A new day at the first trial concerning the safety of Merck & Co’s withdrawn COX-2 inhibitor, Vioxx (rofecoxib) [[18/07/05d]], [[01/10/04a]], and as testimony begins, the gloves are most definitely off.
Proceedings in the Angleton, Texas court, in a case that sees the family of a deceased man claiming that his death was linked to the drugmaker’s now-withdrawn painkiller, saw Merck’s chief epidemiologist Nancy Santanello facing questions from the plaintiff’s colourful lawyer Mark Lanier.
The latter’s opening gambit saw him show the jury a Merck training document called “Dodge!” according to a Reuters report, which implies that Merck had been less than scrupulous in revealing data about Vioxx but Ms Santanello was not biting.
She responded by saying that the aforementioned document was part of “a game the marketing people played on how to teach the marketing people how to answer questions”, and that the point of the exercise was not avoid questions about the safety of the painkiller.
Mr Lanier then moved on to a warning letter sent by the US Food and Drug Administration to Merck almost four years ago [[26/09/01a]], which described the company’s safety claims on Vioxx as “simply incomprehensible given the rate of (heart attacks) and serious cardiovascular events compared to naproxen.” But Ms Santanello responded by saying that the firm took steps to address the FDA’s claims: “My experience at Merck is we take warning letters very seriously and address them very promptly,” she noted.
Mr Lanier went on to criticise the advertising Merck has used in promoting the drug but the company’s stance is that the deceased, Robert Ernst, died from an arrhythmia and Vioxx has never been shown to cause this problem.