

In a study of nearly 240 patients with low back pain, doctors said that the artificial spinal disc surgery procedure had worked much better than conventional surgery in which patients’ vertebrae were fused.
But wait. The manufacturer of the artificial disc, Prodisc, paid for the study and many of the doctors who participated. Doctors at about half of the 17 research centers involved in the study stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.
The study raises important ethical considerations. Should doctors who participate in the study stand to profit off of the product? Many say no. The way the Prodisc was tested and approved shows how conflicts of interest can raise doubts about the results of a particular study. Many doctors see no problem and will deny that their financial interests played any part in the outcome. But many experts say that instead of serving as objective gatekeepers who can screen out potentially harmful or ineffective new devices or drugs, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients.
The NY Times report on this subject can be found here.
In my experience representing back surgery patients, the procedure known as fusion is more common than artificial disk replacement. That is where the disc is removed and the two vertebrae (above and below the removed disk) are fused together using either bone harvested from the hip or by instrumentation. I think the jury is still out on whether artificial disk replacement will be the preferred procedure. However, I have represented clients who have gone forward with the disc replacement who report very positive results.
Christopher M. Davis
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