Before a medication is released to the public, it’s safety and effectiveness must be put to the test. Clinical trials are a key part of this process, but experts say drugs are being proclaimed safe without enough attention on how the impacts differ between men and women.
Dr. Teresa Woodruff, Director of the Women’s Health Research Institute at Northwestern University, suggests the example of the drug Ambien, a common prescription sleep aid that was taken off shelves because of adverse events in women. Even though it was observed that there was a difference in how long it took for the body to clear the drug in men and women, the difference in efficacy was never quantified. The drug was later returned to shelves, but received new labeling instructing women to take smaller doses than men.
Dr. Melina Kibbe, Professor of Surgery at Northwestern University, says this is the first time a drug had explicitly instructed different dosing for men and women, but questions how many more drugs need to be reconsidered. Only one third of research subjects in clinical trials are women and, even if a study has exactly fifty-percent of each sex, issues still remain. “The problem is if you include both sexes but you report the data in aggregate then you won’t know if a drug has say a better effect in men versus women,” Dr. Kibbe explains.
Even before human clinical trials, research is conducted on predominantly male cells and animals, with very little focus on the variable of sex of the subject. Dr. Kathryn Sandburg, Director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown University, says researchers fall victim to the fall belief that there’s less variable in studying male subjects than female because of hormonal cycles. The opposite turns out to be true. Males actually have more variables to control. Recently, there’s been a push to have equality in research subjects, but private pharmaceutical companies are still not required to adhere to these guidelines.
- Dr. Teresa Woodruff, Director, Women’s Health Research Institute, Northwestern University
- Dr. Melina Kibbe, Professor of Surgery, Northwestern University
- Dr. Kathryn Sandburg, Director, Center for the Study of Sex Differences in Health, Aging & Disease, Georgetown University