Report indicates trial data on off-label uses of Neurontin may have been manipulated.

Bloomberg News (11/12, Tirrell) reports, "Researchers say trials of Pfizer Inc.'s Neurontin [gabapentin] epilepsy treatment for uses that were not yet approved may have been skewed to emphasize favorable results." A report appearing in the New England Journal of Medicine states that "comparisons of internal company documents with published data...found inconsistencies between data that made it into the medical journals and findings from the original trials." Among the discrepancies are "reports of positive results from trials that were initially found to be negative, and primary study goals reported as secondary study goals."

"The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers," the AP (11/12, Johnson) reports. The suit alleges that "Pfizer concealed evidence" that "Neurontin didn't work for those unapproved uses." Dr. Sidney Wolfe, a member of the Food and Drug Administration's drug safety advisory committee, noted that "in every instance, the published article made the drug look better than it would have."

The drug is currently approved "to treat seizures and shingles," HealthDay(11/11, Gardner) reported. For the report, researchers "compared internal company documents to 20 trials funded by Pfizer and Parke-Davis, 12 of which were published. For its part, Pfizer argued that "the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research." Reuters (11/11, Steenhuysen) and MedPage Today (11/11, Gever) also covered the story.