I'm sure you all saw the headlines early this month related to the Department of Justice settlement with Pfizer over their past off-label promotions of Bextra and other drugs. The settlement will cost the company a record-breaking $2.3 billion ($1 billion in civil settlements and a $1.3 billion criminal penalty related to Bextra).

Bextra was approved for treatment of arthritis and menstrual pain, but Pfizer allegedly promoted it in doses and for uses not approved by the FDA, putting patients at risk of serious cardiovascular complications including heart attack and stroke. Pfizer voluntarily withdrew Bextra from the market in 2005.

Of course, Pfizer isn’t the only company that has been involved in off label promotions. And we physician are also involved in how off label uses occur, and in relationships with industry that are under increased scrutiny in these regards. Off label usage of pharmaceuticals is often how new therapeutic advances occur and it’s not evil. But, if we had more comparative effectiveness research and dollars (and we soon will) available to research off label use, we could more rapidly advance therapeutics of newer agents and protect patient safety as well.

*** Image from Flickr (DawnVGilmorePhotography). *** 
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