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15 August 2006 | Volume 145 Issue 4 | Pages 284-293
Background: Internal documents from the pharmaceutical industry provide a unique window for understanding the structure and methods of pharmaceutical promotion. Such documents have become available through litigation concerning the promotion of gabapentin (Neurontin, Pfizer, Inc., New York, New York) for off-label uses.
Purpose: To describe how gabapentin was promoted, focusing on the use of medical education, research, and publication.
Data Sources: Court documents available to the public from United States ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company, mostly from 1994–1998.
Data Extraction: All documents were reviewed by 1 author, with selected review by coauthors. Marketing strategies and tactics were identified by using an iterative process of review, discussion, and re-review of selected documents.
Data Synthesis: The promotion of gabapentin was a comprehensive and multifaceted process. Advisory boards, consultants meetings, and accredited continuing medical education events organized by third-party vendors were used to deliver promotional messages. These tactics were augmented by the recruitment of local champions and engagement of thought leaders, who could be used to communicate favorable messages about gabapentin to their physician colleagues. Research and scholarship were also used for marketing by encouraging "key customers" to participate in research, using a large study to advance promotional themes and build market share, paying medical communication companies to develop and publish articles about gabapentin for the medical literature, and planning to suppress unfavorable study results.
Limitations: Most available documents were submitted by the plaintiff and may not represent a complete picture of marketing practices.
Conclusion: Activities traditionally considered independent of promotional intent, including continuing medical education and research, were extensively used to promote gabapentin. New strategies are needed to ensure a clear separation between scientific and commercial activity.
Author and Article Information
From San Francisco Veterans Affairs Medical Center and University of California, San Francisco, San Francisco, California.
Acknowledgment: The authors thank Elizabeth Boyd, PhD, for her careful review of the manuscript.
Grant Support: By a Veterans Affairs Health Services Research & Development Research Career Development Award (Dr. Steinman); by grants from the California Tobacco-Related Disease Research Programs (13RT-0108) (Dr. Bero), the National Institute of Arthritis and Musculoskeletal and Skin Disease (AR02203) (Dr. Chren), the National Institute on Aging (AG00912), and the John A. Hartford Foundation (2003–0244) (Dr. Landefeld); and by the Health Services Research Enhancement Award Program at the San Francisco Veterans Affairs Medical Center.
Potential Financial Conflicts of Interest: Drs. Steinman, Chren, and Landefeld served as unpaid expert witnesses for the plaintiff in the lawsuit that generated these documents (United States of America ex. rel. David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company). Dr. Bero was not involved in this or any other legal action involving Pfizer or Parke-Davis. Seed funding for an online searchable archive of documents from the gabapentin litigation (http://dida.library.ucsf.edu) was provided by a gift from Thomas Greene, lawyer for the whistleblower plaintiff in this litigation, to the University of California Board of Regents. Drs. Steinman and Landefeld participated in the creation and development of the archive, including solicitation of start-up funding from Mr. Greene. The cost of obtaining and photocopying documents used in this research was paid by the archive, which incorporated these documents into the collection.
Requests for Single Reprints: Michael A. Steinman, MD, San Francisco Veterans Affairs Medical Center, 4150 Clement Street, Box 181G, San Francisco, CA 94121; e-mail, mike.steinman{at}ucsf.edu.
Current Author Addresses: Drs. Steinman and Landefeld: San Francisco Veterans Affairs Medical Center, 4150 Clement Street, Box 181G, San Francisco, CA 94121.
Dr. Bero: University of California, San Francisco, 3333 California Street, Suite 420, Box 0613, San Francisco, CA 94143.
Dr. Chren: San Francisco Veterans Affairs Medical Center, 4150 Clement Street, Box 151R, San Francisco, CA 94121. REVIEW
Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents
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