Women have long been left out of clinical research studies funded by the federal government. Despite a law passed in 1993 by Congress that ensures both women and minorities are included in health research, their underrepresentation continues today.
This is especially true for women with severe mental illness because most clinical research into the efficacy of antipsychotic medications happened prior to the 1993 law passage. In fact, the last new approved medication for schizophrenia occurred more than 30 years ago.
The Biden administration has an opportunity to correct the underrepresentation of women in psychiatric clinical research through the proposed multibillion-dollar Advanced Research Project Agency for Health (ARPA-H), a new science agency focused on breakthrough health care cures modeled after the Pentagon’s research arm, DARPA. Recently, the Biden administration announced the appointment of Dr. Renee Wegrzyn as the first director of APRA-H. Wegrzyn should ensure ARPA-H includes funding of research into promising new treatments for severe mental illness, including how treatment effects may differ in women.
According to a new report published by my organization, Treatment Advocacy Center, women with severe mental illness have unique experiences and treatment needs compared to men with the same disorders, such as different side effects from medications and greater difficulty in accessing inpatient psychiatric care. A common theme among our focus groups of women with schizophrenia and bipolar disorder was how participants felt like their distinctive needs were not met and currently available medications did not provide adequate relief of symptoms.
Most currently effective medications for severe mental illness were studied primarily in men, without any exploration of how the efficacy may differ in women with these disorders. For example, in the clinical trial for clozapine, the most effective medication for treatment-resistant schizophrenia, which was approved by the FDA in 1989, only 20 percent of study participants were women.
This is despite the fact that there are clear sex differences between men and women with severe mental illness. Men have an earlier age of onset of the illness, typically developing symptoms in their early 20s, compared to the late 20s for women. Symptoms of mental illness in women often cycle with their menstrual cycle because estrogen is a protective factor for psychosis. This also may explain why some women develop psychosis after terminating a pregnancy or giving birth when estrogen levels are reduced. Women with bipolar disorder are more likely to experience rapid-cycling —quick alterations between mania and depression — than men with bipolar disorder.
Equal representation of women in the research projects funded by ARPA-H to understand sex differences in psychiatric treatments for people with severe mental illness should be a minimum. Even better would be research that specifically targets understanding the unique treatment needs of women, such as estrogen treatments for reducing psychotic symptoms in women that don’t have the side effects of increasing cancer risk.
In advance of the bill markup in the House, the House Appropriations Committee released a report that urged ARPA-H to “consider mental health research, including diagnosis and treatment of SMI to address widespread behavioral issues to spur industry developments and new academic partnerships.” The Senate Appropriations Committee should include similar language, demonstrating clear congressional intent on the need to include research into serious mental illness in the ARPA-H initiative.
As Treatment Advocacy Center Executive Director Lisa Dailey recently wrote about ARPA-H, “the next breakthrough in schizophrenia research is waiting for us to decide that we must find it. This is our chance.” It is also our chance to correct the inadequacies of the past 70 years of psychiatric clinical research to provide better hope for women with severe mental illness.
Elizabeth Sinclair Hancq is the director of research for Treatment Advocacy Center, a national mental illness policy nonprofit.