NAS report recommends renewed federal leadership in nuclear medicine science

A blue ribbon panel convened by the National Academies of Science recommends after a year of hearings and deliberations that the U.S. government recommit itself to the advancement of nuclear medicine science.The committee, chaired by Dr. Hedvig Hricak, linked many of nuclear medicine's lingering research and development problems to deteriorating infrastructure and loss of federal research support, especially at the Department of Energy. The problem of educating the next generation of nuclear medicine scientists is severe enough for the committee to recommend federally funded advanced training programs outside the nation's borders to compensate for the lack of student interest in nuclear chemistry and physics in the U.S. "If we are serious about personalized medicine, then the vehicle to personalized medicine will be through basic research in nuclear medicine," said Hricak, director of radiology at Memorial Sloan-Kettering Cancer Center, in an interview. "Nuclear medicine may be small compared to radiology as a whole, but it provides infrastructure and discoveries essential for our progress into molecular medicine."The NAS was contracted by the DOE and National Institutes of Health to prepare the study in response to protests following the DOE's decision in 2006 to greatly reduce its 50-year involvement in nuclear medicine research. Though that decision led to the loss of $26.8 million in DOE funding, nuclear medicine experts were as upset about closure of advanced research laboratories that were responsible for the discovery and development of imaging instruments, radionuclides, and radiopharmaceutical agents that formed the basis of clinical nuclear medicine practice.The committee findings, based on hearings and an extensive literature review, confirm what many academic nuclear physicians suspected: An 85% funding cut for the Medical Applications and Science Program at the DOE in 2006 led to a substantial loss of support for the basic research that underlies nuclear medicine. The report concludes that no specific, programmatic, long-term commitment exists in the federal government for maintaining the infrastructure that has provided the engines of discovery for 50 years, including high-energy particle accelerators, research nuclear reactors, and instrumentation and chemistry laboratories.In response to the report, the SNM called for the restoration of DOE funding for basic molecular imaging/nuclear medicine research. "The loss of funding for nuclear medicine research in the U.S. Department of Energy budget has been a tremendous blow to our current and future patients and our field," said SNM president Alexander J. McEwan. "The NAS study confirms the importance of basic nuclear medicine research, and the society -- with this report in hand -- intends to convince Congress to continue its funding."

The report details several recommendations:

• Relating to radioistope development, production, and availability, panelists recommend the formation of a cooperative mechanism between DOE and the National Institutes of Health for oversight of basic scientific research relating to radionuclide discovery, production, and translation into routine clinical practice. The committee asks the DOE to reconsider reinstating the DOE-Office of Biological and Environmental Research (DOE-OBER) nuclear medicine research program.
• To overcome barriers to radiopharmaceutical clinical trials and FDA approval, it calls for the FDA to clarify final guidelines for performing pre-investigational new drug evaluation for radiopharmaceuticals. The report recommends that the FDA issue final guidelines for current good manufacturing practices with a sliding scale of stringency accounting for agents that have minimal risk It recommends consultations between the imaging community and DOE, NIH, and FDA to cut the Gordian knot that restricts clinical trial protocol standardization needed for multicenter testing.
• Relating to another seemingly intractable problem, the committee underscores problems from the lack of a domestic source for medical radionuclides used in daily nuclear medicine practice. It recommends funding a dedicated accelerator and upgrading an existing nuclear reactor to play that role.
• To exploit recent discoveries identifying disease biomarkers, it stresses the need for improved detector technology, image reconstruction, advanced data processing, and economical radionuclide production techniques. Again, the committee asks DOE-OBER to get back into the act of encouraging collaborations between the various scientific disciplines for the discovery and development of next-generation radiopharmaceuticals and instrumentation.
• To address the need for young scientists to succeed the numerous nuclear chemists, physicians, and engineers who are approaching retirement, the report recommends an expert panel to prioritize the national needs for training and develop curricula to train the necessary personnel. Recognizing that few U.S. students specialize in chemistry, it recommends establishing DOE-supported educational programs outside the country.

The demand for nuclear medicine scientists has exploded in the last five years, Hricak said.

"We are going to soon find ourselves with a tremendous gap as the current generation of scientists retires," she said. The problems underscored in the report are relevant to science and medicine as a whole, Hricak said.

Laboratory-based nuclear medicine scientists may not realize that they are part of a tradition, responsible for monumental achievements in science and medicine."If we don't continue to support this kind of development, progress will end, and everybody will suffer," she said. For more information from the Diagnostic Imaging archives:

Nuclear medicine experts dominate national panel

Fed appraise the value of nuclear medicine research

Government scrutinizes strategic importance of nuclear medicine research