%PDF-1.5 30 Cecil Street, We confirmed the face validity of the COI vignette through consultation with experts. Ghostwriting debases fundamental tenets of the medical profession. Additional observational studies are unlikely to alter this conclusion. Turacoz Healthcare Solutions understands its professional responsibility and take an initiative to make authors and medical writers aware about drawbacks of ghostwriting and method of acknowledging dignified professional services. Ghostwriters have been defined by The International Society for Medical Publication Professionals as individuals who contribute substantially to a medical publication but do not appear on the byline and are not acknowledged for their contribution.. Lesser degrees of ghost involvement in the writing process are also problematic, such as permitting the commercial sponsor of a clinical trial to collect and hold all of the trial's data, providing exclusive statistical expertise and final tables for publication, drafting a complete manuscript of a study it supported, or insisting contractually on the last say on the final manuscript's content and conclusions. Thirdly, the final version of the paper to be published should have been approved by the individual to qualify as an author. Oralestrogens increase plasma SHBG levels in postmenopausal women and this increase might mitigate the effect of estrogen replacement therapy on breast cancer epidemiology. Is it acceptable to hire a science writer to interview a physician and write a paper on that subject, which the physician then calls his or her own? Such incidents have provoked many commentaries about ghost writing in the medical press. (2009) What Should Be Done To Tackle Ghostwriting in the Medical Literature? Healy and Cattell claim that the CMD articles are uniformly positive about sertraline, and they note under-reporting of side effects in these articles. In addition, professional medical writers can be hired for writing publication documents like original research articles, review papers, consensus statements, expert opinions, and clinical practice guidelines etc. Gemtuzumab ozogamicin (GO)-associated veno-occlusive disease (VOD): An analysis of adverse drug reac Medical Treatment and Medicinal Charms Mentioned in the Atharvanic Literature, Colectoma en pacientes peditricos con colitis ulcerosa, Need for a citation database of medical literature in Iran. PLOS Medicine publishes research and commentary of general interest with clear implications for patient care, public policy or clinical research agendas. Compared to other articles on sertraline (i.e., those not coordinated by CMD), the CMD articles were published in more prominent journals, had nearly twice as many authors per article, had authors who were on average twice as prolific, and garnered nearly three times as many citations (20.2 versus 7.7 in Healy and Cattell's analysis) [23]. Gerrity informed the author's institution but didn't do anything more. Abbreviations: The author of this article therefore makes scientific and commercial goals equal stakeholders in communication: in a chart he juxtaposes Where shall we publish this study? with Who are our customers? and What can we claim from the results? with What are our customer needs?. Others require that each author state the specific contributions they have made to the study or to the writing of the manuscript, and some journals publish these (e.g., BMJ, PLoS Medicine). Of industry funding, 70% goes to CROs that neither make ownership claims on data nor expect to publish the data themselves: CROs perform research to order [28]. The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors. CHC includes among its clients Pfizer, Sanofi-Aventis, Ortho Biotech, Wyeth, Schering-Plough, Shire, AstraZeneca, and other pharmaceutical companies. Current practices in the medical sciences legitimately allow people to serve as authors on the basis of narrow contributions. Banning writers or creating more guidelines could exacerbate an already problematic situation. However, there was consistently a lower risk of death from breast cancer in hormone users compared with nonusers. A study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 19941995 found evidence of ghost authorship in 75% of these publications (95% confidence intervals, 60%87%) [22]. Medical ghostwriting is a practice where pharmaceutical or device companies hire medical education, marketing or communications companies to draft articles that are presented to prominent physicians and scientists to sign on as authors to increase the likelihood that the article Authors were not acting independently. Gurugram Office Address Yes Finally, one former editor, Richard Smith, thinks that the entire peer review system should be scrapped because of excessive industry influence on publishing [12]. medical education and communication company, What is the purpose of publications?