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FDA To Scrutinize Mobile Medical Apps

timothy posted more than 3 years ago | from the because-regulation-is-always-good dept.

Medicine 142

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?"

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Yes, because we need government in everything (0, Troll)

roman_mir (125474) | more than 3 years ago | (#36863744)

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 [burzynskimovie.com] and you can't choose to exercise your freedoms, you are not your own person.

Re:Yes, because we need government in everything (1)

NoNonAlphaCharsHere (2201864) | more than 3 years ago | (#36863774)

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 (1)

ColdWetDog (752185) | more than 3 years ago | (#36863838)

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 (1)

NoNonAlphaCharsHere (2201864) | more than 3 years ago | (#36863864)

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 (1)

ColdWetDog (752185) | more than 3 years ago | (#36864880)

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

Re:Yes, because we need government in everything (2)

ColdWetDog (752185) | more than 3 years ago | (#36863920)

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 (1)

ceoyoyo (59147) | more than 3 years ago | (#36865018)

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 (0)

Anonymous Coward | more than 3 years ago | (#36865056)

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 (1)

ColdWetDog (752185) | more than 3 years ago | (#36863808)

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.

But wait, it's not yourself (1)

Anonymous Coward | more than 3 years ago | (#36863814)

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.

Re:Yes, because we need government in everything (-1)

Anonymous Coward | more than 3 years ago | (#36863816)

same thing applies to the drug war. we're property.

Re:Yes, because we need government in everything (3, Insightful)

ChromeAeonium (1026952) | more than 3 years ago | (#36863852)

Protecting me from snake oil salesmen (like your Burzynski [quackwatch.org] quack [scienceblogs.com] ) 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 (1)

roman_mir (125474) | more than 3 years ago | (#36863942)

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. [wikipedia.org] 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 [washingtonpost.com] the cost [wsj.com] of drugs [healthcare-economist.com] [usatoday.com] or [wikipedia.org] worse [nejm.org] . If FDA even has to exist, it's role should be limited [supplementquality.com] to questions concerning safety and nothing more, as it's useless in most important cases [youtube.com] anyway.

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

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

Try again (0)

Anonymous Coward | more than 3 years ago | (#36864188)

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 (0)

Anonymous Coward | more than 3 years ago | (#36865514)

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.

Re:Yes, because we need government in everything (0)

Anonymous Coward | more than 3 years ago | (#36864208)

>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 (1)

ChromeAeonium (1026952) | more than 3 years ago | (#36864276)

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.

Why protect the stupid? (0)

Chemisor (97276) | more than 3 years ago | (#36864056)

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? (2)

MacTO (1161105) | more than 3 years ago | (#36864186)

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? (1)

OrigamiMarie (1501451) | more than 3 years ago | (#36864502)

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? (2)

ceoyoyo (59147) | more than 3 years ago | (#36865126)

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? (1)

roman_mir (125474) | more than 3 years ago | (#36864658)

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 [youtube.com] 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? (1)

twidarkling (1537077) | more than 3 years ago | (#36866168)

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? (1)

uglyduckling (103926) | more than 3 years ago | (#36864200)

"Doctors are the third leading cause of death in this country". Bullshit. Heart disease, Cancer, Stroke, Chronic lower respiratory diseases and Accidents [cdc.gov] 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? (3, Insightful)

Calibax (151875) | more than 3 years ago | (#36864246)

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? (1)

ChromeAeonium (1026952) | more than 3 years ago | (#36864448)

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? (1)

Thing 1 (178996) | more than 3 years ago | (#36865866)

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? (1)

Chemisor (97276) | more than 3 years ago | (#36864556)

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? (1)

Calibax (151875) | more than 3 years ago | (#36864852)

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? (1)

Chemisor (97276) | more than 3 years ago | (#36865224)

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? (1)

twidarkling (1537077) | more than 3 years ago | (#36866234)

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:Yes, because we need government in everything (1)

superwiz (655733) | more than 3 years ago | (#36864102)

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 (0)

Anonymous Coward | more than 3 years ago | (#36865594)

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 (1)

superwiz (655733) | more than 3 years ago | (#36864122)

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 (1)

superwiz (655733) | more than 3 years ago | (#36864182)

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 (1)

superwiz (655733) | more than 3 years ago | (#36864192)

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

Re:Yes, because we need government in everything (1)

ChromeAeonium (1026952) | more than 3 years ago | (#36864316)

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 (0)

Anonymous Coward | more than 3 years ago | (#36864456)

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 (1)

sjames (1099) | more than 3 years ago | (#36864466)

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.

