On Guest authors and Ghostwriters

The legal disputes following the withdrawal from the market of two drugs for the treatment of pain (the COX-2 inhibitors rofecoxib and valdecoxib) have led to another critical examination of the paper publishing process. I have written in February about the drug company Pfizer trying to obtain confidential peer review documents from the journals JAMA and NEJM. Courts in Chicago and Boston have denied such requests.

An article and accompanying editorial in this week's JAMA look at guest authorship and ghostwriting in publications related to rofecoxib (better known as Vioxx, produced by Merck). Guest authorship was defined as an author that does not meet authorship criteria. The Uniform Requirements for Manuscripts to Biomedical Journals from the International Commitee of Medical Journal Editors (ICMJE) define authorship as follows:

Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

Ghostwriting was defined as the failure to designate an individual that made significant contributions to the research or writing of a manuscript.

The JAMA article did a systematic analysis of the court documents obtained during litigation related to rofecoxib. Guest authorship was identified in 16% of research articles and 26% of review articles; ghostwriting was identified in 13% of research articles and 10% of review articles. The editorial in the same issue is called Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence and dicusses this article as well an another article called Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment in the same issue. The editorial proposes that drastic action is necessary and includes a list of 11 measures.

Criteria for authorship and disclosure of financial interests are clearly defined not only by the ICMJE, but also by the World Association of Medical Editors (WAME) and by most journals. And the European Medical Writers Association (EMWA) has published guidelines on the role of medical writers in peer-reviewed publications. As medical writers usually don't fulfill the authorship criteria defined above (with the possible exception of review articles), they should rather be acknowledged. The EMWA guidelines propose the following wording:

We thank Dr Jane Doe who provided medical writing services on behalf of XYZ Pharmaceuticals Ltd.

The rules are clear and it is also clear that there will be violations of these rules. Guest authorship and ghostwriting are probably common practices, not only in publications supported by drug companies. Typical examples would be the inclusion of the department head that did little more than to provide financial support or the exclusion of the technician that did critical experiments but is not acknowledged. Cases of suspected guest authorship or ghostwriting should be taken seriously and the papers in JAMA will ignite a renewed discussion on these topics.

For different views on this topic, look at Exit ghost by Juan Carlos Lopez over at Spoonful of Medicine and Cut it out. Cut it out now. by Derek Lowe at In the Pipeline.

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10 Responses to On Guest authors and Ghostwriters

  1. Graham Steel says:

    Reminded me of a recent PLoS article “Authors, Ghosts, Damned Lies, and Statisticians”:http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040034 by Liz Wager.

  2. Massimo Pinto says:

    Mis-behavior in sports is readily punished with very tangible actions: you get sent out of the pitch for a couple of minutes, or for a wee bit longer, or for a few matches. Either way, the team as a whole gets damaged. Alternatively, a ban on your home stadium is made, so that supporters cannot watch the future matches.
    What kind of actions may be taken against guest authorship or, may be even worse, ghostwriting? Should the authors (the lead, the last, all of them?) be banned from publishing on that journal for some time? Should their money for research be frozen for some months?

  3. Lee Turnpenny says:

    ‘Typical examples would be the inclusion of the department head that did little more than to provide financial support or the exclusion of the technician that did critical experiments but is not acknowledged.’
    Good points! And let’s not overlook the disregard of those whose dogged work on a project generates all that unpublishable preliminary ‘negative’ data, but which is crucial to honing the hypothesis that eventually leads to the ‘positive’ data that makes it into press. Careers are stunted by such occasional shameful omissions by group leaders/P.I.s.

