Women's Health Initiative A Farcical Waste

The following article reprinted from The Health Gazette certainly won't get the exposure all of the reports giving space to the researchers involved will get, but if you are reading it now, at least that's one more person who may stop and think a little about the abuse of women that the Women's Health Initiative actually represents. Any way, here it is.

How disappointing. The grandiose Women's Health Initiative appears to be a complete misnomer. Well, to be fair, it is about women so complete may be a tad strong. It sure isn't about health though and it definitely lacked initiative, among other things.

The $628-million federally funded project involves more than 161,000 women -- 18% of them minorities, ages 50 to 79. It is widely billed as the largest, most comprehensive research study of women's health at midlife in the United States, which only goes to show that women's health is sadly neglected. The research program started in 1992. It aims to provide information about whether hormone, calcium and vitamin D supplements or a low-fat diet reduce the risk of heart disease, cancer and osteoporosis in U.S. women after menopause.

Unfortunately it was poorly informed, designed and managed and though at times it appears to have amounted to little more than a farce, it did usefully conclude what many have always said, that hormone replacement therapy did more harm than good and that estrogen alone did not provide enough health benefits. Both segments of the hormone therapy trial had to be stopped early, in 2002 and 2004, because of increased risk of stroke, blood clots and breast cancer.

The fuss in the press today is about the findings in the Journal of the American Medical Association (JAMA) reporting the outcome of the diet component of the "Initiative". This portion of the ongoing study included 48,835 women. The conclusions are that there is:

• No significant differences in heart disease and stroke between women following a low-fat diet compared to those who did not.
• A modest reduction in risk of breast cancer, but not high enough to be statistically significant.
• No significant difference in colon cancer. Those with the healthier diet did have fewer polyps and benign tumors, but there's no telling if that will mean less colon cancer over time.

So, in short, the conclusion is that a low-fat diet isn't enough to protect women aged 50 to 79 from heart disease, colon cancer or breast cancer. Unfortunately, whether any of these findings are correct or not is impossible to tell from this ill-conceived study.

As the article in JAMA rightly points out, there are weaknesses in the study. I would call them fatal flaws. For example, consider the following.

It's possible that not enough women were able to achieve the required 20 percent dietary fat goal. At year six, the low-fat group got 29 percent of calories from fat, indicating that a fundamental difference that was intended to exist between the experimental and control groups according to the design, simply didn't exist.

The study did not offer sufficient guidelines about so-called bad fats, such as saturated or trans fats found in processed foods. Targeting saturated and trans fats may have been expected to pay off more in fewer heart attacks.

Astonishingly, exercise was not part of the study yet it may make a difference when combined with a low-fat diet. I believe this raises doubts about the ethical standing of the study.

Perhaps the study simply started too late in life and the changes need to be implemented well prior to the menopausal years.

Perhaps it takes longer for a diet-alone change to make a difference. The women were followed for an average of eight years.

Many women preferred fruits to vegetables. Vegetables might provide better protection but such details were not considered.

The diet study is one of the three clinical trials that make up the Women's Health Initiative. Results of the third trial, studying the effects of calcium and vitamin D supplements on osteoporosis-related bone fractures and on colorectal cancer, will be published in the New England Journal of Medicine next week.

Interestingly, according to the National Health and Nutrition Examination Survey, in 1977, women consumed 45.5 percent of their calories from fat. This consumption of dietary fat fell to 35.9 percent in 1987 and to 33 percent in 2000. These figures are not exclusively for women aged 50 to 79 but they do represent a substantial reduction. However, deaths in women from heart disease, colon cancer and breast cancer have not declined.

To address these risks in both men and women a healthy lifestyle is required and that requires rather more than a half-hearted reduction in some fats in an otherwise uncontrolled, conventional diet. That researchers wasted so much funding and knowingly exposed so many women to uncontrolled risks when quality health education could instead have been provided is tragic. The Women's Health Initiative seems to have been an exercise in political grandstanding and academic career-building and in both cases the kudos is undeserved.