Merck had a trial, (036), to test Vioxx and low dose aspirin combined use. Aspirin defeated Vioxx gi protection thus making Vioxx a more dangerous more expensive motrin. This study never made it into the label although results were avaialble in November 2001.

Vigor had more patient years & patients on aspirin than Advantage even though the protocol prohibited such use. Another disparity between the things Merck said it was doing & what it actually did.

Kim Klausner
Digital Libary Manager

I believe I am right that a difference between ADVANTAGE and VIGOR is that pts using low-dose aspirin were not excluded in former, but were in latter. This is underlined in the protocol (p. 8) that is linked on the other thread on this issue. I assume Merck intended to highlight this point for FDA reviewers.

As I recall, and here I could certainly be wrong, some of the internal memos suggest that there was some debate within Merck on this point - whether allowing ASA would erase whatever GI benefit and/or whether it might be used as evidence (in the context of other company materials) that Merck anticipated potential CV problems. Again, I could be wrong, but I think the discussion of whether the study was “redundant” was partially shorthand for: Why do an additional study that could show problematic results on both GI and CV sides - and risk “killing the drug”?

In that context, I must say that ADVANTAGE being done had a certain “advantage” - but this is independent of the ethical issue of informed consent.

From the protocol, I also note that pts with the most debilitating OA (class IV) were excluded from participating. I acknowledge that class III is no picnic! It would be interested to know the breakdown of subjects by OA class. As noted on another thread, Merck has justified the study on the basis of helping people with “deblilitating arthritis.”