Ghostwriting guest authorship

Commentshow to join pubmed commonshow to cite this comment:Ncbi > literature > on: stern s, lemmens t (2011) legal remedies for medical ghostwriting: imposing fraud liability on guest authors of ghostwritten articles. Plos med8(8):Racketeer influenced and corrupt organizations actprovenance: invited; externally peer riting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal l journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective practice of ghostwriting could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghostwritten argue that a guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the racketeer influenced and corrupt organizations act (rico). This claim also appropriately reflects the negative impact of ghostwriting on the legal uctionthere are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical interventions and overestimation of the clinical benefit of a drug used to treat patients [1]. An especially problematic issue involves the industry practice of publishing studies prepared by hired medical writers but signed by academic “guest authors” who are invited to add their names without fulfilling authorship criteria. In this case, “guest authorship” is accompanied by “ghostwriting,” which occurs when a published article fails to acknowledge the original writer or writers' contributions [2]–[4]. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article based on data generated by the group. Here, we concentrate on ghostwriting and guest authorship in industry-controlled research, where several examples have revealed the use of ghostwriters to insert concealed marketing messages favourable to a company's product, and the recruitment of academics as “guest” authors despite not fulfilling authorship criteria [5]–[9].

Ghostwriting i guest authorship

Have condemned the practice as unethical and unacceptable and have discussed the harms resulting from this form of medical ghostwriting, recommending that journal submissions be policed more aggressively and that the “guest authors” be suitably sanctioned by journals, academic institutions, and regulatory agencies [1]–[14]. Here, we discuss some of the reasons for this lack of response and suggest that the law may offer a solution, given these other institutions' failure to impose ns about guest authorshipguest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability [15]. In turn, academics receive considerable credit for publication, thus providing an incentive for their willingness to act as “guests. Industry-controlled publications that are prepared by ghostwriters or that use guest authors may distort perceptions about current knowledge concerning a product's safety and effectiveness. By facilitating publication in peer-reviewed journals, guest authorship creates the impression that standards of academic independence and integrity have been satisfied even when they have not, and makes it more likely that the research will be treated as legally admissible even when this is ations on which academics appear as guest authors also give credibility to these authors in the legal setting. As a result, the treatment of the guest author as a legal expert may prevent scrutiny of the practice that is being challenged for contributing to serious harm. Often, the manipulations that influence the outcome are not visible to the guest author, whose role in the study or article may be minimal and may fall short of authorship criteria that would require involvement in the development and conduct of the study, and final approval of the paper.

Thus, guest authors help create the appearance that a study reflects the kind of “scientific methodology” that is required to render evidence admissible under the daubert standard, and in the process they credentialize themselves as expert witnesses who can speak authoritatively about a product's efficacy and g ghostwriting practicesthe international committee of medical journal editors (icmje), in establishing leading standards for biomedical publications, has sought to curb inappropriate and unethical authorship practices by requiring that journals ask detailed questions about what exactly each author has contributed to an article [23]. For example, the world association of medical editors (wame) says that ghostwriting is “dishonest and unacceptable,” and recommends that on detecting the practice, a journal should “(1) publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author; (2) alert the authors' academic institutions, identifying the commercial companies; (3) provide specific names if contacted by the popular media or government organizations; and (4) share their experiences on the wame listserve and within other forums” [24]. Similarly, the committee on publication ethics (cope) recommends that journal editors “adop[t] authorship or contributorship systems that promote good practice (i. Ghost and guest authors)” and recommends that when the integrity of research is corrupted, “[e]rrors, [and] inaccurate or misleading statements must be corrected promptly and with due prominence” [25]. Journals, such as plos medicine, have called for bans on future submissions by authors who act as guests, formal retraction if unacknowledged ghostwriting is discovered after publication, and reporting of authors' misconduct to institutions [26]. Various reasons explain an institutional reluctance to take this route: the guest's role in the ghostwritten publications may be unclear; academic institutions may be challenged by their dual commitments to safeguard academic integrity while also protecting their employees against unjust accusation; and universities in particular tend to approach authorship questions with understandable prudence, considering the serious potential impact on academic careers. Academic institutions may also be reluctant to act because ghostwriting cases often involve successful academics who hold positions of power due to their prestige, academic status, publication record, and grant er, institutions may decide not to act because the practices involved in ghost and guest authorship may not be far removed from other common publication practices in academic medicine where laboratory directors, departmental chairs, and supervisors often claim authorship on publications because of those institutional roles rather than by standard authorship criteria [2].

