Eli Lilly's current full page color ads for Evista, a synthetic hormone with both estrogenic and anti-estrogenic effects, in major national and regional newspapers claim that it offers "a new way to prevent osteoporosis" while admitting that "its effect on fractures is not yet known." The ads also claim that "women taking Evista had no increased risks of breast and uterine cancers" in contrast to hormone replacement therapy, and that it reduces LDL or bad cholesterol blood levels. This should be welcome news to women worldwide, particularly as osteoporosis has now reached epidemic proportions, affecting fifteen to twenty million American women each year; osteoporosis causes over a million fractures including 250,000 hip fractures, and killing some 50,000 elderly women from complications of their fractures.

While warning of some possible side effects, such as blood clots or hot flashes, Lilly fails to warn of the more serious risks of ovarian cancer. A company-sponsored publication in the December 4, 1997 issue of The New England Journal of Medicine also ignores this risk. However, Lilly's pre-market clearance study clearly shows that Evista induces ovarian cancer in both mice and rats. Furthermore, carcinogenic effects were noted at dosages extending well below the recommended therapeutic level. However, the study concluded: "The clinical relevance of these tumor findings is not known." Lilly reached this conclusion despite the strong scientific consensus that the induction of cancer in well-designed tests in two rodent species creates the strong presumption of human risk. Nevertheless, Lilly fails to disclose this critical information in its ads and in its "Warning" to patients.

Responding to such criticisms by Dr. Samuel Epstein on the January 12, 1998 "Jim Lehrer News Hour" 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 as their ovaries are inactive, and that no warning is therefore necessary. However, apart from the fact that the rodent studies were specifically designed to evaluate Evista's safety, ovarian cancer is a scientifically documented complication of long-term estrogen replacement therapy in the post-menopausal. Also disturbing is the claim that Evista poses no risks of breast and uterine cancers as this is based on clinical trials over only some 40 months, a period totally inadequate to possibly manifest any such risks.

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 of all female reproductive cancers. Lilly's suppression of its own evidence of ovarian cancer risks from Evista is reckless and threatening to women's health and life. Equally reckless is FDA's December, 1997, marketing clearance, especially in the absence of any requirement for warning. Such conduct clearly merits urgent Congressional investigation. 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 fully informed consent. The doctrine of informed consent is ethically and legally protective only when all facts relevant to benefits and risks are affirmatively disclosed. This is clearly not the case with women who have been involved in the Evista trials. These women should be offered semi-annual lifelong surveillance for the early detection of ovarian cancer, at Eli Lilly's expense.

Samuel S. Epstein M.D., University of Illinois School of Public Health, Chairman, Cancer Prevention Coalition, Chicago, and co-author of The Breast Cancer Prevention Program, Macmillan, 1997.

Pat Cody, President, DES Action, Oakland, California.

Reprinted from the Chicago Tribune, April 19, 1998

Note from the editor: With so much conflicting information available, it can be difficult and frustrating to try and make the best decision about taking hormones. For personal decisions about your own health care, I encourage you to speak with your health care provider. Please do not send inquiries. For thoughtful and reasoned discussion about hormones, menopause, and alternative approaches to menopausal symptoms, we also recommend the newsletter A Friend Indeed. To request more information about A Friend Indeed, you can contact its publisher at afi@pangea.ca.

For more information contact the National Women’s Health Network at 202-347-1140.

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