Illegal practices by a Pennsylvania-based company called Synthes have been linked to the deaths of five patients. But according to a story on the affair by Fortune magazine, those practices are common among manufacturers of medical devices.
Four high-ranking executives are doing jail time for their role in “off-label marketing” of a bone cement called Norian XR. That occurs when manufacturers specifically market a product for a use not approved by the U.S. Food and Drug Administration.
Synthes officials allegedly marketed Norian XR for spine surgery, despite being aware that it put patients at risk for fatal blood clots.
According to Fortune: “Off-label marketing is so common among drug and device makers that it’s often dismissed as the equivalent of driving slightly over the speed limit.”
The story notes that pharmaceutical giants such as Merck, Pfizer, Abbott Labs, and GlaxoSmithKline have paid billions in fines to settle charges related to off-label marketing over the past decade. Yet potential profits exceed the fines, so the practice continues.
The Synthes case is particularly egregious, the article says, because patients weren’t informed before their surgery that Norian XR hadn’t been approved for that use, and they were taking part in an unauthorized clinical trial. In effect, the patients were serving as unwitting human guinea pigs.
See the story here:
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