# 1 News Flash: Women’s Bodies Are Different From Men’s Bodies!

The 60 Minutes piece, Sex Matters: Drugs Can Affect Sexes Differently in 2014, revealed the FDA didn’t require testing on female and male subjects for drug approval and that Pharma traditionally preferred male subject who don’t have “pesky hormones” to mess up the trials was one of our favorites of the year. In the piece we learned that Ambien, the popular sleeping aid effects women much longer than men, and is the first medication to have different prescribed doses for men and women. Since that piece aired we’ve wondered what’s happening with these realizations? Are we studying women’s reactions enough?

In this NY Times piece we are reminded once again that men and women are not identical.

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.

Despite the obvious differences in our bodies, we’re learning more and more that hormones seem to be the regulator of health — just as we’re learning in regards to obesity — and here women are at a huge disadvantage, simply because they have not been studied:

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.

Scientists need to start from the very beginning.  In this recent nThe good news is the FDA has created stricter guidelines that encourage testing on both sexes. It’s about time!

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.

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.

check out the whole story at The New York Times 

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