National Heart, Lung, and Blood
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
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.