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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'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.
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.
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."
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.
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
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.
Motorcycles, Robots, Space Gossip and More!
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
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. . . .
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.
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.
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? ]=-
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."
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."
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.
Unfortunately thanks to Wickard v. Filburn, while they are factually correct, they are not legally correct. Basically the Supreme court ruled unanimously that if you make something that someone in another state sells, it can be regulated by the Federal government under the Interstate Commerce clause of the constitution.
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.
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.
And don't forget that you miss out on a ton of research data by using unapproved procedures instead of going through a proper research study.
If the patients from the article get cancer (or other complications), it would be a shame for the rest of us if not enough data was collected beforehand to identify risk factors, etc.
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."
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.
hence this doctor's flaunting of FDA regs
The word is flouting, FYI.
"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.
Oops. You're right. Thanks for the correction.
"This post contains words, known to the State of California to cause thought. Wash brain thoroughly after reading."
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.
He was feeding the wheat to the chickens he on the open market. It's not exactly "self-use" if you're using it to make another product you then sell. Any other ruling would have forced all chicken growers to grow their own food since they couldn't compete in the market otherwise.
-- Political fascism requires a Fuhrer.
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
EXACTLY! If there is a medical procedure or drug that one must spend millions to prove is effective, and it can't be patented, it will never be developed no matter how well it works. That's because its use without approval will be illegal and it will cost millions just to give it away. This is the biggest problem in all of medicine and why we have DSHEA and other regulations.
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.
The enemies of Democracy are
Is it any more risky than having vertebrate fused, or having teflon discs inserted in the place of natural cartilage?
The Christian Right is Neither (Christian nor right). See: Matthew 23, Matthew 25, Ezekiel 16:48-50
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.