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

arch."

"The safety and efficacy of gabapentin has been widely published, both by Warner-Lambert/Pfizer as well as independent researchers, and Pfizer has supported the dissemination of the results of these studies, regardless of outcome. At Pfizer, science and medical integrity come first and foremost," the statement concluded.

Although regulations require that all clinical trials be registered at some point, the study authors feel that's not enough.

"We need to actually have the protocol itself available for people to look at so there aren't opportunities for people to fiddle around with what they submit," Dickersin said.

One possibility would be to register the protocol itself. "This doesn't necessarily fix it, but it does mean that it's transparent, that the public has access to what people say they're going to do before they do it," she added.

"The peer-reviewed scientific literature is how we write our guidelines and how we make decisions about what therapies to give patients," Nissen said. "If the material available to us is severely distorted by commercial influences, then the evidence we use to take care of patients is flawed. That is too high a price to pay."

More information

The U.S. National Institutes of Health has a registry of current clinical trials.



SOURCES; Kay Dickersin, Ph.D., professor, epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, director, Center for Clinical Trials, Johns Hopkins; Steven E. Nissen, chairman, department of cardiovascular medicine, Cleveland Clinic Foundation, Ohio; Nov. 10, 2009, statement, Pfizer Inc.; Nov. 12, 2009, New England Journal of Medicine


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