Senators Chuck Grassley (R-IA) and Max Baucus (D-MT) have fired off a letter to newly installed Medtronic CEO Omar Ishrak. The duo is seeking more information about the financial relationships between his company and doctors conducting clinical trials on Infuse, a product designed to spur new bone growth after spinal surgery that can increase the risk of infertility in men.
The letter, which was sent on behalf of the Senate Finance Committee, raises concerns about press reports that doctors conducting clinical trials examining Infuse's safety and effectiveness may have been aware of certain complications caused by the product "but failed to report this in the medical literature." It singles out one of the authors of an early study testing the product who received more than $23 million in royalty payments from Medtronic since 2002, the Star Tribune reports.
"Reports that doctors conducting medical trials while on Medtronic's payroll may have hidden serious side effects for patients are deeply troubling," Senator Baucus said in a statement, as quoted by the New York Times. "We need to do everything we can to ensure companies aren't concealing serious medical complications from patients just to increase profits," he added.
Medtronic spokeswoman Marybeth Thorsgaard said three specific complications listed in the letter--abnormal bone growth, swelling in the neck and throat, and sterility--were all listed as side-effect warnings on the Infuse product label, according to the NYT. The company said that it will respond to the senators' request.
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