1 Boring Old Man

Ghosts In The Pharma Attic: Jon & Jeff Explain
Pharmalot
By Ed Silverman
June 12th, 2012

… Some might say it is a minor point but in academic medicine there is currently an institutionalized loophole in place, that essentially says that anyone deserving of the term “author” should be listed on the byline, unless they are employed by a pharmaceutical company, in which case it is acceptable to mention them in the acknowledgement section. We do not think this is a good idea. For each segment below we discuss how various groups or organizations have approached this idea. We would appreciate any comments or thoughts on this.

International Committee of Medical Journal Editors
Ironically, the most problematic policy in terms of allowing ghostwriting comes from the group with the most power to curb the practice. The ICMJE, a group of medical editors who have developed policies related to the medical publishing process, has proposed three criteria for determining who should be given a byline as author on scientific papers. These criteria are:

1. substantive contributions to conception and design, acquisition of data, or analysis and interpretation of data
2. drafting the article or revising it critically for important intellectual content
3. final approval of the version to be published.

While these are now the traditional, oft-cited criteria for authorship, they do not address the contemporary concern of ghostwriting. In fact, although unintended, use of the ICMJE criteria may facilitate ghostwriting while creating the impression that medical journals have strict policies on authorship.

Consider this hypothetical situation:

^{An industry-funded medical writer authors a paper in conjunction with academic researchers. The medical writer authors the first draft of the paper and makes many substantive edits, eventually writing 99 percent of the paper. Before the absolute “final” version is reached, the medical writer turns it over to the academic researchers, and never approves the final version; the medical writer is acknowledged for editorial assistance.}

Thus, an inaccurate byline and a ghost author are created, but the authors followed the ICMJE rules to the letter — writer who does not approve the final manuscript cannot be an author. If accused of ghostwriting, all concerned can simply declare that they followed ICJME guidelines. We do not think that the above example follows the spirit of the guidelines as envisioned by the ICMJE but that is an example of exploiting a loophole in the policy. Merriam-Webster defines “loophole” as “an ambiguity or omission in the text through which the intent of a statute, contract, or obligation may be evaded.” Typically, when a loophole is discovered the authors of the policy seek to close it.

We are not the only ones pointing this out. In a 2011 in PLoS Medicine, a current ghostwriter, Alastair Matheson, published “How Industry Uses the ICMJE Guidelines to Manipulate Authorship – And How they Should be Revised.” In discussing the loophole in the ICMJE guidelines that allows industry authors to write the majority of the paper and then bow out at the last moment, he states:

^{“Provided academics make some contribution to design or data analysis, some revisions to a manuscript, and approve it, they are required to be named as authors. By contrast, industry may conduct most of the design, data collection and analysis, and all the writing, but if sign-off is ceded to the academic, it is disqualified from authorship. Unsurprisingly, the practice of ceding final sign-off to academic ‘authors’ is widespread in commercially driven publications.”}

^{Matheson refers to this loophole as the “tool for the industry and that because of this error in logic, “industry and medical writers’ organizations are thus able to publicly condemn ghostwriting using comparable framings while the misattribution of authorship remains widespread.” It is no surprise that industry does this, but what will probably surprise many academics is that, as we discuss below, universities do the same thing…}

^{University of Miami Miller School of Medicine:
In 2009, the University of Miami hired Charles Nemeroff to chair its pychiatry department. Nemeroff has been at center of numerous allegations about problematic authorship practices. Most recently, US Senator Charles Grassley wrote the NIH to ask why it gave Nemeroff a $2 million research grant since he is under investigation by the Office of Inspector General. Bernard Carroll has in-depth discussion of the ghostwriting allegations. For a medical school to hire someone involved in ghostwriting as chairman of a major department, the message sent to the entire medical school faculty appears to be that ghostwriting is considered an acceptable practice. Some might even suggest that they value it.}

Ghost authorship is a "conscious crime." People know what they’re doing [mens rea] at the time they’re doing it [actus reus], and the rationalizations they give when confronted are already prepared [alibi]. There is no accidental ghost-writing scenario. If it were murder, it would be first degree [premeditated], not second degree [heat of the moment] or manslaughter [reckless behavior gone awry]. And unlike criminal court, it’s more in the realm of guilty until proven innocent. In the examples in this Pharmalot post, there’s little question about any of the examples.