It should come as no surprise that women's bodies are different from men's. And yet for the drug industry it did.
A recent “60 Minutes” report detailed how medical professionals are learning that women's bodies metabolize drugs differently than men's.
The finding is of particular concern because all too often drugs on the market have been tested exclusively on males — whether testing on humans or with lab animals.
Although on its face the omission seems somewhat sexist, it does have a medically grounded explanation.
Traditionally, medicinal professionals have believed that other than gynecological differences and hormones, men's and women's bodies were the same. So they excluded women from many drug studies to avoid the variable that hormones presented.
But it has become increasingly clear that medically there are important differences between the sexes.
The Food and Drug Administration cut the recommended dose of Ambien for women in half after discovering women had higher concentrations of the drug in their blood the morning after taking it.
Women taking antidepressants or antipsychotic drugs have been found to have higher concentrations of those drugs in their bloodstreams. They have also been found to respond differently to some high-blood-pressure medications and anesthetics.
Women experience different heart attack symptoms than men. Women get autoimmune diseases at far greater rates than men. And males are much more likely to have autism.
Women also have differences in pain receptors, liver enzymes and the wiring of the brain, according to the “60 Minutes” report.
Medical professionals are beginning to suspect that the gene differences between the sexes may account for how diseases affect each sex.
Efforts have been made in the past to increase the focus on women's health issues.
A bill passed by Congress in 1993 did direct the National Institute of Health to begin increasing clinical trials with women, and the Food and Drug Administration does have an Office on Women's Health, which it says was “established by congressional mandate to advocate for the participation of women in clinical trials and the analyses of data by sex.”
Now the Society for Women's Health Research is calling for more medical studies involving both women and minorities, and is urging Congress to hold hearings on the matter to gain more information on “the way biological sex impacts the onset, prevalence and severity of diseases and conditions.”
It would be a daunting task to go back and conduct new studies that include women on already approved drugs, but going forward the FDA must ensure that the effects of drugs on women are studied before new drugs are approved, and the medical profession must do more to recognize that men's and women's medical needs can vary greatly.