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FDA Could Delay Adult Stem Cell Breakthroughs

kdawson posted more than 4 years ago | from the culture-club dept.

Medicine 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.'"

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261 comments

FTC != FDA (5, Informative)

Anonymous Coward | more than 4 years ago | (#27840719)

Heh.

Re:FTC != FDA (0, Funny)

Anonymous Coward | more than 4 years ago | (#27840727)

But, it is true that 0! = 1

Re:FTC != FDA (2, Funny)

Anonymous Coward | more than 4 years ago | (#27840901)

Which is true, but also 0 != 1

Re:FTC != FDA (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841085)

how does anon commets work on this site?

Re:FTC != FDA (0)

Anonymous Coward | more than 4 years ago | (#27841111)

They does with poor grammar

drats (2, Funny)

ifeelswine (1546221) | more than 4 years ago | (#27840725)

now christopher reeve will never walk =(

Re:drats (0)

Aphoxema (1088507) | more than 4 years ago | (#27840757)

Now now, I'm sure he'll be able to afford the treatments, or buy his way into trials. It won't be as dramatic, but he does have power still.

Re:drats (1)

paitre (32242) | more than 4 years ago | (#27840893)

Now, if only he weren't DEAD.

Re:drats (0, Offtopic)

rts008 (812749) | more than 4 years ago | (#27841321)

*start sarcasm*Well, that was only a minor technicality until the Federal Trade Commision got involved, after kicking out the FDA for not being 'IP friendly' enough.

IP!=Progress! *end sarcasm*

Damn! I did not mean to conflate the two, but it just seemed to happen 'naturally' in this current environment.

Acropocalypse! (0)

Anonymous Coward | more than 4 years ago | (#27840741)

So how long has the FDA been operatin

That's really dumb (-1)

Anonymous Coward | more than 4 years ago | (#27840743)

I suppose some of these could cause cancer, but with a little care they won't (e.g. make sure that you don't turn on telemerase).

Bad move FTC.

Re:That's really dumb (0)

Anonymous Coward | more than 4 years ago | (#27840951)

Bad move FTC.

I love it when there's a mistake in the headline. You can tell who didn't even read the summary.

Re:That's really dumb (1)

mangu (126918) | more than 4 years ago | (#27841243)

make sure that you don't turn on telomerase

Indefinitely, you surely mean. I wouldn't mind some of my cells splitting a few extra generations.

Non-Story (5, Insightful)

afabbro (33948) | more than 4 years ago | (#27840759)

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 (5, Interesting)

Kell Bengal (711123) | more than 4 years ago | (#27840867)

It might be the point of view of one man, but it's not a crazy position to take. I for one would want any medical treatment fully tested and certified, irrespective of if it's made out of 'modified' bits of me. Cancers, if you recall, are actually a part of you gone wrong. If I'm dying of cancer, sure, I'll try damn near /anything/ in my last days. However, if it's something that will be offered as a routine treatment to non-critical patients then it needs to run the full gamut of testing, like every other contender.

Re:Non-Story (2, Interesting)

oldhack (1037484) | more than 4 years ago | (#27840955)

Interestingly enough, some researchers see connection between tumor and stem cells.

Re:Non-Story (4, Insightful)

rts008 (812749) | more than 4 years ago | (#27841335)

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 (4, Funny)

.orvp (208389) | more than 4 years ago | (#27840983)

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.

Re:Non-Story (0)

Anonymous Coward | more than 4 years ago | (#27841301)

Go, Frank B. Parker!

Re:Non-Story (4, Funny)

mellon (7048) | more than 4 years ago | (#27841313)

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 (5, Insightful)

Celeste R (1002377) | more than 4 years ago | (#27841485)

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?

...Oh wait, this is /. That should go without saying.

Re:Non-Story (4, Insightful)

Smallpond (221300) | more than 4 years ago | (#27841027)

After all, we don't want to have doctors developing new treatments. That's what government bureaucrats are best at.

Re:Non-Story (0)

Anonymous Coward | more than 4 years ago | (#27841135)

right. the doctors would treat everyone with every experimental sham on the market. like blood letting. or vioxx.
what we really need is government bureaucrats to STOP the doctors from developing new treatments which may KILL US ALL.

