Health System Struggles Against New Bugs

Since World War II, most of the developed world has lived through a golden period where infectious diseases were a concern of generations past.

Vaccines and antibiotics like penicillin kept the most virulent diseases at bay, and children grew up in a world where scarlet fever, cholera and tuberculosis were virtually unheard of.

Our victory over these illnesses seemed so complete that in 1967, Surgeon General William H. Stewart announced it was "time to close the book on infectious diseases, declare the war against pestilence won, and shift national resources to such chronic problems as cancer and heart disease."

Now that halcyon period may be ending. "The golden era of medicine has come to term," said Kate Robins, a spokeswoman for drug maker Pfizer.

As new and deadly strains of bacteria and viruses emerge, government officials and the pharmaceutical industry have devoted few resources to address this immediate threat.

Health Doesn't Pay

Most drug companies, in fact, have severely cut back or eliminated all research and development in antibiotics.

"Antibiotics ... are a victim of their own success," said Dr. Mark Goldberger, director of the office of drug evaluation in the Center for Drugs at the Food and Drug Administration.

"One sees drugs that can be used for five to 10 days and are likely to be very effective," he said. These antibiotics yield relatively little profit for manufacturers, compared to drugs to treat chronic conditions such as hypertension, HIV and hepatitis.

Pharmaceutical industry critics decry what they see as an industry trend away from lifesaving antibiotics and antivirals, and an increased investment in "lifestyle" drugs to deal with conditions such as baldness, erectile dysfunction and obesity. Though these drugs have little or no medical benefit, they virtually guarantee huge profits for pharmaceutical companies.

But Dr. John E. Edwards, professor of medicine at the David Geffen School of Medicine at UCLA and chief of infectious diseases at Harbor-UCLA Medical Center, finds no reason to blame the pharmaceutical industry for the shortage of new antibiotics.

"There are very significant financial disincentives for pharmaceutical companies to pursue these anti-infectives," Edwards said. "It's not their fault -- it's a societal conundrum."

R&D Costs Soar

A significant part of the problem is the lengthy and expensive process of developing, testing and bringing a new drug to market.

According to a 2001 study by the Tufts Center for the Study of Drug Development at Tufts University in Boston, the average cost to develop a new drug is more than $800 million. Part of the cost includes years -- even decades -- of research and clinical evaluation before a drug can gain FDA approval.

When the stakes are as high as that, it's no wonder large drug companies shy away from expensive, time-consuming antibiotic research that may produce little profit and could expose the company to expensive lawsuits.

"That's why it's going to boil down to legislative reform before we address this issue, which is a major public health problem," said Edwards.

But even as major pharmaceutical companies are scaling back or eliminating antibiotic research and development, a handful of other companies is stepping in to gamble on new antibiotics.

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