The initial 40 WHI centers across the U.S. have been grouped into four regional centers to carry out this new initiative. UB will oversee scientific direction and the participant contacts of the Northeast region's nine institutions.
These include Harvard University, Brown University, Albert Einstein College of Medicine, University of Massachusetts at Worchester, Stony Brook University, George Washington University, University of Medicine and Dentistry of New Jersey and Medstar Health Research Institute, in addition to UB.
Jean Wactawski-Wende, PhD, co-PI of UB's original $13 million WHI Vanguard Center, is principal investigator on the new award. Wactawski-Wende is professor and associate chair of the Department of Social and Preventive Medicine, School of Public Health and Health Professions, and professor of gynecology-obstetrics, School of Medicine and Biomedical Sciences. In addition, she serves as UB's vice provost for strategic initiatives.
The WHI 2010-2015 Extension Study will fund continuing research into many chronic diseases of aging, including cardiovascular disease, cancer, osteoporosis, stroke and cognition, and will support new studies focusing on predictors of healthy aging.
WHI is the largest clinical trial ever undertaken in the U.S., involving more than 162,000 women across the nation, including 4,000 in Buffalo. The goal of WHI is to gather essential clinical data on the major diseases affecting women.
The WHI is interested, in particular, in studies concentrating on WHI participants who now are over the age of 80, and underrepresented minority women, primarily African-American and Native-American WHI participants. The WHI represents the largest prospective cohort of these older women in the United States.
"The impact of this new WHI extension study is going to be huge," says Wactawski-Wende. "This work will change lives and paradigms regarding health in postmenopausal women and has, and will, continue to impact human health. The scientific discovery from WHI to date has been enormous. I expect in the next five years we will more than double the scientific discovery emanating from this study.
"Working on this science is exciting and personally rewarding," she continues. "I expect funding for the WHI extension study to serve as a catalyst for further research, and that many additional funded studies will branch off of this work. We already have seen that type of scientific outgrowth here in Buffalo."
UB Provost Satish K. Tripathi notes that since 1993 when the University at Buffalo was designated a Vanguard Center for the Women's Health Initiative, UB researchers have been at the national science forefront in women's health. "This multi-million-dollar award, orchestrated and led by Professor Wactawski-Wende, recognizes the national leadership role that UB has demonstrated in our understanding of factors contributing to chronic disease in older women, and how preventative strategies and interventions can reduce this disease burden in our communities," Tripathi says.
"Effectively, the Women's Health Initiative has impacted public health by informing us on the balance of risks and benefits of certain medications and health behaviors. And, as a result, today women are making more-informed health decisions in mid-life and beyond. Moreover, the research associated with the WHI further contributes to the important work being conducted as part of the UB 2020 "Health and Wellness Across the Life Span" strategic strength," he adds.
One purpose of this new WHI extension, which gathers the initial research institutions into regional groups, is to promote further collaboration between institutions and regions, points out Wactawski-Wende. Investigators will have access to data and biological samples from across the WHI, providing opportunity to network and collaborate on studies nationally.
The other three WHI regional centers are headquartered at Stanford University (western region), Wake Forest University (southwest region) and Ohio State University (midwest region). The coordinating center for the extension study has not yet been announced, but is expected to be the Fred Hutchinson Cancer Institute in Seattle, Wash., Wactawski-Wende says.
A significant portion of the work will be conducted by researchers in UB's School of Public Health and Health Professions. "Here at Buffalo we have an exceptional group of investigators joining the WHI," Wactawski-Wende says. "These include Drs. Amy Millen, Michael LaMonte, Heather Ochs-Balcom and Matthew Bonner, all assistant professors in the Department of Social and Preventive Medicine, and Christopher Andrews from biostatistics and Lara Sucheston from Roswell Park Cancer Institute. Each of these investigators is proposing cutting edge science as part of their work on WHI."
UB's Millen already has been funded to study the relationship of vitamin D status and chronic diseases of aging in the WHI. Lamonte has a grant under review to study the effect of physical activity and physical function in older women from WHI. Ochs-Balcom and Sucheston are investigating the roles of genetics in cancer and other conditions. Bonner will look at various factors influencing cancer risk.
"Many others from our region who are not funded directly on this new award, but who will play important scientific roles, will be working on the WHI data and proposing ancillary studies," says Wactawski-Wende. "They have proposed many additional studies that fully exploit this rich dataset. This is team science at its best."
More than 100,000 women from across the nation are expected to participate in the WHI extension study, including thousands from Buffalo and the greater Western New York region.
The major and unexpected results from the initial trial showed that estrogen didn't reduce the risk of heart disease and increased the risk of stroke in postmenopausal women who had a hysterectomy, and in post-menopausal women who did not have a hysterectomy, hormone therapy increased the risk of breast cancer, heart disease and blood clots.
"The WHI findings already have had enormous impact on our understanding of factors influencing health and chronic disease in older women," says Wactawski-Wende.
"We owe these dedicated study participants our thanks for their contributions to date, and sincere appreciation for their willingness to continue to allow us to learn so much more from them over the next five years."
The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.