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Tamoxifen Controversy-Negative Effects

The Project apologizes: we lost the reference for where this story was obtained.

Tamoxifen Controversy Continues

Here's the latest on tamoxifen. When healthy women take this drug to prevent breast cancer, the side-effects can outweigh any potential benefits, according to a new Canadian study.

Dr. Phyllis Will and her colleagues in Ottawa will be reporting in the British Journal of Cancer that healthy women on tamoxifen face a four-fold risk of developing endometrial cancer (tumor of the womb lining) and a two-fold risk of developing deep vein thrombosis.

These conclusions are likely to dampen some enthusiasm for using tamoxifen as a preventative medicine. This hopefully will remind the medical profession that long-term assessment of a powerful drug is required before product champions line up to announce that the drug is "remarkable" or "stunning."

This was the sorry spectacle when the American clinical trial involving 13,000 healthy women was stopped early because women on the drug had fewer cases of breast cancer than women not taking the drug. The media reports made it seem as though tamoxifen was a miracle drug for healthy women who were at higher risk for breast cancer.

The fact is, the breast cancer risk reduction in these higher-risk healthy women was slight - only about 1 per cent. Less than two women in 100 developed the disease. Less than three women in 100 on the placebo developed breast cancer. Count it yourself. Three in 100 minus two in 100 equals one in one hundred. That's one percent less for those on the drug. This tiny drop was shamelessly touted as a 45 per cent risk reduction. But medical researchers who want to make it look as though there is a spectacular risk reduction do this phony math all the time. And, of course, this is what the patient gets from the GP, who often doesn't know any better.

When I first looked at the available science on tamoxifen and healthy women, I wrote in my ABCNEWS.com column about how "Tamoxifen may bring slight benefit to some women, but it also increases the chances that healthy women will develop endometrial cancer, blood clots in the lungs or cataracts." There were already hints that negative effects of the drug could prove troublesome. Now with more study we are getting an indication of how high the risk of developing disease might be. More studies will now almost certainly be conducted as tamoxifen becomes a bigger battleground for competing views. Assume that some careers are on the line regarding this issue. And assume there will be controversy about which healthy women should still take the drug.

Tamoxifen works by interfering with the hormone, estrogen, which promotes the growth of breast cancer cells. The drug is deemed effective in women who already have breast cancer.

11/5/01 British J of Cancer

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