Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial
| Autor: | David Egilman, Sam Krumholz, Joseph S. Ross |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Male
Marketing Clinical Trials as Topic Medical education medicine.medical_specialty Cyclohexanecarboxylic Acids Conflict of Interest business.industry Alternative medicine Conflict of interest Seeding trial Product liability Clinical trial Data quality Internal Medicine Humans Medicine Female Narrative Amines Gabapentin business gamma-Aminobutyric Acid Smarketing |
| Zdroj: | Archives of Internal Medicine. 171 |
| ISSN: | 0003-9926 |
| DOI: | 10.1001/archinternmed.2011.241 |
| Popis: | Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail.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.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.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. |
| Databáze: | OpenAIRE |
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