Health System Struggles Against New Bugs

"We can control the costs of development in one basic way -- that is to try to shorten the development time," said Goldberger. The FDA was, for example, able to fast-track the approval of Cubicin, recognizing the importance of the drug in combating methicillin-resistant Staphylococcus aureus, one of the new drug-resistant "superbugs."

There are cases, Goldberger says, where the medical community and the public are willing to accept the introduction of a disease-fighting drug even if there are some concerns about the drug's safety.

"For serious infections, you will tolerate a little more of a safety issue," he said. "For the drugs that are really important -- those for cancer and HIV -- the trend has been to move those drugs through more quickly."

The public influences this debate by insisting on inexpensive and highly effective drugs that are also extremely safe for large populations of users -- a difficult endeavor for any drug maker or regulatory agency.

But in choosing between safety and availability, "there's always going to be tension between those two areas," Goldberger said.

10 Years Behind Schedule

Even the best efforts of those working in the drug industry, academics and the government may not be enough to stem the rising tide of antibiotic-resistant infectious organisms.

Dr. John G. Bartlett, professor of medicine and chief of infectious diseases at Johns Hopkins University School of Medicine, notes that if research began immediately on antibiotics to combat new strains of bacteria, it would be many years before any of these drugs were available.

"We're trying to deal with the bugs of 2008 and 2010," he said. "There are constant surprises, and ... we're at a period where there aren't any drugs in development."

As the IDSA report notes, "Time is running out. Even if all the incentives outlined in this paper were implemented today, it likely would take 10 or more years for companies to move safe and effective new drugs to market."

This article is the second of a three-part series.

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