Marilynn Larkin was given an outline, references and a list of drug-company-approved phrases. Ronni Sandroff was told what to play up and what to play down Larkin, Susanna Dogson was asked to slant a paper in favour of the drug company Wilde, Susanna Rees was told to replace the names of drug company employees with those of the named authors in the File Properties of MS Word manuscripts. David Franklin became concerned about patient safety and spoke out against his employers Parke-Davis Lenzer, Doctors were encouraged through articles published in medical journals to prescribe Neurontin, a drug licensed for treating epilepsy, for a wide range of off-label disorders.
Franklin sought legal advice for fear that his employers might retaliate against him for raising questions about the legality of the ghost-writing schemes used to promote off-label sales of the drug ibid. Documents disclosed in court proceedings allowed Healy and Cattell to conduct a study on ghost-writing and its effectiveness. They investigated two types of articles with sertraline in the title.
Sertraline is the generic name for Pfizer's antidepressant drug Zoloft. One type of article was listed on a document requisitioned during court proceedings from a medical communications agency contracted by Pfizer. Of the 85 articles on the list, 55 were written by medical writers employed by the agency.
The remaining 30 were funded by Pfizer or used economic models based on data provided by Pfizer, where the authors would not have had access to the raw data. Only two articles declared writing assistance. All the articles reported positive results. Of these 41 articles, 18 reported positive, 3 ambiguous and 20 negative findings. The articles on the agency's list that had been published appeared in more prestigious journals than the independent articles indicating the effectiveness of the agency's work and influence of the credentials of the named authors in increasing the chances of acceptance for publication.
Documents disclosed in court proceedings also revealed that Merck hired ghost-writers to write articles favourable to its painkilling drug Vioxx generic name rofecoxib Krumholz et al. Vioxx entered the market in but was voluntarily withdrawn in September because it increased cardiovascular disease. In-house scientists at Merck had from the beginning suspected that the drug increased thrombus formation. Nevertheless outside academic authors of a study the company had sponsored changed a manuscript at Merck's request to hedge their findings.
One named author of a Vioxx article subsequently said he had never seen any revision of the paper Barnett, and another that he had had little to do with the research Liane, David Healy also provided an example of the third type of event that has exposed ghost-writers Select Committee on Health, He was sent a review article that had been written by a ghost-writer.
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He was asked to approve the article and put his name to it as the author. He found the claims made for the drug exaggerated and sent back his own version. The pharmaceutical company that had sent the article to him preferred their original version, which they said, had important commercial points in it that were missing from Healy's own version.
The pharmaceutical company's original version was subsequently published in a journal with the name of another scientist as author. David Healy's disclosure of the name of this author alerted me to make enquiries when the journal where I worked as managing editor received an article from the author. If a person employed by a commercial enterprise or organisation with an agenda to promote writes the first draft, the potential for bias is increased. But readers have a chance to weigh potential bias in the balance if full information about the document's history and financing is disclosed and if the raw data of original research is available for scrutiny.
As long ago as , David Sharp, former editor of the Lancet , stated that assistance with translation or through an author's editor service of the sort that many universities offer, is entirely legitimate Sharp, In contrast, he considered the practice of a medical writer producing a first draft in which the writer's employer, rather than the named author, has first sight and input should be outlawed.
These sentiments were echoed more recently by Special Assistant US Attorney Cathy Young Thomer who considers ghost-writing to be a fraud when the writing precedes the author Jirik, There is some ambivalence among medical writers over writing of the first draft. The GPP and medical writer association ethics guidelines focus on guidance for medical writers in preparing drafts of documents publishing the results of clinical trials in journals.
The need for close consultation between medical writers and authors is emphasised. The guidelines state that authors must determine the content of the articles and the contribution of the writer should be acknowledged. The GPP consider it inappropriate for medical writers to prepare the first drafts of editorials or opinion pieces.
The background commentary to the EMWA guidelines warns that medical writers may qualify for authorship of review articles if they conduct an extensive literature search. These guidelines therefore envisage medical writers preparing review articles, which can be as influential as editorials GPP in , EMWA in Although medical writers are not ghost-writers if they are acknowledged, acknowledgement alone does not satisfy current concerns.
There are three aspects of acknowledgement that need to be considered. One is the information that should be included. The second is the requirement, adopted by some journals, in the ICMJE guidelines that authors obtain permission to acknowledge from all those mentioned in the acknowledgements. The third is whether the authors had access to raw data. Journals differ widely in the amount of guidance their instructions to authors give on acknowledgements, from giving no guidance — one could suspect that they care little about the subject themselves — to just referring to the ICMJE guidelines or variously requiring authors to give the name, the role and funding source of any person providing writing assistance.
The EMWA guidelines suggest wording that has been endorsed by some journals e. This formula, however, is not so detailed as the one used in a review article in Neuropsychopharmacology Nemeroff et al. We maintained complete control over the direction and content of the paper. Preparation of this report was supported by an unrestricted grant from Cyberonics, Inc. Krumholz et al. Clearly, a cohesive approach is called for.
