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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.
Does that mean we just crack open the fetuses and suck out the stem cells?
- None can love freedom heartily, but good men; the rest love not freedom, but license. -- John Milton
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.
Finally. One daring little company, and we finally move forward. Thumbs up for the Colorado mavericks.
Religous speak to God. Insane are spoken to by God. When all shut up, one can finally hear Shostakovich in peace
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.
But..but.. it meant that all those precious fetuses that would have been otherwise thrown into the incinerator weren't "killed" in order to harvest stem cells! Think of the unborn children!!
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.
FTFA: "How can Centeno and Schultz flaunt the lack of federal approval?"
Personally I'd flaunt it in the trade press!
The next news story is a large group of people in Colorado are uncontrollably chasing cars. Didn't these stem cell researchers learn anything from Toyota?
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.
Me and his urologist know that his PSA rises on the stuff and we think we may be stirring up a hornets nest in his prostate, but on balance, the anaerobic effects, higher blood counts, and cognitive effects outweigh the downside of giving an 81-year-old, a potentially few less years.
Even if stem cell treatment was demonstratively resulting in increased cancer risk, a whole class of older patients could still benefit.
Dad's double-knee replacement surgery took a lot out of him. If we could resurface his knees with a treatment that might cause him cancer in his 90's, we would probably go for it.
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.
Medical treatment that skirts federal regulations? Sounds like a lawyer's wet dream. Stem cell treatment has great potential, but they better tread carefully.
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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
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.
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.
FTA
The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs. As such, they would need FDA approval, and would likely only be developed by large pharmaceutical companies.
Boo! There are lot of people on this planet... it's time to let the willing take risks in the name of advancing science and medicine instead of throwing up procedural and monetary barriers.
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!
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? ]=-
Right on the other side of the border are fancy all-English-speaking hospitals with American doctors doing procedures the FDA bans.
As long as you're avoiding regulation, go where it's been done for years.
Science & open-source build trust from peer review. Learn systems you can trust.
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."
This is an abomination! God will surely strike down (either in this life or the next) those who would be Him. SHAME on them.
There are so many things that people put in their body that the FDA refuses to regulate.
What job is it of the FDA to decide how I want to use my own body's stem cells within my own body. I will put them where I please.
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.
> Are there really people who believe the lump of cells has a soul, but it is okay to destroy it to fix cancer in papa?
No necessarily. The efficacy of the treatments may or may not change the moral position of individuals but is likely to alter the political landscape. Consider the hypothetical position of a Politician before and after stem cell treatments shown to be efficacious:
[Before] Politician faced with one vocal constituent who believed that the "lump of cells has a soul' along with two apathetic ones.
[After] Politician faced with same one vocal constituent who still believes that the "lump of cells has a soul' along with two who are clamouring for treatments to be approved to "fix cancer in papa".
Just to be clear here. I'm not formally involved in this field, but I not believe that research using fetal stem cells is illegal. The only restriction I know of is that federal funded research can only use certain pre-existing strains of cells.
You might think this was spearheaded by christian lobbying groups. Nope. They were pawns and puppets of pharma. This was a field showing great promise. If federal dollars developed tools and procedures to use stem cells, that technology would exist in the public domain. The right-to-lifers' perspective was amplified to hide the real agenda-- keep stem cell therapy research in the exclusive hands of the private pharma corporations. The resulting proprietary treatments will be far more expensive and lucrative than if the federal government had made the breakthroughs in this science.
Seth
$5 / month hosted VPS on linux = awesome!
I'd have to say that I'm opposed to this "baby eating" that you advocate, laser-vision notwithstanding.
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.
And the other part is that nobody else does this.
So, the way to improve health care is to _bypass_ the Federal Government. Somebody should tell Obama!
Um, all of them? That's how it was supposed to work, you know, when we put together The Law (that'd be the Constitution): The federal government gets a small, well-defined set of powers, and the states decide everything else individually. In practice, however, the Feds use the interstate commerce clause to lord over anything and everything you might toss over a border.
