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."
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.
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?
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.
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)
Uh, dude... I have family members that buy bottles of new age memory water that have been impressed with good memories and are supposed to help you along on your path to enlightenment. They've also bought polished black rocks that "retune the negative energy of cellphones into good energy that can heal any illness" which if cellphones aren't around they'll fall back on the energy of underground streams.
Actual snake oil was so much more straightforward.
People form groups. Bullshit is spread around. When someone hears the same bullshit from two places, they tend to go "oh my god, that must be true!".
Never underestimate the power of stupidity and ignorance. The general population of the world is nowhere near rational.
Re:What's the point? (Score:3, 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?
One of the saddest things I ever heard was about the AIDS precautions taken by haemophiliacs in the late 80's when AIDS was on the rise. People who knew *everything* about blood had the same rate of protected sex as the rest of the population. Nothing like seeing a CDC researcher report that.
I think sex is in a different class from medical treatment. People who have unprotected sex generally don't plan to do it, so it makes perfect sense that people with more information don't make any better decisions. In this case people are making foolish decisions because they don't think, not because they don't know.
Re:What's the point? (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: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.
Re:What's the point? (Score:2, Insightful)
I have family members who buy 3D TVs and iPhones, which are probably more expensive than that water. Are you saying they're stupid and ignorant, and shouldn't be allowed that choice?
Re:What's the point? (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.
Re:uhm, they also had an infected blood supply (Score:3, Insightful)
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]
Re:What's the point? (Score:2, Insightful)
Nope. That's why it's answerable to we, the people.
On purpose.
It'd be unfair to ask any given individual to be that accountable, but the collective whole? That's another matter.
Of course, sometimes the answers you get may not be what you want, but when has that ever not been true?
Re:What's the point? (Score:5, Insightful)
Re:What's the point? (Score:2, Insightful)
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.
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.