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Trial Data on Anti-Seizure Drug Might Have Been Manipulated: Report
Date:11/11/2009

s, 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.

Typically, clinical trials are set up to track both primary and secondary outcomes. These initial decisions then dictate other aspects of the trial, such as how many participants will be included. And that feeds back into how valid the final results are for that specific trial design and that specific primary outcome.

But here, Dickersin and her colleagues discovered that the primary outcomes specified in the early company protocols were not always the same as those appearing in later reports.

"What appears to be happening is that outcomes are changing between what was planned and what was published," Dickersin said.

Sometimes researchers changed what the primary outcome was (if a different outcome cast the drug in a more positive light), neglected to report the primary outcome at all, turned a secondary outcome into the primary outcome or simply added new outcomes, the report said.

"This distorts the scientific evidence that's available on the benefits and risks of therapies," Nissen said.

On Tuesday, Pfizer issued a statement in response to the study, part of which read: "The suggestion that Pfizer attempted to mislead the medical community about the effectiveness of gabapentin [Neurontin] for certain off-label conditions is untrue. The review recently published in the New England Journal of Medicine, regarding the reporting of industry-sponsored trials for gabapentin for off-label use, was derived from a report created for litigation and coauthored by plaintiffs' expert witness, who was hired to produce opinions to support plaintiffs' arguments. We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific rese
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