A leading medical journal said Thursday it has retracted a key study that Merck has relied on in its Vioxx defense.
In making the retraction, the New England Journal of Medicine said data from the 2000 VIGOR study — funded by Merck may have been skewed by its authors, according to a report Thursday on CNBC.
In an “expression of concern” on NEJM’s Web site, the journal claimed the VIGOR study omitted three incidents of heart attack from the data sent to NEJM for publication.
NEJM further charges that the study’s authors knew of the three additional cardiac events before the study was submitted to the journal for publication and had ample time to make revisions.
Specifically, the journal said the study authors knew of the three adverse events two weeks before submission of the study to NEJM and a full four and a half months before the study was published in the journal.
In fact, NEJM said it learned from a “computer diskette” that the data on the three adverse events were deleted one day before the study was sent to NEJM May 18, 2000.
For its part, Merck released a statement saying it “promptly and appropriately” disclosed the cardiac events in question.
The firm said it told the FDA of the incidents in 2000 and an FDA advisory panel in 2001.
Shares of Merck reportedly fell 7 percent on the news of NEJM’s action.
Merck has relied heavily on the VIGOR study for assertion in a rash of Vioxx-related personal-injury lawsuits that Vioxx was safe when used properly. Merck took Vioxx off the market in September 2004.
About 6,500 suits are currently pending against Merck. The embattled firm paid out $253 million in the first suit but prevailed in a second suit in New Jersey. The first federal lawsuit based on Vioxx is now under way in Houston.