Washington, DC– Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee member Chuck Grassley (R-Iowa) asked medical device manufacturer Medtronic on Tuesday to produce documents related to its controversial bone growth product Infuse. In a letter sent to Medtronic, the Committee raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially-harmful bone growth. The letter also notes many of these investigators had substantial financial ties to the device manufacturer.
“These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” said Senate Finance Committee Chairman Baucus. “Information is one of the most important tools patients and doctors have when making medical decisions. Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”
“A patient having surgery has to rely on his doctor’s knowing the risks and benefits of a medical device. The doctor in turn has to rely on the medical literature. If the medical literature has been written by those with financial ties to the device maker, the doctor and his patient should know that. A lack of transparency leaves doctors and patients in the dark on something any of us would want to know before surgery. It’s alarming to learn after the fact that articles draw conflicting conclusions about a device’s safety and complications. The lack of disclosure of payments raises questions about the integrity of the conclusions reached, whether integrity was compromised or not,” said senior committee member Grassley.
Click here for Baucus’s and Grassley’s letter to Medtronic.