Letter to FDA on Serious Problems With INRatio Measuring Device Used in ROCKET AF Anticoagulant Trial
December 10, 2015
Public Citizen urges the FDA to investigate the possible impact of inaccurate measurements, by a device called INRatio, on subjects’ anticoagulation during the ROCKET AF trial, which sought to compare the standard anticoagulant warfarin with the newer drug rivaroxiban (Xarelto). Public Citizen has found 1,445 injury and almost 10,000 FDA malfunction reports connected with this device , raising serious questions about the validity of the study’s findings. FDA Commissioner nominee Dr. Robert Califf co-chaired the steering committee advising Johnson and Johnson on the study and should thus recuse himself from any investigation.