Columbia University brain lab injected impure drugs into study patients | DC Metro Area Medical Malpractice Law Blog

The New York Times reported that Columbia University has closed the research arm of its Kreitchman PET Center, a prominent brain-imaging clinic, after the U.S. Food & Drug Administration found in 2008 and January 2010 that the Center had injected patients with drugs containing high impurity levels.  Lab staffers are accused of falsifying records to hide the improper injections from auditors.

A positron emission tomography (PET) scan requires the patient to be injected with radioactive drugs, which move through the brain and allow the PET scan to build a three-dimensional model of the brain.  But the drugs have a short shelf life, and the FDA regulates them to keep patients safe.  The impurities could have been especially damaging to the Center’s patients, many of whom were schizophrenic or depressed.  Columbia’s own investigation apparently did not find evidence of harm to any patients.