A theme I read in many of the replys were centered around "I should be able to make my own choices". Yes to a certain extent. But how many of these people will run back to the gov't when they develop bone cancer? How does the average person who has trouble with their VCR make an informed decsion on a new experimental medical procedure. Medicine will turn into (if not already there) a salemanship game. "Cures baldness, impotence and raises IQ's, come one come all, only 10 cents". The FDA ensures a standard of research and documentation required to provide some common level of proof. Its not perfect, but I dont trust the masses to make informed decisions. There were a whole bunch of women who thought Thalydimide was a wonder drug, until their babies were born. But for every bad story there is also a good one. If the treatment has the success purported, why not get some investors, and get the approval required and own the procedure, instead of the cowboy approach. This is only going to lead to a legal battle, someone else will find the investors, but the treatment itself could end up in court for years as well as the FDA process.
I'll finally be able to clone a Shakey's, and have one for myself!
Slashdot's rate-of-post filter: Preventing you from posting too many great ideas at once.
I am unimpressed by that MRI image before-and-after, which simply shows localised swelling resolving later on. Cancer risks have been explored enough in this thread, but what about any randomised testing against placebo or sham surgery? It's not like orthopaedics hasn't had repeated booms in lucrative, minimally invasive "treatments" that RCTs have later shown to be no better than placebo, or worse if you take the risks into account.
Da Blog
http://www.quackometer.net/?suspectquack=Dr.+Centeno:
This person may be associated with Quackery.
(founded 95,000,000 yrs ago, very space opera)
>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.
_Astounding_ editor John Campbell once suggested that quack doctors should be allowed to practice under a special quack license, which would alert patients to the fact that they weren't going to a mainstream doctor. He added a really interesting wrinkle, which was that a quack license would be conditional on keeping lab-grade records of treatments and results, so that quack treatments would get empirical testing with informed volunteers.
We can all agree however, that whatever the result the FDA will look bad no matter the outcome.
The middle road of course. That the idiot came up with a treatment that doesn't really do anything except the complications of having a big freaking needle shoved in a joint. (Which will probably amount to quite a bit of pain, some infection, some bleeding, but mostly just waste alot of the patients' money.)
Did you know 80 to 90% of the moderators on slashdot wouldn't recognize a troll even if one dragged them under a bridge.
They claim to skirt the FDA because they operate solely in state.
The Commerce Clause of the U.S. Constitution serves to ensure that there are no inter-state trade wars (e.g. due to tarrifs at state borders).
However, it has been used broadly within states when an argument can be made that internal commercial activities affect commerce outside the state's borders.
In this case, it could be argued that stem-cell treatment within Colorado affects the markets for prosthetics outside of Colorado and therefore falls within the purvue of the Commerce Clause.
You can read more on the Commerce Clause but the main problem is that the Feds decide what constitutes "commerce". In fact, the Commerce Clause has been use to require sex offender registration outside the states where they were convicted. This is a contentious issue and the circuit courts are split on the matter, leading to a likely ruling by the U.S. Supreme Court (expected in 2010).
In Liberty, Rene
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.
This is first-year constitutional law in law school. Wickard v. Filburn. http://en.wikipedia.org/wiki/Wickard_v._Filburn This is during the Roosevelt administration. Roosevelt is trying to keep supplies of food low so the price stays high enough for farmers to stay in business as opposed to prices dropping until they are all out of business. Filburn grew wheat for his own use to feed his own chickens. The idea was that since Filburn was not buying from the limited supply of wheat allowed, he was depressing prices in interstate commerce. The Supreme Court accepted this argument. This has been the basis of interstate commerce ever since with just a few notable exceptions. (United States v. Lopez for example. Ok, you say, this wheat and chickens things is silly. But what about a meal at a lunch counter? Guess what. Civil Rights laws depend on this expansive notion of Interstate Commerce. This is not a small or trivial issue. The doctor will not win it.
So... awesome.
At times, the FDA... must go... (bleep) themselves.
If this had been done with embryonic stem cells, I have little doubt they’d have prominently featured this in the headline. But since it was an adult stem cell treatment, this pertinent fact is not considered worthy of mention in the headline, or even the summary.
And then there are the typical responses about how the evil Republicans were trying to prevent these treatments just to save a few embryos, which of course are completely irrelevant because no embryos are involved in these treatments and Republicans, to my knowledge, are not opposed to research in adult stem cell treatments.
In fact, the whole situation here was that the typically slow-moving FDA just hasn’t decided whether the treatments are safe yet.
Alexander Peter Kristopeit bought his basement from his mommy for one dollar.
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.
