The US medical device company Medtronic was “heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants,” who were paid hundreds of millions of dollars by the company through royalties and consulting fees, a US Senate Finance Committee staff investigation has found.1
The committee investigated 13 journal articles related to Medtronic’s product Infuse, a bone growth stimulating protein approved by the US Food and Drug Administration (FDA) in 2002 for use in spinal fusion surgery.2 The protein is used in conjunction with a Medtronic spinal fusion device for treatment of degenerative disc disease in the lower spine.
The protein, a genetically engineered version of bone morphogenetic protein 2 (rh-BMP2), has been used to treat more than 500 000 patients. In Europe it is known as dibotermin alfa and it is marketed under the trade name InductOs.
According to the report, Medtronic employees inserted language into medical journal articles that promoted the product without disclosing to the journals “the company’s significant role in authoring or substantively editing” the manuscripts. The company paid “approximately $210 million dollars (£130m; €163m) to physician authors of Medtronic sponsored studies from November 1996 through December 2010,” the report alleges.
The report also claims that Medtronic employees sought to downplay adverse events associated with the product while emphasising problems with competing procedures...