Twenty-five years ago, a federal report established that women were not being included in any systematic way as participants in clinical research funded by our nation’s largest single funder of biomedical science, the National Institutes of Health. This meant that we did not know if the vast array of treatments developed by these studies resulted in the best or even appropriate treatments for women.
As revealed in a report released Friday by that same agency — the General Accountability Office — it appears that we have successfully included women in clinical trials generally, but we still don’t quite have the answer as to whether results provide the best treatment for women as well as men.
The accepted practice of generally excluding women in NIH-funded trials was reversed by a federal law signed in 1993. Subsequent NIH guidance and practices were assessed in a 2000 report by the GAO. Again in April 2014, concerned members of Congress requested that the GAO provide an update of NIH practices in regard to inclusion of women. Last week’s report supported the 2000 findings that women were increasingly being enrolled in clinical trials that test new interventions for various illnesses.
Even so, this optimistic note of increased enrollment of women is offset by the finding that the NIH is unable to identify whether women are appropriately represented in studies of specific diseases. This presents reason for real concern and is supported by published reviews of studies in cardiovascular disease and cancer, the greatest killers of women, suggesting that women are still under-represented in trials of these conditions.
Of even greater concern, the GAO Report found that the NIH is not ensuring that health outcome data are analyzed by gender. This means to me as a researcher that women are now included in our studies but still not recognized. In practical terms, this means that data from men and women are being combined in a single analysis so that findings across genders are averaged. These averages can mask gender differences if they exist so that the resulting data do not serve women or men.
To be sure, there are undoubtedly studies in which the influence of gender on health is examined and differences between men and women do not emerge. But, as biomedical scientists across the country look to the NIH for funding of their research applications, they also incorporate the research standards and directions set by the NIH. As a consequence, studies often are not designed to analyze gender differences and scientific publications reflect this approach. For example, in a review of published studies for treatment of depression, a condition found repeatedly in nationally representative samples to be twice as common in women than men, data were not analyzed by gender in half of studies surveyed. Of 768 ongoing trials examined in a given year, investigators reported an intent to analyze the results by gender in less than 1 percent of studies.
Data from men and women are being combined in a single analysis so that findings across genders are averaged and these averages can mask gender differences.
Dr. Carolyn M. Mazure
Some may question the extent to which gender differences have an impact on health. Emerging studies show gender differences in the symptoms and outcomes of various health conditions. For example, we now know that women and men can have different symptoms of heart attack and respond differently to low dose aspirin in the prevention of heart attacks and strokes, and women experience pain differently and have more complications from anesthesia. Women also are more likely to develop musculoskeletal problems such as osteoporosis and suffer fractures, have higher rates of relapse to smoking and are at higher risk of mortality due to smoking-related illnesses, are more reactive to stress resulting in different disease outcomes, and have declining longevity.
To its great credit, the NIH has embraced the recommendations of the GAO report in ensuring that the implementation of NIH-funded research does “meet the purposes of its Inclusion Policy.” But, in addition to the NIH providing and enforcing required guidelines for the conduct of gender-based analysis, we all must take responsibility for ensuring this change.
If we don’t finish the work begun 25 years ago, we will all suffer from a lack of important data and potentially misguided medical decisions.
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