developed. The possibility of encouraging collaboration between pharmaceutical companies in this area by waiving antitrust restrictions—in specific cases justified by the national interest—must also be considered. Thus, in addition to the FDA, the Departments of Commerce, Treasury, and Justice should also be involved in these discussions.

Clearly, in an emergency, someone or some agency has to be authorized to decide, for example, that INDs may not be required, that the informed consent process can be modified, that companies might have to be indemnified, or that companies might have to exchange information or work together, which would require a waiver of antitrust law. The factors that go into such decisions should be discussed by government and industry, and possible approaches recommended to federal agencies.


Understanding of biological agents as threats to human, livestock, and crop health, as well as to the U.S. economy, must be improved. Special emphasis might be placed on an urgent short list of recognized agents, including Bacillus anthracis (the agent responsible for anthrax), variola virus (which causes smallpox), and a few others, for obvious reasons; but much of the preparation should target a broader list and effectively prepare the nation for the unknown.

Appropriate government agencies and scientific organizations must evaluate emerging viruses and the genetic modification of existing viruses. Similarly, they need to consider the impact of genetic manipulations of pathogenic bacteria that enhance their virulence, particularly manipulations that render them resistant to the available antibiotics.

Although there are gaps in the scientific understanding of many potentially deadly biological agents and in the technological advances needed to anticipate and respond to their release, reliance on purely scientific or technological solutions is misguided. A much more inclusive effort is needed to build a seamless system of preparedness and response—one that can exercise the best available tools to counter biological threats.

This task depends first and foremost on rebuilding the public health infrastructure of the United States, which has been allowed to decay as the nation conquered some of the more common infectious and other disease challenges of the past century. The terrorist events of September and October 2001 should serve as a wake-up call to those in the position of setting science and health policies in the United States. Many of the scientific goals described in this chapter cannot be achieved in the absence of trained and well-equipped public health officers, educated and prepared first responders, and clear communication among leaders, the medical community, and the public.

HHS, CDC, and other federal agencies, along with state departments of

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