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Stem Cell Firm May Have Administered Unproven Treatments

samzenpus posted more than 2 years ago | from the snake-oil dept.

Biotech 221

ananyo writes "With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company. Celltex Therapeutics 'multiplies and banks' stem cells derived from people's abdominal fat and its facility in Sugar Land opened in December 2011 and houses the largest stem-cell bank in the United States. But Nature has uncovered evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases."

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What's the point? (0, Flamebait)

msauve (701917) | more than 2 years ago | (#39204953)

Why should the government be the gatekeeper for healthcare? As long as the patient is made aware of the risks, it's their life, their money, their risk to assume. Stop the nanny government.

Re:What's the point? (5, Insightful)

Misanthrope (49269) | more than 2 years ago | (#39204979)

Because the average patient doesn't have the background to understand what they're getting themselves into. Without laws to the contrary snake oil salesman can claim whatever they want about a treatment or medication. Do you really want to live in the 19th century?

Re:What's the point? (-1)

Anonymous Coward | more than 2 years ago | (#39205007)

If people want to know whether a treatment is proven or just experimental, they can figure that out now with this vast research tool called the Internet. The government isn't the only party you can trust.

Re:What's the point? (0, Offtopic)

Anonymous Coward | more than 2 years ago | (#39205017)

You can trust information on the internet????

Re:What's the point? (0, Funny)

Anonymous Coward | about 2 years ago | (#39205245)

You can. You can do a lot of things. Mix Bleach and Ammonia. Add Antifreeze to your drinks. Believe in Jesus killing the Dinosaurs.

With an AK-47.

Ouch.

Re:What's the point? (0)

sjwt (161428) | about 2 years ago | (#39205479)

You can trust the government??

Re:What's the point? (2, Insightful)

Anonymous Coward | about 2 years ago | (#39205589)

Nope. That's why it's answerable to we, the people.

On purpose.

It'd be unfair to ask any given individual to be that accountable, but the collective whole? That's another matter.

Of course, sometimes the answers you get may not be what you want, but when has that ever not been true?

Re:What's the point? (3, Funny)

Dan541 (1032000) | about 2 years ago | (#39205597)

More than the tin-foil hat salesmen.

Re:What's the point? (3, Funny)

Seraphim_72 (622457) | more than 2 years ago | (#39205063)

Yes, because everyone has access, ability and understanding. I know I keep up with the latest in stem cell research as it relates to cancer....don't you?

Re:What's the point? (2)

Anthony Mouse (1927662) | more than 2 years ago | (#39205069)

Do you have cancer? Because I bet cancer patients keep up with it.

Re:What's the point? (4, Insightful)

Anonymous Coward | more than 2 years ago | (#39205091)

But do they have the education to understand what they are reading?

Re:What's the point? (3, Insightful)

sjwt (161428) | about 2 years ago | (#39205549)

Many do, See learning happens out side of school, its hard sometimes to find those who do it, many who get seriously ill do research and learn a lot about their own diagnoses, large support groups exist out their to, these ppl research and look into any aspect that could help improve their lives and are quite often filled with those who *do* know that homeopathic remedies are BS and can talk your ear off about current treatments and clinical trials going on, I have seen this with family members with Cancer and Lupus.

Unless dealing direct with a specialist, these sorts of ppl can know a lot more about their own issue then most GPs.

As a reminder, their is so much that GPs and doctors need to know that covers such a wide area that mistakes do often happen, take the 50-100k ppl a year who die in America from having adverse known drug interactions Study Says E-prescription Systems Would Save At Least 50k Lives a Year [slashdot.org]

Re:What's the point? (4, Interesting)

Seraphim_72 (622457) | more than 2 years ago | (#39205135)

Nope I dont, but I have sure been in enough research labs. But if you have colon cancer how long are you going to wait to 'educate' yourself? How long do your doctors want you too? What type and how aggressive. Care to be Steve jobs?

And no they don't. They fall for snake oil all the time. ALL THE TIME.

One of the saddest things I ever heard was about the AIDS precautions taken by haemophiliacs in the late 80's when AIDS was on the rise. People who knew *everything* about blood had the same rate of protected sex as the rest of the population. Nothing like seeing a CDC researcher report that.

uhm, they also had an infected blood supply (0)

decora (1710862) | more than 2 years ago | (#39205185)

that is an interesting anecdote.

but the more commonly told story about hemophiliacs and aids is that the non-profit blood centers refused to ban homosexual people from giving blood in the early stages of the epidemic because it would have been non-correct politically. the supply, relied on by hemophiliacs for basic survival, got infected and tens of thousands of hemophiliacs died. now, of course, they still ban homosexual people, even when it is no longer helpful nor wise to do so (when blood banks are complaining they are always short of blood, why are you banning an entire group of people who could have safe blood now that we understand the disease and have good tests for it?).

Re:uhm, they also had an infected blood supply (0)

Seraphim_72 (622457) | more than 2 years ago | (#39205235)

decora mine was a badly worded sentence. What I meant to say was that their safe sex practices (ie wearing condoms) was the same as the general population. The CDC simply could not get them to do it!

Re:uhm, they also had an infected blood supply (2)

DarwinSurvivor (1752106) | about 2 years ago | (#39205251)

Is this a US thing or something, because I thought that was permanently changed long ago. In Canada they ask information about recent sexual activity, but to the best of my knowledge it's all about quantity and risk, I don't think there are any questions regarding orientation.

