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.'"

Delayed

[dmomo]

My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.

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

[oldhack]

Interestingly enough, some researchers see connection between tumor and stem cells.

Re:OUtrage for everyone!

[jmorris42]

> 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.

Things change when outside your body

[noidentity]

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.

If I piss into a bottle, it comes out of my body sterile and is safe to drink, but left to sit for a few days, it is full of bacteria and not safe. 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.

Re:Unclear Summary

[fuzzyfuzzyfungus]

TFA doesn't actually say either way; but I'd overwhelmingly assume the former. Consider donor blood use and organ donations. Those were once experimental, are now routine, and they clearly don't run "Will the late Mr. X's liver work in Mr. Y, a randomized, controlled, 5 year study" every time somebody takes a flying leap off their donorcycle.

Comment removed

[account_deleted]

Comment removed based on user account deletion

Re:Non-Story

[QuantumG]

Meh, if you sign a waiver you can pay a doctor to do anything to you.. short of deliberately killing you.. the legality of that varies from state to state.

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 [economist.com] is a decent popular science article.

Re:Looking at the comparisons

[rts008]

Yes, "fully tested" has to involve human trials at some point;

While I singled this quote to respond to, I do agree with the 'nature' and content of your post. But, I felt the need to address this statement, if even as a pedant.

The 'scientific/research' community may consider "x" to be 'fully tested' in 'human trials', but currently does not address the misconceptions between 'populace's perceptions' and these trials.
*disclaimer-I am currently dismayed by the divide between science and 'public perception', and see a 'hard road ahead' for any new advances in science.*

I am not saying that I implicatively trust the 'drug companies' view, but there is a middle ground that may be more relevant in dealing with this specific issue...and 'issue' it is, IMHO.

"Fully tested" brings up many questions that cannot be answered without a NDA, or similar...'Trade Secrets','IP', and all that shite, you know.
I am dubious without full disclosure.
And yes, I am familiar with the 'process' to get a drug to the 'market'. As long as 'IP' is involved, I don't trust it to be in the publics best interests...I've seen how it works out too many times.

Yes, I am excited and hopeful about some of the 'new med tech', but I am dubious about it's utility to society due to 'IP' laws/trends...so no 'breath holding' works for me.

Re:Non-Story

[iluvcapra]

I wasn't replying to the article, I was replying to Kell Bengal. The article excludes embryonic stem cells artificially, probably because the author didn't want to start a fight, even though everything he says applies to embryonic cells too. He's a coward.

You can chill, I'm not a pro-lifer or anything, I'd just like to know that embryos are destroyed to saving life and curing disease, not make some guy rich peddling a fraud. Even if they ain't people, and even if we're talking about adult stem cells, they're both still human tissue; I wouldn't want someone selling chunks of human liver as an ingredient in a "miracle cure" either. There's really only a difference of degree between that and chopping of the arms of albinos to make potions...

Re:Precautionary Principle

[nilbog]

Okay but if you know X will kill you in a month, and Y *might* kill you some unknown amount of time down the road, which would you choose?

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.

no plan

[conspirator57]

i don't see a plan to thwart anything here, just a good old fashioned fiefdom territory grab. Stem cells are an attractive avenue, therefore gov managers want to be associated with the success. its good for the career.