FDA Could Delay Adult Stem Cell Breakthroughs 261
destinyland writes "A Colorado medical advocate says, 'The FDA contends that if one cultures stem cells at all...then it's a prescription drug,' in arguing that revolutionary new treatments could be delayed by 20 years — even using cells extracted from your own body. According to the FDA, even therapies that simply re-inject your body's adult stem cells could be prohibited without five years of clinical trials and millions of dollars of research. How useful are cultured stem cells? 'In animal models, they routinely cure diabetes.'"
FTC != FDA (Score:5, Informative)
Heh.
Re:FTC != FDA (Score:5, Insightful)
Also, kdawson != editor.
But I suppose we already knew that.
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drats (Score:2, Funny)
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Now, if only he weren't DEAD.
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The idea that in the age of intellectual property, if your not inline with the US gov policy, you will be given a demonstration of US might.
Fined into bankruptcy.
The DIA and CIA where hints at the long deep connections with Big Pharma.
No upstart is going to win the race to the next generation of medical treatments.
If the USA cannot or will not invest in basic science, move to a part of the world where 'biology' is not a dirty word.
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But that's impossible, he's Superman.
Re:drats (Score:5, Funny)
Never underestimate zombie Superman.
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Non-Story (Score:5, Insightful)
This is not the government saying this, it's a "Colorado medical advocate". It's one guy's opinion on what might happen. And, gosh, guess what industry he's in...
Re:Non-Story (Score:5, Interesting)
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Re:Non-Story (Score:4, Insightful)
Yes, and interestingly enough, some researchers see a connection between video games and violence, running Windows and a botnet, and watching violent movies will cause you to go 'postal', and...
Do I have to go on?
Re:Non-Story (Score:4, Interesting)
Re:Non-Story (Score:4, Informative)
To clarify THAT, one hypothesis is that there are stem cells in tumors. This makes it tough to treat tumors, as the cells you really need to get are the stem cells seeding the tumor, but they tend to be missed by a lot of chemotherapy drugs as they may be slower-dividing, as stem cells may be in other contexts.
There are some cancers that may arise from normal populations of stem cells as well, but no one is saying all cancerous cells came from a population of stem cells. No one is saying all cancers have stem cells keeping them going either.
Note that's all theory, some of it may be outdated, some or all of it may have been disproven. I'm not too up to date, and stem cell biology moves really fast compared to most other fields in bio.
Re:Non-Story (Score:5, Funny)
Definitely fully tested. I remember one episode of 7 Days involved a cure for cancer having been found, but what they didn't know was that there was a long term side effect to the cure that reared an ugly head 15 years later when it wiped out 80% of the population or something. The cure had looked so promising that they mass produced and distributed the drug to as many people as they could, even if the cancer could have been treated in other means. They did this without the full clinical trial period because it was seen as vital.
Dealing with mutations is always a risky business. While it would be nice personally to not have to die from cancer, or have a relative die, there are safety procedures in place for a reason.
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Re:Non-Story (Score:5, Funny)
Yeah, that's almost like that episode of Sliders with the vampires. Or zombies. I forget which. Anyway, yeah, that's a really good reason why we shouldn't ever release any new medicine. It's just too dangerous to humanity as a whole! :')
Looking at the comparisons (Score:5, Insightful)
Definitely fully tested. I remember one episode...
I know of lots of "end of the earth stories". Science doesn't back it up completely, unless you're talking about real threats (like grey goo or a mutant airborne and massively contagious e-bola virus).
Just because there's media hype about "what if" doesn't make it true. Yes, "fully tested" has to involve human trials at some point; but with the success we've had in curing rat diabetes and growing spare organs, I believe it has proved itself (definitely at least as an experimental therapy).
Dealing with mutations is always a risky business. --- there are safety procedures in place for a reason.
There are already therapies available that are much more dangerous. Mutations are a problem though? Wow, there's been too many horror movies on that subject; and that's all they continue being. Mutations mean cancer at worst, not the next fictional zombie threat.
Take for example: bone marrow cancer. Treatment is difficult, and even -if- it is successful, it can still rear problems that will kill. This is a treatment, because people choose to try an experimental (albeit common) treatment rather than none at all.
