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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...
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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.)
Did you know 80 to 90% of the moderators on slashdot wouldn't recognize a troll even if one dragged them under a bridge.
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?
Never underestimate zombie Superman.
I Am My Own Worst Enemy
"FTC could delay Adult Stem Cell Breakthroughs"
In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.
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.
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.
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/
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.
refactor the law, its bloated, confusing and unmaintainable.