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.
Despite 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.

January 4th, 2006 | Chem-Bio | 30126 Comments »http://defensetech.org/2006/01/04/biodefense-big-bucks-small-results/Biodefense%3A+Big+Bucks%2C+Small+Results2006-01-04+21%3A57%3A50jason You can skip to the end and leave a response. Pinging is currently not allowed.