The maker of Neurontin disguised an effort to promote the anti-seizure drug to physicians as a clinical trial and failed to inform involved physicians and patients, according to a new analysis published Monday in the Archives of Internal Medicine journal.
That conclusion was based on an analysis of internal corporate documents that companies involved in marketing Neurontin, including the drug’s current owner, Pfizer Inc., were required to be disclosed in litigation. The authors of the analysis in the Archives of Internal Medicine include paid consultants to plaintiffs in litigation over the drugmaker’s promotion of Neurontin for off-label indications.
After the U.S. Food and Drug Administration approved Neurontin for epileptic seizures, the company launched what it presented as a dosing study to institutional review boards and physicians participating in the Neurontin trial, according to the Archives of Internal Medicine article.
In fact, the Archives of Internal Medicine article says, the study was a “seeding trial” aimed at introducing the drug to physicians, inducing them to prescribe it and increasing the prescribed dosages. The initiative also was aimed at fending off efforts by a competitor to introduce a rival drug, according to the Archives of Internal Medicine study. “Marketing was extensively involved in its planning and implementation,” the article in Archives of Internal Medicine says.