Has That Drug Been Tested on Women?

How printing more information on medicine bottles would improve scientific transparency.

Maria Fab­riz­io

Paula Johnson, executive director of the Connors Center for Women's Health and Gender Biology at Brigham and Women's Hospital, has proposed—along with  a team of researchers from Brigham, the Kaiser Family Foundation, and George Washington University—putting labels on medicine bottles explaining how extensively the drug has been studied on female subjects. I recently spoke with Johnson about how medicine impacts men and women differently, and how printing more information on pill bottles would improve scientific transparency. Our conversation has been edited and condensed.

—Zach C. Cohen

What are some of the challenges involved in sex-specific research on medicine?

I can remember back in the early '90s, when I was a young faculty member, giving talks to cardiologists on women and heart disease, and basically none of the big trials had women at all. So we have come a long way since then, but where we are in 2015 is in no way adequate. Women are included in clinical trials, but they are often not included in numbers adequate to really report statistically significant results. Moreover, the data are frequently not stratified by sex, even though we know there are significant differences between the sexes. (We also know there are racial and ethnic differences.) We know that there are sex differences in the way medications are metabolized, and it's not just that women are little men.

Let's promote transparency. Let's point out the data that we have, and let's also point out when the data are inadequate. Without searching through appendices, you should be able to tell not only the percentage of women and minorities, but whether or not the data are stratified in the report and what the findings are.

How do you and your coauthors envision these labels looking?

What we recommended was almost like a nutrition label, but instead of "Nutrition Facts," it says, "Research Facts," and then it gives you the sex-specific breakdown for whatever the study showed. It doesn't have to look like this, but the idea is to have a way of standardizing the very high-level reporting. It would actually go a long way toward promoting transparency, because if you had to present these data in a label format, it would really make scientists think very hard about reporting the data in their publications.

So it includes the total number of subjects and the percentage of the study participants who were women?

What it's giving you is an easy wayfor any given studyto understand the data.

Does this improve consumers' ability to choose which medicines will be best for them?

It isn't as though, if a drug or its efficacy has not been established by sex, you would not take it. But it would be a flag to actually begin  a discussion with your physician.

There are areas where the data are in the FDA, but it hasn't necessarily been translated into actual clinical practice. Ambien is a case in point. We knew there was a difference in the way the drug was metabolized, but that had not been translated into actual practice until you really saw the impact a good while later on women.

What are some of the obstacles to implementing this idea?

It's not clear to me why this has not been done. The FDA isn't a funder of research, but the FDA obviously looks at research and determines whether they're going to approve drugs and the way that the drugs will be labeled. So the FDA has a lot of power in directing how that research is going to be done. There's been a lot of pressure, I think, some through Congress, and the FDA is now examining the issue, and we're waiting to see how they're going to think about these considerations and implement them. So we're making some progress, but we are a long way from being in a place where we understand the most current scientific advances and how they impact women versus men.