Vioxx-New England Journal of Medicine Article

The New England Journal of Medicine now knows Merck withheld important information from it, too.

It was recently revealed that Merck & Co. failed to disclose to a prominent medical journal important information about additional heart attacks in a Vioxx clinical trial.  The New England Journal of Medicine recently issued an editorial which said at least two authors of a Vioxx study called VIGOR knew at least two weeks before the paper was submitted and 4 months before it was published that there were three heart attacks not included in the article's data. The absence of the data led to incorrect calculations and conclusions, the editorial said.  Moreover, a spokeswoman for the Journal said Merck deleted a chart which included the additional heart attacks from the manuscript that was submitted.

VIGOR was designed to see if Vioxx was gentler on the stomach than naproxen, an older pain reliever. The original Journal article was published in 2000 and said that Vioxx caused fewer gastrointestinal problems than naproxen. It also said patients taking Vioxx had four times the rate of heart attacks as patients taking naproxen. If the three additional heart attacks were included, the rate jumped to five times.

At the time, Merck explained the difference in the rate of heart attacks by saying that naproxen is cardioprotective.  Merck said in a statement after this news broke that the additional heart attacks "did not materially change any of the conclusions of the article." Merck also said the information was not included because the heart attacks were reported after Merck's cut-off date for collecting information on the patients in the study.  Merck went on to say that the additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001 and included in numerous press releases.

The VIGOR study has figured prominently in the three Vioxx trials that have taken place.  While Merck has used VIGOR to show (among other things) that 18 months exposure is required, it has been used by Plaintiffs to illustrate how Merck ignored a huge warning about Vioxx's risk and created a bogus explanation for the results.