Columbia University brain lab's safety violations may have bigger fallout - latimes.com - 0 views
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Energy Net on 26 Jul 10"Some research is suspended at a Columbia University center, but experts fear the case could deter people from participating in crucial brain-imaging studies. The suspension of some research at a prominent Columbia University brain-imaging lab because of sloppy practices could have repercussions beyond that laboratory, potentially affecting brain-imaging studies nationwide and raising questions about the safety of participants, research experts said Saturday. The Kreitchman PET Center in Manhattan, part of Columbia University, halted brain-imaging studies after federal authorities reportedly found safety violations that could endanger patients and invalidate research findings. The center has admitted to poor manufacturing processes of radioactive compounds injected in patients and to sub-par record-keeping. Columbia authorities reported the findings of its own internal investigation in a July 6 letter to the Food and Drug Administration. Lab personnel are alleged to have used chemicals that had failed required purity tests when conducting brain scans of people with mental disorders. The scans, called PET scans, produce images of the brain and various neurological processes. » Don't miss a thing. Get breaking news alerts delivered to your inbox. The chemicals used at the Columbia center were found to have contained impurities at levels well above what is permitted under FDA protocols. The center has halted research using those locally manufactured chemicals; the lab itself remains open, is still conducting other types of research and continues to see patients. Experts disagree on whether the Columbia incident is an anomaly or if such slip-ups are widespread in research labs. But the documented lapses highlight apparent disregard for patient safety that rarely comes to light at major research institutions. No patients were harmed, according to a statement from Columbia University released Saturday. But the practices also include failure to report use of the su