Dr. Jonathan M. Edelman, Director of Scientific affairs for Merck, has offered this reply to the charges leveled in the Annals of Internal Medicine article which had characterized the Advantage trial as a "seeding trial".
Dr. Edelman denies that it was, in fact, a seeding trial and that it was designed to answer a significant, scientific question describing the trial as one in which Vioxx was compared with a widely used drug Naproxen in a "real life" setting and involving patients who were allowed to take aspirin as well and - as such- answered questions that were relevant and pertinent to practicing physicians. He also denies that participants were not properly informed about the purpose of the trial.
Edelman also says that the trial "was designed, conducted, analyzed and interpreted by the scientific department of Merck." I had implied otherwise in my comments in an earlier entry on this subject perhaps inappropriately embellishing this following statement from the Annals article, "Merck's marketing division, ...handled the scientific and marketing data including collection, analysis and dissemination." However, which group or groups within the company designed the trial does not settle the question of if this a seeding trial or not.
Dr. Carlat has also taken up this topic and interviewed one of the authors of the Annals article.See here for the interview. The WSJ.Com Health Blog also writes about this issue here. The Med Page Today blog tackles this topic also.
Details of how much and what was disclosed to the patients and the participating physicians is not made clear by either the Annals article or the Merck reply.
1 comment:
Call it a "seeding" trial or not, when you have 600 "investigators" and less than 5 times that number enrolled in the trial, you have to think something other than high grade scientific research is being done.Of course the drug company would not say "we are doing a seeding trial" Also in this era of much talk about conflict of interest you have to point out that the Annals authors had done some work for the plaintiff lawyers in some of the Vioxx litigation.
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