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FDA blisters Purdue for 'poor' OxyContin data
Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster OxyContin to an expert FDA panel, and promptly had their heads handed back to them.
"I'm fascinated with the poor scientific rigor" of the data, said panel member Jeffrey R. Kirsch, according to the Wall Street Journal. "It's almost insulting."
Purdue says this new version of the drug turns to a jelly-like substance when dissolved, making it almost impossible to inject with a syringe, a common practice among abusers. The panel will consider whether this new version can be marketed before long-term studies are completed.
- read the Wall Street Journal story
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Comments
By Marianne Skolek | Posted 2:43pm | May 6, 2008
Purdue Pharma was found criminally responsible for their marketing of OxyContin which resulted in scores of deaths and addictions in every state in the country. This was all allowed to happen under the watchful eye of the FDA. Not only is Purdue Pharma, Michael Friedman, Howard Udell and Paul Goldenheim convicted criminals, but the FDA and J. David Haddox have accountability in this tragedy being able to occur. Ask Haddox why his patent for "tamper resistant" OxyContin was not used to prevent this epidemic of OxyContin over the years. There is a special place in hell for them all. Marianne Skolek www.oxydeaths.com
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