Jean Wactawski-Wende is assistant professor of social and preventive medicine, and gynecology and obstetrics. She is co-principal investigator of UB's Vanguard Clinical Center of the Women's Health Initiative, the largest clinical trial ever undertaken in the United States.

What is the Women's Health Initiative (WHI)?

The Women's Health Initiative is a 12-year study to investigate the major causes of disease and death in postmenopausal women. It includes both a randomized clinical trial (RCT) and an observational study. The RCT includes three studies:

- A trial of hormone replacement therapy (HRT) versus placebo that will determine if HRT reduces heart disease, osteoporotic fractures and colon cancer. It also will assess potential risks, including breast cancer and thrombic events.

- A trial of dietary fat reduction versus usual diet to see if reduction in fat will result in a reduction in heart disease, breast cancer and colon cancer.

- A trial of calcium and vitamin D (CaD) versus placebo to determine if CaD will reduce osteoporotic fractures and colon cancer.

The observational study records a variety of factors, intakes and activities in postmenopausal women and looks for associations with various health outcomes. A total of 160,000 women have joined the study nationally. Nearly 4,000 women joined the Buffalo clinical center.

How did UB become one of the 16 vanguard centers?

UB became a vanguard center in 1993 after writing an extensive application. We had the collaboration of scientists from across the medical school led by Maurizio Trevisan (PI) and myself (co-PI). The dean of the medical school and many members of the greater Western New York community also gave their support. Forty centers from across the country now participate.

What medical questions will WHI answer?

WHI will tell us the risks and benefits of hormone replacement therapy, dietary-fat reduction and CaD supplementation in postmenopausal women after an average of about nine years of use. The goal is to help women make more informed choices regarding these therapies as they reach menopause.

Why has the vast majority of medical research involved only male subjects? What happened to bring about this interest in women's health?

There are many reasons for involvement of primarily male subjects in medical research. Some researchers believed women would be unreliable subjects in research trials or would be difficult to recruit. Others were fearful of potential for pregnancy while on study medications. The important issue is that this is now changing and trials like WHI are now ongoing and will provide us with much needed information. WHI enrolled more than 160,000 women nationally. That demonstrates that women are certainly willing and able to take part in research studies! The interest in women's health issues has been brought on by women learning to be stronger advocates for their own health, demanding better information on which to base their decisions. Many of our participants have joined this study to provide much needed information for future generations of women to come, namely their daughters and granddaughters.

How will the research results obtained through WHI impact how medicine is practiced for women?

WHI results will allow women to make evidence-based decisions about their medical choices concerning HRT, CaD and diet. Decisions using reliable scientific evidence is how we should all base our medical decisions. Unfortunately, this information is not always available.

What have we learned so far?

Results of WHI will not be available until 2005. Some information on baseline characteristics of the WHI participants is being studied now and may be available before then.

Do you still need volunteers? If so, in what areas?

We already have enrolled all participants. It is important to say that the Buffalo clinic was the first in the nation to meet its recruitment goals and we also exceeded enrollment goals by 26 percent. Women throughout Western New York should be proud of that accomplishment.

What question do you wish I had asked, and how would you have answered it?

What other research studies have been started as a result of WHI? Several ancillary studies have been added to WHI since the start. We are conducting a study of the role of HRT in prevention of Alzheimer's disease. We also are looking at HRT's role in prevention or delay of macular degeneration. A third study we have started is looking at the role of osteoporosis in periodontal disease. WHI has allowed us to conduct a variety of other studies. As you can see our clinical center is extremely busy!