FDA To Scrutinize Mobile Medical Apps

mikejuk writes "It looks like 'first do no harm' is coming to an app near you. The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps. It is almost too easy to create an app that aims to help people detect or manage some condition or other — but should programmers play the role of doctor even in seemingly harmless areas?"

Comments

Yes, because we need government in everything

[roman_mir]

because if there is a word 'health' in it, that's it, you are not your own person, you are property of your government and even when there is cancer treatment that can help you, created by a guy back in 1976, you can't have that treatment because the government says so and you can't choose to exercise your freedoms, you are not your own person.

Re:Yes, because we need government in everything

[NoNonAlphaCharsHere]

Where's Dr. Bob, DC when we need him? I'll bet antineoplastons cause subluxations. Just sayin'

Re:Yes, because we need government in everything

[ColdWetDog]

If the 'antineplastons' are so wonderful, how come this MD PhD scientist type hasn't offered to rid some other country of the scourge of cancer? Europeans, Africans, Asians - they all get cancer and have money.

Re:Yes, because we need government in everything

[ColdWetDog]

No, you have got it all scrambled. Neoplastons cause subluxations. Antioneoplastons are the good guys in this let's-bash-the-FDA-and-cronies psychotic (but unmedicated) mind view.

Re:Yes, because we need government in everything

[ChromeAeonium]

Protecting me from snake oil salesmen (like your Burzynski quack) who have the one true cure for cancer is exactly why I want the government involved in health. You shouldn't be able to make shit up and pass it off as medicine, and you bet I want someone looking over real science before something goes to market where it can do real damage either if it is dangerous or if it just doesn't work and prevents people from getting real treatment. Could this lead to a a legitimate treatment being overlooked due to those big bad close minded doctors who just can't see the brilliance of (insert probable pseudoscience but possible real treatment here)? Maybe. But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.

And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line? You really want them running amok?

Re:Yes, because we need government in everything

[NoNonAlphaCharsHere]

I'd still feel better if I heard it from Dr. Bob. He has a way of explaining complex medical issues that I find very reassuring.

Re:Yes, because we need government in everything

[ColdWetDog]

Oh, and just so I don't wander off into total snark ville - The FDA is really just looking for comments on things that either are used directly by a medical provider to view images or is attached to a medical device (like a glucometer). Makes perfect sense although why the FDA is so wound up about PACS (Picture Archival and Communication System - just a glorified version of a image viewer and database) is beyond me, but that's the FDA for you.

As for all of the other 'Alternative / natural / homeopathic apps - so long as they state they are not designed to diagnose or cure disease then they're fine.

Re:Yes, because we need government in everything

[roman_mir]

AFAIC, I don't actually care whether his treatment is fake or not, I really do not care. He seems to have gotten the FDA Trial Phase I and Phase II approvals. So the stuff is safe for consumption, that's all that is actually important to know.

At that point I don't want government being anywhere near the treatments. There are plenty of cases where FDA involvement does one thing only: increase the cost of drugs or worse. If FDA even has to exist, it's role should be limited to questions concerning safety and nothing more, as it's useless in most important cases anyway.

http://en.wikipedia.org/wiki/Mifepristone#FDA_controversy

http://www.youtube.com/watch?v=9QqIN9EfQwM

Re:Yes, because we need government in everything

[chemicaldave]

Did you read the article? This FDA oversight makes perfect sense.

[Draft guidelines] specifies the following two categories of mobile medical apps:
a: those used as an accessory to medical device already regulated by the FDA. (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.

Re:Yes, because we need government in everything

[Mindcontrolled]

Oh yeah, the basic freedom of fucking people all over. Has the ebil gubbermint shut down your personal snake oil business lately?

Re:Yes, because we need government in everything

[mspohr]

Yes, because our "free market" health care system is working so well...

We have the highest drug costs and highest hospital and physician prices of any country in the world. We end up paying twice as much as any other developed country for lower quality and access to health care.

All other developed countries have strong regulation of health care prices and this gives them lower costs and better access to health services. Government regulation works.

Re:Yes, because we need government in everything

[roman_mir]

For every snake oil business that is shut down (and likely not, after all, they didn't bother with Madoff,) how many real businesses are destroyed, that would have brought costs down, increased competition, increased choices, created jobs and improved economy and increased overall wealth?

I want a competing sewer business, ffs, I want a competing water main, competing electrical lines, competing everything, including roads and education and medical, everything, and it's not a bad thing even to have some overcapacity in any of these things, and lower prices are not bad for business, no matter how much your friend, Bernanke, likes you to believe.

Re:Yes, because we need government in everything

[roman_mir]

Yes, because our "free market" health care system is working so well...

-?? Why should I reply to your comment, as you are replying to my with such an obvious ignorant statement or maybe a lie? Where do you free market in US business and US government?

--

Now if there was actual free market, a US Citizen would have been able to buy health insurance from ANY COMPANY IN THE WORLD. Why not? Why can't you buy health coverage from a company located in Hong Kong or Malaysia or Germany or anywhere?

There is no free market in US, it ended with the invention of the Fed and IRS.

Re:Yes, because we need government in everything

[superwiz]

You are already protected from snake oil salesmen. You are protected from them in the same way that you are protected from people selling land Chernobyl as "exclusive quite rural land in pristine woods." Fraud is fraud. You don't need a special case of medical fraud vs investment vs any other kind of fraud. And don't even bother saying that an average judge isn't able to distinguish a proper medical claim from a fraudulent one. We have family courts. We allow courts to decide on complicated intellectual property claims, etc. They can just as easily decide on medical fraud cases. You don't need a multi-year process by a government agency to create a judgement before fact on whether a claim of medical worthiness is valid. Even if you take the life-saving treatments out of the equation, we still get less treatment options because FDA exists than some other countries do. Germany, for example has surgically implanted contact lenses and contact lenses with soft outside and hard inside membrane -- both of which are not available in the US. And Germany has had them for over 10 years now. The only reason we still get life-saving cancer cures that other countries do not is that we spend many multiples of what those countries do on research. Imagine if instead of litigation and compliance we spend all the money on research.

Re:Yes, because we need government in everything

[superwiz]

Oh, and you NOT protected from snake oil salesman. Atkins diet, anyone? So you get all the negative sides of an overreaching regulatory agency and very few of the positive ones.

Re:Yes, because we need government in everything

[hsmith]

Wait, you fucking think the US health system represents a free market model? Are you out of your fucking mind? Besides nuclear it is the most regulated industry in the United States. What a fucking insane statement, free market my ass.

Re:Yes, because we need government in everything

[roman_mir]

Government regulation works.

- BTW, this.... I have no doubt that gov't regulation works as intended. Except that it's intended to make sure government gets more and more power, the politicians get access to monopoly type money and the voters are used in a ploy to destroy any type of economy that works, by creating monopolies and destroying free market.

Government regulations exist in order to destroy any semblance of real competition and to provide politicians with a way to stay in power.

Re:Yes, because we need government in everything

[Anonymous Coward]

you want incompatability and lower quality standards.

You don't see the forest for the trees.

Re:Yes, because we need government in everything

[superwiz]

Oh and,

But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.

you got any statistics to back that up? Because Milton Freedman's analysis of their incentive structure showed the opposite to be the case -- their built-in bias is against approval.

And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line?

Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.

Re:Yes, because we need government in everything

[superwiz]

buh.. his name is Milton Friedman, of course. (not Freedman)

Re:Yes, because we need government in everything

[Anonymous Coward]

>So the stuff is safe for consumption, that's all that is actually important to know.
The guy claims it cures cancer, but it has been shown that it doesn't. If the guy were to market his antineoplastons as candy and not mention cancer, then "safe for consumption" is a sufficient criterion. But he's claiming to sell medicine, and saying that he should be allowed to market his quack treatment as such, is saying that you don't give a toss about the unnecessary suffering and death that this causes. Also, "safe for consumption" is a relative term; he has prescribed much higher dosages than were rated safe.

>does one thing only
The references you cite fail to substantiate that. The FDA makes sure that you cannot market something as medicine unless it has been tested for efficacy in double-blind clinical trials. Yes, this increases medicine research costs, but it is necessary to protect a vulnerable group of consumers against the vultures of quacks that are only too eager to fleece them out of their money in exchange for something that won't even make them better. It is still possible to skirt the regulations (by being careful not to call your pills medicine on the label for example); this can be confusing for consumers and better regulation is needed, but at least we can tell whether we're buying medicine or not. I'm not saying that the FDA is infallible, but be glad it's there.

The other links that you cite similarly fail to show any failing of the FDA, and are more telling about you yourself.

Re:Yes, because we need government in everything

[ChromeAeonium]

Not surprising. Anyone can put together a compound with homology to a biologically active substance and do a quick short term test to see if it has an effect. But it takes a lot of money to see if it isn't screwing up something in the long term. I'm not saying that the FDA is perfect; given that they are generally have more stuff to look over than resources to look over it all, no doubt they make mistakes. But I don't see how it is an argument against them that they increase costs. Making sure things work and work safely is expensive, and while it is absolutely true that some things out there are way over-regulated, and maybe you could make the case that sometimes that happens with the FDA's drug approval, I don't consider drug oversight in and of itself over-regulation, even if it does increase the cost.

Re:Yes, because we need government in everything

[ChromeAeonium]

you got any statistics to back that up?

Look at how many so-called alternative medicines turn out to be just quackery, and how many turn out to be vindicated. There is a heavy skew toward bad ones.

Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.

Hey, I love living free of polio, measles, mumps, rotovirus, ect. courtesy of the pharmaceutical sector. I like that there's all kinds of helpful medications for things that were once a death sentence developed by the drug companies. I'm not trying to say they're this big evil cabal or anything like a lot of conspiracy nutters make them out to be, just that I still wouldn't put it past them to screw a lot of people over given the opportunity.

Re:Yes, because we need government in everything

[Calibax]

You want your drugs and doctors to be low cost. How about your treatment quality? Want that to be low also?

Want to go back to the 19th century where only the rich could afford good treatment? Doctors figured out a long time ago that people will pay lots of money for good medical treatment. So most good doctors treated the rich and became rich themselves.

That's what happens without government involvement. If you doubt my words, go to a country where the government isn't involved in health-care, and see what kind of treatment you get for your minimal cost.

Re:Yes, because we need government in everything

[Anonymous Coward]

Except we have the FDA happily approving drugs for cock enhancement rather than drugs for actual important diseases. I'd say the FDA is manipulated by the very snake-oil salesmen they are supposed to be protecting us from.

