Biotech Values

[AlpineBV_Miller]

Oscient punts Fleming from panel

I missed this WSJ story today how Oscient asked for FDA biostatistician Tom Fleming to be removed from the Factiva panel because he has been an outspoken opponent of non-inferiority trials for antibiotics (see also Dew's post this message is a reply to).

This is an interesting approach if you have a tough battle in front of a panel meeting -- file a request to jettison people you know are going to be a problem because of their previous voting patterns.

I wonder if you could jettison Pazdur... Seriously, though, if this becomes something of a precedent then a sponsor could use the process at least to get a panel that would know what they are talking about... I mean how different would things be for Genta, to use an admittedly marginal example, if the 2004 ODAC panel would have had melanoma docs instead of breast cancer docs and the 2006 panel woould have had CLL docs instead of a bunch of solid tumor people?

http://online.wsj.com/article/SB115810389885761277.html?mod=health_home_stories