Documents made public in the thousands of product liability lawsuits filed by patients and their families in a federal court in Illinois say the drug’s manufacturer failed to warn about the dangers of Pradaxa because of a fear the information would hurt sales.
New research shows that when using Pradaxa, regular blood monitoring may help to keep you safer.
The document in question is an internal research paper done for the German drugmaker Boehringer Ingelheim. In the paper, company researcher Paul A. Reilly concluded some patients using Pradaxa might benefit from regular blood monitoring. This raised concerns from employees inside the company because the main selling point of Pradaxa, which differentiates it from competitor Coumadin (warfarin), is that frequent and careful monitoring is not necessary.
Warfarin users must monitor the amount of drug in their bloodstream regularly and that is considered the downside and a nuisance. The nuisance opened the door to not only Pradaxa but heated up the competition with the other two new blood thinners on the market, Xarelto and Eliquis.
Reilly felt some patients did not absorb the drug adequately at a level needed to prevent stroke. Another group of patients was at a risk for bleeding because they absorbed too much of the drug. Pradaxa, like Xarelto and Eliquis, has no antidote to stop uncontrolled bleeding unlike Coumadin. Only monitoring the drug levels in the blood would tell if the levels were just right to minimize the risk of stroke while balancing the drug’s risks.
Dr. Reilly’s draft paper was seen by employees and the marketing department wondered whether it was in the company’s interest to make the findings public. Some wanted the story to just go away while others tried to revise the conclusion, sort of “tailor the message,” as one senior executive said in an email, reports the New York Times.
Since its approval in 2010, Pradaxa has brought Boehringer more than $2 billion in sales in the U.S. and no one wants to rock the money boat. It’s also brought more than 1,000 deaths from uncontrolled bleeding.
Dr. Reilly’s stood by his paper saying that he felt the fact some patients would benefit needed to be made clear. The Journal of the American College of Cardiology published his paper this month, although information about the range of drug level considered optimal appears to be missing from the article.
When the potential for such a conflict exists, should Boehringer be serving as its own editor?