Taking the measure of countermeasures: leaders' views on the nation's capacity to develop biodefense countermeasures.

THE PURPOSE OF THIS STUDY was to gather and analyze the views of leaders from academia, government, and industry regarding the capacity of the U.S. to develop biodefense countermeasures and to elicit their recommendations on steps that would improve the nation’s capacities to succeed in these efforts. The anthrax attacks of 2001 hinted at the kind of illness and civil disruption a few letters laden with Bacillus anthracis spores could cause. The attacks also began to illustrate the grave impact that larger, more sophisticated bioattacks could have on the country. In the years since the attacks, the federal government has spent more than $14 billion on civilian biodefense, approximately $5 billion of which has been allocated for research on and development of drugs and vaccines to counter bioterror agents.1 This year, the BioShield Act (P.L. 108-276) was passed, with one of its major purposes being to provoke the development of the medical countermeasures (i.e., therapeutic drugs, vaccines, and diagnostic tests) necessary to cope with bioattacks that might befall the nation in the future. As significant as these steps are, a number of biodefense analysts and leaders from academia, government, and the pharmaceutical and biotech industries have concluded publicly and privately that the measures the U.S. government has taken to date, including the passage of the BioShield legislation, will not be enough to entice pharmaceutical industry leaders into this field and will not produce the countermeasures the nation needs for a truly effective biodefense. Drug development is a complex, multistep process (Figure 1) that can take from 5 to 15 years (an average of 12 years by one estimate2) and can cost several hundred million dollars (one report puts it at $800 million2). The absence of drugs or vaccines for SARS and West Nile Virus and the lack of the capacity to rapidly manufacture large quantities of vaccine for pandemic influenza strains have been cited as important indicators of the type of system challenges involved in drug and vaccine development. These challenges will have to be addressed to cope with large-scale epidemics, be they deliberately induced with bioweapons or natural events.