Stem Cell Firm May Have Administered Unproven Treatments 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."
The loop hole here... (Score:5, Informative)
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.
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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.
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Nobody is asking the obvious question, "did the treatments work?"
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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.
This here's Texas, y'all. We don't need or want no dang gubamint regulations that would keep us from makin' money off'n our snake oil business. Stop messin' with corporations', er... private citizens' rights to turn a profit. It's just un-American.
Consent (Score:4, Insightful)
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.
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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.
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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?
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Sure, because none of them claim to cure anything but my hunger, soberness, or boredom. Health is another issue entirely.
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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.
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Thank your for repudiating your earlier statement.
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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?
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You're lost. This is a discussion on health, not torts.
Re:Consent (Score:5, Insightful)
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.
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If people follow the advice of their doctor, and they're not making informed decisions, then they need a new doctor.
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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.
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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? (Score:2)
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.
Evidence based science (Score:5, Interesting)
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.
Amazing Cutting Edge Science (Score:3, Funny)
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.
Texas? (Score:3)
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I just assumed they were talking about Austin. Sugar Land is nowhere near Austin! The Mayan prophecy is almost complete.
The Wild Wild West all over again. (Score:2)
Whatever the law is, it won't matter (Score:2)
Treatment being developed is unproven (Score:2)
In other news, water is wet.
-- Terry
Re:What's the point? (Score:5, Insightful)
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?
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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.
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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?
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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
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So there should be no laws against fraud at all?
Re:What's the point? (Score:5, Insightful)
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.
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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 rec [forbes.com]
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Unfortunately the Snake Oil salesmen are a have a huge industry. Homeopathy being one of the biggest examples.
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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? (Score:5, Interesting)
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.
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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? (Score:5, Insightful)
... 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? (Score:4, Interesting)
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.
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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.
Exactly, provided there is no fraud (deceit) involved. That is a proper role for goverment.
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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,
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Yes, that's exactly what the FDA does, but only after running simulations to predict drug interactions, running multiple animal studies to test if the drug works for the corresponding animal illness, and then running tightly controlled studies on a limited (and very small, but large enough sample) number of people who already have the illness and are completely briefed on what the FDA knows about the drug so far, and if all of those things return results that indicate that the drug is effective for its desi
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Fen-Phen
Cerivastatin
Vioxx
Rezulin
No, it doesn't work. It protects neither the patient nor the manufacturer.
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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.
What if the majority of the people taking the drug would have been dead within three months anyhow? I have two daughters. One is nearly two years old, and the other is six months old. I'm 31. If you have a moment, you might enjoy the first video recording of my daughter Susan's first steps [youtube.com]. If I were diagnosed with a terminal illness, and any treatment regimen (or combination of regimens, in close consultation with multiple physicians) gave me even a "somewhat possible" chance of spending a few additional m
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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.
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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.
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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 ad
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So you would agree with the following statements:
Because people cannot make informed, rational decisions about their own health care, the government must do it. That includes denying unapproved treatments, requiring treatments with known benefits, and forcing lifestyle changes with known health benefits.
The fat lady down the street shouldn't be allowed to sit
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The Government doesn't intervene to stop people hurting themselves, though, does it? It intervenes to try and make sure that snake oil salesmen don't have a financial incentive to con people into paying money for treatments that are ineffective or even harmful. You can make all the badly-informed, irrational decisions about your own healthcare that you want to, the Government just won't let others misinform you for their own gain.
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The Government doesn't intervene to stop people hurting themselves, though, does it?
Mandatory seatbelts, mandatory seatbelt use, mandatory airbags, mandatory helmets for motorcycle riders ...
people gamble with their money, (Score:2)
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
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Because people would self medicate. This is already a problem without the government encouraging it.
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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?
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I've heard 'snake oil' commercials on the radio using words like 'clinically-proven' and 'FDA-cleared' to try to make people believe their particular 'dietary supplement' can actually cure disease without actually saying it.
I'm as against unneeded gov't intrusion as anyone, but shouldn't anything sold for human consumption be at least tested if not regulated, and anything that claims to be a supplement have to be proven to: 1) actually supplement something the body uses, and 2) work as claimed?
