Society of Nuclear Medicine: National Academy of Sciences Report Supports Restored Federal Funding For Nuclear Medicine Research

Kristina Woodworth

*Medical Writer, SciMantis Communications, Inc, Pen Argyl, Pennsylvania.
 Address correspondence to: Kristina Woodworth, Medical Writer, SciMantis Communications, Inc, PO Box 3, Pen Argyl, PA 18072. E-mail: kristina@scimantis.com.

The Society of Nuclear Medicine (SNM), an organization comprised of professionals in the fields of molecular imaging and nuclear medicine, has weighed in on a report from the National Academy of Sciences (NAS) that supported restored federal funding for critical research in nuclear medicine.

The report, Advancing Nuclear Medicine Through Innovation, was released in September as a result of a mandate from the Department of Energy (DOE) and the National Institutes of Health (NIH) to characterize the impact of funding cuts on research in nuclear medicine. Although the DOE has supported basic research in molecular imaging and nuclear medicine since the Atomic Energy Act of 1954, a $23 million cut in the DOE Office of Science budget for fiscal year 2006 virtually eliminated this funding.¹

A summary of the report¹ stressed the importance of government investment in nuclear medicine over the past 50 years, resulting in the development of new technologies that have improved the diagnosis and treatment of disease. The summary noted that that future advances in nuclear medicine would continue to have an important impact on medical care, stating that research progress “could substantially accelerate, simplify, and reduce the cost of delivering and improving healthcare.” The drive to advance the field of personalized medicine was cited as being particularly dependent on nuclear medicine research that results in new methodologies that improve clinicians’ ability to diagnosis disease and identify patients who are likely to respond to specific therapies.

The report identified critical areas to focus research funding, including:

• the development of new radionuclide production facilities and technologies;
• the development of new radiotracers that improve our understanding of organ function;
• the development of new imaging instruments and technologies to improve disease diagnosis;
• the development of targeted radionuclide therapeutics for personalized medicine applications in the treatment of cancer;
• the use of nuclear medicine imaging to discover and develop new drugs; and
• the translation of research from bench to bedside, including investment in training of clinician scientists in nuclear medicine techniques.

The NAS also noted major findings and appropriate recommendations as a result of their analysis.

The Magnitude of Loss of Federal Funding for Nuclear Medicine Research
The nuclear medicine research community has suffered a substantial blow as a result of reduced federal funding. Congress cut the budget of the DOE Office of Biological and Environmental Research by 85% in fiscal year 2006 (Figure), and no federal support is currently available to maintain high-technology nuclear medicine research infrastructure, according to the report.

In light of this finding, the NAS recommended a renewed commitment to nuclear medicine research on the part of the federal government and suggested an effort to synergize nuclear medicine research efforts between the NIH and DOE.

Regulatory Requirements Hinder Research Efforts
The NAS study also identified cumbersome regulatory requirements that delay efforts to perform clinical feasibility studies on promising radiopharmaceutical tracer compounds. The report noted complex regulatory requirements from the US Food and Drug Administration that do not recognize the differences between diagnostic and therapeutic radiopharmaceuticals; a lack of standards for good manufacturing practice (GMP) for radiopharmaceuticals; and a lack of standardized image acquisition policies when conducting clinical trials that involve nuclear imaging.

The NAS recommended that regulatory requirements should be clarified and simplified, particularly with respect to toxicology studies and current GMP facilities.

Inadequate Domestic Supply of Medical Radionuclides
A lack of a domestic source for most medical radionuclides and dedicated facilities for the year-round production of radionuclides used in medical research further discourages research in nuclear medicine, according to the NAS.

The report urged regulators to improve domestic medical radionuclide production and provide for a dedicated accelerator and reactor to produce radionuclides used in research. The authors of the study noted that this recommendation is consistent with previous studies that noted a shortfall in the US medical radionuclide supply.^2-4

Shortage of Trained Nuclear Medicine Scientists
The field of nuclear medicine is also facing a critical shortfall with respect to clinical and research personnel in all disciplines of nuclear medicine, including chemists, radiopharmacists, physicists, engineers, clinician-scientists, and technologists, according to the NAS report.

The NAS researchers noted an urgent need for additional training programs and innovative grants to support the entry of professionals, particularly nuclear chemists, into the field.

Technology Development and Translation to Clinical Practice Needs Better Coordination
The NAS also recognized an urgent need to advance the development of targeted radiopharmaceuticals for disease diagnosis and management. Furthermore, the NAS researchers stressed the need to effectively translate basic research findings into technologies that are applicable in clinical practice.

Based on these findings, the NAS report recommended policies that encourage interdisciplinary collaboration between basic scientists and individuals devoted to technology development for clinical applications.

Nuclear Medicine Professionals Urge Action to Restore Funding in 2008
The SNM has taken a leadership role in urging Congress to restore funding for nuclear medicine research and development in 2008. Although the Senate has passed an energy appropriations bill that restores $20 million in funding for fiscal year 2008 funding through the DOE Office of Science, the House version of the bill does not specifically address this funding, according to the SNM. Consequently, the SNM urged nuclear medicine professionals and other interested individuals to contact their representatives and ensure that restored nuclear medicine was specified in the final energy appropriations bill. Both the House and Senate approved a DOE appropriations package that was signed by President Bush on December 26, 2007, which specifically called for an additional $17.5 million for nuclear medicine research to restore lost funding in 2008.

References
1. National Academies Press. Advancing Nuclear Medicine Through Innovation. Free Executive Summary. Available at: http://www.nap.edu/catalog.php?record_id=11985. Accessed December 14, 2007.

2. IOM (Institute of Medicine). Adelstein SJ, Manning JF, eds. Isotopes for Medicine and the Life Sciences. Washington, DC: National Academy Press; 1995.

3. Wagner HN, Reba RC, Brown R, et al. Expert Panel Forecast of Future Demand for Medical Isotopes. US Department of Energy, Office of Nuclear Energy; 1999.

4. Reba RC, Atcher W, Bennett RG, et al. Final Report, NERAC Subcommittee for Isotope Research & Production Planning. US Department of Energy, Office of Nuclear Energy; 2000: 1-32.