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NOLVADEX BREAST CANCER PREVENTION TRIAL WILL BE SUBJECT OF HILL HEARING

Executive Summary

NOLVADEX BREAST CANCER PREVENTION TRIAL WILL BE SUBJECT OF HILL HEARING before the House Government Operations/Human Resources Subcommittee on Oct. 22. The hearing will question the use of the drug in high-risk, but otherwise healthy, women and examine "research evidence indicating that tamoxifen [ICI's Nolvadex] can cause uterine cancer, liver cancer, blood clots, birth defects, blindness and other serious diseases," the subcommittee said in an Oct. 15 release. The National Institutes of Health is providing a total of $68 mil. to fund the five-year placebo-controlled prevention study, with approximately $60 mil., coming from the National Cancer Institute. The study began enrolling patients in April 1992 at 270 sites in the U.S. and Canada. The study protocol calls for enrolling 16,000 women age 35 and up, with about half in the treatment arm receiving 20 mg of tamoxifen a day. Women ages 35 to 59 are eligible for enrollment in the trial only if their risk of developing breast cancer is determined to be at least the same as a 60-year-old woman. "Tamoxifen is considered a relatively safe and effective treatment for breast cancer, particularly for older women, but its safety or effectiveness for long-term use in the prevention of breast cancer has not been evaluated," the release states. "In addition to overall issues of safety and informed consent, the hearing will also examine whether the study, as currently designed, is capable of determining the safety and effectiveness of tamoxifen for pre-menopausal women and minority women." NIH Director Bernadine Healy, NCI Director Samuel Broder and several physicians involved in the study have been invited to testify. The hearing will be the first chaired by Rep. Payne (D- N.J.) who assumed the leadership of the panel following the death in September of Rep. Weiss (D-N.Y.). FDA's Oncologic Drugs Advisory Committee approved the protocol for the study with some reservations in July 1991. The committee recommended that the eligibility criteria of the study be modified "to ensure that the study population is at a high enough risk for the development of invasive breast cancer or cardiovascular disease to justify five or more years of therapy." NCI said it later submitted a revised protocol to the advisory committee that received unanimous approval. In correspondance with both FDA and NCI, the National Women's Health Network has opposed the concept of such a large, long-term trial that includes healthy and premenopausal women.

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