Monday, February 11, 2013

Botched Drugs, Broken Trust

Who knew that insects could crawl around a manufacturing site for anesthesia drugs? Or that birds might fly inside that facility? Or that fungi and bacteria would contaminate unopened anesthetic vials and syringes? Or that government inspectors would take two years to notify the manufacturer of detected unsafe practices? Or that hundreds of local compounding pharmacies could manufacture and sell drugs nationally, with woefully little oversight?
I learned all this and more after epidurally injected steroids produced by the New England Compounding Center (NECC), of Framingham, Mass., caused fungal meningitis in hundreds of patients throughout the country.
When the FDA and the Centers for Disease Control and Prevention (CDC) investigated the NECC production site, they found air-conditioning ducts, autoclaves and drug vials contaminated with greenish black and white filamentous matter. Even the “clean room” showed growths of bacteria and mold.

Read more here

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