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(New Scientist)   Court rules that your own stem cells are a drug. FDA to ban them, DEA to raid your pancreas in 3, 2, 1   (newscientist.com) divider line 57
    More: Asinine, stem cells, FDA, pancreas, adult stem cell, clinical trials, Sugar Land, stem cell therapy, Mr. Scott  
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3514 clicks; posted to Geek » on 27 Jul 2012 at 9:57 AM (2 years ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2012-07-27 07:53:48 AM
When grown in a lab and used in the course of a medical treatment it sure seems they should be classified as such.
 
2012-07-27 09:06:11 AM
Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.

Court is correct.
 
2012-07-27 09:27:41 AM

hillbillypharmacist: Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.

Court is correct.


That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.
 
2012-07-27 09:33:33 AM

kingoomieiii: That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.


You're right, this IS America, and that's why you shouldn't be using European spices.

I use acorns to augment my stem cells.
 
2012-07-27 09:35:17 AM
Why is the FDA destroying freedom?
 
2012-07-27 10:04:04 AM
The court found it easy to make this decision...

*sunglasses*

We already had joints in our bodies.

YEEEEAHHH!
 
2012-07-27 10:07:30 AM

kingoomieiii: hillbillypharmacist: Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.

Court is correct.

That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.


smalbanynewyork.files.wordpress.com
"Ugh, soapy! What the hell?"
 
2012-07-27 10:14:21 AM
Taking it out and putting it back in? That's it? Sounds like someone isn't paying the right people.
 
Ant
2012-07-27 10:17:49 AM
I'm thinking this might be a way to stop quacks from bilking people out of their money and/or offering false hope to sick people.
 
2012-07-27 10:17:51 AM
I'm sorry, why should I have a problem with this again? There are currently dozens of clinics in the United States selling what is tantamount to quackery because the regulations have not caught up with the potential scientific and medical applications of Stem Cells, and more-so across the border in Mexico which prey on gullible and desperate people.
 
2012-07-27 10:20:39 AM
Everything is whatever the psychos with the most guns says it is. Invasive lunatics.

Here, I just blew my nose in this and then spit some mouthwash into it. Want a prescription?
 
2012-07-27 10:22:04 AM
Am I allowed to draw my own blood, spin it in a centrifuge and re-deposit only the red cells without fear of prosecution?

// serious question
// I know the US/WADA don't like it, but they have other reasons
 
2012-07-27 10:24:15 AM

Kaymon: Taking it out and putting it back in? That's it? Sounds like someone isn't paying the right people.


That's what she... never mind.
 
2012-07-27 10:27:38 AM

ArkAngel: When grown in a lab and used in the course of a medical treatment it sure seems they should be classified as such.


But they are still your stem cells. A part of your body removed and re-installed.
Sounds more like the government is unfairly depriving you of your own property.
 
2012-07-27 10:34:10 AM
Stem Cell trifecta?
 
2012-07-27 10:34:25 AM
what is a drug?
 
2012-07-27 10:34:55 AM
Aren't testosterone and insulin considered drugs?
 
2012-07-27 10:42:19 AM
girlmeetsfreak.files.wordpress.com

Damn regulators always interfering with my experiments. It's ready for human trials when I say it is, dammit.
 
2012-07-27 10:44:04 AM

way south: ArkAngel: When grown in a lab and used in the course of a medical treatment it sure seems they should be classified as such.

But they are still your stem cells. A part of your body removed and re-installed.
Sounds more like the government is unfairly depriving you of your own property.

FTFA: Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.


Sounds more like the Government agrees with you. Also, sounds like you didn't RTFA. Welcome_to_Fark.jpg
 
2012-07-27 10:47:18 AM

ArkAngel: When grown in a lab and used in the course of a medical treatment it sure seems they should be classified as such.


so if i grow some ice crystals in a lab and then use them in the course of medical treatment it should be classified as a drug?

H20

hillbillypharmacist: Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.


so then things that should not be taken lightly should be overseen by medical authorities and the govt.?

should coffee be taken lightly?
 