This is like when "fruit of the day" suddenly makes the media... then the FDA comes back and says that an UNPROCESSED food (like say Cherry Juice) is somehow a drug... they've jumped the shark because they're not about "wellness" they are about keeping the multi-trillion dollar medical establishment going. We're about to hit a new wave of computerized "wellness management" applications. Like for instance the "tatoo" ink that can monitor blood glucose. While relying on software isn't the best thing in the world, the FDA is clearly spending more time PROTECTING the PROFITS of the companies that play their system, rather than improving the system, or opening the system to things that promote true WELLNESS.

Now that you can get an iPhone... 3G, always connected, gobs of CPU and software abilities for $49 on contract there's no reason not to start developing medial monitoring and wellness apps around that platform. I've worked in a place that manufactures "medical and airline" quality devices... and the entire engineering and quality amounts to going to Newegg, buying thousands of the cheapest motherboards and then throwing half in the trash on some made up criteria.... your average iPhone or Toyota is manufactured to several degrees more precise standards now... without having to throw entire lots in the trash.

I think the current crop of applications definitely stay on the "health accessory" side of the FDA's boundary. Personally, the correct method would be to set limits (and work with Apple or Google) on what the apps can "guarantee" to users. That way applications can work "up to" a line in the sand, without intervention until we can see what apps need to cross into "diagnostic" or "monitoring" needs. Frankly, the dollar value of the market, and the money that can be saved by the health systems is just too big to ignore. So much hospital time is dedicated to "wait and see" when those patients could be sent home with minimal monitoring. This keeps people in their homes, living their lives, which tends to improve WELLBEING more than being in a hospital. Think of this software as the ultimate extension to the "I've fallen, and I can't get up" crowd.. As a country we have more old people under medical supervision (over 65) than we have children (under 16). The cost savings are huge... especially when we need to cut Medicaid..lets start with "meaningless" Doctor appointments.

Re:Yes, because we need government in everything

[sjames]

Now if they would just protect us from the very expensive and occasionally deadly snake oil that comes out of big pharma. Or from the gray area cases where the prescription "drug" turns out to be a fantastically expensive minor variation on a cheap generic dietary supplement.

Meanwhile, in the midst of the food contamination scares, the FDA was busy raising the approved levels of the contaminants and seizing e-cigs in defiance of a federal judge rather than helping to solve an actual problem.

So, there's the problem, they DON'T keep them in line. Their one and only mission these days is expanding their regulatory domain as much as they can get away with.

We would be much better off if the FDA were confined to truth in labeling and as an advisory board. I'm fine with them certifying efficacy and safety and doing PSAs urging people to insist on FDA certified products.

Re:Yes, because we need government in everything

[roman_mir]

back in 19 century economy moved from agricultural to urban/manufacturing, and mid-19 century was the time when first health insurance (critical illness insurance actually) was created at costs that were extremely competitive. Up to 1965 in US the cost of private health insurance and medical treatments were actually extremely affordable, people were paying for most of it out of pocket.

I left a comment with data long ago on this. To reiterate:

Here is a good primer on this, the article comes to erroneous conclusions about the reasons for low medical and insurance costs (they see the reasons being that state of medical technology was rudimentary, which is nonsense, as it was state of the art for the time and prices were falling, just like prices on all and any electronics constantly drop in current market), but regardless, they can't do anything about the facts, they are as always stubborn.

A 1918 Bureau of Labor Statistics survey of 211 families living in Columbus, Ohio found that only 7.6 of their average annual medical expenditures paid for hospital care (Ohio Report, p. 116). In fact, the chief cost associated with illness was not the cost of medical care, but rather the fact that sick people couldn't work and didn't get paid. A 1919 State of Illinois study reported that lost wages due to sickness were four times larger than the medical expenditures associated with treating the illness (State of Illinois, pp. 15-17). As a result, most people felt they didn't need health insurance. Instead, households purchased "sickness" insurance -- similar to today's "disability" insurance -- to provide income replacement in the event of illness.

... then they had more erroneous conclustions that it was insurance companies unwilling to provide health insurance. This is an erroneous conclusion because they contradict it immediately with this:

popular support for the legislation was low because of the low demand for health insurance in general

- well OBVIOUSLY if there is no demand, nobody would be providing the product. It makes perfect sense, but the authors miss it due to their preconcieved notions and ideology. But they have good data.

According to one CCMC study, the average American family had medical expenses totaling $108 in 1929, with hospital expenditures comprising 14 percent of the total bill (Falk, Rorem, and Ring 1933, p. 89). In 1929, medical charges for urban families with incomes between $2,000 and $3,000 per year averaged $67 if there were no hospitalizations, but averaged $261 if there were any illnesses that required hospitalization (see Falk, Rorem, and Ring). By 1934, Michael M. Davis, a leading advocate of reform, noted that hospital costs had risen to nearly 40 percent of a family's medical bill (Davis 1934, p. 211). By the end of the 1920s, families began to demand greater amounts of medical care, and the costs of medical care began to increase.

So they understand that costs increase due to more demand, as health care is a normal good, it's not magical in any way. As the incomes of people grew, so did demand for health care. Of-course they fail to understand that incomes grew due to government inflation, more than anything else.

As the demand for hospital care increased in the 1920s, a new payment innovation developed at the end of the decade that would revolutionize the market for health insurance. The precursor to Blue Cross was founded in 1929 by a group of Dallas teachers who contracted with Baylor University Hospital to provide 21 days of hospitalization for a fixed $6.00 payment. The Baylor plan developed as a way to ensure that people paid their bills.

- $6/year insurance for 21 days in hospital. Done privately.

THEN the DISASTER struck:

The AHA

Re:Yes, because we need government in everything

[mspohr]

I put "free market" in quotes because I do not believe there is a free market in US health care. The US health care market consists of a set of monopolies (insurance, hospitals, doctors, pharma, etc) which, in the absence of effective government regulation means that you have no choice of provider or price. (There is some regulation of drug safety which is a good thing but irrelevant to the current discussion.)

The proper role of government here would be to regulate prices and access in a similar manner as the other 21 "developed" countries. This would give us lower prices, higher quality and better access.

Unfortunately, in the US, the health care monopolists have captured the regulatory mechanism (i.e. bribe all the politicians) so there is a very small chance of real regulatory control. In short, we are screwed.

Re:Yes, because we need government in everything

[mysidia]

I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.

I'd rather the FDA regulate the use of the combination of the app and the attachment in the case of (b). And require a standard of testing for the combination of app on tablet and attachment together. The tablet or app itself shouldn't need to be regulated or certified as an individual unit.

But (I suppose) a consequence of this, would be workers would have to use specific tablet, app version, attachment version. And the Tablet hardware itself would have to be certified for that combination, probably resulting in a much more expensive "Attachment compatible" branded tablet being released to meet the FDA cert requirements.

With regards to (a) I'm strongly opposed to that. Should the FDA start certifying the copy paper and ink used to print medical images on for professionals to make a specific diagnosis, and require them to use "FDA certified paper" costing $100/page to print all pictures on for diagnosis? Let's not forget, all these costs get passed onto the patient too, and sometimes cost lives, when patient/their insurance can no longer, or will no longer pay for treatment.

Oddly FDA "regulations"/certifications are often counterproductive and likely cost lives; it is difficult to determine if the number of lives saved by FDA regulations exceeds the number of lives lost as a result of bureaucracy increasing medical costs and delaying the availability of life-saving treatments.

No. FDA certification of has a cost, and it should be limited to materials where the certification is actually more beneficial.

FDA certification of medical devices that can kill if they malfunction = good

FDA certification of drugs that can kill if they have unintended side-effects = good

FDA certification of diagnostic equipment used in an operating room = good

FDA certification of pen and paper, computer displays, software, or other ancillary tools chosen by professionals to review medical data = bad

Re:Yes, because we need government in everything

[ColdWetDog]

Well, if Dr. Bob won't come to you, I suppose you could use the magic of the Internet to go to Dr. Bob (or his therapeutic equivalent).

Re:Yes, because we need government in everything

[Anonymous Coward]

Price fixing turned out really well for Nixon.

Re:Yes, because we need government in everything

[Anonymous Coward]

A long treatise that does not to address the point - low cost equates to low quality treatment.

We are where we are we can't go back to redo. We can go back to low quality for everyone who isn't a billionaire.

Re:Yes, because we need government in everything

[Anonymous Coward]

It's a virtue not to say anything when you have nothing to say, which you do not.

Re:Yes, because we need government in everything

[ceoyoyo]

Those images are major diagnostic tools. They need to be stored securely, both against loss and theft, and displayed accurately so nobody misses anything or sees something that isn't there.

Re:Yes, because we need government in everything

[Anonymous Coward]

Makes perfect sense although why the FDA is so wound up about PACS (Picture Archival and Communication System - just a glorified version of a image viewer and database) is beyond me, but that's the FDA for you.
 

If that PACS ends up being used by a doctor to diagnose a condition, I think you want some assurance that it's displaying the correct information with the correct settings so false positives or negatives are minimized. I'd hate to have someone get misdiagnosed because the app/device the radiologist was using didn't show some feature in an image correctly.

Re:Yes, because we need government in everything

[ceoyoyo]

Sounds like you could use someone to protect you. If you want to take "antineoplastons" you're welcome to do so (they seem to be found in urine). Governments regulate people who give you medical advice and prescribe treatment.

I do like how your "evidence" prominently includes a Dr Oz endorsement though.

Re:Yes, because we need government in everything

[roman_mir]

I do like how your "evidence" prominently includes a Dr Oz endorsement though.

- no, that's not evidence.

My other comments have various degrees of evidence. The first one was about a point, which is that government wants to run your lives, and it looks like most of you are more than happy to have them do it too.

Re:Yes, because we need government in everything

[0123456]

A long treatise that does not to address the point - low cost equates to low quality treatment.

Why? High cost has only a vague correlation to high quality.

Healthcare is expensive because government makes it so. There are huge swathes of costs which could be eliminated before doctors have to start giving you sugar pills instead of real medicine to cut their prices.

Frankly, I'm thoroughly sick of the worship of medicine when so much of it is barely beyond the level of witch-doctoring. The real breakthroughs in medicine will come from engineering, not feeding people random chemicals to see what happens.

Re:Yes, because we need government in everything

[ceoyoyo]

I guess you're a little fuzzy on what evidence is. An interview with a guy about social security isn't. Neither is your own personal rant about your country's (admittedly broken) medical system. And no, getting a treatment approved for a phase I, II or III trial isn't really evidence it works either. Nor is it evidence the treatment is safe, contrary to your assertion.

The FDA regulates what treatments can be recommend and/or provided by health professionals or others giving medical advice. in order for one of these people say a treatment works, it has to be shown to be effective. That seems perfectly reasonable.

If you want to drink urine for your cancer, go for it. The FDA doesn't care.

