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FDA Panel Wants Anemia Drug Warnings

Experts Concerned Drugs Are Overprescribed Despite Risks
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Overuse Alleged

Most evidence suggests that the increased risks are the result not of recommended use, but instead are due to overdosing and overprescribing to a largely unstudied swath of patients. As many as 450,000 American patients are taking the drugs, which can cost $1,000 per treatment.

Many doctors prescribe the drugs to improve quality of life by helping with the fatigue often resulting from anemia. But FDA scientists said Thursday that no scientific studies have shown the drugs improve cancer patients' quality of life.

At the same time, evidence from at least two recent studies showed they may promote tumors and cause early death, says Vinni Juneja, an agency safety official.

"FDA believes there should be a reconsideration of the risk to benefit ratio ... in cancer patients," he says.

Industry scientists maintain that the drugs can improve quality of life and don't spur cancer growth.

"We do not have data that tumor progression is an issue as a result of erythropoietin treatment. We simply don't," says Roger M. Perlmutter, MD, executive vice president of Amgen, which sells Epogen.

Marketing Questioned

But agency officials and experts blamed aggressive industry marketing for promoting the drugs as a way to boost energy -- a claim not approved by the FDA.

Television and print advertisements widely distributed by Procrit maker Johnson & Johnson urged patients to seek out the drug as a way to improve vigor.

"Most doctors and most patients think this drug has been approved because it improves quality of life, it improves fatigue. There's a lot of sleight of hand here on how the drug is used ... and that's a problem," says Otis Brawley, MD, a professor of oncology at Winship Cancer Institute at Emory University in Atlanta and a member of the panel.

Maha H.A. Hussein, MD, the panel's chairwoman, says she doesn't want to see the drugs pulled from the market because they are important for "supportive care." But she also suggests that company marketing has urged doctors to give higher-than-recommended doses under the assumption that boosting red blood cell counts translated to more comfort for patients.

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