Seeding trials are clinical studies conducted by pharmaceutical companies designed to seem as if they answer a scientific question, but primarily fulfill marketing objectives. They are not described in detail.
The purpose of this study was to describe a known seeding trial, ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), using documents provided by the trial sponsor, Merck & Co. Data were collected using 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.
The authors conducted 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, they did a systematic review of the literature to identify published manuscripts focused on seeding trials and their conduct. Review of the documents revealed three key themes:
Although the systematic review of the literature identified six articles that focused on the practice of seeding trials, none provided documentary evidence of their existence or conduct.
The legal documents in these cases provide useful, but limited, information about the practices of the pharmaceutical industry. This description of one company's actions is incomplete and may have limited generalizability.
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.