2012-07-27 10:52:19 AM
Joke's on them...my pancreas doesn't work.
 
2012-07-27 11:03:06 AM

BronyMedic: I'm sorry, why should I have a problem with this again? There are currently dozens of clinics in the United States selling what is tantamount to quackery because the regulations have not caught up with the potential scientific and medical applications of Stem Cells, and more-so across the border in Mexico which prey on gullible and desperate people.


Because this means that treatments that DO work will be subject to FDA review and approval, which can take an unnecessarily long period of time. Politics is unfortunately far too entrenched in our system, look at the ephedra ban. It's an absolutely cheap, safe weight loss drug, but some kids took too much (fewer people than die from aspirin each year iirc) and suddenly we ban it for no logical reason.
 
2012-07-27 11:10:52 AM
Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials.


It's awesome to just try shiat without actually knowing what you're doing actually does.
 
2012-07-27 11:21:25 AM
Is this the thread where we complain that the FDA does too much and is overly intrusive? Or has there been an outbreak of e.coli caused by some corporation's lack of oversight, but it's the fault of the FDA who should have more inspectors so they can catch these things?
 
2012-07-27 11:41:38 AM

I drunk what: ArkAngel: When grown in a lab and used in the course of a medical treatment it sure seems they should be classified as such.

so if i grow some ice crystals in a lab and then use them in the course of medical treatment it should be classified as a drug?

H20


No, but the treatment itself must be approved.
 
2012-07-27 11:47:05 AM

TheYeti: Joke's on them...my pancreas doesn't work.


Came to say this, you beat me to it.
 
2012-07-27 11:50:21 AM

ArkAngel: No, but the treatment itself must be approved.


[notsureifserious.jpg]

nurse bring me one cup of water, STAT!
 
2012-07-27 12:04:44 PM
A drug is defined as:

A substance recognized by an official pharmacopoeia or formulary.
A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
A substance (other than food) intended to affect the structure or any function of the body.
A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)


Stem cell pizza for everybody! Monsanto corporation is allowed to modify their foods with drugs, yet the FDA won't force them to place labels on GMO foods.? We should be raiding Monsanto corp. The stem cell doctors should have offered more money to the FDA.

What Definition of "Food" Applies?

With some exceptions, the definition in section 201 (f) of the Federal Food, Drug, and Cosmetic Act applies:
i.e., "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."
 
2012-07-27 12:22:09 PM

BraveNewCheneyWorld: BronyMedic: I'm sorry, why should I have a problem with this again? There are currently dozens of clinics in the United States selling what is tantamount to quackery because the regulations have not caught up with the potential scientific and medical applications of Stem Cells, and more-so across the border in Mexico which prey on gullible and desperate people.

Because this means that treatments that DO work will be subject to FDA review and approval, which can take an unnecessarily long period of time. Politics is unfortunately far too entrenched in our system, look at the ephedra ban. It's an absolutely cheap, safe weight loss drug, but some kids took too much (fewer people than die from aspirin each year iirc) and suddenly we ban it for no logical reason.


So you're saying that if we believe a treatment works, then we shouldn't have to then prove it works before we start marketing it to the populace?

How do we know that the treatments that DO work actually work? Have clinical trials been done? Have toxicity testing been completed? What are the side effects? Which treatments work best for which problems? How do we prevent the treatments that DON'T work from being used? How do we separate the ones that DO work from the ones that DON'T work? Or do we not care, because doing such would prevent the ones that do work from being used right now? Is it ok for some "clinics" to scam people with false treatments if other clinics can offer reliable treatments at the same time?
 
2012-07-27 12:37:48 PM

Bossk'sSegway: yet the FDA won't force them to place labels on GMO foods.?


