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Antibiotics: Bad Bugs, No Drugs - 2004-09-04

When the first commercial antibiotic, penicillin, was introduced in the 1940s, it ushered in a revolution in medicine. Once life-threatening diseases could be cured with a simple pill. But the germs are fighting back, and humanity is running short of new weapons to counter their assaults.

One Thursday last October, 12-year-old Nicholas Johnson hurt his shoulder in a football game. The next day, his temperature shot up to 41 degrees Celsius. His mother Janet recalls his doctor gave him antibiotics and sent him home. "And after a couple of days I thought he would start feeling better when the antibiotics started to work. But he was just getting worse," she says.

The antibiotics didn't work. By Monday, an infection that started in his shoulder spread to his lungs, his blood and his bones. Over the next five and a half weeks, Nicholas had surgery on his heart, chest, hip, and elbow. He was on emergency life support for 12 days. "They say it's a miracle he survived," says his mom.

Only the antibiotic of last resort saved Nicholas's life. The number of cases like Nicholas are growing as more and more germs find ways to thwart germ-killing weapons. A recent report from Taiwan showed the powerful antibiotic Cipro is becoming useless against one type of Salmonella bacteria that cause serious food poisoning. Frank Angulo monitors antibiotic resistance at the U.S. Centers for Disease Control and Prevention.

He says it was inevitable that Cipro and its class of drugs, called fluoroquinolones, would lose their power over time. "This is a natural evolution of Salmonella, that it would become resistant to the antibiotics which are commonly used. But unfortunately there are not new classes of antibiotics being developed to take the place of fluoroquinolones. So if we were to lose the effectiveness of fluoroquinolones, it's not clear what alternative drugs could be used," he says.

Ever since the introduction of penicillin in the 1940s, the pharmaceutical industry has stayed one step ahead of evolving germs. But now, the industry is largely getting out of the antibiotics business. A recent study showed that out of more than 500 drugs in development at pharmaceutical companies, only five are antibiotics. Drug maker Bristol Myers Squibb is closing a plant that used to make most of America's penicillin.

John Bartlett heads the infectious diseases department at Johns Hopkins Hospital. He helped write a report called "Bad Bugs, No Drugs" for the Infectious Diseases Society of America, or IDSA. He says the drug companies are more interested today in medicines for chronic diseases, like the heart disease drug, Lipitor, which has been earning its maker $10 billion per year. "The pharmaceutical company looks at an antibiotic, which you take for a week, and then they look at something like Lipitor, which people take? and they take it for the rest of their lives. And they have to say, 'Lipitor, or something like Lipitor, is a good investment.'"

Especially when it costs nearly a billion dollars to develop a new drug and bring it to market, according to industry estimates. Also, industry experts complain that regulations make it harder to develop new antibiotics. Regulatory affairs chief Alan Goldhammer at the drug industry's trade association PhARMA, says to make an antibiotic profitable, it has to be approved for use against several different diseases, or indications. "If I'm going to develop this antibiotic for, say, these five or six different indications, I need to do a different clinical study for each of those indications," he says.

And clinical studies are costly and time-consuming. Members of the IDSA have been lobbying Congress about the lack of new antibiotics. They say the threat of bioterrorism makes the need more urgent. Dr. Bartlett says lawmakers agree that there's a problem. "Where the going gets tough is when you talk about how you're going to deal with the pharmaceutical industry to get back into this business," he says.

One attempt is Project BioShield, a ten-year, $5.6 billion program that President Bush signed into law this summer. It's designed to make countermeasures available against a chemical, radioactive, or biological terrorist attack. New antibiotics could be a part of that. Doctor Bartlett says the IDSA has talked to the drug companies about these and other programs. "And I'll tell you what they have said is, 'You guys are thinking in the right direction, but you're not there. There's just not enough to persuade us to pursue antibiotics.'"

The IDSA proposes giving the industry incentives like tax breaks and patent extensions. And it says the regulatory process needs to be sped up and streamlined. Janet Johnson says something needs to be done, and soon, so that more people don't have go through the same ordeal her son Nicholasendured. "We need to be aggressively working on new antibiotics because what do you do when the last one doesn't work? And it could happen to anybody," she says.