Trial Data on Anti-Seizure Drug Might Have Been Manipulated: Report

Nov. 12 -- 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. If scientists and companies agree to report results in a way that wasn't initially intended, unless you have access to original documents, it is extremely difficult to actually figure out what happened and how it happened," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation in Ohio. "How many other examples like this are there out there that we simply don't know about? That's what's frightening."

Dickersin, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health in Baltimore, gained access to internal company documents when she was asked to testify for the plaintiff in a lawsuit alleging that Pfizer and Parke-Davis (now a division of Pfizer as a result of its Warner-Lambert acquisition) illegally tried to market the drug for off-label uses.

Neurontin is approved by the U.S. Food and Drug Administration to treat seizures and shingles, but is also widely used off-label to fight migraines, bipolar disorder and pain.

Dickersin compared internal company documents to 20 trials funded by Pfizer and Parke-Davis, 12 of which were published.