Ghostwriting in medical literature

By planting this paper in the medical literature, the company was preparing for the approval process by highlighting in the medical literature the deficiencies of the best-selling generic that the new drug would compete with. Instead of the ghostwritten article, fugh-berman published a different article, "the corporate coauthor," which appeared in the same journal -- the journal of general internal medicine (jgim) -- in june 2005, alongside comments from the journal's co-editors and a statement from the world association of medical editors (wame). But the event helped bring to light the role that ghostwriters, and the medical-education companies (mecs) that employ them, have played -- and continue to play -- in shaping the medical-science literature. The event initiated a dialogue on the topic in the community of peer-reviewed journal editors and led to guidelines on dealing with ghostwritten articles that are now embraced by many -- though not all -- scientific ng the authorship occurs when an unacknowledged author writes, or makes substantial contributions to, an article published in the peer-reviewed science literature. Typically, the author is a professional writer with scientific expertise, hired by medical-education and communications companies. Such activities skew the medical literature by injecting a marketing spin that benefits the sponsor, fugh-berman says. Most academics know that it's unethical to sign their names to work they didn't do, but it's just as important not to hide contributions from others, says fugh-berman, who currently writes about how drug companies inject marketing messages into the medical literature on her web site, pharmed cynical injection of marketing messages into the scientific literature sounds outrageous, but abuses common in academic publishing set the stage. Published in medical journals between 1998 and 2005, the articles detailed the benefits of the therapy while minimizing its risks. This suggests that these medical-education companies understand that junior faculty members at academic institutions need to demonstrate academic productivity, and one of the ways of doing it is to have first-author publications in high-quality journals. It's very well thought out, the use of the medical literature as a marketing tool," gerrity says. Fugh-berman says review articles are also popular because busy physicians rely on experts to synthesize the medical literature and provide a clinically relevant one knows exactly how common the practice is; it's a hard thing to study. In a 2006 study published in the journal of the american medical association, the authors reviewed 1000 research articles from 10 high-ranking, international peer-review journals and found that up to 11% of articles had authors who weren't those surveys reveal the percentage of only the people who admit to working with an unacknowledged writer, fugh-berman says; the practice of ghostwriting likely stretches far beyond these high-profile cases. We decided not to push it at that point until there was very clear guidance from a group like wame," an international group of editors of peer-reviewed medical section on ghostwriting in wame's code of ethics was "fairly thin and not very explicit," she says. There wasn't anything that specifically addressed the relationship between pharmaceutical industry's medical-education companies and ghost authorship. Examples of financial ties to industry include payment for research, ownership of stock and stock options, as well as honoraria for advice or public speaking, consultation, service on advisory boards or medical education companies, and receipt of patents or patents pending," the new guidelines that, gerrity and her co-editor, william tierney of the indiana university school of medicine, began scrutinizing manuscripts that came across their desks. Over the course of the next year, the numbers of these manuscripts dropped off precipitously," gerrity academic medical centers, such as the one at yale university, are cracking down on ghostwriting by barring faculty members from being listed as authors unless they make a substantive contribution. And top-tier medical journals, such as the journal of the american medical association, plos medicine, the british medical journal, and the journal of general internal medicine, have developed stringent authorship guidelines to ascertain the contributions of each author and obtain full disclosure of authors' funding sources and financial -berman highlights the conflict-of-interest requirements of the journal american family physician.

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Ghostwriting medical literature

Not all medical journals have taken such measures, and many still publish ghostwritten works, gerrity says. Last year, it came to light that merck had paid the publishing company elsevier to produce a journal, australasian journal of bone & joint medicine, which looked like a peer-reviewed medical journal but was filled with articles and reviews from mecs, including articles favorable to merck products for ng enforceable, specific publication guidelines prohibiting ghostwriting can be tricky, fugh-berman says, because researchers may not recognize conflicts of interest obscured by the intermediation of mecs. Saying that people can't participate in ghostwriting is not useful if people don't know exactly what ghostwriting is," she says. 1); jan-dec s:article | pubreader | epub (beta) | printer friendly | wikipedia, the free to: navigation, l ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. The term "ghostwriting" is often used to encompass all three of these rules for authorship and contribution of the international committee of medical journal editors (icmje, informally known as "the vancouver group" from the locale of the group's first meeting, vancouver, british columbia, canada) are a single, universally-respected set of guidelines for describing authorship of and contribution to professional medical publications. The document "international committee of medical journal editors: defining the role of authors and contributors"[3] is considered the definitive statement of ethical requirements for how authorship in medical journal articles (the prime forum for medical professional publication) and the degree to which a given writer is deemed to have contributed to the content of a medical journal article are determined. Compliance with the international committee of medical journal editors' uniform requirements for manuscripts submitted to biomedical journals[4] is voluntary. A list of medical journals which have stated that they follow the uniform requirements for manuscripts submitted to biomedical journals[5] is maintained by the international committee of medical journal closely individual medical journals and authors of medical journal articles comply with icmje guidelines is a largely self-policed matter. The icmje document "uniform requirements for manuscripts submitted to biomedical journals: publishing and editorial issues related to publication in biomedical journals: corrections, retractions and "expressions of concern"[6] is the section of the icmje uniform requirements laying out guidelines for how potential or actual scientific error and scientific fraud ought to be dealt with. Ghostwriting has been criticized by a variety of professional organizations[9][10] representing the drug industry, publishers, and medical societies, and it may violate american laws prohibiting off-label promotion by drug manufacturers as well as anti-kickback provisions within the statutes governing medicare. The most pernicious practice in ghostwriting involves thanking writers for providing “editorial assistance” in the acknowledgments section of the paper instead of the authorship byline, which essentially changes the rule of authorship attribution so that ghostwriting is acceptable. Tellingly, many medical writers are “editorial assistants” on some scientific papers, but co-authors on others. It would seem obvious that someone employed as a “medical writer” would be an author, but current dialogue on ghostwriting ignores such common-sense interpretations. That this is seen as acceptable in an era of increased disclosure of conflicts-of-interest is several groups in medicine including the european medical writers association (emwa) sanction the practice of thanking medical writers for providing “editorial assistance” in the acknowledgments section of the paper instead of listing them on the authorship byline, the problem with simply thanking ghostwriters in the acknowledgements section is clearly illustrated by study 329, probably the most notorious ghostwritten paper in the medical literature. According to the revised icmje guidelines, professional medical writers who write papers are not exempt from being listed as authors of the paper [21]. 1] a questionnaire using comparable methods in 2005 and 2008 with a 14-28% response rate found a decrease in number of people who reported ghostwriting among professional medical writers. Pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers.

Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. Grassley, ranking member of the united states senate committee on finance issued a report on medical ghost writing. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? Thacker, paul, "how scientific literature has become part of big pharma's marketing machine and how being nice hurts canada: 5 questions with ghostwriting expert trudo lemmens", project on government oversight, jun 22, 2011. Pmid ries: ghostwritingmedical journalismmedical researchethically disputed educational practicesacademiacommunication of falsehoodsmisconducthidden categories: all articles with unsourced statementsarticles with unsourced statements from august logged intalkcontributionscreate accountlog pagecontentsfeatured contentcurrent eventsrandom articledonate to wikipediawikipedia out wikipediacommunity portalrecent changescontact links hererelated changesupload filespecial pagespermanent linkpage informationwikidata itemcite this a bookdownload as pdfprintable page was last edited on 5 november 2017, at 14: is available under the creative commons attribution-sharealike license;. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical on: gøtzsche pc, kassirer jp, woolley kl, wager e, jacobs a, gertel a, et al. Plos med 6(2):International committee of medical journal editors; wame,World association of medical editorsprovenance: this debate arose from an uncommissioned submission by karen l. Gøtzsche: ghostwriting is scientific misconduct and should be handled accordinglyscientific communication depends on trust. Editors' associations, such as the committee on publication ethics, the council of science editors, the international committee of medical journal editors (icmje), and the world association of medical editors (wame), should develop policies that recommend ghostwriting be deemed scientific s should ask authors to specify who wrote the first draft of the paper (and for research studies, who wrote the protocol and did the statistical analyses [5]), and should contact these people to confirm their contribution if they are not authors. Editors should be particularly careful when manuscripts concern drugs or medical s should not accept meaningless statements in the acknowledgments such as “we thank xx” (without specifying for what) or “xx provided editorial assistance” (a euphemism, usually without affiliation, for “xx from company yy wrote the paper”). On good publication practices for drug companies [9] and medical journals [4,10] should be s should retain copies of drafts to facilitate investigations of possible ensure accountability, ethical review committees and drug agencies should not accept protocols that have no named authors, although this is very common [5]. The european medical writers association has stated that writers usually do not qualify for authorship, although their role should be acknowledged [11], and wager has argued, with reference to the icmje criteria, that many writers feel they do not fulfill the principle that authors should be able to take public responsibility for the study [11]. Kassirer: ghostwriting is difficult to define, and we need more evidence of its frequency and impactghostwriting debases fundamental tenets of the medical profession.