What I see in this is the drug companies saying "no" to alternative treatment. They like the profits they make! (after all, who wouldn't?). They are also effective lobbyists (because they have moolah to throw around) and have the most to lose from independence of various drugs.
Is it so surprising that we're simply dealing with an antiquated business model that is stifling innovation?
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Yes, "fully tested" has to involve human trials at some point;
While I singled this quote to respond to, I do agree with the 'nature' and content of your post. But, I felt the need to address this statement, if even as a pedant.
The 'scientific/research' community may consider "x" to be 'fully tested' in 'human trials', but currently does not address the misconceptions between 'populace's perceptions' and these trials.
*disclaimer-I am currently dismayed by the divide between science and 'public perception', and see a 'hard road ahead' for any new advances in science.*
I
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Mutations mean cancer at worst, not the next fictional zombie threat.
Er... I think zombies actually are worse than cancer. Less likely yes, but still worse.
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But when you're dying of cancer, what are you going to do if it doesn't work, die?
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So will you take uncertain chances of success with conventional therapy, knowing that those often include a reduced life expectancy as well, or would you go with another (pretty much guaranteed) 15 years in good health? And take your chances with the possibility that someone might figure out how to fix the new problem as well before your time is up?
Besides, cancer is a disease that for many people strikes in their later years anyway. 15 years is not really that bad. It would even allow some proper planning:
Re:Non-Story (Score:5, Insightful)
After all, we don't want to have doctors developing new treatments. That's what government bureaucrats are best at.
Re:Non-Story (Score:5, Informative)
The private sector has the virtue of (mostly) being extremely responsive to competitive incentives. This is good when those incentives drive development. This is bad when those incentives drive obfuscation, misdirection, and the burial of inconvenient data. Consider the twisted tale of the "Australasian Journal of Bone and Joint Medicine" [ft.com] an entire sham scientific journal printed to order by Elsevier, for Merck.
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Meh, if you sign a waiver you can pay a doctor to do anything to you.. short of deliberately killing you.. the legality of that varies from state to state.
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And I guess doctors should be allowed to sell whatever treatments they want without any government interference. The Dalkon Shield, thalidomide, etc. should have all been allowed without any government regulation. Yay! Doctor knows best. Government is ineffective and useless, etc.
WTF? Sarcasm? Irony? WTF? (Score:2)
After all, we don't want to have doctors developing new treatments. That's what goveernment bureaucrats are best at.
[my emphasis]
Mod's: Give +1 for 'tongue-in-cheek-funny' responses...and hope the 'parent' was trying for +1'funny', if not, then 'Epic Fail!'
Get off of the fence, and say what you mean to say. Why be obtuse?
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If I'm dying of cancer, sure, I'll try damn near /anything/ in my last days.
Yes, and you'll agree to damn near any price, even if the treatment in question only works in one in a thousand cases. Even if you're dying, it's still not permissible for an unscrupulous doctor or medical service company to defraud you (or your insurance, as the case may be), and divert gobs of money from desperate people. Money that should be going to the genius that can cure cancer, and not to some dude that's selling Persian wheat infused with "medicinal silver ions" in an alcohol suspension.
I'm parti
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I'm particularly not crazy about stem cells being cultivated, and possibly embryos destroyed, for frivolous treatments.
I'm not particularly crazy about you not realizing that this has nothing to do with embryos even though the article summary(not even the article itself), mentions twice that the stem cells don't come from embryos.
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I wasn't replying to the article, I was replying to Kell Bengal. The article excludes embryonic stem cells artificially, probably because the author didn't want to start a fight, even though everything he says applies to embryonic cells too. He's a coward.
You can chill, I'm not a pro-lifer or anything, I'd just like to know that embryos are destroyed to saving life and curing disease, not make some guy rich peddling a fraud. Even if they ain't people, and even if we're talking about adult stem cells, the
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Yup, this is basically an infomercial for the next laetrile. Oh noes! We have to test the treatment to see if it works before we try it on live subjects! Regulation is bad! Don't you *want* three arms?
Delayed (Score:4, Interesting)
My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.
Considering how long (Score:4, Insightful)
OUtrage for everyone! (Score:5, Insightful)
When a drug is found to cause significant problems after it's release, we're outraged, and when the FDA says we actually need to test radical new treatments before giving them to people, we're outraged.
Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...
Re:OUtrage for everyone! (Score:5, Funny)
Don't underestimate the ability of average citizens to be both stupid and angry.
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> Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...
Oh it gets worse. Ok, you are a drug company and you have a promising drug. After jumping through hoops for as long as a decade you finally get FDA approval. You have tested your new drug in various animals, several stages of human trials and the whole bit. The government has finally certified your drug to be safe and effective. So you go on the market. We will ignore the untold human misery that could have
Re:OUtrage for everyone! (Score:4, Insightful)
I know you love shoe-horning in "capitalism good government bad" bullshit in every single one of your posts, but I'm curious as to what exactly the FDA did in your hypothetical situation that you imply was worthy of blame?
due diligence (Score:4, Interesting)
I think the notion was that at some point there is a level of effort in testing that should count as due diligence. That any side effects found in the future after that amount of testing should be treated as unfortunate accidents and not cause for litigation. If the FDA isn't implying that this sufficient level of testing has been done by signing off, what is it implying? If it is implying that, it should be solely culpable for the subsequent side effects as the company believed in good faith it had done due diligence. Unless of course it bribed the FDA directly or indirectly, which wouldn't surprise me either. Or falsified test results, which wouldn't raise my eyebrows even a little.
That said, if I want to do something stupid to myself, I should be able to buy "dietary supplements" made from my own stem cells and inject them wherever I please.
Re:OUtrage for everyone! (Score:5, Insightful)
Can't it be both?
It's just another example of not wanting to accept EITHER the risk, or the delay, because no one can make a fucking decision and stick with it anymore.
Brett
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Kudos for the most '+n insightful' comment I have read this month on /.
Personal responsibility is so last century/era. IP has 'enabled/entitled' us to pass the buck. It is no longer our/my fault.[apply sarcasm filter]
Entitlement and bailout is the answer!!!!Please don't make us think or actually take responsibility for our actions/choices...it's the 'American way' now.
Learning and understanding stuff is 'just too hard' now days! Can't some corporation or government think of us that are 'too stupid/can't be
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I read it as meaning that each culture of a different DNA is a different drug, which I can imagine some trying to push if they're trying to curtail stem sell research. The process does need to be tested. But is 20 years of testing necessary to properly test a treatment like this? Maybe that's all hyperbolic.
Re:OUtrage for everyone! (Score:4, Insightful)
TFA, in all its incredibly biased glory (Dr Centeno this, Dr Centeno that, FDA is in Big Pharma's pocket, stem cells are a panacea, end of article) only implied that the protocol itself would be treated like a drug (requiring their standard for clinical trials), and disingenuously compares stem cell treatments to fertility treatments. 'cause implanting an embryo in an uterus, essentially mimicking a natural process and with a "safe" mechanism for rejection, is exactly the same as using stem cells to produce stuff that has no clear parallel -- or maybe not.
Besides, we're talking about implanting engineered tissues based on highly plastic and division-propensic cells. Really, it barely requires long-term testing. I mean, what could possibly go wrong?
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Why would you think it's the same people complaining in bost cases?
Precautionary Principle (Score:5, Insightful)
Take one of your own well-behaved, tightly regulated stem cell out of its milieu, subject it to various biochemical stresses, and then re-introduce it to your body. You may just have transformed it into an unregulated, tumour-producing cell. Or accelerated it along a transformational path that could take a long time to become apparent.
I'd say that precaution is warranted dealing with something like this. Especially when you have a very long-lived animal like a human, with decades of time during which manipulated stem cells could transform malignantly, versus the limited lifespan of most animal models.
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Okay but if you know X will kill you in a month, and Y *might* kill you some unknown amount of time down the road, which would you choose?
Diabetes (Score:3, Insightful)
It's going to take longer than a month for *any* putative stem cell treatment to show results. Human cells simply cannot divide that quickly. So the "ticking time bomb" argument is a little fanciful. Further, the cardinal example given here, diabetes, will not kill you quickly as long as you manage it with meds. Properly controlled, diabetes (either Type 1, Type 2, or gestational/MODY) is a serious disease, but an eminently treatable disease.
