Why Is Medtronic's Infuse Bone Graft Product Still Available - When Recent Clinical Studies Say It Lacks Benefits and Is Possibly Harmful?Jul 2, 2013
It is a mystery that Medtronic’s Infuse bone graft products have not yet been pulled from the market, considering the results of two independent clinical studies overseen by Yale University and commissioned by Medtronic itself. These studies offer strong evidence that Infuse not only does not work better than a traditional bone graft, but that it also seems to raise the risk of cancer, among other medical problems.
Published in mid-June in the medical journal Annals of Internal Medicine, the studies offer several key findings, namely that there is little difference between using Infuse and a traditional bone graft. In addition, there is a small, increased risk of developing cancer, and with men, retrograde ejaculation, a cause of male infertility.
Dr. Harlan M. Krumholz, the Yale professor who oversaw the clinical trials, noted that the findings of the two teams, though slightly varied in some minor areas, were basically in agreement. “The general, overall picture is that they failed to find a big benefit” for Infuse, Dr. Krumholz told the New York Times. “And they found there might be some harms.”
Medtronic approached Yale University researchers after The Spine Journal dedicated every page of its June 2011 issue to criticizing the medical device maker and its bone graft product, Infuse. In addition, Bloomberg Businessweek reported around that time that the U.S. Senate Finance Committee had found problems with most of the initial Medtronic-supported Infuse research used to promote the product. The article noted that doctors and researchers who authored at least 11 medical journal reports about Infuse were paid about $210 million in royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to Infuse side effects, as well as to promote off-label use.
Medtronic specifically agreed to two independent reviews of its trial data. The reviews were part of Yale University’s Open Data Access project, which Dr. Krumholz has been overseeing. The study was split into two teams of researchers, one from Oregon Health & Science University in Portland, and the other from Britain's University of York.
The Oregon team found that the Medtronic product worked no better than bone harvested from a patient's own body; the traditional way.
The Oregon review also found that Infuse was associated with an increased risk of cancer after two years, noting that the risk did not involve one particular type of cancer over another. This group also revealed that the initial published trial data had emphasized the positive and underreported any side effects.
The University of York researchers also found that after two years, Infuse was associated with a possible increased risk of cancer.