Ghost writing clinical trials
1); jan-dec s:article | pubreader | epub (beta) | printer friendly | wikipedia, the free to: navigation, l ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. The named authors may have had little or no involvement in the research or writing process. The term "ghostwriting" is often used to encompass all three of these rules for authorship and contribution of the international committee of medical journal editors (icmje, informally known as "the vancouver group" from the locale of the group's first meeting, vancouver, british columbia, canada) are a single, universally-respected set of guidelines for describing authorship of and contribution to professional medical publications. Ghostwriting has been criticized by a variety of professional organizations[9][10] representing the drug industry, publishers, and medical societies, and it may violate american laws prohibiting off-label promotion by drug manufacturers as well as anti-kickback provisions within the statutes governing medicare. 15] professor trudo lemmens of the university of toronto school of law argues that ghostwritten papers help protect companies when they are sued in court. 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.
Ghostwriting medical journals
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. That this is seen as acceptable in an era of increased disclosure of conflicts-of-interest is several groups in medicine including the european medical writers association (emwa) sanction the practice of thanking medical writers for providing “editorial assistance” in the acknowledgments section of the paper instead of listing them on the authorship byline, the problem with simply thanking ghostwriters in the acknowledgements section is clearly illustrated by study 329, probably the most notorious ghostwritten paper in the medical literature. A 2009 new york times article estimated that 11% of new england journal of medicine articles, 8% of jama, lancet and plos medicine articles, 5% of annals of internal medicine articles and 2% of nature medicine were ghost written. 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. 1] of the articles published from 1998 to 2000 regarding sertraline, between 18% and 40% were ghost written by pfizer.
1] a questionnaire using comparable methods in 2005 and 2008 with a 14-28% response rate found a decrease in number of people who reported ghostwriting among professional medical writers. Pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. Grassley, ranking member of the united states senate committee on finance issued a report on medical ghost writing. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? Thacker, paul, "how scientific literature has become part of big pharma's marketing machine and how being nice hurts canada: 5 questions with ghostwriting expert trudo lemmens", project on government oversight, jun 22, 2011.
Ghost- and guest-authored pharmaceutical industry–sponsored studies: abuse of academic integrity, the peer review system, and public trust". Ries: ghostwritingmedical journalismmedical researchethically disputed educational practicesacademiacommunication of falsehoodsmisconducthidden categories: all articles with unsourced statementsarticles with unsourced statements from august logged intalkcontributionscreate accountlog pagecontentsfeatured contentcurrent eventsrandom articledonate to wikipediawikipedia out wikipediacommunity portalrecent changescontact links hererelated changesupload filespecial pagespermanent linkpage informationwikidata itemcite this a bookdownload as pdfprintable page was last edited on 25 september 2017, at 05: is available under the creative commons attribution-sharealike license;. Medicinebookshelfdatabase of genotypes and phenotypes (dbgap)genetic testing registryinfluenza virusmap vieweronline mendelian inheritance in man (omim)pubmedpubmed central (pmc)pubmed clinical queriesrefseqgeneall genetics & medicine resources... Utilitiesjournals in ncbi databasesmesh databasencbi handbookncbi help manualncbi news & blogpubmedpubmed central (pmc)pubmed clinical queriespubmed healthall literature resources... Ry-sponsored ghostwriting in clinical trial reporting: a case y lb1, jureidini information1department of philosophy, california state university, northridge, california 91330, usa. Y@tractin this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication.
Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Gov'tmesh termsauthorship*clinical trials as topic/ethics*drug industry/ethics*fraud*paroxetine/adverse effectsparoxetine/therapeutic useserotonin uptake inhibitors/adverse effectsserotonin uptake inhibitors/therapeutic usetreatment outcomewriting*substancesserotonin uptake inhibitorsparoxetinelinkout - more resourcesfull text sourcestaylor & francisother literature sourcescos scholar universemedicalhealth fraud - medlineplus health informationclinical trials - medlineplus health informationmiscellaneousparoxetine hydrochloride - hazardous substances data bankpubmed commons home. Commentshow to join pubmed commonshow to cite this comment:Ncbi > literature > on: the plos medicine editors (2009) ghostwriting: the dirty little secret of medical publishing that just got bigger. Because, quite simply, the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general 's just one sample thread [2] that gives an idea of the topsy-turvy world invented by the pharmaceutical and medical writing companies involved. While readers expect and assume that the named academic authors on a paper carried out the piece of work and then wrote up their article or review informed by their professional qualifications and expertise, instead we see a prime example of “ghostwriting”: a writing company was commissioned to produce a manuscript on a piece of research to fit the drug company's needs and then a person was identified to be the “author”:An email from a writer employed by the medical writing company, designwrite, to employees of wyeth, the company that performed the study, and parthenon (another medical writing company) on november 10, 2003 concerning manuscripts on totelle (a brand of hormone replacement therapy manufactured by wyeth) tells the story concisely. 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].
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. 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. 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. The documents that have been made available are a substantial step forward in advancing knowledge of this practice and explaining the mechanics of how ghostwriting campaigns are organized, and will add to the evidence base. 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. In an environment in which drug companies are beholden to their shareholders, and the drive for profit takes center stage, it is naïve to think that companies will put their own houses in 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.
