On May 16 2006, Centers for Medicare and Medicaid Services (CMS) denied Medicare coverage for Charité Artificial Spinal Discs in patients 60 years or older.
The Wall Street Journal reported that there was a lack of evidence to indicate that surgery to implant the device was "reasonable and necessary", not to mention the cost: Charité comes with a price tag of about $11,500 and up to $50,000 to implant.
Charité sales were brisk in 2004; Merrill Lynch reported Johnson & Johnson's sales at $41 million in 2005, but predicts a decrease to $21 million this year, even though about 3,000 surgeons were trained at Johnson & Johnson's (J&J) training center in Cincinnati to learn the implantation procedure since its approval by the Food and Drug Administration (FDA) in October 2004.
J&J are no doubt disappointed but the decision should come as no surprise: the two year trial used to gain FDA approval did not provide data on how it would perform long-term, i.e., over the next few decades or more -- the artificial disc's life expectancy. How could a device that is expected to remain in the spine indefinitely be approved based on a two-year trial? Did J&J, along with the FDA, consider the possibility that the device could become displaced or cause other problems down the road?
As well, the trials compared Charité with a form of spinal fusion no longer considered mainstream and they were designed to show that the device was equivalent, not an improvement. In its attempt to push the device through the FDA's approval process, Johnson & Johnson compared Charité discs with Bagby and Kuslich, or BAK, cages used in spinal fusions. But Charles Rosen, a university-based spine surgeon, saw an immediate flaw with the study design. "The stand-alone BAK is a failed operation; it hasn't been done in years," said Rosen, "So they picked the worst possible operation to compare these things to."
More importantly, the FDA did not find enough evidence that Charité and other spinal disks leave patients with substantially more range of motion over time and that they do less damage to neighboring discs. The trial only showed that 57% of patients who had the Charité disc surgery met modest success measures.
Furthermore, Johnson & Johnson did not consider pain relief as a measure of the success of Charité in the trial.
Rosen says he found that the devices have regularly failed in Europe, leaving patients with life-threatening complications. He says he finds it "unbelievable" that the Food and Drug Administration ever approved the devices.
Already, complaints are pouring in from U.S. patients with degenerative disc disease who chose to have a Johnson & Johnson's Charité spinal disc implanted. At best, many are experiencing no improvement in pain levels compared to before the operation and have little or no improvement in their motion abilities. Some patients are finding that their pain has increased and at worst, some have had to undergo life-threatening revision surgeries.
Johnson & Johnson, what were you thinking of besides profits? As for the FDA, how could it have approved this device after knowing it caused frequent life-threatening revision surgeries?
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No Medicaid for Charité Artificial Spinal Disc
|. By Jane Mundy|
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