Re:uhm, they also had an infected blood supply (3, Insightful)

mtm_king (99722) | about 2 years ago | (#39205465)

The infected blood supply also took a toll on people who needed blood for other reasons, including one of my favorite authors, Isaac Asimov.

Re:What's the point? (2, Insightful)

Anthony Mouse (1927662) | more than 2 years ago | (#39205207)

Nope I dont, but I have sure been in enough research labs. But if you have colon cancer how long are you going to wait to 'educate' yourself? How long do your doctors want you too? What type and how aggressive. Care to be Steve jobs?

And no they don't. They fall for snake oil all the time. ALL THE TIME.

If you have some terminal illness that is killing you so fast that you can't even take two weeks to do your homework and think on it, it seems like the risk:reward for potential snake oil might be quite attractive even thinking rationally. If you're already going to die soon otherwise then what's the worst that can happen?

One of the saddest things I ever heard was about the AIDS precautions taken by haemophiliacs in the late 80's when AIDS was on the rise. People who knew *everything* about blood had the same rate of protected sex as the rest of the population. Nothing like seeing a CDC researcher report that.

I think sex is in a different class from medical treatment. People who have unprotected sex generally don't plan to do it, so it makes perfect sense that people with more information don't make any better decisions. In this case people are making foolish decisions because they don't think, not because they don't know.

Re:What's the point? (1)

Seraphim_72 (622457) | about 2 years ago | (#39205263)

The point is that they had all the information they needed, even from highly trained medical specialist, and *still* didn't make the right choice. And you want to be part of it that even drags the best and brightest out of it so "Duh Gubmint won't terl me, no sah"??? Really?

Re:What's the point? (2)

jackbird (721605) | about 2 years ago | (#39205377)

People who have unprotected sex generally don't plan to do it, so it makes perfect sense that people with more information don't make any better decisions.That wasn't true in the 1980s. Condoms weren't a de rigeur part of the plan until after years of AIDS education and activism. From the advent of antibiotics and hormonal birth control until a decade or so into the AIDS epidemic, contracting an STD wasn't considered a big deal among people who had casual sex.

Re:What's the point? (2)

PopeRatzo (965947) | about 2 years ago | (#39205517)

From the advent of antibiotics and hormonal birth control until a decade or so into the AIDS epidemic, contracting an STD wasn't considered a big deal among people who had casual sex.

That's the important fact: it took people a decade to start doing what everyone knew they should be doing.

Just as it took decades for the smoking rate to start dropping after everybody knew smoking was really really bad for you.

Now we have obesity, and everybody knows that it's really unhealthy to be fat. Is it going to take decades for people to figure out that eating two #1 meals at McD's twice a day is probably not conducive to a long healthy life?

There seems to be something in the US psyche that resists anything like "best practices". Maybe it's something in the human psyche, but just last year I was in Europe, where I traveled from Rome to Belgrade and didn't see the kind of morbid obesity that's normal here in the 'States.

Re:What's the point? (4, Insightful)

Belial6 (794905) | about 2 years ago | (#39205835)

It probably will take decades. Mostly because people are being given wrong information. For example, your McDonalds comment. A McDonalds Quarter Pounder is not bad for you. The Pasta you made at home is. People are buying candy as health food because it is "Fat Free". Then you have the problem that "obesity" is so incorrectly defined that every Mr Universe for decades has been defined as "obese" while people who reduce their BMI by replacing muscle with fat are being patted on the back for "getting in shape".

Re:What's the point? (4, Insightful)

artor3 (1344997) | about 2 years ago | (#39205407)

Nope I dont, but I have sure been in enough research labs. But if you have colon cancer how long are you going to wait to 'educate' yourself? How long do your doctors want you too? What type and how aggressive. Care to be Steve jobs?

And no they don't. They fall for snake oil all the time. ALL THE TIME.

If you have some terminal illness that is killing you so fast that you can't even take two weeks to do your homework and think on it, it seems like the risk:reward for potential snake oil might be quite attractive even thinking rationally. If you're already going to die soon otherwise then what's the worst that can happen?

The worst that can happen is you spend $50k on a treatment that doesn't buy you a single god-damned day of further life. Now, not only are you dead, but you get to go to your grave knowing that you've heaped an extra burden on your loved ones for nothing. But since at the time of making the decision you're still in the bargaining stage of grief, you don't think about that. The heartless scammers running these cons count on that.

Re:What's the point? (0)

Anonymous Coward | about 2 years ago | (#39205721)

Now, not only are you dead, but you get to go to your grave knowing that you've heaped an extra burden on your loved ones for nothing.

The dying person could also choose to live his last few days on a ridiculously expensive cruise vacation, similarly leaving a burden on the family with no extension of his life. Are we to prevent him from doing that, too?

What about all that other useless shit you buy every week? And you aren't even dying.

Re:What's the point? (1)

arogier (1250960) | about 2 years ago | (#39205383)

How many high blood pressure patients understand the nuances of the rein-angiotensin system.

Re:What's the point? (1)

Anonymous Coward | about 2 years ago | (#39205429)

I have no problem finding the information I need from Yahoo Answers.

Re:What's the point? (1)

Dan541 (1032000) | about 2 years ago | (#39205529)

No, 5 minutes on Wikipedia does not make you a researcher.