Bad examples. You're not helping... (1)

Okian Warrior (537106) | more than 3 years ago | (#36866164)

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.

Re:Yes, because we need government in everything (2)

chemicaldave (1776600) | more than 3 years ago | (#36863950)

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 (-1, Troll)

roman_mir (125474) | more than 3 years ago | (#36863960)

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

Re:Yes, because we need government in everything (1)

Mindcontrolled (1388007) | more than 3 years ago | (#36864014)

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 (0)

roman_mir (125474) | more than 3 years ago | (#36864036)

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 (0)

Anonymous Coward | more than 3 years ago | (#36864178)

you want incompatability and lower quality standards.

You don't see the forest for the trees.

Re:Yes, because we need government in everything (0)

Anonymous Coward | more than 3 years ago | (#36865358)

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 (0)

Anonymous Coward | more than 3 years ago | (#36865980)

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 (2, Insightful)

mspohr (589790) | more than 3 years ago | (#36864026)

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 (0)

roman_mir (125474) | more than 3 years ago | (#36864092)

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 (1)

hsmith (818216) | more than 3 years ago | (#36864158)

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 (1)

mspohr (589790) | more than 3 years ago | (#36864540)

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 (0)

Anonymous Coward | more than 3 years ago | (#36864902)

Price fixing turned out really well for Nixon.

Re:Yes, because we need government in everything (1)

Z34107 (925136) | more than 3 years ago | (#36866728)

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 (1)

roman_mir (125474) | more than 3 years ago | (#36864160)

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. [mises.org]

Re:Yes, because we need government in everything (1)

Calibax (151875) | more than 3 years ago | (#36864420)

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 (1)

roman_mir (125474) | more than 3 years ago | (#36864474)

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 [slashdot.org] . To reiterate:

Here is a good primer on this [eh.net] , 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 designed the Blue Cross guidelines so as to reduce price competition among hospitals. Prepayment plans seeking the Blue Cross designation had to provide subscribers with free choice of physician and hospital, a requirement that eliminated single-hospital plans from consideration. Blue Cross plans also benefited from special state-level enabling legislation allowing them to act as non-profit corporations, to enjoy tax-exempt status, and to be free from the usual insurance regulations.

- this was the beginning of real gov't intervention. You know, to 'reduce price competition'.

You see, price competition had a role, as it always does, in hospital care. This was designed to destroy competition. Immediately the destruction of private market has began:

The enabling legislation freed the plans from the traditional insurance reserve requirements because the Blue Cross plans were underwritten by hospitals. Hospitals contracted with the plans to provide subscriber services, and agreed to provide service benefits even during periods when the plans lacked funds to provide reimbursement. Under the enabling legislation, the plans "enjoy the advantages of exemption from the regular insurance laws of the state, are freed from the obligation of maintaining the high reserves required of commercial insurance companies and are relieved of paying taxes" (Anderson 1944, p. 11).4 Enabling laws served to increase the amount of health insurance sold in states in which they were implemented, causing growth in the market (Thomasson 2002).

this caused more havoc and collusion in the market in form of physicians fixing their prices:

to protect themselves from competition with Blue Cross, as well as to provide an alternative to compulsory insurance, physicians began to organize a framework for pre-paid plans that covered physician services.

more collusion:

Within these rules were provisions that ensured that voluntary health insurance would remain under physician supervision and not be subject to the control of non-physicians.

initially plans were cheap:

