We previously heard from our pals Jonathan Leo and Jeff Lacasse on the issue of ghostwriting:
http://brodyhooked.blogspot.com/2012/06/those-persistent-ghosts-key-loophole.html
They are in the process of doing a 3-part blog posting on ghostwriting and I had planned to read all three parts and maybe summarize any new points. But their Part 2 so grabbed me--
http://www.healthnewsreview.org/2013/01/ghostwriting-series-part-2-ghostwriting-about-medtronics-spinal-fusion-surgery-product/
--that I decided to link to it right away, because it contains what would be considered a really bad joke about ghostwriting. Trouble is, no one was trying to be funny.
The issue is Medronic's InFuse-- see:
http://brodyhooked.blogspot.com/2012/10/when-marketing-tail-wags-research-dog.html
I commented on the Senate Finance Committee report in that previous post but need to mention what Drs Leo and Lacasse pulled out of it. The basic point is that Medtronic, and communication companies hired by Medtronic, are writing drafts of papers, sending them to their orthopedic surgeon "key opinion leaders," rewriting parts of the papers to spiff up InFuse's image (mostly by denying any adverse effects), and then having the surgeons send the papers to journals as if they wrote them themselves, with no mention of the company input. The surgeons were paid hefty consulting fees for their work--Leo and Lacasse report a total of $210M changing hands with one prominent surgeon getting $34M all on his lonesome.
As Drs. Leo and Lacasse recount the record, in 2004 a paper appeared in the journal Spine co-authored by Dr. J. Kenneth Burkus, one of the KOLs. The Senate committee uncovered internal company e-mails showing that Medtronic did not like the part of an early draft that said "this review of the results...are [sic] encouraging." So a Medtronic exec, Rick Treharne, sent Dr. Burkus a revised draft in which he had inserted several new paragraphs, which began, "In conclusion, this detailed, independent review of the results..." and went on in that vein extolling the wonders of InFuse. And that was the version that Dr. Burkus and his colleagues submitted to the journal, with their names on the byline, and with no mention anywhere of Treharne or anyone at Medtronic being an author or contributing to the writing of the paper.
Well, the reviewers for the journal, bless them, didn't like the new conclusion. They actually thought it sounded, well, biased. (Who would have guessed?) So Dr. Burkus decided to defend the draft by sending the journal a letter in response to the reviewer's comments, to reassure the editors that the paper was truly an independent work by unbiased scientists. But Dr. Burkus did not write the letter himself. He turned instead back to Mr. Treharne, and Mr. Treharne and another Medtronic executive wrote the letter to the editor to explain why the article was in fact independent and unbiased. And of course when the letter arrived at the editor's desk, it was not signed by Treharne or anyone at Medtronic; it was signed by one of the (purported) physician-authors of the study.
Now, if I told you a joke about a college student who downloaded a class paper off the Internet, turned it in as his own work, and was accused by his prof of plagiariam, and defended himself to the prof with a letter that he also downloaded off the Internet and signed as his own work, you'd think I was telling a bad joke.
And Drs. Leo and Lacasse report that despite all this record being laid on the table by the Senate committee, both Medtronic and the University where one of the key "authors" works stoutly deny that any ghostwriting occurred at all.
Haid RW, Branch CL, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recomlinant human bone morphogenetic protein type 2 with cylindrical interbody cages. The Spine Journal 4:527-38, 2004.
Thursday, January 24, 2013
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