Thursday, December 18, 2008

Ghostwriting: an old and venerable practice

I'm delighted to see that The New York Times has discovered the problem of ghostwriting -- wherein drug companies pay shills to write medical journal articles and then go hunting for respected doctors to put their names on already prepared articles. And I can only applaud the work being done by Senator Charles Grassley's team that led to the Times' article Friday on the ghostwriting behind several journal articles promoting Wyeth's hormone replacement drug Prempro (even after a federal study found the drug raised the risk of breast cancer).

But let's not kid ourselves: ghostwriting by the pharmaceutical industry is neither new nor uncommon. The British psychiatrist and historian David Healy was among the first to write about this widespread practice, when he published a 2003 article in The British Journal of Psychiatry about Pfizer's ambitious ghost-writing efforts to promote its antidepressant, Zoloft, in numerous medical journals. Healy showed that, similar to what Wyeth did with Prempro, Pfizer ginned up a publication plan that indicated all of the studies it had going on Zoloft (sertraline), who the authors were, and what the status of publication for each article was. As Pfizer's plan indicated, most of these articles had originated with ghostwriters (in this case a company called Current Medical Directions) and a number of the planned articles listed the authors as "To Be Determined."

GlaxoSmithKline did the same thing in promoting its blockbuster antidepressant Paxil, as a number of books, my own included, have revealed. According to documents unsealed in a lawsuit, Glaxo hired a ghostwriter by the name of Sally Laden (from Scientific Therapeutics Inc.) to write the first draft of a study comparing Paxil to placebo and an older antidepressant in treating depression among adolescents. The study purported to show that Paxil was more effective than placebo and the older tricyclic, even though the actual data showed that the opposite was true; see back story. As the legal documents show, the principal researchers of study 329, as it became known, made only minimal changes to the ghost-written draft, and it was Laden who, with the help of Glaxo officials, shopped it to several journals, before finally getting the article published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001. Glaxo then used the JAACAP article to heavily market Paxil for pediatric use to doctors in the U.S. (even though such off-label marketing is supposed to be illegal).

Because of the publicity over such flagrant abuses, one former journal editor says that most leading journals now require the authors of submitted manuscripts to attest to the fact that they have written the paper's first draft or tell the journal who did write it. So while that may cut down to some extent on ghost writing, it doesn't mean the practice will disappear. After all, the journals still have to take the researchers' word for it. And that word, as has been demonstrated over and over again in the case of doctors on the take from drug companies, doesn't necessarily mean all that much.


Unknown said...


I just wanted to wish you a happy holiday season, and hope that neither of us find ourselves screaming in the new year, like one of the Beatles on "Helter Skelter" (was it John? was it Ringo?) "I've got blisters on my fingers!"

best wishes,

Anonymous said...

That was Ringo. :) The blisters were from his drumsticks.

Anonymous said...

Alison, in your book you made a reference to the relationships between doctors and pharmaceutical companies, and specifically mentioned Minnesota, the state in which I live. You also mentioned that MN has some of the best laws to make those relationships more transparent.

I remember posting this on a site last year, in 2007, and it must have been what you were referring to, from Minnesota Public Radio: Doctor, drug industry relationship under scrutiny

I wanted to post that for the benefit of your readers. Obviously you're aware of it. :)

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