A new antibiotic that could save lives must await FDA action

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The question of whether the federal government has its priorities straight arises again with news first reported in The New England Journal of Medicine. A new macrolide antibiotic called fidaxomicin has been found to be more effective in treating the common but deadly bacterial infection known as C. difficile than the standard antibiotic currently in use, oral vancomycin. Although fidaxomicin was found to be significantly better, it still must wait six months or more for further FDA analysis before it gains approval for general use. Roughly three million patients per year suffer C. difficile infections in U.S. hospitals.

The research on the drug was done in a controlled study comparing the two medications among 629 patients at Jewish General Hospital in Montreal. The two groups of patients showed similar rates of initial recovery with 88 percent recovering from the infection with fidaxomicin and 86 percent recovering with vancomycin. However, the rate of recurrence was only 15 percent with the new drug as against 25 percent with the standard medication. Granted these results, ACSH's Dr. Gilbert Ross wonders, “Why does it take so long for the FDA to act? The study seems clear-cut. How many will die because of its inaction in the period before it’s approved?”