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Stem Cell Firm May Have Administered Unproven Treatments
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."
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.
"National Security is the chief cause of national insecurity." - Celine's First Law
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.
Sig Battery depleted. Reverting to safe mode.
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.
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.
My Other Computer Is A Data General Nova III.
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.
Does anyone give a shit? Everyone knows stem cells are still in the voodoo stage of development -- buyer beware.
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.
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.
#DeleteChrome
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?).
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.
Texas is pouring millions into stem cell research? OK it is official, the world is coming to an end.
If you could reason with religious people, there would be no religious people
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
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
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.
Apparently Texas may have advanced technologically, but not socially. They still sell snake oil and execute the innocent and the retarded.
Silence is a state of mime.
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.
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?
Might comes from patient's wealth.
Early adoption also has its advantages to create precedents & change Law.
PS In Australia, the chutpah of early Citizens Band radio hobbyists to refuse to pay license fees won them fee-free class licensing.
By contrast, Aussie Radio Hams continue to cringe under their government's need to tax those who earned their hobby radio license through study of radio theory & mastering practical skills that enable them to provide emergency communications during disasters.
Aussie Ham Radio operators pay well over $50 per year (compared to cost-free licensing enjoyed by U.S. Hams, who won their freedom (as in beer) in the Courts, arguing Constitutional Rights of Free Speech would be unduly put upon, were there any periodic license fees to pay (recall poll taxes that precluded poor mnority members from voting).
For all the license fees paid by Auusie Hams, their radio privileges remain well below those enjoyed by their fee-free American couterparts:
1. In Australia, it is still unlawful for Radio Hams to connect their radios to their landline telephone services, while American Hams can freely create such "phone patches" - even automated ones, that enable them to make emergency & other non-commercial phone calls, eg, when outside cellphone coverage areas.
2. US Hams may transmit using 1,000 watts of transmitter power, while even AU's highest Ham license class limits holders to 20% of that amount of transmitter power.
In 2012, following New Zealand's lead to enable their Radio Hams to be better heard, ie, by permitting them to use higher power...
Australia's government permitted its so-called Advanced Class Hams to only "APPLY" to use the Americans' long-used higher power..
over an 18 month "TRIAL" period...
but required payment of another fee... to make application.
Some consider the recent (Labor government) response to the national peak body for Ham Radio an insulting money grab.
In other news, water is wet.
-- Terry
Running trials for FDA approval takes many many years. and as far as i know every different kind of treatment must undergo a now Phase 01234 trial which can easily gobble up 1 Billion (YES BILLION!!!) each.
Stemcell treatment is a umbrella term for a whole veriety of treatments. We should be a bit more open about it and give patients a choice by telling them "this might not work at all, and it could have real bad sideeffects". But i hope the regulations could be relaxed so new companies can arise and give the big pharma overlords a little bit competition.
"Sometimes you gotta run before you can walk." - A talking egotistical genius in an exoskeletal metal suit. (Iron man.)
People kill themselves slowly all the time? Yes. We happily sell known carcinogens, cook our food at dangerous levels and pummel our livers to death.
So why then should anyone be disallowed what could potentially save their lives, at the risk of potential failures?
There is no argument here. Fund it. Fund it with all the riches ever.
FDA can suck my nuts, they are hypocrites.
The Fly
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?
It's much simpler than that. These people aren't experimentalists because they aren't running any sort of scientifically valid experiment. They don't have a control group. They don't have animal testing to base their theories on. They haven't even identified what conditions they are treating. They are just injecting whoever is willing to pay tens of thousands of dollars, for whatever ailment they happen to have.
That isn't a experimental science; that's a scam. If you want to make millions of dollars selling medical treatments, then put your money where your mouth is and prove that the treatment works with a valid clinical trial.
Presumably this is the same technology that was featured on the front cover of Wired in 2010 (http://www.wired.com/magazine/2010/10/ff_futureofbreasts/all/1)
It is actually pretty cool. They get stem cells not from reproductive cells but from abdominal stem cells then they treat the cells with a stew of chemicals and hormones to make them turn into whatever tissue that is needed. The wired article, and the company that made the machines (Cytori Therapeutics) was focusing on breast reconstruction, in part, because of regulatory reasons. Probably also, at least for the article, because Wired could then put a breast on the front cover. As has been mentioned above using a patient's own tissue (think skin graft or bypass surgery) is not regulated.
Of course even solid science can be used by frauds and confidence men. I don't know the facts here, or the history of this company or even the relationship between Cytori and Celltex.
from the article: "Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections."
