Friday, December 09, 2005
NEJM editors claim Merck withheld data re: Vioxx study heart attacks
In a turn of events more typical of John Grisham novel than a real trial in a federal court, editors of the NEJM announced in their online journal they had become aware of Merck withholding data from the Vigor trial manuscript which would have made the cardiovascular relative risk even higher.This occurred while the third Vioxx trial is underway in federal court in Houston.Just when you thought revelations about Merck's alleged misdeeds could not get any worse, the editors at NEJM accuse Merck of deleting data so that three additional heart attack deaths did not appear in the data tables.This change did not alter the basic finding of increased risk in the Vioxx treated patients so you wonder why the researchers bothered to make that change.Material,that included internal Merck e-mails- that become public during the trial seemingly lead the editors to take the unusual action of re-assessing data from a several year old article. This raises the lack of credibility to previously unreached levels as regards clinical trials funded by drug companies. Merck has issued a statement in reply to the NEJM editorial statement that in part states the three deaths occurred after the agreed upon cut-off date for the end of the trial and those deaths were reported to the FDA. We have not heard the last of this. We teach medical students that the reasons for an association or lack of one in a clinical study are: chance, causality,bias and confounding. The fifth factor, fraud, was not typically emphasized in that regard, now it maybe it should be.