Re:Non-Story (4, Informative)

fuzzyfuzzyfungus (1223518) | more than 4 years ago | (#27841167)

But we just might want them telling drug companies that, yes, they do actually have to test for safety and efficacy before they start selling the stuff...

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.

Re:Non-Story (2, Interesting)

QuantumG (50515) | more than 4 years ago | (#27841309)

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.

Re:Non-Story (1)

iluvcapra (782887) | more than 4 years ago | (#27841153)

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 particularly not crazy about stem cells being cultivated, and possibly embryos destroyed, for frivolous treatments.

Re:Non-Story (1)

DJRumpy (1345787) | more than 4 years ago | (#27841537)

They could always expedite the approval if it can be proven to be life saving. Didn't they do the same for HIV medications when early clinical trials showed very promising results with some of the drugs?

Re:Non-Story (0)

Anonymous Coward | more than 4 years ago | (#27840941)

Also, what's with the indignation? What happens when, 20 years down the road, everybody who gets some stem cell treatment gets horrifically virulent cancers. This is just more of the "Lorenzo's Oil" bullshit: drug companies trying to collect profits in the testing phase of a drug so they can shuffle of the risk of making new drugs to the general populace, but still hold onto all the profits.

It's greed, pure and simple.

Re:Non-Story (1)

mellon (7048) | more than 4 years ago | (#27841293)

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 (3, Interesting)

dmomo (256005) | more than 4 years ago | (#27840767)

My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.

Considering how long (4, Insightful)

NotSoHeavyD3 (1400425) | more than 4 years ago | (#27840769)

Considering it took over a decade to go from the hypothesis of "bacteria cause peptic ulcers so lets use antibiotics" to it being standard practice why would anybody expect stem cells to appear with any speed at all. (I mean that example we're talking about giving people an already existing drug with already known properties in humans and it still took years. Stem cells will be MUCH slower to go from any discovery to actual treatment.)

OUtrage for everyone! (5, Insightful)

spinkham (56603) | more than 4 years ago | (#27840791)

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! (5, Funny)

Anonymous Coward | more than 4 years ago | (#27840843)

Don't underestimate the ability of average citizens to be both stupid and angry.

Re:OUtrage for everyone! (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841031)

Indeed. See the headlines on Fox News on any given day. No kidding.

http://feeds.foxnews.com/foxnews/latest

Re:OUtrage for everyone! (3, Interesting)

jmorris42 (1458) | more than 4 years ago | (#27841045)

> 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 been averted with a faster process since everyone else seems to ignore that detail.

But now imagine something goes wrong. Perhaps a statistically significant number of patients have a bad side effect. You are still going to get yer ass sued off. Even after you spent a decade proving to the government's satisfaction that your new drug was safe and effective you are still legally liable. All those sagans of cash you spent provide zero protection from either civil or criminal liability. The FDA, being the State, is of course blameless. Even better, recent lawsuit verdicts say that even if a doctor misuses your drug (i.e. uses it in ways you clearly labeled it as contraindicated for) juries will still force you to pay up.

Oh, memo to the /. editors. It is the FDA, not the FTC.

Re:OUtrage for everyone! (5, Insightful)

Brett Buck (811747) | more than 4 years ago | (#27841071)

Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...

      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

Re:OUtrage for everyone! (1)

rts008 (812749) | more than 4 years ago | (#27841479)

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 bothered' with this stuff?

'Nuke it from orbit', and 'start from scratch' type solutions seem more viable to me more everyday. YMMV.

BTW, what the hell does the 'FTC' have to do with this? I can't figure that out unless it is a typo.[editors?!?..WTF??!!??]

Re:OUtrage for everyone! (0)

Anonymous Coward | more than 4 years ago | (#27841525)

Vioxx is evil, right?

Precautionary Principle (5, Insightful)

meehawl (73285) | more than 4 years ago | (#27840793)

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.

Re:Precautionary Principle (0)

Anonymous Coward | more than 4 years ago | (#27840885)

I couldn't agree more with your assessment. Some cells can transform with even a limited time in culture. Given that there's not a good way to characterize this, with even the most sophisticated tests, it's far better that the FDA take a cautionary stance.

