Labs Are Told to Start Including a Neglected Variable: Females

[n2doc]

For decades, scientists have embarked on the long journey toward a medical breakthrough by first experimenting on laboratory animals. Mice or rats, pigs or dogs, they were usually male: Researchers avoided using female animals for fear that their reproductive cycles and hormone fluctuations would confound the results of delicately calibrated experiments.

That laboratory tradition has had enormous consequences for women. Name a new drug or treatment, and odds are researchers know far more about its effect on men than on women. From sleeping pills to statins, women have been blindsided by side effects and dosage miscalculations that were not discovered until after the product hit the market.

Now the National Institutes of Health says that this routine gender bias in basic research must end.

In a commentary published on Wednesday in the journal Nature, Dr. Francis Collins, director of the N.I.H., and Dr. Janine A. Clayton, director of the institutes’ Office of Research on Women’s Health, warned scientists that they must begin testing their theories in female lab animals and in female tissues and cells.

The N.I.H. has already taken researchers to task for their failure to include adequate numbers of women in clinical trials. The new announcement is an acknowledgment that this gender disparity begins much earlier in the research process.

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http://www.nytimes.com/2014/05/15/health/nih-tells-researchers-to-end-sex-bias-in-early-studies.html?hp&_r=1

[theHandpuppet]

1. Long past due!

Thank you much for posting. I hope you'll consider posting this in "Women's Rights & Issues" as well.

[Warpy]

2. Women react very differently to too many drugs and treatments

and studies that bothered to include us have mostly neglected to study the data along sex lines.

The rationale for years was excluding women from studies on the off chance we might be pregnant and sue them. Since most of us are pregnant for only 9-18 months out of an 80 year lifespan, that viewpoint is utterly insane.

I know a lot of my reactions to medications are weird, to say the least.

[Jim__]

3. Gender differences stand out in measuring impact of Viagra as therapy for heart failure

From MedicalXpress:

New animal studies by Johns Hopkins cardiovascular researchers strongly suggest that sildenafil, the erectile dysfunction drug sold as Viagra and now under consideration as a treatment for heart failure, affects males and females very differently.

The results of their investigations in varied male and female mouse models of heart failure are so clear-cut, says lead scientist Eiki Takimoto, M.D., Ph.D., that physicians may need to take gender into consideration when prescribing certain medications and that drug developers would be wise to take them into careful account when setting protocols for clinical trials of the medication in people. An online description of the new research appears May 16 in The Journal of Clinical Investigation.

Specifically, in female mice modeling human heart failure, the benefits of sildenafil ranged from robust to practically nonexistent, depending on the animals' levels of the hormone estrogen, says Takimoto, an assistant professor of medicine and a researcher with the Heart and Vascular Institute at Johns Hopkins. In male mice, sildenafil generally appears to work well, but only because it targets a different biological process independent of estrogen, he says. Estrogen is present in both male and female mammals, although in different amounts.

"The research is especially significant," he adds, "because it offers a mechanism to explain how estrogen affects sildenafil's efficacy. That's the first time the actual pathway of a hormone's cause and effect on a drug has been mapped out."

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