Countering threat agents

Chapter 2 provides an extensive discussion of the threats and vulnerabilities associated with the employment and effects of biological and chemical threat agents by terrorists. The chapter strives to educate the reader on the relationships among risk (potential for exposure), vulnerability (weakness or situation predisposing one to exposure) and threat as they relate to effectively responding to and countering such an attack Vulnerability + Risk = Threat. 

The committee could find no active U S. research on tularemia. Given the possibility of effective treatment with current antibiotics and the recent increase in antibiotic development to counter resistance in many more common pathogens, tularemia research is not a high priority. USAMRIID conducts assays of 2nd and 3rd generation antibiotics as they come on the market, using all of the bacterial threat agents in animal models. 

The 1995 Tokyo subway incident involved sarin release, which killed 12 and sent over 500 people to hospitals. This incident vividly illustrates how the world community and each individual nation continue to face the real threat of casualties from chemical warfare agents used for terrorist purposes. Since those critical events, however, the preparedness of health-care providers in developed countries towards best countering of chemical terrorist attacks has not significantly improved. 

Activation of the immune system in response to an infection is a vital step in countering the threat posed by the causative agent. Nevertheless, activation of components of the immune system is invariably associated with the enhanced production or exposition of predictable markers, that could serve as targets for the delivery of a biological weapon to those sites. 

FDA has responded to the threat of terrorism with a unique approach towards the development of biopharmaceuticais intended to counter the adverse effects of chemical, biological, radiological, or nuclear substances [83]. In many instances, efficacy trials in humans cannot be ethically performed (e.g., anti-bioterrorism agents). In these instances, animal data can be used in place of human data to model the in-vivo pharmacodynamics. In particular, studies in animals can provide substantial evidence of the effectiveness of biopharma-ceutical products intended for possible use to reduce or prevent the toxicities of these agents under defined circumstances. Such studies should be conducted under GLP (21 CFR 58) and are appHcable when ... 

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