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FDA Could Delay Adult Stem Cell Breakthroughs
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.'"
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?
Is it sad that I am more likely to recognize you and your posts by your sig than your name or UID?
i shit out an obama.
plop!
Indeed. See the headlines on Fox News on any given day. No kidding.
http://feeds.foxnews.com/foxnews/latest
how does anon commets work on this site?
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.
i shit out an obama.
plop!!
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.
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!
No, you closed the deal - you're an idiot.
Fuck systemd. Fuck Redhat. Fuck Soylent, too. Wait, scratch the last one.
*blinks*
Uhmm...No.
Oh fsck it, your level of ignorance is not worth time correcting.
Live happily in your delusions of being informed, and your dreamworld...may it serve you well.(Heh!Heh!Hahahahhoohooheehee!...ROFLCOPTER!!!)
You may want to educate yourself to appear less than informed/educated in these discussions.
Hint:
If it was sterile when you 'pissed in the bottle', then unless the 'bottle' was sterile, it was contaminated from the start. If the 'bottle' was sterile, and you followed aseptic protocol/procedures/technique, then it would still be 'sterile'...until contaminated by an outside source.
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.
It depends on too many variables for this discussion, but for general purposes, 'it depends'...*cue recursive loop*
You have no clue, do you? *debate this at your own 'intellectual risk'- you are trying to bring a flint knife to a 'nuke' fight here*
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
No, your mind is made up with no room for discussion, so you are the idiot here. I made no 'deal' with anyone.
You have an obvious and biased agenda, so your labeling me as an 'idiot' just highlight the fact that you are a 'biased idiot' instead.
Congratulations! Well Done!
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti