According to the New York Times, and as reported by the San Jose Mercury News, one of the nation’s leading brain imaging centers at Columbia University has be temporarily shut down after F.D.A. investigators found that the center had injected mental patients with drugs that contained potentially dangerous impurities.
Brain Imaging done with a MRI - helpful in the treatment of traumatic brain injuy
When someone suffers a traumatic brain injury or has a disease impacting the brain, scanning or imaging must be done in order to assess the injury and determine the best course of treatment.
To perform certain scans, doctors must first inject patients with a radiotracer, but if the tracer contains too many unknown chemicals, the injection may have harmful affects on the body.
The Kreitchman PET Center came under fire from the F.D.A. in December 2008 for violating federal regulations, and the agency raided the labs in January 2010 when the center failed to fix its lax quality control and sloppy procedures for formulating drug injections.
To perform certain scans, doctors must first inject patients with a radiotracer, but if the tracer contains too many unknown chemicals, the injection may have harmful affects on the body.
The F.D.A investigation found that “at least 10 batches of drugs had been released and injected into human subjects with impurities” above federal regulatory levels since 2007.
