"The medical community is currently trying to come to grips with the idea that much of the clinical trial literature has not been written by named authors, and, instead, has been written by medical writers employed by pharmaceutical companies who are not listed on the author byline. The success of virtually all of the blockbuster drugs has been tainted by charges of ghostwriting."
Ghosts In The Pharma Attic by Jonathan Leo and Jeff Lacasse
It has been slow to dawn on me that
virtually all of our psychopharmacological blockbusters in the last twenty-five years have achieved their widespread notoriety by routes other than safety and clinical efficacy – and ghost-writing has been a prominent player on their highway to success. Right now, I’m focused on Paxil Study 352 [paxil study 352 revisited…], a GSK production involving Sally Laden of STI [the editorial assistant for the infamous Paxil Study 329]. But I thought I’d weigh in on the "what’s ghost-writing?" question before continuing to try to parse this clinical trial and article further.
The "what’s ghost-writing?" debate can get pretty silly, sounding more like clinical examples for Anna Freud’s 1934 description of the adolescent defense mechanism called rationalization - the way teenagers flex their newly-found ability to use formal logic by torturing their parents with endless logical reasons that they should be allowed to do whatever they want to do. From my perspective, ghost-writing is more than the spell-checking, the grammar-checking, or the war on stilted language and run-on sentences often provided by the spouses of researchers. Just like authorship is more than edits and marginalia added to someone else’s draft. A ghost-writer is a hired writer who takes the data and creates the structure and arguments that will ultimately become the submitted paper – in other words, the author of the first draft. In that regard, Sally Laden, ghost-writer for Paxil Studies 329 and 352, is the prototype. Recall her testimony about Paxil Study 329 [Deposition of Sally Laden, 2007]:
QUESTION: Okay. Was it your responsibility alone to create the first draft of Study 329 or did you get help from some of your colleagues?
ANSWER: I believe I created it on my own.
QUESTION: Okay. Did Martin Keller tell you what to put in the first draft?
ANSWER: I don’t recall. I don t think I had any conversation with him until we were, you know, afterwards.
QUESTION: Okay. After you prepared the first manuscript?
ANSWER: To the best of my recollection, yes.
Medical Ghostwriting: A University–Sanctioned Sleight of Hand?
by Jonathan Leo & Jeffrey R. Lacasse
As we examined the results of the investigation, we were struck by the fact that the investigative panel seemed to confuse honorary authorship with ghostwriting. To be sure, both are problems in academia, but there are important differences. Honorary authorship consists of someone being placed on the authorship line who did not truly deserve to be listed as an author- often a department head or wellrespected senior researcher in the field. As we have recently argued, ghostwriting is a simpler issue to ascertain, by asking the straightforward question: Was there a writer who contributed significantly to the paper, who was not listed as an author? If the answer is yes, the paper was ghostwritten. This is not just our perspective. In a recent research article on ghostwriting, the editors of JAMA defined a paper as ghostwritten when, “An individual who was not listed as an author made contributions that merited authorship,” or “An unnamed individual participated in writing the article”…
UPenn Looks The Other Way At Ghostwriting
By Ed Silverman
March 1st, 2012
The University of Pennsylvania has denied allegations made by one of its professors that several other academics – including his department chair – allowed their names to be added to a medical journal manuscript, but gave control of the contents to GlaxoSmithKline, according to his attorney. The study, which was funded by the drugmaker and the National Institutes of Health, looked at the impact of the Paxil antidepressant on patients with bipolar disorder.
At the same time, the university has acknowledged a claim by the professor, Jay Amsterdam, that the 2001 study was ghostwritten by Scientific Therapeutics Information, his attorney tells us. However, he says the university is not planning on taking any action in connection with the ghostwriting. The study, which was published by the American Journal of Psychiatry [see here], did not mention that STI played any role.“They said his allegations were not meritorius, although they did find that the publication at issue was ghostwritten,” says Bijan Esfandiari, the attorney, citing a letter and other documents he received from the university. “They acknowledged that a marketing firm was involved in drafting, and everything associated with, the issue. But in response to our complaint, they said that, at the time these events took place, which was between 1998 and 2001, ghostwriting was standard practice and everyone was doing this, so therefore, we’re not going to punish any individuals”…
On the other hand, Exhibit 9 of the Inquiry Committee Report displays draft one of the study 352 manuscript, which was prepared on March 1,1997, for Muriel L. Young, M.D. at GSK by Grace Johnson and Sally Laden at STI…
Exhibit 10 of the Inquiry Committee Report displays draft two of the study 352 manuscript dated April 7, 1997, prepared for Muriel Young, M.D. at GSK by Grace Johnson and Sally Laden at STI…
In contrast, Exhibit 11 of the Committee Report displays draft three of the study 352 manuscript dated September 24, 1997, prepared for Muriel Young, M.D. at GSK and now displaying GSK-designated authors [Laszlo Gyulai, M.D., Gary Sachs, M.D., Dwight Evans, M.D., Charles Nemeroff, M.D. PhD, Muriel L. Young, M.D., Cornelius D. Pitts, RPh, William D. Bushnell, MS, Ivan P Gergel, MD]…
… in Exhibit 13 of the Committee Report, draft three [actually draft four] dated June 24, 1998 … was prepared for Cornelius Pitts, R.Ph. at GSK by Grace Johnson and Sally Laden at STI, and was assigned the following GSK-designated authors: Charles B. Nemeroff, MD, PhD, Dwight L. Evans, MD, Gary Sachs, MD, Laszlo Gyulai, MD, Charles L. Bowden, MD, Muriel L. Young, MD, Cornelius D. Pitts, RPh, William D. Bushnell, MS, Ivan P. Gergel, MD…red = GSK employees & blue = STI employees
Nemeroff, the paper’s first author, says that the data used withstood rigorous peer review in a process that sent the paper back to the authors for revisions several times. "Right in the abstract under ‘results’ we report that ‘Differences in overall efficacy among the three groups were not statistically significant’," he says. "I don’t know how much more straightforward we can be than that. "He adds that "with a 2011 magnifying glass, obviously one would have included in the published paper the use of an editorial assistant". Still, he says: "All [STI] did was help collate all the different authors’ comments and help with references. We wrote the paper."
There’s not the wealth of information for Paxil Study 352 like there was for Paxil Study 329, certainly not the raw data that was finally released for the 329 trial in adolescents this last August. But my own reading of the published Paxil Study 352 article [paxil study 352 revisited…] suggests that they took even deeper liberties with deceitful presentation and analysis than in the Keller et al Study 329. I’m going to start with the recent paper [The paroxetine 352 bipolar trial: A study in medical ghostwriting by Jay D. Amsterdam and Leemon B. McHenry] and chase the references to see what else I can find.