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Thursday, 07/22/2004 9:47:04 AM

Thursday, July 22, 2004 9:47:04 AM

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Doctors urge 'superbug' fight

Incentives sought to push creation of new antibiotics

By Christopher Rowland, Globe Staff / July 22, 2004

The pharmaceutical industry's failure to develop new antibiotics to treat ''superbug" bacteria prompted a warning yesterday from the nation's infectious disease doctors, who urged Congress to create incentives for drug companies to conduct more research.

Drug-resistant bacteria are migrating into locker rooms, prisons, and other settings, ranging far beyond the hospital wards where they have lurked before. Estimates are that 70 percent of the 90,000 fatal infections Americans will contract this year will be from bacteria that are resistant to at least one antibiotic.

But the nation's pharmaceutical industry, without strong market incentives, has slowed development of new antibiotics to a trickle. Instead, lured by bigger profits elsewhere, drug companies are pursuing pills to treat chronic conditions like high cholesterol and ''lifestyle" issues like impotence and baldness, according to a report released yesterday by the Infectious Disease Society of America.

''This is a public health crisis that has the potential to touch us all," Dr. Joseph R. Dalovisio, president of the society and head of infectious diseases at the Oschsner Clinic Foundation in New Orleans, said in prepared remarks delivered in Washington yesterday.

Some big companies like Pfizer Inc. and AstraZeneca Pharmaceuticals LP say they are investing tens of millions of dollars every year into research programs for new antibiotics, but they have few drugs in clinical trials and whatever they do discover won't be available for years. The doctors' group boiled it all down to an alarming study title: ''Bad Bug, No Drugs."

The group's report said Congress should give tax breaks to companies that pay for antibiotic research. Among its other suggestions: allow drug companies to extend patents on blockbusters like Lipitor and Viagra if the companies agree to plow a portion of the new profits into antibiotic research. It said companies should also be granted limited protections against lawsuits in case a novel antibiotic injures someone.

The Washington lobbying group representing drug companies, the Pharmaceutical Research and Manufacturers of America, said it had not reviewed the recommendations for congressional action.

''I don't think it is quite correct that companies are walking away," said Alan Goldhammer, vice president for regulatory affairs at the organization. ''What happens is companies have a limited amount of money to fund research and development projects."

The lobbying group has been in discussions with the FDA and the infections disease society to streamline the government's rules for approving new antibiotics. One formidable hurdle is an FDA requirement that separate clinical trials be conducted for every illness a new antibiotic may treat, from ear infections to strep throat to simple skin infections, Goldhammer said.

Among supporters of legislation to speed up development of stronger antibiotics is Janet Johnson of Stafford, Texas, whose son, 13-year-old Nicholas Johnson, nearly died of an infection last year. Nicholas came home from football practice one day last October with a painful shoulder. It was diagnosed as a sprain, but when he spiked a fever of 104.6, an emergency room doctor gave him an everyday form of penicillin.

The bacteria, later determined to be methicillin-resistant staphylococcus aureus (MSRA), spread unchecked. The bacteria had invaded his blood, his lungs, and his bones. He spent 12 days in the intensive care unit and another month recuperating in the hospital. He is still taking a stronger antibiotic that doctors administered after the penicillin failed.

The experts still don't know how the infection invaded his body, said his mother. The incident was among a string of outbreaks last year. There were at least three deaths in Houston last fall from the same bacteria. The federal Centers for Disease Control and Prevention last August reported MSRA infections among fencers, wrestlers, and football players at high schools and colleges in four states.

''I feel kind of helpless," Johnson said. ''You always think medicine is going to be there when you need it, but that's not always the case."

Christopher Rowland can be reached at crowland@globe.com.


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