retired), St. Augustine, Florida
DAVID E. DANIEL,
University of Texas at Dallas
SARAH C. DARBY,
Clinical Trial Service Unit, Oxford, United Kingdom
ROGER L. HAGENGRUBER,
University of New Mexico, Albuquerque
DANIEL KREWSKI,
University of Ottawa, Ontario, Canada
KLAUS KÜHN,
Technische Universität Clausthal, Clausthal-Zellerfeld, Germany
MILTON LEVENSON,
Bechtel International (retired), Menlo Park, California
C. CLIFTON LING,
Memorial Hospital, New York, New York
PAUL A. LOCKE,
Johns Hopkins University, Baltimore, Maryland
WARREN F. MILLER,
Texas A & M University, College Station
ANDREW M. SESSLER,
Lawrence Berkeley National Laboratory, Berkeley, California
JOHN C. VILLFORTH,
Food and Drug Law Institute (retired), Derwood, Maryland
PAUL L. ZIEMER,
Purdue University (retired), West Lafayette, Indiana
Staff
KEVIN D. CROWLEY, Director
EVAN B. DOUPLE, Scholar
RICK JOSTES, Senior Program Officer
MICAH D. LOWENTHAL, Senior Program Officer
JOHN R. WILEY, Senior Program Officer
NAOKO ISHIBE, Program Officer
TONI GREENLEAF, Financial and Administrative Associate
LAURA D. LLANOS, Financial and Administrative Associate
COURTNEY GIBBS, Senior Program Assistant
MANDI BOYKIN, Program Assistant
SHAUNTEÉ WHETSTONE, Program Assistant
JAMES YATES, JR., Office Assistant
BOARD ON HEALTH SCIENCES POLICY
FRED H. GAGE (Chair),
The Salk Institute for Biological Studies, La Jolla, California
C. THOMAS CASKEY,
University of Texas—Houston Health Science Center
GAIL H. CASSELL,
Eli Lilly and Company, Indianapolis, Indiana
JAMES F. CHILDRESS,
University of Virginia, Charlottesville
ELLEN WRIGHT CLAYTON,
Vanderbilt University Medical School, Nashville, Tennessee
LINDA C. GIUDICE,
University of California, San Francisco
LYNN R. GOLDMAN,
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
LAWRENCE O. GOSTIN,
Georgetown University Law Center, Washington, D.C.
MARTHA N. HILL,
Johns Hopkins University School of Nursing, Baltimore, Maryland
ALAN LESHNER,
American Association for the Advancement of Science, Washington, D.C.
DAVID KORN,
Association of American Medical Colleges, Washington, D.C.
JONATHAN D. MORENO,
University of Pennsylvania, Philadelphia
E. ALBERT REECE,
University of Maryland School of Medicine, Baltimore
LINDA ROSENSTOCK,
University of California, Los Angeles
MICHAEL J. WELCH,
Washington University School of Medicine, St. Louis, Missouri
OWEN N. WITTE,
University of California, Los Angeles
IOM Staff
ANDREW M. POPE, Director
AMY HAAS, Board Assistant
GARY WALKER, Senior Financial Officer
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 of objectivity, evidence, and responsiveness to the study charge. The content 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:
Simon Cherry, University of California, Davis
Chaitanya Divgi, University of Pennsylvania, Philadelphia
Ora Israel, Rambam Medical Center, Haifa, Israel
Jeanne Link, University of Washington, Seattle
Michael Phelps, University of California, Los Angeles
Theodore Phillips, University of California, San Francisco
Donald Podoloff, M.D. Anderson Cancer Center, Houston, Texas
Richard Reba, Georgetown University, Washington, D.C.
Kirby Vosburgh, Center for Integration of Medicine and Innovative Technologies, Cambridge, Massachusetts
Michael Welch, Washington University, St. Louis, Missouri
Chris Whipple, ENVIRON International Corporation, Emeryville, California
Paul Ziemer, Purdue University, West Lafayette, Indiana
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the report’s conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Floyd Bloom, Professor Emeritus, The Scripps Research Institute, and John Ahearne, Manager of the Ethics Program, Sigma Xi, The Scientific Research Society. Appointed by the National Research Council. They were 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 National Research Council.
