Claude Lenfant, M.D.
Director
National Heart, Lung, and Blood Institute

July 9, 2002

Press Conference Remarks

Release of the Results of the Estrogen Plus Progestin Trial of the Women's Health Initiative

Good morning. Today we will present the findings of the estrogen plus progestin component of the Women's Health Initiative or WHI. This clinical trial was designed to examine the effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and to identify any associated risk for breast and colon cancer. It has been stopped early due to an increased risk of invasive breast cancer, and evidence that overall health risks exceed any benefits.

The details of these results are of tremendous importance and will certainly influence medical practice for years to come. They will surely be of interest to the estimated 50 million postmenopausal women in the United States. About 6 million of these women take estrogen plus progestin for a variety of reasons.

One of the burning questions of the estrogen plus progestin trial has been whether this hormone combination prevents heart disease--the number one killer of American women. Today we will answer not only the heart disease question but we will also address study findings about cancer and other risks as well as the benefits of hormones.

Since its creation in 1991, the WHI has been recognized as one of the most important--and certainly one of the largest--prevention studies ever conducted in the United States. WHI has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporosis in menopausal women. Clinical trials conducted under the umbrella of WHI also include a study of a low-fat eating pattern and a study of calcium/Vitamin D supplementation.

Before I introduce today's speakers, I would like to acknowledge several NIH institutes and offices and their directors. These components of NIH and their directors have collaborated with and provided valuable input to the NHLBI since the WHI began. They are: the National Cancer Institute, led by Dr. Andrew C. Von Eschenbach, and represented here today by Dr. Leslie Ford; the National Institute of Arthritis and Musculoskeletal and Skin Diseases, led by Dr. Stephen Katz; the National Institute on Aging, led by Dr. Richard Hodes; and the Office of Research on Women's Health; led by Dr. Vivian Pinn. In addition, NIH Director Dr. Elias Zerhouni has provided invaluable leadership and counsel after the stopping of the trial.

I would like to thank the principal investigators and staff of the WHI for their dedication to the research. Dr. Rebecca Jackson, one of the WHI principal investigators and also the vice-chair of the Steering Committee, is here with us today. She is an expert in osteoporosis and will be available to answer questions after the press conference. Dr. Margery Gass, the WHI principal investigator at the University of Cincinnati, is also here and will be available for interviews following the press conference. Dr. Gass is a professor of obstetrics and gynecology and is president-elect of the North American Menopause Society. Also here is Dr. Susan Hendrix, a professor of obstetrics and gynecology and the WHI principal investigator at Wayne State University in Detroit.

Ultimately, the most thanks must go to the women who participated in WHI, whose time and effort in this landmark study have made it possible to answer one of many important health questions for menopausal women in the U.S.

Finally, I would like to thank and acknowledge Dr. Phil B. Fontanarosa, executive deputy editor of the Journal of the American Medical Association (JAMA). Dr. Fontanarosa expedited scientific review of the WHI paper so it could be available in the online JAMA Express and in next week's print version. His dedication to public health and to improving medical practice is to be praised.

I would also like to thank and to introduce our first speaker Dr. Marcia Stefanick, chair of the WHI Steering Committee and Associate Professor of Medicine at Stanford University. Dr. Stefanick's dedication and her leadership of the WHI have been of the utmost importance. She will discuss the rationale for the WHI and the design of the estrogen plus progestin trial. Our second speaker will be Dr. Garnet Anderson of the Fred Hutchinson Cancer Research Center. Dr. Anderson led the data analysis and she will discuss why the trial was stopped and the important monitoring that was conducted. Our last speaker will be Dr. Jacques Rossouw, acting director of the WHI, who will provide an interpretation of the results and their significance for menopausal women and medical practice. Following Dr. Rossouw's presentation, we will be happy to take your questions.

Dr. Stefanick.