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Rapid Responses to:
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Electronic letters published:
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif){kind=icon}
In Response
Separation of Scientific and Commercial Interests
Gabapentin
Re August 15th Issue
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Michael A. Steinman, MD San Francisco VA Medical Center and University of California, Lisa A. Bero, PhD, Mary-Margaret Chren, MD, C. Seth Landefeld, MD
Send rapid response to journal:
mike.steinman{at}ucsf.edu Michael A. Steinman, et al.
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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 world’s medical literature. Although one might apply principles of evidence-based medicine to each of these studies, in practice it is difficult for practicing physicians to critically evaluate the effectiveness of gabapentin for such a wide range of disorders. We applaud the positive steps outlined by Drs. Peterson and Boyce to reduce commercial influence on educational activities. However, we remain sceptical of the claim that the practices we identified are of historical interest only. Current codes of conduct are largely self-administered and lack an enforcement mechanism, and we are aware of little systematic data on the extent to which they are being followed in letter and in spirit. Similar codes enacted by the pharmaceutical industry, the American Medical Association, and the Accreditation Council for Continuing Medical Education (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 of such influence persists because of a fundamental conflict of interest whereby medical education and communications companies (MECCs) and other providers of CME face an incentive to cast the sponsor’s products in a favorable light, so as to attract future funding from the same 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 what Dr. Sapers identifies 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 MECCs 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. Signed, Michael A. Steinman, MD San Francisco VA Medical Center and University of California, San Francisco mike.steinman@ucsf.edu Lisa A. Bero, PhD University of California, San Francisco Mary-Margaret Chren, MD University of California, San Francisco and San Francisco VA Medical Center C. Seth Landefeld, MD University of California, San Francisco and San Francisco VA Medical Center (1) Code of Pharmaceutical Marketing Practices. Washington, D.C.: Pharmaceutical Manufacturers Association, 1990. (2) Council on Ethical and Judicial Affairs, American Medical Association. Gifts to Physicians from Industry. JAMA 1991; 265: 501. (3) Standards for Commercial Support of Continuing Medical Education. Chicago, IL: Accreditation Council for Continuing Medical Education, 1992. (4) Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BMJ 1990; 300: 307-11. (5) Steinbrook R. Commercial support and continuing medical education. N Engl J Med 2005; 352: 534-35. (6) Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest in physicians’ relationships with the pharmaceutical industry self-regulation in the shadow of federal prosecution. N Engl J Med 2004; 351: 1891-1900. Opinions expressed in this letter are those of the authors and do not reflect positions of the government or the Department of Veteran Affairs Conflict of Interest:Drs. Steinman, Chren, and Landefeld served as 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 |
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Eric D Peterson, EdM North American Association of Medical Education and Communication Companies, Kurt Boyce, Karen Overstreet, EdD
Send rapid response to journal:
eric.peterson{at}ahecme.com Eric D Peterson, et al.
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To the Editor: In the August 15, 2006 issue, Steinman and colleagues offered a purportedly “unique window for understanding the structure and methods of pharmaceutical marketing,” concluding that “new strategies are needed to ensure a clear separation between scientific and commercial activities.”1 The authors explored the well-documented abuses related to the off-label marketing of gabapentin. Unfortunately, they seem to imply that these actions are representative of current practice. Worse, the authors call for various reforms, but seem unaware that many such reforms have already taken place. They state only that “a complex system has evolved” that has been “largely ineffective,” a claim that cannot be supported by the references cited, since the referenced publications predate most of the reforms. The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, released April 19, 2002, has effectively stopped the abuse of advisory boards as described in the article.2 The recommendation that grant functions be separated from marketing functions detailed in the 2003 HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers3, has resulted in organizational changes within pharmaceutical companies that have removed marketing personnel from decisions related to CME grants. Additionally, most pharmaceutical companies now generally prohibit medical education companies that receive CME grants from having any role in promotional or marketing activities. Most medical education and communications companies have also made organizational changes that separate independent education from promotion. In September 2004, the