An Avandia Study Author…Or So We Thought?
4 CommentsBy Ed Silverman // July 13th, 2010 // 10:06 am
Steve Haffner played a relatively modest role in the Avandia scandal, but until now, he was known primarily for leaking to GlaxoSmithkline the damaging meta-analysis of the diabetes pill that was published in The New England Journal of Medicine three years ago. Haffner later acknowledged breaching his responsibility as a peer reviewer, but blamed “bad judgment” because he wasn’t “feeling well.” In doing so, Glaxo was able to respond very quickly to the disclosure (back story).
As it happens, Haffner felt just fine several years earlier when he allegedly had an Avandia study ghostwritten for him. Documents released today by the US Senate Finance Committee appear to indicate Haffner, a University of Texas Health Science Center at San Antonio researcher at the time, was to be the author of a paper that was targeted at the American Journal of Cardiology, according to an internal email from 2001 (please see Attachment H, which is on page 58). “Please find attached the Haffner manuscript,” David Harrison, the Avandia publication strategy manager writes. “The manuscript is currently in rough form and has not been sent to author yet.” There is another email on page 111.
For those who may not recall, SmithKlineBeecham (which Glaxo subsequently purchased) began its Cassper program in 2000 to promote certain drugs, including the Paxil antidepressant, in the medical community. As the memo on page 57 indicates (please refer to the link above), Cassper (or Case Study Publications for Peer Review) was designed to “offer assistance in the preparation and publication of case studies and other short communications relevant to the clinical use of Avandia.” A scary prospect? Well, you can read the manuscript, too, which founds it way into Circulation.
In a statement, however, Glaxo denies doing any ghostwriting for Haffner or that his paper was part of the Cassper program. “GSK follows established authorship practices modelled after the International Committee of Medical Journal Editors (ICMJE) guidelines, which require ’substantial contributions’ by authors as well as final approval of the article before publication. The article referenced by (the Senate committee), ‘Effect of Rosiglitazone on Nontraditional Markets of Cardiovascular Disease with Type 2 Diabetes Mellitus,’ was authored by Dr. Steven Haffner, and reflects his substantial input and his views. This article was not part of the Case Study Publication for Peer Review programme, which was discontinued for rosiglitazone in 2004 and produced only two articles.” [Our thought: How is 'substantial contribution' defined. And given the e-mail, the impression runs to the contrary].
Michael S. Altus, PhD, ELS
“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 .
Michael S. Altus, PhD, ELS
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.
LF Velez
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?
Leemon McHenry
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.