by Samuel S. Epstein, MD

On December 10, 1997, Eli Lilly and Company announced the Food and Drug Administration’s (FDA’s) clearance to market Evista® (Raloxifene), which had been shown to be effective in preventing osteoporosis, affecting over 20 million U.S. women annually, and in reducing low density lipoprotein (LDL) or "bad cholesterol" blood levels. Lilly has submitted applications to market Evista® in more than 30 different countries. Surely, this new drug should be welcomed by women worldwide. Unfortunately, this is not the case, as Lilly, with FDA’s complicity, has suppressed critical information that this drug poses major risks of ovarian cancer.

In a study specifically designed by Lilly to prove the drug’s safety, Evista® was shown to induce ovarian cancer in both mice and rats. Moreover, carcinogenic effects were noted at dosages extending below the therapeutic. However, the study concluded: "The clinical relevance of these tumor findings is not known." Lilly reached this conclusion despite the scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk. Nevertheless, Lilly failed to disclose this critical information in its "Warning" to women. Furthermore, no reference at all is made to these risks in the Lilly-sponsored publication on Evista® in the December 4, 1997 issue of the New England Journal of Medicine.

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Surely, this new drug should be welcomed by women worldwide. Unfortunately, this is not the case, as Lilly, with FDA’s complicity, has suppressed critical information that this drug poses major risks of ovarian cancer.

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Responding to criticisms on the January 12, 1998 Jim Lehrer Newshour program, a Lilly spokesman claimed that the carcinogenic effects of Evista® in the ovaries of sexually mature rodents are irrelevant to such risks in post-menopausal women. However, ovarian cancer is recognized as an uncommon complication of long-term hormonal replacement in the post-menopausal.

Ovarian cancer strikes about 24,000 U.S. women every year, accounting for 4% of all their cancers. About 15,000 women die from ovarian cancer annually, making it the most lethal female reproductive cancer. Lilly’s suppression of the evidence of ovarian cancer risks from Evista® is as reckless as is FDA’s marketing approval, conduct which merits congressional and legal scrutiny. This drug should be withdrawn from the world market immediately. As importantly, a "Cancer Alert" should be sent to the over 12,000 women who have participated in U.S. and international clinical trials in the absence of informed consent. These women should also be offered lifelong bi-annual surveillance for the early detection of ovarian cancer at Eli Lilly’s expense.