This is done for the exact same reason that we don't force any farmer to label their food as a GMO if they're trying to breed a new quality into it. For example: all bananas, or those new oranges that are really easy to peel, or any of the hundreds of new hybrids fruits that have been created by cross-breeding. It's all just different ways to modify the genetics of the plant. Whether you do it randomly by crossbreeding and picking the ones that best match your desired end goal and then cross-breed those (continue until desired product is obtained), or you directly implant a designed genetic sequence to get the exact quality you desire (but you can't control where the genetic sequence is entered, so you have to do it on many different plants until you grow the one with the desired product), they're both the same thing in the end: genetic modification.

Yet, for some reason, people believe one is "bad" because it's done by science, while the other is "good" because it's "natural."
 
2012-07-27 12:55:04 PM

Theaetetus: kingoomieiii: hillbillypharmacist: Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.

Court is correct.

That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.

[smalbanynewyork.files.wordpress.com image 450x328]
"Ugh, soapy! What the hell?"


Sweet Jesus, I should not have laughed as hard as I did at that...

As an aside, did anyone else have "Hannibal" pop to mind?
 
2012-07-27 01:31:19 PM

FormlessOne: Theaetetus: kingoomieiii: hillbillypharmacist: Harvesting stem cells, growing them, and putting them back into someone is not something that should ever be entered into lightly. It might not be a drug per se, but it demands oversight from medical authorities and the government.

Court is correct.

That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.

[smalbanynewyork.files.wordpress.com image 450x328]
"Ugh, soapy! What the hell?"

Sweet Jesus, I should not have laughed as hard as I did at that...

As an aside, did anyone else have "Hannibal" pop to mind?


Hannibal ante portas
 
2012-07-27 02:10:10 PM

mgshamster: Yet, for some reason, people believe one is "bad" because it's done by science, while the other is "good" because it's "natural."


To expand on this:

Technically, they're both done by science. But one is "bad" because it's done by biochemistry, while the other is "good" because it's done by botany.
 
2012-07-27 02:35:30 PM
If this keeps quacks from hurting people with questionable medical treatments i am all for it, but it should not stifle research into stem cell therapy.
 
2012-07-27 02:37:20 PM

grimlock1972: If this keeps quacks from hurting people with questionable medical treatments i am all for it, but it should not stifle research into stem cell therapy.


I prefer the wacko idiots rule out what doesn't work.
 
2012-07-27 02:44:17 PM

StoPPeRmobile: grimlock1972: If this keeps quacks from hurting people with questionable medical treatments i am all for it, but it should not stifle research into stem cell therapy.

I prefer the wacko idiots rule out what doesn't work.


People are already complaining that scientists waste money with their research. What would happen if we started doing research to find out what doesn't work rather than what does?

"...NCCAM officials have spent $374,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer."

Link: Is taxpayer money well spent or wasted on alternative-medicine research?
 
2012-07-27 02:51:38 PM

mgshamster: StoPPeRmobile: grimlock1972: If this keeps quacks from hurting people with questionable medical treatments i am all for it, but it should not stifle research into stem cell therapy.

I prefer the wacko idiots rule out what doesn't work.

People are already complaining that scientists waste money with their research. What would happen if we started doing research to find out what doesn't work rather than what does?

"...NCCAM officials have spent $374,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer."

Link: Is taxpayer money well spent or wasted on alternative-medicine research?


Am I going to get a refund?
 
2012-07-27 02:59:31 PM

StoPPeRmobile: I prefer the wacko idiots rule out what doesn't work.


Or (continuing on my last reply to you), if we actually let the wacko idiots decided which treatments work and which ones won't work (assuming by "wacko idiot" you mean people who peddle fake medicine), we get things like this:

Acupuncturists compare real acupuncture to a sham treatment (effectively a placebo). It's shown that that the real treatment is no better than the placebo. Any rational person would conclude that acupuncture doesn't work, but these idiots claim that not only does this research show that acupuncture works, it is so powerful that even the placebo works!

Link: Acupuncture for Bad Backs: Even Sham Therapy Works
 
2012-07-27 03:11:05 PM

mgshamster: StoPPeRmobile: I prefer the wacko idiots rule out what doesn't work.

