( grandchildren. Officially the dr...)Anemia Drug Overused and Could Hasten Death in Some, Say Experts,Health

grandchildren.

Officially, the drug is used only to treat anemia and avoid blood transfusions; its makers have not proved to FDA's satisfaction that it restores vigor and improves quality of life.

"There is a fine line between rights of the First Amendment speech and the protection of the American public against false and deceptive advertising," said Richard Pazdur, director of FDA's Office of Oncology Drug Products. "The American public is owed an explanation of why these advertisements were allowed to go on."

Reports of several clinical experiments in which high-dose erythropoietin appeared to shorten the lives of some patients were presented on at a FDA session on Thursday.

Taken together, the FDA developments are considered a serious blow to one of the first, and by far the most lucrative, of today's biotech-made "targeted" drugs.

In 2006, it was the fifth-best-selling class of prescription drugs in the United States. Last year, $10 billion worth was sold, an amount about half the value of the leading class, cholesterol-lowering drugs, whose sales were $21.6 billion, according to the market research firm IMS Health.

What troubled the 17-member FDA advisory committee most was data from five studies - of breast, lung, lymphoid, and throat cancers - suggesting that erythropoietin caused "tumor promotion" and shorter survival in patients randomly assigned to get it rather than a placebo.

Officials of Amgen, the biotechnology company that makes all erythropoietin sold in this country, countered that in those studies the drug was given earlier and more liberally than is current practice. When physicians and patients use the medicine more sparingly, there is no difference in survival, they argued, citing other studies.

Related worries had led the FDA in March to add a special warning to the drug's label, advising doctors to use it less aggressively in kidney-failure patients, in w
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