Trial Data on Anti-Seizure Drug Might Have Been Manipulated: Report
WEDNESDAY, Nov. 11 (HealthDay News) -- An unusual look at internal documents from a pharmaceutical company suggests that clinical data was manipulated to make a popular anti-seizure drug, gabapentin (Neurontin), look more effective than it actually was, thereby increasing possibilities for its off-label usage, according to a new report.
"This means we're not seeing the full picture, and the picture we are seeing is suspect because perhaps there was selective reporting of outcomes so that only the positive outcomes were reported," said Kay Dickersin, senior author of a paper reporting the alleged deception in the Nov. 12 issue of the New England Journal of Medicine.
But this revelation may just be the tip of the iceberg, especially given that internal company research protocols are rarely available to outsiders, stated another expert.
"The reality is that a deliberate fraud is extremely difficult to unearth.
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