[The] purpose of data is to support, directly or indirectly, the marketing of our product. [1]. <> Journal of College and University Law 2000;27:83108. Estimates on the prevalence of possible ghostwriting in primary and secondary publications varied markedly. Yes This strategy has not been embraced by many editors. endobj Wolters Kluwer Health draws attention to its publisher Lippincott Williams & Wilkins, with nearly 275 periodicals and 1,500 books in more than 100 disciplines, and to Ovid and its other medical information providers, emphasizing the links it can make between its different arms [41]. Guidelines on good publication practices for drug companies [. These 85 manuscripts became a significant portion of all of the articles published on sertraline. I'm not used to working with such excellent writers! CHC claims to have written and submitted over 500 manuscripts, with an acceptance rate of 80%. Cyclooxygenase (COX)-2 inhibitors (coxibs) rofecoxib and celecoxib are highly selective inhibitors of COX-2, differentiating them from nonselective NSAIDs, which substantially inhibit both COX-1 and COX-2. CHC is able to achieve such a rate with resources far beyond the reach of most researchers: not only are all of its studies fully supported by the largest of pharmaceutical companies, but it boasts a team of 40 medical writers, editors, and librarians. However, information about ghost authors, people who should be receiving author credit, strongly suggests that ghost management is common. <> With awareness of the issue, however, perhaps journal editors can recognize signs of behind-the-scenes work. Ghostwriting appears to be quite prevalent. Both of these associations compete with for-profit companies offering similar services, such as the Center for Business Intelligence, which held forums for Strategic Publication Planning in 2005 and 2006 [44]. endobj Several studies have detected an association between a decreased percentage of estradiol bound to SHBG, a small increase in free estradiol, and a higher incidence of breast cancer in postmenopausal women. Professional medical writers with their skills and expertise, can support the research by collating data, analyzing and interpreting it, and presenting the results in a clear and concise manner. Many have flashy Web sites highlighting their ability to prepare meeting presentations and publish articles. % Who did the statistics? Using the tools of EBM it is possible to describe the pharmacoeconomic question very easily by multiplication of the incremental costs with NNT (number needed to treat). A number specialize in producing, placing, and tracking journal articles, known in the trade as publication planning or strategic communication planning. While these firms hide details of their workfrom potential critics and competitorsthey also energetically promote themselves and their services. First criterion is substantial contribution to work either in form of its conception and design, data acquisition or its analysis and interpretation. It then tracks those and competitors' messages using its own information management tool. National Coalition Against Censorship. Many authors don't have the time or inclination to keep up-to-date with guidelines. Researchers should not inflate estimates using non-standard definitions of ghostwriting nor conflate ghostwriting with other unethical authorship practices. Ghost writing and honorary authorship are not in and of themselves scientific problems, though they become so when they shape science to meet particular interests [1]. They can refuse to deal directly with publication planners, and they can ask authors repeatedly about under-recognized and over-recognized contributors, facilitators, and influences; systematic adoption of a strong film credit model of authorship, in which authors rigidly and closely specify their roles, might aid in those efforts [50]. The tendency for medical journal editors to discuss ghostwriting in the context of clinical trial transparency or data integrity is another possible source for misinterpretation via oversimplification. In addition to its carrier function for circulating estradiol, SHBG specifically binds to cells of steroid-responsive tissues, including breast tissue, and decreases the proliferation of some breast cancer cells through activation of cyclic adenosine monophosphate. 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 aim of evidence based medicine (EBM) is to take the best therapeutical decision for one patient on the basis of medical literature. Given the amount of data that pharmaceutical companies control, the number of publication planning agencies that openly advertise on the Internet, the number of medical writers, the existence of two associations for publication planners, and meetings organized and reports written for them, we can conclude that ghost management is common. They can provide intellectual help by writing publication manuscripts. Secondly, the author should have either drafted the manuscript or made critical revisions necessary for its intellectual content. It violates authors' personal integrity, responsibility, and accountability. A person/writer is considered an author as per ICMJE guidelines (available at http://www.icmje.org/) if he has substantial intellectual contribution towards the research or content of publication. He would replace the current system by an open, Web-based disclosure of protocols, data, and statistical assessment, with publication only of systematic reviews based on the study data [13]. To assess whether recent epidemiologic evidence supports an association between use of estrogen replacement therapy or hormone replacement therapy and risk of breast cancer. Copyright: 2009 Gtzsche et al. The European Medical Writers Association has stated that writers usually do not qualify for authorship, although their role should be acknowledged [. It also inhibits CYP2D6 and may affect concentrations of CYP2D6 substrates. https://doi.org/10.1371/journal.pmed.1000023. Yes NJ 08550, Singapore Office Address e286. Unfortunately, we cannot. Complete Healthcare Communications (CHC) claims on its banner that it has honed the systems and skills needed to develop the intellectual heart of pharmaceutical marketingthe publication plan. The result for your product? Articles in medical journals have real effects upon physician prescribing behavior, which is why pharmaceutical companies invest so much in their publication. This suggests that a decrease in the binding capacity of SHBG could potentially diminish SHBG binding to breast cell membranes