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The makers of the blood thinner Pradaxa indicate that the clinical trial data used to obtain FDA approval for the controversial anticoagulant failed to include nearly two dozen reports of major bleeding events.
In a press release issued last week, Boehringer Ingelheim announced that it discovered the bleeding incidents during a review of the RE-LY study data, which was used as the basis to establish that Pradaxa is safe and effective for the prevention of strokes among patients with atrial fibrillation.
The additional serious bleeding incidents on Pradaxa were identified during the re-evaluation. However, the drug maker maintains that the cases identified do not change RE-LY’s conclusions.
The revelation comes as Boehringer Ingelheim continue to face thousands of Pradaxa bleeding lawsuits filed on behalf of individuals throughout the country who allege that the drug maker failed to provide adequate warnings about the risk of uncontrollable hemorrhages and the lack of a reversal agent for the relatively new blood thinner.
Earlier this month, the FDA also announced that a review of the safety of the drug concluded that there is a higher risk of gastrointestinal bleeding on Pradaxa when compared to warfarin, which has been the standard go-to drug for atrial fibrillation stroke prevention for decades. However, the agency also found that Pradaxa appeared to lower the risk of stroke and had about the same mortality rate, and did not recommend any changes to the label warnings.
RE-LY was an 18,000-patient study that pitted Pradaxa against warfarin, which is more commonly known by the brand name Coumadin. The clinical trial was conducted by researchers at the Population Health Research Institute in Hamilton, Ohio, comparing the safety and efficacy profile of the drugs when used to prevent strokes in atrial fibrillation patients.
Boehringer Ingelheim indicated that it recently conducted its own, targeted review of RE-LY after learning about one previously uncategorized major bleeding event during the Pradaxa litigation.
At least 22 previously uncategorized bleeding incidents were identified during the re-evaluation of the data, including five involved patients taking a 110 mg Pradaxa dose, 11 among those who took a 150 mg dose of Pradaxa and six for patients who took warfarin.
A number of allegations have been raised questioning the accuracy of the RE-LY clinical trial. The RE-LY trial was published in September 2009, and has already been amended once before.
In November 2010, the researchers issued a correction, admitting they had left out some bleeding events and other complications that had been overlooked. As many as 81 complications affecting 80 patients, including bleeding events, blood clots, heart attacks and at least one stroke, were found to have been omitted even before the recent revelation by Boehringer Ingelheim.
The results of RE-LY were questioned yet again in October 2011, by researchers from the University of British Columbia, who wrote a letter to Therapeutics Initiative, warning that the RE-LY was fundamentally flawed. They concluded that Pradaxa was prematurely approved and that it is unsafe to use for many patients. The researchers also determined that an independent audit of the RE-LY clinical trials needs to be done to look at irregularities in the conduct, bias and RE-LY’s findings.
Researchers are not the only ones who have found questionable conduct linked to Pradaxa. Boehringer Ingelheim has been hit with sanctions at least two times by the federal judge presiding over all Pradaxa lawsuits, finding that the drug maker has acted in bad faith during discovery proceedings.
In December 2013, U.S. District Court Judge David R. Herndon fined the company $1 million for failing to preserve numerous files related to Pradaxa’s research and marketing. Despite knowing that it faced legal action over Pradaxa, the judge found that the company destroyed or failed to preserve files of a high-ranking scientist and other employees, among other violations of discovery rules. The judge said that excuses given by the company during the litigation strained credulity.
Judge Herndon also sanctioned the company again in March, ordering Boehringer Ingelheim to pay for plaintiffs’ attorneys from the U.S. to go to Europe to depose Boehringer Ingelheim employees. The company is based in Germany.
In the federal court system, more than 2,300 Pradaxa cases are centralized before Judge Herndon in the Southern District of Illinois as part of an MDL, or Multidistrict Litigation. The coordinated proceedings are designed to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
As part of the coordinated proceedings, a series of cases are being prepared for early trial dates in the Pradaxa MDL, known as “bellwether” lawsuits. The first of four bellwether trials are set to go before a jury in September 2014, with the last case expected to begin in March 2015.
While the outcomes of these bellwether trials are not binding on other cases, they are designed to help the parties gauge the relative strengths and weaknesses of their cases and may lead to Pradaxa settlement agreements that would avoid the need for hundreds of individual trials to be scheduled throughout the country.