Inside the Spore Wars

Had you listened to President Bush on Jan. 28, 2003, you might think the U.S. would have a bustling biodefense industry by now. In a State of the Union speech laced with references to terrorism, Bush asked Congress for nearly $6 billion to fund Project BioShield, a program he said would "quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, Ebola and plague." That sounded like a good idea, considering the havoc wrought by the anthrax mailings of 2001, which killed five people and set off a near panic for treatment. So Congress anted up. Eighteen months later, Bush signed BioShield into law. The measure set aside $5.6 billion for drug companies, offered the promise of a guaranteed and speedy contract--even an opportunity to sell the government novel treatments before they are fully approved by the Food and Drug Administration (FDA). The law, Bush promised, "will transform our ability to defend the nation."

Yet BioShield hasn't transformed much of anything besides expanding the federal bureaucracy. Most of the big pharmaceutical and biotech firms want nothing to do with developing biodefense drugs. The little companies that are vying for deals say they are being stymied by an opaque and glacially slow contracting process. The one big contract that has been awarded--for 75 million doses of a next-generation anthrax vaccine--is tangled in controversy; it went to a California firm, VaxGen, which in its 10-year history has never brought a drug to market. In the scientific community, biodefense is viewed as yet another boondoggle that is sucking money and resources from critical public-health needs like new antibiotics and vaccines. Indeed, the consensus outside the Administration is that the program is broken before it even gets off the ground. "BioShield has failed miserably," says Jerome Hauer, a former senior official with the Department of Health and Human Services (HHS). "The intent of BioShield was to attract new companies to get involved in developing countermeasures. It has not only failed to do that; it has kept a lot of other companies away because they're so concerned about the program's lack of focus and direction."

Administration officials say the criticism misses the many steps being taken to shore up the country's biodefenses. They point out that the U.S. has been stockpiling countermeasures, such as 300 million doses of smallpox vaccine. Since 2001 HHS has doled out $5.5 billion to state and local governments for bioterrorism emergency-response programs, and including BioShield, the government has spent about $18 billion on biodefense. "No matter how hard we try, some steps in the process cannot be rushed," said Stewart Simonson, assistant secretary for Public Health Emergency Preparedness, defending BioShield's slow start before Congress in July.