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Evista: A Prevention Drug That Has A Fatal Risk

CPC CHICAGO, IL, December 6, 2010 --/WORLD-WIRE/-- Eli Lilly's full page advertisement in the October 18 New York Times offered post-menopausal women a free trial month voucher for the prescription drug Evista, with the trade name Raloxifene. This has been widely promoted and marketed since 1997 for preventing and treating osteoporosis, affecting over 20 million women annually.

The ad warns that the side effects of Evista may include "hot flashes and joint pain, blood clots in the legs and lungs, and dying from stroke." What the ad particularly fails to warn is Evista's risk of ovarian cancer, which strikes about 24,000 women each year, accounting for 4 percent of all their cancers, according to the Cancer Prevention Coalition.

Based on the latest National Cancer Institute data, ovarian cancer death rates have increased dramatically in white and African American women over the age of 65 by 15 percent and 36 percent, respectively. There are now about 15,300 deaths from ovarian cancer each year, making it the most lethal cancer in women after colon, breast and lung.

On December 10, 1997, pharmaceutical company Eli Lilly announced the FDA's clearance to market Evista. This had been claimed to be effective in preventing osteoporosis, affecting over 20 million U.S. women annually, and in reducing LDL or "bad cholesterol" blood levels. Lilly also submitted applications to market Evista in more than 30 different nations.

"Surely, this new drug should have been welcomed by women worldwide. Fortunately, this was not the case," says Cancer Prevention Coalition Chairman Samuel S. Epstein, M.D.

"With FDA's complicity, Lilly has attempted to suppress explicit evidence that Evista poses major risks of ovarian cancer on the alleged grounds that the 'clinical relevance of these tumor findings is unknown,'" asserts Dr. Epstein.

In Lilly's November 21, 1997 Pharmacology Review, designed to prove the drug's safety, Evista was reported to induce ovarian cancer in both mice and rats, Dr. Epstein points out.

"Moreover," he explains, "the carcinogenic effects in mice were noted at dosages extending down to one-third less than the recommended standard treatment dose."

"This critical information never made it to the drug label warning," Dr. Epstein warns.

Furthermore, he says, the pharmaceutical company's own data revealed an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to have been treated with Evista, from 1997 to 1999.

"Responding to my criticisms of Lilly on a January 12, 1998 Jim Lehrer Newshour program debate, a company representative claimed that carcinogenic effects of Evista in the ovaries of rodents are irrelevant to any such risks in postmenopausal women," Dr. Epstein says. "However, these claims were critically discounted by Jim Lehrer."

Of further and related concern, Dr. Epstein points to a July 2001 study by Dr. David Taurgeman, of the University of Southern California School of Medicine. He reported that Evista, alone or in combination with estrogen, increased the growth rate of ovarian cancer cells, and could increase the risks of recurrence of ovarian cancer.

Dr. Epstein warns, "The October 18, 2010 New York Times advertisement shows reckless disregard for women's health and lives."

Samuel S. Epstein, M.D. is professor emeritus of Environmental and Occupational Medicine at the University of Illinois at Chicago School of Public Health; Chairman of the Cancer Prevention Coalition; Recipient of the 1998 Right Livelihood Award ("Alternative Nobel Prize") and the 2005 Albert Schweitzer Golden Grand Medal for International Contributions to Cancer Prevention; Author of over 270 scientific articles and 20 books on the causes and prevention of cancer, including the award-winning The Politics of Cancer (Sierra Club Books, 1978) and Cancer-Gate: How To Win The Losing Cancer War (Baywood Publishing, 2005).

Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
Professor emeritus Environmental & Occupational Medicine
University of Illinois at Chicago School of Public Health
Chicago, Illinois
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