PLoS Med 2009; 6: e1000156. What might this mean in practice for journals? 2009; 6 :e1000156. The FCA, in conjunction with the Anti-Kickback Statute, can also be utilized to curb unethical ghostwriting. Looking beyond the spin of Big Pharma PR. FCA inflicts civil liability against persons or entities presenting false payment claims or using false records or statements to get claims paid or approved or causing third parties to do so. Add your ORCID here. Made critical revisions and approved final version: XB BE LM. Frederic Curtiss, editor-in-chief of the Journal of Managed Care Pharmacy, recently told Brendan Borrell of Reuters Health he’s found a way to suss out undisclosed writers by analyzing the metadata on Word documents that he receives. But journal polices should also include enforceable sanctions. “I’ll publish right or wrong. In 2008, the overall prevalence of articles with honorary authorship, ghost authorship, or both, was 21.0%, which represented a decline from 29.1% in 1996. They concede individual damages would be nominal but suggest that potential liability and reputational harm may curb ghostwriting. Recruitment of academic “authors” appears, within some academic circles, to have come to be considered acceptable, and marketing campaigns are no longer orchestrated around paid display advertisements but instead center on “evidence” provided by seemingly respectable academic review articles, original research articles, and even reports of clinical trials. Conceived and designed the experiments: XB BE LM. WAME (2005) Ghost writing initiated by commercial companies. Add your ORCID here. Nonetheless, even for a casual reader, they are a compelling read. They are posted in the form in which we received them and hence are not categorised. The PLoS Medicine Editors are Virginia Barbour, Jocalyn Clark, Susan Jones, Larry Peiperl, Emma Veitch, and Gavin Yamey. By . University Diaries » UD is, at bottom, sentimental. The manufacturer then retains various KOLs and reputable university professors to lend their names and credentials to the drafted article. Clearly, deliberately omitting legitimate names from the authorship line-up is unethical,  and medical writers are justified in demanding that they be appropriately acknowledged. For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries. The PLoS Medicine Editors (2009) An unbiased scientific record should be everyone’s agenda. Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger, http://dianthus.co.uk/ghostwriting-survey, Big Pharma and Medicine: Is it Unrealistic to Apply the Same Ethical Standards to Publishing Research? In addition to the claims for personal injuries caused by the guest authors' fraud, should the article constitute illegal off-label promotion by the pharmaceutical company, then the guest author may be held liable potentially as a conspirator under the federal False Claims Act (FCA) [32]. Curr Med Res Opin 19: 149-154. But the distinction that is less clear deals with ghostwriters who are independent of all industry, simply medical wordsmiths whose services are sometimes hired to help improve a paper’s grammar, flow, and overall clarity. In the case of the documents deposited here, a good start, and a signal of the seriousness of journals’ intent, would be the formal retraction of all the papers mentioned in which ghostwriting has been conclusively shown. Wager E (2007) Authors, ghosts, damned lies, and statisticians. Enter your email address to follow this blog and receive notifications of new posts by email. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Obtaining formulary coverage for off-label drug uses in the US can be especially hard, but approval can be advanced by articles supporting off-label use. Ghostwriting: The dirty little secret of medical publishing that just got bigger. Of course, in those cases, the name of the ghostwriter typically appears on the cover. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. As the influential Justice Benjamin Cardozo noted long ago: “It is ancient learning that one who assumes to act, even though gratuitously, may thereby become subject to the duty of acting carefully, if he acts at all.” [26] When US courts have considered misrepresentations that implicate a risk of physical harm to others, they have often looked to the rules set forth in the Restatement Second of Torts, sections 310 and 311 [27]. Finally, once guest authors realize they could be personally liable for the bodily injuries resulting from their misrepresentations, they and other potential guest authors will be deterred from engaging in such unethical and illegal behavior. In addition, despite efforts to reinforce authorship and publication requirements, journals' responses to ghostwriting remain unsatisfactory, as shown by a recent study of 630 articles from six high impact medical journals [24]. We’d argue, therefore, that all involved must adopt a much tougher approach of complete nontolerance to practices that aim to conceal authors or where the involvement of medical writers goes beyond technical support. If you are an editor, author, reviewer, or reader of medical journals, or if you depend on your doctor or health care provider getting unbiased information from medical journals, then the 1,500 documents now hosted on the PLoS Medicine Web site should make you very concerned and angry. Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. Medscape Gen Med 2007;9:16.) Over the past several years some journals and editors’ organizations [9,10], and even some individual medical writers [11], have pursued what might be called a war of attrition against the practice by requiring contributorship statements for authors and publishing them, insisting on the naming of all who were involved in writing, requiring detailed competing interest statements, and detailing and publishing the provenance of non-research articles. Ghostwriting: The dirty little secret of medical publishing that just got bigger. But even in condemning ghostwriting they revealed the complexities of its definition. In an academic_editorial highlighting the 1,500 documents made public after PLoS Medicine's intervention in a court case, the PLoS Medicine academic_editors call for strong action to be taken to eradicate this practice Topics: Editorial . « Kate Johnson's Medical Musings. Moreover, the US Supreme Court has firmly held that “the First Amendment does not shield fraud” [49] and courts have consistently rejected such First Amendment arguments in cases in which drug companies have been sued for fraudulent or off-label promotion [50]. […] I guess. Couldn’t agree more with Roger Collier, at CMAJ. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. Hide notes; Make a general comment; Xavier Bosch 1 *, Bijan Esfandiari 2, Leemon McHenry 3. In other words, intellectual contribution alone is not enough. We therefore recommend that in cases where patients are harmed as a result of a pharmaceutical manufacturer's fraudulent representations involving ghostwritten articles, serious consideration should be given to naming as defendants the guest authors who lent their names to the misrepresentations. Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, et al. The threat of civil and potential criminal prosecution is another potential manner of curbing guest authorship, especially when it is the result of reciprocal agreements between physicians/guest-authors to prescribe the drug and manufacturers promising to use the physician as a guest author. We fully agree with Stern and Lemmens that the legal system could be effective in curbing ghostwriting, and suggest the following models of liability. While editors, medical schools, and universities have turned a blind eye to, or at the least failed to tackle head-on the pervasive presence of ghostwriting, drug companies and medical education and communication companies have built a vast and profitable ghostwriting industry. Make your work accessible to all, without restrictions, and accelerate scientific discovery with options like preprints and published peer review that make your work more Open. Article; Metrics; Related Content; Comments: 0; To add a note, highlight some text. As a medical editor I strongly discourage this degree of “co-operation” because of the disjointed and chaotic results. Ghostwriting from “The Inside” : Outrage Hinges on Unclear Definitions. We have also passed these documents to the Drug Industry Document Archive at UCSF who will be sorting and posting them on their site. [ PMC free article ] [ PubMed ] Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, et al. 2009;6(9):e1000156. Save my name and email for the next time I comment. In particular, the FCA qui tam provision permits a private person, known as a relator, to file a lawsuit on behalf of the US government, on grounds that he or she has information that the named defendant has intentionally submitted, or instigated the submission of, false or fraudulent claims to the United States [34]. So what can be done? Substantial contribution to manuscript design or drafting is of little significance when marketing messages are planted in the ghostwriter's first draft well before a nominal author is selected. 