iPhone Urinalysis App Draws U.S. Government Scrutiny

[sbrhwkp3]

I'm pointing to yelp as a free market example of how technology has helped people learn about things that are unfamiliar.

Without the FDA, there would be human interest organizations created by the free market that verify drugs and treatments. They would compete with one another for reliability and reputation, which means that they couldn't be bought by drug companies themselves like many of the people in the FDA are today.

Don't you think your doctor would give you proper recommendations for drugs? Don't you think that, without results, he would recommend you didn't take something that wasn't proven or could be harmful?

Stop and think about something for a minute before you call it insane. You might just find that it's the only thing that makes sense.

ylp are barely reliable for reviews, but you think it would make a superiior replacment for drug approval process?

Which drugs are you on, adn are thy reviewed on yelp?

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So, how do you plan on suing once you have died in the crash at 80mph?

 

[StyxMaker]

I'm pointing to yelp as a free market example of how technology has helped people learn about things that are unfamiliar.

Without the FDA, there would be human interest organizations created by the free market that verify drugs and treatments. They would compete with one another for reliability and reputation, which means that they couldn't be bought by drug companies themselves like many of the people in the FDA are today.

Don't you think your doctor would give you proper recommendations for drugs? Don't you think that, without results, he would recommend you didn't take something that wasn't proven or could be harmful?

Stop and think about something for a minute before you call it insane. You might just find that it's the only thing that makes sense.

You keep using Yelp as an example of how these drug approval businesses should work. Wasn't Yelp involved in a bit of a scandal a few years ago where they were taking payments from businesses to erase bad reviews? Does anyone really believe that these 'Drug rating companies' couldn't be bought (or even, behind the curtain, owned by) the drug manufacturers?

 

[maxosx]

I'm sure for a mere Billion dollars or so, the Government will be happy to create a department complete with the finest test equipment. Then hire some untrained, clueless overpaid, unaccountable employees. That ought to keep us safe & save us money

 

[jeff051177]

You truly have no idea what you are talking about.

^this x 1,000

Always good to hear some opinions from the tin-foil hat wearing brigade, but some of the posts on here are really quite worrying.

 

[cmwade77]

The problem with the FDA is they aprove things that are known to be unsafe, such as GMO food, food dyes, preservatives, various medications that there are herbal alternatives to that work better, but because they don't have the money to get approved can't say so.

Bottom line is money is king at the FDA, if they cared about safety, they would ban these things and approve herbal stuff that does work and actually look out for public health.

 

[kingtj]

re: medical testing of devices

Roller, no I don't, as I work in corporate I.T. and have done so for 25 years or so.

My wife, however, has held a job at the FDA as well as other govt. agencies, so I get some insight into the "inner workings" from what she's told me.

I agree that as a rule, an imperfect process beats not having one. But my only contention is with an assertion that the device should be subject to the SAME scrutiny given to devices used in hospitals or medical offices.

Maybe that's not exactly what you're suggesting here? Not sure ... But as far as I'm understanding all of this, that's what it currently amounts to. Either a given device is considered NOT applicable and doesn't get tested by the FDA, or it's labeled a medical diagnostic device, and gets treated like it's used and relied on by medical professionals to make medical diagnoses.

How about an "in between"? Some sort of basic certification that the device doesn't give completely erroneous readings based on some test samples across the spectrum of what it purports to measure -- and then it's approved as a CONSUMER device?

Do you have any experience with testing medical devices and medications prior to FDA approval? I do, and I'll be the first to admit that the process is far from perfect. However, even an imperfect process is better than none at all. In this case, the device is clearly intended to perform the same function as some hospital- or office-based diagnostic equipment, and should be subject to some scrutiny.

I'm all for development of smartphone apps and related devices, which have the potential to reduce costs and give people more direct control over their healthcare, but only as long as there is appropriate oversight.

 

[jmacr]

Pshhh...

The FDA is a crackpot organization anyway. Why would they need to "approve" such a device? They need to go back to "approving" all the crap they allow to get put in our food.

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Preach preacha!

The problem with the FDA is they aprove things that are known to be unsafe, such as GMO food, food dyes, preservatives, various medications that there are herbal alternatives to that work better, but because they don't have the money to get approved can't say so.

Bottom line is money is king at the FDA, if they cared about safety, they would ban these things and approve herbal stuff that does work and actually look out for public health.

 

[slughead]

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.

You do know that the FDA-vetted "readers" cost $800, and that dip sticks are often read by the human eye as a result. Most likely the FDA wasn't standing around looking at every single thing that comes to market--most likely a company who makes readers complained to the FDA.