and increase the rate of cellular proliferation. Join ResearchGate to discover and stay up-to-date with the latest research from leading experts in, Access scientific knowledge from anywhere. https://doi.org/10.1371/journal.pmed.0040286. Additionally, they can be hired by pharmaceutical companies for developing regulatory documents required for drug approval or research protocols, clinical trials and their results etc. Yes stream Such efforts would have to go hand-in-hand with penalties for misconduct [12]. To properly document misconduct, journals and PubMed should use the term misappropriated authorship. Currently, this type of misconduct is listed under erratum, but it is rarely an error. More importantly, ghostwriting threatens the very fabric of science and thus the validity of our medical knowledge, and in doing so it jeopardizes patient care. We offer the perspective of professional medical writers on three strategies that have been considered for tackling ghostwriting. Copyright: 2007 Sergio Sismondo. The involved parties have a common interest in secrecy, and junior researchers can ruin their careers if they reveal that the professor did not write the papers that bear his or her name. Essay All Rights Reserved. The PLoS Medicine Debate In preparing this article, I spent six hours searching web pages for MECCs offering publication planning or similar or overlapping services to the pharmaceutical industry, and found 23 (list available from the author). Authorship makes a person/writer accountable for the published information. (function(d, s, id) { I have seen single-authored meta-analyses on drugs presenting sophisticated analyses that went far beyond the capability of the author, without a word about who did the analyses (and presumably even wrote the paper). Thus, it is important that the scientific articles should be written and published in an ethical manner and should uncover all the advantages and disadvantages/side effects of newer treatment modalities/drugs so that the medical literature is free from bias. We developed two research vignettes presenting a fictional antidepressant medication study, one in which the principal investigator had no COI and another in which there were multiple COI disclosed. ICMJE, Peer review has not been proven to be an effective tool for quality control, so we cannot rely on journals' peer review systems to guard against biases created by ghost managing [4749]. Why are they authors? Phone +1 647 557 6871, USA Office Address With the advances in medical technology and innovations in field of medical sciences and drug development, there has been widespread increase in scientific research papers. 3542AA Utrecht, No, PLOS is a nonprofit 501(c)(3) corporation, #C2354500, based in San Francisco, California, US, https://doi.org/10.1371/journal.pmed.0040286, http://observer.guardian.co.uk/uk_news/story/0,6903,1101680,00.html, http://www.nytimes.com/2005/04/24/business/24drug.html, http://www.cbc.ca/consumers/market/files/health/ghostwriting/, http://query.nytimes.com/gst/fullpage.html?res=9F0DEEDF1239F931A15752C1A9649C8B63&sec=health, http://www.thes.co.uk/search/story.aspx?story_id=2026307, https://doi.org/10.1016/j.cct.2007.08.001, http://www.healyprozac.com/GhostlyData/zoloftpublications.htm, http://www.medicalnewstoday.com/articles/20845.php, http://www.pharmexeceurope.com/europharmexec/article/articleDetail.jsp?id=180670, http://www.chcinc.com/images/datam/report_16.pdf, http://www.pharmexeceurope.com/europharmexec/article/articleDetail.jsp?id=180614, http://www.envisionpharma.com/publicationsPlanning/, http://www.amwa.org/default.asp?Mode=DirectoryDisplay&id=11, http://www.amwa.org/default.asp?Mode=DirectoryDisplay&id=116&DirectoryUseAbsoluteOnSearch=True, http://www.amwa.org/default/conference/2007/opensessions2007.pdf, http://www.excerptamedica.com//index.cfm?vid=59BE809F-C09F-296A-6138C29EE8C69671, http://www.publicationplanningassociation.org/about.aspx, http://www.cbinet.com/show_conference.cfm?confcode=PC07084. It often occurs simultaneously with its opposite, guest authorship (sometimes called honorary or gift authorship), where the contributions of the named authors are so small, or nonexistent, that they do not merit authorship [5,6]. To read the article of this research, you can request a copy directly from the author. It has been repeatedly and firmly established that pharmaceutical company funding strongly biases published results in favor of the company's products [1719]. On the other side, it is possible that some of the identified firms misrepresent themselves, and perform only minimal publication planning. I have some suggestions that might reduce the prevalence of misappropriated authorship: To put it simply: if a cook isn't cooking, what is a cook then doing? Like nonselective NSAIDs, coxibs are hepatically metabolized: rofecoxib primarily by reduction by cytosolic enzymes and celecoxib by the cytochrome P450 (CYP) enzyme system. tel: for Teachers, Parents, and School Officials. For this reason, we must be careful not to impose excessive regulations to solve problems that may not be threatening. <> There may also be policy solutions that would increase transparency in authorship [19,37. Meanwhile, investigators need to be aware of the mechanisms of ghost management of work that goes under their names, and to refuse to participate. But misappropriation of authorship is dishonest [4] and is regarded as scientific misconduct in some jurisdictions like Denmark, where the law states that misappropriation of author role, either deliberately or through serious neglect, is a type of scientific misconduct [7]. 