Chicago Tribune | By Lisa Black
September 2, 2014
Women and men often react differently to illness and treatment, yet surgical researchers rarely use female animals or cells in their published studies--to the detriment of patients, a Northwestern University professor has concluded. Dr. Melina R. Kibbe, senior author of a study published Thursday in the journal Surgery, said she was stunned by what she found during her review of five medical journals published in 2011 and 2012.
"The manuscripts we reviewed were really pitiful," Kibbe said Friday. "About one-third of the manuscripts did not state the sex of the animals or cells. That was a surprise to me because these are peer-reviewed." Of the 2,347 articles reviewed, 618 included animals and/or cells, she found. In the surgical literature where sex was identified, 80 percent of the studies used only males.
Yet medical evidence shows that women metabolize drugs differently from men and experience different side effects from treatments, she said. The prescription insomnia medication, zolpidem, for instance, became the only drug on the market that differentiates dosage by sex in 2013, after women began reporting they were still impaired the day after taking the drug, she said.
Aspirin is another widely used medication that benefits men differently from women, research has shown. "The public needs to be made more aware of this problem," said Kibbe, a professor of surgical research. "They should feel free to ask their physicians about the medications they are taking and if they have been tested specifically for their sex." More attention has been paid to the inclusion of women in clinical research, but there is "little to no focus on the importance of including both sexes in basic science and translational research that studies animals or cells," her paper notes.
Her study followed a "60 Minutes" segment in February that helped bring attention to the problem, Kibbe said. Since then, the National Institutes of Health has announced that it will develop a policy that will require all of its funded researchers to study both sexes for all preclinical research. The Food and Drug Administration in August announced an action plan to "enhance the collection and availability of demographic subgroup data."
Such studies will cost more, requiring more animals for testing, Kibbe said. But researchers, she said, can no longer plead ignorance to the importance of studying females and males separately. "Just including men and women together (in studies) isn't enough," she said. "You need to study both sexes and then report the data separately."