A Look Inside the WHI: An Interview with Dr. Vivian Pinn
To mark the 10th anniversary of the release of the Women's Health Initiative, MSNBC interviewed Dr. Vivian Pinn, the former Director of the Office of Research on Women's Health at the NIH. During this interview, Dr. Vinn described the Women's Health Initiative and how it changed the way medical science thinks about women's health:
"This was the first major opportunity to look at the health of women in the post-menopausal years and to determine, through a long-term randomized clinical trial, the validity of commonly used treatments to prevent the most common conditions that lead to mortality and morbidity of post-menopausal women.
One of the things we were told when the study was being designed was that it was difficult, if not impossible, to get women, especially ‘older’ women, to participate in clinical trials and research and that we would never be able to recruit that many women of post-menopausal age. [The study] really came at the beginning of current efforts to include large numbers of women in prevention studies, and the success of the recruitment helped to demonstrate that women are willing and even eager to be a part of research that may have its greatest benefits for generations to come. There had been relatively little research actually done on menopause and the post-menopausal years, especially long term studies on the menopausal transition.
Everyone had just assumed that using hormone therapy in post-menopausal women was important and valid. That was mainly because cardiovascular disease increases in post-menopausal women, and knowing that changes in blood vessels of women became more prominent after menopause when there was a decrease in estrogen levels, it seemed logical that giving estrogen to restore levels to those of the premenopausal state would then protect women from cardiovascular disease.
This study was actually designed to help us learn more about the traditional and commonly used methods to prevent the major causes of death and disability and frailty in older women, such as heart disease and stroke, cancer and fractures associated with osteoporosis, so we would know if what we as physicians were doing was scientifically appropriate. Even though women said they wanted hormone therapy for hot flashes, most physicians justified the use of hormone replacement therapy long-term on the basis of wanting to protect women from cardiovascular disease and osteoporosis.
Menopausal hormone therapy had been used for many years, but the WHI was the first long term randomized study of the risks and benefits of doing so. To have a long-term, randomized clinical trial – considered to be the “gold standard” of research -- that then showed the major basis of the practice we had been using was not valid was one of the most important and significant findings from the Women’s Health Initiative."