Slashdot Mirror
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.'"
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?
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 wonder if those exercises your physiotherapist asked you to do after the accident, and if that diet the nutritionist asked to you take to lose some weight, shouldn't also be considered "drugs" and require FDA approval. Jesus how can marketing people be allowed to waste taxpayer funds on a bullshit project like this. I'm not saying the program doesn't work (although it might not - they haven't done real clinical studies yet), I am saying however that dragging the FDA into this is completely irrelevant and a marketing ploy at best.
Seven puppies were harmed during the making of this post.
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"...
There is no single player version. Co-op/multi only :-)
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.
Give me Classic Slashdot or give me death!
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.