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INTRINSA FOR A WOMANSafety of IntrinsaA panel heard testimony that three of four women who developed breast cancer during the clinical trials were using Intrinsa. Lisa Soule, a medical officer in the FDA's division of reproductive and urological drugs, said those cases pointed to the limitations of short-term clinical trials. Soule dismissed as inadequate Procter & Gamble's suggested post-marketing study comparing 5,500 women expected to use Intrinsa in the first year against matching women from a database of 10 million patients for rates of cancer and cardiovascular disease. A federally funded research project, by contrast, had to enroll nearly 17,000 post-menopausal women to begin to detect the safety problems with hormonal therapy, Soule said. The Women's Health Initiative, a program established by the National Institutes of Health, found that post-menopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer. There is debate about how much hormonal therapy is to blame for some ailments. But there is general agreement that this treatment increases the risk of development of clots in blood vessels, said Dr. Charles Lockwood. "There is just no doubt. And no debate. And no discussion about that," said Lockwood, an expert in maternal fetal medicine at the Yale University School of Medicine and a member of the panel. "So, I think if there is one single element of safety that deserves the most scrutiny, it is the potential role of this patch" in promoting blood clots. |