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Bone-fusion protein raises questions about doctors’ financial stakes

Journal Sentinel, August 30, 2010

In January 2002, a group of Food and Drug Administration advisers met on whether to approve a powerful new biological agent that promised to revolutionize back surgery.

The product was like nothing the burgeoning field of spinal fusion surgery had seen before. If used properly, it essentially turned whatever it touched into bone. This was a good thing if it could be confined to the tiny space between vertebrae, but potentially calamitous if it leaked out.

One of the FDA advisers at the meeting raised a concern about nine of the doctors whose research on the product had been submitted to the FDA: The doctorsall had a financial stake in the product, and their test results with it were nearly twice as good as the doctors who did not have a financial interest.

The concern by the FDA advisory panel member was laughed off with a joke, according to a transcript of the hearing, and the panel ultimately deferred to Medtronic, a company that stood to get billions in sales as the maker of the product known as Infuse.

What has happened since is no laughing matter.