Slashdot Mirror
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.'"
My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.
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.
Scientists point out problems, engineers fix them
altslashdot.org: The future of slashdot.
> 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.
Democrat delenda est
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
The only title of honor that a tyrant can grant is "Enemy of the State."
more specifically, the hypothesis is that cancer is caused by stem cells. http://www.economist.com/science/displayStory.cfm?story_id=12202589 is a decent popular science article.
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.