Re:Yes, because we need government in everything

[Anonymous Coward]

it's not a bad thing even to have some overcapacity in any of these things

Assuming you get the government out, how are you going to get the shareholders in?

Re:Yes, because we need government in everything

[roman_mir]

There is plenty of evidence in my comments showing that FDA is not only ineffective at figuring out efficacy, but it is criminally effective at pushing for the dangerous drugs to be sold, when there is evidence that those drugs are in fact dangerous, and FDA does not regulate chemicals that are not immediately acutely dangerous, like fructose.

However in that very comment there is also evidence of how FDA 'approval' provides a company with a monopoly to sell a drug, which pushes the prices up by many orders of magnitude and there is evidence of drugs that are not allowed by FDA while they are used across the world, thus FDA is causing deaths in USA with these actions.

Should FDA be allowed to prevent any treatment, if it is already used around the world to be available in USA?

It's your country, you decide.

Re:Yes, because we need government in everything

[ceoyoyo]

Oh, you're giving me evidence to support your conspiracy theory! Wonderful. Just bypassing the issue of the craziness of your main example, hey?

And no, it's not my country.

Re:Yes, because we need government in everything

[Anonymous Coward]

Oh yeah, I can sue somebody, great. Except they've already disappeared with whatever they fleeced me with, so there's nobody to sue.

You don't know how con-artists work, do you?

They love being judgement proof. Maybe you think the best time to deal with a problem is after, but some of us believe that an ounce of prevention is worth a pound of cure.

Re:Yes, because we need government in everything

[Anonymous Coward]

A competing sewer business? Water main? Electrical lines?

You have proven yourself to be a moron.

Maybe you want the ground under the streets to be crowded as can be, but me, I'd rather choose otherwise, and instead focus on competition where it matters, namely in the supplying of parts to my locally managed and operated infrastructure providers.

There are just some things where multiple providers does not make sense.

Feel free to work on generation of electricity, but delivery? I only want one set of lines to worry about.

Re:Yes, because we need government in everything

[roman_mir]

Conspiracy?

The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. Thatâ(TM)s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nationâ(TM)s bloated annual health-care tab would swell by more than $4 billion.

What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost â" about $10 or $20 a shot.

---

Here come the unintended consequences. While the FDA says it hoped there wouldnâ(TM)t be a significant run-up in the price of colchicine â" sold as Colcrys by URL â" the retail cost has soared to more than $5 a bill from the previous pennies a tablet. URL Pharma also sued five makers of manufacturers of colchicine, saying they have been illegally marketing their colchicine products since Colcrysâ(TM)s approval. One of those makers has settled the matter and stopped production. The other four companies are fighting the lawsuit.

---
Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. ...

Despite these discoveries, FDA managers presented study 3014 to the advisory committee in January 2003 without mentioning the issues of data integrity.1 The managers have stated that they were legally barred from disclosing the problems to the committee because there was an open criminal investigation, but they have not explained why the data were presented at all, in view of the evidence of the study's lack of integrity. Unaware of the integrity problems, the committee voted 11 to 1 to recommend approval of Ketek.

--

etc.etc.

You can't dismiss facts, but you sure can call them conspiracies if you wish.

Re:Yes, because we need government in everything

[Z34107]

The proper role of government here would be to regulate prices and access in a similar manner as the other 21 "developed" countries. This would give us lower prices, higher quality and better access.

We call it "Medicare." Parts of it (like Diagnosis Related Group-based reimbursement) are remarkably similar to the Netherlands' Diagnosis Treatment Combinations (DBCs).

It's been around for awhile; I wonder why no one deciding the future of healthcare has heard of it.

Re:Yes, because we need government in everything

[Anonymous Coward]

No one has made any offers for reasons unknown to us. Therefore, he is a fake.

Re:Yes, because we need government in everything

[Anonymous Coward]

A fine attitude when you don't have any serious health issues. Now let's see if they hold up when you get old. Or when you have a child who is seriously ill. Or you have a parent with heart disease or a stroke or cancer or some other illness that might be terminal.

So young, so naive.

Re:Yes, because we need government in everything

[cheekyjohnson]

I would rather not have government involved in anything that has to do with business, including medical business.

No regulation at all, then?

I like my costs low, my drugs cheap, my doctors competing with each other based on price and efficiency, maybe I am the only one, in which case it's a non-starter here.

And I'm sure many people don't like monopolies or businesses cooperating with one another in order to gain more profit.

Re:Yes, because we need government in everything

[ceoyoyo]

You're very determined to avoid the issue of whether Burzynski is a fraud hey?

Re:Yes, because we need government in everything

[flink]

There's a lot more to a PACS than "just" a DB of images. For example, a lot of times radiology has their own registration system, so you have two different patient identities you have to correlate, possibly through an MPI. You also want to make sure that relevant medical history or notes are available to the doc reading the film. And then at the end of the day, you may want to package the film and the read up into a clinical document and ship it off to an XDS or some other document system.

If any of that goes wrong, you could potentially file a DX to the wrong patient. So yes, some regulatory oversight is warranted.

Having said that, the FDA exercises oversight of clinical information systems, but does not require approval like it does with actual medical devices. So you're supposed to stick to certain procedures and be able to prove traceability from requirements through design down to code. You can and occasionally will be audited, but you don't have to submit each and every software release for approval like a new drug or something.

Re:Yes, because we need government in everything

[mspohr]

The Republican politicians are adamantly against Medicare. During the health care reform debate, there was a proposal to expand Medicare to everyone. Of course, this didn't have a chance since it would have cut out the insurance companies and reduced reimbursement for everyone else.

Re:Yes, because we need government in everything

[Anonymous Coward]

Unlike someone selling you land in Chernobyl (which would just put you out some money), fraudulent medicine could kill you, cause irreparable harm or even cause some weird arse side-effects (which could cause you to go kill others).

Re:Yes, because we need government in everything

[roman_mir]

Maybe you should have read the thread.

I said earlier that to me it does not matter whether this guy is a fraud or not. If his treatment is harmless, then there the rest of it, the efficacy of it should be left up to the market to decide, not to a fraudulent government monopoly.

Re:Yes, because we need government in everything

[roman_mir]

No regulation at all, then?

- obviously, there should be no government regulations at all in any business and there should be no subsidies or any bail outs to any business or person, and there must be no income taxes, corporate taxes or payroll taxes, no taxes on work.

And I'm sure many people don't like monopolies or businesses cooperating with one another in order to gain more profit.

if people don't like it, they should stop their governments from creating them, which is what government's real role in economy is - creating and maintaining monopolies, because that's where the real money for governments are.

Re:Yes, because we need government in everything

[shentino]

Gotta keep that pharmaceutical lobby going.

Re:Yes, because we need government in everything

[cheekyjohnson]

if people don't like it, they should stop their governments from creating them [mises.org], which is what government's real role in economy is - creating and maintaining monopolies, because that's where the real money for governments are.

Sometimes monopolies can happen because of government intervention. But not always. And there can be monopolies and businesses that cooperate with one another (in order to maximize their profit) without any regulation at all, as far as I know (though it would depend on the circumstances).

Re:Yes, because we need government in everything

[roman_mir]

Actual competition is a constant dynamic process, which is only stopped by government intervention. Monopoly forms when some business gets preferential treatment from government (patents, franchises, subsidies, special tax provisions, etc.)

Re:Yes, because we need government in everything

[cheekyjohnson]

It's possible for monopolies to exist without government intervention. Perhaps the business in question is a risky endeavor that no one but a select few wish to take up. Perhaps very few people have the money to provide competition towards an already established business. Perhaps the majority help create a monopoly themselves by not shopping elsewhere enough (for whatever reason, and this would doom the minority).

And without regulation, how would anyone stop companies that cooperate with one another (which could happen if they would receive more money by doing so)?

Re:Yes, because we need government in everything

[roman_mir]

It's possible for monopolies to exist without government intervention.

- without gov't intervention no monopoly can exist, and if there is some dominant business, it's domination is totally temporary.

. Perhaps the business in question is a risky endeavor that no one but a select few wish to take up.

- what does that even mean? Every business is a risky endeavor that only very few are willing to take up. Case in point is private space launches, what can be more risky and time/resource consuming that that? Well, there are things, but this is definitely one of them:

http://www.space.com/11298-spacex-rocket-private-spaceflight-falcon9.html

http://copenhagensuborbitals.com/

http://www.virgingalactic.com/

http://www.armadilloaerospace.com/n.x/Armadillo/Home

Perhaps very few people have the money to provide competition towards an already established business

- this wasn't a problem in the beginning of 20th century, before the Fed started printing all that money and IRS started taking people's incomes away, so there were hundreds, even thousands of competitors in phone business, dozens in electrical power generation AND transmission. Of-course this happened before some businesses in those industries started colluding with the government to get monopoly statuses. Same with pharma and medical profession, which always were private enterprises but eventually became monopolies due to government involvement.

Perhaps the majority help create a monopoly themselves by not shopping elsewhere enough

- that's called demand, if one company provides a solution that is so cost effective and provides so much value, that most people do not bother looking for alternatives, then for a while this business will dominate, but the competition arises anyway, just like with the phone and electrical companies that I mentioned. Those are tough businesses, especially due to name recognition, and still the monopolies there only formed after government intervention.

And without regulation, how would anyone stop companies that cooperate with one another (which could happen if they would receive more money by doing so)?

- nobody wants to share their pie with somebody else, who may or may not succeed being a competitor.

If you have a business and I come over and tell you: I am going to take over your market share because I am going to build a business better than yours. So you think you'd just start paying me money only so that I wouldn't do it? How many people would you be willing to support this way, because that's what this amounts to. No no, what you do is you laugh me out of your office and tell me to go do it if I can, and then you concentrate more on your market share because I promised to take it away.

Cartels do not work, it's clear with oil cartels - they don't work. It's because there is no upside for you to keep your promise to only meet your quota at some preset price and not to sell more and not to sell more at lower price, because clearly, if you have to collude with others in your cartel, then the prices are artificially set, and in reality (IRL) you make more money by having more customers who buy more of your product, not by setting artificial barriers to your customers by raising prices too high.

Businesses know that it's better to have as much market penetration as possible, you do this by providing product as cheaply and at highest quality that can, that way you get the most market penetration. The only time cartels work is when government is standing there with a gun - just like in case of big pharma and FDA.

Re:Yes, because we need government in everything

[cheekyjohnson]

- without gov't intervention no monopoly can exist

How so? It's logically impossible?

- what does that even mean?

Businesses far more risky than others could easily end up as monopolies.

- nobody wants to share their pie with somebody else, who may or may not succeed being a competitor.

It's easily possible if it would help maximize their profits. They know that if they do something that will attract customers (but still increase costs), the others will probably follow (if they have good business sense and do not want to lose customers). It would be a pointless thing to do if your intention was to maximize profits.

