Powerful Antibiotic May Bring Death in Some Cases

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Antibiotics are supposed to cure infections, not kill people. But data suggest that Ketek, a new, powerful and expensive antibiotic drug, may occasionally cause death. The Food and Drug Administration has asked an advisory committee to consider the risks and benefits of the drug. Robert Siegel talks live with NPR's Joanne Silberner.

ROBERT SIEGEL, Host:

You're listening to ALL THINGS CONSIDERED from NPR News.

Health experts today are weighing whether a controversial drug should stay on the market. The drug is called Ketek. It's an antibiotic used to treat respiratory infections like bronchitis and pneumonia. The Food and Drug Administration approved Ketek two years ago, but since then the drug has been linked to liver damage, sometimes fatal.

Today some advisors to the FDA met to consider whether Ketek's risks outweigh its benefits.

And joining me now is NPR's Joanne Silberner. Joanne, what did the committee decide about Ketek?

JOANNE SILBERNER: Well, the committee gave it a mixed reaction. They voted 16 to three that it should continue to be used for pneumonia, that it's worth those risks.

But on bronchitis and sinusitis which are two illnesses that are uncomfortable but they're kind of self-limited--they don't usually go on--they voted strongly against it, two to 17.

SIEGEL: Now, the FDA has come under some criticism for how it approved the drug. Tell us about that.

SILBERNER: Well, there were two areas of criticism. One was on science, and one was on politics. On the science side, the tests that they allowed to be submitted for approval were what they called noninferiority tests. All the company had to show was that their drug wasn't any worse than other antibiotics.

And no one even knows with bronchitis and sinusitis whether drugs are really all that helpful. So saying that you're just as good as your competitor isn't saying you're making a major difference in the disease. In order to do that, you have to run a test against the placebo.

And the political issue is a little more complicated. What happened was the FDA asked the company to do another study before they approved it. The company contracted with a firm that does studies but the data that came in - some of the results from some of the doctors who were sending in descriptions of their patients, specifically Senator Chuck Grassley of Iowa - and he wanted to know a little bit more about how did this drug get approved?

This fraudulent data had - or the test itself had been submitted to the previous committee that considered this drug. And Senator Grassley is a little upset about that, has been asking the FDA for information. And the FDA hasn't been giving him all the information that he wants.

SIEGEL: Well, what is next then for Ketek?

SILBERNER: Well, what happens now is all this information goes back to the Food and Drug Administration. They're going to consider everything the committee said. They're going to decide whether or not to leave this drug on the market.

And my guess is that they will, at least for, they will for pneumonia because the committee was pretty clear that with pneumonia, you're talking about a serious disease. It can kill you. There's a lot of drug resistance to pneumonia from other bacteria that just don't respond to the old antibiotics. It's good to have something in reserve to try.

So I think that they've certainly got reason to continue to allow it on the market, given what the committee said. What they'll do with the other two, you know, they have options. They can just tell the company, you can't advertise it for these other two treatments. You can't say that it treats these two other conditions, and that's what may happen.

SIEGEL: And is this seen as having an impact, possibly, on the efforts to develop other new antibiotics?

SILBERNER: Well that's a great question because that's one of the reasons a lot of people think that the Food and Drug Administration approved Ketek in the first place. There is a real concern out there and it's a real one, among infectious disease experts.

They're losing their weapons. You know, if you have an antibiotic around long enough, the bacteria will figure out a way to get around it. So by coming up with anything, they want - you know, the FDA and everybody wants to encourage companies to develop these drugs.

Of course, no one wants to encourage them to develop unsafe drugs. And there are people who say that the FDA approved this drug in the first place in order to keep the pipeline flowing.

SIEGEL: Thank you, Joanne.

SILBERNER: Thank you.

SIEGEL: That's NPR Joanne Silberner who was covering the FDA advisors meeting on the drug Ketek in Maryland.

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