New NIH Policy to Address Sex Bias in Animal Studies Will Not Solve the Problem in Humans

The Physicians Committee
NEWS RELEASE May 15, 2014
New NIH Policy to Address Sex Bias in Animal Studies Will Not Solve the Problem in Humans

Statement of Sarah E. Cavanaugh, Ph.D., Medical Research Specialist

The NIH announced on May 14, 2014 a new policy that will require researchers applying for grants to address the gender bias in preclinical research by including more female animals in their studies. Despite its noble intentions, this policy does nothing to address the inherent flaws of animal-based research and will not result in improved public health.

Studies show that women and men generally respond very differently to treatments; for example, women taking new medications often experience severe side effects that were not predicted in preclinical trials. However, as large as the gender gap is between men and women in terms of response to treatment, the species gap between humans and nonhuman animals is far larger. Because animal studies do not predict human health outcomes, using both female and male animals in research will continue to produce ineffective and dangerous treatments for humans, regardless of gender.

The FDA reports that 92 percent of new drugs fail human trials, even after successful tests on animals.  Reducing this colossal failure rate requires a shift away from animal research—not a modification of this intrinsically flawed practice.

Although the new NIH policy is founded on the incorrect assumption that animal experiments produce knowledge about human diseases, it also encourages researchers to refine human-relevant research methods such as in vitro tests to more accurately determine how treatments will affect women.

We support this aspect of the policy and encourage the NIH to move toward requiring its grantees to use only human-relevant, sex-unbiased, nonanimal methods to evaluate potential treatments.

Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research.

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