The FDA will likely quash this app, or at least take it offline for a protracted period of time while their snail-paced bureaucrats toss it around trying to trip it up, or demand funds for testing purposes from the tiny company who created it. This app has been studied by reputable organizations and found to give 100% identical results to existing "industry grade" readers. That's enough for me to trust it to make a diagnosis--at least more than my own eyeballs. I'm glad I downloaded it before this app, made by a small business, is shut down by the FDA.

This is one of the reasons American health care is so expensive: Regulators wont allow anything to be used until it jumps through expensive hoops, even if things have already been vetted.

How many people died because Beta Blockers, which were already approved by Europe's "FDA", were awaiting approval in the US? It's in the thousands. "First, do no harm...." Why not let me as a practitioner read the studies and make a decision; and have FDA approval be "optional"?

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Nonsense, these are point of care diagnostics devices for use by the patient that need FDA approval. They are no toys. The reason for FDA approval is that diabetes 1 patients for instance that use these strips to test their glucose levels, need to determine their insulin requirement. Inaccurate measuring can cause hypoglycemia or hyperglycemia.

Uhhh a urine test should NEVER be used to titrate insulin dosing. Those are blood glucose monitors and they're totally different.

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The problem is not with white balance or measurement capabilities of the iPhone. The problem is the fact that this system advocates the use of urine strips for diagnostic purposes, while for many diseases systems are available with superior accuracy.

It is a step back presented as a new development in healthcare.

You do know that the test strips are sold ON AMAZON.COM already and are commonly read by HUMAN EYES using the color key included with the strips, and that this is undisputedly more accurate than that practice? Of course you do, you're a well-informed member of the internet.

Give it a shot; how hard can it be?!

 

[grapefruitx]

Medical Device regulations

This is a viperously regulated market, self test devices even more so, the regulations didn't come from nowhere they are there because of device failures and you lot, the general public getting litigious when they don't do what they say.

If you are going to put out a device where the outcome of in incorrect test (diabetic of instance) would have consequences for human health, you had better be able to show that that device can meet its claimed performance be manufactured to the highest standards of quality and traceability, What happens when the specifications or a component is changes, the lens material for instance, will that affect performance? will your supplier notify you?

So if your diabetic daughter is using this system, breaks her iPhone and gets a replacement, but because of a FW change there is a bug and an incorrect reading is made and she ends in a coma. what do you do, what do you expect the authorities to do, shrug shoulders

Now that may be unlikely given there are visual checks as well by the operator, but you sure as hell be able to show that, and it be clear in the documentation that CW the device when the regulator comes knocking or your company is toast.

 

[slughead]

For ___'s sake, nobody is titrating insulin dosing based on urine tests!!

This is a viperously regulated market, self test devices even more so, the regulations didn't come from nowhere they are there because of device failures and you lot, the general public getting litigious when they don't do what they say.

 

[APlotdevice]

You do know that the test strips are sold ON AMAZON.COM already and are commonly read by HUMAN EYES using the color key included with the strips, and that this is undisputedly more accurate than that practice? Of course you do, you're a well-informed member of the internet.

As a photographer, let me tell you that cameras respond very differently from the human eye. Simply put they do not have the same dynamic range or color sensitivity. So there are things we can pick up very easily that a machine might actually have trouble with.

 

[WayneH1]

I can't let this sleeping dog lie. I'm surprised that no one raised the simple point: The FDA is a branch of government and only has authorities granted to it under our constitution. It has zero enumerated constitutional authority to tell me I cannot choose to use a machine to do a chore for me. If I want to use a lightbox, smartphone and an app to read my pee stick, I have that right. If I want to design such a box, write software and sell it to others that want the tool, I also have that right.

The law establishing the FDA (how did our ancestors ever survive without it?) was passed in 1906 and was directed toward preventing misbranding and adulteration of the food supply. Preventing and punishing such fraud is a legitimate duty of government.

Over the years, the FDA has expanded its scope and positioned itself as the preemptive arbiter of "safe and effective". You cannot sell a wonder drug - even if it is safe and effective - without prior approval of the FDA. You're guilty until proven innocent. That may be a good thing part of, and maybe most of the time. It's hard to say whether the FDA ensures safety any better than our absurdly litigious civil tort system, which is a far bigger threat to a fraudulent company than is the FDA. But the FDA process is a very handy way for big companies to ensure that little companies cannot compete.

Just imagine that all software was controlled by an FDA, and that the rules for getting software approved were written by Microsoft and Apple (the Pfizers and Mercks, if you will, of the software world). Do you think it would be cheap and easy to get through the approval process these guys would come up with? Of course not! If you force the process to cost $1B, you can always be sure your competition comes from a very short list. This doesn't necessarily have to be done out of malice. It's just natural that the big guys that write (er, advise on) the rules of the process are going to tailor them to the processes used by those behemoth companies.

