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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.'"
Heh.
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...
Advice: on VPS providers
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...
Blessed are the pessimists, for they have made backups.
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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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.
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.
'In animal models, they routinely cure diabetes.'
That's great for models, but what about ugly people? Don't we get a cure?
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?
There are no perfect answers, only the right questions. More questions at http://foresightandhindsight.blogspot.com/