In 2011 The Spine Journal took on the morass of hyped scientific papers, multi-million dollar payments to researchers and adverse effects surrounding Medtronic’s Infuse product. As I posted in August 2011
Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.93 billion for the fiscal year that ended April 29. Medtronic’s Infuse product is a bioengineered bone-growth protein that has been used in spinal fusion procedures for the past nine years and is used in about half of the 80,000 anterior lumbar fusion procedures performed every year in the United States.
Now the NY Times reports that
The controversy reached a climax in 2011, when a medical publication, The Spine Journal, devoted an issue to reports that repudiated the Medtronic-sponsored research, calling it misleading and biased. The journal’s move was significant because it is published by the nation’s biggest group of spine surgeons, the North American Spine Society.
Experts involved in research, like Dr. Zdeblick and Dr. Burkus, defended their work and insisted that their ties to Medtronic had not influenced them. But facing a firestorm, Medtronic agreed in 2011 to provide $2.5 million to Yale University to oversee an independent review of study data.
The resulting examinations, published Monday, involved reviews by two separate teams.
One of the teams, headed by scientists at Oregon Health and Science University in Portland, reported that Infuse appeared to have no advantages over a bone graft and might pose patient risks, including possibly a small added risk of cancer.
The other team, led by researchers at the University of York in England, found that Infuse fused spinal vertebrae more quickly than a bone graft but that the added speed appeared to lack clinical relevance.
Both the British and Oregon teams found no significant difference between Infuse and a bone graft in measures critical to patients, like reducing pain or improving physical function.
……
A professor at Yale who oversaw the review, Dr. Harlan M. Krumholz, said that while the two teams had slightly different findings, they pointed in the same direction.
“The general, overall picture is that they failed to find a big benefit,” for Infuse, Dr. Krumholz said. “And they found there might be some harms.”
Doctors and patients, he said, could use the review’s information to decide which treatment was best for them.
Some reviewers also concluded that the Medtronic-financed research had — unwittingly or not — presented a misleading picture.
“Selective reporting or underreporting of outcomes in journal publications may have misrepresented the benefits and harms,” of Infuse, the Oregon group wrote.
The selective reporting or under-reporting or non-reporting of scientific research to suit the commercial interests of the pharmaceutical and medical industries is not likely to disappear anytime soon. And Infuse is still in use and still generates significant revenues for Medtronic.
The review’s results, however, are likely to lead to further drops in Infuse sales. Annual sales of the product, which stood at about $900 million before The Spine Journal’s issue devoted to it, were $528 million in the company’s most recent fiscal year.”
Tags: Infuse, Medtronic, Spine Journal
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