A company rushing a new treatment to make quicker money. Or an malfunctioning government agency that often resembles a whorehouse ?
But what about a meal at a lunch counter? Guess what. Civil Rights laws depend on this expansive notion of Interstate Commerce.
Really? What about the 14th Amendment ("No State shall...deny to any person within its jurisdiction the equal protection of the laws.") ?
(that and I'd hope that most states have their own Civil Rights laws as well by now)
As part of the firearms community, there have been high profile cases dealing with machine guns, food products, and narcotics that have reached the community's radar, so to speak.
There was a guy a while back that made a Sten - a simple but effective submachinegun - in his basement and declared that it was exempt because it nor the materials used to make it ever crossed state lines. If I recall, the case was summarily dismissed after a decision in Raich, which was a similar situation, but with marijuana. Raich, in turn, built on Wickard v. Filburn, which makes my head hurt.
In Wickard, the court ruled that a commodity produced (grain) wholly inside a state, for personal consumption, could be regulated as interstate commerce because if it had not been produced, the consumer would have purchased it in interstate commerce. Raich takes the leap to say that this also applies when the interstate commerce of the product is illegal, as is the case with marijuana.
From a firearm's advocacy POV, this whole thing revolves around clearing out federal restrictions on firearms, such as the National Firearms Act of 1934. We are making progress in this arena today via direct challenge, though - first with DC v Heller, which affirmed the Second Amendment as an individual right, and now in McDonald v. Chicago, where we are seeking incorporation of this right against the states, either under the "privileges and immunities" clause or the "due process" clause of the 14th Amendment. It looks like we're going to get it under "due process", but be denied under "P&I".
Learn about Photography Basics.
1. People need enough good info to make an informed decision, as the previous poster says.
2. Lawyers are going to get in on the act. It doesn't matter what kind of agreement is signed. All the lawyer has to do is show some lack of good information to win.
Aye, there's the rub. You have a bum leg at age 30, sign up, and ten years later it has to be amputated. Turns out there was some vague info out there ten years ago that under certain rare circumstances involving patients with red hair who ate more candied apples than most, the infusion turned cancerous. You have black hair and eat lots of sundaes with caramel, and claim you should have been told of the possible link to too much sugar.
It's no good arguing about personal responsibility. Maybe the doctor should have dumped a hundred research articles in your lap. Maybe you would have said that's too much, just give me the essentials. The lawyers will step in and screw it up because the boundaries are so vague.
Infuriate left and right
Whatever the merits of the legal argument, I can only chuckle at what sort of clients this LAW FIRM is trying to attract by suggesting that Montana is likely to secede from the US on a public document on his web site.
I'm pretty surprised at some of the naive comments on here. Many seem to be completely in the dark about the differences in stem cells and stem cell therapies. Several years ago, there were few visionary doctors and scientists out there willing to stick their necks out. Fortunately, for those of us with serious chronic and terminal diseases, there may be a renewed campaign to allow us to opt for stem cell therapy if we wish. So much research nowadays is to me, nothing but a jobs program or a way for a university to get more money through grants. It has to stop.The FDA has ties to Big Pharma and everyone knows that. The safety cry is getting old when the public is well aware of the Vioxx and now the Avandia boondoggles by the FDA. They are short on funds they claim. I suspect they are also short on science and too influenced by drug companies to be effective any more. It is time to clean house. Other countries are surpassing the U.S. in stem cell clinicals and treatment clinics. We not only lose economically, but we lose as far as being a country that is visionary and caring about its citizens, be they well or sick. I have never seen so many armchair critics who don't give a hoot about those of us that are very ill who believe that stem cell therapy may halt the progression of our disease and heal and regenerate. Dr. Centeno is a respected doctor. I live in Colorado. We are proud of him. I also am co-founder of the Stem Cell Pioneers. This is a patient moderated forum. Dr. Centeno has devoted a great deal of his time to ICMS, an organization that advocates safe stem cell therapy with guidelines and a patient registry that member doctors must agree to. Instead of spending valuable time conjecturing or bashing or keeping your head in the sand, I would invite you to join ICMS and get active. Millions of people are dying in this country. The medications I can get, no longer help with my disease. I have gone offshore to have stem cell therapy and it has saved my life. Others are not able to physically travel to offshore clinics. We need to be able to make the decision to have autologous stem cell therapy with our doctors, not a regulatory agency. Prior to my becoming ill, I probably would not have realized the magnitude of the problem that chronically and terminally ill patients face in this country. To deny us treatment or use scare tactics to convince us we are likely going to get cancer or something else quite dreadful from stem cell therapy is ridiculous. No, the long term (20-30 years down the road) is not known, but if stem cell therapy can reverse my disease that is 20-30 years I would never have in the first place. I'll take my chances thank you. Read the ICMS guidelines for safe stem cell treatment. I think you would agree that this is something that makes far more sense than hit and miss clinical trials that involve billions of dollars and many long years to be completed. Fertility clinics have been operating for years with such guidelines. Why the double standard? I think we all know the answer to that.
