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News of the Day ... In Perspective

5/30/2007

Purdue fined $635 million for "misbranding" OxyContin

To settle a case of alleged misbranding brought by John Brownlee, U.S. Attorney for the Western District of Virginia, Purdue Frederick agreed to pay $635 million.

The company admits that its sales force underplayed the abuse potential of OxyContin, and that it should have issued strong warnings in the face of overdose deaths.

"But the real public health damage," writes psychiatrist Sally Satel, M.D., "comes from the pitched campaign conducted by zealous prosecutors and public-interest advocates to demonize the drug itself. This is tragic because OxyContin has been a godsend for millions of patients with searing, unremitting pain…."

Satel details the media hype surrounding deaths related to OxyContin. In only 2% of 919 deaths was OxyContin the only drug found at autopsy. The Orlando Sentinel retracted a 2004 story when it was found that two-thirds of the deceased had taken other drugs (such as alcohol or heroin) that could have been fatal alone or in combination with OxyContin. In the other one-third, it was not possible to ascertain the role of OxyContin because name-brand drugs were not identified in the autopsies.

Satel believes that the penalty paid by Purdue Frederick may derail development of improved slow-release opioids. And more law-abiding physicians may withdraw from prescribing potent painkillers (Sally Satel, Wall St J 5/15/07).

But then the FDA has already determined that "we’ve got enough painkillers" in declining to approve the new COX-2 inhibitor Arcoxia (Scott Gottlieb, Wall St J 4/17/07).

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