"In a vote of 8 to 6, the FDA's Oncologic Drugs Advisory Committee recommended approval of the drug for postmenopausal women with osteoporosis, and, in a 10 to 4 vote, it also recommended the drug for postmenopausal women at high risk for breast cancer."

"While the FDA usually follows the recommendations of its expert panels, it is not obligated to do so."

"Evista's approval would give women a valuable option in fighting breast cancer, one expert said."

""We've got a drug out there, tamoxifen, with its advantages and its possible flaws,'' panel member David Harrington, chairman of the biostatistics department at Dana-Farber Cancer Institute in Boston, told "

" news service. "Women at high risk for breast cancer, it would be very nice to have a second option for them," he said."

""The reason that we are concerned and will continued to be concerned about it is the history of every drug that's ever been used to 'prevent breast cancer,' " explained Barbara Brenner, the executive director of Breast Cancer Action."

""In addition, the number of women who are going to be exposed to a drug with very serious and potentially fatal side effects in the interest of reducing very small numbers of breast cancer is very frightening to us," Brenner said. "We would like to see this disease prevented but not at the risk to women's health," she said."

"While Evista has been shown to reduce the risk of breast cancer among postmenopausal women with osteoporosis, and postmenopausal women at high risk for breast cancer, it also increases their risks for blood clots and stroke."

"In the Raloxifene Use for The Heart (RUTH) trial -- which included more than 10,000 postmenopausal women -- researchers found that, compared with placebo, Evista had no significant effect on the risk of first-time coronary events."

"At the same time, it reduced the risk of invasive breast cancer by 44 percent -- meaning about 1.2 fewer cases of cancer per 1,000 women treated with raloxifene per year."

"However, while the study showed no significant difference in deaths from any cause, or total deaths from stroke, women in the raloxifene group did have a 55 percent increased risk of fatal stroke (0.7 excess fatal strokes per 1,000 women treated per year) and a 44 percent increased risk of blood clots (1.2 more cases per women treated per year), according to a report published last July in the "

""We fail to understand why any woman in her right mind would want to expose herself to such risks," Brenner said. "If the drug is approved by the FDA, Eli Lilly & Co. [the maker of Evista] will heavily promote the drug, and many women will be made sick by in the interest of preventing breast cancer that will be in nobody's interest," she said."

"Women should learn what this drug can and cannot do for them and make an informed choice, Brenner said. "Do not depend on the FDA to do that for you.""

""The drug has been demonstrated to have benefit in preventing breast cancer in women at increased risk," said Dr. Len Lichtenfeld, the deputy chief medical officer at the American Cancer Society. "The drug should be approved. That would then give us two options, and Evista may have a better safety profile than tamoxifen," he said."

"In the STAR (Study of Tamoxifen and Raloxifene) trial published last June, almost 20,000
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