FDA, Taleb Alexander, Johns Hopkins University discussed on Marketplace All-in-One


The of unique and have an aid package since think want no matter what the sponsor says they can say okay were peruvian here's the p i period but as you can imagine we have respect and responsibility for the developers as well so we always always worked hard with a sponsor of the illusion of versus sufficient i should mention after the fda dance biker went on to work for purdue pharma the maker of oxycontin that package insert damn was talking about oxycontin was approved by the fda in 1995 and it had that sentence we told you about at the beginning of the episode delayed absorption as provided by oxycontin tablets is believed to reduce the abuse liability of a drug it's like both simple and common arrived it's a pretty short sentence right i mean listen its one two three four or five six seven the doctor taleb alexander is going to help us impact that fifteen or sixteen seventeen word sentence he's an epidemiology and medicine professor at johns hopkins university he and the chairman of an fda advisory committee on drug safety for neurologic diseases he knows a lot about regulations and about prescription painkillers we asked him to help make sense of that sentence will catches dr alexander's ear is that word believed verse or caviar here of a sudden says it's boom leave to reduce the abuse liability of a drugs so they're not fading that it does reduce the abuse liability of a drug but but this is a slippery slope oxycontin was the only opioid that had a sentence like this and its label a sentence that suggested it was less abuse both than other opioids based on a belief so this is a pretty unusual sentence and officials at purdue later testified when the sentence was written purdue had not done any clinical studies to test oxycontin is abuse potential studies that would have backed that sentence up i'll just read a little bit from a sworn deposition from two thousand three that we obtained where purdue official is being questioned.

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