Ten years after 9/11 and the subsequent anthrax attacks alerted America to the threat posed by bioterrorism, progress in developing and procuring vaccines and drugs to protect the civilian population has been frustratingly slow. An investment of over $20 billion has yielded a few new medical countermeasures, but there is nothing for most of the pathogens that top government threat lists.
The Department of Homeland Security has identified a dozen pathogens as serious bioterrorism threats. Of these, the U.S. has stockpiled sufficient smallpox vaccine for the entire population and sufficient vaccine for post-exposure anthrax protection for about 9.6 million civilians. The stockpile also includes treatments for anthrax and botulinum toxin.
"Progress has been far too slow," Thomas Ingelsby, CEO of the Center for Biosecurity of the University of Pittsburgh Medical Center, said on BioCentury This Week, BioCentury's public affairs television program. "We have [added] only a few new medicines and vaccines in our stockpile since 2001."
Even worse, Ingelsby said, "we don't really have a clear sense of the priorities going forward, and the money for these programs is due to run out next year unless Congress appropriates more."
An HHS report released in August 2010 noted the "well-known problems of having insufficient numbers of reasonably mature advanced products in the pipeline" for future addition to the U.S. stockpile.
Robin Robinson, who heads U.S. efforts to develop and procure medical countermeasures, argued that progress has been impressive considering the biodefense effort was started from scratch a decade ago.
Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA), told BioCentury that the U.S. biodefense effort is on track to have medical countermeasures against the full range of probable bioterror pathogens procured or under development within four to five years.
This projection is based on what might be viewed as extraordinarily optimistic assumptions about the speed and success of drug development, including development and procurement of new classes of broad spectrum antimicrobials that have yet to reach proof-of-concept (POC) studies (see "BARDA Bioterror Pipeline," A3).
Former senior government officials, current government advisors and academic experts all warn that the combined efforts of government and industry are not on a trajectory that is likely in the foreseeable future to lead to the development, stockpiling and deployment of countermeasures to protect the civilian population from a sophisticated biological attack.
According to the National Biodefense Science Board, dramatic improvements would require substantial increases in congressional funding and oversight, elevation of the stature of biodefense preparedness to a top priority for the White House, and better coordination among government agencies.
NBSB is a congressionally chartered advisory body that includes biodefense experts from industry, academia and government. In a March 2010 report, "Where Are the Countermeasures," it noted that government "has failed to mobilize the productive skills and efforts of industry."