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.
-- From "FDA challenges stem-cell clinic" by David Cyranoski, Nature News 8/17/10
The FDA asserted its authority on 6 August, when it requested a federal injunction from the US District Court of the District of Columbia to prevent stem-cell clinic Regenerative Sciences in Broomfield, Colorado, from preparing its treatments. The company isolates, cultures and processes adult stem cells from a patient's bone marrow or synovial fluid. Doctors then inject the cells to treat fractures, torn tendons and other ailments.
In July 2008, the FDA told Regenerative Sciences that its treatments are drugs according to the Federal Food, Drug and Cosmetic Act, and biological products under the Public Health Service Act. But the company did not apply for FDA approval and continued to offer the treatment. Now the agency says that the company is not following good manufacturing practice, and that the treatment's safety and efficacy is unproven.
But Christopher Centeno, Regenerative Sciences' medical director, argues that as the treatment uses a patient's own stem cells, it is a medical procedure akin to in vitro fertilization, and therefore none of the FDA's business.
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From "Obamacare hits! Closes pain-treatment program" by Bob Unruh © 2010 WorldNetDaily 8/16/10
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."
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."
Centano told WND that despite the company's repeated efforts [since 2008] to obtain a resolution in the disagreement, the FDA continually declined to respond – until Obamacare was adopted.
Now the federal agency has moved to "enjoin" the company's operations, and Centano told WND his company will fight.
"I think what we're seeing is a massive federalist move here," he told WND. "I think this represents that [for] Obamacare to work there has to be strict federal control over medicine. . . . The government is trying to get more and more positive control over what your doctor does or doesn't do."
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