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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."
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.
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?
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.
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.
The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.
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?
Slashdot, where armchair scientists get shouted down and armchair theologians get modded up.
Do you have cancer? Because I bet cancer patients keep up with it.
But do they have the education to understand what they are reading?
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.
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.
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.
Slashdot, where armchair scientists get shouted down and armchair theologians get modded up.
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
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.
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.
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.
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.
... 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.
"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.
"National Security is the chief cause of national insecurity." - Celine's First Law
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.
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".
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 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.
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.
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.
http://www.aaronrogier.net
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?
The infected blood supply also took a toll on people who needed blood for other reasons, including one of my favorite authors, Isaac Asimov.
world was created 5 seconds before this post as it is.
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.
You are welcome on my lawn.
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.
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
You have 5 Moderator Points!
Which Helpless Linux zealot/MS basher do you want to mod down today?
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?
More than the tin-foil hat salesmen.
An SQL query goes to a bar, walks up to a table and asks, "Mind if I join you?"
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".
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 designated purpose, does not have serious or poorly-studied side effects, and is likely to be safe the population at large, then yes, the FDA does run tests to see what happens.
However, that is strikingly different than the libertarian dys/utopia that is the topic of discussion, where companies and anybody with a needle can just inject anybody with or without informed consent to study the effects of whatever arbitrary chemicals they have concocted. Now, I'm sure people will respond with something along the lines of "but those people can still sue", and while this is true, lawsuits do not bring people back from the dead (SCO excepted), money is a notoriously poor substitute for a loved one, and this society has simply decided that it is safer and more valuable for us all to have a centralized authority to conduct those tests in a carefully controlled manner before the chemical concoction is made publicly available in the form of a prescription.
I do not know why we are having this discussion in the year 2012, but I guess that is the result of people not remembering their history lessons in grade school and the current crop of ideologically-driven politicians and influential people who overpower the more pragmatic and realistic of us without sufficient means (read: money) to be heard on as broad of a scale.
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".
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Serious? Seriousness is well above my pay grade.
Riiight, because they listened to us so well on the war with Iraq, free speeches zones, waterboarding and rendition rides, doing something about the border leaking like a sieve...oh wait, they completely ignored us. Hell the people in several states voted to legalize pot as well as gave the POTUS a petition and he gave in return the most flowery "LOL Goatse bitches!" speech i'd ever heard, frankly i'd have had more respect if he'd have just said "go fuck yourselves".
In the end with everything from Halliburton and the MIC to Monsanto the gov has made it clear they don't give a shit what you think, that is why ultimately the choice should be with the individual. Power corrupts and with the revolving door between the halls of power and the halls of industry frankly they don't care if you vote them out, as long as they do what their masters say they get a cushy job afterwards, oh and free healthcare and benefits for life to boot. must be nice.
ACs don't waste your time replying, your posts are never seen by me.
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.
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, without question. We need to pay more attention to that part as well.
Life is hard, and the world is cruel