" At least two women's health advocacy groups oppose such a move, and, in a briefing document for the panel, FDA scientists question whether Evista's benefits outweigh its risks. The FDA usually follows advisory committee recommendations. "

" Evista was approved to prevent osteoporosis in 1997 and to treat it in 1999. Now, Eli Lilly wants to market it for lowering invasive breast cancer risk in postmenopausal women who either have osteoporosis or a high risk for breast cancer. "

" "There's a large, robust body of data that has to be looked at," Lilly spokesman Gregory Clarke says, noting that Evista's ability to cut breast cancer risk has been tested in four trials totaling 37,000 women. And, he says, more than 22 million worldwide have taken it to treat or prevent osteoporosis. "

" The FDA scientists say their analysis of one of those trials found Evista reduced breast cancer risk only in women at normal risk, not high risk. "A careful consideration of the risk/benefit ratio is especially important" because Lilly wants to market Evista to healthy women, the scientists say. "

" Only tamoxifen is approved for trimming breast cancer risk in women who have never had the disease. But tamoxifen's risks -- a higher rate of uterine cancer, blood clots and stroke -- have put off many women. "

" Tamoxifen is "very much underutilized for breast cancer prevention," says Len Lichtenfeld, American Cancer Society deputy chief medical officer. "There are clearly women who are at high risk of getting breast cancer who would benefit from preventive therapy." Women and doctors might
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