Clinical study of epilepsy drug may have served primarily to promote drug and increase prescribing

A review of documentation relating to a clinical trial of the epilepsy drug gabapentin (drug giant Pfizer’s Neurontin) suggests that the study may have been a "seeding trial" used to promote the drug and increase prescribing, according to a report in the June 27 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

According to background information in the article, a seeding trial is a clinical trial conducted primarily for marketing purposes and intended to promote the drug and increase prescribing by exposing physician-investigators to it. Although seeding trials are not illegal, they are unethical," write the authors, because of the promotional nature of the trials and because participants and physicians may not be told the true purpose of the studies.

Samuel Krumholz, from Never Again Consulting, and colleagues sought to determine whether the Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) study was a seeding trial. They assessed documents relating to the marketing, sales practices, and product liability litigation of the drug Neurontin. The authors were consultants to the plaintiffs in a law suit involving the drug, and had access to depositions and the document database, which included correspondence, clinical research reports and market research analyses.