An investigation by The BMJ finds that companies were aware of concerns about a faulty device in a regulatory trial and reveals data that suggests participants were put at unnecessary risk. Deborah Cohen reports
A drug manufacturer knew about problems with a blood testing device but did not share data before the crucial approval process, an investigation by The BMJ has found.
Janssen, the pharmaceutical arm of Johnson and Johnson, withheld data from the Food and Drug Administration about problems with the INRatio device, which was used in the phase III trial (ROCKET AF) of the blockbuster anticoagulant.
