Former FDA Commissioner Mark McClellan recently addressed a number of State AG's and AAG's and urged them to consider themselves health care policy makers. For lawyers used to taking cases one at a time, his remarks forced those present to ponder a bit in their role.
I think that McClellan is correct. Although few in the AG community think about it, the truth is that every case an AG brings - or does not bring - impacts in the way that pharmaceutical products are perceived by both the general public and by investors. Once the decision is made, there is no way of predicting the ultimate result.
These thoughts came to mind this morning as I read that the NE Journal of Medecine has published an article based on meta data that attacks the diabetes drug Avandia. Glaxo - the manufactuerer - dropped 7% in the market in one day and other companies that made similar drugs went up.
What does this have to do with AG's? A careful review shows that the data upon which the Avandia study is based came from a databank created by Glaxo after then NY AG Spitzer sued them for not fully revealing that some of their studies about Paxil. Some studies showed that Paxil increased the liklihood of suicidal thoughts among some adolescents.
So, Glaxo creates a broader data base (a good thing) because of an AG suit. Google allowed researchers to see the meta data. (a good thing). Indpendent researchers write a report (a good thing) and here we are again.
I have no opinion on the merits of the Avandia controversy - although the FDA's lost credibility from the early Bush years when it was run by former drug/tobacco lawyers and lobbyists causes any thoughtful person concern - but today's headlines prove yet again that what the AG's do is of great importance to everyone.
From my biased view and 25 years of AG watching, I believe that the AG's generally (but not always) get it right. Let's hope that they stay on top of their game. McClellen is right,. The stakes are very high.