FDA To Regulate Your OWN Stem Cells...

[Bionic]

... To protect the bottom line of pharmaceutical sales. :banghead:

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:

Stem cells are drugs and therefore fall within their jurisdiction.(The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.

This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.

Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).

The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body.

The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.

However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.

Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.

The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.

Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.

Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”

 

[Pitbullmike007]

Honestly, what steps would the American public have to do to jus do away with the FDA ? They do absolutely nothing for us yet impose so man laws to keep us unhealthy

 

[johnjuanb1]

We lose more and more freedom with each passing day. The fed govt now believes it owns our bodies. This disgusts and enrages me!

 

[Pitbullmike007]

U ever see "the end game" documentary on YouTube ,, makes u mad yet depressed bout the truth to what is actually happening in our country an in others ,, an they get away with it ,, it starts off slow but really shows the history of some of these programs an sections of gov originate from ..

 

[TheTank]

At least they haven't yet built a containment wall to keep all US citizens from defecting abroad. Most Americans are so indebt that their debt and their job are the containment wall.

 

[raw33man]

imagine what the government would do if guns were illegal...

they are afraid of people going nuts and start riots with guns, otherwise they would have fucked us already

doing it slowly but surely and quietly

 

[teebagginwagon]

Dam Tank I had to laugh about the debt remark but thats the sad truth. Dam liberals are destroying this country! Now they are going to tell me what I can do with my own body!! This is enough people have to put their foot down!

 

[teebagginwagon]

This brings me to the no refusal every day in San Antonio. Where if we get pulled over for DWI we have no choice to give a breath sample and if we refuse they take are blood! This is unconstitutional and a problem! Government at the sate and Federal levels are getting to cocky and are constantly overstepping their boundaries.

 

[sodzl]

This brings me to the no refusal every day in San Antonio. Where if we get pulled over for DWI we have no choice to give a breath sample and if we refuse they take are blood! This is unconstitutional and a problem! Government at the sate and Federal levels are getting to cocky and are constantly overstepping their boundaries.

Here's a thought. Don't drink and drive.

 

[Hmmm]

The FDA is such bullshit, they are supposed to be here to protect us from the pharmaceutical companies, not vice versa.

 

[Ataraxia]

ughhhhhhh disgusting!!

 

[maldorf]

Its shit like this that will probably force me someday to go overseas and get stem cell treatments for my heart. I just hope the stem cells will do good even though my heart attack occured so long ago. I dont see things changing in our country, and in fact I think I can see things in this respect getting worse depending on who is in congress and the White House.

 

[Mr.Bungle]

Here's a thought. Don't drink and drive.

I think the problem is, just because you are accused of DWI does not mean you are DWI. So just cause one cop says your under the influence they can hold you down and stick a needle in your arm. Just an example that relates to the OP about how the government is taking jurisdiction over our own bodies. Scary shit in my opinion. But I'm with you, don't drink and drive.

 

[Mr.Bungle]

Dam Tank I had to laugh about the debt remark but thats the sad truth. Dam liberals are destroying this country! Now they are going to tell me what I can do with my own body!! This is enough people have to put their foot down!

I don't think it's got anything to do with liberals or conservative, democrats or republicans, this country has two classes, the ruling class and the working class.

 

[Ehren]

So...I have two big testicles overflowing with Testosterone (a drug)...can they be confiscated? Seems so.

There IS precedent...and all similar procedures show that the FDA clearly has no jusridiction:

*Hair transplants are just hair removed from one site on YOUR body and replaced to another site.

*Skin grafts (for burn victims) are taken from one site on YOUR body and replaced to another site.

*Lipo-injection (for wrinkles) is fat taken from one site on YOUR body and replaced into another.

This Stem cell replacement is EXACTLY the same thing. Even more importantly, the three above could be perceived as cosmetic procedures. Whereas the stem cell treatment has zero cosmetic benefit and is clearly a medical procedure.

 

[Bionic]

Don't give them any ideas! Next thing you know, they'll be regulating wet vaginas because they make men maintain erections better than Viagra!

 

[Bio]

Honestly, what steps would the American public have to do to jus do away with the FDA ? They do absolutely nothing for us yet impose so man laws to keep us unhealthy

You can't! These agencies are run/influenced by the big dollars coming from lobbyists for the Pharmaceutical Industry...It is around to protect them...Not us!! It's not liberal or conservative thing. This country is corporation...USA Inc!! The big money and the lobbyists that represent them will always get there way, whether we know about it or not!!