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Developer Seeks FDA Approval For Therapeutic Game
dotarray writes "In what's believed to be an industry first, a developer has begun talks with the American Food and Drug Administration to get its game recognized as a therapeutic drug. 'Brain Plasticity has been fine-tuning a game to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder. Early next year, they will conduct a study with 150 participants at 15 sites across the country. Participants will play the game for one hour, five times a week over a period of six months. If participants' quality of life improves at that "dosage," Brain Plasticity will push ahead with the FDA approval process.'"
How long will I have to wait until my insurance buys me video games?
Ok, on a serious note, this seems to ne the next logic step if It's going to be used for legitimate therapy.
Should violent videogames be considered narcotics?
Somehow I can't take them seriously as "developers" without any sort of company web page. The most you can find is a short entry in a business directory and links to the various copies of the above article. Did anyone have better luck?
based on Gears of War 3!
Then as a recreational one.
If a game can have a medically recognisable affect, it falls under the purview of those who would regulate your private activities for reasons of their morality.
If this is approved, what's the over/under on how long it takes before it is used as a justification for government interference with a tool that is used to bring pleasure in a manner contrary to a morality?
I had to read the summary about 3 times before I noticed it was GAME not GENE.
GENE would be a way more interesting /. story.
I'm mystified why a therapeutic game is noteworthy to anyone who have ever had occupational therapy or knows anyone who ever took OT...
Admittedly the OT games I'm familiar with were mostly pretty lame, like, "you took 5 steps last time, now try for 6" but I've heard of some that got pretty elaborate.
The fact that this one is mental not physical seems irrelevant to me. If my sister in law does repetitive addition drills using a video game, thats called "being a modern teacher". If a doc re-teaches addition to a stroke victim using the same game, thats not noteworthy.
I learned a lot from playing hex-based military sims when I was a kid... patience, planning, delayed gratification, concentration, cooperation, how to judge competitors, "good sportsmanship"... Other games would have worked just as well, but I love hex based military sims. Sometimes I think I personally keep matrixgames.com in business... Having a dr prescribe the same games to a kid with poor impulse control would not exactly be the most insightful thing ever.
"Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
So the Food and Drug Administration is now taking its cues from the laughably named "Defense Department" ("Team America World Police" has been a more appropriate name for, at least the lifetime of my parents...) and branching out. Good for them I guess.
It does however make me wonder whether I will be able to play these games without a prescription? Will I be labeled a "recreational player"? Perhaps I should refer to roaming the New Vegas Wasteland as "self medicating"? Will gangs kill each other over the ever escalating prices of black market games? A rash of wild illegal "lan parties" where addicts setup illicit temporary networks.
Eventually they will setup game courts and monitor people to make them kick their habit, which will actually result in a black market for secondary computers that can be hidden inside normal looking furniture.
"I opened my eyes, and everything went dark again"
I'd be very curious to know what the cost/benefit is for them to seek FDA approval is: Their game has copyright protection even if it is of no theraputic value whatsoever, and games are only ever regulated by Team Morality if they are overtly sexual or violent, so they are totally clear to sell the thing subject only to the generic constraints of trade laws.
Similarly, friends/family/etc. of patients are free to do more or less whatever in the hopes that it might help, assuming it isn't otherwise forbidden, and buying a game wouldn't be. Even psychologists and psychiatrists have a fair amount of latitude to try unproven things, so long as they don't amount to malpractice(and, since a game is pretty much a waste of time at worst, that would be a hard claim to make.)
Because of that, I'm curious as to why they would go for full FDA approval, rather than just kick out a few positive preliminary studies and/or some word of mouth, and move more units, faster, albeit probably at somewhat lower unit price, rather than go through the entire approval process, with the risks and delays that can entail, in the hopes of getting it formally recognized as a treatment...
I think he's going with the wrong strategy...
If he tries to position the game as a therapeutic drug, then he's gonna have problems with people that play it too much being considered "drug abusers".
Whereas if it's considered a treatment, like for example exercising on a pool for people that suffer from Arthritis, abusing it is not going to be considered "something bad"...
The noteworthy thing appears to be that they are trying to get a full FDA-approved-for-the-treatment-of badge, rather than just generating some modestly positive results and selling it semiformally based on the fact that you have pretty broad latitude when trying potentially theraputic stuff that isn't drugs(which, as you note, has been going on for ages). Because that strategy has already been in use for so long, apparently reasonably successfully, I'm wondering why they are trying this; but it is novel.
There is no single player version. Co-op/multi only :-)
What's the point of doing this it's not like they need approval to use it on people.
get its game recognized as a therapeutic drug.
