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Spine Surgery Complications with BMP-2 Leads Medical Journals to Change Policies

Information about the efficacy of new drugs and medical devices is shared by medical doctors through professional journals, of which there are many. These journals carry articles that report the results of research studies. What many of the articles fail to report, however, is how much the doctors who conducted the studies were paid by the drug company or device manufacturer. And yet that information can be critical assessing the credibility of the research.

Case in point is the back surgery product BMP-2 (bone morphogenetic protein). Originally touted as a biotech breakthrough that would lead to 100 percent success rates for spinal surgery, serious complications were only known later. The research published by a number of prominent surgeons failed to disclose the complications that could result. Only over time did it become known that cancer, infections, sterility and overgrowth of bone were possible side-effects.

Reporters at the Milwaukee Journal-Sentinel discovered that, as a group, the doctors who researched and published papers about BMP-2 had received tens of millions of dollars in royalties from the manufacturer, Medtronic. Rarely was this financial conflict disclosed in the journal articles they published.

Often when pharmaceutical companies and medical manufacturers fund research into their product, the company not only collects the data and does the analysis, it may even choose which journals the study is published in and when. For example, in 2008, Schering-Plough may have delayed telling the public that research showed its cholesterol drug, Vytorin, provided no benefit in reducing plaque.

A number of medical journals are now requiring authors to disclose more information about research methods, study funding and other financial relationships, which is then published with the study. Because of BMP-2, 18 orthopedic journals institute a new conflict-of-interest disclosure form for its authors. In June, the Journal of Bone and Joint Surgery published an entire issue devoted to exposing BMP-2 and the financial conflicts of the doctors who promoted it.

Reforms are sorely needed to protect patients from defective medical devices and dangerous drugs. Making the financial conflicts of interest visible is certainly one step in the right direction.

Source: Milwaukee Journal-Sentinel, "Fallout from back surgery product case prompting reforms," by John Fauber, December 29, 2012.

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