Facing intensifying scrutiny over one of its bone growth products, Medtronic announced Wednesday that it was giving a $2.5 million grant to Yale to oversee a complete review of the study data that examined the product’s safety and effectiveness.
In June, a medical journal charged that researchers sponsored by Medtronic had generated misleading studies about the product, called Infuse, that overstated its benefits and asserted that it did not pose risks.
Infuse is a bioengineered material used primarily in spinal fusions, a procedure in which vertebrae are joined to reduce back pain. Industry analysts have speculated that sales of Infuse have dropped since the periodical, The Spine Journal, published its special issue on the product.
Experts said that Medtronic’s action was the first time that a medical device maker would turn over the underlying and detailed patient data from company-sponsored studies to independent experts so that they could review it and draw their own conclusions.
Typically, companies release only summaries of that information, a practice that can hamstring the ability of experts to examine it.
Infuse has been used in about a quarter of the estimated 432,000 spinal fusions performed in the United States each year.
When The Spine Journal special issue first appeared, the company announced that it would respond to the publication’s assertions by conducting a review of all Infuse-related study information.
Under the plan announced Friday, Yale will use the $2.5 million provided by Medtronic to assemble of panel of outside experts, who will then commission two academically recognized research organizations to review the company’s study data.
Dr. Harlan Krumholz, a cardiologist at Yale, who will oversee the effort, said that Medtronic’s decision was groundbreaking because it would allow independent researchers to assess the underlying data supporting a product’s safety and effectiveness.
“Published data is often missing critical information,” Dr. Krumholz said.
Dr. Eugene Carragee, editor of The Spine Journal, said he was pleased that Medtronic officials had decided to release the data.
The plan will give access to the study data to other researchers along with the groups Yale retains.
Dr. Carragee, a professor at Stanford, said that he remained concerned that little study data exists for one major use of Infuse, a type of spinal fusion, because a study of that application was halted early when patients suffered complications.
Still, he added Medtronic’s decision was “a big step in the right direction”.
Side effects associated with Infuse include infection, bone loss, unwanted bone growth and male sterility.
A stronger version of Infuse called Amplify, was recently rejected for approval by the Food and Drug because of concerns about possible cancer risks.
Along with the recent issue of The Spine Journal, the Justice Department is conducting a criminal investigation of Medtronic’s marketing of the product and a Senate committee is also conducting an inquiry.
Medtronic has not been accused of any wrongdoing, and researchers who conducted research on Infuse have defended their findings.
Article source: http://feeds.nytimes.com/click.phdo?i=f7b810f5e9af8de32eaa623e943d352e
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