Magazine article Drug Topics

How Genders Differ in Their Response to Drugs

Magazine article Drug Topics

How Genders Differ in Their Response to Drugs

Article excerpt

Rx Care

Viva la difference! Researchers are realizing that men and women respond differently to medications. This gender difference was discussed at the 62nd Congress of the International Pharmaceutical Federation (FIP), held in Nice, France, last month. The academic, clinical biology, and industrial sections of the organization joined together to present the program "Gender Analysis of Medications: Challenges to the Sciences and the Profession of Pharmacy." A panel of speakers addressed the important emerging awareness of the need to go beyond the "70-kg male" conventional model in clinical studies of medications.

Phyllis Greenberger, CEO of the advocacy group Society for Women's Health Research, Washington, D.C., spoke of the organization's work in lobbying. Through its efforts, women's health issues have become a part of the national public policy agenda. The National Institutes of Health and Food & Drug Administration guidelines for drug trials now include gender analysis as part of their research protocol.

Another result of the society's efforts was a recent Institute of Medicine (IOM) report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?"

Carmen Sapienza, Ph.D., of Temple University, a geneticist and a member of the study team that developed the IOM report, explained that the difference in sex is not just in women's and men's gene configurations but is an intrinsic difference at a cellular level that begins in the intrauterine environment. "Every cell has a sex," according to Sapienza, and it is necessary to study the differences "from womb to tomb" in order to maximize therapy The genetic differences influence other levels of biological organization from cell to organ, organ system to organism.

Sapienza emphasized that hormonal influences must be distinguished from the effects of the gene. It is imperative that clinical studies monitor sexual differences and similarities for all human diseases that affect both genders. "Until the question of sex is routinely asked, and the results-positive or negative-routinely reported, many opportunities to better understand the pathogenesis of disease and to advance human health will surely be missed."

Matthieu Kaltenbach, Ph.D., of France, addressed the specific pharmacological differences between men and women. Utilization of pharmacokinetic studies and pharmacodynamics during phase I and phase II clinical studies is a signal event for sex differences in medication metabolism, he said. …

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