Eli Lilly and Company Responds
To Articles About Evista Drug
The following was submitted in response to two articles published in the Healthcare section:
I am writing in response to an editorial posted on inmotionmagazine.com that first appeared in the April 19, 1998 issue of the Chicago Tribune by Dr. Samuel Epstein and Pat Cody, in which they questioned the safety and efficacy of a new osteoporosis drug, raloxifene (trade-name Evista).
Attached for your readers' reference are two letters that support the drug's safety: one authored by two independent researchers and the other by Eli Lilly and Company, the drug's manufacturer. I feel that it is in your readers' best interest to be presented with this critical information, as these facts were not included in the Epstein and Cody editorial.
Eli Lilly and Company
Recently there have been some media reports questioning the safety of Evista (raloxifene hydrochloride), Lilly's new drug for the prevention of postmenopausal osteoporosis. These reports suggest that Eli Lilly and Company, with the FDA's "complicity," may have suppressed critical information about the drug and its purported risk for ovarian cancer. The allegations raised in these reports are without merit and are in conflict with the totality of safety data accumulated on Evista.
In light of these accusations, it is important for you to understand the facts.
These recent allegations are based on unsubstantiated claims and an uninformed interpretation of findings in rodents (rats and mice). The findings in rodents do not translate into human health concerns for several important scientific reasons. First, rodents do not go through menopause. It is also well-established that mice are especially susceptible to development of ovarian tumors. Because the animals were treated with Evista throughout their entire reproductive lives, hormonal changes occurred that are known to cause ovarian tumors in rodents. In contrast, Evista does not produce similar hormonal changes in postmenopausal women. Additionally, other marketed products, including one which has been on the market for more than 15 years, have produced similar effects in rodents, but have not been found to cause an increased risk of ovarian cancer in women.
The United States Food and Drug Administration (FDA), an independent FDA advisory committee of experts in the field, and Lilly Research Laboratories all rigorously reviewed the animal and human data for Evista prior to the product's approval and came to the same conclusion: Evista is safe and effective for the prevention of osteoporosis in postmenopausal women. Lilly supports the integrity of the FDA's review and approval process.
The clinical program to evaluate the safety and efficacy of Evista is the single largest program in Lilly's history, involving more than 12,800 women in 28 countries worldwide. Clinical trials (up to 39 months in duration) with Evista in postmenopausal women have produced no evidence of ovarian abnormalities or increased ovarian cancer incidence. Postmenopausal women taking Evista were no more likely to develop breast, uterine, or ovarian cancer than women taking a placebo.
We can make available to you background information about Evista, and provide referrals to expert scientists and physicians who can offer more information about this issue. If you would like a copy of the full package insert for Evista, please call or visit our website at http://www.evista.com. I can be reached at (317) 276-3570.
Director, marketing communications
(Orignially written - February 12, 1998)
In response to a recent article by Dr. Samuel Epstein and Pat Cody that appeared in the "Their Say" section (April 19), we would like to affirm our belief in the efficacy and safety of raloxifene (trade name Evista), Lilly's new drug for the prevention of postmenopausal osteoporosis.
Epstein and Cody claim that Lilly acted "recklessly" by not providing certain medical information to women on raloxifene. The United States Food and Drug Administration (FDA), an independent FDA advisory committee of experts in the field (in a public meeting) and Lilly Research Laboratories all rigorously reviewed the animal and human data for raloxifene prior to the product's approval. They all found that raloxifene is safe for postmenopausal women and not associated with ovarian cancer. In fact, studies are now planned to explore whether raloxifene may even prevent breast cancer. Dr. Epstein and Cody's statements are what are truly "reckless," causing unwarranted fear and anxiety among women who might otherwise benefit from this important new therapy.
In clinical studies of nearly 13,000 women, raloxifene was shown to help preserve a woman's bones and prevent osteoporosis. Raloxifene also has demonstrated a positive effect on cholesterol levels and is safe in the breast and uterus. Studies are ongoing to explore raloxifene's potential in preventing heart disease and breast cancer.
Today, women are living a full one-third of their lives past menopause. It is important for these women to have new options to protect their postmenopausal health. Keeping a true scientific advancement like raloxifene from potential patients through unfounded scare tactics does a disservice to all women.
Ethel Siris, MD
Madeline C. Stabile Professor of Clinical Medicine
Toni Stabile Center for Prevention and Treatment of Osteoporosis,
Columbia Presbyterian Medical Center
Murray Favus, MD
Center for Prevention and Treatment of Osteoporosis,
Professor of Medicine,
The University of Chicago;
Director, Bone Program
Director, General Clinical Research Center,
University of Chicago Medical Center
(Originally written May 5, 1998, to: Editor, Voice of the People, Chicago Tribune, 435 North Michigan, Chicago, IL 60611)