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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 imagine both sexes have something to look forward to from this exciting development in the self improvement industry.
Only I can judge you.
I don't remember anyone saying stem cells were bad, it's always embryonic stem cell that caused controversy.
This doesn't surprise me. I always figured some other country would start doing this, get amazing results, and then the laws would change fast once it stopped being claims of future magic and became real, testable results. When you start getting these kind of great results, the moral argument gets harder.
Comment forecast: Bits of genius surrounded by a sea of mediocrity.
Also hard to tell if this doc is just another snake oil salesman or is God's Gift to Medicine. FTFA:
Right. Must be stem cells. Couldn't possibly be natural healing of an acute injury - which is exactly what it looks like. Seems to be a T1 weighted image which shows localized edema. Wait awhile and magically the body heals itself. Take another MRI and profit!
Nice thing about bypassing the FDA - you don't have to prove safety or efficacy. Just take people's money.
Faster! Faster! Faster would be better!
Just in case you were asking a serious question, and not looking to insert a South Park reference...
These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you.
They harvest a small amount of your own bone marrow, extract the stem cells from it, and inject them into the spots where they are needed.
Having said all that, this is a really glowing report that claims to be taking a harsh look at the company, then uses testimonials and reference materials from their own web site to "prove" it. It may be legit, but I smell just the faintest tang of green-colored artificial grass product.
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
I am all for this therapy, but the hard numbers they talk about say things like "%x patients feel %y better..." I know that it will receive a standing ovation in slashdot but, these are not hard results, they are anecdotal. I'd like to see x-ray or cat scan evidence of, say % regeneration after x months, etc. If the topic were alternative eating regiments or differences from eating organic vs non-organic (spare the rants, we know that words mean different things in different contexts and we're not talking o-chem), or improvement from chiropractic care, then I'm sure no one here would accept their "hard numbers" easily.
Only I can judge you.
Do not rule out the importance of ethics in science. They guide us in possible repercussions of our actions. The interesting point is that there are more kinds of stem cells than just embryonic. To argue that embryonic cells are the only way is to ignore equally viable options. Simply to say that embryos aren't people is to apply the same logic used to pardon the continuation of slavery. I say that if there's a way to get scientific results while avoiding ethical concerns, then that should be our main focus.
I like losing arguments, it just means that I can take your point and make it my own.
I can't speak to the medical benefits/drawbacks of stem cell therapies as I am not a doctor. However, I have to say that the attitude and gumption displayed by Dr. Centeno in his field is inspiring. Despite all the legal bullshittery and political asshatting going on around the country with regards to stem cell therapy, he managed to pioneer forward, develop some techniques and facilities, and find enough of a technicality to bring an actual treatment to his actual patients. That's a classic American cowboy attitude on display right there. He didn't let his exhaustion or cynicism get him down. He pioneered and worked hard and now ~80% of his patients are reaping the benefits. I have to say, that is very inspiring.
Folk like Dr. Centeno deserve a lot of recognition and thanks. I, for one, wish him luck. As soon as the blood-sucking lawyers get ahold of him, he's going to need it.
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As a biomedical researcher, I'm glad to finally see some of the promises of stem cells. However, this must be tempered by knowing that there exists a fine line between stem cells and cancer cells. Both grow outside of the normal controls that keep excess cell division in check. For stem cells, this is developmentally controlled by the neighboring cells. I wonder how these stem cells will respond when moved to a new environment and what the long term effects will be. I guess that FDA sanctioned or not, we're going to find out.
"Me fail English, that's unpossible." --Ralphie
Summary: ...allowing many patients to walk or run who have not been able to do so for years
Reality:
Within months some patients can walk or run in ways they haven’t been able to in years.
What is this? A late night infomercial?
When Fascism comes to America, it will call itself Anti-Fascism, and tell you to give up your guns.
Real safety testing is very, very difficult to do in a controlled way.
The only way to test on humans is to actually test on humans. People are always willing to take a risk when they are living with constant pain, as are these people. I wonder if the real culprit on the delay is the insurance companies? Or is it the established medical community who are not tooled up yet for maximum profit on the procedure?
