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Doctors Skirt FDA To Heal Patients With Stem Cells
kkleiner writes "For many years countless individuals in the US have had to watch with envy as dogs and horses with joint and bone injuries have been cured with stem cell procedures that the FDA has refused to approve for humans. Now, in an exciting development, Regenerative Sciences Inc. in Colorado has found a way to skirt the FDA and provide these same stem cell treatments to humans. The results have been stunning, allowing many patients to walk or run who have not been able to do so for years. There's no surgery required, just a needle to extract and then re-inject the cells where they are needed. There has always been a lot of hype around stem cells, but this is the real deal. Real humans are getting real treatment that works, and we should all hope that more companies will begin offering this procedure in other states soon."
I'm bullish on these techniques, and feel strongly that they will usher a new wave of medical breakthroughs, redefinitions of disease states, and significant increases in longevity.
However, there are real concerns about neoplastic growth from stem cells - that older cell used to create "autologous" transplants (cell lines that start from the given subject and are re-injected back into that subject) may have damage that leads to uncontrolled growth. Real safety testing is very, very difficult to do in a controlled way.
Results don't have anything to do with the moral argument. Proof that eating babies gives you laser vision would not lead to legalization of baby eating.
Furthermore, embryonic stem cell research was never actually banned. The federal government just wasn't willing to pay for embryonic stem cell research, which seems like a fair response to morally questionable research. At any rate, my understanding is that adult stem cells have produced more and better results anyway, and that's exactly what this doctor is doing: taking your own stem cells and giving them back to you. No fetuses = no moral problem. What's actually being skirted here is federal regulation over medical and drug procedures, not anything specific to stem cells.
I personally think people should be permitted access to experimental medical procedures, as long as they understand that as they are experimental, they're waiving their right to sue for wrongful death or medical malpractice, as well as any federal mandate for it to be covered by their insurance. If you have money and want to take the risk, by all means have at it. As for me, the state can pay for it when I'm reasonably convinced of the scientific validity—which includes that the long-term side effects do not outweigh the short-term benefits.
Per the article:
So at least part of their legal claim that the FDA can go jump in the lake is based on the notion that their work is limited to one state. Others are saying the same thing. Gun-rights activists are pushing legislation, some of which has been passed into law to make firearms made and sold in a single state exempt from federal regulation. (That's an odd link, but it was one of the first I found. Google a bit and you'll see lots of pages devoted to this stuff.)
How many other issues are being pushed in this way? There's medical marijuana, of course, (I didn't figure I needed to find a cite for that one) but are there any others?
I'm curious about how widespread this trend is.
Helps if I screw up the link when I try to insert it (boo me, I forgot to preview).
Document referenced in above post is here.
"Trolls they were, but filled with the evil will of their master: a fell race..." -- J.R.R. Tolkien on Olog-hai
With the addition of one more step in that they cultivate the stem cells after extraction to increase their numbers before re-injection. Many other clinics already do extract, spin, inject. The higher numbers of stem cells after cultivation is what they say improves their effectiveness rate.
It must have been something you assimilated. . . .
IMO parent has a point, what's flamebait about it?
That "one daring little company" is gonna get shut down, which is a good thing. Clinical testing of their treatment method has yet to be completed, and a lot of people could get hurt if it turns out there are problems.
In general I agree, you have to do clinical tests. However, I don't see why patients should not be able to voluntarily accept this or other untested treatments provided that a full disclaimer is made. In a case where the approval of a treatment with a great deal of evidence in it's favor has long been delayed due to political or religious reasons as is the case with human stem cell therapies, working around the FDA might be a good thing.
Negative moral value of force outweighs the positive value of good intentions.
It's not embryonic stem cell issues at work here, it's the unknown effect of taking stem cells from the marrow, concentrating them, and re-injecting them into the patient. Stem cells might grow into the material you want, or they might go all cancerous. Testing it is hard because people die if it goes badly, and without testing the FDA isn't about to put a seal of approval on it.
So, on one hand this guy's a maverick boldly testing out a new procedure and helping his patients in the short term, and doing clinical trials on real patients to determine the risk levels. On the other, he's putting each and every one of them at an unknown level of risk of dying of a virulent strain of cancer.
Only history will tell if he was a heroic maverick, bucking the system and getting good medicine done a' la hundreds of bad American cop movies (and we'll all point and laugh at the slow stupid FDA for not making a faster decision and wasting our tax dollars delaying real help to real people), or a reckless asshole who ended up killing a bunch of patients with particularly virulent strains of cancer and, by doing so without FDA approval, managed to screw up their medical coverage of that condition so they ended up dying in pain and broke (and we'll all point at the FDA for not stopping this nefarious villain like they were supposed to and wasting our tax dollars allowing real people to be killed by dangerous experiments).
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
Wickard v. Filburn dealt with a fungible commodity (wheat). This guy is performing a specific service that must be done under specific circumstances, so Wickard may not apply. Regardless, I'm sure we'll find out when the FDA comes knockin' in the not-too-distant future.
God invented whiskey so the Irish would not rule the world.
I have devices in both my eyes that allow me to see at better than 20/20 vision. They're flexible plastic discs that I attach to my corneas.
I think GP was referring to acrylic replacement lenses, the sort that replace your own when they turn yellow and opaque like an old convertable car's plastic back window. They reside behind the pupil, and are a cure for cataract blindness. I wear a pair of those too. Visual acuity with them is astounding, better than before I went blind.
Do not mock my vision of impractical footwear
They can't.
This is probably not patentable, and therefor no one will do the necessary trials to get it approved.
Unpatentable but useful procedures are a big hole in FDA policy, and I think the whitehouse should fund the HIH to get approvals for such procedures.
-Ariel
This is probably not patentable, and therefor no one will do the necessary trials to get it approved.
I thought that was the argument for why nobody would ever develop a non-patentable treatment in the first place. And yet, here it is. I doubt we got to the point of an actual stem cell therapy without expending lots of money on the research.
FDA approval costs a lot of money, it's true. Valid scientific clinical trials cost a lot of money even if you aren't trying to get approval, it's true. Maybe NIH funding the trials themselves for cases where industry won't is the answer.
Whatever the solution to this conundrum is, it isn't to forgo the clinical trials.
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While I don't know the exact procedure (only scanned the article)... In general you would fear cancer because the cells are being extracted then cultured in a flask and being stimulated to divide (using growth factors present in your own blood platelets I'm assuming) moreso than usual. Since theres something like 3-300 errors everytime a cell divides (but compare that to the 3 billion nucleotides in each of your cells, and that most of the mutations won't lead to cancer and its not that big a deal), the logic is that the more times a cell divides the more likely a set of mutations can happen that makes a cell start doing its own thing which is grow whether the other cells around it tell it not to (cancer). Within the body you also have immune cells surveying everything making sure cells arent expressing mutant proteins or in the wrong place and killing them off before they become an issue. This isnt occuring in the flask. Also the cells in the flask may be more exposed to whatever UV radiation or chemicals are around thus increasing the mutation rate. Disclaimer: thats just off the top of my head. I don't know very much about stem cell culturing in particular, its just what I would expect to happen.