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.'"

Comments

Re:Non-Story

[Kell Bengal]

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

[smegmatic]

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.

due diligence

[nten]

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.