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Recent Changes in Relationships Between Medical School Physicians and Industry
Comment From the Editor Recent Changes in Relationships Between Medical School Physicians and Industry
A
s undoubtedly most of our readership knows, significant changes have been made by many medical schools in the United States regarding the relationship between faculty physicians and industry. The American Association of Medical Colleges (AAMC) implemented a series of guidelines (http://www.aamc.org/ research/coi/compendium2008.pdf) in the wake of serious allegations made against several faculty physicians at some of the nation’s most prestigious medical schools. More recently, the Department of Health and Human Services (DHHS) requested public input into the proposed rule for promoting objectivity in research (http://edocket.access.gpo. gov/2010/pdf/2010-11885.pdf). These changes reflect the increasing complexity of interactions and relationships among academic institutions, the private sector, and the government, and are meant to expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance, and effective institutional oversight and management of investigators’ financial conflicts of interest (COIs). At the heart of the COIs was how thought leaders (highly influential faculty physicians) were compensated for their work, for example, as consultants, for industry. The consequences of these exposures have resulted in undeniable and dramatic changes that affect nearly everybody in medical schools and their affiliated health care systems. In many academic institutions today, pharmaceutical representatives cannot provide lunch for resident lectures or pens with a copyright logo that is an advertisement for a particular mediGASTROENTEROLOGY 2010;139:1442–1443
cation. Faculty members are required to declare outside activities such as gifts, royalties, and consulting fees on an annual basis. These actions taken were laudable and necessary, but should have probably been implemented much earlier. Aside from the restrictions in faculty physician compensation, free lunches, and pens, all of us are also required to provide information in any published manuscript the potential COI that could be perceived as a COI between the author and the data, methods, and conclusions that are dispensed. At present declaration of COIs are not only required for peerreviewed publications, but also for dissemination of knowledge in medical student lectures, grand rounds, national meetings, and continuing medical education materials. For example, owning stock in or receiving compensation from a company that makes ‘Drug X’ that will be discussed in a lecture now needs to be disclosed in an article or lecture. Most investigators would agree that, despite the nuisance, medical schools and their faculties have improved the degree of transparency with respect to our relationships with industry. Although many of the guidelines seem to be rigid and academic organizations have almost certainly come to recognize a markedly diminished source of revenue to support teaching and research, the vast majority of faculties are now in compliance. Faculties understand that transparency in an academic and financial relationships must take precedence in reporting critical information to students, colleagues, and the public. The question, however, that must always be central to this issue is whether the ethical concerns on behalf of science in the public interest are being adequately addressed? Do in fact the practices the AAMC or DHHS put in place actually render better science? Have in fact the implementation of the AAMC or DHHS guidelines—
although very stringent—adequately addressed the fundamental concerns about what is potentially the result of the relationship between thought leaders and academia on the one hand and what is published in conjunction with the industry, and where it is published on the other? Even though thought leaders declare information about their relationships with a pharmaceutical company for whom they have provided data, the guidelines say very little about whether the conclusions that are presented, or the way in which the data are collected or reported may mislead the readership, the media, and in turn the public. Naturally, industry desires to have leading academic figures in their respective fields conduct clinical trials. Such outstanding scholars by their presence in a published manuscript add significant stature to the potential indications for which a proposed drug or device will eventually be not only marketed, but approved by regulatory agencies such as the US Food and Drug Administration. Results of clinical trials with new agents for long-standing clinical indications continue to appear in prestigious medical journals with exceedingly high impact factors. The stature of the scholars and the journal are not only an important impetus on the part of industry to aide in approval by regulatory bodies, but even more vital to ‘launch’ the marketing strategy upon which physicians will come to decide to select a new drug for an old indication. Furthermore, in advertising to the public, such laudatory comments from the academic press are cited on grounds to advance the particular industry’s argument that the newest agent or device is superior to conventional ones already in existence. But the subtleties in which we write are even more subtle than they may appear on first examining them. Data collection for industry-sponsored trials may have extensive exclu-
Comment From the Editor continued
sion criteria that would render general applicability to a particular patient population invalid or may lend credence to a new drug or device as being safe and at least as efficacious—if not more so—than an older or less expensive treatment modality. It is difficult to know whether sophisticated statistical analyses, often being performed, and manuscript written, by a company, provide data that in turn result in conclusions that are misleading or at least potentially skewed. With the advent of professional recertification, articles from high-impact journals are frequently cited in sponsored review material that is readily available on-line through various commercial outlets. The American Board of Internal Medicine (ABIM) statement concerning recertification underscores lifelong learning by updating the candidate on the latest treatments: “Maintenance of Certification (recertification, MOC) promotes lifelong learning, and the enhancement of the clinical judgment and skills essential for high quality patient care”; and the ABIM website continues. “MOC self-assessment [modules] enables you to keep up with recent, clinically relevant developments in your certification area.” Hence, to save time, the writers of review material and perhaps those who write the questions themselves, turn to articles for educational review that are more likely to come from high-impact journals with wellknown scholars in a particular discipline because the findings reported would seem inherently important for continuing medical education and improved practice. In writing this editorial, we wondered whether examiners themselves have inherent COIs in assisting the ABIM in generating ques-
