Medtronic, FDA Asked by Senator Franken for Details of Infuse Study

In letters to Medtronic CEO Dr. Omar Ishrak and U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, Senator Al Franken expressed his concern over a report published recently in the Star Tribune. The report centered on Medtronic’s bone graft device, called Infuse, and a study that was conducted from 2006 to 2008. The study involving 3,647 patients was shut down after two years, but the company failed to report more than 1,000 “adverse events” until five years later.

The Senator from Minnesota said that this “lack of information potentially skewed the risk profile of the device, which may have affected the treatment of thousands of patients.” Sen. Franken is a member of the Senate Health, Education, Labor and Pensions Committee, which oversees the FDA. He questioned the agency’s possible “insufficient vigilance in its industry watchdog role,” the Star Tribune reports.

The FDA posted a three-sentence summary of 1,039 other adverse events in February 2014. The agency did not publicize the number calling it a “corporate trade secret.”

Lisa Giffert, the director of the Consumers Union Safe Patient Project said that, “timely detailed, and public reporting of patient complications is critical. People depend on these oversight systems like the FDA to protect them. There is a lot of trust from the public that companies are responsible, that doctors are responsible, that this would not happen in our system,” reports the Star Tribune.

Senator Franken responded to Medtronic’s claim that the Infuse study reports were misfiled by employees and wanted to know what steps the company has taken to ensure that the staff going forward would be adequately trained. He also said, “Patients deserve a system that works” and asked both Ishrak and Califf to provide “the range of injuries” in the data, as well as the “severity” of the adverse events and how they “related to Infuse.”