Independent review finds “no intentional bias” in Medtronic Spine BMP studies |

Independent review finds “no intentional bias” in Medtronic Spine BMP studies

Kern Singh - CopySTUDY: NO INTENTIONAL BIAS IN MEDTRONIC BMP STUDIES (Orthopedics This Week)

Study Finds NO Intentional Medtronic BMP Bias

His national database work was nominated for “Best Clinical Paper” at NASS. Kern Singh, M.D. an orthopedic surgeon with Midwest Orthopaedics at Rush who says that he has NO involvement with Medtronic, has found no intentional bias on the part of the company or in the studies it sponsored. Dr. Singh tells OTW,

“My colleagues and I used Medicare data, as well as a hospital database registry to look at trends in BMP from 2000-2011. This work, published recently in Spine, revealed a dramatic increase in the utilization of off-label BMP in back and neck surgeries. It was clear that after the FDA warning letter of 2008 there was a downward trend in the use of BMP in the cervical spine. Due to litigation concerns we are seeing a downturn in all uses of BMP because doctors are afraid that they would be sued for using it despite its effectiveness.”

“Then we decided to look at cost. Oddly, we saw an increase in the cost of BMP to hospitals from 2002 to 2011…even though the pricing of BMP had not changed. We had assumed that it would be viewed as a commodity with time, i.e., it would experience a valuation decrease, but that was not the case. Then we examined things from a different perspective. We conducted a systematic review of all BMP papers as related to spine from all possible angles—front, side, lateral—and did an analysis and categorization of the papers. We looked to see if the study was sponsored by Medtronic, if the surgeon was paid by Medtronic, and compared it to the date from non-conflicted studies.”

“To our surprise, we found that the complication rates were similar whether or not there was a conflict of interest. Essentially, from the published papers we did not find any intentional bias in the reporting of complications whether the surgeon had Medtronic relationships or not. This is contrary to the subtle innuendos that have been implied.’”

“The bottom line is that Medtronic probably did not do as good a job of elucidating potential complications. Some of this may have been due to the FDA limitations of a company discussing off-label applications. At this point, unfortunately, this debate has developed into more of a personal attack as opposed to a scientific debate. And we can’t ignore this question: ‘Why, as BMP has become more of a commodity, has the price not decreased?’ From a neutral and unbiased perspective no one party is damned, but all of these things happening in concert has resulted in this negative situation.”

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