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Lessons Learned from Deceptive Marketing of NeurontinTM


ARTICLE SUMMARY:
Recent lawsuits alleging injury from illegal marketing of gabapentin (Neurontin™) have yielded remarkable discoveries about the structure and function of pharmaceutical marketing. Sales for NeurontinTM, an adjunctive therapy for partial complex seizures manufactured by Parke-Davis, rose from $98 million in 1995 to $3 billion in 2004 before the drug faced generic competition and lost most U.S. sales. However, in 1996 a lawsuit was filed against Parke-Davis (division of Warner-Lambert) alleging that off-label marketing of NeurontinTM constituted “false claims” to induce payments by the federal government. In May 2004, Warner-Lambert agreed to pay more than $430 million to resolve criminal charges and civil liabilities. A class action suit that was filed afterward remains active. Both cases placed thousands of pages of corporate documents in the public domain. This article summarizes the marketing tactics used and offers actions to prevent similar occurrences.

KEY FINDINGS:

  • The NeurontinTM marketing campaign involved the systematic use of deception and misinformation to create a biased evidence base and to manipulate physicians’ beliefs and prescribing behaviors. For example, a “publication strategy” was designed to increase use of the drug for neuropathic pain and bipolar disorder – off-label indications with great revenue potential.
  • This comprehensive marketing campaign involved many individuals and institutions that apparently failed to recognize the serious ethical and legal issues regarding their actions.
  • The authors advocate actions to preserve the integrity of medical science and justify public trust:
  • Routine placement of legally discovered documents in the public domain, as decided by Judge Patti Saris in the NeurontinTM cases;
  • Study of legally discovered documents to inform strategies to minimize abuses;
  • Penalties that eliminate the profit from illegal marketing;
  • Development of mechanisms to assure that the results of all clinical trials are analyzed as specified in the initial protocol and placed in the public domain; and
  • Independent public funding of peer-reviewed pharmaceutical research through a National Institute for Pharmaceutical Research that might be funded by a tax on all drug sales.

AUTHOR/FUNDING INFORMATION:
Dr. Steinman is supported by an HSR&D Career Development Award. Drs. Landefeld and Steinman are part of the Program to Improve Care for Veterans with Complex Comorbid Conditions, located in San Francisco, which is an HSR&D Research Enhancement Award Program (REAP). A disclaimer is included in the editorial which states that "The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government."

EXPECTED PUBLICATION DATE:
January 8, 2009 in The New England Journal of Medicine Embargoed until publication.

PubMed Logo "The Neurontin Legacy: Discovery of How Marketing Can Manufacture Misinformation and Manipulate Physicians" by C. Seth Landefeld, MD and Michael Steinman, MD.

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What are HSR&D Publication Briefs?

HSR&D requires notification by HSR&D-funded investigators about all articles accepted for publication. These journal articles are reviewed by HSR&D and publication briefs or summaries are written for a select number of articles that are then forwarded to VHA Central Office leadership to keep them informed about important findings or information. Articles to be summarized are selected by HSR&D based on timeliness of the findings, interest of leadership, or potential impact on the organization. Publication briefs are written for only a small number of HSR&D published articles. Visit the HSR&D citations database for a complete listing of HSR&D articles and presentations.