Businesses know that it's better to have as much market penetration as possible

I doubt that. Otherwise, why would there ever have been companies that cooperated with one another? They don't even have to explicitly agree to do it. They just keep what they have in place and continue "harming" consumers.

Re:Yes, because we need government in everything

[roman_mir]

How so? It's logically impossible?

- it's physically impossible, as there are always new people being born, new people come to the market with new ideas, new stuff gets invented, old stuff becomes old, ideas and fashions change, technologies change, there is always movement. You are thinking about the world in weird way, the way I thought of it when i was 4, and I thought that everything around me was stable and was that way forever and will stay that way forever.

Even governments fall and countries fall, I was born in USSR, that country does not exist anymore. There is competition for power between countries and within them, everything is in constant competition and markets provide dynamic equilibrium, not static, they you see it.

Businesses far more risky than others could easily end up as monopolies.

- they do not end up as monopolies, they cannot maintain static equilibrium between themselves and the market, which is constantly looking for new ideas, for ways to do the same thing cheaper or differently or stop doing it and do something else instead, like in the case with the music industry. They are dead, they just don't fully recognize it yet, riding on the inertia of past success, which was, by the way, guaranteed to them by government laws.

It's easily possible if it would help maximize their profits.

- of-course, if there are 2 large businesses, both are already subsidized and protected by the government (like with Bell Canada and Rogers for example and also Telus), they are already government protected monopolies (oligopolies), they can collude on prices and services and products. But this does not apply in free market, because it makes no sense, like in the case with oil cartel, which does not work.

It doesn't work, because participation means you sell at a preset price, which you negotiate not with the market, but with others in the cartel. But then you go to the market and you see all the extra sales you can have if you only don't bother with your cartel buddies, you lower the price a little here and there, you have more customers, same with every other participant, so what starts as a cartel preset price, ends up being the price set by the market and your ability to deliver.

This is why I don't believe for a second that oil cartel has any real extra capacity on stand by, otherwise they would have been selling. For probably a decade from 95 to 2005, they've been able to keep a number of competitors out of business, because they said they had all this extra capacity they could put on line, but now everybody knows it's BS, and the prices are high enough that there is plenty of room for making the previously unprofitable reserves profitable (because it's more expensive to develop them). That's why Canada does the oil shale now and the cartel couldn't do anything about it. They didn't deliver on the promise to put more production on line, it was a clear lie that they had it. They don't have it, whatever they can produce they already do, and with all this gov't created inflation, the prices are going up, more and more competitors are entering the market.

I doubt that. Otherwise, why would there ever have been companies that cooperated with one another? They don't even have to explicitly agree to do it. They just keep what they have in place and continue "harming" consumers.

- these companies have government protections. Name me one cartel that actually 'works' and that has no government protection besides DeBeers?

DeBeers is the only successful cartel in history and it's because it's a non-essential luxury item that has little market demand in itself.

Re:Yes, because we need government in everything

[cheekyjohnson]

- it's physically impossible

It's either impossible or it isn't. I see no reason why it would be logically impossible (as unlikely as it may be).

as there are always new people being born, new people come to the market with new ideas, new stuff gets invented, old stuff becomes old, ideas and fashions change, technologies change, there is always movement.

Which could take quite a while.

You are thinking about the world in weird way, the way I thought of it when i was 4, and I thought that everything around me was stable and was that way forever and will stay that way forever.

I don't recall saying that (nor do I see what age has to do with anything).

- they do not end up as monopolies

I'm talking about businesses that are incredibly hard to start up (unless you have a lot of money). Competing with an established business is quite difficult (and the chances of someone trying to do so when it is incredibly risky lessen even more).

you lower the price a little here and there, you have more customers

Only if the ones you were previously cooperating with have no sense of business and don't follow your moves. The thing is, they probably know that that will happen, so they don't even bother. What's the point if it won't even help maximize their profits?

Name me one cartel that actually 'works' and that has no government protection besides DeBeers?

Not sure (I was just listing possibilities). I'd like to know the name of a country with an absolutely free market (no regulations for businesses whatsoever) that does well. That would help me far more.

Re:Yes, because we need government in everything

[GameboyRMH]

You know I sort of agree on this. Let the libertarians and "alternative medicine" kooks get their non-FDA approved medicine. Bring a little Darwin back into our idiot-safe modern world >:-)

Re:Yes, because we need government in everything

[roman_mir]

Whatever you want to call it, get rid of government monopolies on drugs and there will be more drugs. Many of them will not help you, many of them will help you, and the market will sort it out. The way it's done now is ridiculous, apparently you are not your own person, you are property of your government, which decides for you what is it that you need and are allowed or not.

Re:Yes, because we need government in everything

[roman_mir]

It's either impossible or it isn't. I see no reason why it would be logically impossible (as unlikely as it may be).

- it's physically impossible, because it never happened. There is no monopoly and there was no monopoly that had its status in a free market, all monopolies are creations of government.

Is it logically possible? As in, is it theoretically possible to have a monopoly? Yes. If the combination of factors is such, that one company satisfies all customers at all times with the price/value combination for the product that there is just no way for a competitor to form because there is no space for more sales and there is no way to lower prices anymore (that's an impossibility right in itself with new tech and new requirements coming on line), but let's pretend.

But then you are looking at a monopoly that formed there purely by market forces, then it's a monopoly because there is truly no way to provide the product cheaper and better. Let's say it's a free product. So the only way to provide the product 'cheaper', is to give something away with it, like money.

Let's say you are in business and you have a monopoly that got its status because it's giving the product away for free and even is paying something to the 'customers' to take the product off the hands of the company. Then what is the problem with that monopoly?

Do you want somebody to come and provide the same product for half the price? But it's already free. So you want somebody to give you a better product and give you more money to take it off their hands? I guess that's the only way, and if somebody finds a reason to do it, they will.

So a monopoly that is there because nobody can do the work any better is the best outcome for the market and then what is the problem with it? The problem with it is that if it's doing this and bleeding red ink, it's not going to last, it will die away, like many Internet based dot.com companies during the late nineties.

They WERE giving their stuff away for free, they were bleeding red ink and eventually they all went bust. But some of them were monopolies in their own right, because they were giving something away for free or better - paying you to take off them. That actually happened, it's not a fairy tale, we have seen this.

I'm talking about businesses that are incredibly hard to start up (unless you have a lot of money). Competing with an established business is quite difficult (and the chances of someone trying to do so when it is incredibly risky lessen even more).

- when one person cannot start a business without lots of money, he needs to convince investors that he can make money starting that business, and if he convinces them, they'll provide the capital, this is not necessarily rocket science, it's called a business plan.

Only if the ones you were previously cooperating with have no sense of business and don't follow your moves. The thing is, they probably know that that will happen, so they don't even bother. What's the point if it won't even help maximize their profits?

- anything that gives you more market penetration helps you to maximize your profits, that's an axiom, because while you are in business A right now, if you have a bigger customer base you can also enter business B and be more efficient because you already have the customer base. All businesses want more market penetration and the way to do it is not not collude on prices in a cartel (you can pretend you collude on prices, but if you do that and there is space for some profit there, somebody else will come in and break your monopoly via competition, so you are always better off to make your offering really competitive.)

Not sure (I was just listing possibilities). I'd like to know the name of a country with an absolutely free market (no regulations for businesses whatsoever) that does well. That would help me far more.

- there are no absolutes,

Re:Yes, because we need government in everything

[ceoyoyo]

Where's the evidence his treatment is harmless? Don't forget to include the harm of people seeking his treatment and not getting or not being able to pay for an actual treatment that does work.

Come on, pony up some evidence instead of just spewing meaningless rhetoric.

Re:Yes, because we need government in everything

[cheekyjohnson]

- it's physically impossible, because it never happened.

So it's impossible because it hasn't happened yet? What? I also don't see any reason that it's "physically" (whatever that means in this context) impossible. But, then again, I think debating over something like this is rather pointless.

- when one person cannot start a business without lots of money, he needs to convince investors that he can make money starting that business, and if he convinces them, they'll provide the capital, this is not necessarily rocket science, it's called a business plan.

Someone could already have lots of money (enough to start it). Or drive out small businesses. Once they are established, competition may become difficult.

- there are no absolutes, and they are not necessary to have mostly free markets.

There are no absolutes? Well, that may be true, but getting rid of all regulations would get rid of all regulations.

And I thought we were talking about no regulation at all (I even asked you and you said that that is what you meant). The thing is, we currently have many regulations right now. So, anyone saying something to the effect of "an absolutely free market would be far better than what we have now" isn't going to be as convincing to me as if they had an example of it working to point to (so people would be able to better understand its advantages and disadvantages far more easily and believably). I think it should be tested.

There is no logical reason for prices to go up in ANY business today

Not everything that humans believe is logical, either.

Re:Yes, because we need government in everything

[roman_mir]

So it's impossible because it hasn't happened yet? What?

- I gave an example of how it is theoretically possible, but it's very unlikely, given that it never happened, so it's improbable, as good as physically impossible.

Someone could already have lots of money (enough to start it). Or drive out small businesses. Once they are established, competition may become difficult.

- so what? So what that it is difficult? You are ignoring the examples I gave earlier of very difficult things that private businesses are doing - launching rockets to space with useful cargo.

(so people would be able to better understand its advantages and disadvantages far more easily and believably). I think it should be tested.

- USA 19 century was such a market, it's in the past for USA, but in Asia that's sort of what some countries have there. Even China has a freer market than any Western economy, and its wealth is increasing as its production capacity is growing.

Not everything that humans believe is logical, either.

- no no, it's very logical that the prices are going up instead of falling when there is government interfering with the market, it's logical and it is happening.

Re:Yes, because we need government in everything

[cheekyjohnson]

- I gave an example of how it is theoretically possible, but it's very unlikely, given that it never happened, so it's improbable, as good as physically impossible.

I believe that the right words should be used for the right situations. If it's not impossible, but just unlikely, then just say that. But, really, there's technically no way that I see to know that it's unlikely, either.

- USA 19 century was such a market, it's in the past for USA, but in Asia that's sort of what some countries have there. Even China has a freer market than any Western economy, and its wealth is increasing as its production capacity is growing.

But all of them have (or had) at least some regulation, correct? I was referring to a place where absolutely no regulation exists at all. That would be the way to truly test this theory.

Re:Yes, because we need government in everything

[roman_mir]

In USA in 19 century most of the industries had no regulations, the government was very tiny, involved only with the largest tycoons, that's why in 19 century USA switched from being an agriculture based society, that owed huge debts to the largest manufacturer of cheap, high quality consumer goods, while driving innovation by allowing the people to come over from around the world and start their own businesses in the freest (at the time), society in the world.

