Doctors Skirt FDA To Heal Patients With Stem Cells 394
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."
cancer worries (Score:5, Interesting)
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.
Re:Not surprising (Score:5, Interesting)
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. [wikipedia.org] 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.
Guns and weed, too. How big is this trend? (Score:3, Interesting)
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 [panamalaw.org] 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.
Re:How great (Score:4, Interesting)
Document referenced in above post is here [state.co.us].
Re:No Surgery Required? (Score:5, Interesting)
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.
Re:cancer worries (Score:3, Interesting)
However, I also know researchers at the FDA, and these guys are not dumb. If they are cautious about approving a new procedure, it is usually because there is insufficient data to really declare it safe. In other words, more research is certainly needed before stem cell therapeutic techniques become widespread. Giving someone back their ability to walk is fantastic--but rather less so if we discover in 5 years of lethal side-effects.
TFA does link to a study published by the doctors offering these treatments [benthamdirect.org]. They describe that for the 227 patients studied, none had neoplastic complications. This is encouraging, but again I think more research is needed: first these kinds of results need to be double-checked by others, and secondly over longer timespans (the study in question only followed patients for ~1 year).
Re:Implants are a thing of the past? (Score:1, Interesting)
IMO parent has a point, what's flamebait about it?
Re:cancer worries (Score:5, Interesting)
Well, we apparently have a pool of willing volunteers who are knowingly accepting medical treatment from a doctor that is not FDA approved. You know for sure this guy's malpractice insurance isn't going to cover it if his patients all end up with sudden cases of terminal cancer, and in the meantime his procedures on willing subjects are going to give the FDA tons of useful data. So, studies are being done, no worries about malpractice insurance rates going up. Sounds like a winner to me.
I just hope the risks have been explained to the patients who are receiving the treatment. I mean, REALLY explained. Not in terms of the vacuous testimonials on this site, but in terms of "we don't know how big the risk really is yet, because we don't do this a lot in humans."
I know a few people who are suffering from severely reduced mobility (permanent crutches) who get far less exercise than they would if their legs worked properly. If you told them there was a $10,000 cash treatment that gave them an 75%+ chance of significant improvement within a year year, but a chance they could eventually develop cancer, I expect at least a couple of them would go for it. One of them is in her 40s and due to weight (brought on by 15 years of waiting to qualify for surgery) is a relatively poor candidate for knee replacement. She can't exercise because she can barely get out of bed, and she can't get surgery because she can't exercise (any movement = pain), so she's in a nursing home. I think she'd gladly trade a risk of dying of cancer a couple of decades from now for the ability to get some exercise and at least enjoy those decades.
Re:How great (Score:5, Interesting)
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.
Re:Not surprising (Score:5, Interesting)
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).
Re:Guns and weed, too. How big is this trend? (Score:3, Interesting)
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.
Re:cancer worries (Score:5, Interesting)
I am a musculoskeletal radiologist.
On the pair of MRI images, which are probably proton density fat saturated images, the bone at the top of the pictures is the patella, shown here near the center where there is complete cartilage coverage, some of which is included in the circle. This cartilage is slightly irregular or frayed on the left, and smooth on the right. The bone near the bottom of the image is the femur, which is shown at a level above the cartilage. The dark signal material near the femur, more of which is included in the circle than patellar cartilage, is fat. Note that the patellar cartilage is different brightness than all of the fat (subcutaneous, or suprapatellar pouch) in these images.
In my opinion, there is no change between the two images. The knee didn't look severely damaged to begin with, and the area adjacent to the femur wasn't even cartilage.
Re:cancer worries (Score:4, Interesting)
Cancer of the tendon isn't common, until you start injecting stuff like stem cells in there. Even if one in 10 million stem cells is cancerous, you've still got cancer in that region. If one in 20 million is cancerous, you've still got a 50/50 chance of getting cancer there immediately, and whos to say our stem cell techniques don't cause cancer 10 years down the road?
Re:Implants are a thing of the past? (Score:3, Interesting)
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.
Re:No Surgery Required? (Score:2, Interesting)
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.
Re:No Surgery Required? (Score:3, Interesting)
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.
Re:No Surgery Required? (Score:3, Interesting)
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.