There is one major flaw in your obvious "carbs are bad" idea. Carbohydrates have been the backbone of human caloric intake since the dawn of agriculture thousands of years ago. The "staple" food in nearly every country in the world is a grain, legume, or starchy root. Rice, Wheat, Potatotes, Plantains, Cassava, Corn, Yams, Soybeans, Lentils, etc. Nearly Every. Single. One. (The exception would be soil-poor areas such as the Arctic; you eat enough whale blubber and caribou jerky, you can avoid scurvy, but it's tough.) Once we shifted away from being hunter-gatherers, it is only in relatively recent times, and even then, only in some countries, that a high-protein, low-carb diet was even POSSIBLE for the average man. Yet the obesity epidemic is far more recent than the ready availability of surplus caloric intake (in the form of starch and sugars) throughout the developed world.
We can't even blame it on white flour and white rice: they've also been available and used for centuries, due to the superior longevity of flours (or rice) with the bran removed.
A McD's quarter pounder value meal (with fries and soda), consumed on a regular basis, along with other high-calorie, low satisfaction food choices, and the sedentary lifestyle of the average American, IS unhealthy for you, and far more so than the same-sized plate of pasta made at home you could eat instead of the McD value meal.
You eat plenty of those plates of pasta, but keep yourself fairly active, eat vegetables, and supplement the diet with some amount of protein, and it won't hurt you at all, in addition to being much cheaper, lower in cholesterol and fat, and better for the environment, than high-protein choices such as dairy or meat. If you try and live off those QuarterPounder meals, you'll learn in short order how much more unhealthy it is than plates of pasta at home.
OK, so try restating your position in a more legitimate way. Saying that eating carbs (french fries and soda) is less healthy than eating carbs derails any point you are tying to make.
Umbrella Corp?
If you think that carbs (McDonalds french fries and soda) are the same as carbs (home cooked pasta) then you clearly have very little knowledge about nutrition. McDonalds french fries have almost as much fat as they do carbs. The fact that you could only find one bit of his argument to nicpick, and then didn't even get that right, isn't really helping your case.
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Try being less obnoxious.
There is nothing unhealthy about "eating carbs". People aren't getting the kind of globby, scary fat that you see in your town's K-Mart from "eating carbs". Even the phrase "eating carbs" is about as meaningless as "drinking liquids". Humans have thrived on carbohydrate-heavy diets for most of our history. It's only recently that we are seeing the kind of science-fiction fat that is common. The problem is not "carbs". And it's not the little charts that you see in doctors' offices that display healthy ranges of height/weight or BMI.
Don't get people thinking that the reason they are morbidly obese is "too much homemade pasta". It's incorrect and misleading.
And please provide a link to a Mr Universe being told by the government/medical establishment/etc. that he is too fat. You've made the assertion several times now, and I know you're just waiting to be called on it. So please, provide your little triumphant show-and-tell about all the Mr Universes being told they are too fat.
You are welcome on my lawn.
Pants on Fire! I know for a fact that you and the government have been in collusion with so-called "tinfoil" manufacturers to dupe the public into thinking that they were purchasing tinfoil, when, in fact, what they are buying is aluminum foil. It has been a conspiracy decades in the making, as aluminum foil became used in the vocabulary to indicate tin foil and vice versa, lulling the public into believing that they were one and the same. Everyone who knows The Truth: from Glenn Beck to the Time Cube guy to Ron Paul, know that aluminum foil does not protect you from the mind control rays of the Government, the EPA, or Major League Baseball. Only genuine tin foil can protect you! Breitbart knew it, and he was killed for threatening to release the doctored tapes proving it!
The carbs in french fries are the same as the carbs in home made pasta. The fat in french fries are something different. The fact that you don't know this shows that YOU clearly have very little knowledge about nutrition OR the English language. That fact that I pointed out your intellectually dishonest argument and stopped there doesn't mean the rest of your post isn't wrong. When you blatently misrepresent the issue, there isn't much point in analyzing your whole post.
http://www.schwarzenegger.it/mro/schwarzenegger.html
Height: 6' 2"
Off Season Weight: 260 lbs
Competition Weight: 235 lbs
http://stanfordhospital.org/clinicsmedServices/COE/surgicalServices/generalSurgery/bariatricsurgery/resources/bmi_calculator.html?utm_source=google&utm_medium=cpc&utm_term=body%20mass%20index&utm_content=!acq!v2!s-b-13529620060-1678836940&utm_campaign=Bariatric+-+Search&gclid=CKKEoK2ayK4CFaJeTAodUWZV-w
Calling you out on your intellectually dishonest statement where you tried to claim that eating carbs is really eating fat is not "Obnoxious". Asking for a reference while implying that when it is presented, it doesn't count IS obnoxious. The fact is that pretty much every Mr Universe is now classified as "Obese", and that means the word no longer has meaning. Besides, your claim that "It's only recently that we are seeing the kind of science-fiction fat that is common." isn't even accurate. It is made up.
