Kreitchman PET Center of Columbia University
Kreitchman PET Scan Center of Columbia University Research Misconduct Lawsuits
Kreitchman PET Scan Center of Columbia University | Lawsuits, Lawyers | Research Misconduct, Violations, FDA, Exposure
Have you or a loved been a patient subject in brain studies at the Kreitchman PET Center of Columbia University? If these studies involved PET scans, you may have been exposed to dangerously impure imaging drugs. Investigators from the U.S. Food & Drug Administration (FDA) have found that researchers at the Kreitchman PET Center repeatedly violated FDA regulations for these drugs over a four-year period. Columbia University has since quietly suspended research at the Kreitchman PET Center and reassigned top managers there as a result of the FDA investigation.
Our firm is aggressively investigating potential lawsuits and legal claims relating to research misconduct perpetrated by the Kreitchman PET Center and Columbia University. Unfortunately, because the results of the FDA probe of Columbia University's Kreitchman PET Center have not been made public, most patients who were research subjects there are probably not aware that they could have been exposed to dangerously impure imaging drugs during PET scans. If you were a patient in a brain study involving PET scans at the Kreitchman PET Center, it is vital you contact us today to protect your legal rights.
If you or a loved one were victimized by researchers at the Kreitchman PET Center, you may be eligible to file a lawsuit seeking compensation for any injuries you may have sustained. Our firm is offering a free lawsuit consultation to anyone who underwent a PET scan as part of a brain study at Columbia University's Kreitchman PET Center between 2006 and 2010. If you or a loved one were part of such research, it is vital you contact us today to protect your legal rights.
Kreitchman PET Center Misconduct
The Kreitchman PET Center, located at on West 168th Street in Manhattan, New York City, is considered the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research. It receives millions of dollars each year from the pharmaceutical industry 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. While such drugs are considered very safe, they 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 unpredictable consequences for the patients who have received them.
According to a July 2010 New York Times article detailing research misconduct at the Kreitchman PET Center, many of the patients involved in such 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 New York Times' report was the first time the FDA's investigation into misconduct at the Kreitchman PET Center was made known to the public.
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, that latest FDA investigation, which took place from Jan. 5 to Jan. 21, listed six categories of violations. According to the Times, investigators found that:
- 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.
- At least four injections “had impurity masses that more than doubled the maximum limit implemented."
- The lab routinely used an equation resulting in injections that exceeded the limit for acceptable impurities.
- The lab did not adequately check “the identity, strength and purity of each active ingredient prior to release” for injection into patients.
- 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 also points out that the misconduct at the Kreitchman PET Center was not the work of a few rogue employees trying to hide their mistakes. Several unnamed former employees told the Times that the practices uncovered by the FDA investigation "were not only commonplace but also condoned." These employees said the center was under a great deal of pressure to produce studies. As a result, personnel there routinely papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite FDA warnings.
According to The Times, Columbia's own internal audit found "sufficient substance to warrant an investigation." That audit found, among other things, an instance were the lab replaced a compound it was testing for the drug maker Eli Lilly with one it was testing for Novartis. It did not mention the switch in its report to Eli Lilly.
It is impossible to know yet how many patients may have been harmed because of the outrageous research misconduct perpetrated by Columbia University’s Kreitchman PET Center. Our firm is working to get the word out about this scandal, and we are looking to speak to anyone who underwent, or knows someone who underwent, a PET scan at the center as part of a brain research project.
Legal Help For Victims Affected By
If you or a loved one were the victim of the Kreitchman PET Center's research misconduct, you have valuable legal rights. Please fill out our online form, or call 1 800 LAW INFO to discuss your case with us today.