1
Introduction

This study was prompted by discussions between the U.S. Department of Energy (DOE) and the Office of Management and Budget (OMB) about future scientific areas for the DOE Office of Biological and Environmental Research Medical Applications and Sciences Program.1 OMB recommended that program functions be retained, but that funds for the program be reduced beginning in fiscal year (FY) 2006. However, they agreed to delay decisions about program restructuring pending a state-of-the-science review of nuclear medicine from the National Academies. In FY 2006, Congress passed and the President signed an 85 percent ($23 million) reduction in the funding for the DOE budget for basic nuclear medicine and molecular imaging research, leaving only support for the neuroimaging program at Brookhaven National Laboratory2,3 (Figure 1.1).

Historically, basic nuclear medicine research has been funded primarily by the DOE and its predecessor agencies, the Atomic Energy Commission (AEC) and the Energy Research and Development Administration (ERDA) (DOE 2007a, DOE 2007b). The desire to apply radioactivity’s promise for peaceful use instigated a transfer of research in atomic energy from the War Department to AEC in 1947. Its mission was to oversee research pro-

1

DOE’s Office of Biological and Environmental Research (DOE-OBER) Medical Applications and Measurement Sciences Program provides federal support for basic scientific studies in nuclear medicine.

2

Joanna Fowler is the Director of the Center for Translational Neuroimaging at Brookhaven National Laboratory.

3

An earmark appropriation continued a program at UCLA as well.



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Advancing Nuclear Medicine through Innovation 1 Introduction This study was prompted by discussions between the U.S. Department of Energy (DOE) and the Office of Management and Budget (OMB) about future scientific areas for the DOE Office of Biological and Environmental Research Medical Applications and Sciences Program.1 OMB recommended that program functions be retained, but that funds for the program be reduced beginning in fiscal year (FY) 2006. However, they agreed to delay decisions about program restructuring pending a state-of-the-science review of nuclear medicine from the National Academies. In FY 2006, Congress passed and the President signed an 85 percent ($23 million) reduction in the funding for the DOE budget for basic nuclear medicine and molecular imaging research, leaving only support for the neuroimaging program at Brookhaven National Laboratory2, 3 (Figure 1.1). Historically, basic nuclear medicine research has been funded primarily by the DOE and its predecessor agencies, the Atomic Energy Commission (AEC) and the Energy Research and Development Administration (ERDA) (DOE 2007a, DOE 2007b). The desire to apply radioactivity’s promise for peaceful use instigated a transfer of research in atomic energy from the War Department to AEC in 1947. Its mission was to oversee research pro- 1 DOE’s Office of Biological and Environmental Research (DOE-OBER) Medical Applications and Measurement Sciences Program provides federal support for basic scientific studies in nuclear medicine. 2 Joanna Fowler is the Director of the Center for Translational Neuroimaging at Brookhaven National Laboratory. 3 An earmark appropriation continued a program at UCLA as well.

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Advancing Nuclear Medicine through Innovation FIGURE 1.1 DOE-OBER funding for nuclear medicine research, 2002—2007. SOURCE: Data provided by DOE-OBER. grams in health measures and radiation biology conducted at the national laboratories. Subsequently, the Energy Reorganization Act of 1974 created ERDA, which assumed and expanded on AEC’s responsibilities. Three years later, the DOE was created. Within the DOE, the Office of Nuclear Energy (DOE-NE) provides radionuclides to the research community on a full-cost-recovery basis through its Isotope Program, while the DOE-OBER provides federal support for basic scientific studies in nuclear medicine through its Medical Applications and Measurement Sciences Program. The mission of the program has been “to deliver relevant scientific knowledge that will lead to innovative diagnostic and treatment technologies for human health.” The specific objectives of the program are as follows (DOE 2006): to utilize innovative radiochemistry to develop new radiotracers for medical research, clinical diagnosis, and treatment; to develop the next generation of non-invasive nuclear medicine technologies; to develop advanced imaging detection instrumentation capable of high resolution from the sub-cellular to the clinical level; and to utilize the unique resources of the DOE in engineering, physics, chemistry, and computer sciences to develop the basic tools to be used in biology and medicine, particularly in imaging sciences, photo-optics and biosensors. The program directly supported nuclear medicine research through radiopharmaceutical and instrument development and the development of

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Advancing Nuclear Medicine through Innovation radionuclides for diagnosis and targeted therapy (Chapter 4).4 It also supported dedicated cyclotrons5 for the production of short-lived, positron6-emitting radionuclides for use in NIH clinical research. In FY 2005, the program provided approximately $30 million in federal research support for facilities and scientific investigations at seven national laboratories and 35 universities. Over the years, research supported by this program has provided new technological and clinical tools in nuclear medicine that have resulted in medical breakthroughs. For example, the research has enabled: the development of positron emission tomography (PET) scanners to diagnose and monitor the treatment of cancer and other diseases; the advancement of radiotracer chemistry, leading to the synthesis of fluorine-18-labeled fluorodeoxyglucose (FDG)7 and many other tracers for imaging the human brain and other organs with PET; the development of the molybdenum-99m/technetium-99m generator, which is the most widely used tracer in nuclear medicine, worldwide; and further advances in the application of “exotic” therapeutic pharmaceuticals, such as the alpha-particle emitters that have great promise for cancer therapy. Additional discoveries and developments are highlighted in Chapter 2. Funding for nuclear medicine has also come from the National Institutes of Health (NIH), particularly the National Cancer Institute (NCI) and, more recently, the National Institute of Biomedical Imaging and Bioengineering (NIBIB). In FY 2006, $44.7 million and $17.8 million were expended by NCI and NIBIB, respectively, for extramural nuclear medicine research (Figure 1.2). Other Institutes,8 such as the National Institute of Mental Health, have also funded nuclear medicine research ($70.8 million in FY 2006 for both intramural and extramural programs). However, an informal analysis of NIH’s nuclear medicine portfolio suggests that ap- 4 Targeted radionuclide therapy is a form of treatment that delivers therapeutic doses of radiation to malignant tumors, for example, by administration of a radiolabeled molecule into the blood stream that is designed to seek out certain cells. 5 A cyclotron (Sidebar 5.1) is a machine used to accelerate charged particles to high energies. 6 A positron is an elementary particle of antimatter that undergoes mutual annihilation with a nearby electron, which produces two gamma rays traveling in the opposite direction. 7 The use of FDG with PET scan technology has now been validated and its importance documented in the diagnosis, staging, and follow-up of approximately two dozen different types of malignancies. 8 Data were not available for the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute of Drug Abuse.

