For Immediate Release
Contact: Mary DeLucco
Breast Cancer Action
(415) 243-9301 ext. 16
San Francisco—Breast Cancer Action (BCA) opposes today’s recommendation by a U.S. Food and Drug Administration (FDA) advisory panel to approve the use of raloxifene (tradename Evista) to reduce the risk of breast cancer in postmenopausal women who do not have breast cancer but are considered at high risk for developing the disease.
In December 2005, raloxifene’s manufacturer, Eli Lilly, paid a fine of $36 million for illegally promoting the drug to doctors as a breast cancer “preventative.” Now, the company is one step closer to getting FDA approval to market the drug to reduce the risk of breast cancer in women deemed at high risk, despite the fact that the drug increases the risk of serious—and potentially fatal—side effects.
BCA has long opposed a pills-based approach to breast cancer prevention, believing that any pill powerful enough to prevent breast cancer will most certainly cause another disease.
“The relatively few number of women who may avoid breast cancer by taking raloxifene is far outweighed by the risk of blood clots and strokes from the drug that they and thousands of other women will experience,” says BCA Executive Director Barbara A. Brenner.
“If Eli Lilly is permitted to market raloxifene, many women will consider taking it because most women overestimate their risk of breast cancer,” Brenner says.
Tamoxifen, the only other drug that the FDA has approved to reduce the risk of breast cancer, has not sold well for this purpose because most women are not willing to take a drug with such serious side effects. Raloxifene was tested against tamoxifen, and the data from that study showed very little difference in the side effects of the two drugs.
BCA strongly urges FDA Commissioner Andrew von Eschenbach to seriously consider the views of the FDA scientists and committee members who opposed approval, and oppose today’s recommendation.
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Breast Cancer Action (www.bcaction.org) is a non-profit education and advocacy organization that does not accept funding from pharmaceutical companies or any other organizations that profit from or contribute to the breast cancer epidemic.