It’s About Time: The NIH Tells Scientists to Include Females in Their Medical Animal Testing

You have heard of the lab rats — the mice, rats, bunnies and other animals that scientists have used for decades in controlled scientific studies, searching for that medical breakthrough via animal testing before bringing their testing to human trials.

What you may not know is that up until now, those animals have been almost completely male.

We’ve written about the disproportionate harm caused to women by pharmaceuticals before. The lack of females in animal testing is a big part of this ultimate harm.

What it comes down to is the female reproductive system, it’s different than a man’s (who would have thought?!) and that difference equates to more money and trouble for researchers searching for that breakthrough.*

Because of women’s different reproductive systems and the cycles and hormone fluctuations that go along with it, researchers had thought that a women’s “extra” reproductive and hormonal variables would upset the results of their experiment, requiring more animals to be tested in order to make sure that their calibrations were correct given the extra variables.

That may be true. But so is the consequence: Women have been inundated with side effects and dosage miscalculations that were only discovered once the product hits the market — whereas, for men, the risk of side effects and dosage miscalculations is more rare once the product hits the market because the effects of pharmaceuticals on men is much better tested from the onset. Way before pharmaceutical products hit the market, way before the human testing trials begin, even, comes animal testing. For men, their health and risk of side effects is better taken care of because they are represented from the onset, through male mice, rats, bunnies and other animals. For women, we could only dream — until now.

We’ll get into what this means for women and medical researchers in a second. But first we’ll talk about just how important this new mandate is using some key examples that likely could have been prevented had females been represented, and their health and different bodily systems respected, from the outset of the drug’s medical testing.

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Ambien

Last year, the FDA had to tell women that they needed to cut their doses for the sleeping pill by a dramatic 50 percent because studies conducted well after the product hit the market revealed that women metabolize the active ingredient in Ambien much more slowly than men do.[/one_half]
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Lipitor

The disproportionate harm to women caused by this cholesterol-lowering medication is two-fold. First, women taking Lipitor may develop Type 2 diabetes while taking the drug. Two, the evidence of Lipitor’s benefit to women is very limited and women taking Lipitor may reap very little reward. These two unfortunate points have to do with the fact that Lipitor was mostly tested in men.[/one_half]

Statins are one of the most widely prescribed drugs in America and sleeping problems, well, you may think they are a fifty/fifty problem but in reality more women suffer from sleeping difficulties more than men do. (That’s why we see the lack of females in animal and human trial testing more as a crime than a disregard!)

Thankfully, the National Institutes of Health has done the right thing and has said that this gender bias in animal testing must end. What that means is that scientists have been warned that they must begin testing on female lab animals, and on female tissues and cells, in addition to males.

Now this may be the dreamers in us, but we would also like to think that this may be one small step to help nudge researchers in the direction of thinking of their target patient from the outset. If women take more pharmaceuticals than men (true) and women have more sleeping difficulties than men (true), than would it not make sense to include more not close-to–none females in your medical product testing? Likewise, if statins are prescribed to both women and men and if both women and men make up the population equally (actually, there are a little bit more women in the world and in the United States than there are men), then would it not make sense to test Lipitor and statin medication in both men and women, you know, equally? We’d think so.

This news is big but let’s not get ahead of ourselves. Women are still underrepresented in drug companies and medical device manufacturer’s clinical trials and in the basic biomedical research and neuroscience that often serves as the foundation for new treatment ideas themselves. What that means is that women are not only more likely to be harmed by pharmaceutical drugs and devices than men, but are also less likely to have those medical breakthrough drugs be invented in the first place to help them. Instead, us women get the same drugs men do and all too often the special-to-women side effects are only discovered once it’s all but too late.