Re:What's the point? (1)

retchdog (1319261) | about 2 years ago | (#39205617)

sure, we can do that after we abolish trade secrets and patent protection (we'd of course retain the mandatory publication part, so as to have that information there in the first place). fair enough?

Re:What's the point? (1, Flamebait)

TheRon6 (929989) | more than 2 years ago | (#39205025)

Because the average patient doesn't have the background to understand what they're getting themselves into. Without laws to the contrary snake oil salesman can claim whatever they want about a treatment or medication. Do you really want to live in the 19th century?

You're right, laws to protect citizens from "snake oil salesmen" were indeed important in the 19th century since no one could google "snake oil" and realize that this wasn't going to cure their cancer. Now you can. Welcome to the 21st century.

Re:What's the point? (1)

joocemann (1273720) | more than 2 years ago | (#39205061)

You might be on gooogle for a long time before you 1) got a clear anwer and 2) learned enough to be sure what a clear answer looks like.

You play pedantic, but youre acting stupid.

Re:What's the point? (5, Interesting)

Anthony Mouse (1927662) | more than 2 years ago | (#39205103)

OK, so forget the wider internet. Why doesn't the FDA maintain a website containing the approved and known-safe drugs, the experimental drugs, the known-dangerous drugs, etc. The doctor recommends the treatment, the patient goes to the FDA website (which the doctor is required to tell them about) and gets all the information, now the patient can make an informed decision.

You can make all the arguments you want about young children or patients with mental disabilities, but that doesn't justify depriving normal adults of a decision about their own medical treatment.

Re:What's the point? (2)

similar_name (1164087) | more than 2 years ago | (#39205151)

Interesting. Would still be for the FDA regulating what requires a prescription and which ones don't? If I'm informed and I am able to make my own decision I don't think I should need a doctor either.

Re:What's the point? (1)

zill (1690130) | about 2 years ago | (#39205265)

Prescriptions can be eliminated in that case. The pharmacy will just have you sign a waiver form.

There are millions of items on store shelves that can kill you. How come only prescription drugs need a permission slip from the government?

Re:What's the point? (0)

Anonymous Coward | more than 2 years ago | (#39205217)

And how, pray tell, would that help?

Suppose you (or a loved one) as some sort of pernicious disease, either with no treatment or none of the approved treatments have been successful. Someone close does a google search on the condition, and comes up with a site peddling some treatment that doesn't appear on the FDA website. What do you do now? Without access to the test data (if any exists) nor the education to evaluate it, how do you make any sensible decision under extremely emotional conditions? Just doesn't seem sensible to me.

Re:What's the point? (1)

zill (1690130) | about 2 years ago | (#39205391)

Suppose you (or a loved one) as some sort of pernicious disease, either with no treatment or none of the approved treatments have been successful.

Ok, suppose I have cancer.

Someone close does a google search on the condition, and comes up with a site peddling some treatment that doesn't appear on the FDA website.

I googled "magic cancer treatment" and this [cancertutor.com] is the first result.

What do you do now? Without access to the test data (if any exists) nor the education to evaluate it, how do you make any sensible decision under extremely emotional conditions?

I ignore it because it's not FDA approved.

Simply, wasn't that?

Re:What's the point? (0)

Anonymous Coward | about 2 years ago | (#39205769)

I'm not sure why I've been seeing this recently, but you said "Simply, wasn't that?" when it should have been "Simple, wasn't that?". "Simply" is an adverb, and is used to modify a noun, like "He simply walked through the door.", where the word "simply" modifies "walked" in describing what the man did. The adjective "simple" is what you wanted, because it describes the properties of a noun, like "That was simple, wasn't it?", where "simple" is describing "that".

I say this not to be rude but only to satisfy my own curiousity so please don't take this the wrong way, but are you a native English speaker, and if not then what is your principle language? I ask because I wonder if there is a language that does not distinguish between adverbs and adjectives.

Cheers!

Re:What's the point? (1)

zill (1690130) | about 2 years ago | (#39205823)

Sorry, that was a typo.

Re:What's the point? (5, Insightful)

darronb (217897) | more than 2 years ago | (#39205227)

... because desperate people will do desperate things.

Sure, things could be a lot better... but it's a big assumption that people will (a) make informed decisions and (b) not get totally taken advantage of.

The second one person out of a hundred has a positive outcome on some test drug, all known dangers are totally ignored and everyone wants it. The corp selling the drug starts to suspect there's a problem, but they are making a lot of money so they wait for more conclusive proof. Two years later, everyone's dead of kidney failure.

People are not rational. Even otherwise quite rational people given desperate choices will take wild gambles and will blindly trust anyone saying they can help.

Re:What's the point? (3, Interesting)

msauve (701917) | about 2 years ago | (#39205247)

"it's a big assumption that people will (a) make informed decisions and (b) not get totally taken advantage of."

It's an even bigger assumption that the government can (a) make informed decisions on specific individual cases and (b) not be subject to biased, politically motivated influence.

Re:What's the point? (1)

darronb (217897) | about 2 years ago | (#39205371)

Really? That' s ORDERS of magnitude more manageable.