7. In 2008, the percentage of respondents who said their requests for authorship were always or usually granted was 48% and 40% respectively. After all, even drug company employees get sick; do they trust ghost authors? PLoS Med. The article is published in a widely read medical journal and physicians begin to prescribe the drug in reliance on the article's claims and the “authors'” reputations. The PLoS Medicine Editors * Author ... What's clear is that ghostwriting can no longer be considered one of the “dirty little secrets” of medical publishing that nothing can be done about. The journal’s authorship policy requires disclosure of anyone who contributes more than 1% of a manuscript, while anyone who contributes more than 25% of a manuscript must be a listed author, writes Borrell. Suffice it to say, there is no widely accepted definition of what precisely constitutes medical authorship, so it is not surprising that the idea of ghostwriting, even when it is clearly independent of all industry connections, is accepted by some, while vehemently rejected by others. Ghostwriting: the dirty little secret of medical publishing that just got bigger. 2009 Jun;15(5):383-95). PLoS Med. Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger . Abstract. Classified as a felony, the maximum individual punishments are fines of up to US$250,000 and imprisonment for up to five years [46]. (2009) What should be done to tackle ghostwriting in the medical literature? If ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals are used as clinical evidence to establish medically accepted indications for off-label drugs, they are arguably inducing prescriptions to be written and paid for by the US government under false pretenses. 12. The potential damages at issue can be significant and will depend on the plaintiff's injury and the egregious nature of defendants' conduct. Your email address will not be published. Analyzed the data: XB BE LM. (2007) Ghost Authorship in Industry-Initiated Randomised Trials. Ghostwriting documents now fully available on PLoS Medicine website. Lea A (2003) Totelle manuscripts sign-off and review [E-mail]. Building upon the recent Stern and Lemmens article that proposed viewing ghostwriting as fraud [16], this Essay expands on the possible legal remedies for medical ghostwriting that can help outlaw a practice that has long tainted journal content and jeopardized patient safety. Another 29% based their instructions on the ICJME criteria, while 14% proposed other criteria and 14% stated only that all authors should approve the manuscript (Wager E. Do medical journals provide clear and consistent guidelines on authorship? However, the same level of protection does not apply to commercial speech, i.e., speech promoting the safety/sale of a drug. Ross JS, Hill KP, Egilman DS, Krumholz HM. doi:10.1371/journal.pmed.1000038, 4. Whatever the reasons, as the pipeline for new drugs dries up and companies increasingly scramble for an ever-diminishing proportion of the market in “me-too” drugs, the medical publishing and pharmaceutical industries and the medical academic community have become locked into a cycle of mutual dependency, in which truth and a lack of bias have come to be seen as optional extras. Without a clear definition of authorship, the extent of a writer’s contribution is subjective, and the issue becomes very delicate indeed. In an editorial after the story broke, entitled Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger, the PLoS editors wrote “attempting to hide the presence of ghostwriters or the involvement of writers beyond technical support, such as copyediting, is unacceptable”. doi:10.1371/journal.pmed.0040019. Sections 310 and 311 of the Restatement allow injured third parties to recover from a person who has made an intentional and negligent misrepresentation inducing action that involves a risk of physical harm [28]. If the ghostwritten article causes physicians to prescribe a drug for off-label use to patients on government assistance, the prices paid by the government for these off-label prescriptions can be obtained as damages (and trebled) in a successful FCA prosecution. Third, this will, we hope, force guest authors to review the data and independently confirm the conclusions prior to lending their names to articles drafted for them by manufacturers. OpenUrl CrossRef PubMed ↵ Ross JS, Hill KP, Egilman DS, et al. [33], private individual actions under the FCA (also known as qui tam actions) allow company insiders and others with special knowledge of potential violations to initiate legal actions, which the government may join or take over. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers. This study concluded that inappropriate authorship remains a significant problem in high impact biomedical publications. Under the FCA, lawsuits have been brought for FDCA violations against drug companies, based in part upon the company's utilization of ghostwritten articles to support illegal off-label use that induces physicians to prescribe medication for unapproved uses. […] scientific ghostwriting? JAMA 299: 1800-1812. PLoS Med. Corruption of the scientific literature through ghostwriting persists in medicine due to the enormous profits for all stakeholders [15], including the pharmaceutical industry that creates the publication strategy, academic researchers acting as key opinion leaders (KOLs) for industry, universities employing KOLs, medical journals and their proprietors, including medical societies and publishers, and medical communication companies employing ghostwriters. 