Biodefense: Big Bucks, Small Results

The must-read article of the day comes from Time magazine, which has a long expose on the clusterfuck that is Project Bioshield, the government's $5.6 billion plan to shore up the country's defenses against germ attacks.tularemia.GIFDespite all the cash, "BioShield hasn't transformed much of anything besides expanding the federal bureaucracy," says Time. "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."

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...[S]ome scientists [also] 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.
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