A study of nearly 240 patients seemed to show that Prodisc, an artificial spinal disk, worked much better for lower back pain than conventional vertebrae fusing.
But doctors at roughly half of the research centers involved in the study had more than a medical interest in the outcome. They stood to profit financially if the Prodisc succeeded. It is unclear whether or not the disk’s maker fulfilled its legal obligation to inform the FDA of the researchers’ financial interests before it the study results were used to win approval for Prodisc.
What’s more, in the study results submitted to the FDA, an unusually large number of patients were not included. Some of those patients have said they fared poorly, leading critics of the research to argue that Prodisc was cast in an overly flattering light.
The New York Times has called the way Prodisc was tested and approved “a stark example of conflicts of interest among clinical researchers -- conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug.”
* New York Times January 30, 2008