One reason for the study was concern over the fact that women are often excluded from clinical studies of diseases and drugs. This practice dates to a post-World War II law excluding women for liability reasons. It also springs from the practical concern that women, at different stages of their hormonal cycles, have different biochemical reactions to tests. But tests developed in the past decade make it much easier for scientists conducting clinical studies to control for womens cycles, Vandenbergh said.
The IOM committee recommended some changes in the way clinical studies are done. "Our committee does not recommend that all clinical studies include both men and women. What it does recommend is that investigators and funding agencies make sure they consider using both men and women and evaluate the importance of doing that," Vandenbergh said. "If youre studying the effect of a drug on prostate cancer, it doesnt make much sense to put women into the study. On the other hand, if youre studying a drug for breast cancer, it might make sense to put men in some of the studies. Men do have mammary tissue, and they, at a very low rate, get breast cancer. By including men in a study of breast cancer, you might learn something about women."
Vandenbergh, whose research interests include hormonal changes during puberty and reproduction, has explored how fetal exposure to sex hormones -- the male hormone, testosterone, and the female, estradiol -- affects animals later in life. Research has shown that animals sexual behavior, anatomy and physiology are influenced by the hormones they encounter in the womb.
Litter-born animals such as rodents and pigs are exposed to sex hormones in utero from other fetuses surrounding them, said Vandenbergh.
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Contact: Dr. John Vandenbergh
vandenbergh@ncsu.edu
919-515-5174
North Carolina State University
13-May-2001