According to researchers, the results of studies of Pfizer’s drug Neurontin for uses unapproved may have been skewed to emphasize favorable results. 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, according to a report in the New England Journal of Medicine. Discrepancies included reports of positive results from trials that were initially found to be negative, and primary study goals reported as secondary study goals.
Pfizer has paid $430 million in criminal fines and civil penalties in 2004 for urging doctors to prescribe Neurontin for off-label uses. But the drug maker says the new review isn’t credible and the company didn’t attempt to mislead the medical community. In reply, the study’s author, Dr. Kay Dickersin, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, stated:
The trouble is, as a scientist, the publication has always been held up to me as the truth. It’s the scientific record. What this study indicated is we can’t believe that record.
The internal documents revealing the discrepancies were obtained as a result of lawsuits filed against Pfizer for promoting Neurontin, or gabapentin, for off-label uses, according to the Journal report. Dr. Dickersin, who has been an expert witness in litigation against Pfizer, agreed to participate on the condition that she be allowed to publish information from unsealed documents. Her earnings as an expert went to related research at Johns Hopkins.
Internal documents show that the study originally had 21 primary objectives of off-label uses of Neurontin. Six of these objectives weren’t included in published reports, and four were reported as secondary goals, according to the study as published in the Journal. For eight of the 12 published trials, the definition of the primary study goal differed between the internal and published documents. Seven of the nine trials published as full-length research articles reported statistically significant results for the study’s main goal, and in more than half of those, the outcome differed between the published account and the internal documents, the study showed.
According to Dr. Dickersin, doctors are allowed to prescribe drugs for uses not approved by the FDA, and drug makers are allowed to provide publications about off-label uses. She believes more disclosure is needed, however, to ensure the validity of studies on off-label uses funded by the drug industry. Dr. Dickersin pointed out that doctors “have nothing but the published literature” when deciding how to use drugs for unapproved uses. The American public is slowly catching on to how the powerful drug industry operates and they don’t like what they are seeing!
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