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The Promotion of Gabapentin
- Michael A. Steinman, MD;
- Mary-Margaret Chren, MD;
- C. Seth Landefeld, MD; and
- Lisa A. Bero, PhD
- From San Francisco Veterans Affairs Medical Center and University of California, San Francisco, San Francisco, California.
IN RESPONSE:
Dr. Finucane's enumeration of the large variety of controlled clinical trials of gabapentin is consistent with the company's support of small research projects to promulgate messages about the drug in the medical literature. Although one might apply principles of evidence-based medicine to each of these studies, in practice it is difficult for physicians to critically evaluate the effectiveness of gabapentin for such a wide range of disorders.
We applaud the positive steps outlined by Mr. Peterson and colleagues to reduce commercial influence on educational activities. However, we remain skeptical of the claim that the practices we identified are only of historical interest. Current codes of conduct are largely self-administered and lack an enforcement mechanism, and we know of few systematic data on the extent to which those codes are being followed in letter and in spirit. Similar codes enacted by the pharmaceutical industry, the American Medical Association, and the ACCME, which were in force during the period we studied, were often ignored (1–3). Other research has shown frequent violations of self-regulation by the pharmaceutical industry (4). Thus, we affirm that self-regulation by all parties in these interactions has been insufficient to control undue commercial influence on the practice of medicine.
The risk for such influence persists because of a fundamental conflict of interest, whereby medical education and communications companies and other providers of CME face an incentive to cast a sponsor's products in a favorable light to attract future funding from the sponsor. Despite recent efforts to strengthen guidelines on commercial support of CME, opportunities for abuse still exist (5). Current guidelines allow commercial supporters to raise concerns about content and permit CME providers to consult with commercial supporters about suggested speakers and topics. This creates a condition analogous to that identified by Dr. Sapers as the situation of individual physicians, balancing our ethical and professional obligations against financial interests. However, while physicians and universities that host CME programs have both financial incentives and a fiduciary responsibility to patients and the public, the private, for-profit status of medical education and communications companies raises special concern that financial interests may encroach on the scientific integrity of their educational programs.
Recent strengthening of codes of conduct, stimulated in part by the threat of federal prosecution, has been a welcome improvement in the management of direct and indirect forms of pharmaceutical promotion (6). However, major conflicts of interest and loopholes persist and must be addressed by vigorous regulation with independent oversight to separate commercial from scientific activities.
Michael A. Steinman, MD
Mary-Margaret Chren, MD
C. Seth Landefeld, MD
San Francisco Veterans Affairs Medical Center and University of California, San Francisco
San Francisco, CA 94121
Lisa A. Bero, PhD
University of California, San Francisco
San Francisco, CA 94143
Article and Author Information
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Disclaimer: Any opinions expressed herein are those of the authors and do not reflect those of the U.S. government or the U.S. Department of Veterans Affairs.
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Potential Financial Conflicts of Interest: Drs. Steinman, Chren, and Landefeld were unpaid expert witnesses in the litigation on which their manuscript was based, and Drs. Steinman and Landefeld participated in the creation of an online searchable archive of documents funded by the plantiff's lawyer in that litigation.
