An Assessment of the NIH Women's Health Initiative

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.

Table of Contents

• Front Matter
• Executive Summary
• Introduction
• Clinical Trial
• Observational Study
• Community Prevention Study
• Concluding Remarks
• References
• Appendix A: Clinical Trial Exclusion Criteria
• Appendix B: U.S. House of Representatives Appropriations COmmittee
• Appendix C: Statement of Task
• Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health
• Appendix E: Meeting Participants June, July, and August 1993
• Appendix F: Primary and Subsidiary Hypotheses of the Women's Health Initiative Clinical Trial
• Appendix G: Women's Health Initiative Committees
• Appendix H: NIH-Sponsored Women's Health Studies
• Appendix I: NIH Cost and FTE Summary for Vanguard Clinical Centers
• Appendix J: NIH Power Calculations
• Appendix K: Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators
• Appendix L: Abbreviations and Acronyms
• Appendix M: Committee and Staff Biographies
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