Inside the Spore Wars

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VaxGen CEO Lance Gordon vigorously defends his product. He says lab tests on rabbits and primates, conducted by the government since 2003, have found VaxGen's vaccine "highly effective" against inhaled anthrax. In September the company released results from a study conducted with the Battelle Memorial Institute and the National Institute of Allergy and Infectious Diseases (NIAID)--the "first ever," VaxGen said, to show that an anthrax vaccine worked post exposure. (The results have not yet been peer reviewed.) As for the delivery delay, Dr. Noreen Hynes, who oversees BioShield at HHS, describes it as a "hiccup" that's "de rigueur in product development." She says HHS didn't want to split the contract with other companies to achieve economies of scale, and she points out that VaxGen won the contract "in a full and open competition." In the meantime, HHS is adding 5 million doses of BioPort's vaccine to the Strategic National Stockpile at a cost of $122.7 million.

Beyond the anthrax-vaccine controversy, some scientists question the government's "one bug, one drug" scientific approach to biodefense. Developing a new smallpox vaccine for a strain found in nature may sound reasonable, but what about bioengineered strains produced at old Soviet labs, say, which may be floating around on the black market? There's no guarantee that those germs will respond to drugs tailored to other strains. Dr. Steven Projan, vice president of biological technologies for the pharmaceutical firm Wyeth, argues that it would make more sense for the government to stockpile and invest in broad-spectrum antibiotics, antivirals and new vaccine technologies that could be applied to biodefense. He and other scientists are also concerned that the FDA's approval standard for biodefense drugs, which is lower than that for commercial medicines, could lead to unforeseen, perhaps dangerous side effects in humans. Companies aren't required to conduct human clinical trials to show that a biodefense drug is effective; they only have to demonstrate that the drug works in animals and is safe in humans (since infecting people with a disease like anthrax to test a medicine is obviously unethical).

Public-health experts are also worried that money is flowing into terrorism-related medicine at the expense of more basic needs like hospital beds and respirators, which may be just as critical to saving lives in a crisis. And they are concerned that the government's obsession with biodefense is distracting from research into infectious diseases. Last March, 758 microbiologists signed a petition to the NIAID, complaining about the "massive influx of funding" for bioterrorism agents like anthrax, tularemia and plague. The institute now spends nearly $1.7 billion on biodefense--up from just $42 million in 2001--out of a $4.3 billion budget (although the biodefense funding hasn't detracted from other research, according to the agency). Meanwhile, hardly any new antibiotics have been approved by the FDA in recent years, despite the fact that scientists have grown more concerned about antibiotic-resistant bacteria. "The big challenge is how we deal with epidemic infectious diseases, not anthrax," says Dr. David Ozonoff, a professor at Boston University's School of Public Health.