EDITORIAL * EDITORIAL
Medical journals and conflicts of interest Bruce P. Squires, MD, PhD
M any manuscripts submitted to CMAJ and other medical journals are about the use of a product, be it a drug, a medical device or some form of technology. Therefore, it is not surprising that the content and conclusions of the manuscript may have considerable impact on the subsequent commercial success or failure of the product. Similarly, it is not surprising that the authors may have some financial interest in the product or that the owners of it may have provided considerable financial support for the study being reported. It is common, for instance, for a pharmaceutical firm to support either financially or materially a clinical study that compares the therapeutic effect of a drug with the effect of a placebo or another drug. Indeed, the firm may provide epidemiologists, statisticians and even writers to assist the investigators with the study and the subsequent manuscript preparation. On the one hand, editors historically have viewed with suspicion such financial relationships between authors and a commercial venture. Since the scientific integrity of the journal is one of its most important attributes editors are especially sensitive, perhaps even oversensitive, to the need to ensure that what is reported is unbiased and the result of rigorous scientific design, implementation and analysis. On the other hand, it is unfair to assume - just because authors have been supported by a commercial organization or have a financial interest in a product or technique - that their scientific work is unduly biased. Much of it is not. What, then, must editors do to ensure that their readers are protected as far as possible from biases that may inadvertently or deliberately arise from the authors' commercial affiliations? The primary mechanism, of course, is disclosure at the time of submission of the manuscript. Our instructions for authors' clearly state that in the letter accompanying the manuscript "the authors must disclose the source of any financial or material
support, any commercial interest they may have in the subject of the study and any affiliation or involvement with an organization that has a financial interest in the research materials used or the topic." Such disclosure does not ensure that the manuscript is free from bias, but at least the editor, reviewers and readers are forewarned. Occasionally, we receive manuscripts - usually reports of clinical trials - in which it is obvious that the manufacturer of the product described has initiated the study and maintained an active involvement in its design and conduct, in the analysis and interpretation of the results and in the preparation of the resulting manuscript. Sometimes it is clear that the designated authors are not the "real" authors but merely those who agreed to participate in the trial according to a protocol devised by the manufacturer. This practice should not be allowed unless the designated authors fulfil the criteria for authorship outlined by the International Committee of Medical Journal Editors:2 "Authorship credit should be based only on substantial contributions to (a) either conception and design or else analysis and interpretation of data and to (b) drafting the article or revising it critically for important intellectual content and on (c) final approval of the version to be published." In most situations clinicians who merely participate in a trial by following a protocol should be simply identified in the acknowledgement section of the manuscript. In the case of review articles or editorials the disclosure of the authors' affiliation with a firm that has a financial interest in the treatment, device or topic is equally important. At least one major medical journal solves the problem by refusing to publish an editorial or review article written by someone with a financial affiliation with an interested manufacturer. We do not have as stringent a policy but demand that the authors indicate clearly any direct or indirect potential conflicts. By direct I mean that the author has had a direct financial
Dr. Squires is editor-in-chief and scientific editor ofCMAJ.
Reprint requests to: Dr. Bruce P. Squires, CMAJ, PO Box 8650, Ottawa, ON KIG OG8 -
For prescribing information see page 1513
CAN MED ASSOC J 199 1; 145 (H)
1439
affiliation with the manufacturer (e.g., as a paid consultant or author); by indirect I mean that the manufacturer has given money to an intermediary, which then pays an author or authors to write an editorial or review for submission to a peer-reviewed medical journal. Without exception we will not consider for publication an unsolicited manuscript by an author who has been paid to write it. We also receive manuscripts reporting the deliberations of symposia or conferences. Normally, we will not consider reports emerging out of a manufacturer-initiated symposium if the manufacturer has influenced or controlled the content of the symposium and the speakers. However, we will consider reports of symposia if the choice of content and speakers (representing an academic institution, hospital or professional society) has been under the total control of the conference leaders, even though the organizers may have subsequently sought and obtained financial or material support from a manufacturer. Again, it is essential that the authors of symposium or conference reports identify for the editor.all sources of financial support. It is equally important that reviewers and editors ensure that their own judgement not be tinged. For example, reviewers with a financial interest in a particular drug or device may be biased in their assessment of a related manuscript. Also, reviewers' relationship with the authors may bias their judgement. We believe that most reviewers are sensitive to this potential conflict and have been diligent in reporting it to the editors. However, we now warn reviewers to inform us of any potential conflict of interest and ask them to destroy or return the
manuscript. In the case of editors the rule is very simple: they must not have any commercial affiliation that might in any way influence their editorial judgement. Thus, editors must not only eschew investments or financial affiliations with health-related firms but also ensure that they do not make editorial judgements with one eye on the advertisers. The contribution that manufacturers of pharmaceutical products and other health-related devices have made to medical research is substantial. But the credibility of medical journals and their advertisers will ultimately be compromised unless authors and reviewers disclose their potential biases and editors avoid any affiliation or action that might influence what they print in their journals.
