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Biotech / Medical : Eli Lilly -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (176)	4/22/1998 8:45:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 641

Gov't Considers Breast Cancer Drugs APRIL. 21, 18:00 EST By LAURAN NEERGAARD AP Medical Writer WASHINGTON (AP) -- Amid optimistic reports that two drugs might help prevent breast cancer, the government is struggling to help women decide who should start using the pills -- or if the side effects are too risky. For one of the drugs, the government had a stark message Tuesday: Despite headlines trumpeting raloxifene, Eli Lilly's new osteoporosis drug, there is no good evidence yet that the medicine truly wards off breast cancer. But a National Cancer Institute study did find that a related medicine called tamoxifen cuts the chances of breast cancer by a significant 45 percent in certain women -- and the NCI said Tuesday it is preparing kits to help doctors target just those women whose potential benefit from the pills would outweigh the side effects. ''The message very much is, each woman is different,'' said Dr. Richard Klausner, NCI's director. ''There is no cut-and-dried formula'' to say which woman needs the drug. A 35-year-old woman whose mother and aunt both had breast cancer and who has undergone biopsies herself for early signs of the disease is a good tamoxifen candidate, said Dr. Norman Wolmark, the Pennsylvania doctor who led the tamoxifen study. But tamoxifen can cause potentially life-threatening side effects, including uterine cancer and blood clots, and women over 50 were particularly vulnerable, noted Cynthia Pearson of the National Women's Health Network. For every 1,000 women over 50 who still had a uterus, tamoxifen prevented 20 breast cancers but caused 22 life-threatening complications, she said, concluding that taking tamoxifen may not be a good choice for such women unless they have had a hysterectomy. The decision isn't based just on breast cancer risk -- among other things, doctors must know if a woman has high blood pressure and already is at increased risk of a blood clot. And Klausner acknowledged that doctors still don't know how long women should take tamoxifen -- there are other studies that suggest taking it for longer than five years makes tumors that crop up later harder to treat. Nor do they know if tamoxifen is delaying breast cancer's appearance instead of totally preventing it. ''It is a step forward,'' stressed Klausner, who has been traveling the country to explain the findings to doctors confused about prescribing tamoxifen. But ''many questions remain.'' Federal researchers announced on April 6 that tamoxifen, which has been used for more than two decades to fight cancer, also is the first drug shown to prevent breast cancer in some women. They cautioned at the time that it was only for women at high risk -- but just which women that means has been a source of confusion for doctors and their patients. So the NCI is making available to physicians, over the Internet and to doctors who call its cancer information offices, information to help them evaluate a woman's health record and decide whether she's a good tamoxifen candidate. But the news also raised hopes that related drugs could fight cancer without tamoxifen's side effects. Next month, scientists at a major cancer meeting in Los Angeles will present studies suggesting that raloxifene can cut breast cancer risk by 58 percent to 74 percent. The researchers are not providing details before the meeting, so it is unclear if raloxifene is any safer. But the studies have a big problem: They did not pick women at high risk for breast cancer, and they were not designed to identify breast cancer. Instead, they were secondary findings in a study of osteoporosis patients. That means the studies were designed in such a way that random chance could have caused the cancer findings. The NCI is preparing to study raloxifene vs. tamoxifen, to see if the osteoporosis drug really does prevent breast cancer and if so, if it's less risky. The study should be under way by fall. ''Women should wait'' until doctors have better answers, said Fran Visco of the National Breast Cancer Coalition. ''Neither drug is a drug that's for every woman.''