Pursuing sanctions for ghostwritten articles may open a pandora's box, leading to scrutiny of other authorship practices in academia, or to anxiety-laden efforts to justify those practices [30]. Organizations, such as state medical boards in the us, colleges of physicians and surgeons in canada, and the general medical council in the united kingdom, could also intervene when evidence of guest authorship by licensed heath care professionals is uncovered, particularly if it involves outright misrepresentation of data [1]. These professional organizations have so far failed to issue serious sanctions in the rare cases when an organization has looked into allegations of authorship violations [31]. Finally, for the same reasons as the academic institutions, professional organizations may be uncomfortable about confronting problems of guest authorship and ghostwriting that damage their light of the lack of institutional responses to curb the practices of ghostwriting and guest authorship and in light of the significance of these practices for the legal system, we suggest that a firm legal response is liability for ghostwritingan important starting point for a legal response involves the icmje uniform guidelines [23] and the authorship forms used by many medical journals based on those guidelines. The guidelines were designed to ensure that authorship credit is reserved to those who have played a significant role in the study's design, conduct, and analysis, and writing of the article. Guest authors” often fail both of the first two requirements, as suggested by evidence that has been revealed in recent class actions involving drugs such as vioxx (rofecoxib), prempro (combined estrogen/progestin), and paxil (paroxetine) [6],[7],[27]. For example, an individual who reads an article and/or offers minor comments has offered nothing substantial under criteria 1 and authorship requirements are known not only to named authors but also to readers.

The warranty of authorship is an important factor in ascertaining an article's integrity and quality. To see this, we need only ask how readers would react to an article prefaced with a statement that a lead author has refused to sign (or has repudiated) the authorship warranty, and now wishes to clarify the contributions of an industry-based medical writer. Authorship as above thought experiment, involving a guest author who admits to playing that role, shows that a false affirmation of authorship is an example of fraud. Here, the guest's false claim—asserted in the authorship warranty—induces the journal to publish the article, and misleads readers about the scholarly care and scrutiny lavished on the research. The journal gives the guest credit for an article that may serve as a valuable credential, by impressing academic merit committees, grant agencies, conference organizers, and others including judges and juries if the guest later acts as an expert witness [37]. The journal loses the opportunity to publish an article that would legitimately have satisfied the authorship requirements. If the journal became aware that the lead author was a mere guest, and that the journal's authorship requirements had not been satisfied, the journal would not publish the characterization of guest authorship as fraud has received limited but important recognition in suits involving the false claims act (fca), which imposes liability on those who cause fraudulent claims to be presented to the us government [38].

In strom, it appears that the unwarranted claims made in the ghostwritten articles, rather than their fraudulent authorship, helped to support the allegations of fraud. This approach has great potential, but it will not always be easy to prove the falsity of ghostwritten strom shows, the fraud underlying these articles cannot be attributed solely to the guest author, who after all has responded to an invitation. If a guest lends her name to two or more articles for the same product, she may satisfy the rico criteria in several different ways, because the purposes, results, participants, and methods of commission are the same. A journal's readers are all harmed by the fraud, they may sue the guest in a civil rico class action [43],[44]. Readers would not willingly pay for the fraudulent articles, as shown by the hypothetical example of a guest author who disclaims responsibility for authorship. These readers, too, will assume that the article meets the journal's requirements, and they would also be unlikely to pay if they first saw a disclaimer of authorship responsibility. These purchasers might constitute a distinct subclass in a rico class action, with damages based on the cost of the prevail, the plaintiffs would not have to prove individually that they relied on the guest's fraudulent claim.

Once a plaintiff establishes that the article was ghostwritten, and shows that he or she paid for a subscription or a download, she has sufficiently established fraud, reliance, and harm for the whole class of rico should this approach be directed against guest authors, rather than the others who are complicit in the same fraud? Just as the integrity of medical research is a key factor in recognizing false authorship warranties as fraud, the courts' concern about the integrity of their proceedings is key to the doctrine of “fraud on the court. The facts are worth reviewing, because their significance is easily misunderstood—and to the best of our knowledge, the case has not been cited by any commentators on medical ghostwriting. Explaining why hartford's actions merited sanction, the supreme court offered several observations that apply with equal force to current examples of medical ghostwriting. The court stated that using spurious claims of authorship to legitimate claims before the patent office and the courts “is a wrong against the institutions set up to protect and safeguard the public” [48]. Precisely the same could be said about ghostwritten articles published in medical journals through false warranties of authorship. However, a restriction on the legal use of articles to which guest authors have added their name could significantly diminish their overall value.

