(BlackDoctor.org) — In 1996, the National Institutes of Health (NIH) established the Women’s Health Initiative (WHI), a 15–year study to address the most common causes of death, disability, and impaired quality of life in postmenopausal women: cardiovascular disease, cancer, and osteoporosis. The WHI was a multi-million-dollar endeavor, and one of the largest U.S. prevention studies of its kind. More than 160,000 generally healthy postmenopausal women, aged 50 to 79, participated in one or more of several studies: an observational study to identify predictors of disease, a randomized controlled clinical trial of promising but unproven approaches to prevention, and a study of community approaches to developing healthful behavior.
Gene Gary–Williams, PhD, and a former Dean of Allied Health Sciences at Howard University, was recruited by one of her colleagues, who said, “I think you ought to be a part of this study.”
“I was 60 years old when I started,” recalls Gary-Williams, “and I was in the study seven years. I went through to the end, even though along the way I was out of the Washington area. “I just felt good about doing something I felt was important.”
She couldn’t understand friends who decided not to participate because they didn’t have time, or “don’t like to do things like that,” or “found it inconvenient.”
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“I think a lot of times people are suspicious and they don’t even know it,” said Gary-Williams. “It’s not something we deal with easily as people. But it is my strong belief that as we grow older we need to leave something. African-American people in general have not been involved in many of the medical studies. For a long time, we weren’t invited and then, when the opportunity presented itself, we were too suspicious. I’m a health care professional, and I do understand the importance of this study — for my daughter, for any grandchildren I have, and for all of the other women of color who come after me. As women of color, we need to participate so that we can provide information researchers would not be able to get otherwise.”
The clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer. There were two hormone trials. Women with a uterus were given progestin in combination with estrogen, a practice known to prevent endometrial cancer. Women without a uterus were given estrogen alone. In both hormone therapy studies, women were randomly assigned to either the hormone medication being studied or to a placebo. Neither the women nor the doctors knew to which group each woman was assigned.
“When I signed up,” said Gary–Williams, “they told me the options I had: the nutrition study, the Vitamin D-calcium study and the hormone study. So I got involved in the hormone study. I’d never taken hormones. In the beginning they did blood tests, pelvic exams, breast exams, the whole kit and caboodle. Later, every time I came in they did blood work and breast exams, height and weight and all of those parameters that they want to keep up with, but the pelvic exam was not every time. A lot of it was self-reporting, answering questionnaires, which took you from the last time you were in until this time. They would ask all kinds of things: Have you been in the hospital? Did you suffer a broken bone? Did you have a fainting incident? You had to fill out the forms, and that’s no problem.”
Another purpose of the trial was to study the side effects of the hormones.
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“It didn’t happen in a large number of women, but I developed incontinence,” said Gary-Williams, “and for the longest time I did not know that that was associated with the hormones, until I came to the conference last year and someone reported on it.” Medication corrected the problem and she assumes she might have had the problem whether or not she participated in the study. In any case, she says, “I consider that small stuff for the kind of findings that came out of the study.”
