Approval of OxyContin, the drug that "arguably opened the floodgates of the opioid epidemic," came with a misleading sentence that the U.S. Food and Drug Administration allowed in the drug's official label, Caitlin Esch reported for Marketplace last month. Her report, based on court files she unearthed, was excerpted this week on West Virginia Public Broadcasting's "Inside Appalachia."
On page 15 of the 21-page official label FDA approved for OxyContin in 1995 was this sentence: "Delayed absorption as provided by Oxycotin tablets is believed to reduce the abuse liability of a drug." A drug, not the drug; Purdue Pharma, its manufacturer, had done no research on its potential for addiction. Another sentence said addiction was rare under a doctor's care, but the study wasn't based on OxyContin.
The addiction potential was huge. The "contin" part of the drug's name stands for "continuous release," but the time-release pills were easily crushed, delivering the whole dose, which was 16 times a typical 10 mg Percocet pill, Esch reports. Purdue had rejected an FDA toxicologist's call for testing of crushed pills' addiction potential in 1993, and Dr. Curtis Wright, a FDA medical review officer, agreed. He and others approved the label in 1995, and he later testified that he couldn't recall who suggested the key sentence. He later worked at Purdue and declined to comment for the story. Purdue said in a written statement replying to questions that the sentence was suggested by FDA. The FDA declined to be interviewed, but offered a statement that looked forward, not backward.
The sentence was replaced with a warning label six years later, but by that time "the horse was out of the barn," Esch reports. The epidemic had begun, with prescriptions for Oxycontin increasing tenfold from 1995 to 2000. "Oxycontin was the only opioid that had a sentence like this in its label," Esch reports, and had been the centerpiece of its marketing campaign.
"That claim became the linchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller," The New York Times reported in 2007. "Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion. Purdue Pharma heavily promoted OxyContin to doctors like general practitioners, who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients. In 2007, the privately owned company agreed to pay the federal government more than $600 million in civil fines, and three executives pleaded guilty to misleading the FDA and agreed to pay $34.5 million in fines.
About 100 states and local governments are suing Purdue for its role in the opioid epidemic. Marketplace's story was based largely on files, some previously sealed, in a lawsuit that West Virginia filed in McDowell County in 2001 and settled in 2004 for $10 million.
On page 15 of the 21-page official label FDA approved for OxyContin in 1995 was this sentence: "Delayed absorption as provided by Oxycotin tablets is believed to reduce the abuse liability of a drug." A drug, not the drug; Purdue Pharma, its manufacturer, had done no research on its potential for addiction. Another sentence said addiction was rare under a doctor's care, but the study wasn't based on OxyContin.
The addiction potential was huge. The "contin" part of the drug's name stands for "continuous release," but the time-release pills were easily crushed, delivering the whole dose, which was 16 times a typical 10 mg Percocet pill, Esch reports. Purdue had rejected an FDA toxicologist's call for testing of crushed pills' addiction potential in 1993, and Dr. Curtis Wright, a FDA medical review officer, agreed. He and others approved the label in 1995, and he later testified that he couldn't recall who suggested the key sentence. He later worked at Purdue and declined to comment for the story. Purdue said in a written statement replying to questions that the sentence was suggested by FDA. The FDA declined to be interviewed, but offered a statement that looked forward, not backward.
The sentence was replaced with a warning label six years later, but by that time "the horse was out of the barn," Esch reports. The epidemic had begun, with prescriptions for Oxycontin increasing tenfold from 1995 to 2000. "Oxycontin was the only opioid that had a sentence like this in its label," Esch reports, and had been the centerpiece of its marketing campaign.
"That claim became the linchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller," The New York Times reported in 2007. "Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion. Purdue Pharma heavily promoted OxyContin to doctors like general practitioners, who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients. In 2007, the privately owned company agreed to pay the federal government more than $600 million in civil fines, and three executives pleaded guilty to misleading the FDA and agreed to pay $34.5 million in fines.
About 100 states and local governments are suing Purdue for its role in the opioid epidemic. Marketplace's story was based largely on files, some previously sealed, in a lawsuit that West Virginia filed in McDowell County in 2001 and settled in 2004 for $10 million.
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