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ADVANCE Discourse: Lab

"Neglected Variable"

Published June 11, 2014 10:47 AM by Michael Jones

A mouse is a mouse is a mouse is a mouse – or so the research community had thought. As it turns out, a major component has been missing from the majority of animal testing for clinical drug production: more female animals. In a recent article from the New York Times, experts in the field discussed the importance of incorporating more female subjects into clinical testing and the subsequent impacts of current, male-dominated models on women in terms of side-effects after production.

“One of the underlying assumptions has been that females are simply a variation on a theme, that it isn’t a fundamentally different mechanism, that if you’ve learned about the male you’ve learned enough to with both males and females,” said Jill Becker, PhD, a senior research scientist at the University of Michigan, in the article. “We’ve discovered that’s not always the case.”

The use of male animals as the primary subjects in clinical testing has resulted in some particularly harsh and often serious consequences for women once a drug has already been in production due to different physiological responses to a variety of treatments. An example of this is the FDA’s recent warning for women to cut Ambien pills in half because the female metabolic process in slower in processing the active ingredient. According to the NY Times Piece, the NIH has new policies regarding male and female testing scheduled to be introduced in October, with exceptions most likely to be made for gender-specific ailments like prostate and ovarian cancers.

“Every cell has a sex,” explained Janine A. Clayton, MD, director of the NIH office of research on women’s health, in the story. “Each cell is either male or female, and that genetic difference results in different biochemical processes within those cells.”

The article also predicted some resistance among scientists in the research community due to additional strains the new regulations might place on experiments as the inclusion of animals of both sexes could potentially double the number of subjects needed to deliver the necessary results. Additionally, the article noted scientists' concerns regarding the need for more extensive calculations made to factor in changes in hormones and the reproductive cycle. On the other hand, the long-term decrease in serious, potentially harmful side effects of drugs incorrectly calibrated for women stands to drastically improve the effectiveness of clinical medications.  

posted by Michael Jones


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