9 0 obj Ghost management of medical journal publications is clearly a substantial business, employing thousands of marketers, writers, and managers. Professional medical writers, who must be distinguished from ghostwriters [18], could be valuable allies to those determined to eradicate ghostwriting. Can all authors take public responsibility for their roles? An alternative strategy is required to tackle ghostwriting. 28 Warwick Road, West Windsor, Methods: We searched PubMed (search terms: ghost writ*, ghostwrit*, ghost writer, ghostwriter, ghostwriting, and ghost writing). 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. Other journals review components of study protocols that are vulnerable to manipulation by the sponsor and will only publish clinical trials that are registered in a public database endorsed by the ICMJE. e1000023. }(document, 'script', 'facebook-jssdk')); 2014 - 2015 Turacoz. Editors and peer reviewers should not accept articles that incorrectly cite or interpret primary publications that report the prevalence of ghostwriting. Such papers incorporate good effects of product while making exaggerated promises and omit its side effects that might adversely affect its usage/ approval/marketing. Authors should retain copies of drafts to facilitate investigations of possible misconduct. Medical ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. It is the responsibility of authors to ensure that the medical writers whose help was sought while preparing manuscript do not remain as ghosts in the underworld. The recent stream of books about the corruptive influence of money on health care research and practice, some of which have been written by editors of our most prestigious journals [13], illustrates just how bad the situation is. Introduction: The systematic review of biomedical ghostwriting has proven challenging due to problems in consistency and in study design. KLW, EW, AJ, AG, and CH have published or presented papers on ethical medical writing practices, are active members of associations in Europe, North America, and the Asia Pacific region for professional medical writers, and provide professional medical writing services to authors from academic, biotechnology, medical device, or pharmaceutical organizations. World Association of Medical Editors. Fully honorary authors may not see enough of the process of the production of their articles to know that they are ghost managed. Similar to NSAIDs, many pharmacodynamic interactions involving coxibs are related to inhibition of production of renal prostaglandins. There are many reports of medical journal articles being researched and written by or on behalf of pharmaceutical companies, and then published under the name of academics who had played little role earlier in the research and writing process [214]. Unadjusted or age-adjusted risk estimates for breast cancer among ever users of estrogen therapy compared with never users were abstracted from published articles or calculated using the data provided in the published reports. CHC, Some honorary authors are senior professors and chairs of departments, who are added to articles because of local academic politics rather than at the request of drug companies [15,16]. No, Is the Subject Area "Advertising" applicable to this article? Regulatory authorities, on the other hand, use this literature for drug approval process or for formulating new policies. Studies have consistently documented that HRT use is associated with improved mortality and survival rates for women with breast cancer. While the impact of conflicts-of-interest (COI) is of increasing concern in academic medicine, there is little research on the reaction of practicing clinicians to the disclosure of such conflicts. endobj Citation: Gtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A, et al. It is usually deliberate. Ghostwriting an ongoing problem in medical literature This week in PLoS Medicine , an article concludes that ghostwriting is still a widespread problem with few solid solutions visible, following the exposure by PLoS Medicine and The New York Times of substantial ghostwriting by Wyeth, a pharmaceutical giant, to promote its hormone drug Prempro two years ago. In addition, MeSH or clearer indexing terms may be helpful to separate usages of ghostwriting in scientific settings (e.g., genetic research) versus biomedical publishing. More stringent requirements may be necessary, however. Neither the industry nor the profession can afford further damage to their reputations. xU[o0~G?G35wcZ,I:jm4R@$n^|.1=OH*ON|g8J/)PKQ OPneGVrG'Xf09@zIt0B0AG; %tII1S y/F&U".qdFiQ&n Much of the information on ghost writing does not help to answer this question. To read the full-text of this research, you can request a copy directly from the author. In addition to the publication planners, a much higher number of medical writing companies and individual writers create articles and presentations without engaging in broader publication planning; these may be adjuncts to publication planners. https://doi.org/10.1371/journal.pmed.1000023.st001. endobj "It was clear in my e-mail interaction with the author that this person was frightened and didn't realize that they had gotten themselves into such hot water that it could have potential implications for their position," she says. On its Web site is a list of ten hypothetical trials and at least 24 articles that can be written from them, which will lead to a completed bibliography of publications [34]. if (d.getElementById(id)) return; Is the Subject Area "Medical journals" applicable to this article? Some journals require that authors have had full control of the primary data, have carried out the statistical tests themselves (e.g., JAMA), and have created tables and figures themselves. And research funding or consulting opportunities may follow. Nonetheless, 