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Advancing Nuclear Medicine through Innovation
existing hospital-based cyclotrons are, in general, fully committed to their own programs and cannot be considered as a reliable resource for exotic research radionuclides. In addition, many of these radionuclides can only be made on accelerators with energy of 30 MeV or above or require particles other than protons, neither of which can be provided by current hospital-based cyclotrons.
5.4.2 Non-Technical Needs and Impediments
The DOE-NE Isotope Program is failing to meet the needs of the research community because the effort is not adequately coordinated with NIH activities or with the DOE-Office of Biological and Environmental Research. Additionally, P. L. 101-101 (Sidebar 5.3), which requires full cost recovery for DOE-supplied radionuclides, whether for clinical use or research, has stifled research radionuclide production and radiopharmaceutical research. As a consequence, few new radiotracers have become commercially available over the past decade and there is a lack of radiotracers in the commercial pipeline.
In terms of research, the user community is a single investigator or small number of investigators, for whom the cost of producing exotic radionuclides exceeds available budgets. It has been difficult to include such expenses in research grants because the dollar value is disproportionately higher than other research expenses. Therefore, unlike commercial vendors who can pass on the costs to a wider user community, investigators looking into new ways to use radionuclides for diagnosis and treatment cannot afford the full costs of radionuclides sold by the DOE. Such a barrier reduces the demands for novel radionuclides. It has also created the perception that the nuclear medicine community is not interested because it is not requesting the radionuclides. While it is true that there are no new radionuclides with the requisite physical and chemical properties for use in imaging and therapy, there will continue to be investigations into new applications of the known radionuclides. Thus, an argument can be made that the DOE radionuclide production facility, which might benefit from new uses, should bear all or at least some of the development costs. However, the production facility is not a research organization, and so, some mechanism would need to be set up to vet applications for subsidy.
RECOMMENDATION 1: Improve domestic medical radionuclide production. To alleviate the shortage of accelerator- and nuclear reactor-producedmedical radionuclides needed for research, a dedicated accelerator and anupgrade to a nuclear reactor should be considered.