Staff report on Medtronic's influence on INFUSE clinical studies

摘要

Background: On June 21, 2011, the US Senate Finance Committee staff initiated an inquiry into whether Medtronic, Inc improperly influenced peer-reviewed studies of Medtronic's bone-growth product InFuse, also known as bone morphogenetic protein 2 (BMP-2). Methods: In response to the June 21, 2011 request by Chairman Baucus and Senator Grassley, Medtronic produced more than 5000 documents pertaining to 13 studies sponsored by Medtronic where there was absolutely no reporting of adverse events associated with InFuse. Committee staff conducted a review of the documents submitted by Medtronic and other materials. Findings: Staff found that Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants; that Medtronic paid a total of approximately $210 million to physician authors; and that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse; among other findings. Conclusion: The Committee's investigation discovered troubling evidence that Medtronic officials influenced the content of articles in peer-reviewed scientific publications to present InFuse in the best possible light. In order to address the problem of biased research in medical literature, drug and device manufacturers and journal editors need to implement stringent disclosure policies that detail industry funding to physician authors. Medical journals should critically examine past studies that may exhibit industry bias that harms patients and misleads physicians. A company employee involved in the drafting of a scientific article should be listed as an author.