Submitted by Diane Farsetta on
An analysis of Merck internal documents concluded that the pharmaceutical company carried out a clinical study of Vioxx in 1999, "primarily to support a marketing campaign before the drug's launch." Merck stated that the study was done "to test side effects of the painkiller Vioxx," which was pulled from the market in 2004, after being linked to an increased risk of heart attacks. The 1999 study compared Vioxx to the widely-used painkiller Naproxen, in order "to accelerate uptake and advocacy for Vioxx," according to the Merck documents, which were disclosed during litigation. Another document -- a nomination of the 1999 study for a marketing award -- said the study was "designed and executed in the spirit of Merck marketing principles." Carrying out clinical studies for marketing purposes "would raise ethical and scientific questions, from whether study participants were unknowingly -- and needlessly -- put in harm's way, to whether a company's research is reliable." Earlier analyses of Merck documents found evidence the company ghostwrote academic articles and minimized patient deaths in Vioxx trials. The authors of the Merck document analyses were paid consultants in Vioxx lawsuits against Merck.
Diane Farsetta replied on Permalink
[http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=7027 PM Live reports] that Merck has responded to the Annals of Internal Medicine study in an open letter, which claims that the study "contains numerous inaccuracies."
The Annals study concluded that the 1999 Vioxx clinical trial was designed by one of Merck's marketing units. However, Merck maintained that the trial was "designed, conducted, analysed, interpreted and published by the scientific department of Merck’s US Human Health organisation." Merck also stressed that there were legitimate scientific reasons to conduct the trial, such as assessing "the gastrointestinal tolerability of VIOXX compared to naproxen."