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.

Nine years after Operations Desert Shield and Desert Storm (the Gulf War) ended in June 1991, uncertainty and questions remain about illnesses reported in a substantial percentage of the 697,000 service members who were deployed. Even though it was a short conflict with very few battle casualties or immediately recognized disease or non-battle injuries, the events of the Gulf War and the experiences of the ensuing years have made clear many potentially instructive aspects of the deployment and its hazards. Since the Gulf War, several other large deployments have also occurred, including deployments to Haiti and Somalia. Major deployments to Bosnia, Southwest Asia, and, most recently, Kosovo are ongoing as this report is written. This report draws on lessons learned from some of these deployments to consider strategies to protect the health of troops in future deployments. In the spring of 1996, Deputy Secretary of Defense John White met with leadership of the National Research Council and the Institute of Medicine to explore the prospect of an independent, proactive effort to learn from lessons of the Gulf War and to develop a strategy to better protect the health of troops in future deployments.

The Institute of Medicine (IOM) Committee on Improving the Disability Decision Process has been working since it first met in January 2005 to develop recommendations to the Social Security Administration (SSA) on how to improve the medical aspects of its disability determination process. By law, Social Security can only pay benefits to those unable to engage in substantial gainful activity because of a "medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months (emphasis added)." Medical and psychological expertise is critical both in developing the criteria for measuring the severity and functional impact of an impairment or impairments on an applicant's ability to work and in applying the criteria to individual cases where the medical evidence does not clearly meet the criteria in the eyes of a nonmedical disability examiner.

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

In January 1995 the Institute of Medicine released a preliminary report containing initial findings and recommendations on the federal government's response to reports by some veterans and their families that they were suffering from illnesses related to military service in the Persian Gulf War. The committee was asked to review the government's means of collecting and maintaining information for assessing the health consequences of military service and to recommend improvements and epidemiological studies if warranted. This new volume reflects an additional year of study by the committee and the full results of its three-year effort.

More than 200,000 U.S. military personnel participated in atmospheric nuclear weapons tests between 1945 and the 1963 Limited Nuclear Test Ban Treaty. Questions persist, such as whether that test participation is associated with the timing and causes of death among those individuals. This is the report of a mortality study of the approximately 70,000 soldiers, sailors, and airmen who participated in at least one of five selected U.S. nuclear weapons test series1 in the 1950s and nearly 65,000 comparable nonparticipants, the referents. The investigation described in this report, based on more than 5 million person-years of mortality follow-up, represents one of the largest cohort studies of military veterans ever conducted.

Infectious diseases continue to pose a substantial threat to the operational capacity of military forces. Protecting Our Forces reviews the process by which the U.S. military acquires vaccines to protect its warfighters from natural infectious disease threats. The committee found that poorly aligned acquisition processes and an inadequate commitment of financial resources within the Department of Defense vaccine acquisition process â€" rather than uncleared scientific or technological hurdles â€" contribute to the unavailability of some vaccines that could protect military personnel and, implicitly, the welfare and security of the nation. Protecting Our Forces outlines ways in which DoD might strengthen its acquisition process and improve vaccine availability. Recommendations, which include combining all DoD vaccine acquisition responsibilities under a single DoD authority, cover four broad aspects of the acquisition process: (1) organization, authority, and responsibility; (2) program and budget; (3)manufacturing; (4) and the regulatory status of special-use vaccines.

More than 5,800 military personnel, mostly Navy personnel and Marines, participated in a series of tests of U.S. warship vulnerability to biological and chemical warfare agents, Project SHAD (Shipboard Hazard and Defense), in the period 1962-1973. Only some of the involved military personnel were aware of these tests at the time. Many of these tests used simulants, substances with the physical properties of a chemical or biological warfare agent, thought at the time to have been harmless. The existence of these tests did not come to light until many decades later. In September 2002, the Institute of Medicine (IOM) agreed to undertake a scientific study, funded by the Veterans' Affairs, of potential long-term health effects of participation in Project SHAD. In general, there was no difference in all-cause mortality between Project SHAD participants and nonparticipant controls, although participants statistically had a significantly higher risk of death due to heart disease, had higher levels of neurodegenerative medical conditions and higher rates of symptoms with no medical basis. Long-Term Health Effects of Participation in Project SHAD focuses on the potential health effects of participation in Project SHAD. It is a useful resource for government defense agencies, scientists and health professionals.

Since 1992 the Department of Defense (DOD), through the U.S. Army Medical Research and Material Command, has received congressionally earmarked appropriations for programs of biomedical research on prostate, breast, and ovarian cancer; neurofibromatosis; tuberous sclerosis; and other health problems. Appropriations for these Congressionally Directed Medical Research Programs are used to support peer reviewed extramural research project, training, and infrastructure grants. Congress has become concerned about funding increases for these programs given current demands on the military budget. At the request of Congress, the Institute of Medicine (IOM) examined possibilities of augmenting program funding from alternative sources. The resulting IOM book, Strategies to Leverage Research Funding: Guiding DOD's Peer Reviewed Medical Research Programs, focuses on nonfederal and private sector contributions that could extend the appropriated funds without biasing the peer review project selection process.

Anthrax Vaccine Adsorbed (AVA) was licensed in 1970 to provide protection against infection with Bacillus anthracis. AVA was initially administered on a limited basis, primarily to protect veterinarians and workers processing animal products such as hair or hides that could be contaminated with anthrax spores. In the 1990s, with growing concerns about the possible use of anthrax as a biological weapon, use of the vaccine was substantially expanded. The Department of Defense (DoD) vaccinated some of the military personnel deployed for the Gulf War in 1991 and in 1998 initiated the Anthrax Vaccine Immunization Program, calling for mandatory vaccination of all U.S. service members. By late 2001, roughly 2.1 million doses of AVA had been administered. Production of AVA was suspended in 1998 when the facility manufacturing the vaccine was closed for renovations, which were undertaken to meet regulatory requirements of the Food and Drug Administration (FDA). Concerns about the efficacy and safety of AVA, and about vaccine production, led Congress to direct the DoD to support an independent examination of AVA by the Institute of Medicine. In October 2000, the Institute of Medicine convened the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. The committee reviewed all available data, both published and unpublished, and heard from representatives of DoD, FDA, and other federal agencies; from the vaccine manufacturer BioPort; from researchers studying the efficacy and safety of the vaccine; and from service members and others with concerns about the safety or efficacy of the vaccine. After the bioterrorism of fall 2001, the committee accelerated its original timetable for its review. As indicated by evidence from studies in both humans and animals, the committee concluded that AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax.