The U.S. Secretary of Defense, the U.S. Secretary of Health and Human Services, and the U.S. Secretary of Homeland Security should work closely with industry and academia to ensure the rapid development and deployment of vaccines for naturally occurring or intentionally introduced microbial threats to national security. The federal government should explore innovative mechanisms, such as cooperative agreements between government and industry or consortia of government, industry, and academia, to accelerate these efforts.

The Administrator of USAID, the U.S. Secretary of Health and Human Services, and the U.S. Secretary of State should work in cooperation with public and private partners (e.g., leaders of foundations and other donor agencies, industry, WHO, UNICEF, the Global Alliance for Vaccines and Immunization) to ensure the development and distribution of vaccines for diseases that affect populations in developing countries disproportionately.

NEED FOR NEW ANTIMICROBIAL DRUGS

Antibiotics

Unfortunately, complacency toward infectious diseases in the 1960s, overconfidence in existing antibiotics, and competition from highly profitable opportunities for pharmaceutical development and sale in other fields of medicine resulted in a lag in the production of new classes of antibiotics. This occurred despite significant advances in the fundamental science that has fueled pharmaceutical innovation in many other areas.

As a result of the looming crisis previously discussed, public pressure, and apparent scientific opportunities, many companies intensified their efforts in antibiotic drug discovery in the early 1990s. The complete sequencing of all major bacterial pathogens affecting humans, development of high-throughput screening, combinatorial chemistry, and microarray assays promised a golden age of antibiotic drug discovery. Indeed, at first glance, the situation with respect to antibiotics currently in clinical development looks encouraging. Several new antibiotic variations are in the first three phases of clinical development, with billions of dollars having been invested in their development (see Table 4-2). Not one new class of antibiotics, however, is in development. Rather, these “new” antibiotics belong to existing classes, including macrolides and quinolones, that have been used to treat humans for years. The absence of new classes in the pipeline and the fact that, even for compounds in Phase I, an additional 8 years is required



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