National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

An Assessment of the NIH Women's Health Initiative

Committee to Review the NIH Women's Health Initiative

Food and Nutrition Board

and

Board on Health Sciences Policy

INSTITUTE OF MEDICINE

Susan Thaul and Dana Hotra, Editors

NATIONAL ACADEMY PRESS
Washington, D.C.
1993

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

NATIONAL ACADEMY PRESS
2101 Constitution Avenue, N.W.Washington, DC 20418

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.

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

Library of Congress Catalog Card No. 93-86833

International Standard Book Number 0-309-04989-X

Additional copies of this report are available for sale from:

National Academy Press
2101 Constitution Avenue, NWBox 285Washington, DC20418
Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area).

B248

Copyright 1993 by the National Academy of Sciences . All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

COMMITTEE TO REVIEW THE NATIONAL INSTITUTES OF HEALTH WOMEN'S HEALTH INITIATIVE

MARION J. FINKEL (Chair),

Sandoz Pharmaceuticals Corporation, East Hanover, New Jersey

LUCILE L.

ADAMS-CAMPBELL,

Howard University Cancer Center

ABDELMONEM A. AFIFI,

University of California, Los Angeles

KELLY D. BROWNELL,

Yale University

GARY R. CUTTER,

Pythagoras, Inc., Birmingham, Alabama

JOHN W. FARQUHAR, *

Stanford University School of Medicine

M.R.C. GREENWOOD, *

University of California, Davis (Resigned July 7, 1993) Stanford University School of Medicine

PENNY M. KRIS-ETHERTON,

The Pennsylvania State University

JOANNE LYNN,

Dartmouth Medical School

LYNN ROSENBERG,

Slone Epidemiology Unit, Boston University School of Medicine

DIANE B. STOY,

The George Washington University Medical Center

Staff

SUSAN THAUL, Study Director

DANA HOTRA, Research Associate

FELICE LEPAR, Research Assistant

DONNA ALLEN, Project Assistant

*

Member, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

FOOD AND NUTRITION BOARD

M.R.C. GREENWOOD * (Chair),

University of California, Davis

EDWIN L. BIERMAN * (Vice Chair),

University of Washington School of Medicine

PERRY L. ADKISSON, *

Department of Entomology, Texas A&M University

LINDSAY H. ALLEN,

Nutritional Sciences, University of Connecticut

DENNIS M. BIER,

Pediatric Endocrinology and Metabolism, Washington University School of Medicine

HECTOR F. DELUCA,

Department of Biochemistry, University of Wisconsin, Madison

MICHAEL P. DOYLE,

Department of Food Science and Technology, University of Georgia

JOHANNA T. DWYER,

Frances Stern Nutrition Center, New England Medical Center Hospital, Boston

JOHN W. ERDMAN, JR.,

University of Illinois, Urbana

CUTBERTO GARZA,

Division of Nutritional Sciences, Cornell University

Department of Pediatrics, University of Colorado Medical Center, Denver

JANET C. KING,

Department of Nutritional Sciences, University of California, Berkeley

LAURENCE N. KOLONEL,

Cancer Center of Hawaii, University of Hawaii, Honolulu

SANFORD MILLER,

Graduate School of Biomedical Sciences, University of Texas, San Antonio

ALFRED SOMMER, *

School of Hygiene and Public Health, The Johns Hopkins University

VERNON R. YOUNG, *

Laboratory of Human Nutrition, Massachusetts Institute of Technology

STEVE L. TAYLOR (Ex Officio),

Department of Food Science and Technology, University of Nebraska

ARTHUR H. RUBENSTEIN * (IOM Council Liaison),

Department of Medicine, The University of Chicago

Staff

CATHERINE E. WOTEKI, Director

MARCIA LEWIS, Administrative Assistant

SUSAN WYATT, Financial Associate

*

Member, Institute of Medicine

†  

Member, National Academy of Sciences

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

BOARD ON HEALTH SCIENCES POLICY

J. CLAUDE BENNETT * (Chair),

Department of Medicine, The University of Alabama School of Medicine, Birmingham

DAVID R. CHALLONER, *

University of Florida

RAMZI S. COTRAN, *

Harvard Medical School, Department of Pathology

DEBORAH COTTON, *

Health Policy & Management, Harvard School of Public Health

EMILIO DADDARIO, * Attorney,

Washington, D.C.

WILLIAM N. HUBBARD, JR., * Retired President,

The Upjohn Company, Hickory Corners, Michigan

THOMAS INUI, *

Department of Ambulatory Care and Prevention, Harvard Medical School

RICHARD J. JOHNS, *

Department of Biomedical Engineering, The Johns Hopkins University School of Medicine

ERIC R. KANDEL, *

Center for Neurobiology & Behavior, Columbia College of Physicians and Surgeons

PATRICIA A. KING, *

Georgetown University Law Center

ELAINE L. LARSON,

School of Nursing, Georgetown University

JOSHUA LEDERBERG, *

The Rockefeller University

ROBERT I. LEVY, *

Wyeth-Ayerst Research, Philadelphia

MARY LAKE POLAN,

Department of Obstetrics and Gynecology, Stanford University

JOHN D. STOBO,

Department of Medicine and Physician-In-Chief, The Johns Hopkins Hospital

JOHN E. WENNBERG, *

The Center for the Evaluative Clinical Sciences, Dartmouth Medical School

JEAN DONALD WILSON,

Department of Internal Medicine, University of Texas, Southwestern Medical Center, Dallas

Staff

VALERIE P. SETLOW, Director

RUTH E. BULGER, Senior Program Officer

JOSEPH CASSELLS, Senior Program Officer

PHILOMINA MAMMEN, Administrative Assistant

*

Member, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
This page in the original is blank.
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

Preface

For many years women have not been included in large prospective trials examining the benefits and risks of therapeutic interventions in diseases with significant morbidity and mortality that are common to both men and women. Such exclusion was not due to a lack of concern for the health of women, but rather an assumption that results obtained in men could be extrapolated to women. Other reasons for excluding women from clinical trials included concerns about the difficulty of recruiting and retaining women as compared with men and the need to increase sample size and costs. Implicit in the argument for larger sample sizes, ironically, is the need for a separate analysis by gender, which undercuts the assumption that the results can be extrapolated from males to females.

