The relationship between pharmaceutical companies and their intermediary publishing or communication organizations and scientific journals can be a most satisfactory one, or it can arouse great ire and passion. Serious and highly publicized conflicts of interest have recently surfaced regarding the influence of drug companies on editorial content. [1–3]
Some journals have adopted conflict of interest rules to avoid the perception that when writing an article, professional judgment has been improperly influenced. Professionals who do not take precautions to avoid conflicts of interest or who do not observe rules regulating such conflicts and their disclosures are considered to have acted unethically. [4] In 1993, the New England Journal of Medicine decided not to publish review articles or editorials by authors with financial holdings in a company or its competitor whose product figures prominently in the article. [2] In 1985, the International Committee of Medical Journal Editors (ICMJE), also known as the “Vancouver Group,” adopted methods to attempt to eliminate, among other problems, honorary authors. However, pharmaceutical firms or their communication's intermediaries have used ghostwriters to write scholarly reviews about new drugs without identifying the source of authorship. They then pay prominent physicians substantial money to allow their names to be attached as “authors” before the reviews are submitted to learned journals. [5] Kasper, [6] responding to an editorial by Rennie, [7] reported the exact scenario we describe in this editorial.
Brennan [1] addressed an analogous issue in 1994 when he criticized the practice of pharmaceutical companies paying substantial amounts of money to prominent academicians to assign their names to an editorial that commented on original research published in the same issue. Brennan advocated improving disclosure because conflicts of interest will remain with us but should be better managed. [1]
Another related problem is that although physicians can advocate unproven indications for approved drugs, drug companies cannot do so. Therefore, if drug companies can get physicians to write about new and unapproved uses of their drug, they can legally distribute these “scientific” articles to other physicians, thus encouraging and expanding the unapproved use of approved drugs.
Recently, I was shown a letter written to an academic anesthesiologist that seriously undermines the integrity of the publication process as it applies to scientific peer-reviewed journals. The full text of the letter, minus any identifiers, is reproduced herein:
Dear Dr. ___:
Thank you for agreeing to review the enclosed article titled ___. As mentioned during our phone conversation, ___ is working with ___ on publishing this paper. We'd like to submit this article for publication as soon as possible. Please give the article a cursory review and let me know within a few days if you are interested in authoring this paper. If so, please send any revisions to me by Friday, September 6th.
Please feel free to take complete editorial control, adding, changing, or deleting whatever you feel is necessary. (We'd like the neurosurgery section to be expanded (sic) a bit.) Indicate your changes on the enclosed copy. We will make these changes and return a manuscript, styled according to the journal's guidelines, for you to submit. ___ will obtain permission from the publishers to use borrowed figures/graphics. If you prefer to work from a disk, please let us know.
We've targeted Journal of Clinical Anesthesia as the journal for this article. If you have another journal in mind, please let me know.
___ will pay you $1000 for authoring this article. If you have any questions, please call. My direct line is ___.
I'm looking forward to talking to you.
Thank you.
Sincerely yours,
Managing Editor
The implications are clear. Representatives of a drug company or its intermediary communication's company wrote or obtained a review article promoting the specific use of the company's drug. They then asked an anesthesiologist to give the article a cursory review, modify it as he or she saw fit, and attach his or her name to the article for which they would pay the anesthesiologist 1,000 dollars. The actual person or persons who performed the literature search and composed the article was never identified. Not only is it apparent that the idea for the manuscript was not generated by the anesthesiologist who was asked to sign his or her name to the article, but the work involved in researching the subject matter, writing the article, and supporting the material with bibliographic citations was performed by the ghostwriter. The potential for bias inherent in such an approach is obvious. The article may not have been written by an objective independent practitioner but by an unnamed source working for the drug company whose job it was to use this drug in a new setting, thereby enlarging the drug's market. It is especially concerning that this was a review article because available negative data about the drug could be withheld, and only positive references to the use of the drug in this particular situation could be included.
None of the criteria for authorship are satisfied when physicians are paid to place their names on reviews written by someone else because they did not participate to any major degree in the research and writing of the manuscript. Those who actually do the research and then write review articles and editorials for scientific journals should be clearly acknowledged as authors of those articles and take responsibility for the work. If a drug company wants the work of their employees to be considered for publication, I have no objection to the drug company's authors submitting an article with appropriate disclosure of financial or commercial conflicts of interest. If, after appropriate peer review and in the opinion of the editor-in-chief, the article merits publication, such publication should proceed in the usual fashion, provided the reader is made aware that the article was written by those who openly disclose their potential conflict of interest.
Beary, [8] representing the Pharmaceutical Research Manufacturers of America, acknowledged that honoraria received to support writing review articles should be disclosed as part of the biomedical publishing process and is “consistent with the general practice of disclosure so that readers can effectively evaluate information. Such disclosure is consistent with promotional practice guidelines adopted by Pharmaceutical Research and Manufacturers of America member companies.”[8] However, others may view industry support for publication of review articles as part of a company's marketing efforts, namely to provide a financial incentive for a professional to publish his or her opinion about the company's product. [9] Further, to pay an academician for allowing his or her name to be used without disclosing the source of the honorarium or those who actually wrote the paper is inimical to the integrity of scientific publications and should not be tolerated.
Accordingly, the Journal of Clinical Anesthesia's and Anesthesiology's Guidelines for Authors have now been amended to deal with this new intrusion into the world of ethical scientific publishing.
It is important to notify the anesthesia community that the practice of ghostwriting articles is unacceptable.
David J. Cullen, M.D.
Editor-in-Chief, Journal of Clinical Anesthesia; Department of Anesthesiology; St. Elizabeth's Medical Center; 736 Cambridge Street; Boston, Massachusetts 02135–2997
