Pfizer wins HRT trial as new study knocks safety

The latest lawsuit over hormone replacement therapy went Pfizer's way, but a new study has not. Yesterday, an Arkansas jury found that Pfizer's Wyeth unit properly warned patients about the cancer risks of its Prempro drug, and so it isn't liable for one woman's breast cancer. Cue the statements of disappointment from plaintiff's lawyers and contentment from Pfizer.

Pfizer's happiness didn't last long, however. About an hour later, research based on Women's Health Initiative data made its debut -- and it showed that not only do women who use estrogen-progestin therapy--like Prempro--for menopause experience an increased risk of cancer, but an increased severity of disease as well.

Some 385 women using the hormones developed invasive breast cancer over the 11-year study, compared with 293 women in the placebo group. More of the women on HRT had advanced breast cancer when diagnosed. The proportion of breast cancer-related death was increased as well. Until now, research on the breast cancer link seemed to show that any disease spawned by HRT would be easier-to-treat, estrogen-fueled cancers, rather than more treatment-resistant forms.

Since early WHI research identified a link between the hormone therapy and breast cancer, use of Prempro has declined; the drug's label was updated to advise women to use the lowest dose for the shortest time possible to relieve their menopausal symptoms.

As the New York Times notes, doctors had figured that four or five years of use would be okay. "I don't think you can say that now," lead author Rowan Chlebowski, lead author of the JAMA study, told the Times. "I know some people have to take it because they can't function, but the message now is that you really should try to stop after a year or two."

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