Bradley Merrill Thompson Quoted in “Need Mental Health Help? There Are Apps for That, but Picking the Right One Is Tough”

Los Angeles Times

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Los Angeles Times, in “Need Mental Health Help? There Are Apps for That, but Picking the Right One Is Tough,” by Jenny Gold.

Following is an excerpt:

In the eyes of the tech industry, mental health treatment is an area ripe for disruption.

In any given year, 1 in 5 adults in the U.S. experience a form of mental illness, according to federal estimates. And research indicates only about half of them receive treatment in a system that is understaffed and ill distributed to meet demand.

For tech startups looking to cash in on unmet need, that translates into more than 50 million potential customers.

Venture capital firms invested more than $2.4 billion in digital behavioral health apps in 2020 — more than twice the amount invested in 2019 — touting support or treatment for issues such as burnout, depression and attention deficit hyperactivity disorder. At least seven mental health app companies have achieved “unicorn” status — being valued at more than $1 billion.

But even as industry hype mounts, researchers and companies are scrambling to prove these apps actually work. Of the estimated 20,000 mental health apps available for download on personal computers and smartphones, just five have been formally vetted and approved by the Food and Drug Administration, which largely has taken a hands-off approach to regulating the space. …

Type “depression” or “anxiety” into an app store, and you’ll be met with a dizzying list of results. There are thousands of “wellness” apps such as Headspace that counsel people on breathing exercises and other techniques to help them feel more mindful. Apps such as Woebot and TalkLife profess to help manage conditions such as anxiety and postpartum depression using games, mood journaling or text exchanges with peers or automated bots.

Some apps are meant to be used alongside in-person therapy, and others are meant to be used on their own. Several of the most popular, such as Talkspace, BetterHelp and Ginger, promise access to treatment with a licensed therapist over text message, phone or video. Others, including Brightside and Cerebral, connect users to psychiatrists who can prescribe antidepressants.

Most products make their money by charging consumers a monthly or annual fee, with the option to purchase extras such as video sessions with a therapist. Others contract directly with employers or insurers.

And, yes, a small portion of these apps have promising research to back them up. Several studies, for example, have found that cognitive behavioral therapy, a mainstay of treatment for depression and anxiety that seeks to help patients change negative thought patterns, is as effective when delivered using web-based platforms as when done in person by a licensed professional. And the pandemic has bolstered claims that patients are willing to trade in-person visits for the ease of online connection. …

The challenge for consumers is separating the apps that might help from those that offer little more than distraction — or could actually do harm.

Some companies offering mental health treatment had recently been doing something totally different. For example, an online seller of erectile dysfunction and hair loss treatments has started offering psychiatric evaluations and prescribing and selling antidepressants.

Tech companies are by nature for-profit and, in the rush to compete in a saturated market, many are selling a product with an appealing user interface but little evidence of effectiveness. A 2020 analysis by Australian researchers reviewing nearly 300 apps for anxiety and depression found just 6% of the companies that boasted an evidence-based framework in the app store description for their products had published any evidence.

Nor do star ratings and download totals offer much context: An April study from Beth Israel Deaconess Medical Center and Harvard Medical School found little correlation between app store metrics and treatment quality. …

Cerebral offers online therapy and medication management and delivery for a variety of mental illnesses. The monthly subscription fees range from $29 to $325, depending on the level and frequency of care, as well as insurance coverage. …

Even critics of the tech explosion are quick to acknowledge that the current brick-and-mortar system of mental health is dated and inadequate. In recent years, the issues surrounding mental illness and lack of access to treatment have infiltrated public dialogue. Brain illnesses that many families once squirreled away from view have become the stuff of celebrity culture and dinner-table chatter.

Yet even as advocates have made strides in acceptance, truly improving the lives of people with mental illness has proved to be stubbornly difficult. Over the last several decades — while the U.S. successfully lowered death rates for cancer, heart disease and other major illnesses — deaths by suicide and drug overdose have continued to climb.

Federal law theoretically requires insurance companies to cover mental illness as they would any other illness. But finding affordable care remains a challenge, largely because of a shortage of licensed mental health professionals and ongoing inequities in insurance coverage.

In a nation where huge swaths of the population lack a primary care doctor and health insurance — but most everyone has a cellphone — connecting people to treatment via mobile apps would seem a logical solution. And, for some, the opportunity to talk about their mental health challenges anonymously makes online treatment an attractive alternative.

Still, many of the experts who welcome the potential for innovation in mental health treatment acknowledge that consumers are getting little guidance in how to choose a reputable option. “Wellness” apps that promote a healthy lifestyle or apps that help people manage their disease without providing specific treatment suggestions can avoid FDA regulation. But even those that offer patient-specific diagnoses and treatment recommendations that would seem to fall squarely under the FDA’s authority do not seem to garner the agency’s attention, according to industry experts.

“The FDA has been really, really lax on enforcing in digital health for reasons that are not entirely clear to me,” said Bradley Merrill Thompson, a lawyer at Epstein Becker Green who advises companies on FDA regulations. “Anybody could spend 20 minutes on the app store and find dozens of examples of apps that make medical device claims, and that have been doing so for some time, without any effort by the FDA to rein them in.”