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Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial

Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial ORIGINAL INVESTIGATION HEALTH CARE REFORM Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial A Narrative Account of a Gabapentin Seeding Trial Samuel D. Krumholz, BA; David S. Egilman, MD, MPH; Joseph S. Ross, MD, MHS Background: Seeding trials, clinical studies conducted Results: Documents demonstrated that STEPS was a seed- by pharmaceutical companies for marketing purposes, ing trial posing as a legitimate scientific study. Docu- have rarely been described in detail. ments consistently described the trial itself, not trial re- sults, to be a marketing tactic in the company’s marketing plans. Documents demonstrated that at least 2 external Methods: We examined all documents relating to the sources questioned the validity of the study before ex- clinical trial Study of Neurontin: Titrate to Effect, Profile ecution, and that data quality during the study was of- of Safety (STEPS) produced during the Neurontin mar- ten compromised. Furthermore, documents described keting, sales practices, and product liability litigation, company analyses examining the impact of participat- including company internal and external correspon- ing as a STEPS investigator on rates and dosages of ga- dence, reports, and presentations, as well as depositions bapentin prescribing, finding a positive association. None elicited in legal proceedings http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial

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Publisher
American Medical Association
Copyright
Copyright 2011 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/archinternmed.2011.241
pmid
21709111
Publisher site
See Article on Publisher Site

Abstract

ORIGINAL INVESTIGATION HEALTH CARE REFORM Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial A Narrative Account of a Gabapentin Seeding Trial Samuel D. Krumholz, BA; David S. Egilman, MD, MPH; Joseph S. Ross, MD, MHS Background: Seeding trials, clinical studies conducted Results: Documents demonstrated that STEPS was a seed- by pharmaceutical companies for marketing purposes, ing trial posing as a legitimate scientific study. Docu- have rarely been described in detail. ments consistently described the trial itself, not trial re- sults, to be a marketing tactic in the company’s marketing plans. Documents demonstrated that at least 2 external Methods: We examined all documents relating to the sources questioned the validity of the study before ex- clinical trial Study of Neurontin: Titrate to Effect, Profile ecution, and that data quality during the study was of- of Safety (STEPS) produced during the Neurontin mar- ten compromised. Furthermore, documents described keting, sales practices, and product liability litigation, company analyses examining the impact of participat- including company internal and external correspon- ing as a STEPS investigator on rates and dosages of ga- dence, reports, and presentations, as well as depositions bapentin prescribing, finding a positive association. None elicited in legal proceedings

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Jun 27, 2011

References