Today, as in 1944, one might expect the sponsors of ghostwritten articles to treat the question of false authorship as an insignificant detail that merits no legal sanction. The us supreme court's comments provide a sufficient rebuttal to such paper was presented at the conference on the ethics of ghost authorship in biomedical research: concerns and remedies, organized by the authors with support from the centre for innovation law and policy, the centre for ethics, and the faculty of law at the university of toronto on may 4, 2011. Wrote the first draft of sections 1 and 2, and had primary responsibility for the discussion of concerns associated with ghostwriting: tl. Matheson2008corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical d, cattell d (2003) interface between authorship, industry and science in the domain of therapeutics. Cattell2003interface between authorship, industry and science in the domain of j 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 -berman aj (2010) the haunting of medical journals: how ghostwriting sold ‘hrt. The international journal of risk and safety in medicine 20: 183– jureidinilb mchenrypr mansfield2008clinical trials and drug promotion: selective reporting of study international journal of risk and safety in n kr, lassere mnd (2008) guest authorship, mortality reporting, and integrity in rofecoxib studies.

Jama 300: 900; author reply 904-906: kr johnsonmnd lassere2008guest authorship, mortality reporting, and integrity in rofecoxib 300: 900; author in a, carey la, fontanarosa pb, phillips sg, pace bp, et al. Hróbjartssonhk johansenmt haahrdg altman2007ghost authorship in industry-initiated randomised states senate committee on finance (2010) ghostwriting in medical literature minority staff report, 111th congress, sen. United states senate committee on finance2010ghostwriting in medical literature minority staff report, 111th congress, s e. 2010) the financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication. Lieb2010the financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and arztebl itz a (2006) turning medicine into snake oil, how pharmaceutical marketers put patients at risk. Pirg plos medicine (2009) ghostwriting: the dirty little secret of medical publishing that just got bigger. Plos med 6: plos medicine2009ghostwriting: the dirty little secret of medical publishing that just got y lb, jureidini j (2008) industry-sponsored ghostwriting in clinical trial reporting: a case study.

Jureidini2008industry-sponsored ghostwriting in clinical trial reporting: a case tability in r (2006) lapses at the new england journal of medicine. Moffat2011responsible authorship: why researchers must forgo honorary t d (2006) a short history of the general medical council. Irvine2006a short history of the general medical l e jr, leo j (2011) knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research. Leo2011knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research vlife investors ins. Plos riting revisited: new perspectives but few solutions in the ghost in the machine: a medical ghostwriter's personal industry uses the icmje guidelines to manipulate authorship—and how they should be ed in the following riting more information about plos subject areas, want your feedback. Authorship and ghostwriting in publications related to rofecoxiba case study of industry documents from rofecoxib s. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little ive to characterize different types and the extent of guest authorship and ghostwriting in 1 case sources court documents originally obtained during litigation related to rofecoxib against merck & co inc.

In addition, publicly available articles related to rofecoxib identified via extraction all documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or synthesis approximately 250 documents were relevant to our review. Recruited authors were frequently placed in the first and second positions of the authorship list. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of merck sponsorship or a disclosure of whether the author had received any financial compensation from the sions this case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial ing the integrity of medical in to access your in to your personal utional sign in: openathens | a free personal account to download free article pdfs,Sign up for alerts, and ibe to the in to access your in to your personal a free personal account to access your subscriptions, sign up for alerts, and ibe to learning for one in to download free article in to access your in to your personal utional sign in: openathens | a free personal account to download free article pdfs,Sign up for alerts, and more. Pmc3149079legal remedies for medical ghostwriting: imposing fraud liability on guest authors of ghostwritten articlessimon stern. Bibliography and of reviewers – ct of interest and animal rism, ghostwriting and guest authorship for ure of the graphy and rism, ghostwriting and guest authorship rism means that significant parts of the article are not paraphrased and / or resources are not given, but are copied as in the original text. This also concerns not mentioning the role of persons having contributed in one or the other way to the authorship (honorary authorship) means that a person is mentioned as the author or co-author of an article without having contributed at all to the editorial board of the journal implements anti-ghostwriting  procedure and strict plagiarism detection the detected cases of plagiarism, ghostwriting and plagiarism  will be exposed, including notification of relevant institutions.

All the authors must fulfill and sign the declaration concerning plagiarism, ghostwriting, and guest a more advanced search engine, enabling to search full texts of all the articles published by borgis publishing, please visit medical publisher.