Hutch News

Building on the Women's Health Initiative findings

More than 20 years after WHI began, half of the original 160,000 trial participants are still followed, providing new information as they age

May 1, 2014
Dr. Garnet Anderson

Dr. Garnet Anderson, lead Women's Health Initiative investigator and director of Fred Hutchinson Cancer Research Center's Public Health Sciences Division, speaks at the opening session of the two-day Women's Health Initiative investigator conference.

Photo by Robert Hood / Fred Hutch

Dr. Garnet Anderson looked out at a crowd of more than 100 scientists gathered for the annual Women’s Health Initiative investigator conference and remembered the last time they’d met in that same room at Fred Hutchinson Cancer Research Center. It was 1993 and 16 member centers had come together to launch the Women’s Health Initiative. 

“We gathered to launch this great program,” Anderson said during a Thursday morning session of the two-day conference where researchers share updates of what they’ve been learning. Since that day more than 20 years ago, the WHI’s findings have made history.  

In 2002, it issued a landmark finding regarding the significant health risks of combined hormone replacement therapy, which at the time was prescribed to 15 million postmenopausal women in the U.S. 

Fred Hutch is the coordinating center for the WHI, which currently involves 10 regional research centers nationwide.

Anderson opened the session with a brief update on the trial participants who make up the backbone of the WHI, one of the largest, most ambitious clinical research projects done in the U.S. to date. Upon its inception, the program recruited more than 160,000 ethnically and geographically diverse postmenopausal women for clinical trials and observational studies. In 2002, it issued a landmark finding regarding the significant health risks of combined hormone replacement therapy, which at the time was prescribed to 15 million postmenopausal women in the U.S. 

Since then, it has continued to build on its findings with additional studies that tap into the data it continues to collect yearly from trial participants.

Currently, the WHI is following 87,000 women, Anderson said, which represents about 54 percent of the original group. 

“What we are following are the survivors and those who are very committed to WHI and that is really obvious when you look at our follow-up rates to our annual mailings,” she said. “That’s been well above 90 percent throughout the history [of WHI] that women provide their health updates. It’s falling a little bit each year but not dramatically. They are wonderfully committed women out there.”

She then went on to discuss a new Life and Longevity After Cancer study, dubbed LILAC.

“What we’re looking for is to collect information on cancer treatments and outcomes, particularly recurrence,” she said, adding that the new study will focus primarily on breast, ovarian, endometrial, colorectal and lung cancers as well as melanoma, lymphoma and leukemia.

WHI’s impact

Launched in 1991 as a $625 million contract with the National Institutes of Health, the WHI was motivated by the need to address gender disparities in clinical research. Previously, most studies focused on men’s health issues. The WHI was created as a major, long-term research program designed to address cardiovascular disease, cancer and osteoporosis, the most frequent causes of death, disability and poor quality of life in postmenopausal women.

Since its transformative finding about combined hormone replacement therapy and its link to heart disease, stroke and breast cancer, the WHI has continued to tease out results from its rich pool of data on everything from low-fat diets and the risk of breast and colorectal cancer to calcium and vitamin D supplementation and the risk of fractures.

“We have blood and DNA collected from over 160,000 women,” said Anderson. “And it’s available to all researchers who collaborate with us to study everything from early detection of cancer to genetic risk factors for cancer and other diseases.”

On the agenda

The annual conference reflects the latest phase of research which is currently being funded by the National Heart, Lung and Blood Institute. 

Thursday morning’s session focused on heart failure in women with presentations from several investigators including Dr. Marian Limacher from the University of Florida College of Medicine, who discussed the state of the science regarding heart failure in women, which she termed a common problem suffered by 2.5 million women.

“The lifetime risk is 20 percent of all Americans greater than the age of 40 and that does not actually change as you get older,” she said. “It stays 20 percent as you get older.”

Mortality is high and remains high, she said. Women do survive longer but report lower quality of life.

“[Heart failure] is prevalent, it’s costly -- $39 billion a year – with lifetime cost of $110,000 per year for heart failure and that is largely due to in-patient care,” she said.

Later on Thursday, sessions focused on osteoporosis screening guidelines, the Women’s Health Initiative Memory Study (known as WHIMS) and the Cocoa Supplement and Multivitamin Outcome Study (known as COSMOS), which made national headlines earlier this year. 

Participants heard from Dr. Greg Wellenius of Brown University, who presented information on stroke risk and ambient and traffic-related air pollution and Dr. Andrea LaCroix, who is currently involved in a study of physical activity and cardiovascular health in women over 80.

The last plenary session of the day tackled cardiovascular health and cancer survivorship, examining cardiotoxic effects of chemotherapy, radiation and hormone therapies.

Dr. Tochi Okwuosa of Rush University Medical Center noted that more and more people are surviving cancer – “We are making a difference in terms of therapy,” she said – but pointed out that 50 percent of all patients exposed to chemotherapy will show some degree of cardiac dysfunction 10 to 20 years later.

Dr. Lee Jones of Memorial Sloan Kettering Cancer Center discussed the benefits of exercise in counteracting chemotherapy’s impact on the overall cardiovascular system.

“There is a hit to the system – whether it’s cardiac dysfunction, pulmonary dysfunction, vascular dysfunction or damage to the muscle,” he said. “The point is because it is multifactorial you need a multifactorial intervention that’s going to address each one of these organ systems at the same time. So of course the only thing that will do that is exercise.”

WHI’s breadth of research

Friday's session will focus on diet and mortality in women with heart failure, diabetes-related issues and aging and cardiovascular disease research.

For Anderson and the dozens of researchers who continue to glean crucial health information from this initiative, WHI appears to be the gift that keeps on giving.

“We have some very innovative, entrepreneurial investigators all around the country,” she said. “And a very comprehensive, well-designed and well-maintained database and specimen repository that can support a breadth of research. I’m really proud of the staff here at the Hutch coordinating center. They’ve put incredible thought and effort into making this a really robust and comprehensive resource.”

For more information about WHI and its ongoing research, go to www.whi.org.

Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has also written extensively about health issues for nbcnews.com, TODAY.com, CNN.com, MSN.com, Columns and several other publications. She also writes the breast cancer blog, doublewhammied.com.Reach her at dmapes@fredhutch.org.

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