Urm? (Score:5, Insightful)
Now, if you don't like the FDA, or think that the FDA approval process needs to be modified, great. That is a perfectly legitimate position, and might even be true(the situation is complex enough that it probably varies a bit from case to case). However, if that is so, just say so. A strategy of attempting piecemeal exemptions for various powerful biological interventions is just bullshit.
It's like the difference between being a libertarian and having an accountant in the cayman islands.
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I just think that maybe people who stand to die while the FDA employs useless parasites to carry cars full of files around should have the right to take the risk. You know? You own your own body? Sounds crazy doesn't it? Sorry... :-)
And no, I don't have an account in the Caymans.
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My objection is not to that position; but to the special pleading with which TFS and TFA are laced. "I think that the FDA is wrong/illegal/unethical" is a perfectly coherent and respectable position. "I think that my area of interest should be excluded from FDA oversight b
Animal models... (Score:5, Funny)
'In animal models, they routinely cure diabetes.'
That's great for models, but what about ugly people? Don't we get a cure?
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Re:Animal models... (Score:4, Funny)
Re:Animal models... (Score:5, Funny)
You have several cures. Money, beer, and plastic surgery.
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Well, only if 'the cure' is for being 'ugly'...YMMV.
So? (Score:2)
Re:So? (Score:4, Insightful)
But if they aren't available, then you don't get them.
If they aren't well tested, and you have problems with the drug, the doctor is much more open to malpractice suits or investigations by the friendly Board of Medical Examiners.
Insurance companies routinely won't pay for 'experimental' therapies.
Besides, this whole article is a bunch of whining from the people invested in the new tech. The writer waxes breathlessly enthusiastic about something that has barely been attempted. It is really unclear that dumping pluripotent cells back into the body is either safe or effective or even particularly sane given the fact that MOST of a multicellular organism's time and energy is spent controlling cell division and PREVENTING things from growing.
Whatcouldpossiblygowrong?
At least I'm young... (Score:2)
When one realizes (Score:3, Insightful)
Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.
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Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.
Then it is in their interest to cure you from many maladies, not to let you die from the first one. Dead people don't need doctors.
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Re:When one realizes (Score:4, Insightful)
Okay, I've seen this 'mindlessness' echoed down this thread, so I 'went for the head of the serpent', so to speak.
Speaking as someone that has worked in the medical profession, and has close ties to those that still do, I will categorically deny the delusional accusations of your post.
What you accuse all of us for may be true on the 'C*O', PHB level, but I can assure you from the 'Doctor' level and down, that the prevailing attitude is 'take care of the patient to the best of our abilities'. Period.
Yes, there will be exceptions/outliers, but that is true with any profession.
Your blanket assertions and overly broad generalizations do an insulting disservice to the medical community.
I await your apology.
Re:When one realizes (Score:4, Informative)
Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.
As a physician, let me ask: What are you talking about? What are these diseases that you speak of that can be easily cured with a pill that the pharmaceutical companies don't want to make?
Heart disease is the most common cause of death in this country. Why? Usually, it's because of lifestyle issues: no exercise, eating poorly, smoking, etc.
The most common cancer that kills people? Lung cancer. Want to decrease the risk of lung cancer? Stop smoking.
Stem cell treatments have resulted in cancer (Score:3, Insightful)
Stem cell results are dangerous. Should we just ignore the risks?
Until we get a good handle on it it certainly should be treated like it is potentially hazardous, because it is.
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Stem cell results are dangerous.
As is too much sunlight(UV causing melanomas), and too much water(see:water intoxication.
So, what is your agenda here?
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Not a problem if you are rich enough (Score:2)
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Frigging Bureaucracies! (Score:3, Insightful)
They want their own fingers in the pie. It is as simple as that. And we should not let them do it.
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Things change when outside your body (Score:2, Interesting)
If I piss into a bottle, it comes out of my body sterile and is safe to drink, but left to sit for a few days, it is full of bacteria and not safe. Just because it came from my body doesn't mean it's safe to put back in later or after things have been done to it.
Comment removed (Score:3, Insightful)
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So, I don't quite get it: Are you not old enough to remember thalidomide, or are you so old that you've forgotten it? Thalidomide was the logical result of the kind of free market you're promoting.
