ing of the differences between men and women with regard to treatments and response.

Carolyn Clancy, director of the Agency for Healthcare Research and Quality (AHRQ), added that the first randomized trial of estrogen to prevent heart disease was conducted in the early 1960s in men. The effect of estrogen on heart disease in women was not studied in a randomized trial until the Women’s Health Initiative, 35 years later.

The Need to Study Both Sexes

Martha Nolan, vice president for public policy of the Society for Women’s Health Research (SWHR), said that there is a great need to identify biologic and physiologic differences between men and women and to understand the implications of the differences for diagnosis and treatment. She noted, for example, that more women than men take antidepressants; women respond more slowly and are less likely to achieve an optimal response to treatment for depression; and women are more likely to stop using the medication because of adverse events. There are many other examples of differences that are not fully understood. Female athletes, especially those in contact sports, sustain a higher percentage of concussions during play than male athletes do, but virtually all the literature and mass-media attention is on male football and ice-hockey players. Transplantation of donor organs from females is less successful than transplantation from males. Boys are more likely than girls to receive a diagnosis of peanut allergy early in life, but by the age of 24, more women than men are receiving the diagnosis.

Parekh provided further support for the need to study both sexes. Women make up more than 50% of the U.S. population (50.7% according to the 2010 U.S. Census) and on the average outlive men (80.7 years vs 74.8 years). Many diseases place a heavier burden on women than on men (consider, for example, heart disease, cancer, rheumatoid arthritis, lupus, and osteoporosis); however, treatment guidelines are based largely on data on men. Women also rely more on medical systems than men do and are likely to seek treatment sooner.

Jesse Berlin, vice president of epidemiology at Johnson & Johnson Pharmaceutical Research and Development, said that sex-specific reporting helps to define the most appropriate population for treatment and to determine whether benefits or harms differ by sex. Differences between the sexes are more than just pharmacokinetic, however. For example, Berlin cited a recent report that describes sex-specific differences in cell regulatory processes (Mittelstrass et al., 2011).


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