Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts