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Wanted: Women for studies

Martha Behnke and Gloria Elliotte enrolled in research studies for different reasons, but by participating they are adding to a larger body of knowledge about women's health.

Experts say there may be too few women like them seeking to be a part of medical research - and the result might be delaying effective treatments for women's gender-specific and overall health issues.

"There are a lot of benefits to enrolling in trials that people may not be aware of," said Dr. Susan Kornstein, a researcher and co-founder and executive director of the VCU Institute for Women's Health. "I think unfortunately the most common reaction when you mention [a clinical trial] is that 'I don't want to be a guinea pig.' That is not what clinical trials are about."

Kornstein is running several research studies at VCU, including the one Behnke is enrolled in that is studying severe premenstrual syndrome. Kornstein is having trouble recruiting participants.

"When I see something that looks like it might be interesting or appropriate for me, then I always kind of have my eye out for that," said Behnke, who works at VCU. "I just want to support research."

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Elliotte is a study veteran, having enrolled in several at National Clinical Research in Henrico County. The current study is for people who have diabetes and need to lose weight.

"Even though I am an RN, I was not eating healthy. . . . I was on a fast pace to killing myself," said Elliotte, who has gone from 248 pounds to 206 since enrolling in the study last year.

For a long time, women were not recruited for research studies, for reasons that included risks to a fetus if they got pregnant, or because it was believed that drugs and therapies worked the same in men and women. Those assumptions and exclusions continued for years until it became apparent that women were being shortchanged.

"There are all kinds of differences. There have been differences in the way women respond to drugs, sometimes in side effects, sometimes in differences in doses," said Sherry A. Marts, vice president of scientific affairs at the Society for Women's Health Research.

"Sometimes people intuitively think women are smaller and need a lower dose. There are some drugs women break down quicker than men, so they need a higher dose or to take medication more often," Marts said. Her organization, based in Washington and formed in 1990, lobbied Congress to require researchers to include women and minorities in publicly funded research and for study results to include gender difference when appropriate as part of the National Institutes of Health Revitalization Act of 1993.

In the years since the strengthened policy, the number of women in federally supported research has grown. In 2005, women were 63 percent of participants in NIH-funded studies, up from about 52 percent in 1995.

It's a mixed picture, though. Some recent research suggests women are not equally represented in definitive studies on treatments for heart disease, the No. 1 killer of U.S. men and women, and that women's participation in some large gender-specific studies might skew the real picture. A 2007 paper from researchers at the Cleveland Clinic suggests women are still underrepresented in randomized control studies of cardiovascular disease.

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Kornstein hopes to enroll 100 women in the study that is testing whether the antidepressant sertraline, if taken when symptoms start, can help women combat severe premenstrual problems such as mood swings, anxiety, irritability and sadness.

The NIH-funded study is also under way at two other sites - Cornell University in New York and Yale University in New Haven, Conn.- and Kornstein said those sites are having the same recruitment problems.

"We are having an awful time," agreed Dr. Margaret Altemus, a psychiatrist at Cornell University. "I think a lot of people just get treated at their gynecologist's office because there are known things that can be helpful."

Marts said it's hard to say what drives women to studies or what keeps them away. The NIH rules, she said, don't require a 50-50 gender distribution in studies.

"They want to see a study population that reflects the incidence of the diseases," said Marts, and investigators don't report in any systematic way whether they have trouble recruiting women.

"It's hard to say whether it is study specific. There are so many factors that go into enrolling in a study," Marts said, explaining that she lumps those factors into two categories. One she refers to as the hassle factor - such as how many visits are required, how easy the study site is to get to, and if there is child care available, for instance.

"The other side is more the do-they-trust-the-system kind of question, whether or not women feel like their interests are going to be taken care of when they volunteer. Are they going to be taken care of as an individual or as just another cog in a research wheel," Marts said.

Volunteers, Marts said, "are like gold. The investigators and nurses regard them as their heroes. They are the folks who make it possible to really advance our knowledge and advance medical therapies."

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Kornstein wondered if the controversy around the Women's Health Initiative study a few years ago might have dampened women's enthusiasm for research. One arm of the high-profile study dealing with hormone replacement therapy was stopped early, in July 2002, because women in the study taking estrogen plus progestin had higher risk of breast cancers, strokes, heart attacks and blood clots in the legs and lungs.

Yet, the findings alerted women and their health-care providers to possible risks of hormone replacement therapy that many had anecdotally assumed for years was beneficial.

At Virginia Women's Center, Dr. Peter Zedler says patients are attracted to studies that help them. The practice, which has several offices in the Richmond area, has done clinical trials since 1996.

Former patient Michele Stehle, 29, is enrolled in a study there of Gardasil, a vaccine that can help prevent cervical cancer. The vaccine has been approved for girls and women ages 9 to 26. Ongoing studies are testing its effectiveness in older women. Stehle is in a five-year study that requires two to three visits a year.

"Five years sounds like a long time. I have had a little more than 10 visits," Stehle said.

She has since moved to Charlotte, N.C., but comes back to Richmond for study visits. Her travel costs are paid, and there is a small stipend for participation. She does not know if she received the vaccine or placebo, a fake vaccine used for comparison. Either way, she feels like she is making a difference.

"When Gardasil came out for the younger women it was neat to say that is something I am part of," Stehle said.

Contact Tammie Smith at TLsmith@timesdispatch.com or (804) 649-6572.