ARPA-H could revolutionize medicine for women with severe mental illness

ARPA-H could revolutionize medicine for women with severe mental illness

Women have long been excluded from federally funded clinical research studies. Despite a 1993 law passed by Congress that ensures women and minorities are included in health research, their underrepresentation continues today.

This is especially true for women with severe mental illness, as most clinical research into the effectiveness of antipsychotic drugs took place before the 1993 law was passed. In fact, the last new drug approved for schizophrenia dates back more than 30 years.

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 scientific agency focused on breakthrough healthcare treatments inspired by the Pentagon’s research arm, DARP. Recently, the Biden administration announced the appointment of Dr. Renee Wegrzyn as the first director of APRA-H. Wegrzyn should ensure that ARPA-H includes funding for research into promising new treatments for serious mental illnesses, including how treatment effects may differ in women.

According to a new report published by my organization, Treatment Advocacy Center, women with serious 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 accessing psychiatric care in a hospital setting. A common theme among our focus groups of women with schizophrenia and bipolar disorder was how participants felt that their particular needs were not being met and that currently available medications were not providing adequate symptom relief.

Most currently effective drugs for serious mental illnesses have been studied primarily in men, with no exploration of how effectiveness may differ in women with these disorders. For example, in the clinical trial of clozapine, the most effective drug for treatment-resistant schizophrenia, which was approved by the FDA in 1989, only 20% of study participants were women.

This is despite the fact that there are clear gender differences between men and women with serious mental illness. Males have an earlier age of disease onset, typically developing symptoms in their early twenties, compared to late twenties for females. Symptoms of mental illness in women often follow their menstrual cycle because estrogen is a protective factor against psychosis. It may also 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 – rapid changes between mania and depression – than men with bipolar disorder.

Equal representation of women in ARPA-H funded research projects to understand gender differences in psychiatric treatment for people with severe mental illness should be a minimum. Even better would be research that specifically aims to understand women’s unique treatment needs, such as estrogen treatments to reduce psychotic symptoms in women who don’t have the side effects of increased cancer risk.

Before the bill was tagged in the House, the House Appropriations Committee released a report urging ARPA-H to “consider mental health research, including diagnosis and treatment of SMI to address prevalent behavioral problems in order to stimulate industry development and new university partnerships”. The Senate Appropriations Committee is expected to include similar language, demonstrating clear congressional intent on the need to include serious mental illness research in the ARPA-H initiative.

As Lisa Dailey, executive director of the Treatment Advocacy Center, recently wrote of ARPA-H, “The next breakthrough in schizophrenia research is waiting for us to decide we need to find it. This is our chance. It is also our chance to correct the shortcomings of the last 70 years of clinical research in psychiatry to give better hope to women with serious mental illness.

Elizabeth Sinclair Hancq is director of research for the Treatment Advocacy Center, a national mental illness policy nonprofit.

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