Played a roll

[NoNonAlphaCharsHere]

Nope, never played a roll, but I have baked them.

Re:Played a roll

[Maritz]

You gotta role with it.

Re:Played a roll

[NoNonAlphaCharsHere]

I see what you did there - kind of a 'roll reversal'. It's no fun when they fix the miss takes in the summaries.

Bad Summary

[microcars]

This only applies to apps that are used to communicate with an external device of some sort.

It isn't planning to oversee all health apps - just those medical apps that could present a risk to patients if the apps don’t work as intended.
It specifies the following two categories of mobile medical apps:
a: those used as an accessory to medical device already regulated by the FDA.
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
The FDA wants interested parties including software creators to comment on its proposals during the next 90-days.

Re:Bad Summary

[Anonymous Coward]

The FDA wants an app that works like the medical profession, it doesn't do a damn thing but take every cent you have.
The money is in searching for cures, not in finding them.

Re:Bad Summary

[Trepidity]

I can see that being a good idea in some cases, like monitoring for heart attacks, but I'm worried that the definitions will be too broad. As a private individual, it seems like I should be able to hook up a smartphone to a sensor and install an app that, say, monitors my sleep patterns. Maybe I'm "self-treating" some sort of sleep disorder; but maybe I'm just curious; or maybe I'm collecting data for an art installation based around my sleeping patterns. Either way it doesn't really seem like it should be the government's business to regulate it, unless it's actually being sold as a medical product.

Re:Bad Summary

[ColdWetDog]

Either way it doesn't really seem like it should be the government's business to regulate it, unless it's actually being sold as a medical product.

They're not. They are going after real 'medical devices'. If you claim that your device is not intended to cure or diagnose disease then you get a free pass. Just don't try to sell it with advertising suggesting that it's a real medical device.

But wait, it's not yourself

[Anonymous Coward]

There's a difference when you go beyond yourself to serving others.

And as serving others is what the app market is about, I don't see a reason for you, or anybody else to have an unrestricted freedom to do what you want unto others in this regard.

You'll have to find another set of circumstances if you want to be convincing that there's something outrageous going on.

computers and health care

[girlintraining]

Now is probably a bad time to point out to the FDA that the last time they tried regulating this, it was because the computer diagnostic program didn't have a license to practice medicine. They ignored the fact that the program was better at diagnosing medical conditions than the doctors that asked for its removal.

I fail to see how giving people the resources to diagnose their own problems is a public health concern, any more than providing people with information about how to fix their own cars. Yes, some people will do it wrong and get themselves or others hurt, but at some point the government needs to give people back their personal responsibility.

Re:computers and health care

[Anonymous Coward]

No it doesn't. The sad fact is, people don't want personal responsibility.

Hurricane took out Florida? God did it.

Economy in the shitter? Must be them there queers or something.

Chained to a cubicle and slowly rotting away? It's definitely your manager, and not you being too lazy to endure the risks of changing careers or employers.

Can't manage to put together a decent GUI after what, like twenty years? Definitely Microsoft's fault.

Bitch cut you off? What was that? Had nothing to do with you driving like an asshole, I'm sure.

Re:computers and health care

[skaffen42]

Posting about personal responsibility... anonymously...

I'd make a joke, but I think you covered it.

Re:computers and health care

[hedwards]

There's a significant amount of researching and testing that has to be done before you're allowed to advertise something as having a medical use. With good reason, while a pillow might really treat certain types of sleep apnea you would have to do the trials necessary to back it up.

I'm guessing that the issue wasn't solely about not having a license to practice medicine. Personally, I'd rather have somebody that's been trained working on me than some random quack. I have had a lot of luck with complementary medicine, but allowing random people to offer advice which may or may not have been properly researched is a bad idea.

The FDA is if anything too lenient on supplement manufacturers and people that program apps like this.

Re:computers and health care

[uglyduckling]

If you knew anything about medicine, you would know that no computer has come close to out-diagnosing an experienced clinician. Computers are great at giving lists of possibilities, but real medicine is all about risk and uncertainty, where intuition and clinical skills play a big part. How do you think a computer would even be able to form a reliable diagnosis without an experienced clinician performing an examination?

Re:computers and health care

[Anonymous Coward]

An easier and cleaner solution would be a medical version of Underwriter's Laboratory that verifies product claims - consumers would soon take any medical app as unverified and be able to determine whether such an app still meets their needs - a unverified pillow is probably okay to try but an app adjusting or even monitoring a pacemaker, not so much.

Re:computers and health care

[Thu Anon Coward]

I've had some medical issues and work as an IT troubleshooter by profession, so I think I know when to suspect that someone is throwing me a line of bullshit, whether it be computer or user. In the case of a medical practitioner, I have found a few doctors (over 20 yrs experience) who try to bullshit me with a potential line about what they think the cause of my medical problem is or what the solution may be.

What it boils down to is that doctors are NOT omniscient. Just like us IT troubleshooters who do a lot of diagnosing of IT problems based on past experience, suspicions, and gut feelings, doctors do the same. They use their clinical training, their past experience to arrive at a PROBABLE DIAGNOSIS that is then usually borne out by any tests that may need to be performed.

MY STORY
------------------
With a pinched nerve and ruptured vertebra disc in my neck causing me major pain, one surgeon swore up and down that I _HAD_ to have a spinal fusion. Took his word for it. Spoke with my father about it who told me to get a second opinion....glad I did. The 2nd surgeon was a bit upset that #1 surgeon didn't try anything else prior to recommending surgery, so we did therapy first and then steroid shots (which resolved the issue). Prior to the therapy/steroid shot, I was sitting next to the anesthesiologist while my wife gave birth via C-section who noticed my twisted neck and painful expression (I was supposed to get the steroid shot that morning but my wife decided to go into labor instead ). He asked my story, I told him and named the doctor. His comment? "Yeah, I've heard that he [the surgeon] is surgery happy"......greeeeeeat......

Before the whole thing even started, my Primary Care Provider said "it's probably just a pulled muscle" (painful and sore all the time). Asked for x-rays, refused. Demanded them, got them. First comment from PCP was "Wow! You have HUGE bone spurs". Sent me to Physical Therapy. After 6 sessions of weekly therapy with little relief, therapist says "I don't think you have a pulled muscle, I think you have a pinched nerve or disc problem". Back to the PCP, who said "Well, they're just a PT, they're probably wrong." After 1st experience with PCP with x-rays, demanded a referral to a spinal specialist. You've already seen my story about him in the preceding paragraph.

Long story short - doctors are not god, hold them accountable. they are only as good as GIGO, and if they don't keep up with all the changes in their chosen field or open to using the most conservative treatment possible, then they are worse than useless, even dangerous.

And, mind you, there were "experienced clinicians"

Re:computers and health care

[uglyduckling]

Thanks for the non sequitur. I don't deny that doctors make mistakes (and bear in mind that back pain is notoriously difficult to diagnose), but the debate was that "the [computer] program was better at diagnosing medical conditions than the doctors", to which your story adds no information. I'm pretty sure that a computer program could have helped provide a list of possibilities for your condition, but ultimately it was a good doctor who got you sorted.

It's also interesting to note the intuition of the anaesthetist who noticed your problem - something that a computer program would probably never do, because the anaesthetics program would just do anaesthetics and not notice the obvious discomfort of the other person in the room who wasn't even its patient.

As an IT troubleshooter you can probably bear witness to the fact that there is currently no algorithm that can successfully fix an intermittent problem with a computer - it requires the complexity and intuition of human thought - even though the spectrum of problems that can affect a computer system is orders of magnitude less than that of the human body.

"for entertainment purposes only"

[nurb432]

If you use it for a real medical issue and hurt yourself, its your own damned fault.

I can see an 'app czar' coming soon :(

could they go after the 'one secret to trim belly'

[decora]

could they go after the '1 secret to trim belly fat' or 'dermatologists hate this woman' ads first?

those are out and out fraud, but more than that, im sick of looking at them.

The shape of things to come

[Okian Warrior]

Medical apps are just one step in a trend that will redo the way we manage health.

Health care is broken in the US. The problem is that the system is so unbelievably entrenched that it's impossible to dislodge. Health insurance companies that make billions, safety rules that require half a billion investment to test a drug, physicians' inability to make exceptions... everything is frozen in bureaucracy that will not change.

Any entrenched fixed system will eventually be overtaken by smaller innovative solutions. Big companies become risk-averse, big government becomes "politically correct", and eventually all are overtaken by smaller groups. We see it in companies over time, we're seeing it in selected companies right now: cable is dying due to its inability to change (on demand video), the music industry is dying due to its inability to change (internet purchases), the book publishing industry, newspapers, lots of obvious examples.

We're seeing the start of this in health care right now. People are doing their own research, reading medical papers online. People are having medical tests done without a doctor's order - and taking the results home. People are buying medical devices which are not FDA approved: heart rate monitors, blood pressure readers, also programs such as sleep quality monitors (using a laptop microphone), 24/7 body temperature monitors, and the like.

This is how health will change in the US. Not by billing reform or electronic records, but by having access to cheap medical services that can bypass the entire system. When you can get a $20 test which will definitively diagnose or rule out the top 10 reasons why you're feeling tired, that will be true reform.

And yes, it's scary and we shouldn't step out of the house without a physician's approval and "woo woo" be afraid and all that. And yes there will be some disinformation which may be fraudulent or may mislead people or may just be outright wrong.

At first. These systems will self correct, because there are enormous system forces to do so. For example, sites which publish physician reviews.

This is the shape of things to come. It'll be a blessing. Don't worry about it. Indeed, pitch in and help.

why bother?

[Anonymous Coward]

Why even bother with this when they let the supplement and "alternative medicine" industries literally get away with murder. The FDA is joke, we might as well just dismantle it and at least we'll save some money. In their defense, it's not the fault of the FDA, they are hindered by horrible legislation.

Why not scrutinize airport scanners?

[Anonymous Coward]

Seriously, we're exposing hundreds of thousands of people to ... well.. no-one seems to know exactly what.

kindumb come; where fear & hatred thrive

[Anonymous Coward]

& only a chosen few (.5 billion) out of all of us are scheduled to remain alive.

no gadgets required

should it not be considered that the domestic threats to all of us/our
freedoms be intervened on/removed, so we wouldn't be compelled to hide our
sentiments, &/or the truth, about ANYTHING, including the origins of the
hymenology council, & their sacred mission? with nothing left to hide,
there'd be room for so much more genuine quantifiable progress?

you call this 'weather'? much of our land masses/world are going under
water, or burning up, as we fail to consider anything at all that really
matters, as we've been instructed that we must maintain our silence (our
last valid right?), to continue our 'safety' from... mounting terror.

meanwhile, back at the raunch; there are exceptions? the unmentionable
sociopath weapons peddlers are thriving in these times of worldwide
sufferance? the royals? our self appointed murderous neogod rulers? all
better than ok, thank..... us. their stipends/egos/disguises are secure,
so we'll all be ok/not killed by mistaken changes in the MANufactured
'weather', or being one of the unchosen 'too many' of us, etc...?

truth telling & disarming are the only mathematically & spiritually
correct options. read the teepeeleaks etchings. see you there?

diaperleaks group worldwide. thanks for your increasing awareness?

wrong question

[Sloppy]

should programmers play the role of doctor even in seemingly harmless areas?