I'm so sick o
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Re:What's the point? (Score:4, Insightful)
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.
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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?
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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 t
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If that's the case, then the FDA can't make a correct decision, either. You've solved the healthcare "issue." If you get sick, do nothing and die, because no one can use information to make a correct decision.
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The FDA stand a far better chance of making the correct decision because they have personal access to a whole bunch of experts and the entire medical research community is watching them. It's just not possible to give the same level of support to an individual patient in making the right decisions - there aren't enough experts to go around - which is why we need to delegate the decision-making to the FDA.
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Indeed. My iphone is a total chick magnet, and 3DTV? When they come over and watch that, their panties literally drop right off!
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people can google 'subprime mortgage' too (Score:3)
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
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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 rewardin
Re:What's the point? (Score:4, Funny)
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?
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Do you have cancer? Because I bet cancer patients keep up with it.
Re:What's the point? (Score:4, Insightful)
But do they have the education to understand what they are reading?
Re:What's the point? (Score:4, Insightful)
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]
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Re:What's the point? (Score:4, Insightful)
But do they have the education to understand what they are reading?
Ah, the Cult of the Expert.
Not that we don't need experts. We do, obviously. What we don't need is the Cult of Expertise, which tells us that only experts understand things in their field, and that everyone else should, without question, just shut up and do as they're told by said experts. Nevermind that even in highly specialized fields, experts can disagree with each other vociferously on things.
You wouldn't want your next door neighbor to perform surgery on you. But it's silly... and quite arrogant... to miss the fact that it's quite easy to pick up books and fire up a browser to access a wealth of information where your neighbor can learn enough to understand the issues involved in surgery and make informed decisions regarding his self. This goes for any field. I don't have to be an expert in auto transmissions to read enough to spot trouble signs when they happen with my car. With stem cells, there's enough info out there... much of it peer reviewed... that's freely available to the public.
Eisenhower famously warned of the Military-Industrial Complex in his farewell speech. What he also warned of in the same address was the danger of citizens falling into line behind a scientific-technological elite [youtube.com], without question. We need to pay more attention to that part as well.
Re:What's the point? (Score:5, Interesting)
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.
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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
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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?
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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.
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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
Re:What's the point? (Score:5, Insightful)
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The obesity is attributable to diet, but Europeans also walk a lot more than Americans do, because of the way the cities are organized, especially true the farther west you travel.
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I didn't say a Quarter Pounder was "bad" for you. I said that eating two of them lunch and two more and dinner every day was bad for you. Maybe it's not that "people are being given wrong information". Maybe it's that they don't pay attention to what they read and hear.
Oh, and I challenge you to walk through any US Wal-Mart and tell me that the morbidly obese people waddling and riding around in there got to that level of lab-
Re:What's the point? (Score:5, Insightful)
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.
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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.
Nope, the worst that can happen is that you get a reaction or other problem from the stem cell treatment and die from the treatment possibly fairly quickly after the treatment. So a patient with something that might have been chronic but manageable or treatable ends up dying prematurely. Stem cells can cause cancers or do other bad things such as develop into the wrong type of tissue (e.g. bone tissue in the middle of an organ), the trick is getting them to turn into the right type of tissue in the right
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No, 5 minutes on Wikipedia does not make you a researcher.
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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?
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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?
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Re:What's the point? (Score:4, Funny)
More than the tin-foil hat salesmen.
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Hey, I take offense to that. My tinfoil hats are top quality headgear, specially tuned through our secret process to not only block mind control rays from the US Government, but all governments of the world, *AND* known and unknown extra terrestrials.
If you can provide clear documentation that your mind has been controlled by such entities due to any fault of our headgear, we will offer a "full moneyback guarantee".
(*) The full guarantee applies to the value(**
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It's called population control, if you are stupid enough to ingest snake oil without knowing all the side effects, Darwinism has chosen you.
How do you know the side effects without the FDA forcing the manufacturer to test the drug. Hell, some side effects don't show up until tens of thousands of people have been taking a drug or class of drugs for years and database to monitor drugs being prescribed gets mined for correlations between prescriptions and side effects.
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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).
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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
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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