Spine Experts Criticize Medtronic Studies as being Biased

 

In a recent issue of The Spine Journal, a group of spine specialists criticized the research of other medical experts who have supported the use of the Medronic bone growth product Infuse. The reports in The Spine Journal claim that the research on Infuse is misleading and biased. It marks the first time a medical journal has devoted an entire issue to repudiating the questionable research of colleagues.

Medtronic is one of the largest medical device manufacturers in the country. In recent years, the company has faced growing criticism over their promotion of Infuse, which is used in spinal fusion procedures. Currently, the product is used in about 25% of all spinal fusion surgeries performed annually across the United States. According to the articles published in The Spine Journal, researchers receiving large financial contributions from Medtronic overstated Infuse’s benefits while ignoring the risks associated with the product.

Side effects associated with Infuse include:

  • Male sterility
  • Infection
  • Bone loss
  • Unwanted bone growth

According to experts published in The Spine Journal, the incidence of adverse events associated with the use of Infuse ranged from 10-50%, depending on how the product was used. Yet, many earlier studies published by researchers with financial ties to Medtronic chose to ignore these risks while even recommending the dangerous product over alternative procedures such as a bone graft. In contrast, the editor of The Spine Journal stated that while Infuse was a good alternative for patients who do not qualify for bone grafts, it should not be the primary option in all cases.

The Spine Journal estimates that researchers involved in earlier studies of Infuse received on average between $12-16 million over an extended period of time.

In light of the high incidence of injuries caused by defective medical devices throughout the country, it seems that information regarding financial conflicts of interest should be mandatory when researchers release studies in support of a new medical product. Failure to do so represents a gross disregard for the safety of patients using these devices.