As a programmer, not only am I not interested in doing that, but I'm not qualified either, and no user would have reason to trust me even if I did it. So the answer (in my case) is obviously no.

But that's irrelevant anyway, because someone already mentioned the FDA. The question is now, "Should government use force to prevent people from using programs written by people who play doctor?"

You might think that answer is just as clear cut, since no programmer has the ability to learn about medicine and no doctor has the ability to learn to program, and on top of that, it's impossible for people with these two skills to ever communicate and collaborate. And furthermore, it's impossible for a user to avoid completely trusting a program with their life, or evaluating the expertise of those who created it. I understand that viewpoint. But then, I understand lots of stupid things...

Why protect the stupid?

[Chemisor]

Here's a question for you: why should the government protect the stupid? If somebody believes that his cancer can be cured by drinking this doctor's urine (which is, hilariously, what the treatment basically is), why in the world would I want to prevent him from trying? It's people like you who try to make everybody "safe" from any possible harm that are part of the reason people have been getting stupider and stupider. Natural selection always works, whether you try to deny it or not, and by helping idiots survive you merely succeed in breeding more idiots. Think of the children! The children who are protected from everything and who trust every quack's most outrageous statements simply because they have this unwavering faith that the government would not allow anything bad to happen. They grow up into adults who still believe in the government's omnipotence and think that doctors are good for them. The real truth is that all doctors are quacks. Doctors are the third leading cause of death in this country (google it). Anybody who believes otherwise deserves exactly what he gets.

Re:Why protect the stupid?

[MacTO]

We protect the stupid, because we are all stupid in our own way. I highly doubt that many of the people on Slashdot are qualified to assess medical treatments and those who claim to do so are mostly choosing their own authority (one of which could be the FDA).

I, for one, welcome institutions like the FDA because it is comforting to know that there is an independent organization that evaluates the claims of medical devices and treatments. It may not be a perfect institution, but it is fully accountable to the law as well as public ire when things do go wrong. But most of all it uses rational methods in order to test medical claims.

Re:Why protect the stupid?

[uglyduckling]

"Doctors are the third leading cause of death in this country". Bullshit. Heart disease, Cancer, Stroke, Chronic lower respiratory diseases and Accidents are the top 5 causes in the US, according to CDC. Doctors and other health professionals work hard to prevent disease. Why prevent people from peddling quack therapies? Perhaps you don't have many friends or family that you love and care about, but most people will know at least one person that means a lot to them, who doesn't have the means to properly understand medical information, and wastes their money - or even worse risks their health - on quackery. That's why I vocally oppose quacks.

Re:Why protect the stupid?

[Calibax]

First of all, without the FDA, he doesn't have to say it's his urine. He'll claim it's "insert some scientific description", Without the FDA he might be charging $16,000 per treatment - which is what just one of my cancer drugs cost. When MY life is on the line, and I'm not in a position to tell what's going to help and what's snake-oil, I WANT THE FDA TO OVERLOOK HIS RESEARCH. I'm a software guy, I can't be an expert on drugs, especially cancer drugs.

That doesn't guarantee that my cancer won't kill me, it doesn't even mean his product won't kill me. But it does mean that people have been able to check his research and I'll have good idea of the risks involved in taking it and potential benefits.

You call me stupid to rely on a doctor. All medicine is empirical. We are a long way from understanding the physiology of the human body. Deal with it. Doctors make mistakes, so get yourself a doctor you trust, one who oozes competence, who enjoys his job, who is willing to give you the time to discuss all the issues involved. But be aware he is relying on medical research also, and without the FDA he wouldn't have any real data about the drugs he's about to pump into you.

When YOU have a life threatening disease, then you can decide whether you want factual data behind the drugs you are taking, or whether you want to go with whatever the drug maker claims. As for me, I'm damn glad there is an FDA.

Re:Why protect the stupid?

[ChromeAeonium]

This. No one can be an expert on everything. A lot of people aren't scientifically literate enough to understand why, say, homeopathy is wrong, let alone the medical value of a questionable treatment that actually has an active ingredient, and even people who are scientifically literate can still get fooled if they're in something outside their area of knowledge. In my field (agriculture) I can usually tell a good claim from a questionable one, but once I go into drugs & medicine, although I consider myself a skeptical, rational, scientifically literate person, I could very likely still be taken advantage of because that's not my area of expertise. I know I've seen perfectly rational intelligent people say things about my field that, from my point of view, where just dumb, so I have no illusions that, without some trustworthy source of information to look to, I could just as easily do something dumb. No man is an island, and there's nothing wrong with not knowing everything, and just because someone can't tell good science from some jackass's magical potion (or some less than honest pharma company) doesn't mean they deserve to get conned, and the fact is, none of us are immune to a good enough con. And when you factor in that people are sick, scared, and sometimes desperate, you're damned right someone should be looking out for all those who could not navigate through this stuff on their own.

Re:Why protect the stupid?

[OrigamiMarie]

Sure, we need accrediting agencies. The problem with having the government be the accrediting agency is that you aren't free to take or leave their advice.

Re:Why protect the stupid?

[Chemisor]

First of all, without the FDA, he doesn't have to say it's his urine. He'll claim it's "insert some scientific description". When MY life is on the line, and I'm not in a position to tell what's going to help and what's snake-oil.

That's exactly right. Only, if you are not in a position to tell what the treatment is, why are you taking it? There is a simple solution to this problem that does not require the FDA: don't take it! If instead of trusting the government to decide what's good for you, you only decided it yourself or with the help of someone you personally trust, you wouldn't fall for snake oil because your default response when faced with a miracle treatment about which there is no research should be to reject it. Those who do not label their "treatments" would get no customers if people thought before they bought into quackery. Those who are quacks would not get very far if they had to prove they are not quacks to people for whom that is the assumption until proven otherwise.

You call me stupid to rely on a doctor. All medicine is empirical. We are a long way from understanding the physiology of the human body. Deal with it.

That's right. Deal with it. Every doctor should be treated like a quack until proven otherwise. Proven to you, not the government, because what business is it of the government to dictate what your standards of "not quack" ought to be?

But be aware he is relying on medical research also, and without the FDA he wouldn't have any real data about the drugs he's about to pump into you.

If he pumps drugs which he has no real data about into you, he's no doctor - he's a quack. If there is not data about a drug, don't take it!. If the FDA disappears we will not have to take any drugs that are unsafe or ineffective. The difference is that the verification of these facts would fall onto somebody else. There would be rating agencies, in the same line of business as Consumer Reports, that would test the drugs like any other product and publish reports about it. You would have a choice of whose opinion to trust, or even to make your own opinion if you believe yourself sufficiently qualified. Bad drugs will disappear just as easily this way, by the free choice of the consumer instead of at the point of the government gun.

Re:Why protect the stupid?

[roman_mir]

We protect the stupid

- those who 'protect the stupid', are using this argument in exactly the same way as the 'think of the children' and 'terrorist' and 'pedophiles' so called arguments are used. What do you think, government is better at handling your money than you are yourself? Really? Seriously? Is that why SS is such a disaster? If government was better than you are at handling your money, the SS program would have been an actual fund, rather than being an income transfer program, with the fund being managed as an investment - an asset. Instead the money SS taxes always go up, never come down, those who got in early got an excellent return on that investment, while those who got in later, got a worse return and those who are in now, will get nothing but are paying the most of all other people, who came before them.

Here is an interview with
-Charles Blahous (One of two public trustees for Social Security & Medicare)
-Andrew Biggs (Former principal deputy commissioner at the Social Security Administration )

both were asked a question: what is the difference between the way SS is funded and a ponzi scheme is funded. Both couldn't answer the question better than saying that the difference is 'intent' and that a private ponzi scheme does not require participation.

Of-course Roosevelt pushed for SS creation at first only for people who were employees, not business owners, and those who were self employed didn't have to participate. This changed over years as well, not because people, like Bill Gates need SS, no, it's because SS is a ponzi scheme and it needs more and more money to operate while paying less and less return

YEAR RATE SELF.EMPLOYED.RATE
1940 2% Not applicable
1950 3% Not applicable
1960 6% 4.5%
1970 8.4% 6.3%
1980 10.16% 7.05%
1990 12.4% 2.4%
2000 12.4% 12.4%
2010 12.4% 12.4%

Obviously SS and Medicare taxes will go up now, that the programs are insolvent (paying out more than they are taking in). The taxes will go up likely by a factor of 2.

So when you tell me that government is there to protect the stupid... I think that government is there because of the stupid alright, but it's not there to protect them, it's there to abuse them.

Re:Why protect the stupid?

[Calibax]

Rating agencies, eh? I'm sure the drug companies won't try to bribe them, or get their employees into those agencies, or just plain buy the agencies (as they will be commercial entities). You really think this is better than the FDA?

How do I prove a doctor isn't a quack? Give him a medical test? Rely on the reports of others? That won't work - nobody starting out would have any reports so nobody would go to them so they won't get any reports.

And you expect me to know what treatment I'm taking. How? You have no idea at all of the complexity of treating a serious cancer. The decisions that have to be made, the drugs available, the combinations of surgery, radiation, medications and chemotherapy that might work and the complexities of dealing with the side-effects. Your solution? Understand them all, and only then start a course of treatment. The penalty for failure or for taking too long? Death.

I was tempted to start an ad hominem attack on you, but that would be pointless. And it certainly wouldn't change your naivety :)

Re:Why protect the stupid?

[ceoyoyo]

Sure you are. If you want to drink urine or eat peach pits for your cancer you're free to go ahead and do that. What you're not free to do is call yourself a doctor and tell other people with cancer that drinking urine and eating peach pits will cure them.

Re:Why protect the stupid?

[Chemisor]

Rating agencies, eh? I'm sure the drug companies won't try to bribe them, or get their employees into those agencies, or just plain buy the agencies (as they will be commercial entities). You really think this is better than the FDA?

I think this is at least as good as the FDA. The FDA is bribed all the time, as evidenced by the amount of dangerous crap they let through.

The difference is not that a rating agency would be better than the FDA, but that you would be able to make your own definition of "better" (and yours is clearly very very different from mine), and that this definition would not be imposed upon you at the point of a gun.

