The Cochran Firm Legal Blog

Just two months after being fined a record $2.3 billion for illegally marketing drugs, an article appearing in the New England Journal of Medicine states that Pfizer Inc.'s reports of studies of an epilepsy drug were often misleading. According to the article, results showed the medicine worked better than company documents showed. Unfavorable results were buried and another aspect of the drug highlighted to make it seem the medicine was okay. The change in information was never disclosed.

Pfizer is disputing the report and says the company never tried to mislead anyone about the effectiveness of the drug called Neurontin. However, the report only came to light after lawyers seeking class action status for cases related to obtaining refunds on prescriptions from Pfizer that were paid for by consumers and insurers made documents under review public.

Off-Label Uses

Neurontin was approved by the Food and Drug Administration ten years ago for treating seizures. This approval was later opened to treating pain caused by shingles, but nothing else. Doctors often prescribe drugs for unapproved, or off-label, uses, but drug companies are forbidden from marketing drugs for off-label uses. However, it is believed that Neurontin sales, which peaked at $2.7 billion in 2004, were mostly for off-label uses. Pfizer paid a $430 million fine to settle allegations it was marketing Neurontin for unapproved uses.

Two of the potential side effects of Neurontin are depression and suicidal thoughts. Pfizer and its Parke-Davis unit had begun patient studies of prevention of migraines, and treating nerve pain and bipolar disorder. In eight of the 12 published studies that showed up in medical journals and presented at conferences over the last decade, the central outcome listed later was different than what internal documents showed. In half of the cases, the information was substituted and in others the original outcome was either reported as a secondary conclusion or not disclosed at all.

It is not known who made the changes.

If you or a loved one has been injured by undisclosed side effects of a drug, please contact the experienced pharmaceutical injury lawyers at the Cochran Firm. We serve clients nationwide.

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