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Advancing Nuclear Medicine through Innovation FIGURE 1.2 Extramural funding for nuclear medicine research, 2004—2006. SOURCE: Data provided by NCI and NIBIB. proximately 75 percent of these funds represent application of currently available radiotracers and technologies (e.g., FDG-PET) rather than fundamental research on next-generation technology and radiotracer development in nuclear medicine (Figure 1.3). The removal of funding with neither provision of bridge funding nor transfer of the research portfolio to another agency has created a sense of urgency about the need to assess the state of the science in nuclear medicine and to address two pre-existing problems that have been noted in other reports, namely (1) the critical shortage of trained chemists and clinical investigators in nuclear medicine and radiopharmaceutical science, and (2) the lack of a domestic source of radionuclides for research and development. To address uncertainties about whether and how future research in nuclear medicine should be funded, the DOE-OBER and the NIH jointly requested that the National Academies carry out this study and jointly sponsored this report. The statement of task for this study (Sidebar 1.1) evolved out of discussions between the sponsoring agencies and the National Academies. Based on the discussions of the committee during the course of the study, the original fourth charge—to examine shortages of radiochemists—was expanded to include examination of shortages of highly trained nuclear medicine scientists.

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Advancing Nuclear Medicine through Innovation FIGURE 1.3 Breakdown of funding expended by NCI and NIBIB on nuclear medicine research by research area: 1 = Basic instrumentation development, 2 = Basic radiopharmaceutical development, 3 = Basic image reconstruction/analysis development, 4 = Development of new imaging procedures, 5 = Development of new therapy procedures, 6 = Clinical trials. SOURCE: Data provided by NCI and NIBIB. 1.1 STRATEGY TO ADDRESS THE STUDY CHARGE The sponsors of the study requested that the National Academies produce a report for public dissemination within 13 months. This report fulfills that request. The National Research Council of the National Academies appointed a committee of 14 experts to carry out this study. Biographical sketches of the committee members are provided in Appendix D. The committee met six times to gather information and develop this report. Details on the information-gathering sessions and speakers are provided in Appendix A. All of the information-gathering sessions were open to the public. Comments from interested organizations and individuals were encouraged and considered. Within the specific scope outlined above, the committee reviewed information provided to it by members of the public, outside subject matter experts, scientific and medical societies, industry, and federal agencies. The committee made multiple requests for information from the DOE and the NIH. The committee was also able to access experts who could answer its technical questions. One meeting was devoted to perspectives from professional societies; another meeting focused on issues surrounding training of nuclear medicine personnel; and others were focused on gathering infor-

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Advancing Nuclear Medicine through Innovation SIDEBAR 1.1 Statement of Task The National Academies will perform a “state of the science” review of nuclear medicine and will provide findings and recommendations on the following issues Future needs for radiopharmaceutical development for the diagnosis and treatment of human disease (addressed in Chapters 3, 4, and 6). Future needs for computational and instrument development for more precise localization of radiotracers in normal and aberrant cell physiologies (addressed in Chapter 7). National impediments to the efficient entry of promising new radiopharmaceutical compounds into clinical feasibility studies and strategies to overcome them (addressed in Chapters 3, 4, 5, 6, and 8). Impacts of shortages of isotopes and highly trained radiopharmaceutical chemists and other nuclear medicine scientists on nuclear medicine basic and translational research, drug discovery, and patient care, and short- and long-term strategies to alleviate these shortages if they exist (addressed in Chapters 3 through 8). In light of these future needs, the National Academies should examine the Medical Applications and Measurement Sciences Program and make recommendations to improve its research and isotope impacts on nuclear medicine. These recommendations should address both research thrusts and facility capabilities but should not address program management issues. mation on the current state of the science of nuclear medicine and future directions of the field. 1.2 REPORT ROADMAP The committee held extensive discussions about its interpretation of the statement of task (Sidebar 1.1) and the objective of the report. From these discussions, the committee determined that the primary focus of the report would be future opportunities in the field of nuclear medicine, within the context of the statement of task. The committee identified six specific issues originating from the statement of task, each of which is discussed in a separate chapter. The issues are: nuclear medicine imaging in diagnosis (Chapter 3); targeted radionuclide therapy (Chapter 4); radionuclide shortages (Chapter 5); radiopharmaceutical development (Chapter 6); computational and instrument development (Chapter 7); and

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Advancing Nuclear Medicine through Innovation training of nuclear medicine scientists and clinical investigators (Chapter 8). Chapter 2 provides an overview of nuclear medicine as a discipline, which may be helpful to non-experts. It briefly summarizes important discoveries, challenges, and opportunities in the field. The appendixes provide supporting information, including a glossary and acronym list, descriptions of the committee’s meetings, a list of commercially available radiopharmaceuticals, and biographical sketches of the committee members.