Accreditation Council for Continuing Medical Education (ACCME) adopted new Standards for Commercial Support. These Standards obligate providers to develop education that is independent from commercial influence, and require providers to identify and resolve conflicts of interest for faculty or authors, who develop or contribute content.4 Finally, the International Committee of Medical Journal Editors undertook major revisions of their Uniform Requirements for Manuscripts Submitted to Biomedical Journals in 2001, 2003, and 20065, aimed at preventing the abuses of the publication process described in the article. While seemingly provocative, the findings of Steinman and colleagues are mostly of historical interest. To imply that these findings are indicative of current practices is both inaccurate and misleading. The North American Association of Medical Education and Communications Companies (NAAMECC), an association of over 70 companies involved in CME, is deeply concerned about, and works to ensure, the integrity, quality, and educational value of CME. We assert that the CME of today has little in common with the actions described in the article. For the NAAMECC Board of Directors, Eric D. Peterson, Past President Kurt Boyce, President Karen Overstreet, EdD, President Elect 1. Steinman MA, Bero LA, Chren M, Landefeld CS. The promotion of gabapentin: an analysis of internal industry documents. Arch Intern Med. August 2006;145:284-293. 2. Pharmaceutical Research and Manufacturers of America. The PhRMA code on interactions with healthcare professionals. Available at: http://www.phrma.org/files/PhRMA%20Code.pdf. Accessed August 21, 2006. 3. Health and Human Services Office of the Inspector General: OIG compliance program guidance for pharmaceutical manufacturers. Federal Register. May 2003;68:23731-23740. 4. Accreditation Council for Continuing Medical Education. Standards for commercial support: standards to ensure the independence of CME activities. Available at: http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725- 80a1504e520c_uploaddocument.pdf. Accessed August 22, 2006. 5. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publications. Available at: http://www.icmje.org/. Accessed August 22, 2006. Conflict of Interest:None declared |
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Thomas E. Finucane, M.D. Johns Hopkins Bayview Medical Center
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tfinucan{at}jhmi.edu Thomas E. Finucane
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Annals of Internal Medicine To the Editor: Steinman and colleagues describe an explicit promotional campaign by gabapentin’s vendor that included efforts to inflate the literature on gabapentin “by contracting with medical education companies to develop review papers, original articles, and letters to the editors” favorable to gabapentin and then hiring physicians and pharmacists to be authors on these papers. Knowing this was done makes the literature on gabapentin very difficult to interpret. A pub med search of gabapentin limited to randomized controlled trials done on August 25, 2006, found 148 RCTs. In this primary research literature, there are multiple positive trials of gabapentin for hot flashes, bi-polar disorder, alcohol withdrawal, pain syndromes, spasticity, restless leg, chronic headache and acquired nystagmus, among a myriad of other conditions. Limiting the search to clinical trials yields 285 studies, ranging from hiccups to priapism. Either this drug has extremely broad (and biologically implausible) effectiveness for a variety of unrelated conditions or the literature is so corrupt as to be unsalvageable. Unfortunate consequence of this is we are unlikely to know for what conditions that gabapentin is actual useful. Conflict of Interest:None declared |
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Benjamin L Sapers, MD RIH
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bsapers{at}pol.net Benjamin L Sapers
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In the great 1942 movie Casablanca, Captain Renault (Claude Rains) orders his men to close Rick’s bar, saying he was "shocked, shocked to find that gambling (was) going on…"at the bar. The cashier hands him his winnings. In the August 15th Issue of the Annals, there is an article discussing the value of “financial incentives” and “[paying] for performance” to make physicians do the right thing (1). Twelve pages later, we have a well-researched indictment of a drug company trying to sell its product (2). Do we see ourselves as physicians and patients or as health suppliers and demanders? If we are the former, then we should act as such, and we must demand that those organizations with whom we must work (insurance companies, drug companies and, recently, the FDA) behave less like business people and more like professionals. If we are the later, then let us do what is right for capitalism: deregulate the health care market, let drug companies pedal their wares in peace, and let herbalists and other traditional healers compete on even ground for the attention of health care consumers. 1. Petersen, LA et alia.Does Pay-for-Performance Improve the Quality of Health Care. Ann Intern Med. 2006; 145:265-272 2. Steinman, MA et alia. Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents. Ann Intern Med. 2006;145: 284-293 Conflict of Interest:None declared |
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