A frightening meningitis outbreak continues to stun the nation today. Fungal meningitis caused by tainted steroid injection vials from the New England Compounding Center is affecting patients in at least 10 states. The current death toll from the outbreak is now 11, with 119 people sickened.
The Center is under scrutiny now, but some inside the industry say they have been raising suspicions over contaminated medications for years, even within the Food and Drug Administration. CNN’s Elizabeth Cohen reports for "Early Start" from Atlanta this morning with the latest.
Cohen, who spoke to former FDA employee Sarah Sellers, says Sellers told her that “she saw this coming.”
Sellers, who is a pharmacist and expert in sterile compounding, told Cohen “she went to go work for the FDA specifically to help clean up compounding pharmacies.” Sellers wanted to “write some guidance on how to do this compounding in a more sterile way,” Cohen says. “They never had her do it,” Cohen says, and Sellers “ended up leaving the FDA in frustration.”
The document Sellers meant to write was supposed to be issued in 2006, but it never came out. The FDA told Cohen it is “‘in progress,’ and they had no other comment.” According to Cohen, Sellers would “tell you it’s because there’s money from compounding pharmacies pressuring them not to do it. The compounding pharmacies say that’s not true.”
Saw Ms Cohen on Dr Oz today. It's not just the insurance people. My health care service, Drexel/Hahnemann, in Philadelphia, charged Medicare $5028 for a Pulmonary Function Test which required 1 technician, 1 device and 1 hour. I am outraged.
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