121:
groups in medicine including the
European Medical Writers Association (EMWA) sanction this practice. While the average reader likely interprets “editorial assistance” as help with grammar or improvements to the overall readability of the article, in reality, such “assistants” make major contributions to papers, and would commonsensically be considered co-authors. 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. Listing ghost authors as editorial assistants allows pharmaceutical companies to publish articles with conflicts-of interest that are not transparently reported. Editorial assistants are not mentioned in the abstract, are not indexed in publication databases, are not mentioned in subsequent citations, and are never mentioned in news media accounts of the article. In other words, the fact that a pharmaceutical company directly co-authored the paper is concealed from view. That this is seen as acceptable in an era of increased disclosure of conflicts-of-interest is puzzling.
63:
authorship of and contribution to professional medical publications. The document "International
Committee of Medical Journal Editors: Defining the Role of Authors and Contributors" 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 is voluntary. A list of medical journals which have stated that they follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals is maintained by the International Committee of Medical Journal Editors.
129:, probably the most notorious ghostwritten paper in the medical literature. The study examined the use of Paxil in adolescents and concluded, “Paroxetine is generally well tolerated and effective for major depression in adolescents.” Several years after the paper was published, court proceedings revealed internal company documents admitting that the study found that Paxil was not any better than placebo on the pre-registered outcome measures, and that the company was concerned about how to manage the negative findings. According to the revised ICMJE Guidelines,
56:"Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting the author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices.
62:
The 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
214:
of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of the drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses,
116:
Scandals involving prominent physicians researchers have been reported at over a dozen universities in the United States, however, there have been no reports of any professors being disciplined. Professor Trudo
Lemmens of the University of Toronto Faculty of Law argues that ghostwritten papers help
33:
are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. Physicians and other scientists are paid to attach their names to the manuscripts as though they had
120:
Perhaps 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. Several
124:
While 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
209:
Most 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
66:
How 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
231:
Committee on
Finance issued a report on medical ghost writing. The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc.
80:
Medical ghostwriting has been criticized by a variety of professional organizations representing the drug industry, publishers, and medical societies, and it may violate
American laws prohibiting off-label promotion by drug manufacturers as well as
71:
ought to be dealt with. It refers readers to the relevant guidelines from the
Committee for Publication Ethics (COPE) - specifically COPE's flowcharts outlining a systematic approach toward scientific error and possible fraud.
198:. It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg. Of the articles published from 1998 to 2000 regarding
420:"Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Publishing and Editorial Issues Related to Publication in Biomedical Journals: Corrections, Retractions and "Expressions of Concern""
67:
Biomedical
Journals: Corrections, Retractions and "Expressions of Concern" is the section of the ICMJE Uniform Requirements laying out guidelines for how potential or actual scientific error and
206:. 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.
787:
588:
Studdert; et al. (2004). "Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry—Self-Regulation in the Shadow of Federal Prosecution".
964:
Flaherty, Dennis K. (2013-07-01). "Ghost- and Guest-Authored Pharmaceutical Industry–Sponsored Studies: Abuse of Academic Integrity, the Peer Review System, and Public Trust".
427:
788:"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"
110:
365:
553:
155:
98:
188:
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47:
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provisions within the statutes governing Medicare. Recently, it has attracted scrutiny from the lay press lawmakers the
483:
1028:
1023:
173:
721:
Boseley, Sarah (February 7, 2002). "Scandal of scientists who take money for papers ghostwritten by drug companies".
343:
286:"Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry?"
667:
551:
Rennie, D.; Flanagin, A. (1994). "Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin".
689:
236:
risk of hormone therapy products and then invited academic researchers to sign on as the primary authors."
943:. Minority Staff Report,111th Congress, United States Senate Committee on Finance (Report). Washington, DC
216:
86:
68:
937:
228:
1038:
631:
255:
245:
857:
997:
141:
It is difficult to determine how frequently ghostwriting occurs due to its covert nature. A 2009
82:
210:
distributed to doctors in their offices or at medical meetings by drug company representatives
989:
981:
808:
766:
607:
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194:
Previously secret internal Wyeth documents providing evidence of this are viewable on the
179:
130:
34:
authored them. The named authors may have had little or no involvement in the research or
673:(Report). London: House of Commons Health Committee, The Stationery Office Limited. 2005.
761:
Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?
759:
528:
495:
320:
285:
143:
922:
1012:
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511:
233:
167:
1001:
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484:
http://publicationethics.org/files/All%20Flowcharts%20English%2017%20July%202012.pdf
452:
431:
17:
723:
652:
302:
884:"Decreased evidence of ghostwriting in a 2008 vs 2005 survey of medical writers"
125:
thanking ghostwriters in the acknowledgements section is clearly illustrated by
29:
199:
161:
102:
985:
519:
311:
260:
133:
who write papers are not exempt from being listed as authors of the paper
126:
993:
611:
537:
329:
809:"Why Does Academic Medicine Allow Ghostwriting: A Prescription for Reform"
648:"How drug companies' PR tactics skew the presentation of medical research"
603:
574:
101:, while it is prohibited and considered a particularly pernicious form of
711:, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011
351:
35:
977:
401:
383:
227:
On June 24, 2010, Senator Charles E. Grassley, Ranking Member of the
203:
184:
366:"Recommendations — Defining the Role of Authors and Contributors"
472:"What to do if you suspect redundant (duplicate) publication"
858:"Ghostwriters Paid by Wyeth Aided Its Drugs - NYTimes.com"
215:
or grants. The academics or doctors are known as "KOLs" ("
738:
Giombetti (1992). "UW's Friendly Corporate Ghostwriter".
