Biodefense Research Supporting The Dod

The general public often assumes that medical products will be available to members of the U.S. armed forces in harm's way. Availability of safe and effective drugs and vaccines, however, is never an accident; such products are the fruition of focused and methodical research, testing and evaluation over many years. Medical research is inherently a high risk endeavor, and even the most efficient programs can span almost 15 years and cost over $1 billion from product discovery to Food and Drug Administration licensure. In this monograph, Colonel Coleen Martinez examines the productivity of the Department of Defense's biodefense research program over the course of more than 35 years, coupled with changes in the global research environment since the events of September 11, 2001. Few will argue the need for a national investment in biodefense. Where the deployment of a biologic agent of mass destruction is largely an unpredictable risk, the outcome certainly could be catastrophic for an unprotected population.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

Biological weapons have threatened U.S. national security since at least World War II. Historically, however, the U.S. military has neglected research, development, acquisition, and doctrine for biodefense. Following September 11 and the anthrax letters of 2001, the United States started spending billions of dollars per year on medical countermeasures and biological detection systems. But most of this funding now comes from the Department of Health and Human Services rather than the Department of Defense. Why has the U.S. military neglected biodefense and allowed civilian organizations to take the lead in defending the country against biological attacks? In American Biodefense, Frank L. Smith III addresses this puzzling and largely untold story about science, technology, and national security.Smith argues that organizational frames and stereotypes have caused both military neglect and the rise of civilian biodefense. In the armed services, influential ideas about kinetic warfare have undermined defense against biological warfare. The influence of these ideas on science and technology challenges the conventional wisdom that national security policy is driven by threats or bureaucratic interests. Given the ideas at work inside the U.S. military, Smith explains how the lessons learned from biodefense can help solve other important problems that range from radiation weapons to cyber attacks.

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

This Congressionally-mandated report identifies areas for further cooperation with Russia and other states of the former Soviet Union under the Cooperative Threat Reduction (CTR) program of the Department of Defense in the specific area of prevention of proliferation of biological weapons. The report reviews relevant U.S. government programs, and particularly the CTR program, and identifies approaches for overcoming obstacles to cooperation and for increasing the long-term impact of the program. It recommends strong support for continuation of the CTR program.

The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

The National Academies of Sciences, Engineering, and Medicine was asked to articulate a 5-year strategic vision for international health security programs and provide findings and recommendations on how to optimize the impact of the Department of Defense (DOD) Biological Threat Reduction Program (BTRP) in fulfilling its biosafety and biosecurity mission. Because BTRP is just one of several U.S. government programs conducting international health security engagement, both the strategic vision and the success of the program rely on coordinating actions with the U.S. government as a whole and with its international partners. This report provides several recommendations for optimizing BTRP success in its current mission and the wider-looking strategic vision it proposes.