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I too am a bit worried about the cancerous implications of this. Of course, if you're age 40+ have a gimp leg (knee), and you gain use of it for 10 years, but then have to have it amputated due to it going cancerous, is that better or worse than hobbling about during the last active years of your life? That's a hard decision to make, but I think I would rather have 50 good years with a leg and lose functionality later, than lose most of the functionality now and be hobbled for the rest of my life.
moox. for a new generation.
beginning countdown till a lawsuit drives the cost to do so so high that only the elite can afford it... lawyer litgation gold rush in 10... 9... 8...
Face it, without real tort reform this will get litigated into oblivion...
-=[ Who Is John Galt? ]=-
This. People should be informed and make a decision. You wil probably be able to walk again but there is a slight slight chance of getting cander in a few years which may or may not be treatable. I imagine a large number of people would be signing on the dotted line.
Stick with the back pain for now. Stem cells are still in the experimental stage on humans, hence this doctor's flaunting of FDA regs.
Unless you have a particular desire to be a guinea pig, or your quality of life is so poor that it's worth the risk of dying of cancer (and having your health insurance able to bail out on coverage because you had a non-FDA-approved procedure that contributed to it)...
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
Isn't it much easier to cut a cancer out, than to wish flesh into existence? Cancer of the tendon or whatever isn't all that common anyway.
Now realize the cancer rate will NOT be zero, because the cancer rate of human flesh, natural or otherwise, is not zero. Therefore people whom get stem cell therapy will get cancer and die. Therefore, their Drs will get sued out existence. That will be the problem.
"Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
That is a good idea but I doubt that there's much chance of it being allowed for any amount of time because it doesn't allow for forcibly protecting people from themselves. See the drug war for details.
Sigs are too short to say anything truly profound so read the above post instead.
Except that injecting stem cells doesn't necessarily mean all of them will stay nicely in the area where you injected them. If they're naughty enough to turn into cancer cells, you can bet they won't be nice enough to stay in place.
So, would you risk not only losing that leg, but your liver as well? How about an unknown risk of a fully-metastasized cancer all through your body? Does that change the equation?
I imagine stem cells would make an easily-metastasized base from which to develop cancer. I'm not a doctor, but if you ask a competent one they'll tell you they don't know yet either. It hasn't been fully tested in humans. Hence why the FDA is freaking out.
And, to head off the inevitable question of "well, what's the risk, then?".. Medical science appears to lack that information right now. This is why the FDA has not yet approved this procedure - they don't know the risks and they need human trials, and getting human trials on risky procedures is HARD.
These patients are going to find out for the rest of us. We should thank them for that. Hopefully they understand what they are getting themselves into. I really hope this pans out as a viable procedure. There's a good chance it will. And it could help so many people.
But right now this procedure could just as easily be a relatively short term death sentence for an unknown percentage of these patients.
THESE are the human trials. They are happening right now.
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
"If they are cautious about approving a new procedure, it is usually because there is insufficient data to really declare it safe."
That doesn't stop them from taking bribes and pushing bullshit pharmaceuticals into the market without required testing - Vioxx, anyone?
Still waiting on Serviscope_minor to wake up to fucking reality and realize that Jessica Price isn't going to fuck him.
The trouble is that, unless somebody bothers to do a real study(and no, filling a brochure with flattering anecdotes doesn't quite cut it) nobody is informed.
History is full of novel treatments that turned out to work, that is why we aren't still sacrificing chickens to Aesculapius; but it is even fuller of treatments that didn't work, were actively counterproductive, or were initially promising but didn't pan out.
Unless these guys step up with some science, I'd say that this article is just a libertarian snake-oil infomercial. "The Exciting Cure that the fascist FDA DOESN'T WANT YOU TO HAVE!!!!"
The FDA has not approved this, because they have not tested it and do not know if it is effective AND safe.
You may feel free to continue to get this kind of treatment, and take the risks that are involved in it. The FDA exists to make sure you are aware of those risks, and to stop businesses who make unsupported claims from doing so. Your insurance company can also deny any claims you may make that could feasibly have been caused by buying this procedure.
This guy is making claims that are currently unsupported by a properly documented body of science, selling a procedure that has not been fully tested in humans and may have unknown side effects, including death by cancer. The FDA exists to make sure that, should you choose to engage in a procedure, you understand the risks involved in that procedure and how likely it is you will benefit.
You may continue putting your stem cells where you please. No one says everyone who does things to you needs to be a doctor. Maybe along with chiropractor, homeopathic consultant, and crystal therapist, we'll have a stem cell therapy technician. But understand that your insurance company might not be terribly happy with you making body modifications they don't understand and haven't been approved, so if you come down with cancer and it metastasizes from your knee to your liver, they aren't on the hook for the millions of dollars it will take to make you comfortable in your last few years.
