The investigation comprised two parts. The first showed how the manufacturers of a blockbuster anticoagulant stroke drug withheld from the regulators important analyses regarding how to use the drug as safely and effectively as possible. It found that Boehringer Ingelheim, the maker of Pradaxa, has failed to share with regulators information about the potential benefits of monitoring the drug and adjusting the dose to make sure it is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent. The second revealed how the company failed to calculate the number of major and fatal bleeds (the major harms of anticoagulation) in people who had participated in a key clinical trial accurately. The reduced number of bleeds compared to the much older anticoagulant, Coumadin, had been a key component of their marketing campaigns. It concluded that even today there are doubts whether all events have been properly accounted for.