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. Other kinds of ghost involvement are more ambiguous. So how common is ghost management? fjs.parentNode.insertBefore(js, fjs); 145 Traders Boulevard East, #20, Mississauga, ON L4Z 3L3 It has been estimated that 6% of all papers in medical literature are developed by the help of medical writers and are based on studies sponsored by nonprofit organizations. Company statisticians were common unacknowledged contributors, but so were the creators of trial designs and protocols, and the writers of manuscripts. | 19 Fulton Street, Suite 407, New York, NY 10038 Lastly, the accuracy or integrity of the work should have been adequately investigated by the authors and issues if any should have been resolved by them. In trying to understand the prevalence, we are stymied because we just don't know what we don't know. var js, fjs = d.getElementsByTagName(s)[0]; 4 0 obj Such articles are ghostly because signs of their actual production are largely invisibleacademic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility. 7 0 obj Changing contexts and definitions of scientific authorship. Citation: Gtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A, et al. Even if the more typical figure is half that, ghost management exerts a huge force on the shape of scientific opinion on new drugs, and does so in the service of marketing. Ghostwriters are the ones who are hired by pharmaceutical companies for drafting scientific articles for purpose of marketing their product. While we cannot know all of the ways in which the CMD document represents other publication efforts, there is strong evidence that ghost management of medical research is common and is part of campaigns by pharmaceutical companies to publish favorable results and key marketing messages. Yes Results, including abstracts, were reviewed for relevance (relationship to ghostwriting in biomedical journals) to aid in removal of inapplicable work and duplicate publications. Funding: Research for this article was supported in part by a grant from the Social Sciences and Humanities Research Council of Canada. Part of the problem is that good names give papers credibility. Yes Some busy independent research units hire writers to improve manuscripts; Max Lagnado has argued that professional medical writers can benefit the scientific community when used in a responsible manner [15]. Clinicians in the COI group were also less likely to recommend the antidepressant medication discussed in the vignette (Odds Ratio = 0.163, 95% CI = .03 = 0.875). While medical writers are hired for their skill, efficiency, speed, and expertise in the field, ghostwriting is perceived by scientific community as an intent to deceive. Perhaps they need to be more modest about how many articles they can publish, and more realistic about the amount of effort, legwork, and/or creativity it takes to publish an article. 1 0 obj To get authorship credit without breaking a sweat can help with publish or perish pressures. Organizations trying to eradicate ghostwriting could educate their members about the checklist. We should be able to believe what we read, and trust that knowledge when we plan experiments and treat patients. No, Is the Subject Area "Oncology" applicable to this article? Perceived credibility ratings were much lower in the COI group, with a difference of 11.00 points (31.42%) on the credibility scale total as calculated through the Mann-Whitney U test (95% CI = 6.99 - 15.00, p < .001). Distancing himself from the Annals article, first author Jeffrey Lisse said in an interview that Merck designed the trial, paid for the trial, ran the trialMerck came to me after the study was completed and said, We want your help to work on the paper. The initial paper was written at Merck, and then it was sent to me for editing [4]. None of the viewpoints have been externally peer reviewed. It is large enough that the industry has established the International Publication Planning Association. Yes More recent journalistic uses of the term ghostwriting suggest confusion with topics such as financial disclosures or patient monitoring. The professor may have contributed, but almost certainly wrote only a minority of them. New legislation will shortly mandate increased disclosure of industry payments to physicians, and once this information is available on the internet, it will be a simple matter for medical journals to aggregate these data and disclose the exact amounts of financial COI [36], exactly as we did in our vignette. Until such changes come about, at least we can hope for more awareness of and responsiveness to the issue. Yes Editors 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). We found little consistency among studies that estimated the risk of breast cancer in hormone users compared with nonusers and in studies assessing the risk by duration of use. 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Statistical assistance, some researchers need statistical assistance, some researchers need writing assistance your manuscript, you can a Making exaggerated promises and omit its side effects that might adversely affect its usage/ approval/marketing the journal guidelines As rifampin, may decrease rofecoxib concentrations because of the articles published on sertraline secondary. Failure of medical writers can help authors avoid nonpublication by completing many of ghostwriting in medical literature article writer! The issue, however, coxibs have No antiplatelet activity and may affect concentrations of CYP2D6 substrates more! Definition of ghostwriting Gtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs a, al Journals and containing original data were included in this study, increased disclosure of journal