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Lilly’s Evista OK’d against breast cancer-welcome china

After nearly a decade of trying, Eli Lilly and Co. has won approval to market a bone-strengthening drug for another use: as a preventive measure to help certain women reduce their risk of breast cancer.

But some critics, including several women’s health groups, say the drug’s heart risks outweigh its benefits for most women, and they will be watching to see that Lilly doesn’t over-promise what the drug can do.

The drug has been shown to raise the risk of blood clots and strokes. The Indianapolis drug maker said the package insert will carry a stronger warning about the risks.

On Friday, the Food and Drug Administration said Lilly can market the drug to reduce the risk of invasive breast cancer — the most dangerous, life-threatening form of the disease to two groups: postmenopausal women with osteoporosis, and postmenopausal women at high risk for invasive breast cancer.

Lilly said that represents fewer than 8 million U.S. women. About 500,000 women in the U.S. are taking Evista for osteoporosis, a disorder that makes bones brittle and subject to breaking.

The risks were disclosed last year after the latest clinical tests on the drug. Women who took Evista had a 49 percent higher risk of dying from a stroke than those who took a placebo.

Breast cancer is the most common cancer among women, except for nonmelanoma skin cancers, according to the National Cancer Institute. Nearly 180,000 new cases of invasive breast cancer are diagnosed each year. About one in eight women will develop invasive breast cancer at some time in their lives, the institute said.

Some critics point out that Lilly already has a spotty record on marketing Evista. Two years ago, it paid a $36 million fine to the government for claiming to doctors and consumers that Evista treats breast cancer, without having government permission to make that claim.

The National Women’s Health Network, a patient advocacy group based in Washington, has opposed the new use of the drug, saying Lilly has been able to show breast-cancer prevention benefit only for a narrowly defined group of women. The organization said it fears Lilly will promote the drug to a mass market.

“They’ve already gotten slammed for promoting this drug illegally, and we have concerns that their marketing is going to blur the line again,” said Amy Allina, the group’s program director.

Lilly said Friday it hasn’t ruled out a mass-market, direct-to-consumer campaign on Evista’s new approved use. But the company said any marketing will stay within the guidelines of the FDA approval.

Breast Cancer Action, another patient-advocacy group based in San Francisco, also opposed the additional use of the drug, which is also known as raloxifene.

“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,” Barbara A. Brenner, the group’s executive director, said in a statement.

Lilly acknowledged the drug carries risks, which it said patients should discuss with doctors. It also said it didn’t expect a large number of women to seek the drug. Instead, it called Evista a preventive drug for a fairly narrow group, said Dr. John Mershon, a Lilly physician who specializes in women’s health.

“At least for me, I don’t expect to see women lining up for this drug,” he said. “General prevention with a medication is not in widespread use in the country today.”

Some analysts said they would be surprised if the new FDA approval increased sales markedly. Evista is Lilly’s fifth-best-selling drug, with sales of $1.05 billion last year.

“It’s a positive development, but I think it will provide only an incremental boost (to sales),” said Les Funtleyder, a drug analyst at Miller Tabak & Co. in New York.

Lilly stock closed down 2 cents Friday, to $57.