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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."
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 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
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?
The only thing worse than a Democrat is a Republican.
People will still pay, because their desperate for any sliver of hope and the pharma industry would be automatically protected from lawsuits.
So, your answer is to create a decades long bureaucratic process that removes all hope whatsoever.
I don't think I like that alternative. Oh, I know I just presented a false dichotomy and that's probably not what you meant, ideally things can move along faster than that, but in practical terms they don't.
So we have the ongoing cases right now of people wanting to take experimental drugs for their cancer... the government won't let them. On the one hand, they may die if they take these experimental drugs; on the other, they most assuredly will if they don't. Shouldn't it be their choice?
Full disclaimers, of course... patients need to know the drugs or procedures are not vetted by the FDA, that's fine, it's the government telling me I CAN'T do something that bothers me... if they want to warn me before letting me make my own decision, that's fine with me.
Stupid, sexy Flanders.
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.
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.
This is a straw man argument though. Not really talking to you, but rather, others who make this argument against fetal stem cells. The stem cells from fetuses are from already dead, aborted fetuses. No one, that I know of, is advocating killing fetuses for the sake of getting the stem cells. But since they are already dead, why not harvest them instead of throwing them in the trash? Kind of like harvesting organs from a dead guy, only aborted fetuses usually do not have funerals or viewings. I think the bigger question is "is abortion moral?" Talking about taking the stem cells seems to be just dancing around the topic. If abortion is immoral, then certainly taking the cells is too. If abortion is not immoral, then not sure why throwing the fetuses in the trash is an more moral than experimenting with them.
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.