The Senate Finance Committee is investigating whether spinal surgeons with financial ties to medical device maker Medtronic Inc. failed to disclose complications linked to one of the company’s products even though they were aware of the problems.
As The Wall Street Journal reports, the Senate probe apparently was triggered partly by an upcoming medical journal study. Sources told the Journal that the journal study shows that a dozen research papers sponsored by Medtronic omitted mention of numerous complications that occurred during clinical trials of a Medtronic bone-growth protein, Infuse Bone Graft, between 2000 and 2009.
Those papers, which ostensibly were intended to determine Infuse’s safety and effectiveness, were written by surgeons at hospitals and universities across the country collectively paid tens of millions of dollars by Medtronic over the past decade in consulting fees or royalties.
Sen. Max Baucus, the Montanta Democrat who is chairman of the Senate Finance Committee, and Iowa Sen. Charles E. Grassley, the ranking Republican on the committee, have demanded from Medtronic, among other documents, a detailed account of the payments made to the surgeons. Recently Medtronic began disclosing on its website its payments to surgeons, but only those made in 2010 and the first quarter of 2011.
Medtronic issued a statement that it provides the Food and Drug Administration with data about adverse events that occur during clinical trials of its products “irrespective of any financial relationship between the company and the clinical investigator or study author.”
Infuse was approved by the FDA in 2002 for use in surgery that involves fusing vertebrae in the lower spine. The product does away with the need to use bone from patients’ hips to help vertebrae fuse.
The product, however, has become widely used on an off-label basis–meaning uses not officially approved by the FDA, but also not prohibited—in other types of spinal surgeries. And the growth in the off-label use was fostered, in part, by the research papers now at issue in the Senate investigation.
More recently, however, worrisome side effects have come to light. In 2008, the FDA issued a safety alert about the use of Infuse in the neck after receiving dozens of reports of serious complications.
In addition, Dr. Eugene Carragee, a professor of orthopedic surgery at Stanford University, recently published a study in The Spine Journal suggesting that Infuse can cause sterility in men when used in a particular type of spinal fusion surgery. That complication wasn’t reported in the original clinical trial about the use of Infuse in that surgery. Carragee wasn’t involved in the original trial.
As MedPage Today reports, Medtronic already has been under investigation by the Department of Justice for possibly marketing the drug illegally.
Infuse generates about $900 million in annual revenues for Medtronic, which had $15.9 billion in sales and $3.1 billion in profit last year.
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