9. Guest authors cannot claim immunity from the law by stating that they relied on data summaries presented by the pharmaceutical company. Competing interests: BE has participated as an attorney in litigation involving Prozac, Paxil, and Avandia and other pharmaceutical products. PLoS Med 6(2): e1000023. Abbreviations: FCA, False Claims Act; KOL, key opinion leader. We endorse this novel theory and the other theories (i.e., fraud on the court) Stern and Lemmens advance. PLoS Med 4(1): e19. Some would like to see that practice adopted by medical publishers”. PLoS Med. In this Essay, we build on a recent analysis by Stern and Lemmens in. The Corporate Corruption of Higher Education: […], […] an editorial after the story broke, entitled Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger, the PLoS editors wrote “attempting to hide the presence of ghostwriters or the involvement of […]. Wrote the first draft of the manuscript: XB BE LM. doi:10.1371/journal.pmed.1001163. To quote a section of the article: In the […], […] (2)   PLoS One. “We are a journal that has very tough policies, very explicit policies on ghostwriting and contributorship, and I feel that we’ve basically been lied to by authors,” she told the New York Times. If you are an editor, author, reviewer, or reader of medical journals, or if you depend on your doctor or health care provider getting unbiased information from medical journals, then the 1,500 documents now hosted  on the PLoS Medicine Web site should make you very concerned and angry [1]. Curtiss estimates that every third manuscript he receives has metadata that doesn’t match listed authors,” writes Reuters’ Brendan Borrell. To Prevent Dementia, Keep Your Heart Young. Funding: No specific funding was received for writing this article. By . Accordingly, the First Amendment should not provide any sanctuary to guest authors and pharmaceutical companies engaged in fraudulent commercial speech. But we also hope that the papers not only will become the subject of academic scrutiny but will help to guide the way to identifying reforms that will eventually stamp ghostwriting out. JAMA 299: 1833-1835. Indeed, even the policies adopted by the International Committee of Medical Journal Editors have failed to clarify how the corruption of medical literature could be curtailed [14]. Copyright: © 2012 Bosch et al. Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. The following hypothetical case, which is applicable to many real world events, illustrates how liability can be established: A drug manufacturer conducts a study whose primary endpoints show the study drug poses serious risks and is not effective. We wish to thank Michael Baum for suggestions on style. PLoS Med 6(2): e1000038. (2011). PLoS Medicine became involved in this particular ghostwriting story when we intervened in an ongoing court case in which women were suing Wyeth, the manufacturers of Prempro, a hormone replacement therapy. Accessed 19 August 2009. Although other journals, most notably PLoS Medicine, as well as several editors' associations have produced policies against the practice, in some cases adopting clear and visible positions, little has changed [1],[6],[11],[21]–[23]. Why then the outrage from the general public? ( Log Out /  Obviously, if four names appear on a paper, it is unlikely that all four people sat down and typed individual sections. LINK TO THE FULL SET OF GHOSTWRITING DOCUMENTS: http://www.plosmedicine.org/static/ghostwriting.action, Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger. It seems that many scientific papers receive funding from food corporations, the source of which is often disclosed. Available : http://www.plos.org/ghostwriting/Exhibits2/CONSG204-014513.TIF. Others have written about ghostwriting campaigns concerning single drugs that have led to catastrophic health effects [7], and how even research papers and clinical trials are affected by ghost authors [7,8]. « Kate Johnson's Medical Musings, Spinning the Science: Big Pharma’s Not Alone. In their defense, guest authors and pharmaceutical defendants may try to argue they have a First Amendment right to participate in ghostwriting. For example, if nothing is declared on submission but inappropriate involvement of a medical writer subsequently comes to light, any papers where this breach is substantiated should be immediately retracted and those authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions. Editorial Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger The PLoS Medicine Editors* Scientists credited on ghostwritten articles 'should be charged with fraud' Ghostwritten medical articles called fraud CBC News Posted: Aug 02, 2011 6:18 PM ET Institutions whose academics are shown to be involved should investigate as a matter of urgency. 