Columbia University's Kreitchman PET Center Halts Research, Patients Exposed to Impure Imaging DrugsJul 17, 2010 | Parker Waichman LLP
Columbia University’s Kreitchman PET Center is coming under fire for the way brain research was conducted there. Apparently, the center has violated Food & Drug Administration (FDA) regulations over the past four years, causing patients involved in brain studies to be exposed to impure imaging drugs.
According to a New York Times article published yesterday, Columbia University has since quietly suspended research at the Kreitchman PET Center and reassigned top managers there as a result of an FDA investigation.
Kreitchman PET Center, located in Manhattan, New York City, is considered the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research, according to The Times. Pharmaceutical companies provide millions of dollars to the center every year to study drug actions and the biology of brain disorders.
To perform a PET scan, patients must first be injected with a drug called a radiotracer. According to The Times, such drugs are considered very safe, but degrade quickly. As such, many labs make these drugs themselves, following strict FDA protocols which regulate the allowable radiation levels and the purity of the drugs. Drugs that contain impurities can have effects in the body that are unpredictable.
According to The New York Times, an FDA investigation found that researchers at the Kreitchman PET Center routinely injected mental patients with drugs that contained potentially dangerous impurities, repeatedly violating agency regulations over a four-year period. The FDA first wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections. It warned that: “Failure to promptly correct these violations may result in legal action without further notice.”
Then in January 2010, FDA investigators returned and found that many of the Kreitchman PET Center’s lab practices had not changed. The agency cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents, The Times said. One former lab worker told The Times that the FDA “raided the place like it was a crime scene, seizing hard drives.”
According to The Times, during its last investigation, , which took place from Jan. 5 to Jan. 21, the FDA cited six categories of violations. Since 2007, “at least 10 batches” of drugs had been “released and injected into human subjects” with impurities that exceeded the level the lab had agreed to set, investigators said. At least four injections “had impurity masses that more than doubled the maximum limit implemented.” Agency investigators also found a forged document, a hard copy record that had been altered to hide a drug impurity that showed up clearly in the computer records, The Times wrote
The FDA did not make its investigation public.
Many of the patients involved in this type of research suffer from schizophrenia and other brain disorders that make them especially vulnerable to poorly prepared imaging drugs, as these medications may act on the brain receptors involved in their illness, The Times said.
Perhaps one of the most disturbing aspects of The Times report is that, according to former employees interviewed for article, this conduct was commonplace and condoned. They told The Times the center was under “such pressure to produce studies that it papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite FDA warnings.”
A resignation letter from one former employee obtained by The Times stated: “These are not the actions of a rogue, but instead are systematic forgeries condoned and approved by the lab director.”