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Medical Journal Accuses Pfizer of Skewing Test Data


November 13, 2009
Topic: Medical Claims: Dangerous Drugs

A report in the New England Journal of Medicine is expected to show that the drug manufactuer Pzifer, skewed test data to make its test results on Neurontin look more favorable. Neurontin is primarily used to treat epilepsy, and is being marketed by Pfizer for treatment for uses that have not yet been approved. The Journal is reporting that comparisons of internal company documents with published data from 12 clinical trials found inconsistencies between data that made it into the medical journals and findings from the original trials. Discrepancies included reports of positive results from trials that were initially found to be negative, and primary study goals reported as secondary study goals. The internal company documents were obtained as a result of lawsuits filed against Pfizer and a subsidiary for promoting Neurontin, or gabapentin, for "off-label uses",uses which are not approved by the U.S. Food & Drug Administration.

The New England Journal of Medicine reports that of 21 primary study objectives of off-label uses of Neurontin described in original documents:


•1. six weren't included in published reports;

•2. four were reported as secondary goals, according to tomorrow's study in the journal;

•3. For eight of the 12 published trials, the definition of the primary study goal differed between the original and published documents;

•4. Seven of the nine trials published as full-length research articles reported statistically significant results for the study's main goal, and

•5. In more than half of those, the outcome differed between the published account and the original documents.

Pfizer has already paid $430 million in criminal fines and civil penalties in 2004 for urging doctors to prescribe Neurontin for off-label uses.

This report emphasizes how important it is for drug manufacturers to be held accountable for their actions and for the truth of their statements to the FDA and in their research results as doctors are forced to rely on the accuracy of the findings in published literature when deciding which drugs to prescribe for patients.

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