tions for examinations because, to our knowledge, there is no declaration of COI on behalf of the test authors readily available. It is foolish to think that any system to prevent COIs is perfect. However, there are other mechanisms that the readership of any outstanding journal must expect from the editorial board and its reviewers. GASTROENTEROLOGY asks reviewers to sign a pledge of honesty before submitting reviews of articles stating that they have no potential conflicts in their review of the data and conclusions presented. We maintain that this is but the first step to guard against the subtleties mentioned here concerning perceived COIs. Reviewers and editors must rigorously examine methods of data collection, inclusion and exclusion criteria, and become familiar with sophisticated statistical analysis. The anonymity of peer review should encourage transparent and thoughtful reviews that allow for discussion of more contentious issues— ghost writing, as one example—and without concern about intimidation or retribution. For better or worse, medical schools and thought leaders have done their part in shedding light on potentially bad practices that a minority of faculties participated in the past in their respective associations with industry. Although not perfect, academia has made more transparent potential COIs that their faculties may have in association with industry, and on this point we can all agree. However, accurate and unbiased information must be available to the practicing physician and the public for whom we care. The problems we cite here cannot be fixed by the AAMC, government or individual schools alone. In a recent article in
the Boston Review, the former editor of the New England Journal of Medicine, Dr Marcia Angell, continues to have harsh words about the relationship that ensued over the past several decades between industry and medical schools. Of her many suggestions, she contends that industry-driven faculty financial compensation should be given directly to the medical schools for the purpose of a general research fund. We believe that, to minimize the potential hazards of faculties involved in clinical investigation with industry, transparency can be improved at a more fundamental level. In the end, manuscripts get published because reviewers, editorial board members, and editors grant the privilege of publishing in their respective journals. Hence, it is up to the editorial leadership, the integrity of the peer-review process, and an honest review of the issues mentioned here, that such practices be discontinued. The professional readership must be equally engaged by submitting letters to the editors without time restrictions that some prestigious journals have adopted to be more discerning and inquisitive about industry-sponsored reporting. It is in the end our responsibility to end these subtle practices, which, probably would not be served by further AAMC or government intervention. FRANK A. ANANIA Division of Digestive Diseases Emory University School of Medicine VINCENT W. YANG Division of Digestive Diseases Emory University School of Medicine Associate Editor doi:10.1053/j.gastro.2010.09.019
1443
A
s undoubtedly most of our readership knows, significant changes have been made by many medical schools in the United States regarding the relationship between faculty physicians and industry. The American Association of Medical Colleges (AAMC) implemented a series of guidelines (http://www.aamc.org/ research/coi/compendium2008.pdf) in the wake of serious allegations made against several faculty physicians at some of the nation’s most prestigious medical schools. More recently, the Department of Health and Human Services (DHHS) requested public input into the proposed rule for promoting objectivity in research (http://edocket.access.gpo. gov/2010/pdf/2010-11885.pdf). These changes reflect the increasing complexity of interactions and relationships among academic institutions, the private sector, and the government, and are meant to expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance, and effective institutional oversight and management of investigators’ financial conflicts of interest (COIs). At the heart of the COIs was how thought leaders (highly influential faculty physicians) were compensated for their work, for example, as consultants, for industry. The consequences of these exposures have resulted in undeniable and dramatic changes that affect nearly everybody in medical schools and their affiliated health care systems. In many academic institutions today, pharmaceutical representatives cannot provide lunch for resident lectures or pens with a copyright logo that is an advertisement for a particular mediGASTROENTEROLOGY 2010;139:1442–1443
cation. Faculty members are required to declare outside activities such as gifts, royalties, and consulting fees on an annual basis. These actions taken were laudable and necessary, but should have probably been implemented much earlier. Aside from the restrictions in faculty physician compensation, free lunches, and pens, all of us are also required to provide information in any published manuscript the potential COI that could be perceived as a COI between the author and the data, methods, and conclusions that are dispensed. At present declaration of COIs are not only required for peerreviewed publications, but also for dissemination of knowledge in medical student lectures, grand rounds, national meetings, and continuing medical education materials. For example, owning stock in or receiving compensation from a company that makes ‘Drug X’ that will be discussed in a lecture now needs to be disclosed in an article or lecture. Most investigators would agree that, despite the nuisance, medical schools and their faculties have improved the degree of transparency with respect to our relationships with industry. Although many of the guidelines seem to be rigid and academic organizations have almost certainly come to recognize a markedly diminished source of revenue to support teaching and research, the vast majority of faculties are now in compliance. Faculties understand that transparency in an academic and financial relationships must take precedence in reporting critical information to students, colleagues, and the public. The question, however, that must always be central to this issue is whether the ethical concerns on behalf of science in the public interest are being adequately addressed? Do in fact the practices the AAMC or DHHS put in place actually render better science? Have in fact the implementation of the AAMC or DHHS guidelines—
