Posts Tagged ‘ Upjohn ’

Pfizer’s Secret Friend

April 9th, 2010. By Hunter West

Mom and Dad told us not to be ‘too big for your britches.’ However in the Land of Big Pharma, that basic chestnut of moral integrity need not apply… 

Remember the debacle over Bextra? Pfizer was found to have actively marketed the drug for off-label use, for things not approved by the US Food and Drug Administration (FDA), and was called to the carpet over it, paying about $2 billion in penalties. 

However, it could have been a lot worse, according to a special investigation by CNN that found Pfizer escaped the expected death knell in such cases by being permanently excluded from Medicare and Medicaid. 

Most know the story of Bextra, the Cox-2 inhibitor that Pfizer brought to the painkiller market in 2001 with big plans. Cox-2 inhibitors were thought to be safer than generic drugs.

Also more expensive, coming in at 20 times the cost of ibuprofen. 

Nonetheless, the plan was to market Bextra for acute pain, such as that experienced by patients following surgery. 

Enter the FDA, which put a noose around Pfizer’s neck when it decreed that Bextra was not safe for patients at high risk for heart attack and stroke. Thus the approval was limited to pain treatment related to arthritis and menstrual cramps. 

Undaunted, the marketing and sales arms of Pfizer—allegedly without knowledge of top executives—set to work circumventing that regulatory authority by promoting its use off-label to anesthesiologists, orthopedic surgeons, “anyone that use[d] a scalpel for a living,” according to the words of one district manager. 

There were other lapses in marketing judgment that flew in the face of regulatory decorum. In the end, by the time Bextra was Read the rest of this entry »

Tags: Bextra, FDA, Pfizer, Pharmacia, Upjohn
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