Doctors Skirt FDA To Heal Patients With Stem Cells 394
Posted
by
kdawson
from the self-supplied dept.
from the self-supplied dept.
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."
Re:How great (Score:5, Informative)
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.
Good luck with that (Score:5, Informative)
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 [wikipedia.org] 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.
Re:Misleading Summary (Score:3, Informative)
Re:alternative treatment (Score:3, Informative)
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 ...
RTFA noob. They've published a paper detailing the outcomes of 227 patients.
Abstract [benthamdirect.org] and the Article [benthamdirect.org] (PDF)
"Serial MRI's at 3 months, 6 months, 1 year and 2 years failed to demonstrate any tumor formation at the re-implant sites."
Daring? Really? (Score:5, Informative)
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 [wikipedia.org] 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.
Re:It's a shame... (Score:5, Informative)
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.
Re:Not surprising (Score:5, Informative)
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.
Re:Guns and weed, too. How big is this trend? (Score:3, Informative)
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 [wikipedia.org], 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.
Re:cancer worries (Score:4, Informative)
Re:cancer worries (Score:3, Informative)
Repeat after me: "You do not need excercise to lose weight". Calories in Calories out. Being bedridden might reduce calories out to 1200 or so, but you can always eat less. It might not be enjoyable, but if the choice is being hungry every day for 6 months or being bedridden for the rest of my life, I for one would rather be hungry.
Re:How great (Score:5, Informative)
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.
Re:Not to be the bad guy but... (Score:5, Informative)
As someone who has made stuff regulated by the FDA, I can shed a little light on what they regulate.
The first rule of thumb is that doctors can do any medical treatment. There are rules and customs that limit doctors on what they do, but legally once they are a doctor, they can do pretty much anything. So in theory, a podiatrist could do brain surgery (if he could find a patient dumb enough, a hospital dumb enough, staff dumb enough, etc). States tend to have enough rules to prevent it, but they aren't as rigid as you might imagine. And it does mean that doctors can prescribe pretty much any chemical legally available, and some that aren't
The second rule of thumb is that the FDA regulates drugs and devices, not treatments or surgery. Some people argue that autologous cell transplants are surgery maybe with a few drugs tossed into the mix. You're just moving stuff around and using drugs.
The third rule of thumb is that the FDA focuses on medical claims. You've heard the term "off label use?" It means that the product is approved for market, and cannot be marketed as useful for anything but what it was approved for, but doctors can use it for something else. Botox used to be sold that way. Even mentioning off label use by a company is a big no-no.
So what you have here is a doctor, who can do pretty much what he wants, and may not even subject to the FDA. But if his company is making marketing claims, the FDA might still go after him (presumably he is an officer of the company, which makes him subject to criminal arrest by the FDA. Unlike ISO, FDA agents carry badges and can slap cuffs on you)
Re:How great (Score:3, Informative)
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.
Re:cancer worries (Score:3, Informative)
It isn't just as simple as that, see http://www.youtube.com/watch?v=AVvZP2av5Mk [youtube.com]
Re:No Surgery Required? (Score:3, Informative)
hence this doctor's flaunting of FDA regs
The word is flouting [google.com], FYI.
Bad Logic (Score:3, Informative)
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.
Re:Good luck with that (Score:1, Informative)
Let me guess... You are not a lawyer.
The case you cited did indeed happen. However, you left out a VERY important word.
"
man growing and consuming excess wheat entirely on his own property is covered by the Interstate Commerce Clause..."
Roscoe was growing and selling wheat on the open market, and then claimed that only the excess was used for him. See the difference?
Re:cancer worries (Score:4, Informative)
All you have shown is that even with all the safety procedures, sometimes something may get through.
Of course, the actual risk of Vioxx is still debated.
Rofecoxib was tested. No the testing is perfect. Congratulation, you have shown that medicine is hard.
The risk of heart attack from Vioxx is no greater then ibprophen.
No one has shown any scientific evidence of anyone dying from it. Court awards were not around evidence, but around pity.
evidence
It's a problem of litigation. One that had prevented a helpful drug from being on the market.
Re:Not surprising (Score:4, Informative)
Re:No Surgery Required? (Score:4, Informative)
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.