Dr. Meir J. Stampfer, the co-investigator and lead author of a vitamin E study on women, says that some of the recent regulations Congress has imposed on the NIH go too far.
"I don't think we should slavishly follow a particular formula requiring certain percentages of population groups in all studies," he asserts.
But Stampfer acknowledges that the NIH policy to include different groups can be valuable.
"It's giving people an awareness that some subgroups differ in terms of their health risks and, therefore, the research should focus on that," Stampfer says.
Their Motivations
At the WHI clinic in Brookline, the women who have volunteered to participate are grateful for the increased amount of research on women.
"I had not realized that as many [post-menopausal] women have heart attacks as men [in the same age group]," says Joan A. D'Alessandro, a participant in the dietary component of the WHI. "All we hear about is men. For myself personally, I wanted to hear those answers."
As part of her participation in the dietary trial, the slender D'Alessandro has attended regular private and group sessions with a nutritionist for the past year, discussing eating habits and sampling low-fat dishes.
The strongest motivation for the more than 160,000 women across the country who will participate in the WHI during its 15-year course is to find answers for posterity.
"I have a daughter [who] is 35. We are part of a study group that's going to show [what is] important to her diet," D'Alessandro says.
In a separate room, without overhearing the other woman, Beckett expresses the same sentiment. "I have three daughters, and I hope that when they get to be post-menopausal, they will have the answers."
A Pattern of Neglect
When Dr. Bernadine P. Healy became the director of the NIH in 1991, she led the formation of an agenda to find those answers.
Healy explains why there had been no randomized studies of estrogen in women until the WHI began recruiting participants in 1993, even though scientists had debated the benefits and side-effects of estrogen therapy for many years.
"For the longest time, there was the mindset that men are the normative standard," says Healy, a former member of Harvard's lesser governing board, the Board of Overseers. "As a result, it just somehow, curiously escaped people's minds."
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