Observers are raising tough challenges to a newly-released spinal disk study that suggests an artificial spinal disk, Prodisc, works better to improve patient functioning than conventional spinal-fusion surgery. Critics say that the fact that many physicians involved had a financial interest in the study's outcome makes this conclusion questionable. They also point to the fact that in study results submitted to the FDA, an unusually large number of patient results were not included, and some of those patients didn't do well.
The way the study was structured, doctors at about half of the 17 research centers involved in the study stood to make money if the Prodisc became a commercial success, according to information from a patient lawsuit which was settled last year. Surgeons interviewed by The New York Times contend that the financial potential of Prodisc had no impact on their research, and note that their findings were published in peer-reviewed medical journals. However, according to the Times, it's not clear whether the disk's maker, Synthes, met its legal obligation to let the FDA know about the researchers' financial interest before the agency approved the disk.
To find out more about this issue:
- read this article in The New York Times
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