(RTTNews) -  Thursday, pharmaceutical giant Pfizer Inc. (PFE: News ), along with its Detroit-based subsidiary and America's oldest drug maker Parke-Davis, reported outcome of clinical trials selectively for off-label use of seizure medication Neurontin so as to show higher efficacy rates, revealed a study by researchers at the Johns Hopkins Bloomberg School of Public Health.

The study, published in the November 12 edition of New England Journal of Medicine, said that Pfizer substituted a different primary outcome for eight of the 12 Neurotonin trials published. The analysis compared study protocols for off-label use and the manufacturer's internal research reporting with published reports of study findings. Researchers identified 20 clinical trials for gabapentin, the generic name of Neurontin, for which internal company documents were obtained by lawyers from Pfizer and Parke-Davis.

Eight of the 12 trials published in research journals had a different primary outcome defined in the published report when compared to that described in the protocol, a statement from the Baltimore, Maryland-based school said.

Researchers of the study found introduction of new primary outcome in the case of six trials, failure to distinguish between primary and secondary outcomes for two trials, relegation of primary outcomes to secondary outcomes for two trials, and failure to report one or more protocol-defined primary outcomes for five trials.

Of the 21 primary outcomes described in the protocols of the eight published trials, six were not reported at all and four were reported as secondary outcomes. Of the 28 primary outcomes described in the published reports, 12 were newly introduced, a press note from the school said.
Kay Dickersin, director of Center for Clinical Trials of the school, said, "We were concerned that the reporting practices observed in our analysis did not meet the ethical standards for clinical research or maintain the integrity of scientific knowledge."

Lead author of the study, Dickersin Swaproop Vedula said, "As our analysis shows, differences between primary and other outcomes specified in the protocol and those described in the published report are often subtle but may lead to different interpretations of an intervention's effectiveness. We believe that existing registration systems need to go further than they currently do and should include registration of the full study protocol and amendments."

Gabapentin was originally approved as an adjunctive epilepsy treatment by the U.S. Food and Drug Administration. Off-label uses of gabapentin include use as a preventive for migraines, treatment of bipolar disorders, neuropathic pain and nociceptive pain.

To receive FREE breaking news email alerts for Pfizer Inc. and others in your portfolio

 1   2   Next Page