Comments on: An Avandia Study Author…Or So We Thought?

By: Leemon McHenry

Leemon McHenry — Mon, 19 Jul 2010 22:16:21 +0000

In my view, how ’substantial contribution’ is defined is a red herring. The real issue is whether marketing messages that are key talking points of the company’s publication strategy have already been planted into the paper. This occurs well before a suitable ‘author’ is identified for the paper in question.

Moreover, manuscripts that originate in the company’s publication strategy receive ‘final approval for the manuscript’s submission’ by the company’s legal department who sign off on the paper and transfer ownership to the ‘author.’ The ‘author might very well give his or her approval when the paper is submitted for publication, but this can occur only after the sponsor company has approved the manuscript as having met the marketing goals.

By: LF Velez

LF Velez — Tue, 13 Jul 2010 20:50:12 +0000

It’s important to note that “substantial contribution” may be defined differently by different people. While AMWA and JAMA and ICMJE [see "http://www.icmje.org/ethical_1author.html"] make statements about how the assistance of a writer to an author should be handled and disclosed, what an author _actually_ chooses to do when they submit a manuscript is out of the writer’s control. When one is doing work-for-hire, it is difficult to control what is done with the product of your labors. Even graphic designers are starting to realize this is problematic for their profession.

Ironically, it’s the very fact medical writers don’t have “final approval for the manuscript’s submission” that prevents them being considered genuine Authors by ICMJE standards!

In the particular case discussed in this blog post, GSK may very well not have been involved in doing any writing for the physician. That function is now typically outsourced, and any writer would not have appeared on the GSK payroll. MDs typically balk at the prices writers charge for their skills, and so rely on publication companies subsidized by pharma to get that kind of editorial assistance for “free”.

In any event, the real question is whether the cart has been quietly motorized and is pushing the horses around, isn’t it?

By: Michael S. Altus, PhD, ELS

Michael S. Altus, PhD, ELS — Tue, 13 Jul 2010 18:06:15 +0000

The URL was dropped by your system. Please insert as follows:

Altus MS. AMWA’s Ethics FAQs. Available at http://www.amwa.org/default.asp?id=466.

Thank you.

By: Michael S. Altus, PhD, ELS

Michael S. Altus, PhD, ELS — Tue, 13 Jul 2010 18:04:07 +0000

“The phrase ’substantial contribution’ is often used with respect to determining authorship credit. A helpful explanation of what substantial contribution means is in the authoritative AMA Manual of Style [Flanagin, Annette. "Authorship Responsibility" in Iverson C, Christiansen S, Flanagin A, et al. AMA Manual of Style: A Guide for Authors and Editors. 10th ed. New York, NY: Oxford University Press; 2007, p. 127-140.]: “A substantial contribution is an important intellectual contribution, without which the work, or an important part of the work, could not have been completed or the manuscript could not have been written and submitted for publication.”

Altus MS. AMWA’s Ethics FAQs. Available at .