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More importantly, ghostwriting threatens the very fabric of science and thus the validity of our medical knowledge, and in doing so it jeopardizes patient cing ghostwriting is easy; defining its variants is not. These tactics go some way toward stemming ghost involvement in the publication additional “cure” for ghostwriting must take into account its frequency and impact. For this reason, we must be careful not to impose excessive regulations to solve problems that may not be eless, editors of medical journals could devote more effort to define what constitutes appropriate and inappropriate participation in studies and manuscript preparation, especially by companies with products at stake. Biased ghostwritten articles can cause patient harm; others damage the public's trust in both the pharmaceutical industry and the medical profession. Woolley, elizabeth wager, adam jacobs, art gertel, and cindy hamilton: professional medical writers can be legitimate contributors to manuscripts, but ghostwriting is dishonest and unacceptableprofessional medical writers have been recognized by medical journal editors as legitimate contributors to manuscripts [4,10], but concerns remain about “ghostwriting,” namely the failure to disclose such contributions. Professional medical writers, who must be distinguished from ghostwriters [18], could be valuable allies to those determined to eradicate ghostwriting. Professional medical writers have communication expertise and health care knowledge, and abide by ethical guidelines for medical writers. We believe that professional medical writers can offer unique, and too frequently untapped, insight into how to address ghostwriting. We offer the perspective of professional medical writers on three strategies that have been considered for tackling gy #1: why don't we ban medical writers? 2005, the editorial board of the clinical journal of oncology nursing tried to challenge ghostwriting by rejecting “… manuscripts that have been written by medical writers or communication companies” [19]. Instead, the council of science editors, the icmje, and wame strive to discourage ghostwriting by requiring authors to disclose medical writing assistance and support disclosure, rather than prohibition. Only 50% of medical research results may ever be published in full [20], and limited writing time is one of the main reasons for nonpublication [16]. Professional medical writers can help authors avoid nonpublication by completing many of the time-consuming manuscript preparation tasks [18,21]. Encouraging, rather than banning, medical writer involvement may be particularly important for helping authors and sponsors reduce the rate of nonpublication (23%) associated with industry-sponsored clinical trials [22]. Medical writers could also reduce the quality of manuscripts, particularly if authors have limited time, manuscript writing experience, english language skills, or awareness of reporting guidelines. Professional medical writers have the specialist skills required to help authors communicate in a clear, concise, and credible manner, and to ensure manuscripts meet journal requirements [9,18,21,23,24]. The consistency among these guidelines is remarkable, given that they have been developed by different stakeholders, including journal editors [4,10], medical writers [9,18,21,23,24], and industry [25].

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In some instances, appropriate disclosure may only occur because professional medical writers alert authors to their responsibilities. Of the most practical ways to tackle ghostwriting could be the mandatory use of a checklist that could help editors detect ghostwriting and help authors avoid ghostwriters. We consulted professional medical writers and editors in europe, north america, and the asia pacific region to develop a checklist (table 1) that could be completed by all authors who used medical 1. Checklist for authors using medical writers: a practical tool to discourage ghostwritingprofessional medical writers can be legitimate contributors to manuscripts, but ghostwriting is dishonest and s: if a medical writer contributed to the preparation of your manuscript, you must answer the questions checklist, which could be included in journals' “instructions to authors,” could help editors encourage appropriate disclosure of writing assistance, as well as raise awareness of existing guidelines. The checklist would also provide sponsors and professional medical writers with a means of documenting appropriate medical writing use. Indeed, an audit trail of appropriate interactions between authors and professional medical writers should be available. Organizations trying to eradicate ghostwriting could educate their members about the conclusion, we believe the debate about ghostwriting needs to shift from whether authors used writers to whether writing assistance was appropriate and adequately disclosed. Since professional medical writers work with experienced and inexperienced authors from around the world on a daily basis, they could be valuable allies in the efforts to tackle m (2004) the truth about the drug companies: how they deceive us and what to do about it. 272 kassirer2005on the take: how medicine's complicity with big business can endanger your healthoxfordoxford university press272 r (2006) the trouble with medical journals. Hróbjartssonhk johansenmt haahrdg altman2007ghost authorship in industry-initiated randomised js, hill kp, egilman ds, krumholz hm (2008) guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. Jama 299: 1800– rosskp hillds egilmanhm krumholz2008guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib ministry of science, technology and innovation (2005) bekendtgørelse om udvalgene vedrørende videnskabelig uredelighed. Wager2007authors, ghosts, damned lies, and r (2005) medical journals are an extension of the marketing arm of pharmaceutical companies. Smith2005medical journals are an extension of the marketing arm of pharmaceutical r, roberts i (2006) patient safety requires a new way to publish clinical trials. Flanaginla careypb fontanarosasg phillipsbp pace1998prevalence of articles with ghost authors and ghost authors in peer-reviewed medical g, shirran l, grinshaw jm, rennie d, flanagin a, et al. Findlayfa lynch2006declaration of medical writing assistance in international peer-reviewed son bc, anderson ms, devries r (2005) scientists behaving badly. How to work ethically and efficiently with professional medical n-sobel jp (2005) the status of peer review. 2007) international society for medical publication professionals (ismpp) position statement: the role of the professional medical writer.

Bowmanjm faganer gallagherab geraci2007international society for medical publication professionals (ismpp) position statement: the role of the professional medical med res k, bacchetti p, bero l (2008) reporting bias in drug trials submitted to the food and drug administration: review of publication and presentation. Bero2008reporting bias in drug trials submitted to the food and drug administration: review of publication and on cw, royer mg (2003) amwa position statement on the contributions of medical writers to scientific publications. Amwa j 18: 13– hamiltonmg royer2003amwa position statement on the contributions of medical writers to scientific a, wager e (2005) european medical writers association (emwa) guidelines on the role of medical writers in developing peer-reviewed publications. Wager2005european medical writers association (emwa) guidelines on the role of medical writers in developing peer-reviewed med res d plos riting: the dirty little secret of medical publishing that just got unbiased scientific record should be everyone's ed in the following riting more information about plos subject areas, want your feedback.