| WASHINGTON, June 17
WASHINGTON, June 17 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
"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)