The Spine Journal has published a series of articles alleging that side effects of Medtronic's Infuse were downplayed or omitted in scientific articles by researchers with financial ties to the devicemaker.
Medtronic's Infuse is a bioengineered bone growth protein used since 2002. Its label notes male sterility as a possible side effect, but company-sponsored researchers have previously attributed that complication to surgical technique, not the product. The sterility connection was never mentioned in at least four published papers from Medtronic-sponsored physicians. Futhermore, in every large study of the product, and at least one author had received at least $10 million in royalties, consulting or other payments from Medtronic, according to Eugene Carragee, the Spine Journal's editor, as cited by the Times.
"It harms patients to have biased and corrupted research published," five doctors wrote in a joint editorial accompanying the reports. "It harms patients to have unaccountable special interests permeate medical research." And Sohail Mirza, of Dartmouth Hitchcock Medical Center, labels the FDA approval studies for the product "folly."
"I don't think this product should be removed from the market," Forbes quotes Carragee as saying, as some have spines that for various reasons won't heal; therefore, the benefits outweigh the risks. "I do worry that most of the use has been in otherwise healthy people in their middle years who would have healed just fine. And they've been exposed to risk."
The articles could affect Medtronic's finances; the company earned an estimated $900 million from Infuse in its most recent fiscal year, as the NYT notes. Indeed, Omar Ishrak, Medtronic's new CEO, issued a statement in response to the Spine Journal's articles insisting the company has worked to eliminate conflicts of interest and defends the company's data. "Integrity and patient safety are my highest priorities," he adds. "While the Spine Journal articles raise questions about researchers' conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold."
- see the Medtronic statement
- check out the NYT report
- get more from Forbes
ALSO... Medtronic has brought suit against Edwards Lifesciences in two courts for allegedly using technology without permission. The products at issue are Edwards' Embol-X Glide Protection System, Perimount Mitral Valve and Sapien transcatheter valve. Report