The FDA exists to try and identify what things are good for people, and what things can harm them. They try to encourage the former and discourage the latter. If something is harmless but not effective, they allow its sale as long as no claims are made that cannot be supported. If something is harmful, they have the power to regulate its sale and use. Until something is proven safe, it is necessary for them to treat it as potentially harmful.
If you don't like the nanny state bullshit that involves, please do feel free to engage in any treatment you choose. You want to go off and engage in experimental and unproven stuff and you've got the money? Go for it! I'm not trying to be mean, though, when I say that if it doesn't work out for you please don't expect my insurance rates to cover you on it, and don't expect a lot of sympathy.
If this doctor is not disclosing the risks of the procedure to his patients, he must be stopped until he discloses the risks fully. If his patients are knowingly taking this risk, then more power to 'em.
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
They can't be told the risks, because nobody knows what the risks are. Just saying "Well, it might cause cancer someday" isn't telling someone the risks. What sort of cancer? With what probability? What are the chances that it will metastasize? What are the other possible side effects? Until you have some idea about the answers to these questions, then you cannot have informed consent.
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Sure you can.
"We cannot know all the risks, and you are proceeding under the condition that it is impossible to fully understand the impact of your choice."
We, by the way, make those kinds of choices every day. Nobody is psychic, and studies lie.
Besides, in a world where informed consent is impossible in these circumstances, how do you ever get any testing done? If those being experimented on cannot consent, is all testing no longer ethical?
"These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you."
And, finally, we come to the heart of the matter.
TFA states: "The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs."
THIS is what is at issue here. The good Doctor is simply forcing the FDA into a position to either back down from that assertion or validate it somehow. He is forcing debate on the issue.
Just what, exactly, constitutes a drug. The Doctor argues that this is a "treatment" or "therapy", no different then a skin-graft or banking your own blood supply, and he makes a valid point. The actual substance used is from the body it came from. Did it become a "drug" simply by removal from the patient's body?
MASSIVE amounts of money are on the line here, especially if the very definition of the term "drug" is altered as a result as it would also alter the markets associated with drugs. The BigPharma are already trying (and succeeding) in getting patents for stuff that we ALL already possess, and seek to make a profit from those patents.
Who, exactly, do you think their competition will be in this market? Who ELSE might be able to supply YOU with the stem cells needed for such treatments? You! The only viable means the Pharma have to compete is growing their own supply and then make it harder to use your own cells. Enter the Lobbyists and FDA Guideline Revisionists.
I hope the good Doctor has good lawyers.
A research group I worked for was tasked with analyzing the Vioxx data from the APPROVe study, which was the study that led to Vioxx being withdrawn from the market.
Fact: Vioxx did double the risk of MI, stroke, or CV death.
Fact: Vioxx improved arthritis with fewer GI issues than naproxen.
Fact: Vioxx reduces incidence of colon polyps. (APPROVe trial primary endpoint)
My point:
*All* drugs are risk/reward, including Vioxx. Drugs much the same as Vioxx remain on the market with warnings. Patients have told me they would 100% be willing to accept the doubling of the risk of CV event to have daily relief from arthritis.
Now realize the cancer rate will NOT be zero, because the cancer rate of human flesh, natural or otherwise, is not zero. Therefore people whom get stem cell therapy will get cancer and die. Therefore, their Drs will get sued out existence. That will be the problem.
Unless they conduct an actual scientific study and determine that the cancer rate for those who received the treatment is the same as in the general population accounting for other risk factors, science yadda yadda.
At which point their Doctors won't be sued out of existence just like they aren't for anything else that could hypothetically cause cancer but, uh, doesn't.
So as far as I'm concerned the problem is "rebels" like this guy fighting the evil FDA who doesn't want to let him administer the treatment merely because there have been no human safety or efficacy trials.
I mean good for him if he helps people by not waiting for the studies to be done. On the other hand fuck him royal if he hurts people by not waiting for the study to be done. And when the first patient gets cancer after receiving treatment, and they sue him out of existence, hey, who's to say that isn't completely appropriate? The whole point is he doesn't know.
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Is it any more risky than having vertebrate fused, or having teflon discs inserted in the place of natural cartilage?
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