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Edited by Christian Lowe | Contact

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.

Comments

good job,
my daughter who lost her hand above elbow, is sure to be blessed with it as already she is using mechanic one, which weighs and the work is almost that of cosmatic,may I know how much we have to bear the expense and what may be the weight etc may be sent for further information
thanks to one Dr Aurora of Delhi who gave this piece of information vital

Posted by: nagamoney at September 17, 2008 11:22 PM


niceeeeeeeee

Posted by: العاب at August 3, 2008 08:58 PM


"clusterfuck"

That is a very nice example of writing at the primary school level, not expected from someone who is a seasoned writer or blogger.

Posted by: WR at April 3, 2008 07:49 AM


This may be silly,but why would these companies rely on the government for orders.The Govt. & FDA should work hand -in -hand to expedite (safely) all testing & get an "Bioshield" Home Pak developed that can be administered at home,once the problem has been identified;be it small pox,radiation,ebola ,or the bird flu. As an entreprenuer I would rather take this directly to the end user at an affordable price.Since every person would need to be treated -hospitals are unrealistic-self administered aid will be necessary for survival. As the Govt. they should prefer to help the development ,then get out of the way so the cures can be adequately distributed.Maybe the Bio products that get federal asst.(only the ones that get pushed through) through the development pipeline could then carry a Homeland Security Tax.

Posted by: Frank Trilla at January 31, 2006 01:20 PM


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