Or (continuing on my last reply to you), if we actually let the wacko idiots decided which treatments work and which ones won't work (assuming by "wacko idiot" you mean people who peddle fake medicine), we get things like this:

Acupuncturists compare real acupuncture to a sham treatment (effectively a placebo). It's shown that that the real treatment is no better than the placebo. Any rational person would conclude that acupuncture doesn't work, but these idiots claim that not only does this research show that acupuncture works, it is so powerful that even the placebo works!

Link: Acupuncture for Bad Backs: Even Sham Therapy Works


danceswithfat.files.wordpress.com

Sure thing Doc. I think you need to get back to practicing. Practice makes perfect.
 
2012-07-27 03:29:29 PM

hillbillypharmacist: kingoomieiii: That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.

You're right, this IS America, and that's why you shouldn't be using European spices.

I use acorns to augment my stem cells.


Man, you guys must have some lame superpowers.
 
2012-07-27 03:35:19 PM

LordJiro: hillbillypharmacist: kingoomieiii: That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.

You're right, this IS America, and that's why you shouldn't be using European spices.

I use acorns to augment my stem cells.

Man, you guys must have some lame superpowers.


YOU ARE POWERLESS TO STOP MY DIABETES!
 
2012-07-27 03:53:22 PM

LordJiro: hillbillypharmacist: kingoomieiii: That's like saying I shouldn't draw my own blood, infuse it with coriander and thyme, and inject it again. This is America.

You're right, this IS America, and that's why you shouldn't be using European spices.

I use acorns to augment my stem cells.

Man, you guys must have some lame superpowers.


YOU ARE POWERLESS TO STOP MY SQUIRREL ATTRACTION!
 
2012-07-27 03:54:31 PM

I drunk what: so then things that should not be taken lightly should be overseen by medical authorities and the govt.?

should coffee be taken lightly?


Oh look it's an idiot. We haven't had one of those on Fark in awhile.
 
2012-07-27 03:56:52 PM

StoPPeRmobile: Sure thing Doc. I think you need to get back to practicing. Practice makes perfect.


Was that aimed at me, or at the people who claim that sham therapies work?
 
2012-07-27 04:08:10 PM

mgshamster: StoPPeRmobile: grimlock1972:

...$406,000 to find that coffee enemas do not cure pancreatic cancer."


Helluva way to start the morning tho

♪ ♫ The best part of waking up is Folgers in your butt ♫ ♪
 
2012-07-27 04:16:24 PM

mgshamster: StoPPeRmobile: Sure thing Doc. I think you need to get back to practicing. Practice makes perfect.

Was that aimed at me, or at the people who claim that sham therapies work?


Check out siib.org for CAM therapies that actually do work. Subjected to rigorous testing (same as any other treatment protocols) by the DoD - who, you may recall, does not like wasting money to find ways to not fix their soldiers.

In treatment for PTSD, for example, meditation and other "mindfulness" therapies help reduce occurrences of things like flashbacks and irritability. It's almost like someone with a cognitive problem ("I can't get out of the Battle for Kirkuk") can be treated using cognitive therapies. This is a fairly obvious one, but people who dismiss CAM as "sham" read like people 150 years ago who dismissed the microbial theory of disease as "acid-headed whackaloons".

We know what works by testing it. We know what doesn't work BY testing it. So long as you can show a reason why it SHOULD work in theory, study it until it either looks promising or dead-ends.
 
2012-07-27 04:35:43 PM

Dr Dreidel: mgshamster: StoPPeRmobile: Sure thing Doc. I think you need to get back to practicing. Practice makes perfect.

Was that aimed at me, or at the people who claim that sham therapies work?

Check out siib.org for CAM therapies that actually do work. Subjected to rigorous testing (same as any other treatment protocols) by the DoD - who, you may recall, does not like wasting money to find ways to not fix their soldiers.

