Saturday, June 16, 2012

Pradaxa Litigation: The Research Studies and Safety of the Drug



The RE-LY Study

Continuing from Part One of the Pradaxa Lawsuit articles, we continue with the discussion held by attorneys who are interested in Pradaxa litigation and the issues they found to be of primary importance. Discussed at length was the RE-LY study Boehringer Ingelheim used in order to receive FDA approval. RE-LY stands for Randomized Evaluation of Long Term Anticoagulation Therapy and was aimed at evaluating the efficacy and safety of Pradaxa capsules in 18,000 sufferers of atrial fibrillation. Study results showed that 182 Pradaxa users who were taking the 110 mg. dosage of suffered a stroke while 134 patients taking the 150 mg. dosage suffered a stroke.

Heart Attacks in Pradaxa Users

Both groups of Pradaxa users experienced higher rates of heart attacks than those on Warfarin. The safety concerns noted as a result of the RE-LY study were excess dyspepsia, heart attack, a higher accumulation of the drug in those with kidney or liver dysfunction and a higher rate of major GI bleeds. Based on this single study, Boehringer claimed their drug offered a 35% reduction of stroke when compared with Warfarin, however they neglected to mention that there was also as much as a 50% increase in GI bleeds.

In other words, the drug is more effective yet also more dangerous. The Australian government believed the efficacy outweighed the risks however more and more scientists and physicians are now questioning those efficacy claims. There are numerous reasons to believe that Warfarin is, in fact, overall the better drug for most patients. One attorney at the seminar noted that it was his belief the Pradaxa litigation would live or die based on the RE-LY study.

Is the RE-LY Study Flawed?

The belief of many is that the RE-LY study, in addition to being only one study, suffered under inherent flaws. It is difficult to understand how the drug was approved based on a single study which overall does not equate to a real-life setting. The data and integrity of the study have been called into question, and before the FDA would approve Pradaxa based on the RE-LY study they required that it be re-analyzed twice. Further, eighteen out of the twenty authors of the RE-LY publication were found to have financial conflicts regarding the study, meaning they were paid by Boehringer Ingelheim.

There is a huge difference between independent studies and studies which are funded by the company manufacturing the drug. The RE-LY study was neither a double-blind study nor was it placebo-designed which again raises serious questions about the reliability of the study. It is further believed that the manufacturers of Pradaxa targeted a much broader population than was appropriate, therefore the risk of adverse events was also much higher. Further, the 75 mg. dosage, although often prescribed, was not even a part of the RE-LY study which studied only 110 mg. and 150 mg. The third installment of the Pradaxa Litigation articles will discuss venue and the inadequacies of the Pradaxa labeling.
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