Medical Countermeasures Against Radiological and Nuclear Threats

Strategic Planning 

Because threat scenarios involving radiation and radioactive materials vary, both in severity and in the type of radiation involved, not all threats can be addressed simultaneously. Thus, the approach to the strategic planning process used to develop the NIH Strategic Plan and Research Agenda for Medical Countermeasures Against Radiological and Nuclear Threats (PDF, 3.39 MB) has been to identify the critical gaps in knowledge and capabilities, and then to set goals for the development of medical countermeasures that could be broadly applied in many situations.

Radiobiology research has been undertaken by a variety of federal agencies. The Department of Energy (DOE) has a limited research effort focused on low-dose radiation. The National Aeronautics and Space Administration (NASA) supports research on radiation exposure at high altitudes and during space travel. The Armed Forces Radiobiology Research Institute (AFRRI), part of the Department of Defense (DOD), supports a research and development program for medical countermeasures for radiological and nuclear threats to military forces. NIAID conducts a great deal of research on immunology, including research on adult bone marrow stem cells, transplantation, and immune reconstitution. This research is very relevant because ionizing radiation can cause immunosuppression, and hematopoietic cells are easily damaged by radiation. The National Cancer Institute (NCI) maintains an active radiation oncology program, and thus has extensive clinical expertise in radiobiology. However, there has been no program within a federal civilian research agency dedicated to the development of medical countermeasures to be used by civilians in the event of exposure to radiation.

NIH, primarily through NIAID, has invested heavily over the past 3 years in research and development programs for new medical countermeasures against infectious agents and toxins. In late 2001, NIAID began a comprehensive strategic planning process to guide the NIH biodefense research program. After extensive discussions with researchers from academia, industry, and other federal agencies, NIH developed three key documents to guide its biodefense research program: the NIAID Strategic Plan for Biodefense Research, the NIAID Research Agenda for Category A Agents (covering agents that pose the gravest threat to human health, such as those that cause smallpox, anthrax, botulism, and plague), and the NIAID Research Agenda for Category B and C Agents (for agents whose biological properties make them more difficult to deploy or less likely to cause widespread harm than Category A agents). The NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats (PDF, 3.39 MB) was built upon a similar planning process.

Strategic Planning Process

In 2004, the HHS Office of Public Health Emergency Preparedness charged NIH with designing and implementing a national research program for the development of medical countermeasures appropriate for civilian use that can be used against radiological and nuclear attacks. Based on its research mission spanning immune homeostasis and infectious diseases, and its recent experience with rapidly planning and expanding the biodefense research program, NIAID was given the role of coordinating the overall NIH effort and ensuring participation of other NIH Institutes and Centers.

Meetings convened in recent years by the White House Office of Science and Technology Policy (OSTP), the Homeland Security Council, the Radiological/Nuclear Threat Countermeasures Working Group, NIAID, and NCI identified deficiencies in the knowledge base related to radiological injury in humans and in the availability of effective medical countermeasures for civilians; these meetings include

• Animal Models of Radiation Injury, Protection, and Therapy (NIAID, May 2004) (PDF)
• Hematopoietic Stem Cell Expansion and Immune Reconstitution (NIAID, May 2004) (PDF)
• Models and Procedures for Evaluating Radioprotectors (NCI, May 2003) (PDF)
• Radiobiology Research—Expert Panel Review (NIAID, December 2003) (PDF)
• Radiological/Nuclear Threat Countermeasures Working Group (OSTP/Homeland Security Council, 2003) (PDF)
• Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (National Academy of Sciences, June 2002)
• Molecular and Cellular Biology of Moderate Dose Radiation and Potential Mechanisms of Radiation Protection (NCI, December 2001) (PDF)
• Modifying Normal Tissue Damage Post-Irradiation (NCI, September 2000) (PDF)

Based on information assembled from these meetings and other sources, the NIAID Office of Biodefense Research and the NIAID Division of Allergy, Immunology, and Transplantation jointly prepared a draft strategic plan with input from NCI. On October 14, 2004, NIAID convened a meeting of the "Blue Ribbon Panel on the NIH Strategic Plan and Research Agenda for Medical Countermeasures Against Radiological and Nuclear Threats." Panelists with expertise in radiobiology and the health effects of ionizing radiation were selected from academic institutions and research laboratories. Representatives of HHS, the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), NIAID, NCI, the National Heart, Lung and Blood Institute (NHLBI), the National Institute of Environmental Health Sciences, DOD, DOE, DHS, NASA, and OSTP also participated in the meeting. The panel was asked to provide NIH with specific advice and recommendations on immediate and long-term research goals in each of four major areas set forth in the draft plan:

1. Basic and translational research
2. Radiation biodosimetry
3. Focused product development for radiological medical countermeasures
4. Infrastructure for research and product development

Panelists discussed the current state of science in each of the four areas listed, identified gaps in knowledge critical for the development of radiological and nuclear medical countermeasures, and identified shortfalls in radiobiology research. Comments from panel members at the meeting were then incorporated into the final version of the document.

The resulting research strategy is limited in scope to medical countermeasures that could be used with civilians exposed to ionizing radiation or radioactive materials. It does not address environmental/ambient radiation detector systems, physical protection, radiological surveillance, environmental contamination and remediation, or patient management, nor does it address the psychological impact or public communication problems that would follow a radiological or nuclear incident; these issues will be addressed separately by the DHS, DOD, the HHS Office of Public Health Emergency Preparedness, and other federal agencies. 

The ultimate purpose of the plan is to organize and coordinate NIH efforts to accelerate development of new diagnostic tests and patient assessment tools, as well as drugs and therapies that can facilitate recovery following exposure to ionizing radiation. Drugs that protect only if given prior to radiation exposure also fall within the scope of the program, although such agents would be used primarily by first responders and remediation workers. The strategic plan is intended to be a flexible, collaborative, and comprehensive guide for the NIH research and product development program focused on medical therapies and diagnostics to counter radiation injury; the accompanying research agenda describes the mechanisms by which NIH intends to meet these goals.

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