Scientific research has a gender gap, and not just among humans. In many disciplines, the animals used to study diseases and drugs are overwhelmingly male, which may significantly reduce the reliability of research and lead to drugs that won’t work in half the population.
A new study published in the journal Nature Neuroscience suggests that research done on male animals may not hold up for women. Its authors reported that hypersensitivity to pain works differently in male and female mice. For males, immune cells called microglia appear to be required for pain hypersensitivity, and inhibiting their function also relieves the pain. But in female mice, different cells are involved, and targeting the microglia has no effect. If these differences occur in mice, they may occur in humans too. This means a pain drug targeting microglia might appear to work in male mice, but wouldn’t work on women.
Failure to consider gender in research is very much the norm. According to one analysis of scientific studies that were published in 2009, male animals outnumbered females 5.5 to 1 in neuroscience, 5 to 1 in pharmacology, and 3.7 to 1 in physiology. Only 45 percent of animal studies involving depression or anxiety and only 38 percent involving strokes used females, even though these conditions are more common in women.
In 1994, the National Institutes of Health confronted gender imbalance in clinical drug trials and began requiring that women and minorities be included in clinical studies; women now make up around half of clinical trial participants. In June, the N.I.H. announced that it would begin requiring researchers to take gender into account in preclinical research on animals as well.
Under the new requirements, researchers applying for N.I.H. grants in January 2016 and later will need to show “strong justification” if they plan to study only one sex. Justifications can include study of sex-specific conditions like ovarian cancer or limited availability of subjects of both sexes (as with primates).
This new policy for grants sends a good message to scientists and drug makers on the importance of considering sex in designing research projects, if they want to understand diseases that appear to affect men and women differently and develop medicines effective for those diseases.
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