Risks of Ovarian Cancer from the Commonly Prescribed Drug Evista Supported by Recent Evidence, Warns the Cancer Prevention Coalition

(Chicago, IL - October 24, 2002) - The Cancer Prevention Coalition today warned that women taking the osteoporosis drug Evista (raloxifene), marketed since 1997 by Eli Lilly, are at increased risk of ovarian cancer.

"There is ample scientific evidence that Evista poses risks of ovarian cancer. We also know that the National Cancer Institute (NCI) has ignored these risks," said Samuel S. Epstein, M.D., Chairman of the Cancer Prevention Coalition.

Whether the large-scale treatment of women with Evista since 1997 has resulted in an increased incidence of ovarian cancer cannot yet be determined, as the latest NCI cancer incidence data are now two years old. These reveal an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to be treated with Evista, from 1997 to 1999.

"This delay in reporting cancer incidence is unacceptable. This is all the more so in view of NCI's admission, in the 10/16/02 issue of the Journal of the NCI, of additional reporting delays, besides underestimating the increasing incidence of cancer," noted Dr. Epstein.

Lilly's own study specifically designed to prove the drug's safety found that the drug was shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice. The study admitted, "The clinical relevance of these tumor findings is not known."

However, this conclusion violates the strong 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 the: "Warning" section of the Physician's Desk Reference; a 12/4/97 publication in the New England Journal of Medicine; full page advertisements in major national newspapers; and the drug's label. Even more critical is NCI's continuing silence on this avoidable risk of ovarian cancer despite its annual multibillion-dollar taxpayers' funding.

A study by University of Southern California researchers, presented at the European Society of Human Reproduction and Embryology July 2001 annual meeting, has provided further evidence of Evista's cancer risk. It showed that Evista increases the growth rate of ovarian cancer cells in laboratory studies, and may increase risks of recurrence of ovarian cancer.
These warnings were first raised by Dr. Epstein in a 1/12/98 Jim Lehrer Newshour program and a subsequent 2/4/98 (PR Newswire) press release. That release prompted two women to contact the Coalition saying that they had been diagnosed with ovarian cancer following Evista treatment. The first was a 68-year old Delray Beach, Florida woman, following two years treatment to prevent worsening of her osteoporosis. The second was a 53-year old Chicago woman, treated with Evista for over three years to prevent osteoporosis, and recurrence of her previously treated breast cancer. She was contacted by Lilly about a year ago to obtain information for filing an Adverse Drug Reaction with the FDA. Both women were prescribed the drug in the absence of informed consent with regard to risks of ovarian cancer.

Ovarian cancer strikes about 23,000 women annually, accounting for 4 percent for all of their cancers. About 14,000 women die from ovarian cancer annually, making it the most lethal reproductive cancer.

Commenting on these facts, Dr. Epstein charges that Lilly's suppression of evidence of ovarian cancer risks from Evista is as reckless as FDA's marketing approval.

"The FDA should promptly require "Black Box" warnings on Evista labels to warn physicians and patients of the drug's risks. Additionally, women who have been prescribed the drug (or who have participated in clinical trials) should be offered lifelong surveillance for the early detection of ovarian cancer at Lilly's expense," Dr. Epstein said. "Even more reckless is the continued failure of the cancer establishment, the federal National Cancer Institute and the "charitable" American Cancer Society to warn women of Evista's undisclosed and avoidable risk of ovarian cancer, besides a wide range of other cancers," he added.

Finally, the Cancer Prevention Coalition urges Gilda's Club, The Prevention First Coalition, and other women's reproductive health groups to join the Cancer Prevention Coalition in disseminating information on risks of ovarian cancer from Evista treatment.
Samuel S. Epstein, MD
www.preventcancer.com