Do it for your granddaughters: join a clinical trial

Historically, women have not been part of medical clinical trials. There were some valid reasons--generally, health care for women in the past was focused on child-bearing and reproduction; there weren't women in the medical profession; and the conditions that affect women weren't looked at as important. The Women's Health Initiative will change that as some 160,000 women are studied until 2005.

The statistics about women's health are startling. Heart disease is the number one killer of women, yet we still tend to think of it as a man's disease. Ninety percent of the deaths from heart disease in women occur after menopause; this is a significant health risk that deserves attention. Studies have shown that heart disease is more severe in women, and it goes undetected longer. Because of this delay, when a woman is diagnosed with heart disease, she typically has a more unfavorable outcome.

Additionally, studies show that one in eight women will develop breast cancer during her lifetime. I've seen the statistics change in recent years from one in 10 to one in nine and now to one in eight. As our family members and friends are confronted with this, we all realize that this is something that needs attention.

One in six women will have a hip fracture in her lifetime, and even though this isn't a major cause of death in women, it is a major cause of disability.

One reason women were not traditionally involved in clinical trials is the need to exclude pregnant women from trials or the possibility that a woman might become pregnant in the middle of a clinical trial and the test would have to be stopped. Another reason women weren't involved in clinical trials is the concern that a test of a drug or treatment might be affected by hormone variations, and it might make it more difficult to interpret the results of a study.

Based on those reasons, studies were done on men, and it was assumed that if it worked for men it would work for women. Most of the drugs and treatments that are in use now were tested with men, and it was just assumed that they were safe with women, worked the same way in women, and that the dosages worked the same.

Some of the research is showing that women may need different treatments than men, particularly with heart disease. Women are more likely to die after a heart attack than men, and if they do survive, their risk is greater of having a second heart attack than it is in men. Women who have coronary bypass surgery are more likely than men to die of complications from the surgery. The same with balloon angioplasty, which is another treatment used to unblock the arteries. Women are more likely to die during the hospital stay after the procedure than men are.

Some of the other studies, such as the one that showed that aspirin decreased the risk of heart attacks, were just done on men. So again we're making the assumption that it works just as well in women as it does in men.

At the Women's Health Initiative, a National Institutes of Health-funded trial, we are challenging these assumptions. It's important for women to take part in our clinical trial to answer these questions about women's health.

The Women's Health Initiative is the largest clinical trial that's ever been done in the United States, and is certainly the largest research effort including women. It is a nationwide study involving 40 centers across the country. The goal is to enroll 160,000 women--post-menopausal women between 50-79. The trial at Emory has a goal to recruit about 4,000 women. Recruitment is well under way; nationwide there are about 75,000 women enrolled, and here in Atlanta we've already got more than 2,000.

We all need to recognize the importance of this project and encourage women we know to participate. The big step is getting women to be a part of research. Women need to recognize where we are and what we need to do and come forward and be part of research. That's difficult, because women in general don't have role models. They don't know anyone that's been part of research, and they don't know about what's involved. I tell women they're not doing it for themselves, but for their daughters and granddaughters.

Specifically, this study involves a clinical trial and an observational study. There are three parts to the clinical trial:

*A dietary study looking at whether a diet low in fat, and high in fruits, grains and vegetables can reduce the risk of breast and colorectal cancer and heart diesease;

*The hormone replacement study looking at whether hormone replacement can reduce the risk of heart disease and osteoporosis and what are the risks associated with hormone replacement; and

*The calcium and vitamin-D supplementation study looking at whether taking the supplement reduces the risk of osteoporosis and colorectal cancer.

The observational study will look at the relationship between health habits, lifestyle and risk factors of women during the study.

If you know of anyone interested in being a part of the Women's Health Initiative, tell them to give us a call.

Margaret Huber is the clinic manager of the Women's Health Initiative. This article is taken from a lecture she gave to the Emory Woman's Club on Sept. 24. For more information, call 770-473-8600.

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