I keep repeating this, but you left wingers just don't seem to get the point: everything the government does, it does at the point of a gun. The entire debate is exclusively about coercion. You believe you have the right to decide what's good for me and then to enforce it with violence. You think this is all right and proper. I, on the other hand, see little difference between you and the terrorists who blow up planes trying to impose their values upon us. My point of view is that coercion and violence are never acceptable except to stop coercion and violence by others. All other arguments naturally flow from this.

And you expect me to know what treatment I'm taking. How? You have no idea at all of the complexity of treating a serious cancer.

I expect you to take responsibility for your decisions. Of course you can't become a medical expert. Of course you have to defer to someone knowledgeable in the field. I do not expect you to always be your own doctor (even though usually that is a good idea). I merely expect you to be allowed to make whatever decision you believe to be the right one.

The argument is not about forbidding you anything. You can still have your own little FDA as long as its opinion is not forced on me. It is about coercion vs freedom. You have no right to force on me your opinion of safety or efficacy, or anybody elses opinion on the same. Trust your own FDA, but don't make me do so, because I don't. Don't tell me what drugs I can or can not take to treat my problems. Don't tell me what doctors I can or can not consult. Don't tell me how to live, dammit! You have no right to do so.

Re:Why protect the stupid?

[Thing 1]

This. No one can be an expert on everything.

Agreed, with above and also everything else you wrote. However: government should provide only a rating agency, not a sales preventative agency. In other words, government should be able to say, "Bob's chiropractic care is worse than a placebo". Government should not be able to say, "Bob can no longer practice chiropractic." There's a world of difference.

Re:Why protect the stupid?

[twidarkling]

We protect the stupid

- those who 'protect the stupid', are using this argument in exactly the same way as the 'think of the children' and 'terrorist' and 'pedophiles' so called arguments are used.

No, no it's not. I know there's no chance in hell of convincing you of that, but I'm going to try any way. When people profess "beware of terrorists," they themselves are giving in to fear. When people say "think of the children," they're giving in to fear. When people say "we're protecting the stupid," finally, they're fighting fear. Why? Because fear makes EVERYONE stupid. You, me, the guy down the block, Stephen Hawking, EVERYONE. When you're afraid, you'll do anything that might almost sort of work to help even if you need to squint a little, fudge the word "help," and sacrifice something you value. Health issues make everyone afraid, therefore they make everyone stupid. Why does it make everyone afraid? Because when you're gravely ill, you're facing death, and that's scary, either because you don't know what's on the other side, or because you don't like being weak, or relying on others, or some other reason. So, you're afraid, and desperately grasping for anything that will quell your fear. That's where the medical industry comes in, and why it's so important that there is impartial regulation on it. You are literally dealing with people at their most vulnerable and desperate time in their life. A governmental body is much more likely to be impartial than any industry-funded effort, and an impartial regulatory body with no appreciable means of enforcement of rules is worse than useless, so an outside private company with no mandate from the industry is also unable to perform the task.

Not sure where your off-topic rant about money comes from, but it's completely inconsequential, since cost of oversight is substantial, and for things like health, it's cheaper to manage a larger group where risks are defrayed over the largest group possible, and everyone knows Social Security is fucked because of an aging population that's not paying in as much as it's drawing out, and is too entitled to take a reduction in payments in order to save the system, thus proving the greed of people and their eagerness to screw over others to their own enrichment.

Re:Why protect the stupid?

[twidarkling]

I keep repeating this, but you left wingers just don't seem to get the point: everything the government does, it does at the point of a gun. The entire debate is exclusively about coercion. You believe you have the right to decide what's good for me and then to enforce it with violence. You think this is all right and proper. I, on the other hand, see little difference between you and the terrorists who blow up planes trying to impose their values upon us. My point of view is that coercion and violence are never acceptable except to stop coercion and violence by others. All other arguments naturally flow from this.

Damn fucking right I have the right to do so. I don't give a fuck what you think, because those quacks peddling death in a pill ARE using coercion and violence. It's called "Take my pill or you are going to die. I guarantee this pill will let you live. Nothing else can save you." And that's what their sales pitches boil down to. They're using coercion, and don't want to give people the opportunity to test those claims, because those claims will be proven false. And ratings agencies won't help that for shit, because people are going to delude themselves in to thinking it works RIGHT UP UNTIL THE DAY THEY DIE. And then anyone who does read the ratings are going to go "Well, that person must have been an outlier," or "They were more advanced than me," or any other lie that lets them tell themselves "This cure may not have worked for them, but it's going to work for me."

If you think otherwise, you're a fucking moron, and you don't understand how desperate people can get when they have a terminal illness; you should be shot and buried out behind the woodshed for wanting to enable bottom-feeding shitheads that prey on the terminally ill. You make me fucking sick. I hope you fucking die from cancer, so you know exactly what it feels like to be that desperate.

Re:Why protect the stupid?

[Paul Fernhout]

".. because those quacks peddling death in a pill ARE using coercion and violence. It's called "Take my pill or you are going to die. I guarantee this pill will let you live. Nothing else can save you." And that's what their sales pitches boil down to."

Are you talking about the conventional practicioners or the alternative ones?

"The Triumph of New-Age Medicine"
http://www.theatlantic.com/magazine/archive/2011/07/the-triumph-of-new-age-medicine/8554/
"Medicine has long decried acupuncture, homeopathy, and the like as dangerous nonsense that preys on the gullible. Again and again, carefully controlled studies have shown alternative medicine to work no better than a placebo. But now many doctors admit that alternative medicine often seems to do a better job of making patients well, and at a much lower cost, than mainstream care -- and they're trying to learn from it. ... The list of much-hyped and in some cases heavily prescribed drugs that have failed to do much to combat complex diseases, while presenting a real risk of horrific side effects, is a long one, including Avastin for cancer (blood clots, heart failure, and bowel perforation), Avandia for diabetes (heart attacks), and torcetrapib for heart disease (death). In many cases, the drugs used to treat the most-serious cancers add mere months to patients' lives, often at significant cost to quality of life. ... "

And quoting Marcia Angell:
http://www.pdfernhout.net/to-james-randi-on-skepticism-about-mainstream-science.html#Some_quotes_on_social_problems_in_science
"The problems I've discussed are not limited to psychiatry, although they reach their most florid form there. Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine. [Marcia Angell]"

Vitamin D, periodic fasting, and eating a lot more vegetables, fruits, and beans can help prevent cancer, but it is harder to deal with cancer in those ways when you already have it (though they can sometimes still help). See Dr. Joel Fuhrman and Dr. John Cannell for more information with references.

But it also seems like, as above, some (not all) mainstream practices for cancer really are pointless (but profitable).

My mother died of colon cancer (as part of her situation where she also had dementia). A surgeon pushed us into doing an operation for her cancer that I really regret as the testing, hospitalization and recovery process put her through a lot of trauma and did her no real good. A good thing to do with my anger, both at that surgeon and at myself for being persuaded by him, is to tell others how to have a good chance of preventing cancer, and a very much smaller chance at treating it with good nutrition, vitamin D, and sometimes fasting. I even just twittered something on that @ Hugo Chavez (with links to those references for Fuhrman and Cannell):
    http://twitter.com/#!/pdfernhout/status/95159429871321090

Cancer is a horrible disease, and anger about it is common. Like Mr. Fred Rogers might say, all feelings are legitimate, it's what we do with them that matters. I hope you can find something positive and constructive to do with your anger about cancer and those who take advantage of people suffering from it, whoever those people are.

Re:Why protect the stupid?

[cheekyjohnson]

Because fear makes EVERYONE stupid.

Interesting. I wonder how you can speak for everyone in the present as well as everyone in the future and be 100% correct. Such an amazing ability must be useful.

Health issues make everyone afraid

Can you prove this?

Because when you're gravely ill, you're facing death, and that's scary, either because you don't know what's on the other side, or because you don't like being weak, or relying on others, or some other reason.

I doubt that everyone is afraid. I'm sure that there's people who simply don't care.

Re:Why protect the stupid?

[ChromeAeonium]

Yeah, I think pretty much the same way, applying it also to how things can be sold and marketed. If, for example, someone really believes in homeopathy, well that's their right to treat themselves with it, be their ailment a cold or cancer (although you'd really hope they have access to complete information before doing so). And if someone wants to sell them what they need for it, they should be allowed too. However, they should not be allowed to call it medicine, nor should they be allowed to mention any medical benefits whatsoever. If someone wants to sell a one part in a billion tincture of Mountain Dew and someone else wants to take it to cure their insomnia, more power to them, but if vendor wants to claim it is actually medicine, then that is fraud and should be dealt with accordingly.

Re:Why protect the stupid?

[cheekyjohnson]

left wingers

Anyone who disagrees must be a left winger.

I, on the other hand, see little difference between you and the terrorists who blow up planes trying to impose their values upon us.

The average person imposes their values upon other people all the time. Laws against murder, violence, etc. They're really just saying, "I don't like this particular behavior. Therefore, I think that it should be banned."

Re:Why protect the stupid?

[Anonymous Coward]

I keep repeating this, but you left wingers just don't seem to get the point: everything the government does, it does at the point of a gun.

Oh! Now I get it, you want zero government. May I suggest you go live in Somalia for awhile. Let us know how that works out for you.

Re:Why protect the stupid?

[Anonymous Coward]

Without an FDA, who decides it's what is medical fraud? Some private rating agency? Might just well call them the FDA then.

What is some company submits their product for testing and then distributes their product with just half the active ingredient. Who pays for testing the product on the shelves is the same as the one submitted. Or do you put it on the shelves and then get some for testing and hope nobody dies in the meantime. Who pays the rating agency? How do I as a consumer know the agency hasn't been paid to produce a false report?

When it comes to drug testing, you need the resources of the law behind you - which means the government as the only agency able to make law.

Re:Why protect the stupid?

[shentino]

With commercial entities doing the work, the worst that can happen is you get smeared in the media.

They can't raid you armed to the teeth like the feds can.

Re:Why protect the stupid?

[BoberFett]

Why can't more people think like you? I completely agree with government agencies rating products and services, mandating truth in labeling. If that food contains rat droppings, then yes I want to know. But maybe I enjoy rat droppings now and then. Government as an equalizing force between parties, yes. Government acting as my nanny, no.

Re:Why protect the stupid?

[jahudabudy]

Well, that is basically what they do. They don't say "Bob can no longer practice his bullshit", they say "Bob can't call his bullshit chiropractic". If he wants to call it something else, as long as it doesn't actively harm people, he can practice it all he wants. He just can't defraud people by claiming it is something it is not.

Re:Why protect the stupid?

