Columbia University Brain Imaging Center Under Fire

Columbia University, considered one of the leading research centers for positron emission tomography (PET) used in psychiatric research, has been forced to shut down its brain imaging center after the Food and Drug Administration found the center had violated several regulations for the past few years. The center also reassigned the top managers working in the brain imaging center after the FDA discovered they had been regularly injecting mental patients with dangerously impure drugs.

Columbia was warned about the issue in December 2008. The FDA warned them in a letter, “Failure to promptly correct these violations may result in legal action without further notice.” The agency pointed to issues with quality control as well as sloppy injection procedures.

When the FDA returned this year, they discovered that Columbia had not acted on any of the directives, and had actually falsified documents to hide evidence of the impure injections from the FDA. In January the FDA seized documents, computer hard drives, and other evidence for their investigation.

Last week, at the request of the FDA, Columbia University completed its own internal audit and reported that had found “no evidence of harm to patients.” However, the Kreitchman PET Center in Manhattan, where the brain imaging studies are conducted, does have “serious quality control issues” according to Columbia’s executive vice president for research. Columbia is currently in the process of reorganizing the lab, including installing new management and new procedures to prevent further issues.

Kreitchman PET Center’s studies involve patients who are suffering from severe forms of depression or schizophrenia who are unable to advocate for themselves.  The impurities in the injections may not have been related to the radiotracer required for the imaging scans, but it has not yet been discovered what the impurities might have been. Many mental health advocates are calling for stronger protective measures to be enacted against research facilities that attract millions of dollars in grants but fail to adequately protect the study participants. The FDA may take legal action if the safety protocols are not improved.

Shadra Bruce is a contributing writer for Mental Health News.