(WOMENSENEWS)– The federal Food and Drug Administration plans a public information campaign later this year to encourage women to participate in clinical trials.
"Women should be aware of the need for them to participate in these trials," Marsha Henderson, the FDA‘s assistant commissioner for women’s health, said in a recent phone interview.
The agency is also enhancing guidance and training for FDA investigators to try to ensure the inclusion of more diverse populations in drug studies.
It’s a sound idea, but not new.
In 1991, Dr. Bernadine Healy, then director of the National Institutes of Health, and the first woman to hold the post, made an unsettling disclosure. Women who had heart attacks were not getting the same quality of care as men because they often had different symptoms. That raised their odds of being misdiagnosed or improperly treated.
Twenty years later, in 2011, cardiovascular disease in women accounted for about 400,000 deaths, or 51 percent of all deaths in the United States attributable to heart disease. That means more women than men are still dying of heart disease.
For women of color, the impact is even greater. For instance, even though the incidence of breast cancer is lower in African American women than white women, women of color die from breast cancer at a higher rate. The reasons often go back to their access to health care–diagnosis and treatment may be delayed–and because they haven’t been widely included in drug trials.
Drug Trials Exclusion
The reasons for these disparities vary. Women are not routinely in clinical trials and thus treatments can end up being based on how men react to specific drugs, not women. Women of color are also not included in drug trials as often as white women and that can lead to problems in dosing and treatment because they may react differently to drugs based on genetic differences, experts say.
Nakela Cook, a physician and chief of staff in the NIH’s National Heart, Lung and Blood Institute, in April told the 23rd Annual Congress of the Academy of Women’s Health, which was meeting in Washington, D.C., that because women often present symptoms different from men, the "symptoms aren’t recognized."
That alone, she said, is a key reason to expand drug testing and clinical trials.
The reasons women don’t participate will sound familiar to many: family responsibilities, pregnancy, transportation, child care, elder care. Getting to a lab during working hours is often tough for women, who are more likely to work low-wage jobs with inflexible schedules. Evenings may be difficult because of child care and family obligations.
Testers need to find ways to overcome these barriers and consider everything from the time of day to offering assistance with transportation, Cook said in an interview after her presentation.
There are other troubling health disparities between men and women, and between whites and non-whites, but often the data are not sifted according to those subgroups, leaving medical practitioners with limited information about whether a particular treatment will work for a particular patient who is not a white male.
The FDA, pressed by Congress in 2012, is undertaking a major examination of drug trials and the inclusion of women and minorities in testing. In 2013, with new information about the effect of Ambien, a sleeping pill, the FDA cut in half the dosage recommendation for women, citing next morning impairment and dullness in those who had been using the recommended dosage.
It’s not clear yet how effective the government’s efforts will be.
Even though women are required by law to be included in medical research, it’s not happening as often as it should, finds a study published in 2014, "Sex Specific Medical Research: Why Women’s Health Can’t Wait," co-authored by The Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and The Jacobs Institute at George Washington University.
"Cardiovascular disease is the number one killer of both women and men in the United States, yet less than one-third of cardiovascular clinical trial subjects are female and less than one-third of cardiovascular clinical trials that include women report outcomes by sex," the report found.
Lung cancer kills more women than most other cancers considered "women’s cancers," such as breast, ovarian and uterine cancers. But too often, the 2014 study found, when lung cancer treatments are studied, the studies don’t distinguish between the medical outcomes for men and for women.
The higher incidence of depression in women would suggest that gender specific studies are also needed, but data show that is not occurring. And Alzheimer’s may be more of a woman’s disease than a man’s disease, but the data suggest that the studies believe that is because women live longer than men rather than because of gender differences, the 2014 study said.
All this prompted a bipartisan group of women in Congress, led by Sen. Dianne Feinstein, D-Calif., to ask the Government Accountability Office to press for the inclusion of women in clinical trials and led to a policy change at the National Institutes of Health to press for inclusion of more women.
That circles back to the message from NIH’s first female leader more than two decades ago.
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