Friday, April 2, 2010

The Bextra affair

CNN and others have investigated Pfizer and its illegal marketing of Bextra, a COX-2 inhibitor pain drug that it developed with Pharmacia (a smaller company that it later purchased, which shows you how confidently they felt about Bextra). The drug is in the same family as Vioxx (with similar side effects too). Sales began in 2001 and Pfizer wanted to market it as an acute post-surgery painkiller like Vicodin (and many times pricier than Vicodin too). But due to possible cardiovascular side-effects, the FDA only approved Bextra for arthritis and menstrual cramps (maybe worth the risk there!), which really put a dent in Pfizer's profit projections. So the Pfizer sales force was instructed to "encourage" doctors to prescribe Bextra off-label for non-approved indications, such as the intended purpose of post-surgery analgesia. This is completely illegal, but email evidence showed a Florida sales manager instructing his staff to lie to doctors that Bextra got the "all clear" from the FDA for 40 mg doses (even though the FDA's maximum safe dose was half that, and came with health warnings).

Like in my previous Fosamax-Merck email, Pfizer also set up an "education fund" to sponsor doctors who would conduct pro-Bextra research, present favorable findings, and encourage more widespread use. Eventually the FDA had enough, and shut down Bextra and all these antics in 2005. Until then, it's estimated that half of Bextra's $1.7B profits came from off-label use. But prosecuting Pfizer for such a high crime became problematic. By law, any healthcare company convicted of a major fraud is prohibited from doing business with Medicare/aid. Even though Pfizer fit the case, they were "too big to punish". Excluding them from Medicare/aid would essentially put the world's biggest pharma and a major corporate lobbying force out of business (and over 50,000 Americans out of a job), and prevent millions of patients from consuming dozens of Pfizer products (in some cases, life-extending medications without competing products). Ironically corrupt and compassionate interests aligned to spare Pfizer. The Feds decided to slap the biggest government fine in history on Pfizer, $1.2B, and the company also paid out $1B in a class-action settlement for Bextra and 12 other illegally-promoted products. However intimidating that sounds, the $2B hit was a mere 3 months of profit for Pfizer - a slap on the wrist. Just imagine how many billions of extra sales Pfizer has made over the years from improper marketing.   

And just so the prosecutors could claim that they followed the letter of the law, they did ban Pfizer from doing business with Medicare/aid, sort of. From CNN: According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. The Feds shut down Pharmacia & Upjohn Co. Inc., a great-grandson subsidiary of Pfizer, which as far as anyone can tell, is just a name on paper that hasn't done a single dollar of business ever. Would you believe it was founded in 2007 on the same day that Pfizer plead guilty to a federal kickback case unrelated to Bextra? So basically it only existed to take the heat for Pfizer's transgressions.

This is how healthcare works, which is why I'm sick of working in it.

http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html?iref=allsearch
http://en.wikipedia.org/wiki/Bextra

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