If you think that we as a society are now, or will ever be inclined to accept a certain percentage of flipper-babies as the natural result of the implementation of your anarcho-capitalist ideals, well, you're even more naive than you seem.
Laetrile and health care choices (Score:4, Insightful)
Laypeople are not and really can't be expected to be health care experts, in general, and so it's somewhat unreasonable to expect that the average person is sufficiently knowledgeable to solely determine what kind of treatment will be effective for his major illnesses. That is one of the reasons we have medical doctors and researchers, after all. Health and health care have a connection that is so nebulous that it's very difficult to make informed choices without well-organized bodies, ones which do, compile, and disseminate the kind of intensive research necessary to provide the information that enables people to make sound medical choices.
Simply because there is a market for fake cancer cures, for instance, does it then become ethical to let people exploit that market and make money off of the completely natural ignorance of the lay public? However, it'd be hard to stop people from going to Mexico to get these "cures," so I guess perhaps we have to ask ourselves--assuming that we can't dissuade people from wanting these fake cures--if we would rather have them getting them in the States or in Mexico. Honestly, that's a dimension of the problem I hadn't really thought of until I was writing this comment today.
Not news. (Score:2)
Government stands in the way of growth! Interview at 8.
Totally offtopic (Score:3, Insightful)
Now, back to your regularly scheduled Slashdot mayhem.
Re:Totally offtopic (Score:4, Informative)
Those are trade terms...
An animal model is a well characterized and well understood animal, often a very specific line of a given species, used as a model for a disease. You can't know that the results you're seeing are mappable to what would happen in a human if you haven't characterized your model yet. For example, to model a respiratory virus you need an animal that can be infected by it and exhibits similar pathology to humans. Chimps are not a good model for HIV as they don't develop AIDS, as another example.
Animal experimentation would apply to all sorts of things that might not be considered animal models.
Fear? (Score:2)
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Oh that?
That's just the good old All-American tradition of coming up with euphemisms for everything. What we now know as Post Traumatic Stress Disorder was once known as shell shock. Being a fatass is now obesity. Old people are senior citizens. Now lab-rats are called 'animal models'. It's a vicious cycle designed to protect middle-class Americans from anything they might think is even remotely scary.
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I believe it's intended in the sense of modeling a particular feature of human biology by using an animal whose biology supposedly functions similarly in the relevant respect.
I agree it's often over-used as a euphemism, though. It makes the most sense when used in a comparative context, for example explaining the pros and cons of "computational models" vs "animal models" (or even occasionally "physical models") for modeling particular elements of human biology.
Story at 11 ... (Score:5, Funny)
"FTC could delay Adult Stem Cell Breakthroughs"
In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.
Cancer isn't the worst fate. (Score:3, Insightful)
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You wield your words in a foolishly irresponsible way without considering their ramifications, frequently. And you'll grab any excuse at all to interfere rail on the government.
Without the FDA, an enormous number of drugs would never be recalled, or, likely, ever see standard testing in the US to ensure their efficacy and safety.
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Indefinitely, you surely mean. I wouldn't mind some of my cells splitting a few extra generations.
Comment removed (Score:4, Interesting)
Re:Why is this a gov decision? (Score:5, Informative)
The FDA simultaneously enforces standards of ethics and cleanliness that help prevent outbreaks of disease, which affect all of us, and outbreaks of rampant idiocy and ill-advised release of powerful and untested medications.
Without them, we wouldn't ever see salmonella coming. We wouldn't know if any cattle stock had been infected with salmonella, we wouldn't know if the drugs we're buying do what they say they're doing.
They still do what they were originally deigned to do: ensure that we get what we pay for, without the unwelcome side effects that cutting costs brings.
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The answer to that question lies partly in the sordid little tale of elixer sulfanilamide [wikipedia.org]. To make a long story short, Massengill wanted to produce a liquid version of a one of its drugs and one of their chemists discovered that it would dissolve nicely in diethylene glycol. Aside from being a handy solvent, diethylene glycol is sweet tasting, so it made a perfect base for a liquid medicine. The only downside was the fact that it's poison. The FDA tracked the stuff down and managed to prevent most of it fro