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Comment by the_gipsy | Hacker News Reader

$99 a month subscription, because they're FDA or whatever approved.

Is there corruption with these kind of things, or did they just hit jackpot?

There is high corruption at every level of healthcare, from ambulance companies to prosthetists to local doctors to hospitals to pharmacies to insurance to government.

$99/month is pure corruption, and they get away with it because insurance can help cover it.

In healthcare, "Economies of scale don’t lower prices", and "prices rise to what the market will bear" - An American Sickness. Very much what you're seeing here for this price tag.

Well said.

This corruption costs Americans hundreds of billions of dollars every year.

As a healthcare clinic owner:

ITS SO EASY TO MAKE MONEY!

Like, my wife with 0 business experience, is able to profit 6 figs off her workers and 6 figs off her labor. She completely failed to train new/bad people and multiple patients left her clinic because of the poor quality labor.

Doesnt matter, all those patients paid and she is slammed busy.

Limiting licenses is an excuse for quality. These doctors are so absurdly low quality and getting paid for treatment that doesnt work.

I propose a science based medical system as an alternative to the Authority based healthcare system. Never going to happen because clinic owners like myself lobby, but it would be better.

FDA did not approve it, that is the highest level and requires proof that it is more effective than placebo I believe. The FDA only looked for adverse events in the data and granted authorization to market it as they determined it is very low risk for adverse events. But people will be mislead by the FDA-authorized status as some kind of FDA blessing that it works: https://www.fda.gov/news-events/press-announcements/fda-perm...

This is false. The FDA does not grant approval to market anything solely on the basis of "low risk for adverse events." The game makers had to run studies demonstrating that it improved ADHD measures. The link you provided says that as well:

"The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools."

Fair enough, I think I came to that conclusion because reading the next statement was just that they determined there were no major adverse events. But I think it still stands that this is only a marketing authorization, the FDA isn't saying it works, so really the company shouldn't be mentioning the FDA at this point unless they go for a stronger classification.

"When the facts change, I don't change my opinion."

Which facts? I was wrong about the evidence needed for marketing authorization but, if I’m not mistaken, they would need that authorization in order to market the product in the first place so mentioning the FDA authorization would, in my opinion, potentially give people the wrong impression that the FDA has endorsed the product at a level (e.g. approval) which I don’t believe the FDA has done at this point.

They have endorsed the product in the only way applicable. There are different processes for drugs and “medical devices” and this one falls under devices. https://www.fda.gov/consumers/consumer-updates/it-really-fda...

They went through "De Novo" premarket review as their medical device was distinct from any previous devices. This is a higher standard than the normal "510(k)" process. Both tracks involve a lot of evidence, a lot of documents, and a lot of scrutiny from the FDA.

They went through the harder track of FDA approval for medical devices.

I have no idea why you seem to think the primary way for the FDA to approve of new treatments is somehow... not them approving of it?

The wording is really poor. "Pre-market authorization" is their approval process. As in, you don't get to tell anybody that your device has any medical benefit unless we've assessed it.

If it works, then that’s not a bad price at all. ADHD attentional issues will suck orders of magnitude more money out of your life if left untreated in some people.

If it works. If it doesn't, then that's just another $99/month money hole that people with ADHD have a particular difficulty digging themselves out of - subscriptions are like a kryptonite to them.

Hence the studies? /sarcasm.

And, can't you cancel the subscription?

Most people can. People with ADHD usually can, eventually.

So long as cancellation is as easy signing up, I think they’ll be okay.

Not really - cancellation being objectively as easy as signing up is still much harder to actually do for people with ADHD.

Signing up is something exciting and fun and something such person may do impulsively in a moment of weakness. Cancelling is boring and scary (what if dark patterns?) and a chore you don't look forward to, but rather try to not forget. It's not positively rewarding, but merely stops a penalty.

This might seem like an exaggerated difference, but it actually hits the exact points that are affected by executive dysfunction.

I guarantee they didn't invent anything new to gaming. It's just like all those studies that claim tetris helps with ptsd, stress, lazy eye, postpartum depression, etc. It's just a game. There's nothing that makes this game, or tetris specifically special.

Even though there were a lot of studies on other existing games helping "ptsd, stress, lazy eye, postpartum depression, etc.".

I wonder if they were to be used in some treatment, they would also need to be approved? So Tetris itself wouldn't cost, but the doctor administering treatment gets approval to use the game, and that overall treatment costs the money.

I'm little unsure if any joe blow psychologist is allowed to makeup treatments, or if they go through an approval process also.

Genius move, take a crappy mobile game, call it a medical device and sell it for a price not even the best AAA games would ever dream to ask.

Only the USA healthcare system could give life to such an abomination.

Nope, we have the same in Germany (and in the EU), called "digital health applications" (DiGA in German). These are smartphone apps with some medical claims, certified as medical devices and prescribed by doctors. They make about €120-€500 for 90 days.

In some cases, these apps might be useful. But I think there are quite a few cash grabs in there, too.

Germany is the first country, in 2019, to have introduced a pathway for DiGA to be prescribed and reimbursed by health insurance.

But in 2017 the FDA launched the Digital Health Innovation Action Plan. So arguably the concept was born in the USA.

On one hand, this isn’t a drug, so it would probably be much cheaper to test and verify.

On the other hand, the average cost for drug R&D, testing, and approval was $2.87 billion each… in 2016.

That’s going to take serious cash to break even on.

Getting any kind of drug or medical therapy approval is extremely risky and expensive.

Will insurance lower the cost in the case that this is a prescribed treatment?

Just saying there are heaps of free apps that monitor and manage insulin dosing without FDA approval.

I don't see why you need FDA approval for a video game, or even make medical claims about a video game.

Because you can buy it using FSA/HSA. There are very strict laws against what is considered purchasable on those plans.

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