Pradaxa Maker Sought to Revise, Suppress Controversial, Internal Research

pradaxa-maker-suppress-researchThe maker of the controversial blood thinner, Pradaxa, was apparently worried that release of an internal study might impact sales.

Boehringer Ingleheim employees allegedly pressured the study’s author to revise or suppress the study, according to recently unsealed legal documents, The New York Times reports. The federal Illinois judge overseeing thousands of lawsuits filed by Pradaxa patients and their families just made the documents public. 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 and brought in more than $2 billion in sales in the United States to Boehringer, according to research firm, IMS Health. Since its approval, Pradaxa has been prescribed to about 850,000 patients and has been associated with more than 1,000 deaths, the Times reports.

Chief Judge David R. Herndon of the United States District Court in East St. Louis released emails, memoranda, and internal presentations that involved discussions at Boehringer about whether or not the emerging research paper would challenge one of Pradaxa’s key selling points—that taking the drug does not require patients to undergo regular blood work to ensure its efficacy, according to The Times.

For about 50 years, the anticoagulant, Coumadin (warfarin), has been used in patients who are diagnosed with atrial fibrillation (AF), which is an irregularity of the heartbeat, and is also prescribed to people who are at an increased risk for developing potentially fatal blood clots. Pradaxa is prescribed to reduce stroke and blood clots risks in patients diagnosed with non-valvular AF. Pradaxa inhibits thrombin, which, according to News-Medical, is the central coagulation activator in the body’s blood clotting system.

While both drugs may cause internal bleeding, antidotes are readily available for warfarin bleeds. Mounting Pradaxa bleeding lawsuits allege the drug caused serious, uncontrollable bleeding side effects, including GI bleeding and cerebral hemorrhaging, for which no possible reversal or reversal agent exists.

Not all patients, particularly older patients, metabolize Pradaxa in the same way. There are also fewer dosing options available for Pradaxa and there are no monitoring tests available for the drug in the U.S.

Documents reveal that concern was raised within Boehringer when the research paper, written by Paul A. Reilly, a clinical program director at Boehringer, was found to reveal that some patients might benefit from blood monitoring during Pradaxa treatment, The Times reports. The paper indicates that some patients absorb insufficient Pradaxa levels 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 publish research negating 10 years of work indicating that Pradaxa patients do not need regular testing. Should the research be published, she wrote, that would make it “extremely difficult” for Boehringer to defend its position. She added that, the research, should it be released, would “undermine” the company’s efforts to compete with similar drugs being released. “I would like to ask you to check again whether this is really wanted,” wrote, according to Times.

Dr. Andreas Clemens, also of Boehringer, questioned potential legal repercussions should the paper be released. “Maybe I am phobic, but I am not happy with the conclusion,” he wrote. “The world is crying for this information—but the tricky part is that we have to tailor the messages smart,” Dr. Clemens wrote in a separate email. Dr. Reilly defended his conclusions and a version of the paper—without information 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 sought in Pradaxa litigation, according to the judge’s ruling. The “countless” files were sought 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.

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