America is currently facing a mental health crisis — one that is impacting families and individuals in every community.
Mental Health Awareness Month: Fighting the growing mental health crisis and supporting innovation
America is currently facing a mental health crisis — one that is impacting families and individuals in every community, with the COVID-19 pandemic only exacerbating these trends. Mental Health Awareness Month, which is held each year in May, presents an opportunity to discuss ways to address the growing burden of, and stigma surrounding, mental illness.
What you should know:
More than one in 20 Americans have a serious mental illness, which reduces average life expectancy by 10 years. Major depressive disorder is the second leading cause of disability in the United States. Despite the growing prevalence and burden of mental illness, there remains a significant, unmet medical need for treatment options. For instance, a staggering 33% of patients with major depressive disorder have treatment-resistant forms of the illness. The same is true for those with schizophrenia.
Unfortunately, developing medicines to treat mental illness has some of the lowest probabilities of success. This is due in large part to the inherent scientific challenges and complexities that come with developing medicines to treat these illnesses, including a limited understanding of the brain and the neurochemical pathways involved in these illnesses. Though the field of neuroscience has made advancements in recent years, there remains a significant gap in the larger understanding of how mental illnesses develop in the first place. This, combined with the extremely diverse nature of the diseases themselves — which often manifest differently in different people — have made it difficult to identify biomarkers that can aid in diagnosis, treatment and the development of medicines to treat these illnesses.
How the biopharmaceutical industry is fighting mental illness:
Despite the incredible challenges, biopharmaceutical companies are committed to advancing new treatment options for patients with mental illness. There are now more than 160 medicines in development, all of which are either in clinical trials or awaiting review by the U.S. Food and Drug Administration (FDA). This pipeline includes medications targeting common mental illnesses, like depression, schizophrenia, anxiety, bipolar disorder, substance abuse or attention-deficit/hyperactivity disorder (ADHD), among others.
The Inflation Reduction Act Impact
Unfortunately, it is unclear whether advances combatting mental illness will continue to be pursued given additional risks and uncertainty posed by a new law which threatens innovation, at a time when it is needed the most. The Inflation Reduction Act (IRA) has introduced challenges that jeopardize the future of this critical innovation. In a recent survey of biopharmaceutical companies, 82% of respondents with research projects in areas including mental health say they expect the IRA to have substantial impacts on their research and development pipeline. The law also contains provisions that specifically undermine the development of small molecule medicines — which are the primary source of treatment options for mental illness due to their unique ability to cross the blood-brain barrier. As a result, the same survey found 63% of companies say they will shift R&D investment away from these medicines.
The IRA also ignores the critical research and development that occurs in the years following a medicine's FDA approval. Developing a new medicine to treat mental illness is a resource-and time-intensive process. After the 10 to 15 years, on average, it takes to bring a new medicine to market, additional research is often conducted to determine if a medication can be effective in other illnesses or in different patient populations. As scientists learn more about signaling pathways in the brain and the role they play across multiple mental illnesses, post-approval research and development will be essential to helping treat mental illness.
Patients suffering from a mental illness deserve the hope new treatments and cures will one day be available to them. But with the IRA in place, there is much less hope for the development of medicines that could help address America’s mental health crisis.
