BUFFALO, N.Y. – It was, admittedly, a long shot. Twenty
years ago, faculty in the University at Buffalo School of Medicine
and Biomedical Sciences applied for a large NIH contract, the
Women’s Health Initiative, the landmark women’s health
study and the largest clinical trial ever undertaken in the
“At the time, UB had had limited experience with major
multi-centered clinical trials,” recalls Jean
Wactawski-Wende, PhD, then an assistant professor in the Department
of Gynecology-Obstetrics in the medical school, who wrote the
application with Maurizio Trevisan, MD, an expert in preventive
cardiology who was then professor and incoming chair of the
Department of Social and Preventive Medicine.
“We weren’t a powerhouse like Harvard, but we worked
hard to put our best foot forward,” says Wactawski-Wende, now
professor and associate chair of social and preventive medicine and
vice provost for strategic initiatives. “We literally spent
three months, full-time, writing that application. We knew we had
the talent to do this, but not the national reputation. We figured
that we would get the pink sheets with reviewers’ criticisms
and respond to the second round when additional centers would be
added to see if we could better our score.
“As it turned out, the hard work paid off and we were one
of the top reviewed applications. The lesson is: do your best,
because you never know!”
The announcement that UB had been chosen as one of the 16
vanguard centers 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 U.S.;
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. The four remaining regional centers that
coordinate what were 40 centers are Buffalo, Stanford, Wake Forest
and Ohio State. The Fred Hutchinson Cancer Research Center in
Seattle serves as the coordinating center for the study.
In this new role, UB oversees the scientific direction and the
participant contacts of the Northeast region's nine institutions:
Harvard University, Brown University, Albert Einstein College of
Medicine, University of Massachusetts at Worcester, Stony Brook
University, George Washington University, University of Medicine
and Dentistry of New Jersey and Medstar Health Research Institute,
in addition to UB.
WHI is the largest study ever undertaken in the U.S., originally
involving more than 162,000 women across the nation, including
nearly 4,000 women in Buffalo. The goal of WHI was to gather
essential clinical data on the major diseases affecting women, on
whom remarkably few studies had ever been done.
WHI is best known for what it revealed about hormone therapy
through the clinical trials done in these 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 a single clinical trial had been done to
determine that hormone therapy actually was able to prevent chronic
diseases such as cardiovascular disease.
“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
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’s
been great for our younger faculty.”
Data collected by UB’s WHI researchers have been used by
UB faculty studying everything from connections between periodontal
disease and cancer, genome-wide associations with disease,
metabolic syndrome and what role vitamin D plays in chronic
disease. These data also have been a goldmine for master’s
degree and doctoral students who use them as a jumping off point
for their own research.
Perhaps the most important piece of the WHI research at UB was
the development of a comprehensive biospecimen bank, containing
hundreds of thousands of biological samples provided by the Western
New York women who participate in the WHI. “We have samples
of blood, saliva, plaque, urine, DNA, breast milk and tumor blocks.
This has been a goldmine for additional research,” says
Those samples and all the data that WHI continues to collect,
she says, are keys to some of the most valuable research ever done
on women’s health. 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. “You
have to show that you have this kind of capacity,”
“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
The women who participated are an important part of the story,
too, especially in Buffalo. “Recruiting participants for
clinical trials is always just plain hard,” says
Wactawski-Wende, “but the women of Western New York stepped
up. UB was the first center out of the initial 16 that completed
recruiting; in fact, we over-recruited!
“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,” she says. “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.”
In addition to providing samples, they respond to detailed
questionnaires every year about their health habits and diets. That
will continue at least until 2015.
“We are already planning for the next submission to extend
the study to 2020,” says Wactawski-Wende. “It has been
an amazing experience.”