Preface
It has been an honor and a privilege to chair the committee on the state of science in nuclear medicine. As a diagnostic radiologist, a clinician-scientist, and the chairperson of a large academic radiology department, I have been exposed to the many advances in nuclear medicine and have observed their clinical benefits up close. Participating in this review, however, has allowed me to step back and appreciate the magnitude of the progress that has been achieved, and the crucial role that government funding has played in it. Investments in chemistry, physics, engineering, and training are responsible for the state-of-the-art radiopharmaceuticals and imaging instruments that we now rely on to improve our understanding of human physiology through non-invasive disease detection and treatment monitoring.
These advances have already had a major impact on all branches of imaging and medicine, yet, they pale in comparison to those on the horizon. Nuclear medicine offers a unique, non-invasive view into intracellular processes and enzyme trafficking, receptors and gene expression, and forms the theoretical and applied foundation for molecular medicine. The contributions of nuclear medicine are creating the possibility of a future of personalized medicine, in which treatments and medications will be based on an individual’s unique genetic profile and response to disease processes.
Although the progress in nuclear medicine research in the United States has been spectacular, potential obstacles to its continuation have been noted in previous reports, including a critical shortage of chemists and other personnel trained in nuclear medicine, and an inadequate supply of
radionuclides for research and development. In addition, uncertainty has arisen about how, and to what degree, the government should continue to fund nuclear medicine research. For years, the basic chemistry and physics research behind the growth of the field has been supported by the Medical Applications and Sciences Program of the Department of Energy (DOE) Office of Biological and Environmental Research. However, the uniqueness of this program relative to the nuclear medicine research funded by the National Institutes of Health (NIH) has long been under debate. The DOE and the NIH commissioned this study on the state of the science in nuclear medicine because of the uncertainty surrounding the support of the Medical Applications and Sciences Program. Specifically, the sponsoring agencies asked that the National Academies assess areas of need in nuclear medicine research, examine the program and make recommendations to improve its impact on nuclear medicine research and isotope production.
In response to this request, the National Research Council of the National Academies appointed a committee of 14 experts to carry out this study. The committee gathered information from members of the public, experts on nuclear medicine, scientific and medical societies, and federal agencies. In composing its report, the committee decided to describe the needs in nuclear medicine research primarily in terms of future opportunities in the field. Thus the report, in my view, is an exciting, forward-looking document that makes clear the potential of the field for further advancing medicine, and suggests practical steps to facilitate progress. I hope and believe that it will have a positive impact on the future of nuclear medicine.
Hedvig Hricak, Chair
Acknowledgments
The committee is grateful to the speakers and panelists (listed in Appendix A) who participated in the information-gathering sessions for the study. In addition, the committee wishes to thank Belinda Seto, Peter Preusch, and Dan Sullivan at the National Institutes of Health (NIH); and Mike Viola, John Pantaleo, Prem Srivastava, and Peter Kirschner at the Department of Energy (DOE) for contributing their time, efforts, and insights to the study.
I would like to personally thank my fellow committee members for their dedication to carrying out a thorough study and writing a useful report. They all cared deeply about the topic, and their probing questions and lively discussions ensured that we covered a wide range of issues and considered them from multiple angles.
Studies such as this are often long on information and short on time, and the committee would like to thank the many National Research Council staff members whose help was essential in producing this report. Among these, the committee particularly wishes to acknowledge Kevin Crowley, Director of the Nuclear and Radiation Studies Board, for providing guidance on the study process and keeping the committee focused on its charge; Shaunteé Whetstone and James Yates for their administrative support; Toni Greenleaf for making sure that we stayed on budget; and Rick Jostes for his technical contributions to the report. I would especially like to thank the