Tuesday, December 2, 2008

Health

USN Current Issue

Defining the Future

The story behind the landmark women's health study that is creating exciting breakthroughs

By Caroline Hsu
Posted 2/26/06
Page 5 of 5

But Partridge, apparently, was something of an anomaly. The diet modification results, published in February, showed that women did not lose weight. Dieters were also not significantly less likely to experience cancer. However, the subset of women who went from a very high-fat diet to a low-fat diet had a 15 percent lower rate of breast cancer.

Islip, N.Y., town clerk Joan Johnson, 72, has always been active in her community, so being part of the WHI was a natural. She'd like to see more African-Americans volunteer to participate in clinical health trials.
KEVIN HORAN FOR USN&WR

Since the study was created over a decade ago, some of the nutritional recommendations are distinctly dated. "You take fat-free brownies, and you layer it with instant chocolate pudding made with skim milk, and then use the fat-free Cool Whip on top. Let it set for 24 hours so the moisture really soaks into the brownies,"says Swope of one of her favorite WHI recipes. "Oh, the trifle,"sighs Bette Caan, a WHI primary investigator in Oakland, Calif. "I used to love that. But you eat it once and it tastes good, and eat it again and it doesn't taste that real." If the diet were designed today, says Caan, it would emphasize eating good unsaturated fats and more fresh fruits and vegetables and whole grains and avoiding bad saturated fats and trans fats.

All the data from the trials are funneled to a coordinating center in Seattle, which takes the raw numbers from the 40 centers and shapes them into a larger picture of women's health. Every six months, the data are re-evaluated. The results are passed on to an independent monitoring board of non-NIH scientists and ethicists. The coordinating center is also responsible for safekeeping the blood samples that participants have given over the years. Kept frozen at a facility in Rockville, Md., the samples are a rich source of information. Already, researchers looking at inflammatory biomarkers have noted that hormone therapy resulted in higher levels of C-reactive protein, which is a predictor of heart-disease risk. And an article detailing a connection between women on hormone therapy who experience adverse effects like stroke and heart attack and the presence of certain markers in their blood is in the works. Thus far, all private researchers have collaborated with WHI investigators. But in January, NIH opened the door to this treasure-trove of health data when it began soliciting study proposals. "I think we've seen just the tip of what we can learn from the WHI," says Mark Espeland, professor of public health sciences at Wake Forest University in Winston-Salem, N.C., who has used the study data in his research. "I'm expecting to see many things come out of this database."

The intervention trials ended as planned in March 2005. But about 80 percent of participants opted to continue with the extension study. For five more years, investigators will scrutinize the women's health through surveys. Researchers are intrigued by the notion of being able to compare a woman's blood sample from 1993 with the state of her health in 2010 (column, Page 78).

For many, WHI's legacy goes way beyond blood vials and genetic markers. Three years after Madelyn Glaeden, 67, of Jamesville, Wis., began the low-fat-diet trial, she was diagnosed with breast cancer. Her dieting group companions provided emotional support as she underwent surgery and chemotherapy treatments. "I needed that boost, the energy that the group gave me," says Glaeden. And that's exactly what the WHI was designed to do: give a boost--a big boost--to women's health research.

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