Boehringer Ingleheim, the manufacturer of Pradaxa, a controversial blood thinner, is being accused of trying to hide internal study results over fears the information might hamper sales.
Boehringer staff allegedly sought to have the study’s author revise or suppress the study, according to recently unsealed legal documents, The New York Times reported.
Federal Illinois Chief Judge David R. Herndon of the United States District Court in East St. Louis is overseeing thousands of lawsuits filed by Pradaxa patients and their families. Lawsuits involve allegations that Boehringer did not sufficiently warn about Pradaxa’s risks.
Pradaxa received U.S. Food and Drug Administration (FDA) approval in 2010, bringing in over $2 billion in sales in the United States to Boehringer, according to research firm, IMS Health. Since its approval, some 850,000 patients have been prescribed Pradaxa, which has been tied to more than 1,000 deaths, the Times reports.
Chief Judge Herndon recently made a number of emails, memoranda, and internal presentations public. The documents involved discussions at Boehringer about the research paper and if its findings would challenge a key Pradaxa selling point—that taking Pradaxa does not require patients to undergo regular blood work to ensure efficacy, The Times reported.
For some five decades, the anticoagulant, Coumadin (warfarin), has been used to treat patients diagnosed with atrial fibrillation (AF), a heartbeat irregularity, and is also prescribed to treat people at increased risks for developing potentially fatal blood clots. Pradaxa is prescribed to reduce stroke and blood clot risks in those patients who are diagnosed with non-valvular AF, and also inhibits thrombin which, according to News-Medical, is the central coagulation activator in the body’s blood clotting system.
Both drugs may cause internal bleeding; however, antidotes are readily available for warfarin bleeds. Pradaxa bleeding lawsuits allege that the drug caused serious, uncontrollable bleeding side effects, including GI bleeding and cerebral hemorrhaging, for which there is no reversal or reversal agent.
The just-released documents reveal that concern was raised at Boehringer when the research paper, written by Paul A. Reilly, a clinical program director at Boehringer, was found to indicate that patients might fare better with blood monitoring during Pradaxa treatment, The Times reported. The paper also indicated that some patients absorb insufficient levels of Pradaxa to prevent stroke, while others absorb so much that they face increased bleeding risks.
In an email written by Dr. Jutta Heinrich-Nols, of Boehringer, she indicated that she could not believe the firm would allow research negating 10 years worth of work to be published. Should the research be published, she wrote, that would make it “extremely difficult” for Boehringer to defend its position. She also wrote that, the research, if released, would “undermine” Boehringer’s efforts to compete with similar drugs. “I would like to ask you to check again whether this is really wanted,” she wrote, according to Times.
Dr. Andreas Clemens of Boehringer wrote, “Maybe I am phobic, but I am not happy with the conclusion.” In another email, he wrote that, “The world is crying for this information—but the tricky part is that we have to tailor the messages smart,” according to the Times. Dr. Reilly defended his conclusions and a version of the paper—with no details on optimal patient blood-level ranges—appears in the current Journal of the American College of Cardiology.
In related news, Boehringer was recently charged with a nearly $1 million fine for withholding or failing to preserve files that were being sought in Pradaxa litigation, according to the judge’s ruling. The “countless” files were requested by patients who brought lawsuits over Pradaxa, Bloomberg News recently reported. Judge Herndon concluded that Boehringer executives acted “in bad faith” by neglecting to ensure that the documents and files, which involved the development and marketing of Pradaxa, were preserved. “The wrongs here are egregious,” Judge Herndon said in the ruling. “The gross inadequacy” of the company’s efforts to protect the documents warranted a sanction of more than $931,000, the judge added, according to Bloomberg News.