Developer Seeks FDA Approval For Therapeutic Game 48
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Soulskill
from the not-approved-for-off-label-use dept.
from the not-approved-for-off-label-use dept.
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.'"
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And FDA approval is just the first step in letting the corporate bribed commissioners stamp this into the ground.
I'm betting that unless this developer has connections to big pharma it will be delayed indefinitely.
Re:Insurance (Score:4, Interesting)
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I'm also aware that there are FDA regs that say "only a drug can cure, prevent, or treat a disease"
So, if some big pharma corp gets wise to anything his program can do that will reduce the need for the pills he is pushing...look out.
By this logic (Score:1)
Should violent videogames be considered narcotics?
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Back in 2001 the US was thinking about it: "... will find repeated exposure to violent entertainment during early childhood causes more aggressive behavior throughout a child's life, according to a draft of the report obtained by The Times."
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Should violent videogames be considered narcotics?
FPS - to be sold on prescription only and administered by qualified medical personnel.
Net visibility? (Score:1)
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I can't say anything about this company -- I know nothing about it and have never heard about it, but that isn't even remotely uncommon for a small company running dark with nothing to sell. I've done consulting with a number of companies that have gone a year or more like that before having any public visibility, particularly in the healthcare space.
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They probably have no interest in selling anything. The rough formula in pharma is:
1. Get venture capital based on some promising concept or prior research.
2. Develop drug (or in this case video game) using venture capital money
3. Do some early studies to see if drug might be effective
4. If it looks remotely promising, file with FDA
5. IPO!
6. Wait for FDA. File. Refile. Watch the stock price jump around like crazy.
At this point, if the FDA approves the drug, they will likely get snatched up by a big company.
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First as a therepeutic drug... (Score:4, Funny)
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?
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If a game can have a medically recognisable affect, it falls under the purview of those who would regulate your private activities
Most of that crowd is blindly power hungry. Go for common cause with the jocks. Obviously jogging and treadmills have a medical effect and making tennis shoes prescription only or requiring a license to purchase a treadmill will not go over well.
Game? Not Gene? (Score:2)
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
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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.
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In the case of a game, which definitely i
will I be a prescription drug abuser then? (Score:3)
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.
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You know.... after I hit submit I was thinking the same thing...
I am especially looking forward to new forms of "extreme gaming" that will come out of illicit environment. I always thought a game like counterstrike, but where every player's machine was rigged to hit him with a stun gun when he died in game. I imagine that it would quickly change the dynamic of the game and make it quite intense.
I can't wait...bring on the bans and the party vans!
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You already can - there's at least one game for the DS3 that purports to exercise the brain. Not to mention that various puzzle books, etc... for "improving the brain and problem solving skills" have been around for decades. On top of that, and also for decades, you've been able to buy children's toys designed to emphasize learning motor skills or various cognitive skills.
All without the various over e
Some FDA background (Score:3)
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 coul
I wonder why? (Score:2)
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 forbidde
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If you want to sell something as a medical device, you need FDA approval. You can't even make health promises on a box of Cheerios without FDA approval.
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Also, if you want insurance companies to pay for it, you need FDA approval.
If I sell a small device with a button you push to call the fire department if you smell smoke, I don't need FDA approval.
If I sell the same device, same exact hardware, but it calls EMS when you've fallen and can't get up, and I want your insurance company to pay for it, I need FDA approval.
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You want to know why basic hearing aids are so damn expensive? Because they're FDA approved. Thus, they can lock-in the price the market will bare. Given how the average citizen is abstracted from the true cost of medical care thanks to medical insurance, the profit margins are astronomical. The supply/demand ratio is way out of tune with normal market forces. Getting a game FDA approved is pure genius. Games are a dime-a-dozen these days. But, get the insurance to cover the expense and you can charge prett
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I'd be very curious to know what the cost/benefit is for them to seek FDA approval is...
Well, for starters, you'll be able to present the game to schizo lab mice, during trials... who knows, maybe there'd be a new market? (and thanks for all the fish)
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I know somebody who has communications problems. She had the opportunity to purchase some software that would aid her communications (think something like Steven Hawking - but simpler). It ran on a 5-year-old macbook. The whole thing was sold as a bundled package for $10k (yes, with 5 zeros), and was highly locked down (ie no web browsing from the thing, so there would be no possible synergies using it to type emails or something).
The only reason they can get away with it is that insurance would pay most
Treatment... not drug! (Score:2)
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"...
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then he's gonna have problems with people that play it too much
Considering this "game" is targeted at schizophrenics I doubt anyone is going to be playing it too much. Now getting people to stop trying to destroy the monitor because the voices told them that it had demons inside, yeah, that could be a problem. But playing it too much no, I will give you 5 reasons... 1. Morning is green bicycles on my chair, 2. That shirt is pissing me off because of my dog and (insert long, disjointed schizophrenic rant).
I assume (Score:3)
There is no single player version. Co-op/multi only :-)
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There is no single player version. Co-op/multi only :-)
Doh... I really can't afford to buy a computer and a game license for all my personalities.
What's the benefit (Score:1)
Name brand vs generic (Score:2)
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?
Control? (Score:1)
Isn't anyone worried about this? (Score:2)
"...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.)
Weakly Hopeful (Score:2)
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 im