0000-0002-7299-680X), PLOS is a nonprofit 501(c)(3) corporation, #C2354500, and is based in San Francisco, California, US, PLOS will use your email address to provide news and updates. This is clearly a corruption of science and an indisputable attempt to mislead doctors and the public. Ghostwriting: the dirty little secret of medical publishing that just got bigger. And companies need to consider whether the arms race they have started will in the end benefit anyone. Well, yes. Honorary and ghost authorship in high impact biomedical journals: across sectional survey. Since self-regulation has not produced results and the government has failed to have any significant impact, we argue that the only remaining option is the legal system. ( Log Out /  “So a distinction starts to emerge between roles, and authorship starts to become dissociated with writing.”. According to the World Association of  Medical Editors, “everyone who has made substantial intellectual contributions to the study on which the article is based (for example, to the research question, design, analysis, interpretation, and written description) should be an author. Accessed 19 August 2009. Publisher: Public Library of Science. Ghostwriting: the dirty little secret of medical publishing that just got bigger. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute. doi: 10.1371/journal.pmed.1000156 . Post was not sent - check your email addresses! Some editors, fully aware that ghostwritten manuscripts are submitted to their journals, refuse to police their content [20]. Available : http://www.icmje.org/#author. The answer is that, sadly, for some or even many journal articles, we just don’t know. Based on this description, it’s pretty clear that some, but not all editing should confer authorship. We also thank Trudo Lemmens for the invitation to BE and LM to present parts of this paper at “The Ethics of Ghost Authorship in Biomedical Research: Concerns and Remedies,” Faculty of Law, University of Toronto, May 4, 2011. But it seems that these tactics are simply not enough to prevent ghostwriting, and are being sidestepped by those involved. As Roger Collier recently pointed out in the Canadian Medical Association Journal, “Ghostwriting is common in published literature, from the autobiographies of politicians to the memoirs of celebrities. In a recent blog and op-ed newspaper article I wrote about my freelance role as an independent  medical writer and editor. Under these circumstances, the injured patients and their families sue the manufacturer for injuries and death caused by the drug's side effects. JAMA 2008; 299: 1800 – 12. (2009). (J Manag Care Pharm. But the WAME statement continues: “Only an individual who has made substantial intellectual contributions should be an author.” Performing “technical services”, among a list of other things, is not sufficient for authorship, “although these contributions may be acknowledged in the manuscript, as described below.”. You can find out more about how PLOS processes your data by reading our, http://www.plosmedicine.org/static/ghostwriting.action, then the 1,500 documents now hosted  on the, http://www.plos.org/ghostwriting/Exhibits2/CONSG204-014513.TIF, http://www.wame.org/resources/policies#ghost, http://basic1.easily.co.uk/03100E/00605D/GPP.pdf, Ghostwriting Documents Available at PLoS Medicine | The Intersection | Discover Magazine. 11. Available: http://www.wame.org/resources/policies#ghost. You write “the Times focuses on ghostwriters who were hired by drug companies to spin the science in favor of their products. But the same survey also found that writers’ requests for authorship are not always granted. Excellent expose and great example of the need for transparency and open access journals. During the discovery process for this case, one of the lawyers representing injured women in the litigation, Jim Szaller of Cleveland, Ohio, became aware of many documents that laid out in detail the company’s (mostly successful) attempts to publish papers written by unacknowledged professional medical writers in which the message, tone, and content had been determined by the company but the paper was subsequently nominally “authored” by respected academics—in sum a coordinated and carefully monitored campaign of ghostwriting. Ghostwriting – from “The Inside”: Outrage Hinges on Unclear Definitions, on ghostwriters who were hired by drug companies, recently told Brendan Borrell of Reuters Health, he International Committee of Medical Journal Editors (ICMJE).

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