Author Topic: According to the FDA, Your Stem Cells Are Now Drugs  (Read 1118 times)

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Online Pandora

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According to the FDA, Your Stem Cells Are Now Drugs
« on: February 03, 2012, 08:05:31 AM »
Quote
In recent court filings, the Food and Drug Administration has asserted that stem cells—you know, the ones our bodies produce naturally—are in fact drugs and subject to its regulatory oversight. So does that make me a controlled substance?

The bizarre controversy revolves around the FDA's attempt to regulate the Centeno-Schultz Clinic in Colorado that performs a nonsurgical stem-cell therapy called Regenexx-C. It is designed to treat moderate to severe joint, tendon, ligament, and bone pain using only adult stem cells. Doctors draw your blood, spin it through a centrifuge, extract the stem cells and re-inject them into your damaged joints. It uses no other drugs. No drugs means no FDA oversight and that does not sit well with the administration.

The FDA has since argued that a) stem cells are drugs and b) they fall under FDA regulation because the clinic is engaging in interstate commerce. That's right, a process performed at the clinic using the patient's own bodily fluids constitutes interstate commerce because, according to the administration, out-of-state patients using Regenexx-C would "depress the market for out-of-state drugs that are approved by FDA."

Funny, that sounds less like the FDA protecting the health of the country's citizens and more like the FDA defending its enforcement turf. The two parties have been at odds for over four years now, so we may have a while until we know if every American has in fact become a regulatable good subject to government regulation. [ANH-USA via Slash Gear]

http://gizmodo.com/5881492/according-to-the-fda-your-stem-cells-are-now-drugs

H/T Instapundit
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Offline Libertas

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #1 on: February 03, 2012, 08:11:00 AM »
They want us to be nothing better than Soylent Green.

I want them to be nothing better than decomposing matter.
We are now where The Founders were when they faced despotism.

Offline Glock32

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #2 on: February 03, 2012, 10:59:18 AM »
There has been no part of the Constitution more abused or deliberately misapplied than the Commerce Clause.
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Offline IronDioPriest

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #3 on: February 03, 2012, 11:06:49 AM »
If the court can rule that substances from your own body are drugs to be regulated, it can rule that even your own body is not your personal property.

Funny (not), how "privacy" is a term of subjective convenience for the state.
"A strict observance of the written laws is doubtless one of the high duties of a good citizen, but it is not the highest. The laws of necessity, of self-preservation, of saving our country when in danger, are of higher obligation. To lose our country by a scrupulous adherence to written law, would be to lose the law itself, with life, liberty, property and all those who are enjoying them with us; thus absurdly sacrificing the end to the means."

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charlesoakwood

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #4 on: February 03, 2012, 11:33:00 AM »

The human body is a veritable pharmacopia they may choose license us, quantify us,
or given that we are just tissue, break us down into basic elements and distribute us.

Offline Libertas

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #5 on: February 03, 2012, 11:35:11 AM »
"break us down into basic elements and distribute us"

See, back to Soylent Green!

 ::speechless::
We are now where The Founders were when they faced despotism.

Offline LadyVirginia

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Re: According to the FDA, Your Stem Cells Are Now Drugs
« Reply #6 on: February 03, 2012, 12:19:48 PM »
There has been no part of the Constitution more abused or deliberately misapplied than the Commerce Clause.


sooo true

unfortunately
"And for the support of this Declaration, with a firm reliance on the protection of divine Providence, we mutually pledge to each other our Lives, our Fortunes and our sacred Honor."