New England News
6:26 pm
Mon March 3, 2014

Health Summit Focuses On Gender Equality In Clinical Research

Credit http://www.brighamandwomens.org/Departments_and_Services/womenshealth/ConnorsCenter/Policy/summithome.aspx

Twenty years ago Congress passed legislation requiring women and minorities be included in medical trials supported by the National Institutes of Health. A group of health care specialists and lawmakers met for a summit in Boston today advocating for further sex-specific medical research.

The summit served as a celebration of the 1993 National Institutes of Health Revitalization Act and also included the release of a report titled “Sex-Specific Medical Research: Why Women’s Health Can’t Wait.” Dr. Paula Johnson is the executive director of the Connors Center for Women’s Health and Gender Biology. A study co-author, she also served as the event’s host.

“Women were routinely not included in clinical trials,” Johnson said. “If they were, sex differences that were detected were largely unreported. What that meant was that the science that led to diagnose and treatment of disease was predicated predominantly on male physiology.”

Massachusetts U.S. Senator Elizabeth Warren was the keynote speaker.

“We have much to be proud of in health care research, but we must also face the hard truth that research on women’s health and gender differences lag far behind the research on men’s health care,” Warren said. “Too often, even the policy conversation around women’s health lags as well.”

The report focused on the disparities in research, diagnoses, treatments and outcomes between men and women for heart disease, lung cancer, depression and Alzheimer’s.  For example, the report says although heart disease is the top killer of women in the United States, only one-third of clinical trial subjects are female and only about 30 percent of trials that do include women report outcomes by sex. Senator Warren pointed out disproportionate representation of female subjects starts before a study even reaches human trials.

“Analysis shows that only 38 percent of stroke and 45 percent of anxiety and depression studies used any female animals even though these conditions disproportionately affect women,” Warren explained. “The NIH does not currently require researchers to report the sex of the animals they use even though the clinical trials that result are based on data collected from these models. This should change as well.”

Warren did point to progress in that 57 percent of trial participants in NIH studies are now female. But the Democrat said there needs to be greater focus on how the hormonal and biological differences between men and women are researched and documented to find out why diseases and treatments affect the sexes differently.

“Recently the FDA [U.S. Food and Drug Administration] recommended the dosages of certain sleep drugs be changed for men and women,” Warren said. “These are the first and only drugs that actually have prescription levels that differ for males and for females because they are believed to affect men and women differently. Surely this won’t be the last.”

Warren said the federal government should double its investment in clinical research saying it will save lives and help manage future medical costs. Warren pointed out the 2014 federal budget increased NIH funding by $1 billion from sequestration levels while the Department of Defense’s bio medical research budget saw a $400 million bump. New York’s Democratic U.S. Senator Kirsten Gillibrand, who has advocated for more women in governmental and executive positions, was also at the summit. She left for what was called an emergency before giving her keynote address.