Drug manufacturing is a difficult business that requires great attention to detail. So there's bound to be trouble when non-manufacturing professionals do their own manufacturing--and that's what appears to have happened--over and over again--at a Columbia University lab devoted to studying the brain. These repeated violations could potentially have ramifications for brain-imaging studies nationwide, as the L.A. Times points out.
The Kreitchman PET Center in Manhattan uses imaging scans to study patient brain activity in psychiatric conditions. The PET scans require use of radiotracing drugs that are produced on site as they degrade quickly. However, the center's research work that requires use of the drugs is now stopped, and lab managers have been reassigned because of repeated manufacturing violations uncovered by FDA inspectors in January, and failure to heed earlier warnings to take corrective actions. Despite the warnings, the violations have continued over several years.
Among the problems cited by the the agency were excessive impurities in drugs injected into patients, failure to set up appropriate sterility tests, poor record keeping, lax quality control and sloppy formulation procedures.
The FDA visited the lab in January in a follow-up to a 2008 warning letter. "They raided the place like it was a crime scene, seizing hard drives," the New York Times quotes one anonymous former lab worker as saying. And during the process, inspectors allegedly found documents falsified to conceal the lab's knowledge of drug impurities. The center now admits its history of manufacturing transgressions and says it is "fundamentally reorganizing the lab's management and operations."
Experts disagree on whether the Columbia incident is an anomaly, the LA Times notes. But the documented lapses highlight apparent disregard for patient safety that rarely comes to light at major research institutions.
- see the NYT story
- here's the article from the LA Times
- here's more