Merck included the idea that its painkiller Vioxx might increase the risk of heart attacks in the first draft of a paper submitted to the NEJM, but dropped it because a reviewer found the section "awkward" .
So says Dr Alise Reicin, Merck's VP of Clinical Research and PharmaGossip's Person of the Year for 2005.
The fair Alise helped design, oversee and write up the study known as VIGOR. Plaintiffs' attorneys say that study gave the first real indication that Vioxx might be bad for the heart, but Merck sidestepped the issue.
Merck attorney Tarek Ismael read that comment from an e-mail sent from VIGOR's lead author to Marshal M. Kaplan, an associate editor of the journal: "The conclusion is somewhat awkward. I understand that the emphasis on the apparent increased comparative rate of cardiovascular events in the rofecoxib group is relevant. However, this needs to be tightened up."
Reicin will be cross-examined on Thursday in the retrial of the first federal Vioxx case, which ended originally with a hung jury. Attorneys hope to get through all remaining evidence also on Thursday, U.S. District Judge Eldon Fallon told New Orleans jurors at the close of Wednesday's hearing.
Insiders' view: The truth can often be "awkward". The big question is: awkward for whom?
On a personal level, Insider wonders if Dr Reicin now realises that, if Merck have their way, the rest of her professional career will be spent sitting in courtrooms accross the length and breadth of the US going over and over the same events.
Truly a "Groundhog Day" nightmare!
Source: Janet McConnaughey, AP
1 comment:
Has anyone heard of a connection between Fosamax and the onset of vasculitis? Or, is it a concidence that my wife developed a serious vasculitis shortly after starting to take Fosamax for osteoporosis?
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