pharmaceutical companies Pfizer and Parke-Davis (now a subsidiary of Pfizer) shaded results of clinical trials in at least 12 studies to make drug gabapentin seems more effective for off-label use, says a report published today in the New England Journal of Medicine .
The studies examined how well gabapentin, originally approved to help control seizures and sold as Neurontin -treats other neurological conditions such as migraines and bipolar depression. Internal documents from Pfizer and Parke-Davis said the companies have changed the standards they used to measure the effectiveness of the drug in studies, an ethical no-no. In the planning phases of studies, studies have listed the main criteria they use to judge the effectiveness of gabapentin as relieve some symptoms. These criteria are known as key results. Many studies also indicate secondary outcomes, the least important criteria to judge success.
But according to NEJM article, Pfizer and Parkes Davis later exchanged some primary and secondary outcomes, dropped certain criteria altogether when the drug does not treat a symptom, introduced new results halfway through when the drug treated a symptom unexpectedly. None of these changes was mentioned in the final scientific papers published. "All the changes that took place ... have led to a more favorable presentation in the medical literature on the effectiveness of gabapentin," the report NEJM .
The pharmaceutical companies are hardly alone in the rigging of their research results in this way A report earlier this week in Annals of Family Medicine found chicanery similar with many tests clinical :. in 110 studies in the best medical journals, primary results have changed 30% of the time, secondary results of 70% of the time.
Even critics of this practice are not immune, it seems. MedPage Today included this side bite in his history of Annals study, "the researchers [quiontmenél Annals study] noted, either with intentional irony is known that the relationship between the state and the financing of studies of changes in the measurement of results was not one of their original research questions, but they provided an analysis anyway. "
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