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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.
And if you call in the next 15 minutes, you get 5 plastic syringes, absolutely free.
Call now.
* The free syringes may or may not be new pending supply.
Fuck systemd. Fuck Redhat. Fuck Soylent, too. Wait, scratch the last one.
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."
Hah. Shutdown pending in 3... 2... 1...
The clinic that is using this treatment is claiming that the FDA does not apply to them, because they the treatment is within their clinic and has nothing to do with business outside of Colorado.
Good luck with that claim.
For example, is the clinic aware that the State of Colorado requires medical practitioners to comply with federal regulations in order to maintain their license? Please see this document for the legal requirement (PDF; specific location of federal compliance language begins on page 60 of the legal document, which is page 63 of the pdf).
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.
"Trolls they were, but filled with the evil will of their master: a fell race..." -- J.R.R. Tolkien on Olog-hai
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.
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
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. . . .
They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado
If the Supreme Court can rule that a man growing and consuming wheat entirely on his own property is covered by the Interstate Commerce Clause, then everything is. The FDA will have no problem asserting jurisdiction here.
Give me Classic Slashdot or give me death!
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."
Finally. One daring little company, and we finally move forward. Thumbs up for the Colorado mavericks.
Medical history is replete with "mavericks" that hawked miracle cures. The common thread was their claim that the Man was engaged in a conspiracy to surpress their wonderful new miracle treatment. You may or may not be too young to remember the whole Hydrazine Sulfate scam. Bob Guccione (the publisher of Penthouse) sent his wife to a quack named Dr. Joseph Gold, who sold them on Hydrazine Sulfate... formerly an industrial chemical... as a miracle cancer treatment. Guccione railed in Penthouse about how the National Cancer Institute was suppressing this vital new treatment out of greed and jealousy. His wife took the stuff anyway, telling everyone how much better she was feeling.
She died of breast cancer soon afterwards. And to this day, the FDA says there's no evidence for the benefit of that compound.
I'm well aware that sometimes a clique mentality can settle in among scientists. They're human, after all, and are as fallible as anyone else. And in the end, perhaps these stem cell guys will be hailed as heroes. But when someone is crying "conspiracy!", I'd at least be careful before taking what they're selling.
Life is hard, and the world is cruel
Embryonic stem cells had nothing to do with this. Read the article. They are extracting stem cells from the patient.
This has been delayed because of the risks to the patient, not because of the pro-life/pro-choice debate.
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
Fusiongyro,
ESC research funding was cut off completely and entirely. No lab that accepted federal funding could do ESC, and they couldn't even use existing equipment for privately funded ESC if that equipment had been paid for in any way by federal funds. Effectively, the research was banned in every sense but the literal one.
Relevant to the article, which is a poorly written promotional piece of fluff, this clinic that is offering stem cell therapy should warn its patients that there is strong evidence of cancer resulting from stem cell injections. This is one of the main reasons stem cell therapy has not made it into mainstream medicine (it is being used in Brazil with some success).
Religious fundamentalism aside, there's a reason for caution in the approval of new treatments such as stem cell therapy. For example, tysabri is a promising new drug for treating multiple sclerosis, but after several human deaths it was discovered that it activates a normally dormant virus in the brain in a few people, killing them. It was taken off the market, then allowed back under stricter controls. Thalidomide was handed out all over the world in the 1950s, resulting in horrible birth defects. Fortunately, the FDA blocked its approval in the U.S., probably saving thousands of children from disfigurement.
I'm all for stem cell research, and I think the Bush Administration and the fundies were idiotic for blocking it, but we can't just approve every new treatment that comes along without some rigorous testing. On the other hand, if patients are adequately informed of the risks, and I'm not the one paying for the side effects they may encounter, more power to them.
it's = "it is"; its = possessive. E.g., it's flapping its wings.
I have a device implanted in my left eye that not only allows me to see, but gives me better than 20/20 vision at all distances. Ther's at least one other cyborg here with a cochlear implant. There are implanted pacemakers, implanted filibrators, implanted joints, all sorts of cybernetic implants. You will be assimilated, resistance is futile.
Your attempt at humor is futile as well. Going for "funny" is dangerous to your karma, unless your karma's alrady excellent.
Free Martian Whores!
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.
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.
This is actually how medical research studies are performed. The process is called "Informed Consent" and the prospective participant is given a full rundown on the proposed treatments, including a full disclosure of possible risks. However, the research study itself has to conform to various regulations and is subject to the oversight of various bodies who approve the study protocol and also the materials used in the consent process. There are quite a number of hoops to jump through prior to enrolling participants in the study. On the other hand, offering an unapproved procedure as a treatment, rather than as the subject of a research study is a different thing entirely.
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.
"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.