What is a digital medicine, exactly? Akili co-founder Adam Gazzaley explains
Videogames as medicine. It sounds like a sci-fi movie subplot in which scientists repurpose an addictive leisure activity into a prescriptive treatment.
Like many sci-fi scenarios, though, this story arc is poised to play out in real life. Last December, Akili Labs reported positive late-stage trial results for a videogame designed to treat kids with ADHD. Of the 348 children who participated in the randomized trial—all were between the ages of 8 and 12, and all were diagnosed with ADHD— those who played Akili's game over the course of a four weeks showed statistically significant improvements on the metrics of attention and inhibitory control.
While the game hasn't yet been tested alongside ADHD medication, based on the strength of these findings the company filed with the FDA and expects to receive approval this year or early next. For Akili's co-founder, Adam Gazzaley, this is the beginning of an entire new field of medicine.
A neuroscientist by training, Gazzaley has spent more than a decade building and testing game mechanics designed to improve brain function out of Neuroscape, his research lab at the University of California at San Francisco. Akili's ADHD videogame is the closest to commercialization, but Gazzaley says he's working on a range of games and digital medicines designed to medically treat cognitive conditions such as depression and dementia.
MM&M spoke with Gazzaley about what's next for Akili, how he defines “digital medicine,” and where the field is currently positioned on the hype cycle.
This interview has been edited for clarity and length.
How close is Akili to getting FDA approval for its videogame to treat ADHD?
We just had a post-trial meeting with the FDA. We hit our pre-submitted primary outcomes, which is always a really nice statistical hurdle to pass. Right now we are preparing our proposal for a de novo classification [an alternate pathway to classify a novel medical device with the agency]. It's more rigorous to go through. But we don't think there is an FDA-approved product like ours on the market.
We'll probably submit within the next month. Because [the videogame] isn't built on a predicate of a previously approved treatment, it will take longer. But, optimistically, we hope to get approved before the end of the year. We would be surprised if it wasn't approved by Q1 of 2019. From there, we move ahead with the deployment of our first product.
If the videogame is approved, how do you plan to approach providers and payers?
We are in new territory. We have a treatment that we have efficacy for and that has a very low side effect profile, but there's lot more work to be done to figure out the best dosage and things of that nature.
We are moving ahead with this as a prescribable treatment. We're still working out details such as how we monetize, how we sell, and how we target physicians, patients, and their families. At the beginning, it will likely be a pay for treatment [out of pocket]. We've had conversations with payers, but these conversations take a long time. I don't think anyone has an easy time with insurers no matter who you are or what you are creating.
Why did you file as a de novo, when Pear Therapeutics' app to treat substance use disorders was recently approved by the FDA as a digital form of cognitive behavior therapy?
We don't believe this is a predicate for us because we are not a behavioral therapy. In our minds, [Akili's videogame to treat ADHD] is more similar to a drug, in that it works on the network level to change how the brain processes information. The active ingredients are directly targeting neural physiological processes as opposed to behavioral therapies. We think of it more as a digital medicine, rather than a digital therapy.
You've been testing the clinical applications of games for more than a decade. How does the game design process typically work?
We start with a neural system and cognitive operation that we want to improve. We take lessons from neuroscience and cognitive neuroscience about how the system might be selectively targeted through an experience. Using a system of design principles, we create adaptive algorithms that take data in and create targeted challenges and feedback loops. We design around that, building mechanics to target the brain selectively through game design.
It typically takes us two years to build a game. It's a really intense process. And then it takes a couple years to do the first studies. Usually we start in healthy people to figure out, “What do we have here? Do we even have something?” That is the incubation process, which I do at my lab. Akili goes a step beyond that, building out a better interactive experience with the help of a world class videogame professional team, and then rigorously testing it.
So it's an interplay between game mechanics and clinical validation.
I put a lot of value into parallel high-tech development and high-level rigorous scientific validation. We do both at Neuroscape, and both are done at Akili. I think that disconnect that often exists between the tech development and the research side has fragmented the field and prevented it from flourishing.
Sometimes a company that is very tech savvy will build something that might be fine for entertainment, but they don't have the background in the neuroscience and the cognitive science and the type of process that creates effective interactive media for the purpose of building digital medicines.
Scientists who are well-versed in rigorous scientific design will sometimes use the most boring types of exercises to train people that I could ever imagine. I can't understand how people could engage with them for 20 minutes, much less a month.
So the disconnect, I see it on both sides. We try to bridge the neuroscience and the technology at every level. When we build a technology, we know what we are trying to target in the brain, and we know which studies we'll use to understand what is happening.
Why do we see a lot of research and studies from health-focused tech companies, much of which isn't peer-reviewed or evaluated by a third-party?
It's part of the growing pains of a new field. This is what happens. If there is a real good idea that has a solid foundation, then there will be a hyper-inflated growth curve, accompanied by over-inflated marketing claims. You've probably seen these hype cycles, right?
The question quickly becomes: “Is this snake oil; is this really made up?” If it is made up, the idea disappears forever. If not, it grows more slowly. We are hitting that point now. We have hit the top of the overinflated excitement. There is lots of pullback controversy, but hopefully Neuroscape and Akili will help the field regrow.
Disclosure: The author's family member has a financial connection to the company.