Dr. Marcia Stefanick

(WOMENSENEWS)–This month thousands of U.S. women wrap up 7 to 12 years as volunteers in the remaining clinical trials of the history-making Women’s Health Initiative, an unprecedented study of women age 50 and up.

“The studies will give us information as to whether it’s important to have a low-fat diet, whether to take calcium and vitamin D supplements,” said Dr. Marcia Stefanick, steering committee chair of the initiative and a researcher at California’s Stanford University. “They’re answering two big questions.”

Results of the diet and supplement research are expected to be published this fall.

Investigators would like to extend the study, but lack of funding makes them doubt they can. “Now I hope we can do the daughters and granddaughters,” said Stefanick. “Right now the funding situation isn’t very positive. We may have to wait a while.”

The three clinical trials–of hormone therapy, diet, and calcium plus vitamin D supplements–of the 15-year Women’s Health Initiative, funded by the National Institutes of Health and the National Heart, Lung and Blood Institute, studied 68,000 postmenopausal women through 40 clinic centers.

The Women’s Health Initiative stands out not only in size and scope, but in inclusiveness.

“It’s got the largest number of African American, Asian, Hispanic, and Native American women in clinical trials for lifestyle, the diet study and the hormone study,” said Stefanick.

Funding Problems at FDA

Lack of funding, meanwhile, holds back another key women’s health project at the U.S. Food and Drug Administration, say advocates.

Three years after Congress directed the FDA’s Office of Women’s Health to create a database for tracking women’s participation in drug trials and gender-based drug differences, the computerized database is far from up and running.

Now, FDA drug reviewers must comb through truckloads of paper drug trial reports and digital data in as many as 12 formats, all sent by the drug manufacturer, to evaluate the new drug’s safety and effectiveness, said Dr. Sherry Marts, scientific affairs vice president of the Society for Women’s Health Research, a nonprofit in Washington, D.C. With no database, reviewers must handpick gender, age and ethnicity information from the pile and craft their own data comparisons.

“They’re in a paper world over there,” said Marts. “FDA keeps getting their budget cut and keeps being given more to do.”

“The part of the agency addressing those safety questions has been starved for funds,” said Amy Allina, policy director for the National Women’s Health Network in Washington, D.C. “Gender-effects tracking has been low down on the priority list.”

People respond differently to the same drug, and scientists say those responses can be associated with gender, age and ethnicity. While not all drugs display these “sub-group” characteristics, researchers say new drugs should be tested for them because they can amount, in some cases, to a drug failing to work in some people or, at the opposite end, taking an overly strong effect.

FDA Says Gender Effects on Labels

Despite the difficulty, the FDA does evaluate gender differences in drug safety and get that information to the public, said Dr. Katherine Hollinger, FDA Office of Women’s Health, an epidemiologist and veterinarian, who directs the database project. “If there is a difference observed that is clinically relevant,” that fact is included in the drug’s labeling, Hollinger promised.

Dr. Sherry-Marts

Critics, however, recently charged that the FDA failed to warn physicians and the public quickly enough about the risk of heart damage from Vioxx and other pain relievers or to provide information on the drugs’ gender and other subgroup differences.

“We have so few data, you really can’t do subgroups on anybody,” Dr. Bruce Psaty, researcher at Seattle’s University of Washington, said, referring to Vioxx and other pain-relieving drugs. “We don’t have enough to say it’s (Vioxx) more or less safe for men or women.”

In a Feb. 15 online editorial in the New England Journal of Medicine, Psaty and co-author Dr. Curt Furberg criticized Merck’s Vioxx drug trials and the FDA’s delay in warning of the drug’s dangers and contrasting those failings with the achievements of the Women’s Health Initiative.

“The Women’s Health Initiative study is an example of a trial designed to assess risks and benefits with equal scientific rigor,” Psaty and Furberg wrote. “In the evaluation of hormone-replacement therapy, the WHI treated the potential risks of breast cancer and venous thrombosis just as seriously as the hypothesized benefits with regard to myocardial infarction and stroke.”

Part of the hormone therapy trial was halted in July 2002 when investigators found increased heart disease, breast cancer, stroke and blood clots in women taking estrogen plus progestin. The other hormone therapy trial, in which women who’d had hysterectomies took estrogen only, was also stopped early, in March 2004, when researchers found higher risk of stroke and no sign that estrogen prevented heart disease. The trial also found that the women with hystectomies who took estrogen had a lower risk for hip fractures.

Vioxx Missing Gender Studies

“There are no known studies that compare women and men on Vioxx and sex differences were not mentioned when studies about this and other drugs raised concerns about heart problems,” said Marts. “This is a problem because heart disease affects women and men differently.”

Marts said she asked the FDA for gender data on Vioxx shortly after Merck withdrew the drug from the market in September. (Tens of thousands of people sustained heart attacks and strokes from taking Vioxx, researchers reported, a risk that may extend to other pain-relievers.) In early March, Marts said she was still waiting for the Vioxx gender information.

In accepting the database task in 2002, the FDA acknowledged to congress that “when sub-population data are tracked and evaluated in submissions and reviews, the FDA’s ability to collect and report this information is extremely limited because it is time- and resource-intensive.”

Hollinger said that some work has been done on the Web-based database, officially named the Demographic Information and Data Repository or DIDR.

Generating new digital standards and formats over the past three years has meant reaching consensus among information technologists, the pharmaceutical industry, the FDA and other government health professionals, said Hollinger. Meanwhile, funding is falling short.

“To implement the kind of system we’re talking about would take 10 times the amount of money over several years,” she added.

Marts suggested women contact congressional representatives in support of funding for the database.

Meanwhile, Marts recommends that women offered a new medication ask their doctors how long the drug has been on the market, what side effects others have reported and whether the physician has heard of problems that could be gender-related.

Suzanne Batchelor is a journalist based in Austin, Texas.

For more information:

The Women’s Health Initiative:

U.S. Food and Drug Administration–
The Demographic Information and Data Repository:

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