The conspiracy deepens, but will justice prevail? trial on trial, part 1 Just when I think the evidence damning Merck and their killer drug can't get any more incriminating, I'll come across something new about the case that absolutely appalls me… While doing some unrelated research on Cox-2 inhibitor drugs, I happened across a story from the tail end of last year that somehow slipped past my Vioxx radar-but that's relevant to the latest court decisions in the Vioxx debacle (more on this in part 2 of this essay, in the next Daily Dose). Here's the scoop, with some necessary background to help you keep it in context: According to an editorial that appeared in the December 8th, 2005 New England Journal of Medicine, one of the drug trials most frequently cited by plaintiffs' lawyers in the legal proceedings concerning Vioxx's safety-called the VIGOR study-was initially published (also in the NEJM, in 2000) with incomplete data on heart attacks… In short, there were 17.6% MORE heart attacks affiliated with the study's Vioxx group than were originally reported to the Journal by Merck in 2000. The 9-month VIGOR study was designed to compare rates of stomach ulcers and bleeding between Vioxx and the ubiquitous Naproxen anti-inflammatory medication, one of the most common drugs for joint pain before the Cox-2s hit the scene. In the VIGOR study, Vioxx did indeed outperform the older anti-inflammatory drug in rates of digestive distress… But what researchers noticed was that it also caused an alarming spike in the incidence of heart attacks! The VIGOR data that Merck DID disclose revealed that 17 of the patients taking Vioxx during the study suffered heart attacks, while only 4 in the Naproxen group did. But according to new information about the study the Journal editors have obtained, it was actually 20 patients in the Vioxx group who suffered heart attacks-3 of them reporting the events after the study's data collection period. ALL of these additional patients were classified as "low risk" groups for coronary events before the study began-and fortunately, none of the 3 were fatal. Add these additional incidents into the mix and it means that the Vioxx-takers were 5 TIMES AS LIKELY to suffer heart attacks from the drugs as those taking Naproxen. But here's where it gets really seedy-keep reading…
Conveniently hiding behind their data collection "deadline," Merck claims that they didn't withhold any of the data from the VIGOR study. They also claim that they actually called attention to the additional heart attacks in numerous press releases and "public" meetings of an FDA Advisory Committee in February of 2001…
If that's the case, it seems kind of peculiar that neither the New England Journal of Medicine's Editor-in-Chief, Executive Editor, or Managing Editor (who all collaborated on the December 8th editorial) had ever heard of the additional heart attacks. Doesn't it? According to an Associated Press article on the matter, the Journal Editor-in-Chief only found out about the 3 incidents from a plaintiff's lawyer during a deposition in a Vioxx case. At that meeting, the attorney showed the journalist an internal memorandum he'd obtained from Merck via a subpoena that contained the omitted extra data… That discovery is what prompted the editorial, in fact. So how does all this affect the thousands of Vioxx cases currently pending? I'll tell you in part 2 of this essay, in the next Daily Dose. Stay tuned… Reporting, not dis(tort)ing, William Campbell Douglass II, MD
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