Get the word out - FDA assertions that our stem cells are drugs going viral

[barbara]

As many of you know, Dr. Centeno decided a few years ago to fight the uphill battle with the FDA over whether they have the authority to regulate our body parts (stem cells) as drugs. In his case, the judge recently slapped them with an “Order to Show Cause” where she asked the obvious question-since congress only gave you authority to consider chemicals=drugs, how do you get to cells=drugs? Their response (more info here http://www.regenexx.com/2012/02/fda-your-body-is-a-drug-and-we-want-to-regulate-it/) was that since cells produce chemicals, and they have the right to regulate chemicals as drugs, then cells=drugs.

The ridiculousness of this assertion has now hit the media and is going viral. It is on the first page of Digg this morning: http://digg.com/newsbar/topnews/according_to_the_fda_your_stem_cells_are_now_drugs . Since this is an important issue the public needs to know about, let’s buzz this up further on social media. That means log in (or create an account) in Digg (you can log-in with your facebook info) and give it a thumbs up. Alternatively you can “Like it” on facebook or whatever other social media/news sharing sites you use. CC this e-mail to as many friends as you can to get them involved. Here are the original links to some of the best stories:

http://gizmodo.com/5881492/according-to-the-fda-your-stem-cells-are-now-drugs
http://www.slashgear.com/fda-says-your-body-is-a-drug-and-subject-to-govt-regulation-01211697/

[barbara]

Here's the article on Digg. It's easy to connect to Digg. You can then Like the article. You can also connect to Twitter, Facebook and other social media sites through Digg.


FDA
BY ANDREW TARANTOLA FEB 1, 2012 10:20 PM 20,086

According to the FDA, Your Stem Cells Are Now Drugs
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]

Image via the AP