In 1939, the California Physicians' Service (CPS) began to operate as the first prepayment plan designed to cover physicians' services. Open to employees earning less than $3,000 annually, the CPS provided physicians' services to employee groups for the fee of $1.70 per month for employees

there was plenty of competition in insurance market then, as the demand materialized:

the market for health insurance exploded in size in the 1940s, growing from a total enrollment of 20,662,000 in 1940 to nearly 142,334,000 in 1950 (Health Insurance Institute 1961, Source Book, p. 10).

and commercial private insurance won against the public 'non-profit' insurance in terms of total subscribers, and this was BASED ON PRICE!:

So successful was commercial insurance that by the early 1950s, commercial plans had more subscribers than Blue Cross and Blue Shield. In 1951, 41.5 million people were enrolled in group or individual hospital insurance plans offered by commercial insurance companies, while only 40.9 million people were enrolled in Blue Cross and Blue Shield plans (Health Insurance Institute 1965, Source Book, p. 14).

THEN government started Medicare/Medicaide programs for various reasons, most of which was a popularity contest. Politicians wanted to be popular, so they wanted to throw a bone to electorate. Once these were in place, the insurance companies started lobbying the goovernment, as they saw these programs cutting into their profits because they were subsidized (same thing as with private rail and public roads,) and the insurance companies succeeded with Nixon and that was that. Now insurance is prohibitively expensive and it's employer based, so there are even less reasons for employers to hire Americans.

Medicare and Medicaid expenditures have grown as a percentage of total national health care expenditures since their inception in 1966. The figure points to some interesting trends. Expenditures in both programs rose dramatically in the late 1960s as the programs began to gear up. Then, Medicare expenditures in particular rose sharply during the 1970.

- the reasons are simple. Government colluded with insurance companies and health providers on one hand and it provided gov't subsidies through Medicare/Medicaide on another. The market was completely skewed, it had nothing to do with sound economics anymore.

Re:Yes, because we need government in everything (0)

Anonymous Coward | more than 3 years ago | (#36864938)

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 (0)

Anonymous Coward | more than 3 years ago | (#36864970)

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 (2)

0123456 (636235) | more than 3 years ago | (#36865346)

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 (1)

mysidia (191772) | more than 3 years ago | (#36864602)

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 (1)

ceoyoyo (59147) | more than 3 years ago | (#36865084)

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 (1)

roman_mir (125474) | more than 3 years ago | (#36865220)

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

- no, that's not evidence.

My other [slashdot.org] comments [slashdot.org] have various degrees of evidence [slashdot.org] . 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 (1)

ceoyoyo (59147) | more than 3 years ago | (#36865350)

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 (1)

roman_mir (125474) | more than 3 years ago | (#36865438)

There is plenty of evidence [slashdot.org] 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 (1)

ceoyoyo (59147) | more than 3 years ago | (#36865574)

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 (1)

roman_mir (125474) | more than 3 years ago | (#36866134)

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. [washingtonpost.com]

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. [wsj.com]

---
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. ... [nejm.org]

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.

Possible Hints of Higgs Boson (-1)

Anonymous Coward | more than 3 years ago | (#36863746)

A US particle machine has seen possible hints of the Higgs boson, it has emerged, after reports this week of similar glimpses at Europe's Large Hadron Collider (LHC) laboratory.

The Higgs boson sub-atomic particle is a missing cornerstone in the accepted theory of particle physics.

Researchers have been analysing data from the Tevatron machine near Chicago.

The hints seen at the Tevatron are weaker than those reported at the LHC, but occur in the same "search region".

Physicists have cautioned that these possible hints could disappear after further analysis.

But researchers also say when the US and European results are taken together, they start to paint an "intriguing" picture.

The results are being presented and discussed at the Europhysics conference in Grenoble, France.

Professor Stefan Soldner-Rembold DZero spokesperson

The Tevatron and LHC machines work on similar basic principles, accelerating beams of particles to high energies around a tunnel before smashing them together.

These collisions can generate new particles which can then be picked up by detectors built at the points where particle beams cross over.

