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Original Investigation
Health Care Reform
June 27, 2011

Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial

Author Affiliations

Author Affiliations: Never Again Consulting LLC (Mr Krumholz and Dr Egilman) and Department of Community Health, Brown University (Dr Egilman), Providence, Rhode Island; and Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine and Yale–New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut (Dr Ross).

Arch Intern Med. 2011;171(12):1100-1107. doi:10.1001/archinternmed.2011.241

Background  Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail.

Methods  We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation.

Results  Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles.

Conclusion  The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.