Top Brain-Imaging Center Busted

According to this article in the New York Times, the Kreitchman PET Center
at Columbia University had four years to clean up its act and still didn’t.

excerpt from The New York Times by Benedict Carey

Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities.

The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.

“Failure to promptly correct these violations may result in legal action without further notice,” the agency wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections.

F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents…

much more via Brain Center at Columbia Gave Patients Impure Drugs


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