References 1. Instructions for authors. Can Med Assoc J 1991; 145: 37-38 2. International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. Can Med Assoc J 1991; 144: 673-680 1440
CAN MED ASSOC J 1991; 145 (11)
Conferences continuedfrom page 1437
Other Conferences * Conferences diverses Dec. 26, 1991-Jan. 5, 1992: Salon de la Infancia Barcelona Secretariat, Palacio de Congresos, Avenida Reina M. Cristina s/n, 08004 Barcelona, Spain
Dec. 28-30, 1991: All India Obstetric and Gynecological
Congress Madras, India Dr. V.B. Patwardhan, Purandare Griha 31/C, Bombay 400007, India
Jan. 14-17, 1992: National Congress of Cardiology and Cardiovascular Surgery Havana Meetings secretary, Cuban Society of Cardiology, Calle 4, Np 407 e/17 y 19, Vedado, Havana 4, Cuba
Jan. 16-18, 1992: American Academy of Pain Medicine Annual Meeting Registry Hotel, Scottsdale, Ariz. Carol Endicott, administrative assistant, Marketing, American Academy of Pain Medicine, 5700 Old Orchard Rd., 1st floor, Skokie, IL 60077-1024; (708) 966-9510, fax (708) 966-9418 Du 16 au 18 jan. 1992: Congres de la Societe de reanimation de langue francaise Paris
Secretariat general, 14, rue Mandar, F-75002, Paris, France Jan. 17-18, 1992: European Days of the French Society of
Cardiology Paris Secretariat, Organisation Logistiques, Albine Conseil, 16, boul. du Parc, F-92200 Neuilly, France Jan. 24-25, 1992: Tropical Forest Medical Resources and the Conservation of Biodiversity (organized by the Periwinkle Project of the Rainforest Alliance in conjunction with the New York Botanical Garden's
Institute for Economic Botany) Rockefeller University, New York Sarah Laird, director, Periwinkle Project, Rainforest Alliance, 512-270 Lafayette St., New York, NY 10012; (212) 941-1900, fax (212) 941-4986 Jan. 27-28, 1992: Fibrinogen: a Cardiovascular Risk Factor Vienna Professor E. Ernst, AKH, Department of Physical Medicine and Rehabilitation, University of Vienna, Wahringer Gurtel 18-20, A-1097 Vienna, Austria; telephone 011-43-0222-40400-2308, fax 011-430222-40400-5281
continued on page 1443 LE ler DECEMBRE 1991
Medical journals and conflicts of interest Bruce P. Squires, MD, PhD
M any manuscripts submitted to CMAJ and other medical journals are about the use of a product, be it a drug, a medical device or some form of technology. Therefore, it is not surprising that the content and conclusions of the manuscript may have considerable impact on the subsequent commercial success or failure of the product. Similarly, it is not surprising that the authors may have some financial interest in the product or that the owners of it may have provided considerable financial support for the study being reported. It is common, for instance, for a pharmaceutical firm to support either financially or materially a clinical study that compares the therapeutic effect of a drug with the effect of a placebo or another drug. Indeed, the firm may provide epidemiologists, statisticians and even writers to assist the investigators with the study and the subsequent manuscript preparation. On the one hand, editors historically have viewed with suspicion such financial relationships between authors and a commercial venture. Since the scientific integrity of the journal is one of its most important attributes editors are especially sensitive, perhaps even oversensitive, to the need to ensure that what is reported is unbiased and the result of rigorous scientific design, implementation and analysis. On the other hand, it is unfair to assume - just because authors have been supported by a commercial organization or have a financial interest in a product or technique - that their scientific work is unduly biased. Much of it is not. What, then, must editors do to ensure that their readers are protected as far as possible from biases that may inadvertently or deliberately arise from the authors' commercial affiliations? The primary mechanism, of course, is disclosure at the time of submission of the manuscript. Our instructions for authors' clearly state that in the letter accompanying the manuscript "the authors must disclose the source of any financial or material
support, any commercial interest they may have in the subject of the study and any affiliation or involvement with an organization that has a financial interest in the research materials used or the topic." Such disclosure does not ensure that the manuscript is free from bias, but at least the editor, reviewers and readers are forewarned. Occasionally, we receive manuscripts - usually reports of clinical trials - in which it is obvious that the manufacturer of the product described has initiated the study and maintained an active involvement in its design and conduct, in the analysis and interpretation of the results and in the preparation of the resulting manuscript. Sometimes it is clear that the designated authors are not the "real" authors but merely those who agreed to participate in the trial according to a protocol devised by the manufacturer. This practice should not be allowed unless the designated authors fulfil the criteria for authorship outlined by the International Committee of Medical Journal Editors:2 "Authorship credit should be based only on substantial contributions to (a) either conception and design or else analysis and interpretation of data and to (b) drafting the article or revising it critically for important intellectual content and on (c) final approval of the version to be published." In most situations clinicians who merely participate in a trial by following a protocol should be simply identified in the acknowledgement section of the manuscript. In the case of review articles or editorials the disclosure of the authors' affiliation with a firm that has a financial interest in the treatment, device or topic is equally important. At least one major medical journal solves the problem by refusing to publish an editorial or review article written by someone with a financial affiliation with an interested manufacturer. We do not have as stringent a policy but demand that the authors indicate clearly any direct or indirect potential conflicts. By direct I mean that the author has had a direct financial
Dr. Squires is editor-in-chief and scientific editor ofCMAJ.
