Senator Franken Presses Medtronic and FDA for Clarity in Infuse StudyApr 14, 2016
An article published by the Star Tribune has caused United States Senator Al Franken to inquire further about details involving the Medtronic bone graft device known as Infuse. In a letter to Medtronic CEO Dr. Omar Ishrak and U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, Senator Franken expressed his concern about Medtronic's failure to report thousands of complications to the FDA for five years.
The Senator 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 poses the question of the agency's possible "insufficient vigilance in its industry watchdog role."
Medtronic studied 3,647 Infuse patients from 2006 to 2008 but shut down the study early and failed to report over 1,000 "adverse events" to the FDA within 30 days of learning the information as required by law. Medtronic claimed that employees had misfiled the information, whereupon Senator Franken questioned the adequacy of training of Medtronic's staff and asked what steps were being taken to rectify the situation.
In February 2014, the FDA posted a three-sentence summary of 1,039 other adverse events, but did not make the number public, calling it a "corporate trade secret" the Star Tribune reports.
The director of the Consumers Union Safe Patient Project, Lisa Giffert said that, "timely detailed, and public reporting of patient complications is critical."
Franken wrote, "The Star Tribune article suggest that we need a strong commitment from the FDA, companies, and Congress to revamp medical device surveillance in this country with a focus on improving patient safety."