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Lawmakers push bill to end sex bias in medical studies

By Will Dunham

WASHINGTON (Reuters) - Biomedical research backed by the U.S. National Institutes of Health must use both male and female lab animals, tissues and cells under a bill introduced in Congress on Tuesday aimed at stamping out a bias toward males in studies not involving human subjects.

Congress 21 years ago required the NIH, the government's medical research agency, to include women in research it funded that involved human subjects. Before that, some studies being used to determine whether a new medicine or treatment worked simply excluded women, leading to findings that failed to account for important sex differences.

But current law does not require researchers to ensure that both sexes are studied in the basic research that paves the way for human trials. Experts say an existing bias toward male lab animals, tissue and cells can lead to flawed findings.

Legislation introduced in the House of Representatives by Democrat Jim Cooper of Tennessee and Republican Cynthia Lummis of Wyoming would mandate that studies funded and conducted by the NIH include and provide separate analysis of both male and female animals, tissues and cells.

The measure would also direct the U.S. Food and Drug Administration to guarantee that clinical drug trials for expedited drug products determine safety and effectiveness for both men and women.

The NIH announced its own steps last month to address sex bias, mandating that beginning Oct. 1 researchers seeking NIH grants must report their plans for balancing male and female cells and animals in the preclinical studies, with only "rigorously defined exceptions."

"We should study both women and men throughout the scientific process, starting with the earliest levels of research," Cooper said in a statement. "Better research leads to better outcomes."

"Medical research continues to progress, but as it does so, we need to ensure that we do not cut corners that could cost those being treated," Lummis said in a statement. "Data tell us men and women react differently to varying medical treatments."

(Reporting by Will Dunham; Editing by Peter Cooney)

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