Inside the Spore Wars

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Proposals to fix BioShield have gained a new sense of urgency, however, as fears of another biological threat--avian flu--have mounted. China and Indonesia recently reported human fatalities from the disease, bringing the total number of deaths as of late December to 73, and the U.S. is now scrambling to stockpile medicines--such as the antiviral Tamiflu--to thwart a possible pandemic. Bush has asked Congress, as part of his $7.1 billion response plan, for a "crash program" to speed the development of new vaccine technologies, and Congress last month passed a defense bill that included $3.8 billion, mainly for flu vaccines and medicines.

To entice more drugmakers into biodefense, North Carolina Senator Richard Burr is sponsoring a bill that would establish a Biomedical Advanced Research and Development Agency (BARDA) headed by a biosecurity czar. (Estimated cost: $1 billion annually.) His bill would require the government to make gradual payments to drug companies based on R&D milestones, similar to the way defense contracting works, and would grant companies a 10-year period of market exclusivity for drugs designated as countermeasures. (Drug-patent terms typically vary depending on the date the application was filed and when the product is actually marketed.) More controversial, the bill would make it virtually impossible for individuals to sue for damages caused by any drug deemed a bioterrorism countermeasure, and BARDA would be exempt from the Freedom of Information Act, keeping its work largely veiled from public scrutiny. HHS Secretary Michael Leavitt has said new liability protections should apply only to vaccines and medicines for pandemic flu, which is likely to delay action on Burr's "BioShield 2" bill until next year.

Yet the market forces that have given us flu-drug shortages are also working against biodefense. With the industry's profits under pressure, none of the big firms are keen on diverting research from potential blockbusters to drugs for exotic germs like Ebola and plague, which may be stockpiled and used only in an emergency. Biodefense is "not attractive to Big Pharma, which is making money off things we use a few times a day," says Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland. Companies are also leery of huge liability risks if biodefense vaccines and treatments are administered to wide swaths of the population. As for that $5.6 billion that is supposed to be allocated over 10 years? It's a pittance, given that the average cost of bringing a new drug to market is estimated to be $800 million, according to a 2001 study by the Tufts University Center for the Study of Drug Development. "There has to be a big bucket of gold at the end of the rainbow to get the big companies," Greenberger says.