Drat that means I'll only get insurance coverage for the generic version. Speaking of which, what is the generic version of this? Angry Birds? First Person Shooter copycat number 2526? Farmville?
"Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
What's the control condition?
So let's say they get fda clearance to sell this as a therapeutic device (n.b. choice of "clearance" not "approval" -- FDA cares about that difference). Now what are the standards and best practices for correctly maintaining the device. Is every install going to have a pre-flight check?
I'm wondering why they are trying this; but it is novel.
Recently, the FDA successfully stopped developers who claimed their programs helped acne (through use of colored display) and had them fined for all their revenue from the apps. These guys are probably just being preemptive.
"...to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder..."
So they're going to take crazy people and try to make them smarter and more focused without trying to address the craziness. Is anyone worried about this? Do we really need more Hannibal Lecters in this world? (Part joke, part serious.)
The game would not be regulated as a "drug", but rather a "medical device." Software falls in the medical device category.
Why might this game be a regulated device? It depends on what the company claims. If the company wants to claim that the game "helps people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder," then it is a medical device used to treat a health condition, and therefore falls under the Food & Drug Act. Before the company could sell the game with that claim, they would have to present scientific evidence to the FDA that the claim is actually true.
If the company does not want to make a specific health related claim, they can sell the game however they darn well please.
Pretty sure my quality of life would drastically decrease if I were forced to play an educational video game five hours a week for six months, and I am not even schizophrenic.
In theory, this isn't actually that out-there as an addition to a treatment regimen, although the trial should be an order of magnitude larger to produce meaningful data. What we'd hope for is a means of giving the patient a quantifiable, self-directed method of practicing certain aspects of his or her cognitive behavioral therapy -- there's a lot more to therapy than what takes place at the therapist's office. The danger comes from a product that allows the patient to learn to beat the game, rather than improving his or her skills in the real world. (This is where so-called "brain training" games for general entertainment have failed: Play memory cards for a few hours a day, and you'll get very good at turning over memory cards. You still won't be able to find your keys in the morning though.)
Schizophrenia basically means that a person has difficulty assigning priority to ideas. The toast you actually just put in the toaster has no more significance than the goofy idea that just popped into your head about your ex. Sounds reasonable until you consider thinking that way nearly all the time, and actually trying to get anything done. Add a dash of natural human paranoia, and it can cause some serious harm.
We'll hope for the best, but I still prefer to see any new treatment given the level of scrutiny we instinctively give to a new (molecular) medication.
Federal agencies - especially under the current administration are grasping for power - regardless of if there is any enabling legislation! This stupidity is playing right into their hands. If they can gain a foothold on "therapeutic games", it will be like the "medical device" nonsense, where only a licensed practitioner or someone with a prescription can buy the thing.
We are supposed to be self-reliant, yet this takes away yet another tool for self-reliance and autonomy.
I think this is great! Hopefully, this will help stop the flow of pseudoscientific software apps that make medical claims about things they couldn't possibly do, like controlling acne, or boosting mood by shining a dim light at you. If they're going to claim to cure or treat some disease or condition, then this is the only realistic way to handle it. Otherwise their claims are just the same as any other snake oil salesmen. This has nothing to do with regulating video games that make no medical claims. It's only those that claim they do something medical. And they seem to be eager to at least step up to the plate and show proof that their product works or doesn't just like other medical manufacturers do. (Of course, they need to be scrutinized by peer review, too, just like other medical manufacturers are, to make sure their testing was done correctly.)
True, though those devs were slapped down because they were stupid enough to overtly claim specific medical benefits. The FDA can, and sometimes will, slap you down for doing that. However, if your product falls under the DHSEA, you can get away with practically anything, so long as you make your claims in slightly oblique language and don't kill too many people. If it is a food item, you can get away with a similarly broad collection of "Qualified Health Claims".
In the case of a game, which definitely isn't going to be killing anybody, and probably isn't at the top of the list of the dwindling population of FDA inspectors, you could almost certainly run into no trouble so long as you kept your statements of the form "$GAME$ engages player's short-term memory and executive function" rather than "$GAME$ improves player's short-term memory and executive function". At that point, you'd just need a promising preliminary study or two, or some positive word-of-mouth, and there would be absolutely no legal obstacle to selling it, and tacitly promoting it for use in environments where patients with schizophrenic symptoms are treated...
If you make direct, overt, health claims, or try to market a drug that isn't either grandfathered or approved, the law is not your friend; but there are a number of ways around that, most being actively exploited.