http://www.xconomy.com/boston/2009/11/13/genzyme-shares-tank-after-fda-discovers-bits-of-steel-rubber-in-five-different-drugs/ Business + Technology in the Exponential Economy Sat, 11 Feb 2012 03:54:18 +0000 hourly 1 http://wordpress.org/?v=3.0.4 http://www.xconomy.com/boston/2009/11/13/genzyme-shares-tank-after-fda-discovers-bits-of-steel-rubber-in-five-different-drugs/comment-page-1/#comment-93147 biotech guy Tue, 17 Nov 2009 21:33:07 +0000 http://www.xconomy.com/?p=50330#comment-93147 This is truly a bit of muckraking as others have suggested. Why aren't reporters digging a little deeper into this story? Why has the FDA chosen to leak information it has held on to for more than 10 years? Why are they reporting that the particulates found are <1% of manufactured lots when the numbers are closer to <0.01%? This is far lower than the foreign matter threshold for injectable drugs in the industry. Particulates are common in injectable drugs, that is why there is a published threshold for them (in the USP). This smacks not only of sensationalism, but also poor journalism. Did you know that the former Director of Quality from the Genzyme Plant is now the VP of Manufacturing at Shire Pharmaceuticals? Why is it then, that now, after decades of "not taking sides" between pharmaceutical brands, the FDA advocates (yes, outright recommendation) for Shire drugs which compete with Genzyme markets to be approved without clinical trials? Does that sound safe or even positive for the industry? It smells of corruption and dirty politics to me. That is very well the probable source of this "garbage" your so-called journalists allude to. This is truly a bit of muckraking as others have suggested. Why aren’t reporters digging a little deeper into this story? Why has the FDA chosen to leak information it has held on to for more than 10 years? Why are they reporting that the particulates found are <1% of manufactured lots when the numbers are closer to <0.01%? This is far lower than the foreign matter threshold for injectable drugs in the industry. Particulates are common in injectable drugs, that is why there is a published threshold for them (in the USP). This smacks not only of sensationalism, but also poor journalism. Did you know that the former Director of Quality from the Genzyme Plant is now the VP of Manufacturing at Shire Pharmaceuticals? Why is it then, that now, after decades of "not taking sides" between pharmaceutical brands, the FDA advocates (yes, outright recommendation) for Shire drugs which compete with Genzyme markets to be approved without clinical trials? Does that sound safe or even positive for the industry? It smells of corruption and dirty politics to me. That is very well the probable source of this "garbage" your so-called journalists allude to.

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