I'd MUCH rather have government's barely competent management of medical science tell me (and the people I care about) what's safe. It's a big enough target for people to actually monitor and watchdog to some degree. Is it going to make the correct, unbiased decision for every person? Of course not, probably far from it. That doesn't mean we should throw it out and let anyone with an idea and a slick web site inject something into Grandma. Care to try to manage THAT? What possible criteria would you have, if "let's test it and see what happens first" is too much government interference for you?

Caveat emptor?

I can't actually believe I'm having this argument. After all.. Why trust the government with guns? Let's break all this shit down and get rid of all the police, firefighters, teachers, etc. I'm sure we could do SO much better with neighbourhood militias, bucket brigades, and home schooling with that nice Intelligent Design lady down the street.

Re:What's the point? (1)

msauve (701917) | about 2 years ago | (#39205413)

What possible criteria would you have, if "let's test it and see what happens first" is too much government interference for you?

But isn't that exactly what the FDA does - test it to see what happens? If not, then there's no argument, because no progress can ever be made.

Caveat emptor?

Exactly, provided there is no fraud (deceit) involved. That is a proper role for goverment.

Re:What's the point? (2)

darronb (217897) | about 2 years ago | (#39205543)

Well, we've been there before. It sucked.

Fraud is -really- hard to prove. "I really thought this cobra venom cured my back pain, your honor. I was just offering my discovery to others for a small fee to cover my expenses."

Even liability is really weak. "You can't prove my horse adrenaline caused the heart attack. People have heart attacks all the time."

Without some large (perhaps governmental?) organization tracking such things, you'd never figure out what DID work.

Drug testing generally works. It's slow, it's bureaucratic, it occasionally screws up... but it works.

You CAN'T KNOW what the side effects in a real human population are until you've tried it in a decent sized trial. Before you do that, you'd better try a small test segment. Before that, you'd be highly irresponsible not to test it pretty thoroughly in analogues like animals first. Doing it responsibly takes a painful amount of time and money.

Sure, it really sucks when a lifesaving drug COULD have been given if it was known to be safe ahead of time... but you have to wait for the results. "You HAD the drug, my daughter DIED and your drug was available the next day!"...

I hope that's never me, but the alternative is worse.

Re:What's the point? (1)

Seraphim_72 (622457) | about 2 years ago | (#39205289)

It doesn't deprive them of anything. The literature is there. Go make the drug. This isn't rocket science. What they are doing is protecting the populous from the unscrupulous drug companies. If a drug is unregulated you can take it all you want. just don't expect your insurance to cover it.

Re:What's the point? (1)

zill (1690130) | about 2 years ago | (#39205477)

The literature is there. Go make the drug.

You do realize that it's illegal to manufacture drugs without FDA approval, right?

If a drug is unregulated you can take it all you want. just don't expect your insurance to cover it.

I'm not sure what you mean by "unregulated". All drugs in the US are regulated by the FDA. Even over-the-counter drugs. Making your own Aspirin is a federal crime.

Re:What's the point? (2, Interesting)

artor3 (1344997) | about 2 years ago | (#39205315)

Because desperate people don't think rationally, and will throw away huge amounts of money on drugs that don't do shit sold by heartless scammers. That already happens, there's no need to make it more common.

Hardcore libertarians always have this view of themselves as gods-made-flesh, always rational, always informed, always able to make the best decision for themselves, and HOW DARE anyone tell them otherwise. It's all feel-good bunk. Normal adults should be deprived of these decisions because normal adults will get ripped off and end up hurting themselves and their loved ones. It's in everyone's best interests to have impartial experts examine the facts and say "No, this drug is just going to make you worse" without having the consumer get competing "information" from "HowTheGovernmentIsKeepingYouSick.com".

people gamble with their money, (1)

circletimessquare (444983) | about 2 years ago | (#39205323)

people gamble with their health, people make stupid decisions. this includes you. this includes myself

but what doesn't happen is that the individual is the only one who pays for their bad gambles, we pay for it, society, in direct financial ways, and in more disperse ways

we're not going to change human nature, but if we become aware of snake oil salesmen, or ponzi schemes, we shut it down

not because we want to tell people what to do and deny them their god given freedom to shoot themselves in the foot, but because we don't want to pay for their fuck ups

Re:What's the point? (2)

arogier (1250960) | about 2 years ago | (#39205421)

They kind of do. There is this powerful tool known as the Orange book with all approved medications including generics listed with separate entries for each dosage. There is a lot of information out there. Even if you just count the free stuff. The thing is a good portion of it is only really accessible in a useful way to professionals, because the body is a complex system. You pharmacist, the guy who checks your prescriptions for dangers and counsels you on proper drug therapy has at least four years of professional education. Saying any given normal adult should have to accept all of the responsibility for themselves is opening the door for abuse.

Look at statins. There are dangers popping up now that didn't appear in a statistically significant way during the original trials that only had thousands of participants. Now, with post market surveillance more of them can be identified. On the flip side, there are benefits of statins being explored that weren't conceivable during per-approval trials.

Re:What's the point? (1)

Dan541 (1032000) | about 2 years ago | (#39205605)

Because people would self medicate. This is already a problem without the government encouraging it.

Re:What's the point? (0)

philip.paradis (2580427) | about 2 years ago | (#39205797)

Your inability to properly research something is your problem. Are you attempting to make the claim that the government should assume full responsibility for the welfare of citizens? Are you advocating removal or severe curtailing of personal choice from the equation? Are you the sort of person that likes the idea of public servants dictating your choices from cradle to grave?

