Infuse Plagued by “Dirty” Money

Medtronic, Inc., the maker of Infuse, a product used in surgery for synthetic bone growth, has hired researchers at Yale University to review data on its product. The researchers will receive a reported $2.5 million to conduct two different reviews of Infuse.

These reviews come after an article published in The Spine Journal claims that doctors reviewing Infuse, and being paid by Medtronic, failed to report serious complications from the product. The U.S. Senate is investigating the allegations, while the U.S. Justice Department is currently conducting a criminal investigation into Medtronic's marketing of Infuse. Nearly a quarter of the estimated 432,000 spinal fusions that occur in the United States each year use Infuse.

So far, Infuse has generated sales of $750 million this year alone. However, analysts expect that this news about the product's potential risks will curtail sales made in the remainder of the year. Complications associated with Infuse include cancer, infection, bone loss, unwanted bone growth, and male sterility.

The Spine Journal is published by the North American Spine Society. In the article written on Infuse, experts in the practice attacked the previous research, saying it was biased and misleading because it grossly underestimated the risks associated with the product. According to the article, an estimated $62 million were given to 15 surgeons who were charged with reporting the drug's effects over a 10 year period.

Incidents like this raise questions about the accuracy of findings from industry-funded studies. Dr. Harlan Krumholz, a cardiologist at Yale who will be heading up the studies for Medtronic, says "[t]he money has got to come from industry because no one else is going to step up. So how do you create a model that is fair to the company and that also serves the public?"

Although this may be true, consumers are still left to wonder whether the Yale researchers' priorities lie with the consumers or with Medtronic.