In treatment for PTSD, for example, meditation and other "mindfulness" therapies help reduce occurrences of things like flashbacks and irritability. It's almost like someone with a cognitive problem ("I can't get out of the Battle for Kirkuk") can be treated using cognitive therapies. This is a fairly obvious one, but people who dismiss CAM as "sham" read like people 150 years ago who dismissed the microbial theory of disease as "acid-headed whackaloons".


I think you're confusing terminology. A "sham therapy" is similar to a placebo, in that it's supposed to replicate the therapy being tested without actually giving the therapy. For example, in acupuncture, the real therapy is with needles, while the sham therapy is with toothpicks. Alternatively, you could have a real therapy of acupuncture with needles hitting the spots they're supposed to go, and a sham therapy with needles hitting random spots or specific places that professional acupuncturists claim will have no effect.

If you read the literature, you'll see the term "sham therapy" used as that definition.

We know what works by testing it. We know what doesn't work BY testing it. So long as you can show a reason why it SHOULD work in theory, study it until it either looks promising or dead-ends.

This I agree with. We shouldn't be testing things that have no biological plausibility (or chemical or physical, for that matter). For example: homeopathy.
 
2012-07-27 04:42:53 PM

mgshamster: If you read the literature, you'll see the term "sham therapy" used as that definition.


Now that you mention it, I do recall that terminology - I used to work at SIIB, and recall vividly a study about acupuncture where the "sham" was putting the pins in random spots. I more object to people dismissing CAM as "fake" or "just as good as placebo".

And by the by, a buddy who still works there is getting deep into placebo research. Seems pretty cool, and he's trying to parlay a fellowship with THE leading placebo researcher in the country.
 
2012-07-27 05:01:26 PM

Dr Dreidel: mgshamster: If you read the literature, you'll see the term "sham therapy" used as that definition.

Now that you mention it, I do recall that terminology - I used to work at SIIB, and recall vividly a study about acupuncture where the "sham" was putting the pins in random spots. I more object to people dismissing CAM as "fake" or "just as good as placebo".

And by the by, a buddy who still works there is getting deep into placebo research. Seems pretty cool, and he's trying to parlay a fellowship with THE leading placebo researcher in the country.


Nope, I won't do that. I do object to the use of "CAM" or "IM" as a terminology, but that's because I think it creates a division between traditional and alternative that shouldn't exist. If the technique or medicine works, we should be using it. If it doesn't work, we should be rejecting it. If it's unknown but plausible, we should be testing it. If it's unknown and implausible, we should be rejecting it until evidence shows that it is plausible. And regardless of which category it's it, we should be honest about what we know and what we don't know. The problem I have is when certain people try to obfuscate what the literature actually says, and then try to make money off of telling people lies (which then in turn either hurts the patient directly, or prevents them from getting help that's been shown to work).

For example, we know that "like cures like" isn't true, and we know that smaller doses are not more potent. We know that water doesn't have memory. We have no evidence that lay-lines exist, either in the body or outside of the body, despite looking for them. We have no evidence for "energy pathways" through the body as acupuncturists describe them, despite looking for them. Yet we are still testing and promoting the use of acupuncture and homeopathy. On the other end of the spectrum, we have things like Vioxx, which could have been a great drug if Merck had disclosed the problem with heart failure. All they had to say was that there's evidence of heart failure, and that people with heart disease shouldn't be taking it, and it would have stayed on the market. It could have helped many people with arthritis and other chronic pain.
 
2012-07-27 05:01:35 PM

hillbillypharmacist: I drunk what: so then things that should not be taken lightly should be overseen by medical authorities and the govt.?

should coffee be taken lightly?

Oh look it's an idiot. We haven't had one of those on Fark in awhile.


um that's the only thing fark has, where have you been?

only an idiot wouldn't see... uh.. oh nevermind

you're right, anything that goes in or out of your body should be decided by medical authorities and the government, just like you said, sorry i questioned your pure understanding of what drugs are, or not per se

a thousand pardons

besides everyone knows coffee can't have harmful effects on human beings, no matter how much you put into your body

duh
 
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