A respected brain-imaging center run by Columbia University has halted some research after federal officials repeatedly complained some patients were getting drugs that failed purity tests.
Food and Drug Administration inspections found that the center had failed to correct manufacturing problems in a lab that makes experimental radiotracing drugs injected into psychiatric patients to help capture images of brain activity.
In one warning letter, an FDA office in New York described problems since at least 2004. It cited a litany of violations, including a failure to reject batches of medication that didn't pass required tests. The drugs were for patients undergoing positron emission tomography, or PET.
In a statement yesterday, Columbia University Medical Center said it was restructuring the laboratory that produces the drugs for the Kreitchman PET Center. It said an internal investigation, performed at the FDA's request, had found "no evidence of patient harm," but that all activities relying on the manufactured compounds had been suspended while reforms were undertaken.
The problems at the imaging center and the halt in research were first reported by The New York Times.
Dr. Alexander Neumeister of the Mount Sinai School of Medicine said PET centers across the country routinely test tracers for sterility and purity just before they are injected. The tests, he said, make it nearly impossible to unknowingly inject adulterated medication. If an impure tracer is used, any resulting scientific studies "are compromised," he said. - AP