The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fractures--leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.

Contents

• COMMITTEE TO REVIEW THE NATIONAL INSTITUTES OF HEALTH WOMEN'S HEALTH INITIATIVE
• FOOD AND NUTRITION BOARD
• BOARD ON HEALTH SCIENCES POLICY
• Preface
• Executive Summary
• 1. Introduction
  • DESCRIPTION OF THE NIH WOMEN'S HEALTH INITIATIVE
  • HISTORY OF INSTITUTE OF MEDICINE INVOLVEMENT
  • COMMITTEE SELECTION AND PARTICIPATION
  • STATEMENT OF TASK
  • COMMITTEE ACTIVITIES
• 2. Clinical Trial
  • INTRODUCTION
  • RATIONALE
  • DESIGN AND METHODS
  • DIETARY MODIFICATION BRANCH
  • HORMONE REPLACEMENT THERAPY BRANCH
  • CALCIUM AND VITAMIN D SUPPLEMENT BRANCH
  • CLINICAL TRIAL COST
  • FINDINGS AND SUGGESTIONS
  • RECOMMENDATIONS
• 3. Observational Study
  • RATIONALE
  • DESIGN AND METHODS
  • COST
  • RECOMMENDATIONS
• 4. Community Prevention Study
  • INTRODUCTION
  • RATIONALE
  • DESIGN AND METHODS
  • COST
  • RECOMMENDATIONS
• 5. Concluding Remarks
  • RESPONSE TO THE STATEMENT OF TASK
  • SOCIETAL CONTEXT
• References
• Appendixes
  • A Clinical Trial Exclusion Criteria
  • B U.S. House of Representatives Appropriations Committee
  • C Statement of Task
  • D Documents Received by the Institute of Medicine from the National Institutes of Health
  • E Meeting Participants June, July, and August 1993
  • F Primary* and Subsidiary** Hypotheses of the Women's Health Initiative Clinical Trial
  • G Women's Health Initiative Committees
  • H NIH-Sponsored Women's Health Studies
  • I NIH Cost and FTE Summary for Vanguard Clinical Centers
  • J NIH Power Calculations
  • K Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators
  • L Abbreviations and Acronyms
  • M Committee and Staff Biographies

This study was supported by project no. NO1-WH-3-2114 from the National Institutes of Health.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is the president of the Institute of Medicine.