Reprint requests to: Dr. Bruce P. Squires, CMAJ, PO Box 8650, Ottawa, ON KIG OG8 -
For prescribing information see page 1513
CAN MED ASSOC J 199 1; 145 (H)
1439
affiliation with the manufacturer (e.g., as a paid consultant or author); by indirect I mean that the manufacturer has given money to an intermediary, which then pays an author or authors to write an editorial or review for submission to a peer-reviewed medical journal. Without exception we will not consider for publication an unsolicited manuscript by an author who has been paid to write it. We also receive manuscripts reporting the deliberations of symposia or conferences. Normally, we will not consider reports emerging out of a manufacturer-initiated symposium if the manufacturer has influenced or controlled the content of the symposium and the speakers. However, we will consider reports of symposia if the choice of content and speakers (representing an academic institution, hospital or professional society) has been under the total control of the conference leaders, even though the organizers may have subsequently sought and obtained financial or material support from a manufacturer. Again, it is essential that the authors of symposium or conference reports identify for the editor.all sources of financial support. It is equally important that reviewers and editors ensure that their own judgement not be tinged. For example, reviewers with a financial interest in a particular drug or device may be biased in their assessment of a related manuscript. Also, reviewers' relationship with the authors may bias their judgement. We believe that most reviewers are sensitive to this potential conflict and have been diligent in reporting it to the editors. However, we now warn reviewers to inform us of any potential conflict of interest and ask them to destroy or return the
manuscript. In the case of editors the rule is very simple: they must not have any commercial affiliation that might in any way influence their editorial judgement. Thus, editors must not only eschew investments or financial affiliations with health-related firms but also ensure that they do not make editorial judgements with one eye on the advertisers. The contribution that manufacturers of pharmaceutical products and other health-related devices have made to medical research is substantial. But the credibility of medical journals and their advertisers will ultimately be compromised unless authors and reviewers disclose their potential biases and editors avoid any affiliation or action that might influence what they print in their journals.
References 1. Instructions for authors. Can Med Assoc J 1991; 145: 37-38 2. International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. Can Med Assoc J 1991; 144: 673-680 1440
CAN MED ASSOC J 1991; 145 (11)
Conferences continuedfrom page 1437
Other Conferences * Conferences diverses Dec. 26, 1991-Jan. 5, 1992: Salon de la Infancia Barcelona Secretariat, Palacio de Congresos, Avenida Reina M. Cristina s/n, 08004 Barcelona, Spain
Dec. 28-30, 1991: All India Obstetric and Gynecological
Congress Madras, India Dr. V.B. Patwardhan, Purandare Griha 31/C, Bombay 400007, India
Jan. 14-17, 1992: National Congress of Cardiology and Cardiovascular Surgery Havana Meetings secretary, Cuban Society of Cardiology, Calle 4, Np 407 e/17 y 19, Vedado, Havana 4, Cuba
Jan. 16-18, 1992: American Academy of Pain Medicine Annual Meeting Registry Hotel, Scottsdale, Ariz. Carol Endicott, administrative assistant, Marketing, American Academy of Pain Medicine, 5700 Old Orchard Rd., 1st floor, Skokie, IL 60077-1024; (708) 966-9510, fax (708) 966-9418 Du 16 au 18 jan. 1992: Congres de la Societe de reanimation de langue francaise Paris
Secretariat general, 14, rue Mandar, F-75002, Paris, France Jan. 17-18, 1992: European Days of the French Society of
Cardiology Paris Secretariat, Organisation Logistiques, Albine Conseil, 16, boul. du Parc, F-92200 Neuilly, France Jan. 24-25, 1992: Tropical Forest Medical Resources and the Conservation of Biodiversity (organized by the Periwinkle Project of the Rainforest Alliance in conjunction with the New York Botanical Garden's
Institute for Economic Botany) Rockefeller University, New York Sarah Laird, director, Periwinkle Project, Rainforest Alliance, 512-270 Lafayette St., New York, NY 10012; (212) 941-1900, fax (212) 941-4986 Jan. 27-28, 1992: Fibrinogen: a Cardiovascular Risk Factor Vienna Professor E. Ernst, AKH, Department of Physical Medicine and Rehabilitation, University of Vienna, Wahringer Gurtel 18-20, A-1097 Vienna, Austria; telephone 011-43-0222-40400-2308, fax 011-430222-40400-5281
continued on page 1443 LE ler DECEMBRE 1991