Urm? (5, Insightful)

fuzzyfuzzyfungus (1223518) | more than 4 years ago | (#27840811)

The risks, while no doubt ultimately manageable, of playing with pluripotent cells are neither trivial nor theoretical. They have this nasty habit of turning into good old tumors [scientificamerican.com] .

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.

Re:Urm? (1)

marco.antonio.costa (937534) | more than 4 years ago | (#27841273)

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.

Re:Urm? (2, Insightful)

fuzzyfuzzyfungus (1223518) | more than 4 years ago | (#27841415)

Then you would fall under: "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".(which is the "libertarian" half of the analogy)

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 because OMG even your own stem cells!!!" is just specious.

My point was simply that stem cells, even the patient's own, are subject to legitimate questions of safety and efficacy to at least the same extent as other drugs, and to a greater extent than many. Either no drugs should be under the FDA's purview, or stem cells deserve to be. Either option is a fine position. I just don't like "FDA in general is fine; but stem cells are special for some poorly defined and irrelevant reason".

Unclear Summary (1, Troll)

TinBromide (921574) | more than 4 years ago | (#27840823)

Of course I refuse to RTFA, but the summary isn't clear. Right now, if I want to undergo treatment that involves adult stem cells harvested from me, to be re-injected from me, I might have to wait 5 years. However, what is not clear is whether it will take 5 years to approve the process such that in 6 years, it might take 2 weeks, or will it take 5 years in 10 years when(if) this process is well understood and old hat?

Re:Unclear Summary (2, Interesting)

fuzzyfuzzyfungus (1223518) | more than 4 years ago | (#27841221)

TFA doesn't actually say either way; but I'd overwhelmingly assume the former. Consider donor blood use and organ donations. Those were once experimental, are now routine, and they clearly don't run "Will the late Mr. X's liver work in Mr. Y, a randomized, controlled, 5 year study" every time somebody takes a flying leap off their donorcycle.

Animal models... (5, Funny)

Austerity Empowers (669817) | more than 4 years ago | (#27840841)

'In animal models, they routinely cure diabetes.'

That's great for models, but what about ugly people? Don't we get a cure?

Re:Animal models... (2, Funny)

oldhack (1037484) | more than 4 years ago | (#27840959)

Give me a break. Who cares about ugly people?

Re:Animal models... (3, Funny)

bluefoxlucid (723572) | more than 4 years ago | (#27841051)

Amy Winehouse has a "Love Ugly People" movement going on, on alternate Tuesdays from her "Love Jack Daniels" and "Love Crack-Addicted Cock Whores" forums.

Re:Animal models... (4, Funny)

lena_10326 (1100441) | more than 4 years ago | (#27841033)

That's great for models, but what about ugly people? Don't we get a cure?

You have several cures. Money, beer, and plastic surgery.

Re:Animal models... (1)

fractoid (1076465) | more than 4 years ago | (#27841119)

If you think animal models are prettier than humans then possibly there's something you're not telling us. :P

Missing Drug Makers Intent (0)

Anonymous Coward | more than 4 years ago | (#27840853)

As much as I care about safety, those issues can be resolved by requiring the techniques to extract, grow, and alter cells be approved not that every instance of such a act be considered the creation of a new drug. The doctor in this case is talking about the danger of a bio company trying to create regime like Monsanto with its BT line. In this case specialized stem cell lines would be created and owned by companies who would sell them like drugs for enormous profits. If it is legal to take a person's own stems cells and modify them as needed to treat disease, it means no money for the big drug companies. That is the real danger.

So? (1)

Bruce Perens (3872) | more than 4 years ago | (#27840889)

Doctors can write prescriptions for experimental drugs.

Re:So? (3, Insightful)

ColdWetDog (752185) | more than 4 years ago | (#27841265)

Doctors can write prescriptions for experimental drugs.

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?

Re:So? (1)

base3 (539820) | more than 4 years ago | (#27841275)

But insurance companies, whose whims those of us who are not independently wealthy are subject to, don't have to pay for them.

This is just silly (0)

TiggertheMad (556308) | more than 4 years ago | (#27840947)

Why should the FDA object to this? Its silly I say, 'Reefer madness' all over again! I've been shooting, snorting, and smoking my own DNA for years, and other than compulsively posting on /., I am the very picture of normality.

