As reported at Forbes.com, everyone knows the recent criticism by the New England Journal of Medicine of an important Vioxx study by Merck will play some part in the current and future trials. The big question is how much impact will that criticism have? To quote from Forbes:
The disclosure that some negative data was omitted from the study could make manufacturer Merck & Co. look as if it’s hiding something, legal experts say. That is what attorneys for Evelyn Irvin Plunkett, whose husband died after taking the drug for a month, say they can prove in the trial starting Monday.
The journal’s critique noted that its editors learned that the authors had deleted information about three additional heart attacks not reported in the original study, but reported to the Food and Drug Administration. That would have changed a section about side effects, showing that Vioxx patients had five times as many attacks as those on the pain reliever naproxen, rather than four times as many – and that patients not considered high-risk were having heart attacks, it said.
“Taken together, these inaccuracies and deletions call into question the integrity of the data,” the journal said.
The editors found a blank table labeled “CV events” – heart attacks and other cardiovascular side effects – on a first draft of the VIGOR study found on a computer diskette after the recall. It was deleted from later versions on the same disk.
Dr. Gregory Curfman, the journal’s executive editor, confirmed through a spokeswoman that software indicated that data was deleted from the table two days before the manuscript was submitted, and identified the deleting editor as “Merck.”
My opinion is that the omissions from the original study will be devastating to Merck only if handled properly by plaintiff lawyers. Too subtle, or worse, too ham-handed, and the revelations will have little impact on the juries.