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Essay

Challenging Medical Ghostwriting in US Courts

  • Xavier Bosch mail,

    xavbosch@clinic.ub.es

    Affiliation: Department of Internal Medicine at the Hospital Clínic and the Institut d'Investigacions Biomèdiques August Pí i Sunyer, University of Barcelona, Barcelona, Spain

    X
  • Bijan Esfandiari,

    Affiliation: Law Firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California, United States of America

    X
  • Leemon McHenry

    Affiliation: Department of Philosophy, California State University, Northridge, California, United States of America

    X
  • Published: January 24, 2012
  • DOI: 10.1371/journal.pmed.1001163
  • Published in PLOS Medicine

Reader Comments (6)

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What about the journals?

Posted by AdamJacobs on 25 Jan 2012 at 10:32 GMT

We argue that when an injured patient's physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then pursuant to the legal authority outlined above, the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants
http://plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001163#article1.body1.sec3.p3

This is an interesting argument, which I think has merit, but I think exactly the same arguments could be extended to including the journal that published the article on the lists of defendants.

Could Bosch et al share their thoughts on the merits or otherwise of doing so?

Competing interests declared: As stated above

RE: What about the journals?

kimklausner replied to AdamJacobs on 25 Jan 2012 at 19:23 GMT

And what about the people who did the peer-review of the article?

No competing interests declared.

RE: RE: What about the journals?

AdamJacobs replied to kimklausner on 26 Jan 2012 at 09:05 GMT

That's an interesting question, Kim. I'll be interested to see Bosch et al's response to it.

However, FWIW, here are my thoughts. I think it's going to depend very much on the specifics of the case. On the whole, it's not the job of peer reviewers to police fraud. They need to assume that the paper given to them to review is written in good faith. Their job is to see if the paper makes sense scientifically. If it's all internally consistent, but fraudulent, there's probably no realistic way for a peer reviewer to know that, and I wouldn't want to blame the peer reviewer in that case.

However, there may be things that peer reviewers ought to be able to spot. If a paper reports the results of a clinical trial and doesn't mention adverse events (BTW, it's worth mentioning in passing that there is some evidence that papers written with the help of professional medical writers are more likely to report adverse events [1]), a peer reviewer needs to ask the questions about what the adverse events were. Similarly, if peer reviewers spot something about the results that just doesn't ring true, then I think they have a duty to report those concerns to the editor for further investigation.

References:

1. Jacobs A. Adherence to the CONSORT guideline in papers
written by professional medical writers. The Write Stuff 2010;19:196-200

Competing interests declared: As stated previously

RE: RE: RE: What about the journals?

XavierBosch replied to AdamJacobs on 26 Jan 2012 at 12:17 GMT

Yes, I agree that medical journals should do a better job and actively spotting suspicious articles. For instance, imagine a multicenter clinical trial published in a top journal, that only lists as authors 7 renowned scientists who are experts in that field. Nobody else, just the famous ones. I would definitely mark the manuscript as suspicious at the time of submission.

In fact, I wonder whether other people should be named as defendants: what about the passive stance of public agencies, research councils, universities? P

Peer-reviewers are commonly asked by journals to report possible misconduct for the manuscript they are reviewing. Since I argue that ghostwriting linked to guest authorship is a major form of research misconduct, like FFP, reviewers should do the same with potentially ghostwritten papers and let editors know

No competing interests declared.