It's all about power. (2, Informative)

jcr (53032) | more than 4 years ago | (#27841159)

The FDA wields an unconstitutional power, and they'll grab any excuse at all to interfere with the practice of medicine while people die waiting for new treatments.

-jcr

Re:It's all about power. (1)

Anpheus (908711) | more than 4 years ago | (#27841443)

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.

i just got off the toilet (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841001)

i shit out an obama.

plop!

When one realizes (2, Insightful)

WillRobinson (159226) | more than 4 years ago | (#27841065)

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.

Re:When one realizes (1)

marco.antonio.costa (937534) | more than 4 years ago | (#27841329)

Well, if the government doesn't have the power to regulate drug "safety", then when somebody else comes up with a blue pill to sell they don't have much else to do except put up or shut up.

Re:When one realizes (1)

tftp (111690) | more than 4 years ago | (#27841355)

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.

Re:When one realizes (1, Insightful)

Burdell (228580) | more than 4 years ago | (#27841487)

They don't want to cure you, they want to treat you. A cure is a treatment that ends (because duh, you're cured). If you aren't cured, you have to keep going back to the doctor, getting nice expensive prescriptions, month after month, year after year.

Re:When one realizes (1, Insightful)

Anonymous Coward | more than 4 years ago | (#27841367)

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.

QFT.

When Big Pharma can begin profiting from curing diseases, then your ailments will be cured. Until then, continue shelling out your money for their allowing you to live for the next 30, 60, or 90 days.
Take solace in knowing that you help to employ thousands of people to research, develop, test, manufacture, advertise, distribute, diagnose, prescribe, prepare, bill and sell the medicine that you could be doing without, had they actually tried to cure rather than treat problems.

Why is this a gov decision? (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841141)

Individuals and their MDs are quite capable of assessing risk / benefit.

Why do we need a regulatory body to take care of this? European countries have FDA-equivalents which have only advisory powers, they get along fine.

The US FDA has been taken over by the industry it regulates (a normal event, which is why industries like regulation), and now operates to prevent competition. It thus kills 100s of 1000s of Americans every year by preventing the development of new drugs : 19 new drugs made it through their processes 2 years back.

That is an amazingly low number given the explosion of information due to genomics, proteomics, and increased knowledge of biochem in general.

Re:Why is this a gov decision? (3, Interesting)

jcr (53032) | more than 4 years ago | (#27841253)

If there's a legitimate role for an agency like the FDA, it's indicated by its original name, which was the "Pure Food and Drug Administration". Having inspectors who will check up on whether the bottle of pills you've bought is in fact the drug it's sold as and not just gel caps full of chalk, and punish anyone committing fraud, might be worthwhile. How we got from that to the government deciding whether you're allowed to ingest something and whether your doctor is allowed to prescribe it is a tragic story of gradual usurpation by an overfunded bureaucracy.

-jcr

Re:Why is this a gov decision? (4, Informative)

Anpheus (908711) | more than 4 years ago | (#27841455)

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.

Re:Why is this a gov decision? (0)

Anonymous Coward | more than 4 years ago | (#27841349)

excuse me ? how the fuck would you know what drug causes cancer 1 year down the road with no trials ? how the hell are you supposed to assess vioxx's risk with no data ?
are you stupid ?
how the fuck is an MD or individual supposed to assess risk in any form when the FDA has problems with it ? the only reason the "advisory" crap in EU works is because of the FDA which is literally the guardian of the world drug industry. like the FAA. no FDA=deep doodoo for all customers like the "nutritional supplement" loophole which has resulted in actual deaths.

Re:Why is this a gov decision? (0)

Anonymous Coward | more than 4 years ago | (#27841469)

Why do we need a regulatory body to take care of this? European countries have FDA-equivalents which have only advisory powers, they get along fine.

Google "Frances Oldham Kelsey [wikipedia.org] "

Stem cell treatments have resulted in cancer (2, Insightful)

topham (32406) | more than 4 years ago | (#27841147)

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.

Re:Stem cell treatments have resulted in cancer (1)

rts008 (812749) | more than 4 years ago | (#27841547)

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?

