Pfizer fuzzies data?

neurontin.jpgAnalysis of a dozen published clinical trials suggests that the drug company Pfizer selectively reported results to expand the market for their epilepsy drug Neurontin.

Researchers compared internal company documents with published reports, and found some glaring inconsistencies. In 8 of the 12 studies, the main criteria used to judge effectiveness, known as the primary outcome, was changed by Pfizer, they reported today in the New England Journal of Medicine. Sometimes negative results turned into positive results. Other times, primary study goals were reported as secondary study goals.

“The trouble is, as a scientist, the publication has always been held up to me as the truth,” said study author Kay Dickersin, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. “It’s the scientific record. What this study indicated is we can’t believe that record.” (Bloomberg)

Dickersin obtained the company documents while serving as an expert witness for the prosecution in litigation against Pfizer. In 2004, the drug company paid $430 million to settle a lawsuit for promoting Neurontin for off-label uses not approved by the US Food and Drug Administration. (Reuters)

Pfizer disputed the report’s conclusions. “We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement. (Washington Post)

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