Gender Health Risks : Continuing Efforts, Men, Women, and Heart Disease

by Food and Drug Administration (FDA)

(Page 4 of 4)

So far, a small number of differences have been found in the way men and women respond to drugs, says Temple. An FDA study reviewed gender-related labeling for 171 new drugs that were approved for both males and females from 1995 through 1999. Labeling for two-thirds of the drugs contained some statement about gender, although only 22 percent described actual gender differences and none of these differences were considered significant enough to recommend any change in dosage for one gender.

"But just knowing that is useful information," says Miller. "You know you can take these drugs without a higher risk because of your gender."

The FDA is also working to revise drug labeling so that both consumers and health care providers can better understand important information about a drug. A proposed FDA rule will require prescription drug labels to contain "highlights" in a prominent place. The highlights will discuss the more serious and common side effects and significant gender differences found in clinical trials.

Continuing Efforts

The FDA's Office of Women's Health is funding research within the agency to examine gender differences — ;particularly in the areas of heart disease, obesity, and HIV — ;that are important for the agency to consider in regulating medical products.

In one project funded by the OWH, scientists within the FDA's Center for Biologics Evaluation and Research are studying the replication of HIV, the virus that causes AIDS, in human blood cells from male and female blood donors. By infecting the blood cells with HIV in a culture medium and then adding various sex hormones, scientists are learning more about the influence of gender on the concentration of the virus. They are also studying the effect of sex hormones on certain antiviral drugs used to treat HIV.

"Some of the things we're looking at may affect when treatment should be started in men and women," says Andrew Dayton, M.D., Ph.D., an FDA research medical officer. And it may give us preliminary insight into how gender might affect response to HIV treatments, he adds. This information may help in designing clinical trials to test the effectiveness of HIV treatments in men and women.

In another initiative, the OWH is developing an innovative knowledge management approach to make better assessments in groups of people (subpopulations) to protect patient safety. The Demographic Information and Data Repository (DIDR) was mandated by Congress in 2002 to monitor the inclusion of women in clinical trials and to study gender differences and variability in response to medical products.

Katherine Hollinger, D.V.M., M.P.H., a senior health promotions officer in the OWH, says the DIDR will help the agency to look at groups of people — ;including groups characterized by gender, race and ethnicity, older people, and children — ;in a more informed way. "It will allow us to better look at subpopulation issues and differences in drug response that may affect safety and effectiveness," says Hollinger. "And it will allow us to not only track inclusion of women and other populations in clinical trials, but to monitor the types of trials women, children, or the elderly are participating in and identify patterns that are observed."

Other benefits of the agency-wide DIDR include helping the agency to design better studies for new products, enabling more efficient and informed reviews and approval decisions, and allowing better assessments of product labeling.

Part of the problem in looking at study data to determine subpopulation differences in response to medical products is the lack of standard approaches and terminology used in individual studies. The agency is working with the pharmaceutical industry and standards organizations to establish standardized approaches to labeling, study data, and study protocols that will be used in the DIDR to protect the safety of women, men, children, and older people of every race and ethnicity.

Men, Women, and Heart Disease

Heart disease is the leading cause of death in the United States for both men and women, according to the American Heart Association. "But the normal heart is different in men and women," says Marianne J. Legato, M.D., a cardiologist and founder and director of Columbia University's Partnership for Gender-Specific Medicine. "Women's hearts beat faster, even during sleep," she says. And women have different proteins in the heart cells.

"Some data suggest that the whole physiology of the coronary arteries and what keeps them open and what causes them to go into spasm might be significantly different in men and women," says Legato, adding that some women have had heart attacks without any of the fatty buildup of plaque seen in the coronary arteries in most people with heart attacks.

And the symptoms of a heart attack may be different. "Twenty percent of women will not have the 'typical symptoms' of chest pain radiating down the left arm," says Legato, "but will instead describe nausea, profound sweating, and shortness of breath and pain in the upper abdomen."

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.