Studies Backing a Popular Bone Growth Product Called into Question

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In an unusual tactic, The Spine Journal has dedicated its June issue to a series of papers that carefully reject previous research supporting the use of Infuse, a controversial, but popular bone growth product commonly used in spinal fusion surgeries.

Infuse is used in a quarter of the estimated 432,000 spinal fusions performed in the U.S. each year, the New York Times reports, but in the new papers in The Spine Journal experts assert that the data backing Infuse’s widespread use were published by researchers who received large sums of money from its maker, Medtronic, and who pumped up the product’s benefits while concealing its risks.

It is highly unusual for researchers to publicly renounce the work of others. The Times’ Barry Meier and Duff Wilson report:

In one article released Tuesday, experts said those reports played down Infuse’s risks and slanted them to favor Infuse’s performance over a bone graft, the material traditionally used in a fusion. Those experts estimated that the incidence of adverse events in connection with Infuse’s use ranged from 10 to 50 percent, depending on how it was used.

Those side effects, they said, include male sterility, infection, bone loss and unwanted bone growth. A stronger version of Infuse, called Amplify, was recently rejected for approval by the FDA because of concerns about possible cancer risks.

In the past year, Medtronic has made $900 million from Infuse. The median amount of money paid out by Medtronic over time to researchers involved in some of the previous studies ranged from $12 million to $16 million, according to The Spine Journal — and most of that money went to a few people.

“The history of [Infuse] research is a cautionary tale for all medical professionals, researchers and patients,” said Dr. Christopher M. Bono of Brigham and Women’s Hospital in Boston and acting editor-in-chief of the June issue of The Spine Journal. “As this matter demonstrates, the spine care field is currently at a precarious intersection of professionalism, morality and public safety.”

Medtronic’s CEO, Omar Ishrak, noted that the Spine Journal articles did not question the data that the company originally submitted to the FDA for approval of Infuse in 2002.

Click here to read the entire New York Times story.