New research launched with WHI biological samples

Projects aim to explain the results of this large trial on older women's health, as well as investigate possible genetic and proteomic disease markers.

By Victoria Stagg Elliott, AMNews staff. March 5, 2007.

The Women's Health Initiative is having a sequel.

The National Heart, Lung and Blood Institute in January awarded a dozen contracts worth a total of $18,679,000. The money will fund researchers, many of whom have not previously worked on the initiative, to spend the next two years analyzing more than 5 million blood and other fluid samples. These biologicals were collected during the 15-year project that randomized more than 68,000 postmenopausal women to various hormonal and dietary interventions. Thousands more participated in the observational arms.

"When big studies end, the samples are often forgotten. These are too valuable. We are determined that we will not let that happen," said WHI Project Officer Jacques Rossouw, MD. "What comes out of this may be as important as what the WHI contributed in the past."

The hope is that these efforts, which will not require any additional human participation, will better explain the WHI's findings, particularly those related to hormone therapy.

These samples will be used to look at how initial, naturally occurring levels of estradiol and sex hormone-binding globulin affect hormone therapy's impact on cardiovascular disease, blood clots, dementia and fracture. Another project will attempt to determine the influence of hormone metabolism on the incidence of hip fracture and breast cancer.

A paper in the July 17, 2002, Journal of the American Medical Association linked hormone therapy to an increased risk of breast cancer, stroke and heart attack, ending the dream that this was a strategy to protect women from cardiovascular disease. Now, out of the dozen projects, these two are expected to produce the most immediately useful information.