U.S. Senate Report Finds “Violation Of Patient’s Trust”

When a medical journal posts an article about a medical procedure or device, many people assume that the conclusions are reached in an unbiased way. According to a U.S. Senate report, Medtronic may have played a role in influencing such journal articles with regards to the controversial bone growth product known as Infuse. The product, used in spine surgeries, has been the subject of numerous lawsuits and is currently being reviewed to determine its safety and effectiveness.

The report suggested that Medtronic worked to shape the articles concerning Infuse. It called into question the research that was done by doctors who received compensation from Medtronic in the form of royalties and consulting fees. Furthermore, the report pointed out that Medtronic did not disclose the relationship with the doctors who wrote the articles.

At the heart of the controversy are the side effects that some research has tied to Infuse. The journal pieces submitted by researchers connected to Medtronic did not report the dangerous side effects. Later research done by the FDA and physicians who did not receive compensation from Medtronic linked Infuse to a significantly higher number of complications: 10 to 50 times more complications, including cancer, infection and excessive bone growth.

The Senate committee recommended that the editors of medical journals, as well as the drug and medical device makers, themselves, create a disclosure policy that would tell patients about payments received by researchers in producing the articles. Some patients might still be misled, but they would at least know when an article was being produced with the financial backing of a product’s manufacturer.

Source: Star Tribune, “Medtronic’s pull influenced Infuse articles, report finds,” by James Walsh, 25 October 2012