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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.


Anonymous said...

There is a book called Overdosed America (http://www.overdosedamerica.com/) that talks about problems with clinical trials done by drug companies and then those results being published in medical journals.

TXMed said...

"If the data were beyond the cutoff date for the study, then strictly speaking Merck did the correct thing by not including them in the analysis. Questions of propriety would arise only if Merck chose to include other data beyond the cutoff, such as some GI events. If the cutoff had altered the statistical conclusions, Merck would have been ethically obligated to disclose this, but that appears not to have been the case."

-- In The Pipeline comment

The editors seem to have brought this concern about the VIGOR study forward without any real review of the context of the situation. I mean, you can read about the results of the VIGOR study including the three CV events omitted from the data turned over to the NEJM, on the Vioxx safety insert. I'm looking at it right now on the FDA website.

I'm having a real hard time understanding any other motive, than the totally benign one Merck ascribes to the omissions in the NEJM. That is, considering they turned over that data to the FDA and it was for anyone to get their hands on.

Was there anything new added to the knowledge of Merck's handling of Vioxx clinical trials by the NEJM editors coming out with this 'Expression of Concern'? I don't see it.

And on the day of closing arguments for one of Merck's civil suits no less. The NEJM may smell more fishy in this VIGOR story than Merck does...