More recent research with drug therapy has shown important pharmacokinetic differences between males and females, as well as differences in risks and, in some cases, benefits. Thus, it is appropriate to conduct large scale studies in women who have or acquire diseases that are common to both sexes. In addition, women are at great risk for diseases like osteoporosis and breast cancer, for which additional prevention strategies are sorely needed.

The National Institutes of Health (NIH) has invested considerable resources in the past few years to rectify the inequities in research involving women and much useful information is expected to accrue from these efforts. The Women's Health Initiative (WHI) goes beyond NIH's earlier efforts—it is an attempt to not only gather data from over 100,000 women, but also to influence a change in lifestyles toward a healthier future.

The committee constituted by the Institute of Medicine (IOM) to review the WHI protocol faced a challenging task of reviewing a study that already had awarded large multi-year contracts and that was to begin participant recruitment during the IOM committee's review period.

There is a tension evident throughout this report. Had this committee been asked to design a plan for women's health research, it would not have designed this WHI. Although some committee members would have preferred that the WHI be cancelled, others were more willing to take the gamble. The committee focused on what aspects of the WHI

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

it did and did not consider scientifically justifiable and feasible. As will be seen, the committee recommended that the ongoing WHI could proceed but should be modified.

The committee wishes to express its appreciation to the many people who made important contributions to this report by providing source materials or special written reports, sharing their views during meetings, commenting on drafts, or otherwise serving as resource persons. In particular, the committee wishes to thank Dr. Louise Brinton, National Cancer Institute; Dr. M.R.C. Greenwood, University of California at Davis; Dr. J. Christopher Gallagher, Creighton University Medical Center; Dr. David Hunter, Harvard University; Dr. William Insull, Lipid Research Clinic, Houston, TX; Gayle Mowbray, The Johns Hopkins University; Paul Phelps, a free-lance editor and writer; Dr. John Potter, University of Minnesota; and Dr. Christopher Sempos, National Center for Health Statistics.

Many people at NIH shared generously of their time to supply the committee with the documents necessary to perform this review. Susan Clark, Project Officer; Dr. Caroline Clifford, Chief, Diet and Cancer Branch, National Cancer Institute; Laurence Freedman, Acting Chief, Biometry Branch, NCI; Linda Gardner, Contracts Specialist; Dr. William Harlan, Co-Director, WHI; Dr. Carrie Hunter, Special Assistant to the Director, Office of Research on Women's Health; and Dr. Jacques Rossouw, Project Officer, WHI Clinical Trial and Observational Study went to special efforts to assist IOM staff.

The committee would also like to thank Dr. Ross Prentice, Principal Investigator of the WHI Clinical Coordinating Center, and the representatives from the Vanguard Clinical Centers, who were able to join the committee on extremely short notice for its July 1993 meeting and provided valuable information about details of the WHI.

The necessity for rapid review required herculean efforts on the part of the IOM staff, particularly the Study Director, Dr. Susan Thaul, to prepare background material and to formulate the issues for review. The committee itself had only three meetings, at monthly intervals, to debate the issues and to prepare draft statements on several topics. At these meetings, and also behind the scenes, Dr. Thaul and Dr. Catherine E. Woteki, the Director of the IOM's Food and Nutrition Board, provided skillful guidance and input.

The study report itself was thoroughly prepared by Dr. Thaul and Dana Hotra, Research Associate. They not only had to synthesize the discussions that took place at the meetings but also to interpret a multiplicity of comments and recommendations into a report with which all members could agree. In addition, they made major contributions to the report using their own expertise. The committee could not have accomplished its goals in the brief period allotted to it without their dedicated efforts.

The committee also wishes to thank Dr. Ruth Bulger, the past Director of the IOM Health Sciences Policy Division, who was instrumental in developing this project for the IOM; Claudia Carl, Administrative Associate in the IOM Reports and Information Office; Robert Earl, Program Officer; Michael Edington, Managing Editor, Reports and Information

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

Office; Geraldine Kennedo, Project Assistant; Felice LePar, Research Assistant; Marcia Lewis, Administrative Assistant; Dr. Valerie P. Setlow, Director of the Health Sciences Policy Division of the IOM; Susan M. Wyatt, IOM Financial Associate; and the staff of the Food and Nutrition Board for their support.

Finally, much appreciation is also due to Donna Allen, Project Assistant, who smoothed the way for the committee members and the rest of the IOM staff.

Marion J. Finkel, M.D.

Chair

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
This page in the original is blank.
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×

List of Figures

 1

 

Objective Prescheduled Reassessment (OPR) Time Frame,

 

17

 2-1

 

Outcomes for WHI Clinical Trial,

 

27

 2-2

 

Women's Health Initiative Clinical Trial Partial Factorial Design,

 

30

 2-3

 

NIH Organization for the WHI,

 

47

 2-4

 

Objective Prescheduled Reassessment Timeline,

 

76

Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
This page in the original is blank.
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R1
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R2
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R3
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R4
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R5
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R6
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R8
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R9
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R10
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R11
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R13
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R14
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R15
Suggested Citation:"Front Matter." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
×
Page R16
Next: Executive Summary »
An Assessment of the NIH Women's Health Initiative Get This Book
×
Buy Paperback | $45.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!