Published May 7, 2013
The legacy of the Women’s Health Initiative (WHI), the landmark women’s health study and the largest clinical trial undertaken in the United States, lives on at UB 20 years after the university received its initial grant to play a key role in the initiative.
At the outset, the goal of the WHI was to gather essential clinical data about the major diseases affecting women, on whom remarkably few studies had ever been done. The study originally involved more than 162,000 women across the nation, including nearly 4,000 women in Buffalo.
The WHI has resulted in more than $30 million in research funding for UB and the university is now a regional center for WHI research, which is directed by Jean Wactawski-Wende, PhD, professor and associate chair of social and preventive medicine in the School of Public Health and Health Professions.
The data that have been collected by UB’s WHI researchers are used by faculty studying everything from connections between periodontal disease and cancer to genome-wide associations with disease, metabolic syndrome and what role vitamin D plays in chronic disease.
Twenty years ago, when faculty from the school of medicine applied for the large National Institutes of Health contract, UB had limited experience with major multicentered clinical trials, recalls Wactawski-Wende, who was an assistant professor in the Department of Obstetrics and Gynecology at the time.
“We weren’t a powerhouse like Harvard, but we worked hard to put our best foot forward,” she emphasizes.
Wactawski-Wende, who wrote the application with Maurizio Trevisan, MD, an expert in preventive cardiology, says it took three months of full-time work to write the application. “We knew we had the talent to do this, but not the national reputation."
As it turned out, the hard work paid off and UB was one of the top reviewed applications, says Wactawski-Wende. The announcement that UB had been chosen as a vanguard center came through on March 30, 1993.
Along with institutions such as the University of Pittsburgh, Northwestern and Brigham and Women’s Hospital in Boston, UB was awarded a $13 million, 12-year contract, making it one of just 16 Vanguard Clinical Centers for women’s health in the United States. Another 24 centers were added two years later.
In 2005, UB successfully competed for a five-year extension of the original contract. In 2010, based on UB’s success as a vanguard center, the university received an $8.2 million award from the National Heart, Lung and Blood Institute to administer a new round of studies that extend the WHI until 2015 and now leads the entire Northeast region.
In this new role, UB oversees the scientific direction and the participant contacts of the Northeast region's nine institutions, which include Harvard University, Brown University, Albert Einstein College of Medicine and the University of Massachusetts at Worcester.
“We are already planning for the next submission to extend the study to 2020,” says Wactawski-Wende, who is also vice provost for strategic initiatives. “It has been an amazing experience.”
At UB, the WHI award opened horizons for researchers on multiple levels, says Wactawski-Wende.
“Having the vanguard center here has been an amazing training ground,” she says. “Being a multicenter study allowed UB to be affiliated with so many powerhouses around the country and some of the best investigators in the field. It has been great for our younger faculty.”
Also, data collected by UB’s WHI researchers have been a goldmine for master’s degree and doctoral students who use it as a starting point for their own research.
The development of a comprehensive biospecimen bank has been one of the most important aspects of WHI research at UB. The bank, which contains hundreds of thousands of biological samples provided by Western New York women, has been a goldmine for additional research, says Wactawski-Wende.
“We have samples of blood, saliva, plaque, urine, DNA, breast milk and tumor blocks,” she explains. These samples, along with the data that WHI continues to collect, are keys to some of the most valuable research ever done on women’s health, she says.
This treasure trove of information has led to the publication of nearly 1,000 scientific publications from all of the WHI institutions and investigators. About 1,000 more publications are in the pipeline. In addition, the biorepository has allowed UB to apply for some very ambitious grants.
“And in addition to the initial WHI contract and extension studies of over $21 million, UB has attracted over $12 million in additional funding in the WHI center, which we obtained because of this critical infrastructure which we have now,” says Wactawski-Wende.
WHI is best known for what it revealed about hormone therapy through the clinical trials done in postmenopausal women.
“It completely changed what we thought about hormone therapy,” says Wactawski-Wende. She notes that prior to the WHI, one-third of the prescriptions for the most commonly prescribed hormone replacement were given for chronic disease prevention before clinical trials had been done to determine that hormone therapy was able to prevent chronic diseases.
“The conventional thinking at the time, all from observational evidence, was that women were being protected from heart disease by estrogen therapy,” she says. “And while observational evidence often turns out to be correct, in this case, it turned out that it wasn’t. It wasn’t until we saw all the data that we could see that many assumptions about hormone therapy were a likely result of ‘healthy-user bias.’”
“Western New York is just a great location for doing clinical studies. Women in this region are very altruistic, willing to participate in a study to help future generations of women,” says Wactawski-Wende.
In addition to providing samples, they respond to detailed questionnaires every year about their health habits and diets, which will continue at least until 2015.
Recruiting participants for clinical trials is always difficult, but the women of Western New York were cooperative and willing, she says. “UB was the first center out of the initial 16 that completed recruiting; in fact, we over-recruited,” she adds.
“Buffalo is really the city of good neighbors. These women — some of whom are now in their 90s — wanted to do something meaningful, to help someone else. They did it for their daughters and granddaughters.”