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-SD. 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-SD would “depress the market for out-of-state drugs that are approved by FDA”.
Funny, that sounds less like the FDA protecting the health and safety of US citizens and more like the FDA protecting its drug 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]
Nathan
Thursday, February 2, 2012 at 10:13 PMControl for controls sake.
bdc
Friday, February 3, 2012 at 1:05 AMWhat would be cool is if you would actually do an article about the Regenexx instead of leaving it as a simple 1 line explanation.
Not ragging on this article, it is informative still, I just hadn’t heard of this and it sounds very interesting (and I will search anyway, just not now as its 1am : D ).
But I imagine others would find some larger more investigative articles into cool new medical advances quite interesting.
Terrie Mulligan
Friday, February 3, 2012 at 5:43 AMAccording to the US Constitution, every American Citizen is entitled to “DUE PROCESS”…People should be able to make those medical decisions for themselves WITHOUT the interference of FDA. Even if a person chooses to accept donor cells, it should still be THEIR decision. FDA has way too much control over certain things, and this is one of them. My husband has ALS. There WAS a Stem Cell Therapy available, which DOES work. FDA now has a cap on it because of the exact reason in this article. They believe if you put in mor than you take out, it becomes a drug, just so FDA can control it. Who the hell pays their salaries, anyway? If my husband can put his life on the line VOLUNTARILY to defend his country, and has the right to risk his life donating an organ to save some elses life, why is he not allowed to take the risk of receiving stem cells for his OWN benefit? It can’t hurt, it can only help him. TCAcellulartherapy.com is an outstanding Stem Cell Therapy Research Company. What I don’t understand is why there is so little research/therapy/treatments and lack of knowledge about ALS and why their is not more support from our Government for research. ALS patients don’t have 5 years to wait for FDA to approve an answer. The answer is HERE! And it is simply..Adult Stem Cell Therapy..
Daniel
Saturday, February 4, 2012 at 12:16 AMYour Government is going to control your farts if you yanks don’t start doing something about it for God’s sake.