No Mr Universe is classified as "obese", you obnoxious little twit. Apparently, you didn't read the disclaimer that is right next to the BMI calculator:
"BMI is a measure of weight proportionate to height. Generally, BMI is considered an effective way to evaluate whether a person is overweight or obese, though there are exceptions to the rule. Some muscular people may have a BMI that puts them in the overweight range. However, these people are not considered overweight because muscle tissue weighs more than fat tissue "
Further, YOU are the one who tried to claim that "eating carbs is eating fat". YOU are the one who tried to claim that eating "homemade pasta" makes you fat.
I normally don't spend this much time on someone as unpleasant and dishonest as you, so I'll give you this one for free: If you act in your personal life anything like you act in conversation here, you are going to remain very lonely and very sad. Now go back under your bridge and don't come out until you've given this some thought and have learned your lesson.
You are welcome on my lawn.
The problem is WAY worse for those of use that are not body builders. For example, the same CDC page says that I am at a "normal" weight at -20% body fat.
As for the name calling, you seem to think that not believing your incorrect statements is the definition of lying, and get really offended when people make correct statements.
Further, YOU are the one who tried to claim that "eating carbs is eating fat".
Since you didn't seem to remember making the staetment, and think that I made the statement, I looked up 4 posts and found it was actually sirwired that made the statement. I pointed out that it was an illegitimate statement, and that was when you chimed in with obnoxious comments about not being obnoxious.
Okay, let's look at this logically.
Person #1 said: "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?"
You responded: "A McDonalds Quarter Pounder is not bad for you. The Pasta you made at home is."
That was your first logical flaw. They said "two #1 meals at McD's twice a day" and you simplified it to a single Quarter Pounder. Even disregarding their hyperbole about two meals twice a day, you're completely ignoring the entire rest of the meal to focus on the Quarter Pounder.
Person #2 (not the same as person #1) responded with several different arguments about why pasta isn't bad for you and McDonald's meals possibly are. Including the bit "A McD's quarter pounder value meal (with fries and soda), consumed on a regular basis, along with other high-calorie, low satisfaction food choices, and the sedentary lifestyle of the average American, IS unhealthy for you, and far more so than the same-sized plate of pasta made at home you could eat instead of the McD value meal." Which emphasizes the fact that the original discussion was about a full McDonalds meal and not just the cheeseburger.
You responded in a rather insulting manner and said "Saying that eating carbs (french fries and soda) is less healthy than eating carbs derails any point you are tying to make."
So the first time the person said "A McDonalds meal is unhealthy" and you changed the goalposts by saying that a McDonalds cheeseburger is more healthy than pasta. Someone else tried to correct you by saying a full McDonalds meal is less healthy than pasta, and you changed the goalposts in the other direction by focusing on the sides rather than the cheeseburger.
Then i responded to you, and note that i am neither Person #1 nor Person #2, although you seem to be assuming that i am, and pointed out that the nutritional contents of french fries and soda are very different from the nutritional content of pasta. I explicitly pointed out that french fries contain a lot of fat, while leaving it implied that non-diet soda contains a lot of simple sugars, unlike the complex carbohydrates of pasta.
Your response was: "The carbs in french fries are the same as the carbs in home made pasta. The fat in french fries are something different."
First of all, that's about the intellectual equivalent of saying "Salads are on my diet but hamburgers aren't, so i'll just put a hamburger on top of my salad and then it will be on my diet." You can't argue that fries and pasta are the same because the carbs are the same and just ignore everything else about them that's different. If we're going to argue that way than a Quarter Pounder is just as unhealthy as you claim pasta is, because the carbs in the hamburger bun are the same as the carbs in pasta. The protein and fat in the hamburger and cheese are something different.
And note that Person #2 never said that the carbs in french fries are different from the carbs in pasta. They said that french fries and soda _with_ a cheeseburger are less healthy than pastas. You're the one who changed the goalposts once by dropping the cheeseburger part in response to Person #1 and then changed them a second time when responding to Person #2 by trying to make the argument about only the fries and soda and then constructed a strawman argument by saying it was just about the carbs in the french fries vs the carbs in pasta (conveniently ignoring the entirely different kind of carbs in soda) without addressing any of the other nutritional factors.
Finally you claim that since you've "proven" that one part of the argument is intellectually dishonest, via changing the goalposts and a strawman argument, that you then don't need to address the rest of the points. I'm pretty sure that's some kind of logical fallacy itself. Not to mention the fact that when you accuse someone like Person #2 of being intellectually dishonest through a faulty argument but say nothing
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