  4. Martin Fenner says:

    Graham, thank a lot for pointing out the PLoS article by Elizabeth Wager. She is a medical writer and also coauthor of the EMWA guidelines that I mentioned in my post. I believe that medical writers can greatly improve the quality of a paper, but that they usually should be acknowledged rather than listed as a coauthor. Another “JAMA paper”:http://jama.ama-assn.org/cgi/content/full/296/8/932-a from 2006 found that assistance by medical writers is acknowledged in 6% of papers and that the actual number is probably higher.
    The PLoS article is an editorial of a study published in PLos in 2007: “Ghost authorship in industry-initiated randomised trials”:http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040019. The study finds ghost authorship in 75% of the 44 trials examined. These ghost authors were usually statisticians, a group of paper contributors not mentioned in the JAMA article. The proposed solution was again to detail the specific contributions of each author instead of just listing them.
    Massimo, you make a very good point. The authorship system is not perfect, so we have to think about the sanctions when something goes wrong. “Duplicate papers”:http://network.nature.com/forums/harvardpublishingforum/954 would be another issue that was recently discussed here on Nature Network. A paper retraction would certainly be an effective measure, but is probably often too harsh for this difficult topic of what constitutes authorship.

  5. Graham Steel says:

    All interesting so far and let’s hope for continued discussion. From my perspective, being a layman, a lot of this is still virgin territory for me.
    @ Martin, I was aware that Liz was a medical writer but didn’t know that she was co-author of the EMWA guidelines.
    As per _Publications_ on my NN Profile, I had a “letter published”:http://clinicaltrials.ploshubs.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2Fb23923cf-3d13-4e0c-8c2b-d60c6374b78d&root=info%3Adoi%2F10.1371%2Fannotation%2Fb23923cf-3d13-4e0c-8c2b-d60c6374b78d in PLoS Clinical Trials commenting on a previous Wager Publication.

  6. Maxine Clarke says:

    Elizabeth Wager wrote a very good article on ethics for Nature’s peer-review debate, “which is freely available here”:http://blogs.nature.com/peer-to-peer/2006/06/ethics_what_is_it_for.html. Her biographical details state: “Elizabeth Wager is a freelance publications consultant. She is a member of the ethics committees of the BMJ, the World Association of Medical Editors and the Committee On Publication Ethics Council. She has written systematic reviews on peer review and technical editing, and guidelines on good publication practice.”

  7. Martin Fenner says:

    Maxine, thanks for the link. Elizabeth Wager has created a website “Good Publication Practice for Pharmaceutical Companies”:http://www.gpp-guidelines.org/ (GPP) that is relevant to this discussion. A number of contract research organizations (that organize clinical trials for drug companies) and communication companies (that employ medical writers) and EMWA have endorsed GPP.
    Another “JAMA article”:http://jama.ama-assn.org/cgi/content/full/287/21/2769 from 2002 found 39% guest (here called honorary) authors and 9% ghost authors in Cochrane reviews – well-respected systematic reviews in clinical medicine.
    It appears that guest authorship and ghost authorship have been common for many years.

  8. Brian Clegg says:

    Forgive me as an outsider, in being a writer rather than a scientist, but it strikes me that ghost writers on scientific papers would often be a good idea.
    I’ve helped a couple of people turn papers into more readable forms – acting as a ghost writer – and that seems eminently sensible to me. It’s using my expertise, as someone who makes scientific matters understandable to the reader, to make a paper more effective – why is that a bad thing?
    There is no reason at all to assume that most scientists are good communicators – in fact all the evidence is that they aren’t! What’s wrong with getting professional help with that communication, provided the scientist verifies that the scientific content is still correct?
    I’m probably getting the wrong end of the stick here, but if I’m not, I’m afraid I’m with the ghosts!

  9. Martin Fenner says:

    Brian, you are of course right that the help of an experienced writer should be welcomed, and I have “said so”:http://network.nature.com/blogs/user/mfenner/2008/01/19/scientific-writers-can-help-publish-good-papers in a previous post. The issue is significant contribution to a paper without proper acknowledgement. What exactly constitutes significant contribution is of course open for debate, and the references above clearly say that ghost authorship is common.
    The larger issue here is of course the relationship between academic medicine and the pharmaceutical industry. We shouldn’t forget that the only reason the “JAMA”:http://jama.ama-assn.org/cgi/content/full/299/15/1800 paper came into existence is that Merck was sued over side effects of rofecoxib. The authors of the paper acted as consultants to attorneys on the behalf of plaintiffs.

  10. Martin Fenner says:

    Oh, and did I mention that these legal cases were “settled”:http://www.merck.com/newsroom/press_releases/corporate/2007_1109.html for $4.85 billion last November?