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Research suspended over brain lab problems
NEW YORK, Columbia University has suspended research at a New York brain-imaging center after federal investigators found patients were being injected with impure drugs.
Kreitchman PET Center, considered the nation's leading center for positron emission tomography for psychiatric research, allegedly violated Food and Drug Administration regulations over a four-year period by injecting mental patients with drugs contaminated with dangerous impurities, The New York Times reported Friday.
The federal government and pharmaceutical companies have given the center millions of dollars in research funding to study drug actions and the biology of brain disorders, the newspaper said.
"We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping at this lab," David I. Hirsh, Columbia's executive vice president for research, said. "That is why we are fundamentally reorganizing the lab's management and operations in response to what the FDA told us."
To perform a PET scan, doctors inject patients with a drug engineered to settle in the area of the body being studied, where a scanner can detect it.
Many laboratories produce the drugs themselves under FDA protocols, and the agency said "at least 10 batches" of drugs had been "released and injected into human subjects" by the Kreitchman center with impurities that exceeded protocol levels, the Times reported.
NEW YORK, Columbia University has suspended research at a New York brain-imaging center after federal investigators found patients were being injected with impure drugs.
Kreitchman PET Center, considered the nation's leading center for positron emission tomography for psychiatric research, allegedly violated Food and Drug Administration regulations over a four-year period by injecting mental patients with drugs contaminated with dangerous impurities, The New York Times reported Friday.
The federal government and pharmaceutical companies have given the center millions of dollars in research funding to study drug actions and the biology of brain disorders, the newspaper said.
"We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping at this lab," David I. Hirsh, Columbia's executive vice president for research, said. "That is why we are fundamentally reorganizing the lab's management and operations in response to what the FDA told us."
To perform a PET scan, doctors inject patients with a drug engineered to settle in the area of the body being studied, where a scanner can detect it.
Many laboratories produce the drugs themselves under FDA protocols, and the agency said "at least 10 batches" of drugs had been "released and injected into human subjects" by the Kreitchman center with impurities that exceeded protocol levels, the Times reported.
