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Developer Seeks FDA Approval For Therapeutic Game

Soulskill posted more than 2 years ago | from the not-approved-for-off-label-use dept.

Medicine 48

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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Insurance (0)

Anonymous Coward | more than 2 years ago | (#37524722)

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.

Re:Insurance (1)

shentino (1139071) | more than 2 years ago | (#37524746)

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 (3, Interesting)

Dunbal (464142) | more than 2 years ago | (#37525038)

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.

Re:Insurance (1)

shentino (1139071) | more than 2 years ago | (#37525350)

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 (1)

Anonymous Coward | more than 2 years ago | (#37524800)

Should violent videogames be considered narcotics?

Re:By this logic (1)

AHuxley (892839) | more than 2 years ago | (#37525022)

http://www.mail-archive.com/cybershooters@compuserve.com/msg03372.html [mail-archive.com]
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."

Re:By this logic (1)

Dunbal (464142) | more than 2 years ago | (#37525046)

Heh in America (land of the free), possibly. Also add to that list "games_I_don't_like", where "I" is any influential "elected representative".

Re:By this logic (1)

c0lo (1497653) | more than 2 years ago | (#37527154)

Should violent videogames be considered narcotics?

FPS - to be sold on prescription only and administered by qualified medical personnel.

Net visibility? (1)

ashkante (1714490) | more than 2 years ago | (#37524842)

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?

Re:Net visibility? (0)

Anonymous Coward | more than 2 years ago | (#37524868)

got slashdotted without a web page. These guys lost the lifetime marketing opportunity

Re:Net visibility? (1)

tgd (2822) | more than 2 years ago | (#37524932)

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.

Re:Net visibility? (1)

MightyYar (622222) | more than 2 years ago | (#37525054)

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. If the drug fails, then the whole company will sometimes fold, or sometimes raise more capital and start over again. Either way, the scientists, investors, and executives live to fight another day.

Re:Net visibility? (1)

bluefoxlucid (723572) | more than 2 years ago | (#37527980)

I have. The game is called Go, and it's been around for over four thousand years.

Brain Plasticity... (0)

Anonymous Coward | more than 2 years ago | (#37524890)

based on Gears of War 3!

Re:Brain Plasticity... (1)

Errol backfiring (1280012) | more than 2 years ago | (#37524944)

No, Blob Wars.

First as a therepeutic drug... (3, Funny)

elewton (1743958) | more than 2 years ago | (#37524920)

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?

Re:First as a therepeutic drug... (1)

vlm (69642) | more than 2 years ago | (#37525014)

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.

Re:First as a therepeutic drug... (-1)

Anonymous Coward | more than 2 years ago | (#37525154)

By that logic, 99% of porn gets whacked... heh...
Amish porn still stands though... it's like watching an old ghost movie with all the white sheets!

Game? Not Gene? (1)

vlm (69642) | more than 2 years ago | (#37525006)

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.

Re:Game? Not Gene? (1)

fuzzyfuzzyfungus (1223518) | more than 2 years ago | (#37525102)

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.

Re:Game? Not Gene? (1)

coinreturn (617535) | more than 2 years ago | (#37526322)

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.

Re:Game? Not Gene? (1)

fuzzyfuzzyfungus (1223518) | more than 2 years ago | (#37538094)

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". [fda.gov]

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.

will I be a prescription drug abuser then? (2)

TheCarp (96830) | more than 2 years ago | (#37525036)

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.

Re:will I be a prescription drug abuser then? (0)

Anonymous Coward | more than 2 years ago | (#37525306)

That actually sounds pretty fun. Roll on the War On Games!

Re:will I be a prescription drug abuser then? (1)

TheCarp (96830) | more than 2 years ago | (#37526500)

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!

Re:will I be a prescription drug abuser then? (0)

Anonymous Coward | more than 2 years ago | (#37525540)

The regulations for OTC use are basically this:
The lay public are capable of diagnosing the condition, and continued use will not significantly delay them seeking out a doctor for a more serious condition. (e.g. a limit of 14 days for otc prilosec before it recommends you see a doctor because it might be cancer etc.) and the package had adequate directions for safe use by lay public.

