This will be one very interesting - and possibly highly charged - meeting the agency’s Arthritis advisory committee will hold to determine whether the painkiller should be approved.

Not only will the stakes be high for Merck, which desperately needs a new drug in its arsenal, the FDA’s credibility will be on the line. This will be an opportunity to see the extent to which the agency, which rejected Arcoxia in 2004 and wanted more data, takes safety seriously. What will FDA staffers recommend? And how many committee members have ties to Merck?

Remember: Arcoxia is similar to Vioxx, and there’s been controversy over a recent comparitive study. Merck says its pill is no more dangerous than diclofenac in raising the risk of a heart attack, although more patients taking Arcoxia dropped out due to high blood pressure or swelling tissues. Safety experts harshly criticized the comparison, because diclofenac is known to raise the risk of heart attacks and strokes.

Another issue to watch: back in 2005, when an FDA committee last reviewed Vioxx and other Cox-2 inhibitors, there was an uproar after it became known several panelists had ties to Merck and other drugmakers that sell the pills. Here’s a list of the committtee members.

The meeting in Gaithersburg, Maryland, will be jammed with consumer advocates, patients, Wall Street analysts and hedge-fund managers, lawyers who sue and defend drugmakers, and journalists. Make your travel plans now. [tags]Arcoxia, Merck, Safety, Vioxx[/tags]