[jahudabudy]

You believe you have the right to decide what's good for me and then to enforce it with violence

No, I believe I and my fellow citizens have the right to decide what is good for our society. When enough of us agree, that is what happens in our society (to boil an incredibly complex political system down to an overly simplistic version). All society is predicated on force, your ideal one no differently than mine. B/c no society is full of people that 100% approve of all the rules (AKA, our agreed upon compromises for all living together), so without some mechanism for enforcing the rules, a society collapses into anarchy. You don't like the implied violence of police with guns forcing you to obey society's rules, I don't like the idea of starving to death in your society b/c I am poor. Or being murdered b/c I can't afford my own bodyguards, and somebody that can decides I am in their way. Or whatever, I can't really tell b/c I don't know what your society will look like. But I do know it will have rules, and they will be enforced, at pain of imprisonment or death if I continually disregard the rules.

Re:Why protect the stupid?

[Thing 1]

Thanks, new friend. :)

FDA's Incestuous relationship with corporations ..

[Jerry]

leads me to conclude that some corporation wants the FDA to eliminate competition to some of its medical apps. After this plays out, and we see which corporation is still peddling medical apps, we'll know who paid the FDA to go after the others.

It's such a common problem these days. Every government agency is headed by a former corporate CEO or lawyer, and when their term expires they return to the corporate world, being replaced by the CEO they replace. This goes on unchecked because Congressmen and Senators accept bribes, a.k.a. "Campaign contributions", to look the other way, if they don't outright support special interest legislation.

FDA to stamp out innovation

[hsmith]

The fees to get a product 501k approved are $4000 if you are a large business or $2000 if you are a small (and small to them is $100,000,000/yr) and a yearly $2000 fee.

now, easy for gaxosmithkline to afford but not for a two person indie shop. The large companies haven't innovated at all in the mobile market, almost all top apps in the Appe Medical App Store are from small shops

bravo FDA for destroying the innovators in the market reducing health care costs.

Try again

[Anonymous Coward]

So the stuff is safe for consumption, that's all that is actually important to know.

No, you douchebag. Efficacy is paramount. Without demonstrating efficacy, you risk people using $USELESS_TREATMENT instead of an effective treatment. The result is unnecessary pain, suffering and death.

Re:Try again

[Anonymous Coward]

Silly boy, roman_mir lives in a world where nobody would ever tell a lie and everyone knows everything. Anyone who tried to peddle $USELESS_TREATMENT would be immediately outcast before anyone was harmed.

Here in the real world, $USELESS_TREATMENT would outnumber useful ones 20:1 and every other ad on TV would be stars telling you how $USELESS_TREATMENT cured everything that ailed them. People would take $USELESS_TREATMENT for several months and then die, and nobody will know whether $USELESS_TREATMENT was the problem or not. Hell, for all we would know, they were drinking fake piss instead of the real doctor's piss, and that'll be the first thing out of the doc's mouth: "it's not my fault, the manufacturer must have messed it up". Of course, while the manufacturer is arguing that they did it right, the doctor receives his 100% royalty payments from his shell corps, then skips town and lets them fold. You'll call back and the line will have been disconnected (hadn't paid the bills in months).

To be honest, I'd like to see a weaker government, but 90% of the losers pushing to end regulations suddenly start backpedaling when you suggest that the government do away with regulations like incorporation and bankruptcy, because the only freedom they really want is the freedom to defraud as many people as possible, and being held personally responsible for their actions would harsh their buzz.

Tht's stupid

[shoehornjob]

but should programmers play the role of doctor even in seemingly harmless areas?

That's a stupid generalization. A doctor can hire a programmer to create an app but a that still does not make the programmer a doctor.

Re:Tht's stupid

[zippthorne]

Although.. what IS a doctor (MD), really?

A person who has spent the better part of a decade cramming as many (hopefully correct and up-to-date) facts into his head and relating them all to each other in such a way that they will have quick access to the important ones for each patient he is presented with.

In other words, an MD is a medical database in organic form! One that has to be built from scratch on each new piece of hardware running it. (and one whose pruning algorithm is a little aggressive....)

Frankly, I'm starting to wonder if the state of technology is such that we're getting to the point that it might be more effective to train medical technicians: people who are expert at recognizing symptoms, but maybe less skilled at knowing what a collection of symptoms means, who can the use their skills to query a computer database for a list of conditions, treatments, and ways to narrow down the list. Such technicians might be easier to train, so we could have more of them/ train them more robustly.

Researchers would then continue to build the database, but being computer-based, it could be copied any number of times to arbitrary fidelity.

Re:FDA's Incestuous relationship with corporations

[Trepidity]

Indeed, they're hoping to come out of this with the best of both worlds. They want to sell devices using commodity iPad / iPhone hardware, greatly lowering their costs compared to the low-production-run custom stuff that medical devices have typically been, but they still want to sell them in these "certified" packages w/ software for high medical-device prices without any commodity competition.

As long as they don't claim to be diagnosing: NO

[guruevi]

We don't need government involvement in apps, websites or other sources that are simply informative in purpose. If you getting close to medical advice the creators should just tell you: this is not medical advice, if in doubt contact your doctor, do not use for diagnosis etc. If people are stupid and use it for it, why not, some believe and practice lot of old wive tales about medical things, some even believe in homeopathy, faith healing etc., government involvement over those things is simply encroaching on our rights.

FDA is a bleeding pustule

[Alien Being]

Everything at all related to food and drugs is FUCKED UP IN THE U.S.A.. The FDA is one of the major causes of this. They feed on our own money and drop their excrement on us.

Improve the physical and economic health of America by doing whatever you can to take those motherfuckers down.

This is why healthcare costs so much

[scamper_22]

In every other industry there is an acknowledged trade off between quality and cost.

This at least the low-hanging fruit to become cheap and affordable.

But not in the healthcare industry. There, you just mention the world quality and it must be done. Driving up the cost and preventing people from getting cheaper affordable treatment.

No, we're talking about someone hacking you up to do brain surgery at low cost. But the low-hanging fruit.

I've been on the same thyroid medication for years. Yet I always have to go to my doctor to get it refilled. Every once in a while,I have to go get a blood test to confirm my levels. There's a computer program the doctor reads that tell me what my levels should be.

Is the visit any more affordable? Could a nurse do that job? Yep, but they gotta make their money... for quality reasons of course.

If engineers behaved like the medical profession, we'd have regulated wifi devices to the point where you'd need an engineer with residence experience in wireless communication to install your home router. They'd make sure it was secure, safe...

And of course it would cost $1000 to install home router and less people would get it... but it would be 'safe'.

I spent less than a year in the healthcare imaging industry. Just dealing with HIPAA was such a pain. The worst part was reading up on the regulations... then seeing what was actually being done and developed. The quality of the software was not better than any other 'enterprise' like application.

Keep the FDA out of the medical apps. Let the low-cost healthcare products come to life. If it means a few bad apps, that's okay.

Re:could they go after the 'one secret to trim bel

[ceoyoyo]

I was curious what kind of woo was behind the belly fat ads so I followed the link until it wanted to charge for a PDF, then went and found the document on the pirate bay. Once you cut through all the crap, basically the secret is "exercise."

Red herring

[Mr. Freeman]

"but should programmers play the role of doctor even in seemingly harmless areas"

No, obviously no one other than a doctor should play the role of doctor. But this is a red herring. We're not talking about medical apps that claim to be equivalent to doctors. No one is practicing medicine without a license here.

It should be obvious to anyone that an app can be written by someone who does not have a medical degree or any relevant experience. Now, if these apps were claiming to be written by doctors or to be giving advice approved by a doctor or something then that might be a case for intervention.

Bad examples. You're not helping...

[Okian Warrior]

Having never heard of Dr. Burzynski, I took the liberty of reviewing your posted links.

None of the posted information in the links discusses the therapy *or* the evidence, it only discusses the physician and in an uncomfortably bad light. They take the evidence of his credibility and dismiss it out of hand.

For instance, the 2nd link points out that he is an MD and a PHD. Rather than take the obvious stance of "this is a trained scientist, perhaps we should examine his claims", they state this:

"First, he really is a legitimate MD/PhD, proving beyond a doubt that having an MD/PhD double threat degree does not necessarily inoculate one from falling prey to pseudoscience."

That is not science, and this is not protecting me from snake oil salesman. This is protecting the status-quo of academia and mainstream research by using innuendo and ad-hominem attacks.

Maverick, innovative solutions DO occasionally crop up in science, as do the occasional genius theory which is discounted but later proven to be true. I would expect this to happen even more so in the highly structured and rigor-bound field of medicine.

Protect me from bad science, but leave the scientists out of it.

Good...

[clifyt]

I use to write medical applications and instruments years ago, and one of the most expensive things was testing the work, and running it past lawyers -- who tested the work one more time with a different team.

And my products were generally known as being good, accurate, and scientifically tested. ...

And then I would see competitors put out similar works that was not tested, and often times inaccurate. And much cheaper. Hell, one of my competitors put a disclaimer and lawyerly notice with the same guys I had been working with and I asked them if it was a conflict of interest...my guys said that if they were involved, they couldn't talk about it because of client lawyer priv...but then came back and said they could talk about it because they never heard from the guy. And yet, people thought his work was as scientifically tested and rigorous mine.

In my case, I was doing mostly psychological work...I was careful about my clients. I only licensed my software to legitimate psychologists or MDs with the appropriate background. My competitors didn't care...schools would try to buy my work to test kids to see if they were psychos or needed kicked out...and wants software that could take the place of a trained professional (where as I actually took out a few automations that would have been easier to diagnose, BUT it made it easier for people that had no right to diagnose, nor actually understood the ramification of doing this...I wanted the diagnosis to come from a licensed psychologist).

The whole point is, there is too much unregulated work in this world. Too many people that think they are experts, just because they have a book with equations and knowledge of programming. Too many people that are willing to put their name on a product for a percentage of the sales without ever looking at it. I spend the money on making certain things were right -- and it cut into my profit A LOT -- but it was the right thing to do. Everything I hear from this law is that it will actually make the law a little more uniform and a lot of stuff that we had to guess at is now concrete and no guessing needed. It will be actually cheaper to do this than what I paid before...the only people complaining are those that took shortcuts and didn't really care about your health.

(and sadly, these days I have the credentials to do the work...and yet I do no programming any more).

easy solution

[Anonymous Coward]

Have doctors write the apps themselves. I do. : )

May they should play doctor

[Murdoch5]

I've spent 15 yeas with specialists and I still don't know what I have. Imagine if a mobile app actually solved my case and if there wrong there actually on par with the doctors anyway, so no harm no foul.

Re:could they go after the 'one secret to trim bel

[Anonymous Coward]

come on, how could you ever get sick of seeing that person hold their belly fat...