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Commentary

Bad Bugs, Few Drugs
Henry I. Miller, Washington Times, 5-3-06

Even as physicians scramble to keep ahead of the latest drug-resistant pathogens, new antibiotics are in short supply, and the pipeline for future products is alarmingly thin. Miller explains why R&D for new antibiotics has grown scarce, and suggests how policymakers can encourage companies to expand their efforts in this vital area.

Even as we speculate about the likelihood of a pandemic of avian flu and anticipate the beginning of the season of West Nile virus infections, the United States is experiencing another perilous epidemic. As many as 2 million patients nationwide contract bacterial infections in hospitals each year, and 90,000 die, according to the Centers for Disease Control and Prevention (CDC). The death rate in such cases is alarmingly high not because the patients are initially very ill, but because hospital germs increasingly are resistant to multiple antibiotics. Thus, the infections are difficult to treat.

The CDC has adopted four main strategies: prevent infection, diagnose and treat infection, use antimicrobials wisely, and prevent transmission. However, federal officials have paid little attention to the flip side of the problem: the shortage of new antibiotics. For decades we've relied largely on new variations on old tricks to combat rapidly evolving pathogens: Most antibiotics in use today are chemically related to earlier ones discovered between 1941 and 1968. During the last 37 years, only two antibiotics with truly novel modes of action have been introduced -- Zyvox in 2000 and Cubicin in 2003, the latter of which is used only against skin infections.

Marketing considerations and regulatory costs have exacerbated the antibiotics drought. Until about a decade ago, all major pharmaceutical makers had antibacterial research programs, but they have dramatically trimmed or eliminated these efforts, focusing instead on more lucrative drugs that treat chronic ailments and lifestyle issues...

Whereas antibiotics cure a patient in days, and may not be required again for years, someone with high cholesterol or erectile dysfunction might pop expensive pills every day for decades. Moreover, drug development has become hugely expensive, with the cost to bring a drug to market now averaging more than $800 million.



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