Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities.The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.
“Failure to promptly correct these violations may result in legal action without further notice,” the agency wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections.
F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents.“They raided the place like it was a crime scene, seizing hard drives,” said one former lab worker, who requested anonymity because he feared reprisals from the university.
In a statement, the university said on Friday that it had conducted its own investigation of the lab at the request of the F.D.A. had and reported to the agency on July 6 that it found no evidence of harm to patients. The F.D.A. did not publicize its investigations; The New York Times learned of them from doctors who were familiar with the lab’s problems.The office under fire, the Kreitchman PET Center, on West 168th Street in Manhattan, has attracted millions of dollars in research funds from the federal government and pharmaceutical companies to study drug actions and the biology of brain disorders, among other things.
In a nutshell certain compounds known as radio tracers are injected to emit low level radiation to be picked up by scanners and it appears certain protocols may not have been followed. How bad did it get?
Agency investigators also found a forged document, a hard copy record that had been altered to hide a drug impurity that showed up clearly in the computer records.Former employees, speaking on the condition of anonymity because they worked in the imaging field or hoped to, said those practices were not only commonplace but also condoned. They described a center under such pressure to produce studies that it papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite F.D.A. warnings.
“These are not the actions of a rogue, but instead are systematic forgeries condoned and approved by the lab director,” wrote one employee in a 2009 resignation letter addressed to Dr. Ronald L. Van Heertum, the PET center’s co-director at the time.
Pretty damn bad.