The LHC, which is housed in a 27km-long circular tunnel below the French-Swiss border, has two detectors looking for the Higgs: Atlas and CMS. Each is staffed by a different team of scientists.

The Tevatron has a comparable arrangement, with two detectors called DZero and CDF. Just a quirk?

On Friday, the Atlas and CMS teams reported finding what physicists call an "excess" of interesting particle events at a mass of between 140 and 145 gigaelectronvolts (GeV).

The excess seen by the Atlas team has reached a 2.8 sigma level of certainty. A three-sigma result means there is roughly a one in 1,000 chance that the result is attributable to some statistical quirk in the data.

Now, the US DZero and CDF experiments have also seen hints of something at about 140GeV.

Played a roll (2)

NoNonAlphaCharsHere (2201864) | more than 3 years ago | (#36863750)

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

Re:Played a roll (1)

Maritz (1829006) | more than 3 years ago | (#36863768)

You gotta role with it.

Re:Played a roll (1)

NoNonAlphaCharsHere (2201864) | more than 3 years ago | (#36864372)

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 (4, Insightful)

microcars (708223) | more than 3 years ago | (#36863798)

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 (0)

Anonymous Coward | more than 3 years ago | (#36863856)

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 (1)

Trepidity (597) | more than 3 years ago | (#36864028)

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 (2)

ColdWetDog (752185) | more than 3 years ago | (#36864070)

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.

Umm lame? (-1)

Anonymous Coward | more than 3 years ago | (#36863804)

Yep that was pretty stupid.

computers and health care (1)

girlintraining (1395911) | more than 3 years ago | (#36863834)

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 (0)

Anonymous Coward | more than 3 years ago | (#36863882)

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 (1)

skaffen42 (579313) | more than 3 years ago | (#36863994)

Posting about personal responsibility... anonymously...

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

Re:computers and health care (1)

hedwards (940851) | more than 3 years ago | (#36864054)

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 (1)

uglyduckling (103926) | more than 3 years ago | (#36864212)

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?

"for entertainment purposes only" (1)

nurb432 (527695) | more than 3 years ago | (#36863844)

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' (4, Insightful)

decora (1710862) | more than 3 years ago | (#36863866)

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.

Re:could they go after the 'one secret to trim bel (2)

ceoyoyo (59147) | more than 3 years ago | (#36865180)

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."

The shape of things to come (1)

Okian Warrior (537106) | more than 3 years ago | (#36863874)

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? (0)

Anonymous Coward | more than 3 years ago | (#36863924)

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? (0)

Anonymous Coward | more than 3 years ago | (#36863926)

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

kindumb come; where fear & hatred thrive (0)

Anonymous Coward | more than 3 years ago | (#36863980)

& 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 (1)

Sloppy (14984) | more than 3 years ago | (#36864010)

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...

FDA's Incestuous relationship with corporations .. (1)

Jerry (6400) | more than 3 years ago | (#36864060)

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.

Re:FDA's Incestuous relationship with corporations (1)

Trepidity (597) | more than 3 years ago | (#36864428)

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.

FDA to stamp out innovation (1)

hsmith (818216) | more than 3 years ago | (#36864072)

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.

Tht's stupid (1)

shoehornjob (1632387) | more than 3 years ago | (#36864244)

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 (1)

zippthorne (748122) | more than 3 years ago | (#36865818)

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.

As long as they don't claim to be diagnosing: NO (1)

guruevi (827432) | more than 3 years ago | (#36864996)

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 (1)

Alien Being (18488) | more than 3 years ago | (#36865068)

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 (1)

scamper_22 (1073470) | more than 3 years ago | (#36865078)

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.

Red herring (1)

Mr. Freeman (933986) | more than 3 years ago | (#36866010)

"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.

Woot 7p (-1)

Anonymous Coward | more than 3 years ago | (#36866078)

IBE A COCK-SUCKING else 0p their asses

Good... (2)

clifyt (11768) | more than 3 years ago | (#36866384)

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).

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