[Corrected 3/17/15, 7:55 pm. See below.] The phrase “better living through chemistry,” derived from an old DuPont corporate slogan, has accumulated all kinds of ironic and wink-wink connotations over the decades. But there’s a fascinating revival and upgrade underway.
For people with debilitating mental health problems, many researchers, doctors, and businesspeople think the new phrase should be “better living through chemistry and digital technology.” OK, it’s clunky, but it helps describe a range of new digital therapies—delivered via mobile apps, desktop or TV-based games, and even immersive virtual reality—under development for mental health and addiction disorders that thousands of patients have already used.
As I wrote last fall, digital solutions to health problems have a lot of promise—and a lot of hype—but only a few have produced evidence that they improve patients’ outcomes.
In mental health, most digital therapy—and most of the evidence in its favor—has been found in research labs, not in traditional rigorous clinical trials, at least not the kind that new drugs generally have to go through for approval.
“We are taking some things developed in university clinics and test driving them in large HMOs, but we’re still grappling with the problem of when something has enough evidence,” says Farris Tuma of the National Institute of Mental Health’s division of translation research and a specialist in post traumatic stress disorder. “A lot of entrepreneurs don’t like this process, they say it stymies creativity.”
But some developers of experimental digital therapies welcome clinical rigor behind their products. “We’ve seen positive signals in the academic literature. We wouldn’t be here if we didn’t,” says Eddie Martucci, the chief operating officer of Akili Interactive Labs, a Boston startup founded by PureTech that is building video games to treat autism, attention-deficit hyperactivity disorder, depression, and traumatic brain injury. “But at this point we want to take those positive signals to the next level in large controlled clinical studies.”
Those clinical studies, says Martucci, will ultimately point Akili toward the best uses for its video game platform, called Project: Evo. (The startup Sync Project, also founded by PureTech, wants to build a clinical backbone into claims that music is good therapy.)
Claims that apps, games, and other digital products improve brain and mental health will be scrutinized intensely. Online brain-training games, for example, are under fire for making claims without scientific backing, with a long roster of scientists signing an open letter last fall to protest the way the products are promoted.
But for digital therapies aiming to stand alone or to augment pharmaceutical treatments, what will the standards be? Patrick Kennedy, a former U.S. Congressman from Rhode Island and now a mental health advocate, says regulators are lagging behind the facts on the ground. Combat veterans with the “invisible wounds” of PTSD, people with addictions, and others can’t wait for the bureaucracy to set new evaluation standards.
“We need regulatory agencies, the federal government and the Congress to respond to an urgent need,” says Kennedy, who sees a parallel to the 1980s, when activists forced the conservative FDA to allow trials of drug cocktails to treat HIV.
Kennedy, the son of former U.S. Senator Ted Kennedy, knows the regulatory and political system, has battled his own substance abuse and bipolar disorder, and is a cofounder and director of the mental health advocacy group One Mind for Research. “Multimodal therapies,” combining drugs, digital programs, and other services, are “the new end points” that the FDA needs to develop, which is why Kennedy is putting his weight behind Pear Therapeutics, a startup based in Boston and San Francisco. (Kennedy is chair of the advisory board, and another Kennedy, Stephen Kennedy-Smith, is the company’s EVP of corporate development.)
Pear’s business plan shows how a company that doesn’t want to wait for regulatory enlightenment has to proceed with drug-software combinations. Pear initially wants to marry academic work on digital therapies with old, generic pharmaceutical warhorses— a selective serotonin reuptake inhibitor for depression, benzodiazepine for anxiety, and zolpidem (a.k.a. Ambien) for sleep disorders, for example—and create new combination products that Pear is calling ‘eFormulations.’
[Correction: This paragraph has been changed to clarify the ownership of the addiction program and the number of trials the addiction program has been through.] CEO Corey McCann says Pear is farthest along with an addiction product and one for combat-related PTSD, where the bodies of evidence for the “drug-software synergy” are most promising. The digital therapy program for addiction, for example,