This is a matter that should be left between physicians and their patients. Physicians have a responsibility to act in the best interest of their patients, and sometimes this means advocating risky or unproven treatments. That's also how an incredible amount of progress is made in medicine. Patients have a responsibility to learn everything they possibly can about their treatment options, consult additional physicians for further guidance, and make their own decisions based on validation or rejection of recommendations.

The Internet is a fantastic tool for information archival, information retrieval, and global discussion of any topic imaginable. Instead of displacing responsibility for your own health, you could decide to fully utilize the tools at your disposal to connect with thousands of similarly interested parties around the world.

On a final note, I recommend taking a remedial English course at your earliest convenience. Attempting to engage in a discussion on matters like these, while spelling "Google" as "gooogle," spelling "you're" as "youre," and violating commonly accepted composition guidelines with the phrase "acting stupid" doesn't do much to enhance your credibility.

HTH.

Re:What's the point? (4, Insightful)

darronb (217897) | more than 2 years ago | (#39205177)

Uh, dude... I have family members that buy bottles of new age memory water that have been impressed with good memories and are supposed to help you along on your path to enlightenment. They've also bought polished black rocks that "retune the negative energy of cellphones into good energy that can heal any illness" which if cellphones aren't around they'll fall back on the energy of underground streams.

Actual snake oil was so much more straightforward.

People form groups. Bullshit is spread around. When someone hears the same bullshit from two places, they tend to go "oh my god, that must be true!".

Never underestimate the power of stupidity and ignorance. The general population of the world is nowhere near rational.

Re:What's the point? (1, Insightful)

msauve (701917) | about 2 years ago | (#39205293)

" I have family members that buy bottles of new age memory water "

I have family members who buy 3D TVs and iPhones, which are probably more expensive than that water. Are you saying they're stupid and ignorant, and shouldn't be allowed that choice?

Re:What's the point? (2)

darronb (217897) | about 2 years ago | (#39205457)

The point is, people with all the tools in the world to find information on what works and what doesn't aren't going to use it correctly.

Selling black rocks to make fools feel better around cell phones is frustrating but it isn't that big a problem. Selling black rocks as an alternative treatment for cancer, or memory water for diabetes... that's a problem worth regulating.

If you throw out the FDA, you're effectively throwing out testing. What corp would spend even 1% of what they do now to test drugs if they weren't absolutely forced to follow the process to the bitter end?

Civil liability is nowhere near a large enough deterrent. Can you imagine trying to prove your son died due to snake oil salesman #1's special mango juice, vs. some other natural causes?

Re:What's the point? (1)

moderatorrater (1095745) | about 2 years ago | (#39205547)

You have to be trolling. 3D TVs and iPhones might be overpriced, but they do what they claim they can do. That's a world away from snake oil, memory water and magic crystals.

Re:What's the point? (1)

Jah-Wren Ryel (80510) | about 2 years ago | (#39205599)

Indeed. My iphone is a total chick magnet, and 3DTV? When they come over and watch that, their panties literally drop right off!

people can google 'subprime mortgage' too (2)

decora (1710862) | more than 2 years ago | (#39205201)

that doesnt mean they wont all go get one and help Goldman Sachs et al bring down the world economy, while all of the 'experts' who are highly educated, sophisitcated economists continue to say there is no housing bubble, mortgage backed bonds and securities are great, Bear Stearns is a good investment, etc etc etc blah blah blah.

for a more updated version, watch TV during mid day, count the number of for-profit colleges advertising, then go read 'Subprime goes to College' by Steve Eisman.

at some point, you have to have somebody come in and tell one group of people to stop victimizing another at a huge cost to society, and then claiming "not my problem, they should have known i was going to destroy their lives". we dont need any more bailouts.

Re:people can google 'subprime mortgage' too (1)

msauve (701917) | about 2 years ago | (#39205341)

"you have to have somebody come in and tell one group of people to stop victimizing another at a huge cost to society"

Your implied assumption is that society must take care of those who make poor decisions (which you incorrectly call "victims"). Let 'em rot or depend on private charity (in which case the cost is voluntary). If someone is underwater on their mortgage, bailing them out is only making those who made good choices pay for those who made bad ones. You apparently don't have kids, because rewarding bad behavior only results in even more bad behavior.

Re:What's the point? (2)

feepness (543479) | more than 2 years ago | (#39205039)

Because the average patient doesn't have the background to understand what they're getting themselves into. Without laws to the contrary snake oil salesman can claim whatever they want about a treatment or medication. Do you really want to live in the 19th century?

Did you actually read what you replied to?

"As long as the patient is made aware of the risks."

That precludes fraud, which eliminates snake oil salesman.

Re:What's the point? (1)

Seraphim_72 (622457) | about 2 years ago | (#39205489)

Wow, you are right.
Here is a two year old make him aware of the risks of surgery for brain cancer. I mean we are only trepanning .

  At what general age or competence level does this statement; "We are only Trepanning" become nonsensical and an issue?

Re:What's the point? (0)

Anonymous Coward | more than 2 years ago | (#39205041)

Patients have the ability to judge people as trustworthy or not. For example, you don't have to know much about law to select a good lawyer. You can follow recommendations, look at what schools they went to, etc.

