August 16, 2010
By Bob Unruh
WorldNetDaily
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 Centano of the Centano Schultz clinic, whose Regenexx, or Regenerative Sciences Inc., has been successfully treating patients with the process for several years.
Centano 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.
But the Food and Drug Administration, in the wake of the adoption of President Obama's plan to nationalize health-care decision making, has ordered the company to halt, because the federal agency views the process as making "drugs."
The FDA announced Aug. 6 that it wanted an injunction in federal court against the company, alleging "violations of current good manufacturing practice."
"Regenerative Sciences' cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication," the federal agency announced.
Karen Midthun, acting director for the FDA's Center for Biologics Evaluation and Research, said in the announcement, "FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public's health at risk."
An FDA spokeswoman provided the announcement to WND but did not elaborate.
Full story HERE
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