In a recently released Scientific Statement, the Endocrine Society called for sex differences to be studied thoroughly to improve public health. Biological differences between females and males affect virtually every aspect of medicine and biomedical research, according to the statement.
The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions. The society has more than 18,000 members, including scientists, physicians, educators, nurses, and students in 122 countries around the world.
The authors note that failing to consider sex differences can lead to the failure of promising drug candidates. Drugs are tested in cell lines or animals before drug trials are conducted in humans, and most of these foundational studies rely predominantly on male animals or cell lines. Clinical studies similarly fail to consider sex as a variable and instead often report it as a confounding factor.
“When we understand the ways sex differences operate at baseline in health, which can either worsen the course of a disease to amplify differences in health outcomes, or protect against it, we can more effectively prevent and treat medical conditions,” said Aditi Bhargava, a professor at the University of California, San Francisco and the chair of the group that authored the society’s Scientific Statement. “Without exploring sex differences, some drug candidates that could be beneficial to women never have the chance to make it to market. The process of developing drugs using only males of a species in pre-clinical studies likely contributes to the higher rates of adverse drug reactions in women compared to men, failure to see efficacy in clinical trials, and translation to therapeutics.”
The full document, “Considering Sex as a Biological Variable in Basic and Clinical Studies: An Endocrine Society Scientific Statement,” was published on the website of the journal Endocrine Reviews. It may be found here.