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J. Martin Carroll, former CEO of Boehringer Ingelheim.
The manufacturer of a blood-thinning drug tried to hide results of an internal study that the manufacturer feared would hurt sales of the widely-advertised medication, according to recently-unsealed court documents.
, manufacturer of Pradaxa, is being sued by patients and their families, charging it failed to properly warn users about possible dangers of the drug. More than 1,000 of those using Pradaxa have died from bleeding, Katie Thomas of The New York Times
Some of the papers released by Chief Judge David R. Herndon of the United States District Court in East St. Louis, Ill., indicated that a research paper would contradict the company's claims that regular blood monitoring is not necessary while taking Pradaxa.
The lack of regular monitoring is one of the main selling points of the drug over warfarin, a drug long used in the prevention of blood clots and strokes. Warfarin requires frequent blood monitoring and attention to diet.
Boehringer Ingelheim emails released by the court show concern about the effect a change in recommended monitoring would have on sales of Pradaxa. "This may not be a onetime test and could result in a more complex message (regular monitoring), and a weaker value proposition ... vs. competitors," one employee wrote.
An email from another employee expressed concern about the drug's safety risks in older patients, and said "there may be a role" for one or two blood tests in Pradaxa patients.
The case highlights the fact that much of the research on drugs is performed by the drug makers themselves, who have a financial interest in ensuring their products are approved by regulators.