DANGEROUS MEDICAL DEVICES AND DOCTORS

Lawyers who practice in the field of dangerous medical devices and drugs are never surprised to discover relationships between physicians and pharmaceutical and medical device companies. Recently, questionable ties between supposedly objective researchers and the maker of an artificial spinal disk have come to light. An artificial spinal disk is a device that is used in place of conventional surgery during which patients’ vertebrae are fused.
In a study of nearly 240 patients with lower back pain, physicians reported that the artificial spine disk, manufactured by Prodisc, had worked much better than conventional fusion surgeries. A well-known spine specialist and one of the study’s researchers said in a 2006 news release that “as a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily.”
Discovery in a lawsuit against the manufacturer has disclosed that the surgeon had a large financial interest in the outcome of the study. So did other doctors at about half of the 17 research centers involved in the study. Federal law requires that manufacturers inform the Food and Drug Administration of researchers’ financial interest in a product or drug before the study is used to seek approval of a device. It is unclear whether the disk’s manufacturer made this information available to the FDA.
In the study results submitted to the FDA , an unusually large number of patients were not included. Some of those patients had very poor results. As a result, some doctors are very critical of the research stating that the study may have overstated the value of Prodisc. They point out that clinical researchers with financial conflicts have incentives to overstate the value of a new product.
Dr. Richard A. Deyo, a Professor at Oregon Health and Science University, summed up the matter in this way, “The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing. More people are more interested in getting on the gravy train than on stopping the gravy train.”