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19 August 2008 | Volume 149 Issue 4 | Pages 251-258
Background: Seeding trials, clinical studies conducted by pharmaceutical companies that are designed to seem as if they answer a scientific question but primarily fulfill marketing objectives, have not been described in detail.
Purpose: To describe a known seeding trial, ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), through documents of the trial sponsor, Merck & Co. (Whitehouse Station, New Jersey).
Data Sources: Merck internal and external correspondence, reports, and presentations elicited to inform legal proceedings of Cona v Merck and Co., Inc., and McDarby v Merck and Co., Inc. The documents were created between 1998 and 2006.
Data Extraction: An iterative case-study process of review, discussion, and re-review of documents to identify themes relevant to the design and conduct of ADVANTAGE. To supplement the case-study review, the authors did a systematic review of the literature to identify published manuscripts focused on seeding trials and their conduct.
Data Synthesis: Review of the documents revealed 3 key themes: The trial was designed by Merck's marketing division to fulfill a marketing objective; Merck's marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members. Although the systematic review of the literature identified 6 articles that focused on the practice of seeding trials, none provided documentary evidence of their existence or conduct.
Limitations: The legal documents in these cases provide useful, but limited, information about the practices of the pharmaceutical industry. This description of 1 company's actions is incomplete and may have limited generalizability.
Conclusion: Documentary evidence shows that ADVANTAGE is an example of marketing framed as science. The documents indicate that ADVANTAGE was a seeding trial developed by Merck's marketing division to promote prescription of Vioxx (rofecoxib) when it became available on the market in 1999.
Editors' Notes
Context
Contribution
Caution
Implication
—The Editors
Author and Article Information
From McLean Hospital, Belmont, Massachusetts; Mount Sinai School of Medicine, New York, New York; Brown University, Providence, Rhode Island; and Yale University School of Medicine and Yale-New Haven Hospital, New Haven, Connecticut.
Note: All legal documents used in the article are available at http://dida.library.ucsf.edu.
Acknowledgment: The authors thank Leslie Curry, PhD, for her advice on our methods for review of the litigation documents and Greg Mulvey for his help in organizing the documents.
Grant Support: Dr. Hill was a Scholar in the Robert Wood Johnson Clinical Scholars Program sponsored by the Robert Wood Johnson Foundation while working on this project. Dr. Ross is currently supported by the Hartford Foundation.
Potential Financial Conflicts of Interest: All authors were compensated for participation in litigation against Merck at the request of plaintiffs.
Reproducible Research Statement: Study protocol and statistical code: None. Data set: Available at http://dida.library.ucsf.edu.
Requests for Single Reprints: Kevin P. Hill, MD, MHS, McLean Hospital, 115 Mill Street, Belmont, MA 02478; e-mail, kphill{at}partners.org.
Current Author Addresses: Dr. Hill: McLean Hospital, 115 Mill Street, Belmont, MA 02478.
Dr. Ross: Mount Sinai School of Medicine, One Gustave L. Levy Place, New York, NY 10029.
Dr. Egilman: 8 North Main Street, Attleboro, MA 02703.
Dr. Krumholz: Yale School of Medicine, 333 Cedar Street, I-456, SHM, New Haven, CT 06510.
Author Contributions: Conception and design: K.P. Hill, J.S. Ross, D.S. Egilman, H.M. Krumholz.
Analysis and interpretation of the data: K.P. Hill, J.S. Ross, D.S. Egilman, H.M. Krumholz.
Drafting of the article: K.P. Hill.
Critical revision of the article for important intellectual content: K.P. Hill, J.S. Ross, D.S. Egilman, H.M. Krumholz.
Final approval of the article: K.P. Hill, J.S. Ross, D.S. Egilman, H.M. Krumholz.
Provision of study materials or patients: K.P. Hill, D.S. Egilman.
Administrative, technical, or logistic support: K.P. Hill.
Collection and assembly of data: K.P. Hill, D.S. Egilman. ARTICLE
The ADVANTAGE Seeding Trial: A Review of Internal Documents
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