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Last Updated: Jun 30, 2008 - 11:14:37 AM |
Pharmaceutical companies hire some big publicity agencies, but there is no bigger publicity agent than the National Institutes of Health (NIH), which decided to preempt the planned summer release date for its study of two breast cancer drugs with a press release that extols the virtues of Raloxifene. Forgotten is the evidence that high-dose vitamin D can reduce the overall risk for breast cancer by about 50%. The NIH makes no mention of that. Rather, what the NIH study says is that Tamoxifen reduces the risk for invasive breast cancer by about 50% (in hard numbers, it's a reduction of only about 1.2%) and that Raloxifene results in about the same reduction, with fewer side effects. According to the NIH press release, Raloxifene reduces the risk for blood clots in the legs (deep vein thrombosis) by about 29%, and the risk for uterine cancer by 36%.
Now before women go running to their doctors to ask about Raloxifene, this data needs translation. If you were taking Tamoxifen and you switched to Raloxifene, an additional 13 out of 4700 women would avoid uterine cancer, or 2/10th of one percent, or 500 women would have to take Raloxifene for one additional woman to avoid uterine cancer. An additional 22 women out of 9700 would avoid blood clots, or about 1 in 442 women taking the drug. A breakthrough worthy of worldwide headlines? Hardly.
But the NIH had to drum up business for the drug companies. The National Cancer Institute's Dr. Worta McCaskill Stevens says, "Not as many women have been participating because of the side effects of the drug. So now women have a choice."
"With tamoxifen, it put women in a very difficult situation of balancing really scary problems," said Dr. Hope Rugo, director of breast oncology clinical trials at UC San Francisco. "Now you can take raloxifene. It may be that your risk of blood clots and uterine cancer is a little higher than if you didn't take anything at all, but it's markedly less than if you took tamoxifen. You want to get a drug that is good and has less serious side effects, and we've definitely got that now."
Wait, did Dr. Rugo say the risk for side effects was still higher, just not as high as Tamoxifen? Yep, that's what he said. The risk is elevated, but not as elevated as taking Tamoxifen. The risk reduction is miniscule. By sleight of hand with numbers, it makes it sound like Raloxifene is far safer. In fact, it's a very slight drop in side effects.
Since 1998 it has been known that Raloxifene (Evista) reduces the incidence of breast cancer by a reported 76%. But even that figure is specious. The Canada Drug Guide Project explains Raloxifene this way:
It is claimed that Raloxifene (Evista) reduces incidence of breast cancer by 76% with only a 1% risk of side effects. What it didn't make clear is the fact that the patients who took the drug in the study went from having a 1% absolute risk of having breast cancer down to a 0.24% absolute risk of having breast cancer over three years (hence, the '76%' reduction). If measured in relative terms, many of the side effects increased much more than 76%--in fact some risks, such as those for blood clots, increased, relatively speaking, by 300%. (See reference below*)
-Copyright 2006 Bill Sardi, Knowledge of Health, Inc.
reference
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