Opinion ID: 1211810
Heading Depth: 2
Heading Rank: 2

Heading: FDA AAC Hearing (February 8, 2001)

Text: On February 8, 2001, the FDA's Arthritis Advisory Committee (AAC) held a public hearing to consider Merck's request to include the positive GI results from the VIGOR study in its Vioxx labeling. Six days before that hearing, J.P. Morgan issued a research report summing up the state of knowledge about Vioxx after the VIGOR study. The report stated that the basic idea behind the naproxen hypothesis was poorly proven, and that there was no way to retrospectively slice the data to prove the NSAID benefit vs. Vioxx risk argument, although one existing theory might support a `Vioxx risk' hypothesis. App. at 2547. J.P. Morgan warned, [t]his is the type of clinical `signal' that was ignored, and later haunted the FDA in recent drug recalls like Warner Lambert's Rezulin and Glaxo's Lotronex. App. at 2547. During the AAC hearing, defendant Alise Reicin, Executive Director of Clinical Research at Merck Research Laboratories, explained to the panel, when you review the results of VIGOR in isolation you don't know whether the imbalance of cardiovascular events was caused by a decrease in events on a platelet-inhibiting NSAID, naproxen, or an increase in events on a COX-2 selective inhibitor, i.e., Vioxx. App. at 995. She then suggested that naproxen was likely responsible for the difference in CV events observed in users of the two drugs. At the public portion of the hearing, the panel subsequently discussed whether to call for the inclusion of a warning in the Vioxx labeling stating that it was uncertain whether the CV events noticed in VIGOR were due to beneficial cardioprotective effects of naproxen or prothrombotic effects of [Vioxx], and leave it at that, that basically we don't know the reason. App. at 1143. Nonetheless, some press accounts reported that certain AAC panel members asserted that [d]ifferences in cardiac risk between Vioxx and naproxen appeared to result from a beneficial effect of naproxen, not a danger from Vioxx, App. at 2311, and that there was some reassurance that what we see, in effect, is a protective effect of naproxen, App. at 2306. In subsequent coverage, many securities analysts reported that the hearing had benefited Merck and they continued to project substantial future revenues for Vioxx. However, at least one investment firm issued a report stating, our skepticism relating to naproxen having a cardioprotective effect is reinforced by the AAC hearing. App. at 2703.