Columbia University Brain Imaging Center Problems Result in FDA Warning

Federal inspections have uncovered a number of problems at a brain-imaging center operated by Columbia University, where patients with mental disorders were injected with substandard medications.

According to an FDA warning letter, employees of Columbia University Medical Center’s Kreitchman PET Center repeatedly failed to check the purity of drugs they were injecting into patients before brain scans, and in some cases forged documents to hide the fact that testing showed the drugs to be problematic. The university has temporarily shut down the laboratory that was manufacturing the drugs, but maintain that no injuries have been associated with the substandard drug injections.

The drugs were solutions known as radio tracers injected to help gain good results from a type of brain scan called positron emission tomography (PET). The drugs were experimental and made at a laboratory at the center, but are regulated and must meet certain criteria for impurities and radiation levels. Drugs that fall outside of the acceptable parameters could adversely affect patient health and distort test results.

The brain scans are done as part of research on brain activity of people with mental disorders. The radio tracers are often produced in-house for PET laboratories because they degrade very quickly. The drugs are usually tested for quality before each use, however, the FDA says that the Kreitchman PET Center used poor testing equations and in at least one instance falsified records when a computer test found that there were problems. Columbia University officials say they are restructuring the laboratory as a result of the incidents.

The FDA first discovered problems at the brain imaging center in 2004, and then inspectors found problems again in December 2008. In the December 2008 warning letter, the agency says that the laboratory failed to investigate unacceptable quality control test results and did not reject a batch of PET radiopharmaceutical drugs that did not meet specifications. A January 2010 letter has not yet been posted on FDA’s website, but was first reported Friday by the New York Times.

Inspectors who returned this January found that little had changed, and cited the facility for a number of violations. There were at least 10 batches of drugs that had impurities surpassing the acceptable levels. At least four times, patients were injected with drugs that contained twice the amount of impurities that are deemed acceptable.

One former employee wrote in his 2009 resignation letter that there were “systematic forgeries condoned and approved by the lab director,” according to documents obtained by the New York Times.

Columbia University sent the FDA a letter on July 6 saying it was replacing some management and that the lab that manufactures the drugs would stay closed until it was fully restructured. The PET Center itself remains open.