07/22/2010 // West Palm Beach, FL, USA // Sandra Quinlan // Sandra Quinlan
Manhattan, NY—Columbia University’s Kreitchman PET Center is under fire after a U.S. Food and Drug Administration (FDA) investigation exposed several serious violations, including one in which countless mental patients were injected with drugs that were found to have dangerous impurities. While the FDA did not publicize the details of their probe into the brain-imaging center, a July 16, 2010 New York Times report unveiled details into the violations through information provided by anonymous doctors familiar with the facility’s practices.
When performing positron emission tomography (PET) scans, doctors must begin by injecting the patient with a radiotracer. A radiotracer is a drug that collects in the area of the body being studied and releases low-level radiation that can be detected by a scanner.
While radiotracers generally consist of safe compounds, they tend to depreciate in quality quite rapidly. Therefore, laboratories create their own radiotracers but are required to abide by FDA-established regulations.
Though the FDA sets standards regarding allowable radiation and purity levels of the imaging drugs, a probe into Manhattan’s Kreitchman PET Center indicated that such regulations were not being followed. Since 2007, “at least 10 batches” of radiotracers that were “released and injected into human subjects” contained impurities with excessive impurity levels.
Additionally, four of those injections “had impurity masses that more than doubled the maximum limit implemented.” It was also reported that lab technicians failed to verify “the identity, strength and purity of each active ingredient” before they were ready for use in patients.
To make matters worse, FDA investigators also reportedly discovered a forged hard copy record of results from a drug purity test, which conflicted greatly with computer records. By falsifying such records, the PET center was seemingly able to avoid being cited for serious violations during FDA audits.
Experts once deemed the Columbia University’s Kreitchman PET Center to be the nation’s top facility with regard to the use of PET for psychiatric studies and research. However, such recent investigations into the center have brought to light to their crucial infringements.
Research at the facility, located on West 168th Street in Manhattan, was suspended pending further investigations.
Legal News Reporter: Sandra Quinlan- Legal News for New York Medical Malpractice Lawyers.
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