Drug research lacks data on women
Q: I hear talk about how women are underrepresented in clinical trials and lab studies, and that it makes such a difference in results. Should I ask my doctor if medications I am prescribed are tested on women?
A: There are some important biological differences between men and women beyond the obvious reproductive ones — and they can make a significant difference in how medications and medical treatments affect women versus men. One 2020 study found clear evidence of a drug-dose gender gap for 86 different medications approved by the
Federal Drug Administration, including antidepressants, cardiovascular and anti-seizure drugs and analgesics, among others. Turns out women metabolize the medications more slowly than men, boosting exposure — and in 96% of cases this resulted in significantly higher rates of adverse effects. Says professor Brian Prendergast, a University of Chicago psychologist and co-author of the study: “Especially for drugs that we already know have a wide therapeutic range — meaning there’s a wide range of doses that are still effective — we could do a lot better job of titrating dosages with sex in mind.”
When possible, doctors prescribe a smaller dose for women, and gradually increase to reach a balance where the medication is working as intended, but without significant side effects.
But the gap in research doesn’t stop there. In 2019, the FDA said in a review of approved medical devices that it had found “in the surgical literature, for female-prevalent diseases only 12% of [lab] studies that indicated sex of the animals, studied female animals.” In other words, researchers are studying female conditions on male animals.
You can ask your doctors if they know if the treatment being prescribed was tested on women, but it’s likely they won’t know. So, search online for information on problems in women associated with the drug or therapy. The Office of Women’s Health at the FDA is a good place to start. Together you and your doc can make the best decision about your treatment.
Mehmet Oz, M.D. is host of “The Dr. Oz Show,” and Mike Roizen, M.D. is Chief Medical Officer at the Cleveland Clinic Wellness Institute. Submit your health questions at www.doctoroz.com.