Clinical Trials: Women Needed

The drug you're taking might work only in men.


As a young girl growing up in Spanish Harlem in the 1960s, Venus Ginés recalled her mother telling her, "Don't trust doctors. They'll use you like guinea pigs." Divorced and single, her mother had been pressured by her doctor into undergoing tubal sterilization as a form of birth control, with reassurances that the procedure was fully reversible. (It's usually not.) In fact, reading up on this later, I was shocked to learn that many Latina women in the United States and the American territory of Puerto Rico got their tubes tied during that time—often without even knowing that they would become infertile—in a misguided and racist effort by the U.S. government to control population growth. Despite that history, Ginés worked up the courage 15 years ago to enter a clinical trial for the breast cancer drug tamoxifen after treatment for the disease. But frustrated by the paperwork and the time away from work, she soon dropped out; "no one called to ask me why," Ginés said during a press conference yesterday in which Baylor College of Medicine and the Intercultural Cancer Council announced new recommendations to increase the participation of women and minorities in research trials.

Why should we care that women, especially minority women, aren't well represented in studies of new drugs? For one thing, we have to worry about hidden health dangers. Back in 2001, the Government Accountability Office issued a report noting that 8 out of 10 prescription drugs withdrawn from the U.S. market from 1997 to 2000 posed greater risks for women than for men. And Duke University researchers reported this week that women's participation in some areas of research is so low that the findings may not actually apply to them. For example, women account for only 17 percent of participants in studies of cholesterol-lowering drugs, yet millions of women take them; researchers still aren't sure whether statins, the most popular, reduce cardiovascular deaths in women. And anecdotal reports suggest that women suffer more side effects from statins, like muscle pain and mental fogginess. What's more, since women represent only a quarter of those in coronary artery disease trials, we may not be able to trust findings on beta blockers for heart attacks or drug-eluting stents to clear blocked arteries, say. Black women, under-represented as both women and as minorities, might be putting too much hope in tamoxifen. The drug appears to be less effective at preventing breast cancer recurrences in them, possibly because of gene variations that make it harder to metabolize the drug.

Some gains have been made. The Duke researchers noted that women today make up nearly 31 percent of participants in cardiology trials overall, up from 9 percent in 1970. But policymakers at yesterday's press conference said more needs to be done to make it easier for women to participate: providing such services as transportation to medical facilities and "patient navigators" to help with consent forms and roadblocks like baby-sitter coverage. I think, though, that more women need to understand why they should even bother to participate in a clinical trial in the first place.

Certainly, it's nice to know that what you're doing is helping to serve the common good—contributing to medical knowledge about how well a treatment works. But beyond that, participants in clinical trials tend to receive state-of-the-art care at leading medical centers. Yes, those stories of people dying from gene therapy treatments are horrifying, but they're pretty rare. The vast majority of folks enjoy improved healthcare from participating in research studies, even if they're given a placebo or traditional treatment. That's because they're monitored more closely—given regular mammograms, for instance, if they're in a breast cancer prevention study.

Regardless of whether you opt to enter a research study, it's important to be a savvy medical consumer. Before having any new prescription filled, ask your doctor if the drug has been tested in women and in your ethnic group and whether it has been shown to be effective, recommends Barbara Pence, a professor of pathology at Texas Tech University Health Science Center, who helped write the new recommendations. Be particularly wary of a drug that's just recently been approved by the Food and Drug Administration. Unless the drug was designed specifically for women, chances are it was tested mostly on men.