Federal health officials are taking steps to correct a longstanding gender imbalance in laboratory research on potential drug treatments.An Editorial in the New York times states that “For the past two decades, federal law has required that women be included in clinical studies funded by the National Institutes of Health in recognition of the fact that drugs often have vastly different effects in men and women. As a result, more than half of the participants in N.I.H.-funded clinical research are women. But there has been no similar requirement to eliminate the sex bias from more basic laboratory research that can lead up to a clinical trial or doom a drug to the discard pile if it seems not to work.
“That is about to change. Top N.I.H. officials announced in the journal Nature this month that the agency would soon require researchers applying for grants to balance male and female cells and laboratory animals unless there is good reason to include only one sex “based on rigorously defined exceptions.” A laboratory study of ovarian cancer or of prostate cancer could presumably include only animals or cells of the relevant sex, for example. The new rules could have a significant effect on how laboratory research is conducted because the N.I.H. is a major funder of biomedical research around the world.
“The gender imbalance results in part from resistance to any change in ingrained practices, fears that costs may rise, and obsolete views that fluctuations in female hormones would complicate results in female laboratory animals. Yet for some traits and behaviors there is far more variability among males than females.
“Meanwhile, a bipartisan group of 15 female senators has expressed concern that women and minorities are still not adequately represented in clinical trials, despite two decades of remedial efforts. The group called for the Food and Drug Administration to require more women and minorities in industry-sponsored clinical trials, which have lagged behind the federal effort. It will take a concerted effort by government, industry, scientific journals and researchers to ensure that treatments are tested in groups that reflect the patients who will be using them.