Gender Health Risks

by Food and Drug Administration (FDA)

When it comes to health risks, sex does matter. Women are twice as likely as men to get multiple sclerosis, rheumatoid arthritis, and migraines. They're also more likely to get cataracts, hepatitis, and thyroid disease. Women experience depression about twice as often as men. And irritable bowel syndrome (IBS) is thought to affect twice as many women as men. Although men have more heart attacks than women, more women die within a year after having a heart attack.

"Despite this increased susceptibility to so many diseases, females across the world have a longer lifespan," says Joseph Verbalis, M.D., clinical director of Georgetown University's Center for the Study of Sex Differences, in Washington, D.C. "We don't know why," says Verbalis, "but that's one of the things we're trying to find out."

Researchers are finding that men and women are different in ways that go beyond their reproductive systems, hormones, and bone structure. They get many of the same diseases, but they may have different symptoms, their diseases may progress differently, and they may respond differently to treatment. While researchers are working to discover the underlying causes of these differences, scientists and regulators at the Food and Drug Administration are working to ensure that drugs and medical devices are safe and effective for both men and women.

Just as one size doesn't fit all, one treatment or test doesn't fit all men or all women. It's important to test drugs and devices in both women and men of different races and ethnicities in clinical trials, says Margaret Miller, Ph.D., manager of scientific programs in the FDA's Office of Women's Health (OWH).

The FDA has regulations and guidance in place to ensure that both sexes are represented in clinical trials, that study results are analyzed by gender, and that medical products are labeled to alert physicians and patients to any difference in the way men and women respond to a product. In addition, the agency is supporting research to identify gender differences that may affect the use of FDA-regulated products.

Gender as a Starting Point

Men and women are different in every organ of the body — ;even their skin, says Marianne J. Legato, M.D., a cardiologist and founder and director of Columbia University's Partnership for Gender-Specific Medicine. They are different at the cellular level, and these differences may influence the amount and type of medicine they need to treat a disease. "Dosage is not adjustable simply on the basis of body size anymore," says Legato. "I think we have to look at a whole variety of factors in prescribing dosages that are safe on the basis of gender."

"We know that different people, as individuals, respond to drugs differently," says Miller. "People routinely tell me, 'Oh, that drug doesn't do a thing for me.'" Some researchers place priority on studying differences in genetic makeup by individual, not gender, says Miller. They want to determine the exact sequence of DNA in a person's body in order to tailor treatments for that individual. "But even if the DNA is the same, men and women will express it differently," says Miller.

Researchers looking at DNA sequence may think that's a shortcut, says Legato, "which it obviously would be if we can take a slice of people's DNA and decide whether or not they would react appropriately to any medication to which they've not been previously exposed. That would be the ultimate, but I fear that that's years away. I think it would be nice to know the difference between men and women as a starting point."

In 2001, the Institute of Medicine (IOM), part of the National Academy of Sciences, published a report that supported studying potential gender differences during drug development. The IOM concluded that "sex matters"; that is, "being male or female is an important basic human variable that should be considered when designing and analyzing studies in all areas and at all levels of ... health-related research." The IOM defined sex-based differences as biologically based differences in men and women, and described gender-based differences as distinctions shaped by the cultural and social environment. Generally, the FDA does not attempt to determine why men are different from women and refers to any identified difference as a "gender difference."

About the Author

www.fda.gov
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.