Lilly criticized for new Evista ads.

A new ad campaign for Lilly's Evista is drawing fire for promoting the osteoporosis drug as a breast cancer preventative while downplaying significant risks, "The Indianapolis Star" reported June 1.

Evista has been shown to raise the risk of blood clots and fatal strokes. In one clinical trial of 10,000 patients with coronary problems and other health issues, women who took Evista had a 49% higher risk of dying if they suffered a stroke than those who took a placebo. The drug's packaging insert even carries a black-box warning about those risks--the strongest warning required by FDA.

For 10 years, Lilly has sold Evista as a treatment for osteoporosis. But last fall, FDA approved Lilly's request to market the drug for a secondary use: to reduce the risk of invasive breast cancer for certain groups of postmenopausal women--those with osteoporosis and those at high risk for invasive breast cancer.

Lilly has long wanted to market the drug for breast cancer. Two years ago, the company paid a $36 million fine to the government for claiming to doctors and consumers that Evista treats breast cancer before it got FDA approval to do so.

Nearly 180,000 new cases of invasive breast cancer are diagnosed each year; about one in eight women will develop invasive breast cancer, the National Cancer Institute said.

Last month, Lilly began airing its commercials for Evista on daytime and prime-time TV shows and running advertisements in women's magazines such as "Good Housekeeping." The company said the new ads are not a broad-market push, but are targeted at a fairly narrow market of postmenopausal women who have osteoporosis.

"This is about educating those women about the additional benefit this drug has to offer," said Deirdre Ibsen, Lilly's director of osteoporosis marketing. "That will obviously translate into something more (in sales) for Evista. What it is at this point, we don't know."

But some breast-cancer advocacy groups take issue with the ads. They say Evista's risks are too great for healthy women to consider using. They say only a small percentage of women might avoid breast cancer by taking a drug like Evista.

"This is not the approach we should be taking," said Brenda Salgado, program manager of Breast Cancer Awareness in San Francisco. "We believe that any pill powerful enough to lower the incidence of breast cancer will most certainly cause other health problems and diseases. Why should we substitute one problem for another?"

Carolina Hinestrosa, executive vice president of the National Breast Cancer Coalition in Washington, said many women who take Evista will not need it and won't benefit from it.

"Yet there are many vulnerable women who are afraid of breast cancer," she said. "Many women overestimate the risk of breast cancer."

But some cancer advocates say they applaud Lilly's efforts to find a preventive medicine for the disease. "Our hopes are really high for finding a way to prevent breast cancer long before the cancer forms," said Connie Rufenbarger, a breast-cancer survivor from Warsaw, IN, who runs the Catherine Peachey Fund, a nonprofit aimed at supporting cancer research and prevention.

"As far as risks, all drugs have risks," Rufenbarger said. "Nobody is pointing a gun at us and saying we have to take these drugs."

The American Cancer Society, based in Atlanta, has not taken a position on the use of Evista for breast cancer.

"We didn't feel the benefit was so huge or that there was enough risk that we could recommend for or against it," said Debbie Saslow, the society's director of Breast and Gynecologic Cancer. "In general, the higher-risk the woman is for breast cancer, the more benefit she is going to get, which might outweigh the risks."

The commercial acknowledges that the drug does not treat breast cancer, prevent its return or reduce the risk of all forms of breast cancer.

It also warns women about the increased risk of blood clots and stroke and urges them to seek care if they have chest pains, shortness of breath, sudden vision change, leg pain or warmth, or swelling of the legs, hands or feet.