The 19th century? If you knew about the vast improvements made to life during that era, you'd want to bring the essence of it back, too. In 1800, there were no railroads, telegraphs, airplanes, skyscrapers, anesthetics, factories with mass-produced goods, etc. Chemistry was still in its infancy. Slavery was abolished. By 1900 (1903 for flight), all of those things existed, or were developed in a major way. And I'm just skimming the surface. Life expectancy shot up dramatically during that century. Granted, the advances we've made in science and medicine since 1900 are huge, but I say we made a bigger leap from 1800 to 1900 than we did from 1900 to today. Our rate of progress has slowed down, and going back to the _principles_ of the 19th century is the only way we'll pick up the pace again.

Re:What's the point? (1)

msauve (701917) | more than 2 years ago | (#39205045)

It doesn't matter what I want. It's what the patient in question wants. Who is the government to tell them what's proper, or decide where the risk/benefit ratio should fall? Let people assume full responsibility for their own decisions and actions. If they die due to poor choices, so much better for the gene pool.

One can (legally) go and buy a $10 vial of worthless homeopathic "medicine," and some people get relief from that. In what way might this be different, except in scale? Does is actually cause harm, or is it merely a distraction from accepted treatments?

IMO, and that of many others, government is about protecting people from each other, not from their own freely made choices.

Re:What's the point? (0)

Anonymous Coward | more than 2 years ago | (#39205093)

So long as the government picks up the "last resort" case, it can and should dictate some terms. By last resort I mean if you take some crazy snake oil treatment, get violently ill, but can't pay for the real medical treatment, who gets to foot the bill? If you agree that the government should not pay for those without insurance or who are underinsured, effectively letting hospitals kick deadbeats out on the streets to die, then there shouldnt be a problem with letting people choose their own treatment.

Re:What's the point? (4, Insightful)

Daniel Dvorkin (106857) | more than 2 years ago | (#39205049)

People who say things like that generally seem to assume two things: first, that full and accurate information will be available; and second, that they'll be able to interpret the information and make an informed decision -- after all, they're smart and knowledgeable and can think for themselves, not like all those other sheeple! They could, of course, educate themselves about the history of patent medicine (and food production) and why the FDA and similar organizations in other countries were created in the first place, but it's easier to grumble about "government gatekeepers" and decry regulation as a matter of principle.

Re:What's the point? (1)

Fluffeh (1273756) | more than 2 years ago | (#39205055)

Because the average patient doesn't have the background to understand what they're getting themselves into

I thin it is partly that, but probably a much greater part is pure politics. The conservatives and religious types hold much of the voter base, especially in the bible belt and heartlands of the US. A strong approach to "limit the evils of scientists" in political speeches goes a long way to garnishing some of those votes. This isn't new at all, with movement as early as 2006 [guardian.co.uk] during the Bush administration when the US was limiting this type of research, but the EU was pushing boldly ahead. However, more recently, they banned patents which came around due to stem cell research [forbes.com] which is sort of good and sort of bad - it means that companies are less likely to invest as heavily into the research, but it means that all government funding will certainly be to the benefit of the population.

Re:What's the point? (1)

GLMDesigns (2044134) | more than 2 years ago | (#39205099)

And yet we have drugs that people want to take. 25 years ago when AIDS was the topic of the day ACT UP and other groups were demanding that people get access to experimental drugs.

Yes there are snake-oil salesmen - but at the same time there are valuable drugs out there. A compromise needs to be reached where non-FDA approved drugs can be sold.

How is this compromise reached? It can be done - but there will have to public debate until we arrive at a concensus. Remove legal responsibility to adverse reactions and you will have con-men flooding the market. AND yet ... what about a simple concept called freedom?

Re:What's the point? (0)

Anonymous Coward | more than 2 years ago | (#39205189)

It's called population control, if you are stupid enough to ingest snake oil without knowing all the side effects, Darwinism has chosen you.

Re:What's the point? (1)

pjr.cc (760528) | more than 2 years ago | (#39205229)

More to the point (at least in australia) the cost of "fixing" someone is significant for the government and they also consider people to be an "investment" - as in "we spent heaps educating you to year 12, now you owe us".

The point being of course is that they dont want you doing anything that can either cost them money or kill their investment...

Re:What's the point? (0)

Anonymous Coward | about 2 years ago | (#39205363)

What century are you living in? Because in 20th/21st century America the snake oil salesman write the laws. That's not hyperbole either. Here in the U.S. most healthcare laws and regulations are written by paid lobbyists of the pharmaceutical companies. Guess who those laws are designed to protect?

Re:What's the point? (1)

Dan541 (1032000) | about 2 years ago | (#39205539)

Unfortunately the Snake Oil salesmen are a have a huge industry. Homeopathy being one of the biggest examples.

Re:What's the point? (1)

joocemann (1273720) | more than 2 years ago | (#39205029)

You say that as if anyone not working in the stem cell field would understand...

I work in the field, and pretty much nobody is talking about current safe therapies... this is because of the lack of substantially finalized trials. Bone marrow xplants are, in essence, an adult stemcell therapy, but even then not bone marrow precursors (haematopoetic stemcells) derived from iPSC (induced pluripotent stemcells made from fibroblasts, adipose, etc).

Re:What's the point? (1)

msauve (701917) | more than 2 years ago | (#39205123)

"I work in the field, and pretty much nobody is talking about current safe therapies."

