It’s a pretty shocking situation. Respected Columbia University shut down research at its brain-imaging center after federal investigators discovered that the nationally renowned facility had given patients drugs with dangerous impurities.
The New York Times did a Page One story Saturday on the Food and Drug Administration’s investigation of Columbia’s Kreitchman PET Center, which is on West 168th Street in Manhattan. This center over the years has received millions of dollars from the federal government and drug companies to conduct research on the effects of drugs and brain disorders.
The center, according to The Times, is regarded as the leader in the use of positron emission tomography, or PET, for psychiatric research.
In a nutshell, the FDA found that the radiotracers used in PET, which the center has been producing for its own use, had impurity levels above and beyond what the agency permits.
During exams radiotracers are injected into patients. The radiotracers build up in the parts of the body that are being studied — in the brain for psychiatric research – and release low-level radiation that researchers can detect.
The FDA has standards for the radiation levels the purity and purity levels of radiotracers, but the ones that Columbia’s center was injecting into patients didn’t meet those standards.
And the purity levels of radiotracers are particularly important and sensitive in psychiatric research, because the drug can remain active in the brain and change a patient’s moods and behavior. That’s a particularly risky proposition when you’re dealing with people with depression and mental illness.
The FDA has conducted several investigations of the Kreitchman Center, and repeatedly found that the facility was in violation of federal guidelines over a four-year span, according to The Times. In its most recent probe, which was in January, the FDA cited the center for six types of violations.
In that investigation, the FDA said that since 2007 at least 10 batches of drugs with high levels of impurities that permitted had been injected into human subjects, The Times said. And in at least four cases, the impurity levels were twice what are permitted.
In the face of those citations regarding its PET center, Columbia halted research as the facility.
Why would a respected research center inject their subjects with impure drugs? Ex-workers at the center explained that the lab “was 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 FDA warnings,” The Times reported.
Columbia conducted its own audit of its PET center, and decided that the FDA charges had enough substance to warrant an internal investigation. And the university added that so far, it hasn’t found any evidende that patients were harmed.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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