Did the American Heart Association's Circulation journal publish a ghostwritten article about Avandia? There has been disagreement about this ever since the US Senate Finance Committee released a report in July about the controversy concerning the GlaxoSmithKline diabetes pill. Glaxo, you may recall, once ran a program aptly named Cassper, or Case Study Publications for Peer Review, which was designed to assist researchers with their articles.
At the time, the committee sent a wad of documents to the FDA that contained emails and drafts of different manuscripts. One appeared slated for the American Journal of Cardiology and the lead author was Baylor College's Steve Haffner (see this). Also included was a draft manuscript of a study destined for Circulation (see attachments H and I).
Since then, however, the AHA has been in a tizzy over the accusation that Circulation ran a ghostwritten Avandia article. In a sharply worded Aug. 23 letter to FDA commish Margaret Hamburg, the AHA takes umbrage with the committee's facts, and points out the example cited by the committee was never published in Circulation. "...some of the information is in error and requires correction or clarification, particularly as it relates to Circulation," writes AHA’s Scientific Publishing Committee Donna Arnett.
The letter was sent after an AHA lobbyist Sue Nelson implored a staffer at the Senate Finance Committee to correct the record. In particular, she complained that Paul Thacker, a staffer for US Senator Chuck Grassley, the ranking Republican on the committee, was refusing to cooperate and impugned the AHA's integrity by suggesting the organization accepted funding from drugmakers, specifically referring to the Vytorin scandal (read this).
"Our editors (who pride themselves in not publishing ghostwritten work) are very upset," Nelson wrote in an Aug. 11 email to the committee. "There are clearly patient groups who are fronts for drug companies and it’s in all of our best interests that they be exposed. We are not one of those. If we were, I wouldn’t be working here. We represent the best interest of patients, which means working with drug and device companies from time to time, but our firewalls are strict. I can tell you that our advocacy work has never been influenced in any way by their interests and even in these tough fiscal times, our program work remains separate as well...Our editors really take their jobs seriously and believe that their integrity has been brought into question."
In response, the Senate Finance Committee has now clarified the record by sending this letter to Hamburg pointing out that its original attachments did, indeed, contain a draft manuscript of an Avandia article that was ghostwritten. "At the time (of the July report), it was unclear if the emails about ghostwriting concerned the article that appeared in Circulation, or if they were discussing a separate manuscript. Regardless, my staff has consulted with GSK, and the company confirmed that the manuscript which appeared in Circulation was written for GSK by a medical education company," Grassley writes. The lead author, by the way, was Haffner.
The expression 'doth protest too much' comes to mind.
12 Comments
Peekaboo. I see you.
Thank goodness it's not another story about me. Looks like Sue Nelson got owned.
Who ya gonna call?
"GHOSTBUSTERS"!
And, cue Ray Parker, Jr. intoning "I ain't 'fraid of no ghost!"
Namaste
this nelson is not looking good right now.
and the beat goes on. AHA looks bad after this.
Journals don't know which articles are ghostwritten. Do a search of the number of companies in the US that do these articles. The ones that are written all go somewhere. And the companies don't stay in business if the articles don't get published.
One of the concerns with ghostwriting and honorary authorship is that they potentially hide commercial influence under the guise academic credibility. In other words, transparency in the peer-reviewed literature is lacking.
However, in the case of the 2002 Circulation article, "Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes," three of the six authors (Weston, Chen, and Freed) are acknowledged to be employees of GSK. So to any physician-reader, the potential for commercial influence is obvious,* regardless of who actually wrote the article.
The big concern with medical ghostwriting is when drug companies hire writers to draft review or opinion pieces (usually to be published in company-sponsored journal supplements) with the full intent of crediting the work to a willing academician.
*Which is also based on the acknowledged fact that the study was funded by GSK.
bmartinmd, you bring up some very good points. However, I think it is also important to point out that by failing to disclose a ghostwriter, they do create a small misimpression that the academics had more involvement in the study than is actually the case.
Now that we know it was ghostwritten, we also can understand that the academics didn't even bother to spend the time writing it up. Nthis makes it more clear that this research was probably more about marketing than advancing medical knowledge.
Anonymouse, we have no way of knowing how much input the academic authors had into the study or the writing of the 2002 article. And, for that matter, we have no way of knowing how much a ghostwriter contributed. Did a ghostwriter just create the first draft manuscript, or was a ghostwriter involved in all subsequent, edited versions?
My point is: Whether the 2002 article was ghostwritten is an essentially immaterial question, given that the reader is already informed that GSK funded the study and that GSK employees share authorship. That's sufficient information for any physician to understand the source of the data...and to consequently make his or her own opinion about the merits or validity of the presented information.
BTW, the article that the AHA cited in its letter to Hamburg and that was referred to by Baucus and Grassley in their attachments H and I ("Modifying cardiovascular risk in the type 2 diabetes patient") was, in fact, never published in Circulation or any other AHA journal (at least by my search). However, it does appear that Cassells and Haffner (credited in that order) published a review article, "The metabolic syndrome: risk factors and management," in the Journal of Cardiovascular Nursing in 2006. This journal is not an AHA journal.
(And Ed, on a related note, I find your post confusing in that it blurs the distinction between these 2 separate articles.)
Bmartinmd, the fact that you find it immaterial does not make it so. That's just your personal opinion. I'm sure the editor of nejm or jama would think otherwise if it was published in their journal.
Hi Barbara,
Thanks for the comments and yes, the situation is a bit confusing. You are correct that the article “Modifying Cardiovascular Risk in the Type 2 Diabetes Patient" was not published in Circulation, as the AHA points out in its letter to Hamburg. Apparently, the Senate Finance Committe erred in first writing - or suggesting - to Hamburg that this article was published in Circulation.
However, the other journal article that is contained in the attachments in both Senate Finance Committee letters to Hamburg, "Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus," was published in Circulation.
And it is this article that the committee now says was ghostwritten, after being told by Glaxo that it was authored by a medical education company.
In short, the AHA is complaining that the first article mentioned was never published in Circulation and, therefore, objects to any suggestion that its journal runs ghostwritten articles. So the AHA demanded a correction or clarification.
From my read of things, the committee noted the mistake, but then discovered - by contacting Glaxo, according to its most recent letter to Hamburg - that a ghostwritten paper did, indeed, appear in Circulation. Somewhere along the way, the committee mixed up the papers.
It took me awhile to sort this out and I apologize if the post wasn't as clear as could be. But I hope this somehow clarifies things.
All best ed
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