If you missed my article on vitamin D please be sure and read it to understand how you can maximize sunlight and vitamin D to prevent osteoporosis.

However, vitamin K is another big part of the osteoporosis prevention story, and I plan on posting a story on that soon. You can get a glimpse of the story by reading my letter on vitamin K that was published in the British Medical Journal.

However, I find the drug-company push with Evista a familiar story: get the drug approved for one indication and then add other indications for its use based on flimsy evidence.

Even the investigators caution that the study was designed to study Evista's effects on the brittle-bone disease osteoporosis, not cardiovascular health.

To add insult to injury the authors of this study received financial support from Eli Lilly & Co., the maker of Evista. Several of the researchers are employees of the drug company and own its stock.

But what makes this study even worse is that it takes away from the central issue, which is, are these drugs even indicated for osteoporosis in the first place?

There is a confusion with Evista. Most people think of it as an estrogen substitute. It is not meant to be an estrogen substitute, and it's not being marketed as such.

It is being marketed as an alternative to women who cannot take estrogen, who would like to prevent osteoporosis.

The drug's manufacturer, 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 a Lilly-sponsored publication on Evista in the December 4, 1997 issue of the New England Journal of Medicine.

Ovarian cancer is recognized as an uncommon complication of long-term hormone replacement therapy 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."

Samuel S. Epstein, M.D.

Professor of Environmental Medicine at

University of Illinois School of Public Health, Chicago
Chairman of the Cancer Prevention Coalition

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