Eating less WILL cause weight loss. I always believed this and got the proof when gastric bypass surgery became all the rage. If you reduce the size of a persons stomach so they can't eat as much, or remove part so they can't metabolise as much, they lose weight plain and simple. It's also a fact of physics. Now I'll agree that it can be very challenging to do and in that sense it's not simple - sorry if that's what you meant. But I've heard all the thyroid-this and metabolism-that, and in the end chopping out part of the gut causes weight loss.
Cancer from Your Stem cells they inject? They must have missed the part where they get the stem cells from the patient...like saying a diabetic can get AIDS by re-using his own needles...
My guess is that aging may be the body's inability to keep producing stem cells--as you make less stem cells, you age. Research is good-for everyone. However, I'd like to see data analyzed by third parties before I sign up...
It is really like a miracle for the patients. Now there will be no more misery in this world. http://www.articlesbase.com/health-articles/colopure-cleanse-review-faster-weight-loss-supplement-1961267.html
"and we should all hope that more companies will begin offering this procedure in other states soon." ..and we should all be weary of this kind of language.
and we should all drink the kool-aid.
ôó
Although there are laws against euthanasia, there's a lot of effort being used to propagate war and sustain dangerous industries, even by knowledgeable people.
Statistically, lots of homo-sapiens are dying to totally preventable situations.
So if you legalize volunteering of testing to individuals from poorer nations - there are 1000s of Africans and Asians who will take USD $1000 a month and sign on the dotted line. And it might give them a better life, with dignity and respect. Humans have and will be made guinea pigs in various experiments that you may loathe. Instead of doing it brutally, criminally, if we manage to handle the "humanist" liberals, we can also help save a few more people with documented dignified experiments.
You get enough people to volunteer for Iraq and Afghanistan. An equally large number will surely turn up for risky medical procedures.
This is heroism of another kind and real-life heroes are found in plenty in this world.
. . . about damn time.
I'm pretty sure our patriarchy will decide against the practice of miracle cures. After all... only Jesus was supposed to do this stuff.
For me, the issue is quality vs quantity. Avoiding cancer will increase the quantity of your life (+years), but if you have debilitating injuries that severely limit your motion then you'll probably have a dreased quality of life for the years you have left to you. In the example of knee injuries, they can make you just this side of crippled. The obligatory sedentary life that results brings with it a host of other health concerns so that the increased risk of cancer might be offset by the reduced risk of say, cardiovascular disease.
I think that this clinic is playing russian roulette with the FDA, but I hope these therapies aren't rejected out of hand because of the potential for increased cancer. Cancer will get you eventually assuming nothing else kills you. The sooner we find cures/treatments for all other illnesses, the sooner we can divert all biomedical research into curing cancer. (Yes I realize it's a pipe dream)
Bureaucracy expands to meet the needs of the expanding bureaucracy.-Oscar Wilde
This theory of the FDA's scope smells way too much like the theory of anti-tax nuts that claim Ohio is not a state (Or my favorite version, an anti-tax nut that claimed a paragraph noting the IRS jurisdiction "including U.S. Territories" limited the IRS to those territories.)
I want stem cell research, but this is a bad idea.
Pug
An Invisible Entity of Vast Power whose existence must be taken on faith alone: Liberal Media
I wonder if this really is just about the supposed moral issue that goes along with cell cloning, or if just being the tissue is being created as needed and not as a whole human being cut up, can it still fall under the moral grounds issue of not being acceptable?
Has anyone bothered to show the politicians this point, and how absurd this is now because you can clone cells and then help regenerate tissue, nerves and what not, without cloning the whole individual or even the whole body part...?