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Women-in-Towels Evista Ad Critiqued

Posted by medconsumers on July 1, 2008

The women in Eli Lilly’s new ad campaign are attractive, healthy-looking and wearing nothing but towels. “Cut two risks with Evista. The only agent indicated to treat osteoporosis and reduce the risk for invasive breast cancer.”

That two-for-one claim for Evista makes it different from other drugs taken by symptom-free people. Studies showed that the harm related to each disease drops a percentage point or two in those who took Evista, compared to those who did not. The drug is better than a placebo (or it would not get FDA approval), but not much better. This is a recurring theme in Center for Medical Consumers articles because it’s a recurring theme in many drug trials. And often the small risk of a serious adverse reaction to the drug equals that small chance of benefit.

Evista (generic name: raloxifene) has been on the market since 1997 as an osteoporosis drug. It produces a 2%-3% increase in bone density; reduces the rate of vertebral (spinal) fractures; but does not prevent the most serious type of fracture (hip). Vertebral fractures can cause pain and a dowager’s hump in advanced age, but many are symptomless. The studies did not last long enough for Lilly to make claims regarding prevention of a dowager’s hump or loss of height.
Breast Cancer “Risk Reduction”

Last year Lilly received FDA approval to promote Evista as a drug that can “reduce the risk of invasive breast cancer.” This careful wording from the Evista ads is important. Lilly cannot claim its drug prevents breast cancer because the disease can take anywhere from 8 to 17 years to develop. There were, in fact, fewer breast cancers diagnosed in the women taking Evista, compared to those taking placebos. But the trials didn’t last long enough to determine whether the drug prevents breast cancer or simply delays its onset. In Evista trials that lasted up to eight years—breast cancer was diagnosed in 2.5% of the women taking a placebo and 1% of the women taking Evista.

The other claim for Evista is based on the fact that the women in the studies already had osteoporosis (bone loss). One way bone drug companies can inflate the benefit of their product is to count symptomless vertebral fractures that can be detected only on x-ray. (In other words, the women are unaware of them.) At the start of the Evista trial about half the women had painful vertebral fractures and the other half had “fractures diagnosed radiographically.” After four years, things looked better for Lilly when results for all women were combined, but less impressive when women with painful fractures were singled out. In the latter group, only about 1% fewer Evista-treated women had new painful vertebral fractures than the women taking placebos.

Thus far serious adverse reactions to Evista include deep vein thrombosis, pulmonary embolism, retinol vein thrombosis and an increased risk of fatal stroke. (See boxed warning of the FDA-approved label). Separately, each is classified as rare, which, according to FDA standards, describes any drug reaction that occurs in less than 2% of study participants. Collectively, though, these potentially fatal adverse reactions could reach 1-2% which comes close to the percentage of women who benefited from Evista in the FDA-required clinical trials.

And lastly, the visual message conveyed by the women-in-towels ad is misleading. Most of the women look to be in their fifties. At the start of the Evista trials, however, most participants were over age 65 years, a time of life when vertebral fractures are far more likely to occur.

Maryann Napoli, Center for Medical Consumers ©
July 2008

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