A new pitch for an old pill

[Pharma Newshound]

Source: IndyStar.com

Lilly's latest drug ad renews a health and marketing controversy for Evista, a 10-year-old drug now approved for breast cancer

By John Russell
john.russell@indystar.com

Satin bedsheets. Wind blowing through hair. Classical music in the background.

It's a drug commercial, the newest by Indianapolis drug maker Eli Lilly and Co. -- but not for what you might think.

The women in the commercial are in their 50s and 60s. Their hair is showing streaks of gray. They wear satin sheets draped like Roman togas, while standing like statues in a garden.

It's not the typical drug ad, filled with smiling families or cuddling couples.

"You're past menopause and are treating osteoporosis," the narrator says. "Why not ask your doctor about Evista, the only medicine that treats osteoporosis and reduces your risk of invasive breast cancer?"

The women look confident in some shots, nervous in others, and even mildly flirtatious at times. It's an emotional display that Lilly hopes will connect with millions of older women.

But the ads are raising a new round of criticism from some women's health groups.

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 percent 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 the Food and Drug Administration.

For 10 years, Lilly has sold Evista as a treatment for osteoporosis, a disorder that makes bones brittle and subject to breaking. But last fall, the 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.

Breast cancer is the second-most- common cancer for women, after non-melanoma 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, the institute said.

Some analysts, however, wonder if Evista, one of Lilly's oldest drugs, will see much benefit. Sales have stalled at about $1 billion a year for the past four years. In the first quarter of this year, sales actually fell 1 percent, compared with the same period a year earlier, making it Lilly's only major drug to lose ground.

"Lilly is trying to jump-start a product that is losing steam," said Seamus Fernandez, a drug analyst at Leerink Swann & Co. in Boston. "It's a challenge. We've seen tempered growth for a long time for Evista."

Barbara Ryan, a drug analyst for Deutsche Bank in New York, told clients in a research note: "We do not believe that Evista will see much incremental growth from the label expansion for breast cancer risk reduction."

Search for new revenues

Lilly needs to look high and low for additional revenues. The company, like most of its competitors, is beset by slowing industry growth, coming patent expirations and pushback from insurers over the rising cost of drugs.

To cope, Lilly has shed about 5,000 jobs, or 11 percent of its work force, in the past five years. That includes more than 2,000 jobs in Central Indiana. The company also has outsourced big chunks of its sales, manufacturing and research functions.

While Lilly is trying to restock its pipeline with new drugs for Alzheimer's disease, cancer and sleep disorders, the company also is trying to find new markets for its drugs. For about a decade, Lilly has been trying to win FDA approval for Evista as a preventive measure to help women reduce the risk of breast cancer. In September, the FDA finally gave Lilly the green light.

Three weeks ago, 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 in time, we don't know."

The ads are meant to portray older women as strong and confident individuals who take care of themselves and are interested in preventive medicine, the company said.

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?"

Double-edged drug

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. Curing cancer, once it forms, often requires surgery and chemotherapy, with a host of dreaded side effects, from weakness to hair loss.

"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, Ind., 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."

Risk factors for breast cancer include advancing age, family history, how many babies a woman has had, when in her life she had babies, suspicious lesions and other issues.

Lilly says the drug is safe for many women, although not for everyone. 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.

The company said it has studied the drug, which also goes under the name raloxifene, in 37,000 patients in clinical trials over 20 years. The drug has been prescribed to more than 50 million women.

Evista works in different ways. In some parts of the body, such as bones, it mimics estrogen, strengthening the bones and decreasing erosion. In the breast, Evista acts in the opposite way, not mimicking estrogen but protecting the tissue, said Dr. Maria Rivas, Lilly's medical director for osteoporosis and urology.

"It's a unique molecule," she said. "It's been around a long time. It's probably one of the most studied medications in history. We feel good about it."