Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa, was concerned that releasing the results of an internal research paper on the drug would damage drug sales, records recently made public show. The company was so worried about the results of the study that some employees pressured the author to revise it, and the company recommended it be thrown out, according to a recent report by the New York Times.
Records recently made public by a federal judge in Illinois presiding over thousands of lawsuits against the maker of Pradaxa, including emails, internal memos, and presentations, centered on the research project and whether it would be damaging to Pradaxa’s main selling point: that users of the drug aren’t required to undergo regular blood work while taking Pradaxa.
Pradaxa (dabigatran) was approved in 2010 as an alternative to an existing anti-clotting drug, warfarin. Both are anticoagulants used to prevent and treat blood clots and reduce the risk of stroke, but Boehringer Ingelheim marketed its drug as less of a nuisance than warfarin, which requires frequent blood tests and careful monitoring.
Unfortunately, Pradaxa has been linked to more than 1,000 deaths in the United States. Since 2010, an unprecedented number of adverse events related to the drug have been reported to the FDA. Experts have also questioned the reliability of an FDA study affirming the safety of Pradaxa.
Pradaxa has claimed superiority to warfarin. However, documents prepared by the FDA clearly state that “It is important… not to provide dabigatran with a superiority claim to warfarin, because it would imply that even those well-treated with warfarin should be switched to dabigatran. Clearly, that is not the case.”
Furthermore, a research paper written by Paul. A. Reilly, a clinical program director with Boehringer Ingelheim indicates that patients could benefit from having their blood monitored while taking Pradaxa. Reilly states that some patients absorb too little of the drug, rendering it ineffective, while some absorb so much that their risk for bleeding increases.
According to the New York Times, after Reilly’s paper was circulated within the company, Dr. Jutta Heinrich-Nols, a company supervisor, sent an email stating that she couldn’t believe the company was planning to publish Reilly’s work. She warned that publishing his results could make it “extremely difficult” for the company to maintain its claims that patients taking Pradaxa do not need regular blood tests.
Heinrich-Nols also noted that Reilly’s research could “undermine” the company’s efforts to compete with other new anticoagulants like Xarelto and Eliquis. The marketing of Pradaxa is yet another example of the dangers that consumers face when safety information is regulated by pharmaceutical companies primarily concerned with profit.
Boehringer Ingelheim issued a statement saying that the recently-released documents “represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry and in the research and development of any important medication such as Pradaxa.”
Unlike warfarin, Pradaxa has no antidote to reverse its blood-thinning effects. Despite issues with the FDA’s approach to approving the drug, as well as numerous patient bleeding deaths and adverse event reports, Pradaxa remains on the market as a safe drug.