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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.
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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.
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?
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.
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.
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.
... 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
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.
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.
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?
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".
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