Tuesday, May 22, 2007

Marketing Lethal Drugs

"Misbranding of OxyContin leads to $600 million in fines". New York Times

The pharmaceutical industry claim that they provide valuable services to physicians has lately been subject of harsh spotlight. Today we learn that Purdue Frederick, a division of Purdue Pharma, and three of its top executives, pleaded guilty to the criminal violation of misbranding and will pay a total of $34.5 million in fines.

The drug is OxyContin, a powerful narcotic that provides long-lasting [up to 12 hours] relief for serious pain. It is alleged Purdue Pharma misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. The Company did so by asserting in marketing materials that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than do traditional, shorter-acting painkillers like Percocet or Vicodin. These non-FDA approved, false marketing claims were dropped only in 2001, amid heavy regulatory scrutiny. To add insult to injury, Purdue Pharma reportedly marketed OxyContin mostly to general practitioners (prescriber profile purchased from the AMA), who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients.

"Misbranding" is a broad statute that makes it a crime to mislabel a drug, fraudulently promote it or market it for an unapproved use. Stepped-up enforcement under this statute should help curb some of the abuses in pharmaceutical marketing practices. The fines in this case are insufficient, in light of the massive profits Pharma-Purdue earned from the illegal activity. This is also a clear case of white-colar "drug dealers" getting off with a pat on the hand.

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