engaged reaction to it. We try to hit enough high notes that when the person goes in there, their jaw drops.”
Rizzo and Weill Cornell Medical College psychologist JoAnn Difede, who has developed virtual-reality PTSD treatments based on the World Trade Center attack, have tested their VR programs in combination with an old antibiotic, D-cycloserine, that has been revived as a cognitive enhancer. The hypothesis is that retraining traumatized people not to fear their memories, or the triggers that cause PTSD—what’s known as “extinction learning”—is more likely to take hold when the D-cycloserine is altering the brain’s chemistry.
Difede and Rizzo are expanding that investigation with a multimillion dollar multisite trial. Pear’s McCann is confident of bringing an “eFormulation” version to the FDA next year.
He hopes the PTSD and addiction products could get 510(k) clearance and be ready for launch by end of 2016, but both he and Schwab, who has invested in Pear alongside undisclosed angel investors and family offices, acknowledge that they’re treading new ground. “We don’t know what the FDA wants yet,” Schwab says.
That uncertainty speaks to the pioneering nature of all digital therapies, whether combined with drugs or not. For example, Akili is planning an autism trial with more than 100 children who will participate in a four-week “regimen” at home. No drugs exist to treat the disorder itself. How do you compare the therapy to a control group? What’s the digital equivalent of a placebo? “No one has done this before,” says Akili COO Eddie Martucci. “It’s kind of crazy.”
It’s not entirely unlike a drug maker trying to evaluate an experimental drug in a disease with still-mysterious biology, as Biogen Idec (NASDAQ: [[ticker:BIIB]]) R&D chief Doug Williams described to Xconomy earlier this year when talking about a drug meant to reverse the course of multiple sclerosis.
Another question revolves around safety. Biology is complicated; even well-tested drugs can sometimes show pernicious unintended effects years later. What about noninvasive games or apps?
None of the researchers and practitioners I spoke with reported ever seeing any problems. Rizzo says no adverse reactions to VR have been reported.
Kamal Jethwani, who evaluates technology for healthcare delivery at the Center for Connected Health, part of Partners Healthcare in Boston, says he’s followed game-based therapies for autism and hasn’t seen anything to set off an episode or worsen a patient’s condition. However, he did say that getting schizophrenics, who are already paranoid about being tracked and monitored, to comply with app-based regimens, was “a whole can of worms,” and a tiny pilot trial didn’t work.
There’s another paranoia circling around digital apps, that those aiming to replicate face to face therapy, will end up replacing therapists and other mental health professionals.
“We’re not positioning ourselves in any way as competitive with mental health professionals, full stop,” says McCann.
But some digital apps do aim to relieve part of the patient burden. Jethwani says Partners just began a 100-patient study of a tablet-based app that delivers cognitive behavioral therapy, or CBT, to people with moderate to severe depression. “We know that once patients have their meds in place, the CBT is successful.”
Will a digital version be as successful? Partners has 60,000 patients in its system eligible for depression medication, says Jethwani. “Therapists are hammered every day to take more patients on. They know the waiting lists”—four or five months is common in Boston—“and they’re eager to get this going.”
They’ll still need to evaluate patients, prescribe the digital CBT, and follow up, and they’ll still handle “the most complicated patients” who won’t benefit from the app. But if it works, “they won’t as much spend time on people who can watch videos and get better,” he says.