although very stringent—adequately addressed the fundamental concerns about what is potentially the result of the relationship between thought leaders and academia on the one hand and what is published in conjunction with the industry, and where it is published on the other? Even though thought leaders declare information about their relationships with a pharmaceutical company for whom they have provided data, the guidelines say very little about whether the conclusions that are presented, or the way in which the data are collected or reported may mislead the readership, the media, and in turn the public. Naturally, industry desires to have leading academic figures in their respective fields conduct clinical trials. Such outstanding scholars by their presence in a published manuscript add significant stature to the potential indications for which a proposed drug or device will eventually be not only marketed, but approved by regulatory agencies such as the US Food and Drug Administration. Results of clinical trials with new agents for long-standing clinical indications continue to appear in prestigious medical journals with exceedingly high impact factors. The stature of the scholars and the journal are not only an important impetus on the part of industry to aide in approval by regulatory bodies, but even more vital to ‘launch’ the marketing strategy upon which physicians will come to decide to select a new drug for an old indication. Furthermore, in advertising to the public, such laudatory comments from the academic press are cited on grounds to advance the particular industry’s argument that the newest agent or device is superior to conventional ones already in existence. But the subtleties in which we write are even more subtle than they may appear on first examining them. Data collection for industry-sponsored trials may have extensive exclu-
Comment From the Editor continued
sion criteria that would render general applicability to a particular patient population invalid or may lend credence to a new drug or device as being safe and at least as efficacious—if not more so—than an older or less expensive treatment modality. It is difficult to know whether sophisticated statistical analyses, often being performed, and manuscript written, by a company, provide data that in turn result in conclusions that are misleading or at least potentially skewed. With the advent of professional recertification, articles from high-impact journals are frequently cited in sponsored review material that is readily available on-line through various commercial outlets. The American Board of Internal Medicine (ABIM) statement concerning recertification underscores lifelong learning by updating the candidate on the latest treatments: “Maintenance of Certification (recertification, MOC) promotes lifelong learning, and the enhancement of the clinical judgment and skills essential for high quality patient care”; and the ABIM website continues. “MOC self-assessment [modules] enables you to keep up with recent, clinically relevant developments in your certification area.” Hence, to save time, the writers of review material and perhaps those who write the questions themselves, turn to articles for educational review that are more likely to come from high-impact journals with wellknown scholars in a particular discipline because the findings reported would seem inherently important for continuing medical education and improved practice. In writing this editorial, we wondered whether examiners themselves have inherent COIs in assisting the ABIM in generating ques-
tions for examinations because, to our knowledge, there is no declaration of COI on behalf of the test authors readily available. It is foolish to think that any system to prevent COIs is perfect. However, there are other mechanisms that the readership of any outstanding journal must expect from the editorial board and its reviewers. GASTROENTEROLOGY asks reviewers to sign a pledge of honesty before submitting reviews of articles stating that they have no potential conflicts in their review of the data and conclusions presented. We maintain that this is but the first step to guard against the subtleties mentioned here concerning perceived COIs. Reviewers and editors must rigorously examine methods of data collection, inclusion and exclusion criteria, and become familiar with sophisticated statistical analysis. The anonymity of peer review should encourage transparent and thoughtful reviews that allow for discussion of more contentious issues— ghost writing, as one example—and without concern about intimidation or retribution. For better or worse, medical schools and thought leaders have done their part in shedding light on potentially bad practices that a minority of faculties participated in the past in their respective associations with industry. Although not perfect, academia has made more transparent potential COIs that their faculties may have in association with industry, and on this point we can all agree. However, accurate and unbiased information must be available to the practicing physician and the public for whom we care. The problems we cite here cannot be fixed by the AAMC, government or individual schools alone. In a recent article in
the Boston Review, the former editor of the New England Journal of Medicine, Dr Marcia Angell, continues to have harsh words about the relationship that ensued over the past several decades between industry and medical schools. Of her many suggestions, she contends that industry-driven faculty financial compensation should be given directly to the medical schools for the purpose of a general research fund. We believe that, to minimize the potential hazards of faculties involved in clinical investigation with industry, transparency can be improved at a more fundamental level. In the end, manuscripts get published because reviewers, editorial board members, and editors grant the privilege of publishing in their respective journals. Hence, it is up to the editorial leadership, the integrity of the peer-review process, and an honest review of the issues mentioned here, that such practices be discontinued. The professional readership must be equally engaged by submitting letters to the editors without time restrictions that some prestigious journals have adopted to be more discerning and inquisitive about industry-sponsored reporting. It is in the end our responsibility to end these subtle practices, which, probably would not be served by further AAMC or government intervention. FRANK A. ANANIA Division of Digestive Diseases Emory University School of Medicine VINCENT W. YANG Division of Digestive Diseases Emory University School of Medicine Associate Editor doi:10.1053/j.gastro.2010.09.019
1443