690:"Frequently Asked Questions about Medical Ghostwriting"
232:(DesignWrite), to draft review articles regarding the
830:
Wilson, Duff; Singer, Natasha (September 11, 2009).
758:
428:International Committee of Medical Journal Editors
832:"Ghostwriting Is Called Rife in Medical Journals"
627:"At medical journals, paid writers play big role"
496:"Ghost writing initiated by commercial companies"
117:protect companies when they are sued in court.
402:"Journals Following the ICMJE Recommendations"
279:
277:
275:
202:, between 18% and 40% were ghost written by
111:University of Pennsylvania School of Medicine
8:
668:The influence of the pharmaceutical industry
684:
682:
680:
99:University of Washington School of Medicine
183:were ghost written. Between 1998 and 2005
625:Mathews, Anna Wilde (December 13, 2005).
527:
319:
301:
936:Grassley, Charles, ed. (June 24, 2010).
191:(HRT) published in scientific journals.
271:
923:"Ghostwriter werden → jetzt bewerben"
7:
938:"Ghostwriting in Medical Literature"
500:Journal of General Internal Medicine
95:It is permitted at some institutions
48:American Medical Writers Association
284:Sismondo, Sergio (September 2007).
107:Tufts University School of Medicine
50:speaks about the topic as follows:
925:(in German). Business and Science.
856:Singer, Natasha (August 5, 2009).
25:
882:Jacobs, A.; Hamilton, A. (2009).
219:") or "TLs" ("Thought Leaders").
567:10.1001/jama.1994.03510300075043
512:10.1111/j.1525-1497.2005.41015.x
807:Leo, J.; Lacasse, J.R. (2011).
793:Project On Government Oversight
709:Project On Government Oversight
695:Project On Government Oversight
150:New England Journal of Medicine
786:Thacker, Paul (Jun 22, 2011).
765:. Lanham: Rowman-Littlefield.
196:Drug Industry Document Archive
147:article estimated that 11% of
1:
91:National Institutes of Health
897:(2): 118–123. Archived from
646:Ross, Elliot (20 May 2000).
303:10.1371/journal.pmed.0040286
131:Professional medical writers
1044:Social problems in medicine
1034:Communication of falsehoods
189:hormone replacement therapy
174:Annals of Internal Medicine
1065:
966:Annals of Pharmacotherapy
757:Krimsky, Sheldon (2003).
1049:Clinical research ethics
187:had 26 papers promoting
1019:Ghostwriting in science
58:
604:10.1056/NEJMlim042229
506:(6): 549. June 2005.
479:publicationethics.org
457:publicationethics.org
87:Institute of Medicine
54:
42:Definitions and rules
229:United States Senate
223:Senate investigation
18:Medical ghostwriting
632:Wall Street Journal
470:Wager, Liz (2012).
256:Research paper mill
246:Academic authorship
217:Key Opinion Leaders
177:articles and 2% of
105:at others, such as
1029:Cheating in school
1024:Medical publishing
972:(7–8): 1081–1083.
862:The New York Times
836:The New York Times
978:10.1345/aph.1R691
598:(18): 1891–1900.
384:"Recommendations"
344:"AMWA Ethics FAQ"
16:(Redirected from
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350:. Archived from
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171:articles, 5% of
153:articles, 8% of
97:, including the
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69:scientific fraud
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958:Further reading
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891:The Write Stuff
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251:Medical writing
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180:Nature Medicine
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561:(6): 469–471.
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354:on 2013-07-16.
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904:on 2011-07-16
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945:. Retrieved
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906:. Retrieved
899:the original
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839:. Retrieved
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727:. p. 4.
724:The Guardian
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453:"Guidelines"
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436:. Retrieved
432:the original
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352:the original
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30:ghostwriters
27:
26:
296:(9): e286.
93:. as well.
1039:Misconduct
1013:Categories
947:2010-07-11
908:2010-02-23
819:: 371–375.
438:2013-03-19
267:References
200:sertraline
137:Prevalence
103:plagiarism
89:, and the
986:1060-0280
520:1525-1497
424:ICMJE.org
406:ICMJE.org
388:ICMJE.org
370:ICMJE.org
312:1549-1676
261:Study 329
127:Study 329
76:Criticism
38:process.
1002:22513775
994:23585648
612:15509824
538:15987333
348:amwa.org
330:17896859
240:See also
109:and the
83:kickback
28:Medical
867:May 12,
841:May 12,
813:Society
575:8295324
529:1490135
321:1989751
212:in lieu
36:writing
1000:
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984:
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328:
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204:Pfizer
162:Lancet
998:S2CID
941:(PDF)
902:(PDF)
887:(PDF)
746:(19).
671:(PDF)
475:(PDF)
185:Wyeth
81:anti-
990:PMID
982:ISSN
869:2010
843:2010
767:ISBN
608:PMID
591:NEJM
571:PMID
554:JAMA
534:PMID
516:ISSN
326:PMID
308:ISSN
165:and
156:JAMA
46:The
974:doi
600:doi
596:351
563:doi
559:271
524:PMC
508:doi
316:PMC
298:doi
1015::
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988:.
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679:^
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