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Ghost Writers in the Sky
Editorials Ghost Writers in the Sky his title is an obvious play on words that refers to a 1948 song that warns a cowboy to change his ways or he will be doomed to try to catch the Devil’s herd across endless skies for eternity. Unfortunately, the issue of ghost writers is not mythic and continues to plague academic journals which publish industry sponsored trials. The issue and potential abuses of using ghost writers were brought to the fore in an editorial in the New England Journal of Medicine in the early 1990s.1 Most journals now provide clear guidelines for authors and require the identification of professional writers used in the preparation of a manuscript. Furthermore, the International Committee of Medical Journal Editors (ICJME) recommends that authorship be based on 1) substantial contributions to the conception, design or acquisition of data or its analysis and interpretation; 2) drafting and revising the manuscript for important intellectual content; and 3) final approval to be published.2 The World Association of Medical Editors (WAME) implores authors to precisely define their roles in manuscript preparation.3 The Journal of Urology® in its Information for Authors abides by these recommendations. The intent and message of these guidelines are to keep today’s authors alert from promulgating a message prepared by others and avoid risking the loss of their academic credibility. For editing and formatting, the use of professional writers can be valuable and save time. Many of us on this editorial board have worked with writers in preparation of manuscripts reporting the results of clinical trials. The services of writers were provided by pharmaceutical, biotech or device companies. Indeed the arguments in favor of using a centralized core of writers can be compelling. The consistency and quality of writing, need for rapid turnover, details on formatting and a coordinated submission process, especially when there are multiple authors scattered around the globe, are cogent reasons for the use of professional writers. However, there are several additional factors we need to consider. The publication of a study reporting positive results could have as much as a $1 billion impact on market capitalization based on a company’s stock price being influenced by a new drug or device. With this type of “bottom line” effect and potential risk at stake, industry would logically want the best medical writer available. A single writer, especially one familiar with related manuscripts, might not only be stylistically beneficial, but might be particularly amenable in delivering a particular message in a very convincing manner. In recent surveys of the medical literature 6% to 11% of articles had been ghost-written.4,5 Today, these writers are usually identified and given proper credit. However, some claim that even then, the articles are “ghostly because the signs of their actual production are largely invisible.”6
Unfortunately, the real dilemma introduced by this process is the potential it creates for introducing bias.7 An independent author who is not paid or directly affiliated with industry must be extremely careful in having his/her name on these papers. The company that has supported the study and the results being presented literally owns the data, performs the statistical analyses by privately hired and paid statisticians, and generally provides only summaries to the investigators. To have an independent statistician review the raw data is rare. Some journals now require that statistical analysis be performed by an independent investigator when the study is industry sponsored.7 When requesting raw data, an author is often dissuaded or obstructed with reasons based on alleged confidentiality. Not infrequently, secondary analyses are performed on the basis of industry interests and only then are authors’ impressions sought, rather than authors being asked to develop hypotheses and then requesting an analysis. This may have important consequences and ramifications since the same results can often be interpreted with different conclusions. Furthermore, investigators may not be aware that a nearly identical study using a subset or other dataset may have been written and submitted by a different group of academic authors but with the same industry authors. Although this technically is not double publishing if based on the use of different datasets, it is not a given that most authors would agree to be involved in a “me too paper” which might multiply the medical literature on a particular drug or device and serve little if any additional intellectual value. In addition, when alternate interpretations are made, the industry sponsor may be tempted to direct a particular message or downplay the alternatives. The primary investigators can be relegated to serve as proofreaders. If authors are involved in the design and/or recruitment for a trial, their participation in the presentation of results of their investigation is perfectly reasonable. As such, careful scrutiny of the discussion needs to be made for words like “best,” “most efficacious,” “least side effect” and “compared to . . . . . .” in the absence of direct comparative trials. Such overreaching statements are common and may serve more as a marketing tool than an evidence-based conclusion. Authors should ask themselves the following questions. “Did I help design this study?” “Was I a major player in carrying out this study?” “Do I have access to all the data I need and can I have it independently reviewed?” “Is the message portrayed in the Abstract and Discussion one that I would have made based on the data?” “Have I been offered remuneration in some fashion to be an author?” “Are my comments and suggestions readily incorporated into the text?” “Have reasons such as ‘word length,’ ‘consistency’ or ‘the sponsor does not agree’ been used to dissuade personal editorial comment?” “Comments go only to the writer or do they
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0022-5347/08/1793-0809/0 THE JOURNAL OF UROLOGY® Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION
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Vol. 179, 809-810, March 2008 Printed in U.S.A. DOI:10.1016/j.juro.2007.12.006
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go to the entire group of authors for inspection and comment?” These may be warning signs that a problem may have developed or is likely to occur. To address some of these issues, the Information for Authors of The Journal of Urology will be revised so that authors will be required to indicate their specific contributions to the manuscript. The uneasy alliance between authors and industry is beneficial if effectively policed. Although some argue that this is impossible,7 it need not be. Independent researchers need to be involved in the development of manuscripts, and effective checks and balances must be maintained. To help get reports into the peer reviewed literature, circumspect and honest academicians can have a tremendous impact on influencing physician behavior and through this mechanism patient care worldwide. Any one manuscript has a greater impact on patient care than any individual physician writing a prescription or performing surgery on a single patient. However, what is truly at stake is the integrity with which we all must function and not lose control over the primary intent to contribute to the honesty and credibility of our work and the literature we produce, even when in “partnership” with industry. We share a public trust that binds us to
our colleagues and patients. To put one’s name on the byline means the data and conclusions are valid to the best of our knowledge. Editors of The Journal of Urology® REFERENCES 1. 2. 3. 4.
