NEAVS responds to NIH’s misguided plan to fund animal studies with both sexes
Sep 23, 2014 • Letter to the Editor

Guinea pigThe following is in response to the New York Times article, "Health Researchers Will Get $10.1 Million to Counter Gender Bias in Studies." Read article below.

While well intended, the plan falls short in correcting the problem resulting from using only male animals. Even with added data from both sexes of animals, there is no indication the new data will be any more applicable to humans. Human men and women respond to drugs and disease differently – animals studies aside. As we learn of more consequences of biological sex differences, it becomes even more problematic – and unscientific – to rely on data derived from a different species.

Many drugs that appear safe and effective in animals fail in humans, or cause significant harm – even death. Animal use diverts resources away from developments that can lead to real breakthroughs. A 2004 FDA study reported 92% of drugs entering clinical trials following animal testing fail to be approved. Of those approved, half are withdrawn or relabeled due to severe or lethal adverse effects not detected during animal tests.

Meanwhile, better science that does not use animals is available and advancing. For example, in January the first non-animal alternative method for skin allergy testing – developed by Proctor & Gamble – was approved in the E.U. Upon approval, a company spokesperson stated how it is better business to use faster, cheaper, and more accurate non-animal tests. Or consider the promising “organ-on-a-chip” technology being developed at Harvard University among other laboratories.

Ignoring the unique female genetic makeup is shoddy science and must be rectified. But ignoring the even more profound differences between species and issuing a fleeting directive to use animals of both sexes is not a solution.

We are in the age of personalized medicine, and sex variability needs prominent consideration. But it is folly to continue our dependency on other species as models for humans. Only by bringing the study of women to a focus equivalent to that of men, accompanied with leaving animal models behind, can the medical breakthroughs we all await be realized. Learn more about the issue here

Health Researchers Will Get $10.1 Million to Counter Gender Bias in Studies

In an effort to begin addressing persistent gender bias in laboratory research, the National Institutes of Health announced Tuesday that it will distribute $10.1 million in grants to more than 80 scientists studying a diverse array of subjects, including drug addiction, fetal development, migraines and stroke.

The researchers will use the additional funds to include more human participants — generally women — in clinical trials and to ensure that their laboratory animals, even cell lines, are representative of both genders. The money also will be used to analyze gender differences in the resulting data, officials said.

“It’s an early first step we’re taking to encourage people to see the value of studying sex as a biological variable,” said Dr. Janine Austin Clayton, associate director for women’s health research at N.I.H. “What we are after is to transform how people think about science and therefore transform how science is done.”

Women are not adequately represented in many clinical trials of new drugs and medical devices. The gender bias starts at an early stage of the scientific process: Traditionally many investigators have worked only with male lab animals, concerned that the hormonal cycles of female animals would add variability and skew study results.

Scientists often prefer single-sex studies because “it reduces variability, and makes it easier to detect the effect that you’re studying,” said Abraham A. Palmer, an associate professor of human genetics at the University of Chicago. “The downside is that if there is a difference between male and female, they’re not going to know about it.”

This year, in a commentary in the journal Nature, Dr. Clayton and Dr. Francis S. Collins, director of the N.I.H., called for an end to this bias, and warned scientists they must begin testing their hypotheses in female lab animals, tissues and cell lines.

As a result of the over-reliance on male animals and male cell lines, Dr. Clayton said, “We literally know less about every aspect of female biology compared to male biology.”

K. C. Brennan, an assistant professor in neurology at the University of Utah, said he has focused on sex differences in his research on migraines. But including female mice in studies drives up the costs, because his team must do extra experiments to control for the females’ estrus cycles.

Yet it’s important to study female animals: Two-thirds of migraine sufferers are women, he noted, and hormonal fluctuations appear to play a role in triggering migraines. Dr. Brennan said he will use the supplemental funds to include female animals in his current research and double the number of experiments.

“Sex differences are the elephant in the room,” Dr. Brennan said. “You want to have both male and female animals, because something that shows up differently in males and females might be a clue to how the disease works.”

Other researchers will use the grants to evaluate gender differences in stroke, immune responsiveness to vaccines, and molecular differences between the placentas of female and male fetuses, among other topics.

Dr. Palmer, of the University of Chicago, already uses both male and female mice in his research on genes that predispose animals to methamphetamine abuse. The supplemental funding will enable him to look at gene expression in 200 animals instead of 100.

“We know that the way drug abuse plays out in humans is gender specific,” he said. “If we can understand the mechanisms by which the sex differences might manifest, ultimately we may find different treatments are more effective for one sex or the other.”

Read original article here.