Expert Opinion: Digital Therapeutics Can Help Meet Mental Health Goals
Bookshelves in Washington are filled with expert reports that have never been read and with recommendations that have never been implemented.
One recent report that should not be relegated to gathering dust is the White House Report on Mental Health Research Priorities.
“The U.S. is facing an unprecedented mental health crisis amongst children, adults, families, and communities. Even before the COVID-19 pandemic, one in five adults age 18 or older met criteria for having a mental illness, and in the case of more than 13.1 million American adults, to the point where it substantially interfered with or limited one or more major life activities,” the report reads.
Those who treat mental illness have long recognized the need to expand the availability of services, develop new treatments and make care more efficient.
Most of the recommendations in the report had been proposed before. We need more mental health professionals, better and more immediate access to mental health services. We need to focus especially on younger people and minorities, both of whom are undertreated even as their burden of illness increases. We need to develop and improve treatments for serious mental illnesses.
One developing area of mental health treatment has particular promise: digital therapeutics.
There are revolutionary new ways of using digital therapeutics (clinical treatment delivered digitally, automated and personalized) to treat mental health symptoms such as insomnia, anxiety and depression. These treatments are scalable, evidence-based and in alignment with the leading forms of care such as cognitive behavioral therapy (CBT). They have been studied in large-scale trials, just as a new drug would be, to prove their effectiveness and safety.
“There has been explosive growth in digital health platforms for a variety of mental health challenges and disorders in the past five years,” the report said. “Digital mental health interventions are treatments provided via digital platforms, such as smartphones, websites, and virtual reality systems, that aim to improve mental health and deliver treatment on their own or in combination with other types of interventions.”
“[T]he potential to provide mental health treatment at a population level via digital approaches is enormous,” the White House said.
We need to leverage the use of digital treatments and broaden the health system’s capacity for treating people with mental health problems. Not only will digital therapeutics provide broader access to effective mental health treatments, they also will save money and avoid further stress on our healthcare system.
In the regulatory context, we need to make sure that the FDA has the expertise and capacity to help the developers of digital therapeutics in their testing protocols, and then promptly review new and innovative digital therapeutic products. The FDA also needs to help payers, patients, and providers distinguish between digital wellness tools and true digital mental health treatments. In a recent interview, CDRH Director Jeffrey Shuren said that the FDA is prepared to reach out more to payers to help them understand the benefits of new technologies.
Other recommendations in the White House report also need attention. For example, mental health and substance abuse disorders often are regarded as separate categories. They are not. We need to better integrate substance use and mental health research and treatment, and make sure that FDA has the capacity to approve new treatments quickly.
We also need to recognize suicide as a serious public health problem. There are 48,000 suicides per year in the U.S. Suicide is the second leading cause of death for young people. FDA needs to assure that younger age groups are included in clinical trials for drugs and devices. We also need to deal with the role that social media plays in young lives.
We as a society must recognize that mental health challenges affect us all. We need to go into crisis mode. This will require leadership from our medical community, our political and thought leaders, and our regulatory agencies. It would be a grave mistake to let the recommendations in this report linger on the bookshelves.
Read the White House report: https://bit.ly/3n7Y4tR.
Wayne Pines, a former FDA associate commissioner, is president of the healthcare division of consulting firm APCO Worldwide.