FDA cites quality problems at NY brain-imaging lab
By DAVID B. CARUSO and VERENA DOBNIK
A respected brain-imaging center run by
The Food and Drug Administration found in a series of inspections that the center had failed to correct manufacturing problems in a lab that makes experimental drugs injected into psychiatric patients to help capture images of brain activity.
In one warning letter, an FDA office in
In a statement sent Saturday to The Associated Press, Columbia University Medical Center said it was restructuring the laboratory that produces the drugs for the
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. "We acknowledge serious shortcomings of quality control in the manufacturing process and record keeping at this lab," said Dr. David Hirsh, the medical center's executive vice president for research. "That is why we are fundamentally reorganizing the lab's management and operations in response to what the FDA told us. When manufacturing resumes under new leadership, it will meet the strictest standards and best practices for ensuring the quality of these materials," Hirsh said.
The problems at the imaging center and the halt in research were first reported late Friday by The New York Times. The
The problems at the center involved radiotracing drugs injected into a patient's brain to assist in capturing images used to study brain activity. The drugs are not supposed to have any effect on the patient and they degrade quickly — so fast, in fact, that imaging centers must often manufacture them on the spot, rather than buy them from outside vendors. The manufacturing process is strictly regulated by the FDA.
Dr. Alexander Neumeister, a psychiatrist with the molecular imaging program at the Mount Sinai School of Medicine, said PET centers across the country routinely test tracers for sterility and purity just minutes before they are injected, while the patient is lying on the table.
The tests, he said, turn up impurities about 1 percent to 3 percent of the time, and make it nearly impossible to unknowingly inject adulterated medications.
"You'd have to be an idiot," Neumeister said, adding that he was speaking generally about the testing procedure, rather than the situation at the
If an impure tracer is used, any resulting scientific studies "are compromised," Neumeister said. It also might affect a person's health condition in unpredictable ways, like inducing allergies or worsening depression. "It's not that you're killing a patient," he said, but, "you might be exposing your patient to various other levels of danger." Among the problems at
"If you're approved by the FDA to administer compounds that pass purity tests, and then inject substances that do not meet quality assurance regulations, you are breaking a sacred trust," said Dr. Nancy C. Andreasen, a former editor-in-chief of the American Journal of Psychiatry.
Andreasen, of the