Take this app and call me in the morning
Health tech companies are making a big push to digitize medicine, introducing novel tools like digital pills that track when patients take their drugs and smart spoons that can automatically adjust to hand tremors.
Now they want some patients to get prescription treatments from the app store as well.
Later this year, doctors treating patients addicted to substances like cocaine and amphetamines will be able to prescribe Reset, an app that gives patients lessons to help them modify their behavior. The Food and Drug Administration cleared it in September as the first mobile medical app to help treat substance-use disorders.
“It’s all the things you would traditionally associate with a pill or any other medication,” said Dr. Corey McCann, the chief executive of Pear Therapeutics, the startup behind Reset. “But it just so happens to be a piece of software.”
Pear Therapeutics is at the forefront of a new category of medical treatment, offering what company executives call “prescription digital therapeutics.” These products, they say, are medical apps that have been studied in randomized clinical trials, cleared by the FDA, require a doctor’s prescription and allow doctors to track patients’ progress.
Companies like Pear are trying to stand apart in a global market of more than 318,000 health apps by arguing that their products provide assurance of effectiveness and safety.
A few medical experts, however, argue that the apps are essentially just repackaging and rebranding existing treatments. They note that behavioral therapy done on a computer, instead of on a smartphone, was already a long-standing health treatment and backed by research.
“This is a branding effort that is meaningless,” said Dr. Allen Frances, a psychiatrist who is a professor emeritus at the Duke University School of Medicine. “FDA approval comes easily, and a prescription doesn’t guarantee greater efficacy.”
McCann, a former neuroscientist and venture capitalist, cofounded Pear Therapeutics in 2013. The startup has since raised $70 million and licensed a variety of digital therapeutics from researchers and other companies.
The Reset mobile app, for instance, is based on a web-based addiction therapy program. It was originally developed in the late 1990s by behavior modification researchers who digitized long-established methods of inperson addiction therapy.
Anyone will be able to download the Reset app. But to get it to work on a smartphone, patients must enter a prescription access code.
In clinical trial results that Pear submitted to the FDA, substance-abuse patients who used online therapy lessons had higher abstinence rates after nine to 12 weeks than patients who had not used them. However, six months after the study, abstinence rates among the two patient groups were about the same.