To switch from Rx to OTC, the company typically petitions that they can fulfill the above, but the company does not have to necessarily be the one to petition the FDA for the switch. Patent extension is the main reason for the timing of the switch from Rx to OTC in most cases. This is why most drugs don't like to start out as OTC.

In this case though, I could see it being held up as a medical device, which is subject to slightly different regulations. The most important of these is that once it is on the market, an equivalent device may be made assuming it doesn't violate the originators patents, which is why I am guessing they will press it to be a drug for easier exclusivity.

Re:will I be a prescription drug abuser then? (1)

DerekLyons (302214) | more than 2 years ago | (#37527236)

It does however make me wonder whether I will be able to play these games without a prescription?

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 exaggerated effects you hype.
 

So the Food and Drug Administration is now taking its cues from the laughably named "Defense Department"

Nope. The FDA has been in the business of approving and regulating medical devices for nigh upon a century now.

Some FDA background (2)

Kludge (13653) | more than 2 years ago | (#37527632)

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.

I wonder why? (1)

fuzzyfuzzyfungus (1223518) | more than 2 years ago | (#37525084)

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...

Re:I wonder why? (2)

Hatta (162192) | more than 2 years ago | (#37525462)

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.

Re:I wonder why? (1)

mcmonkey (96054) | more than 2 years ago | (#37527124)

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.

Re:I wonder why? (1)

DigiShaman (671371) | more than 2 years ago | (#37526908)

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 pretty much what you can get away with.

Re:I wonder why? (1)

c0lo (1497653) | more than 2 years ago | (#37527310)

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)

Re:I wonder why? (1)

Rich0 (548339) | more than 2 years ago | (#37530428)

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 of that cost, but even the co-insurance would have been VERY expensive. For a poor person on medicare it might very well have been free (for all but the taxpayer, who is buying some software and a $50 ebay mac for $10k).

In the end they opted to not get it since the benefits just weren't there for the costs. If it were sold in a box for $75, or even $300 it might be a different story. The software wasn't actually that sophisticated.

However, the key was that it was FDA approved as a medical device.

Look, if you're taking about an insulin pump or a pacemaker I can see the need for rigorous regulation - those things can kill you if they malfunction. However, when you're talking about things like pacemakers, crutches, or things like this there needs to be more of a common-sense approach.

Treatment... not drug! (2)

felipekk (1007591) | more than 2 years ago | (#37525090)

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"...

Re:Treatment... not drug! (1)

Dunbal (464142) | more than 2 years ago | (#37525134)

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 (2)

Mushdot (943219) | more than 2 years ago | (#37525150)

There is no single player version. Co-op/multi only :-)

Re:I assume (1)

c0lo (1497653) | more than 2 years ago | (#37527242)

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 (1)

Hentes (2461350) | more than 2 years ago | (#37525184)

What's the point of doing this it's not like they need approval to use it on people.

Re:What's the benefit (0)

Anonymous Coward | more than 2 years ago | (#37530412)

Think of the marketing. Recall the intense interest in the medical community wrt the Wii. Now, imagine if it had been actually FDA approved for something (or at least some game for it). Insurance could potentially have been used to buy a Wii (with prescription, of course). Nintendo would now be in the business of building medical devices, as well as game consoles, enlarging their market even further.

Being able to legitimately say your device/program/app/whathaveyou can cure or treat something can bring in lots of publicity and goodwill for the game itself and the company.

Name brand vs generic (1)

vlm (69642) | more than 2 years ago | (#37525286)

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? (1)

Spafticus (2015632) | more than 2 years ago | (#37525312)

What's the control condition?

fda cleared makes software harder (0)

Anonymous Coward | more than 2 years ago | (#37525514)

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?

Isn't anyone worried about this? (1)

s_p_oneil (795792) | more than 2 years ago | (#37526870)

"...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.)

Quality of life (0)

Anonymous Coward | more than 2 years ago | (#37527984)

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.

Weakly Hopeful (1)

SpaceToast (974230) | more than 2 years ago | (#37528006)

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.

The FDA is always grasping for power - BAD! (0)

Anonymous Coward | more than 2 years ago | (#37529032)

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.

This is a good thing (0)

Anonymous Coward | more than 2 years ago | (#37529340)

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.)

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