Brennan TA: Buying editorials. N Engl J Med 1994; 331: 673. www.icmje.org www.wame.org Mowatt G, Shirran I, Grimshaw JM, Rennie D, Flanagin A, Yank V et al: Prevalence of honorary and ghost authorship in Cochrane Reviews. JAMA 2002; 287: 2769. 5. Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD et al: Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 1998; 280: 222 6. Sismondo S: Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry. Plosmedicine 2007; 4: e286 (http://medicine.plosjounals. org/periserve/archive/1549-1676/4/9/pdf/10.1371_journal. pmed.0040286). 7. Kassirer JP: Ghostwriters and ghostbusters. http://www. thefreelibrary.com. Accessed November 5, 2007.
Unfortunately, the real dilemma introduced by this process is the potential it creates for introducing bias.7 An independent author who is not paid or directly affiliated with industry must be extremely careful in having his/her name on these papers. The company that has supported the study and the results being presented literally owns the data, performs the statistical analyses by privately hired and paid statisticians, and generally provides only summaries to the investigators. To have an independent statistician review the raw data is rare. Some journals now require that statistical analysis be performed by an independent investigator when the study is industry sponsored.7 When requesting raw data, an author is often dissuaded or obstructed with reasons based on alleged confidentiality. Not infrequently, secondary analyses are performed on the basis of industry interests and only then are authors’ impressions sought, rather than authors being asked to develop hypotheses and then requesting an analysis. This may have important consequences and ramifications since the same results can often be interpreted with different conclusions. Furthermore, investigators may not be aware that a nearly identical study using a subset or other dataset may have been written and submitted by a different group of academic authors but with the same industry authors. Although this technically is not double publishing if based on the use of different datasets, it is not a given that most authors would agree to be involved in a “me too paper” which might multiply the medical literature on a particular drug or device and serve little if any additional intellectual value. In addition, when alternate interpretations are made, the industry sponsor may be tempted to direct a particular message or downplay the alternatives. The primary investigators can be relegated to serve as proofreaders. If authors are involved in the design and/or recruitment for a trial, their participation in the presentation of results of their investigation is perfectly reasonable. As such, careful scrutiny of the discussion needs to be made for words like “best,” “most efficacious,” “least side effect” and “compared to . . . . . .” in the absence of direct comparative trials. Such overreaching statements are common and may serve more as a marketing tool than an evidence-based conclusion. Authors should ask themselves the following questions. “Did I help design this study?” “Was I a major player in carrying out this study?” “Do I have access to all the data I need and can I have it independently reviewed?” “Is the message portrayed in the Abstract and Discussion one that I would have made based on the data?” “Have I been offered remuneration in some fashion to be an author?” “Are my comments and suggestions readily incorporated into the text?” “Have reasons such as ‘word length,’ ‘consistency’ or ‘the sponsor does not agree’ been used to dissuade personal editorial comment?” “Comments go only to the writer or do they
T
0022-5347/08/1793-0809/0 THE JOURNAL OF UROLOGY® Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION
809
Vol. 179, 809-810, March 2008 Printed in U.S.A. DOI:10.1016/j.juro.2007.12.006
810
GHOST WRITERS
go to the entire group of authors for inspection and comment?” These may be warning signs that a problem may have developed or is likely to occur. To address some of these issues, the Information for Authors of The Journal of Urology will be revised so that authors will be required to indicate their specific contributions to the manuscript. The uneasy alliance between authors and industry is beneficial if effectively policed. Although some argue that this is impossible,7 it need not be. Independent researchers need to be involved in the development of manuscripts, and effective checks and balances must be maintained. To help get reports into the peer reviewed literature, circumspect and honest academicians can have a tremendous impact on influencing physician behavior and through this mechanism patient care worldwide. Any one manuscript has a greater impact on patient care than any individual physician writing a prescription or performing surgery on a single patient. However, what is truly at stake is the integrity with which we all must function and not lose control over the primary intent to contribute to the honesty and credibility of our work and the literature we produce, even when in “partnership” with industry. We share a public trust that binds us to
our colleagues and patients. To put one’s name on the byline means the data and conclusions are valid to the best of our knowledge. Editors of The Journal of Urology® REFERENCES 1. 2. 3. 4.
Brennan TA: Buying editorials. N Engl J Med 1994; 331: 673. www.icmje.org www.wame.org Mowatt G, Shirran I, Grimshaw JM, Rennie D, Flanagin A, Yank V et al: Prevalence of honorary and ghost authorship in Cochrane Reviews. JAMA 2002; 287: 2769. 5. Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD et al: Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 1998; 280: 222 6. Sismondo S: Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry. Plosmedicine 2007; 4: e286 (http://medicine.plosjounals. org/periserve/archive/1549-1676/4/9/pdf/10.1371_journal. pmed.0040286). 7. Kassirer JP: Ghostwriters and ghostbusters. http://www. thefreelibrary.com. Accessed November 5, 2007.