Drug Testers Must Not Forget Women


Women and men are different. Even kids know that. But some who grew up to become researchers must have skipped class the day that bit of biology was taught.

They don’t seem to understand that publicly funded medical research should be conducted in ways that apply to women as well as men.

Despite repeated calls to action, many researchers still use only male animals in their experiments.

Partly as a result, women experience more problems with inappropriate doses and adverse drug reactions than men, National Institutes of Health Director Dr. Francis Collins and Dr. Janine Clayton, director of the institute’s Office of Research on Women’s Health, wrote last week in the journal Nature.

That overreliance on males in studies can mask differences that should guide subsequent research.

When that happens, important gender differences may not be discovered until after a drug is on the market.

For example, the Food and Drug Administration halved the recommended dose of the sleep aid Ambien for women last year after finding that the amount previously recommended for both sexes increases the risk of next-day impairment of driving and other activities that require full alertness.

The NIH is moving to change the unacceptable status quo. Beginning in October, it will require applicants for NIH funding to report their plans for balancing male and female animals and cells in preclinical studies.

Those plans will be taken into consideration when awarding grants. That should get researchers’ attention. The NIH invests $30 billion a year in medical research, most of it through competitive grants to more than 2,500 universities and other institutions.

In 1993 Congress required the inclusion of women in NIH-funded clinical research.

Today more than half of the participants are women.
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It shouldn’t take an act of Congress to extend gender equality to lab animals.

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