Ghostwriting in drug research back in the spotlight

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial author, Alison Bass has a great post on her blog entitled, "Ghostwriting in drug research back in the spotlight."

Alison highlights New York Times journalist, Natasha Singer, who focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Alison writes:

"Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents."


Full article can be read HERE


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