Bioterror Antidote: Unfulfilled Prescription

After Four Years, Scant Progress on Bush's BioShield Plan

When President Bush goes before Congress later this month, it will mark four years since he used his State of the Union address to launch Project BioShield, an ambitious effort to counter bioterrorism attacks with vast new stockpiles of vaccines and treatments.

Progress, however, has been slow.

The $5.6 billion program is still struggling to define its priorities, and officials have spent less than a quarter of their budget. Last month, the project endured the collapse of its largest program, an effort to produce enough advanced anthrax vaccine for roughly the population of Washington and New York. And still unresolved is how the government will address threats like acute radiation sickness or treat the estimated 10 million people with impaired immune systems who cannot take advantage of current stockpiles of smallpox vaccines. In his speech, Bush listed the Ebola virus and plague as among the threats the program would address, but little significant action has been taken on those, either.

The government has yet to release a plan outlining what drugs it will buy and in what quantities, though it says it will do so in the next few months.

Congress passed legislation late last year revamping BioShield, allowing the Department of Health and Human Services to pour more money into the small companies spearheading the effort more quickly and reorganizing the program's management. But HHS officials acknowledge that tougher challenges lie ahead.

"BioShield is still a young program," said Gerald Parker, the principal deputy assistant secretary for preparedness and response at HHS.

The first phase of the program "was low-hanging fruit, taking things that were already in development" and putting them in the stockpile, Parker said. "Now we're getting into the harder phase of this."

Here is a look at BioShield's fitful progress on some of government's top priorities, those bioterror agents that have been labeled national security threats by the Department of Homeland Security:

Anthrax

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Anthrax is best known for the October 2001 attack in which envelopes containing anthrax spores were sent through the mail, killing five people and sickening others. The attack prompted worries that an antibiotic-restraint strain of anthrax could be developed, moving the threat to the top of federal health officials' priority list.

As the result of an effort that began before BioShield, there are enough antibiotics in the national stockpile to treat 40 million people for more than 60 days, HHS says. Stockpiles also include 9 million doses of an anthrax vaccine produced by Emergent BioSolutions of Gaithersburg, with another 1 million to be delivered by the first quarter of this year. In an emergency, the usual six doses of the vaccine necessary for immunity could be cut to three and used with an antibiotic, HHS says. That should be enough to treat 1.3 million patients.

Rockville-based Human Genome Sciences and Cangene of Winnipeg, Canada, are scheduled to deliver 30,000 doses of an anthrax antitoxin. HGS is scheduled to begin delivery in 2009 and Cangene is scheduled to begin delivery later this year, according to HHS.

The agency is struggling to develop a more modern anthrax vaccine that could be administered in fewer doses and with fewer side effects. In 2004, the agency tapped a small California firm, VaxGen, for an $877 million contract to deliver 75 million doses of an anthrax vaccine. VaxGen encountered delays and technical problems, and HHS canceled the contract in December after the firm failed to begin human testing on time. HHS officials are examining ways to get the effort back on track.