An article in The New York Times a few days ago about Vioxx almost makes it sound as if the ghostwriting of new drug studies by pharmaceutical companies is a new and relatively unknown practice. In fact, the ghost-writing of research by pharmaceutical companies eager to publicize positive results about their new drugs in prestigious medical journals has been a widespread industry practice for years.
David Healy, a psychiatrist and professor at the University of Wales in England, was among the first to write about the practice of ghostwriting by drug makers a number of years ago. In several scholarly articles, Dr. Healy drew attention to the fact that Pfizer had ghost-written a series of positive research studies for its blockbuster antidepressant, Zoloft. In a review of internal Pfizer documents unsealed in lawsuits, Healy found that just as Merck did with Vioxx, a Pfizer was preparing a number of Zoloft studies for publication before they had identified authors for the studies. On an internal list of these in-process studies, Pfizer had put question marks next to the line for possible authors.
As my forthcoming book reveals, GlaxoSmithKline resorted to a similar scheme in its effort to publicize the results of a study purporting to show the effectivenes of Paxil in treating depression in adolescents. Unsealed documents from a lawsuit against GlaxoSmithKline show that a consultant for Glaxo ghost-wrote the first draft of this research and then sent it to the principal authors for review and approval. The Paxil study was rejected by JAMA(in large part because its positive conclusion about the antidepressant was not backed up by the actual data in the study), but the study was eventually published in the Journal of the American Academy of Child Psychiatry.
The article in the http://www.nytimes.com/2008/04/16/business/16vioxx.html?ex=1366084800&en=ef29a5f6ea0a6e76&ei=5124&partner=permalink&exprod=permalink” based its news on a recent study in JAMA that looked at documents unearthed in lawsuits over Vioxx, which was pulled from the market in 2004. As these documents show, Merck also hired ghostwriters to draft Vioxx research studies, then the company found prominent authors who would be willing to attach their names to the studies for publication in medical journals. As David Egilman, an associate professor in community health at Brown University, tells Pharmalot blogger Ed Silverman, “By having no outside researchers look at data or be in control of a study allowed Merck to manipulate the trials. They were able to use spin to create the impression that the drug didn’t kill people, which it did.”
As Dr. Joseph S. Ross, the lead author of the JAMA article says, this practice raises broad questions about the validity of much published drug research. Indeed, I would argue that it raises questions about the credibility of the entire system of drug testing and research. And now, finally, the mainstream media is paying attention.