SEATTLE AND NEW ORLEANS - The Women's Health Initiative, a nationwide, federally funded research program coordinated by Fred Hutchinson Cancer Research Center in Seattle, has received the 10th annual Team Science Award from the American Association for Cancer Research. Fred Hutch biostatisticians Drs. Ross Prentice and Garnet Anderson, leaders of the WHI Clinical Coordinating Center, were on hand to accept the award April 17 during the American Association for Cancer Research 2016 Annual Meeting in New Orleans, on behalf of the WHI program.
Launched in 1992 with a $625 million contract from the National Institutes of Health, the WHI is one of the largest U.S. studies of its kind and the largest, most ethnically and geographically diverse study of older women. It initially consisted of three randomized clinical trials and an observational study that together involved more than 161,000 postmenopausal women at 40 U.S. research centers.
According to Anderson, principal investigator of the WHI Clinical Coordinating Center and director of the Fred Hutch Public Health Sciences Division in which it is based, "This award recognizes that the tremendous successes of the WHI program is due to the contributions of tens of thousands of WHI participants and to the tremendous efforts by hundreds of WHI investigators and staff over more than two decades to build, maintain and enhance this resource for the larger goal of improving women's health. This was and is team science writ large."
The clinical trials tested the effects of postmenopausal hormone therapy, dietary changes, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer. Those studies ended between 2002 and 2005. Since then, more than 115,000 WHI participants have continued providing health information that is being used to investigate a variety of key women's health questions. More than 80,000 of these women, ages 67 to 101, remain in active follow-up nationwide. Many of these women are also participating in two new trials: one is testing whether cocoa extract and multivitamins can help reduce the risk of cardiovascular disease and cancer; the other is testing the effect of physical activity on heart disease prevention.
The WHI is best known for its 2002 findings that combination hormone therapy -- at the time prescribed to 5.5 million postmenopausal women in the U.S. to alleviate symptoms of menopause and to prevent fractures and heart attacks -- significantly increased the risk of heart disease, stroke and breast cancer.
Those research findings singularly changed the face of women's medicine around the world. Researchers estimate that because of the decrease in hormone therapy use following the WHI publication, there have been 15,000 to 20,000 fewer cases of breast cancer each year in the United States.
Since then, the use of hormone therapy has plunged in the U.S. and many other countries, and this has been followed by measurable decreases in breast cancer in several countries and, in the U.S., decreases in heart attack and stroke.
The economic return on investment from that WHI trial alone was substantial, according to Fred Hutch health economist Dr. Joshua Roth, who in 2014 published an analysis of the economic impact of the hormone therapy findings. "The original NIH trial cost was $260 million [in 2012 dollars] and the net economic return was $37.1 billion. That's a return of approximately $140 on every dollar invested in the trial," he said. "It really brings the point home when you crunch the numbers. You see that millions of U.S. women likely stopped or never used [combined hormone therapy] and that this change resulted in important reductions in disease incidence and associated medical spending."
Fred Hutch President and Director Dr. Gary Gilliland nominated the interdisciplinary WHI team for its broad impact on public health, not only through its contributions to understanding the effects of hormone therapy and nutrition on cancer risk and prevention, but also its development of unique national resources that support cancer research, such as a massive database and a biospecimen repository that are available to all researchers.
"The WHI, as a national resource open to collaboration, has been and continues to be an engine for driving cancer research in population and translational science both here and throughout the country," he said.
Upon accepting the honor, which comes with a $50,000 honorarium, Prentice, who served as principal investigator of the WHI Clinical Coordinating Center from 1992 to 2010 as well as director of the Public Health Sciences Division for 25 years, acknowledged the contributions of the volunteers at the heart of the study. "These women have given generously of their time to participate in a complex protocol, some for more than 20 years," he said.
The Team Science Award, supported by a grant from Eli Lilly and Company, is given to affect change within the traditional cancer research culture by recognizing those individuals and institutions that value and foster interdisciplinary team science.
This is the second AACR Team Science Award for Fred Hutch; in 2011 a team of researchers led by Dr. Denise Galloway of the Hutch's Human Biology Division received the honor for their research that was instrumental in the development of the vaccine for cervical cancer and other human papillomavirus-related malignancies.
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At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.