If you work in that field, then you must admit that you see potential benefits. Are you claiming that this specific treatment is unsafe, or you simply don't know? Why should patients, making a decision of their own free will, be denied a potential treatment by the government? If you're claiming that your knowledge puts you in a better position to make a decision, who decides who decides, if not the person who is directly affected? By what province does the government get to make decisions which affect only the individual?

Based on the same criteria as is used by the FDA (widespread, mainstream medical acceptance), the once accepted therapy for ill humors was bloodletting. If someone at the time wanted an "alternative" treatment, such as moldy bread on their sores, they would have been ridiculed.

Re:What's the point? (1)

ppanon (16583) | about 2 years ago | (#39205367)

False equivalence. The difference is that there wasn't much in the way of double blind tests establishing the benefits of bloodletting for ill humors. Now, had bloodletting actually been beneficial and so proved by double blind tests, it would have been pretty reasonable to encourage sticking with that treatment until applying moldy bread had been proved superior through similar double-blind testing.

In fact a common treatment [mayoclinic.com] for hemachromatosis is a modern version of blood-letting, and applying moldy bread to the body of hemachromatosis patients isn't going to do them much good. And if hemachromatosis doesn't qualify as a form of ill humor, I don't know what does.

Re:What's the point? (1)

linatux (63153) | more than 2 years ago | (#39205133)

Who is expected to pick up the pieces if the treatment has undesirable side-effects?
Are people (in general) capable of understanding the risks? Would the same people who sign up to this also send money to Nigerian Prince's in exile?

Re:What's the point? (0)

Anonymous Coward | about 2 years ago | (#39205799)

Who is expected to pick up the pieces if the treatment has undesirable side-effects?

Their insurance? That is, provided that they opted for the "untested drug side-effect" policy at significantly increased rate. Not you, of course. You bought the insurance which doesn't cover for such silly things, and you don't end up paying for it.

The loop hole here... (4, Informative)

icebike (68054) | more than 2 years ago | (#39204957)

The company is injecting patients with their own stem cells after massive multiplication of “minimally modified” stem cells.

This seems to be something of a loop hole in current regulation.

Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

...

The legal standing of stem-cell treatments is currently being debated in a court case brought by Regenerative Sciences of Broomfield, Colorado, which was ordered by the FDA in 2010 to stop administering mesenchymal stem cells to patients5. One of the key issues being debated is whether the cells are “minimally manipulated” before being reinjected into the patient. Treatment with the patient's own, unprocessed tissue does not always require FDA approval.

I'm betting this gets reigned in somewhat, if not by the FDA, then by Texas, as the state has already made it clear it wants some oversight.

This whole thing sounds like several bad made for TV movies I've seen.

Consent (4, Insightful)

Jazari (2006634) | more than 2 years ago | (#39204977)

The only question should be: "Were the patients fully informed?" If I have a terminal or otherwise untreatable condition, I want to be able to decide for myself whether or not an unproven treatment is worth the risk.

Some people need "protection" or "hand-holding"? No problem. Protect them. But I also want the right to opt out of the government's protection.

Re:Consent (2)

Seraphim_72 (622457) | more than 2 years ago | (#39205051)

As long as you get your children, grandchildren, great grandchildren, great great grandchildren to sign off as well, go for it. Otherwise your child becomes the end of life Jenna McCarthy.

Re:Consent (2)

msauve (701917) | about 2 years ago | (#39205271)

"As long as you get your children, grandchildren, great grandchildren, great great grandchildren to sign off as well"

Are you willing to do the same every time you eat a greasy hamburger, drink a beer, or sit on the couch watching TV instead of jogging around the block?

Re:Consent (2)

Seraphim_72 (622457) | about 2 years ago | (#39205325)

Sure, because none of them claim to cure anything but my hunger, soberness, or boredom. Health is another issue entirely.

Re:Consent (1)

msauve (701917) | about 2 years ago | (#39205349)

So, you claim that diet, drugs, and exercise have nothing to do with health. You're obviously one of those who can't make healthy decisions for themselves.

Re:Consent (1)

Seraphim_72 (622457) | about 2 years ago | (#39205395)

Nice extrapolation. Any other words you would like to put in my mouth? "Every time" might be once in a life. To put words in your mouth, are you claiming that one beer is going to negatively effect your health? And in any event, my medical behaviour doesn't effect effect my fourth+ generation.

Re:Consent (1)

msauve (701917) | about 2 years ago | (#39205423)

my medical behaviour doesn't effect effect my fourth+ generation.

Thank your for repudiating your earlier statement.

Re:Consent (1)

Seraphim_72 (622457) | about 2 years ago | (#39205533)

If anything I confirmed it. My medical behaviour won't effect my 4th+ gen. What the great+ grand parent wants is unfettered drugs without consequences. My comment was a legal one. Not a health one.

do you think Timmy is not going to sue when Dad scarfs down an experimental drug that kills him?

Re:Consent (5, Insightful)

Anonymous Coward | about 2 years ago | (#39205275)

I worked with a non-practicing MD. He loved to tell stories about his days working with patients, and one of the things that stands out in my mind is when he told us "Informed consent is a joke. I know what's best for my patient, and that's what they're going to choose. It's impossible for me to actually make them understand the pros and cons, so it's all in how I explain the options."

It's true enough. People tend to trust their doctor, and in general don't have the necessary knowledge to make informed decisions.