Not a problem if you are rich enough (1)

flyingfsck (986395) | more than 4 years ago | (#27841149)

Larry King (CNN) got a stem cell treatment years ago. Dr Chris barnard (first heart transplanter), got it decades ago and died in his late eighties.

Frigging Bureaucracies! (2, Insightful)

Jane Q. Public (1010737) | more than 4 years ago | (#27841171)

This is even worse -- much worse -- than the time the FDA tried to regulate the newly-invented pepper spray for defense against bears as a "pesticide".

They want their own fingers in the pie. It is as simple as that. And we should not let them do it.

Things change when outside your body (2, Interesting)

noidentity (188756) | more than 4 years ago | (#27841203)

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.

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.

i just got off the toilet (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841215)

i shit out an obama.

plop!!

See you in Thailand, Mexico, or India. (2, Insightful)

jcr (53032) | more than 4 years ago | (#27841271)

Anyone who needs treatments that the FDA doesn't want to allow will have to incur the added expense of going somewhere with a free market for medicine. Sucks for the people who can't afford it.

-jcr

Totally offtopic (2, Insightful)

rantingkitten (938138) | more than 4 years ago | (#27841319)

I realise this is totally offtopic, but it did catch my eye that the vogue phrase is "animal models" instead of "animal experiments". I don't want to even start a battle about the ethics of animal experimentation, but I just found it interesting that they seem to try to sidestep the issue altogether by cushioning their words. Sounds like politics as usual.. so hey, maybe it's not all that off-topic after all.

Now, back to your regularly scheduled Slashdot mayhem.

Re:Totally offtopic (4, Informative)

Anonymous Coward | more than 4 years ago | (#27841433)

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.

If it kept you sick or made you worse it'd be ok'd (0, Troll)

Yaddoshi (997885) | more than 4 years ago | (#27841379)

If it made you more sick or created serious side-effects that would allow for additional medical treatment ($$$) the FDA would approve it immediately without any trials.

Story at 11 ... (4, Funny)

gordguide (307383) | more than 4 years ago | (#27841409)

"FTC could delay Adult Stem Cell Breakthroughs"

In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.

Revenge of the Republicans (-1, Troll)

Anonymous Coward | more than 4 years ago | (#27841473)

It sounds like a video game. Instead of having G.W. "Dubya" Bush killing off stem cell research, we have the ghosts of "Dubya" doing his bidding. Its bizarre and obtuse at the same time. These sorts of things always brings forward the question: Is it their malice or their incompetence that drives them to do this? I often pondered this question when I worked for a micro-managing ass-hole boss, when he would kill fantastic ideas over red tape, or sloth, or envy or any other reason you can imagine (and many I couldn't). It so sounds like what the FTC is trying to do here. In areas that are clearly none of their business, they poke their collective noses and attempt to wield the axe across the neck of the goose that lays the golden eggs. Dumb, just dumb!

Cancer isn't the worst fate. (3, Insightful)

esinclair (1532509) | more than 4 years ago | (#27841509)

I understand the FDA's desire for caution if caution truly represents its motives but there are also other considerations. Encouraging widespread use of a substance with possible long term effects is not a good idea. However, for many of the people adult stem-cell therapy could help, getting cancer twenty years down the road, or even five, isn't an issue if they die waiting for approval of the treatment. Unfortunately, many people including my Mom, are inflicted with diseases stem-cell therapy has been proven to cure, or effectively treat. Many of these ailments such as ALS or Multiple Sclerosis progress quickly and kill or deteriorate people's quality of life at an aggressive rate. Within a period of six months a twenty-two year old male can go from perfect health to a hospital bed in which he cannot move, talk, breathe or eat on his own. Within six months his only form of communication becomes blinking. Many of the people with these illnesses cannot work or live their life and as their conditions endure they suffer waiting for the final blow. Would it not be more in people's interest to give them the choice. If they don't want to risk getting cancer from a treatment they do not have to get it and can use alternative methods until more research is available. But for those who could benefit and cancer is a less dangerous risk than their original illness or for people who are willing to take the risk for reasons of their own shouldn't they be able to? I just wonder what happened to the allowance for personal responsibility.
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