Wednesday, August 18, 2010

Obamacare Pain & Suffering

Got knee pain? Too bad. Suffer. The government will direct your health care, even if it costs more, takes longer to recover and is more painful.The FDA has struck again, this time announcing an injunction against using a patients own stem cells to regenerate growth of healthy tissue in knee's and hip's.

Obamacare has landed in Denver, where doctors at a pain-management clinic have been told they must stop treating patients with a successful process that extracts their own adult stem cells, cultivates them and then reinjects them to stimulate growth in damaged limbs.

The word of the dispute comes from Dr. Christopher Centeno of the Centeno Schultz clinic, whose Regenexx, or Regenerative Sciences Inc., has been successfully treating patients with the process for several years.

Centeno confirms his work provides a much less costly and significantly more convenient alternative to knee or hip joint replacement surgeries, which sometimes require a year or more of recuperation.

Let's see.

Less costly, faster recuperation. What can possibly be the downside? 

Wait, I know. The government knows best about your health care decisions.

The agency (FDA), in a 2008 letter to the company, said, "In order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product's intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations. … The mesenchymal stem cells utilized in your Regenexx™ procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in FDA seeking relief as provided by law."

So this is not new, but has been going on for 2 years. Why the urgency now?

Centeno told WND that despite the company's repeated efforts to obtain a resolution in the disagreement, the FDA continually declined to respond – until Obamacare was adopted.

Probably just a coincidence . . .

until now, medicine has been provided by doctors and regulated at the state level.

"That's not going to work under Obamacare," he said. "The government is trying to get more and more positive control over what your doctor does or doesn't do."

Welcome to the future of health care. 

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