Editors' bodies such as the international committee of medical journal editors (icmje) expressly define criteria for authorship in biomedical publications [12], and the world association of medical editors (wame) developed a specific policy on ghostwriting [10] initiated by commercial companies that calls the practice dishonest, unacceptable, and sanctionable. But it seems that these tactics are simply not enough to prevent ghostwriting, and are being sidestepped by those involved. Although medical writers can and do have a legitimate place in assisting in the preparation of manuscripts (and, of course, academics and pharmaceutical companies can have legitimate and appropriate relations, and not all papers in this archive will have been written by ghost authors), attempting to hide the presence of ghostwriters or the involvement of writers beyond technical support (such as copyediting) is unacceptable. Primarily, it would mean a sea change in the thinking and behavior of editors, who should create—and be prepared to enforce—journal policies clarifying that involvement with ghostwriting is a serious and punishable breach of publication ethics. 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 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. Institutions whose academics are shown to be involved should investigate as a matter of 's time to get serious about tackling ghostwriting.
Contributed to writing of the paper: jc, sj, lp, ev, plos medicine editors (2009) an unbiased scientific record should be everyone's agenda. Plos med 6(2): plos medicine editors2009an unbiased scientific record should be everyone's med6(2)do s (2007) ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? Sismondo2007ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? Wager2007authors, ghosts, damned lies, and med4(1) js, hill kp, egilman ds, krumholz hm (2008) guest authorship and ghostwriting in publications related to rofecoxib. Hróbjartssonhk johansenmt haahrdg altman2007ghost authorship in industry-initiated randomised med4(1)lis cd, fontanarosa pb (2008) impugning the integrity of medical science the adverse effects of industry influence. Jama 299: 1833– deangelispb fontanarosa2008impugning the integrity of medical science the adverse effects of industry d plos riting revisited: new perspectives but few solutions in unbiased scientific record should be everyone's should be done to tackle ghostwriting in the medical literature?
Authorship in industry-initiated randomised s, ghosts, damned lies, and ed in the following riting more information about plos subject areas, want your feedback. For your ucing a three-part series on medical journal riting, journal pharmaceutical, ghostwriting, jeffrey lacasse, jonathan leo, key opinion leaders, we publish part one of a three-part guest blog series that came to us in an unsolicited submission. Here is the first of the series by jonathan leo, phd, and jeffrey lacasse, one: when should a medical paper be considered ghostwritten? Three easy steps to finding ghost of the hidden secrets of the medical literature is that the named authors on a paper’s byline, particularly in the case of clinical trials, are not necessarily the individuals who wrote the paper. With ghostwritten papers it is hard to know where to draw the line between science and marketing. What will probably surprise much of the general public, and many members of the media, is that the medical community has not called for an outright ban on ghostwriting.
Rather than forbid the practice outright, some in the medical community seem to be trying to develop policies that will allow papers to be published with invisible authors, but that won’t be labeled as “ghostwritten. If the paper’s byline has an “invisible author” (a ghost), then the paper should be considered ghostwritten. However, when charges of ghostwriting appear about a medical paper there are all sorts of reasons given why the paper should not be considered ghostwritten. In many cases of ghostwriting there are other issues such as excessive conflicts of interests or the accuracy of the paper, but these are peripheral issues and do not play a role in determining if the paper was ghostwritten. Also immaterial to the ghostwriting charge is whether the named authors deserve to be on the byline. Granted, honorary authorship and ghostwriting often go together but they are not the same thing.
The named authors might certainly deserve to be on the byline, but the question about ghostwriting concerns unnamed authors – people who should have been on the byline but are not present. Since in most cases the internal company documents about how a paper was developed are not available, the process of detecting ghosts can only be done a limited basis, and is reserved for those cases when court proceedings or freedom of information act requests have made the documents publicly the next two days we will highlight papers whose bylines have invisible authors and would seem to qualify as ghostwritten, yet have been defended by certain segments of the medical community as not being ghostwritten. Keep in mind that one does not need to be an expert in spine surgery, or psychotropic drugs, or really much of anything for that matter, to determine if a paper has been two: medtronic’s infuse spinal fusion surgery three: psych drug paxil – and an leo examines the biological basis of mental disorders such as adhd, schizophrenia, and clinical depression. Rethinking adhd: from brain to culture, a co-edited volume with psychiatrist sami timimi, was released by palgrave macmillan in lacasse has published research on barriers to evidence-based mental health practice, including articles on critical thinking in mental health, clinical treatment of children, and psychiatric er they have published several articles on the serotonin theory of depression and adhd. Over the past several years their articles on ghostwriting have appeared in plos medicine, the chronicle of higher education, and research has been covered in popular media outlets such as the wall street journal, scientific american, science,the chronicle of higher education, fortune, nature, and the journal editors resist transparencyit’s difficult to make a case for hiding or obscuring information about health and the…. The analysis was notable for relying on full data on each patient, contributed by the trial sponsors and individual investigators, not on outcome data as published and proselytized by physicians and clinical oncologists moonlighting as big pharma’s “key opinion leaders.
Y 28, 2013 at 7:18 l ghostwriting seems to be a timeless topic–and, unfortunately, not much has changed over the years. Here’s a link to my lancet feature (1999) on the topic:A pdf of the responses:And a link to a guardian interview (2002):January 28, 2013 at 7:18 l ghostwriting seems to be a timeless topic–and, unfortunately, not much has changed over the years. Here’s a link to my lancet feature (1999) on the topic:A pdf of the responses:And a link to a guardian interview (2002):February 1, 2013 at 4:41 you for writing and covering this 3-part series on ghostwriting.