Anyway, a hardware and software tool that makes it easier to read a pee stick, IMHO, does not fall under the jurisdiction of the FDA any more than does the optical scanner at the pharmacy that reads the UPC on the drug vial when we check out. It's not a food or drug, it's not misbranded or adulterated, and it's not fraudulent to sell such a thing. It's no different than using a pair of glasses or a bright light to help the user read their results. I would predict that the results from the app are on average far superior to what untrained, uncalibrated humans can do. (If not, maybe it is fraudulent!)

I look forward to the response from the company as to why they didn't bow before the almighty FDA before introducing their product. I hope their lawyer empties both barrels. Sadly, they will likely tiptoe as gently as possible. They want to survive.

 

[grapefruitx]

For ___'s sake, nobody is titrating insulin dosing based on urine tests!!

So where is that North America?, very likely, But possibly not in the ROW, or all the time. Diabetics tend to have several devices as backup etc, urine sticks may well be one. the point is as a Medical diagnostic device the regulatory setting is the same! even if they are not used frequently or better technology has comes along. It makes no difference at all.

 

[grapefruitx]

I can't let this sleeping dog lie. I'm surprised that no one raised the simple point: The FDA is a branch of government and only has authorities granted to it under our constitution. It has zero enumerated constitutional authority to tell me I cannot choose to use a machine to do a chore for me. If I want to use a lightbox, smartphone and an app to read my pee stick, I have that right. If I want to design such a box, write software and sell it to others that want the tool, I also have that right.

The law establishing the FDA (how did our ancestors ever survive without it?) was passed in 1906 and was directed toward preventing misbranding and adulteration of the food supply. Preventing and punishing such fraud is a legitimate duty of government.



.

I don't think they can stop you using or buying one, its just that if you want to sell such a device it has to be designed manufactured and monitored in-service, to certain standards, to ensure it is safe to use and it does what it claims on the packet, otherwise the same general public who demand constitutional freedom to sell and buy whatever, start marching up to the factory with clubs and torches (not literally anymore of course we use law) we quirky change tune when these companies screw up.

Although i agree broadly with your sentiment, we sometimes forget were all this stuff comes from is usually us.

 

[slughead]

I don't think they can stop you using or buying one, its just that if you want to sell such a device it has to be designed manufactured and monitored in-service, to certain standards, to ensure it is safe to use and it does what it claims on the packet, otherwise the same general public who demand constitutional freedom to sell and buy whatever, start marching up to the factory with clubs and torches (not literally anymore of course we use law) we quirky change tune when these companies screw up.

That quite the run-on. Why not make FDA approval voluntary? Why is it necessary to take this company down by force (which, yes, will happen if they don't do whatever the FDA says)? That way customers can decide if they want to pay $50 for a urine dipstick at one doctor's office or $5 at another, based on studies which have shown the results are identical.

Although i agree broadly with your sentiment, we sometimes forget were all this stuff comes from is usually us.

This stuff (the FDA) came from companies banding together to make life harder for their competition. There was some public support, but only because the public doesn't know the full implications of any policy so they agree with whatever sounds good, even if it benefits only a few.

There is a reason we have so few drug/medical device companies, it's not for lack of demand / profit, it's because the FDA has made it impossible to break into the market, which is exactly what it was originally designed to do.

 

[sbrhwkp3]

You keep using Yelp as an example of how these drug approval businesses should work. Wasn't Yelp involved in a bit of a scandal a few years ago where they were taking payments from businesses to erase bad reviews? Does anyone really believe that these 'Drug rating companies' couldn't be bought (or even, behind the curtain, owned by) the drug manufacturers?

Do you think that the FDA isn't bought? You realize that there is more corruption in government than any other place in the world, right?

I'm not saying that the private companies can't be bought. But when ONE GROUP does not have a MONOPOLIZATION on something such as this, they are held accountable by the people who fund them, because if they get caught, they're finished, and a more honest and respectable group will come in to fill the void.

This brings us right back to our doctors as well, who you know personally and can trust to prescribe you with something safe. They will be reviewed and scrutinized by the public as well.

In summery; free market solutions, without monopolization, means more thorough scrutiny, with fewer regulations.

This results in much more affordable health care, life saving treatments that reach the market years before they do now, and greater accountability of doctors and big pharmaceutical companies.

 

[617aircav]

The same time some dont govt intervention in case like this, others want government to force cell makers to put more anti theft security on phones.