Boehringer Ingelheim, the manufacturer of the popular blood thinning agent Pradaxa, has been embroiled in litigation over the blood thinner for years. Recently filed discover documents have revealed that the company made an internal effort to cover up the potentially life threatening dangers associated with its product and the need for additional testing of those that had been administered the drug.
The emails expose that the company had an internal dialogue where employees expressed concerns about the aggregating effect of Pradaxa in a patients blood and the need to continue monitoring a patient’s levels to try and prevent cardiac trauma or fatal bleeding.
At the time, the company was pushing its drug toward regulatory approval and worried the publication of a new study would complicate the talks and cast aspersion on Pradaxa.
Boehringer chose to pursue revising the paper rather than being honest about the risks with its drug.
“The world is crying for this information — but the tricky part is that we have to tailor the messages smart,” said employee Andreas Clemens, a medical team leader with the company that worked on the drug.
The need for testing was of key importance to the marketability of Pradaxa. The drug that Pradaxa aimed to replace in the market, warfarin, does not require strict monitoring to ensure that patients blood levels are safe. If Pradaxa required testing and continued monitoring, this would have been a major disadvantage to promoting Pradaxa as an alternative to warfarin.
Warfarin’s effects, however, can be counteracted with an increase of vitamin K. Pradaxa, dabigatran etexilate, does not have an antidote. The lack of a counteracting agent for Pradaxa puts patients taking the drug at a significant risk for hemorrhaging, should they have too much of the drug in their blood.
An international project manager for the company wrote that the publication of the study would “undermine our efforts to compete” and that she could not believe the company would publish such a study after having spent a decade developing such a drug.