Re:Consent (1)

msauve (701917) | about 2 years ago | (#39205439)

"People tend to trust their doctor, and in general don't have the necessary knowledge to make informed decisions."

If people follow the advice of their doctor, and they're not making informed decisions, then they need a new doctor.

Re:Consent (2)

artor3 (1344997) | about 2 years ago | (#39205559)

I suppose you always check the blueprints before driving across a bridge? As a friend of mine likes to say, you can't make a truly informed decision on what to have for breakfast. For every Cheerio you put in your mouth, you're trusting that hundreds of people did their jobs right and that there won't be any mold or arsenic or broken glass in it.

Re:Consent (2, Interesting)

artor3 (1344997) | about 2 years ago | (#39205321)

You need protection and hand-holding just as much of the rest of us. Moreso, since you don't seem to realize it. If you're diagnosed with some terrible disease, you're not going to be thinking rationally. No one ever does.

This is news? (1)

JBMcB (73720) | more than 2 years ago | (#39204989)

Hell, I've seen "stem cell treatment" clinics advertising all kinds of BS therapies for years. Last I heard the only approved treatment was for repairing damage done from chemotherapy - and that has been going on for decades.

Meh... (0)

Anonymous Coward | more than 2 years ago | (#39205035)

If you have something that WILL kill you.

I'd let them inject whatever they wanted if it had half a chance of working at all.

well la di dah -- who cares (0)

Anonymous Coward | more than 2 years ago | (#39205043)

Does anyone give a shit? Everyone knows stem cells are still in the voodoo stage of development -- buyer beware.

Evidence based science (4, Interesting)

Okian Warrior (537106) | more than 2 years ago | (#39205113)

In order to form an opinion on the matter, it would be useful to know if the treatments have any effect.

You know... evidence based science?

Model-based science is all the rage nowadays, and that we can't allow anything to happen unless we have a clear understanding of why it should happen before we try.

The debate as to whether these people should be labelled snake-oil salesmen or experimentalists would seem to rest on this. Is this government intrusion into people's right to choose, or a regulatory agency stepping in to keep people safe?

We need to know the risks and potential benefits in addition to the opinions of an insular, jargonized profession.

It's not always about trusting the experts.

Re:Evidence based science (0)

Lehk228 (705449) | about 2 years ago | (#39205261)

many times the government does not act in the interest of the people

every time the capitalist does not act in the interest of the people

Amazing Cutting Edge Science (2, Funny)

93 Escort Wagon (326346) | more than 2 years ago | (#39205141)

Celltex Therapeutics's patented "Stem Cell Rejuvenation Nostrum and Relief Cream" cures the Colick, Goiter, Dropsy, Issues of Women, Fatigue, Consumption, Black Blood, Great Pox, and Chillblains. It can be boiled in water to create an Efficacious Drench for All Manner of Stomach Ailments. It is 100% Safe and Guaranteed by CellTex to Improve Disposition of Children.

When purchased with the optional Nasal Applicator Sponge, this cream can also be used to relieve Nasal Congestion and Dryness as well as treat all manner of Nasal Infection.

Re:Amazing Cutting Edge Science (0)

Anonymous Coward | more than 2 years ago | (#39205195)

"Celltex Therapeutics's patented "Stem Cell Rejuvenation Nostrum and Relief Cream" cures the Colick, Goiter, Dropsy, Issues of Women, Fatigue, Consumption, Black Blood, Great Pox, and Chillblains. It can be boiled in water to create an Efficacious Drench for All Manner of Stomach Ailments. It is 100% Safe and Guaranteed by CellTex to Improve Disposition of Children."

Does it contain cocaine? If so, I'm in for 3!

Texas? (2)

Brad1138 (590148) | about 2 years ago | (#39205319)

Texas is pouring millions into stem cell research? OK it is official, the world is coming to an end.

Re:Texas? (1)

tunapez (1161697) | about 2 years ago | (#39205431)

I just assumed they were talking about Austin. Sugar Land is nowhere near Austin! The Mayan prophecy is almost complete.

Re:Texas? (0)

Anonymous Coward | about 2 years ago | (#39205441)

Adult stem cell research. Abortion isn't involved, so there's no controversy.

Don't these people read sci-fi? (0)

Anonymous Coward | about 2 years ago | (#39205381)

This is EXACTLY how things go wrong. And soon there'll be screaming. And then the military will have to use electro magnets mounted on tanks in order to isolate the creature but they won't take your advice, or the advice of the scientist's plucky young daughter until whole battalions are eaten.

The Wild Wild West all over again. (1)

wbr1 (2538558) | about 2 years ago | (#39205393)

Apparently Texas may have advanced technologically, but not socially. They still sell snake oil and execute the innocent and the retarded.

Whatever the law is, it won't matter (1)

cwgmpls (853876) | about 2 years ago | (#39205459)

Do whatever you want with U.S. laws. It won't make a difference. Ban it here and people will just drive to Mexico to buy the treatment, usually from other Americans over there. In fact, they already do. I'm not advocating that stem cell treatment should be legal in the U.S. Just saying that whether it is legal or not won't affect people's ability to buy it when they want to.

WHO CARES? (1)

cloakedpegasus (1761746) | about 2 years ago | (#39205781)

At least we're doing stem cell research and companies are investing in it. IF I were dying you bet your ass I'll take my chances on this. After all, what's the alternative when time is running out?
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