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It would be helpful if guidance could come from a central source, e. I drew the ICMJE's attention to this need and submitted proposals for consideration at their meeting in April last year that their guidelines on acknowledgement should be amended to require the following information:. If a named author prepared the first draft, the name and funding source of the person who provided writing assistance, if any.
The names of the people who approved the final draft could, for example, include the publication manager in a drug company or communication agency and would be in line with WAME's statement:.
Other parties, including companies-such as marketing, communications and medical education companies who are paid to assist pharmaceutical and medical device companies in disseminating favourable messages about their products — may initiate the sequence of events for which the author is the final and most easily identified participant.
These other participants are also responsible for ghost written manuscripts and addressing their roles should be part of the solution WAME, Disappointingly they had made no changes to their acknowledgement requirements. This is not without its difficulties. There maybe legitimate reasons why a medical writer does not wish to be acknowledged, not the least being the fact that authors have made changes to the final version that the writer considers inappropriate. But they may also relate to changes that are unacceptable on ethical grounds.
The position on acknowledgement when these problems arise is not clear. The EMWA guidelines recognise that medical writers have a right to withdraw their names in exceptional circumstances but are silent about whether the medical writers should inform the journal of their involvement and subsequent withdrawal Jacobs and Wager, In the reporting of clinical trial results, the problem of ghost-writing goes beyond concealment of the writer and failure of the named authors to approve the final version of the article. Even authors who approve the final version might not have had access to the raw data but only tables compiled from raw data.
They maybe familiar with the raw data generated by their own centre but not that from all other centres spread through several countries. David Healy regards articles that result from the ghost-writing process which do not offer a fair representation of the underlying data as the problem rather than ghost-writing itself. Pharmaceutical companies consider raw data proprietary and strongly resist all moves to make their data available for public scrutiny. The current move is to force publication of documents that accompany applications to licensing authorities for drug licences. Either the applicants or the authorities would make these documents available upon the grant of the licence.
But even more needs to be done towards access to raw data. Guidelines increase awareness. This indicates that medical writers encourage authors to disclose their involvement according to the guidelines.
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Medical writers have also published articles promoting ethical practices e. Dawes, ; Woolley, But guidelines can be a foil, with all those whose writing had never sought to deceive complying, while business carries on as usual for the dishonest sector. Furthermore, the willingness to comply with guidelines must go beyond that of the medical writer.
Employers need to be persuaded. Currently there is little incentive for pharmaceutical companies to stop the practice of ghost-writing. The shame about the well-meant GPP guidelines designed for company sponsors of large clinical trials is that they have been endorsed by only a few pharmaceutical companies even though employees from some other companies helped to develop them. Furthermore one communications company that agreed to recommend the guidelines to its clients has subsequently been involved in a ghost-writing story Fugh-Berman, This hints that medical writers, who work hard through their medical writers associations EMWA in Europe, AMWA in American, AMWA in Australia and a similar organisation that is being created in India to promote acknowledgement, would themselves be happy to be relieved of their underworld status but their employers prefer to keep them there.
Journals can ask the right questions, which few are doing at the moment.
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Journals can also have an antenna for ghost-writing signs and of course avoid being tempted themselves by the lure of industry patronage. There has been a proposal to change authorship to contributorship Rennie, By this system the specific contribution made by every person associated with the publication is listed.
This should reveal who wrote the paper. Unfortunately, although the system is recommended by the ICMJE, it has only been implemented by some large journals.
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Authors get more than an honorarium from selling their name. They accumulate articles on their CVs without effort, gaining career advancement and a reputation as an opinion leader, which in turn attracts lavish invitations — all expenses paid — to speak at congresses in exotic locations. A suggestion has been made to name and shame authors who plagiarise Chalmers, , which could be extended to authors who fail to acknowledge writers.
But editors might be reluctant to do this. There seems to be a protectionist attitude towards authors who are members of the same community as journal editors, a fear that innocent scientists or physicians may have their careers ruined or an anxiety about defending a libel action. The WAME policy statement advises editors who discover ghost-written articles to report the incident to the authors' academic institutions and publish a notice that the article was ghost-written along with the names of the responsible companies and submitting authors:.
When editors detect ghost written manuscripts, their actions should involve both the submitting authors and commercial participants if they are involved. Several actions are possible:. WAME, The statement was prompted by a WAME Listserve discussion initiated by the editor of the Journal of General Internal Medicine when Adriane Fugh-Berman reported that a manuscript she had been sent by the journal to review was identical to the one she had previously been asked to author Fugh-Berman, The name of the replacement author was never published on the Listserve or elsewhere.
Hence other journal editors have been deprived of the opportunity of caution with this author, who would seem to have little to fear. In a recent article Moffatt and Elliott ask whether the ethical problems presented by ghost-written articles would be solved if medical writers were acknowledged as authors. To be acknowledged as authors, medical writers would of course need to satisfy the current ICMJE authorship provisions as stated above. They suggest that university institutions police their faculty members.