(For more information on recently debunked brain imaging studies on “schizophrenia” see link at bottom of this post)
The New York Times
By Benedict Carey
July 16, 2010
Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities.
The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.
“Failure to promptly correct these violations may result in legal action without further notice,” the agency wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections.
F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents.
“They raided the place like it was a crime scene, seizing hard drives,” said one former lab worker, who requested anonymity because he feared reprisals from the university.
In a statement, the university said on Friday that it had conducted its own investigation of the lab at the request of the F.D.A. had and reported to the agency on July 6 that it found no evidence of harm to patients. The F.D.A. did not publicize its investigations; The New York Times learned of them from doctors who were familiar with the lab’s problems.
The office under fire, the Kreitchman PET Center, on West 168th Street in Manhattan, has attracted millions of dollars in research funds from the federal government and pharmaceutical companies to study drug actions and the biology of brain disorders, among other things.
Many of its studies focus on patients with disorders like schizophrenia and severe depression, who are especially vulnerable to poorly prepared imaging drugs because the compounds can act on brain receptors involved in their illness.
“We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping at this lab,” said David I. Hirsh, Columbia’s executive vice president for research. “That is why we are fundamentally reorganizing the lab’s management and operations in response to what the F.D.A. told us.”
To perform a PET scan, doctors must first inject patients with a radiotracer, a drug engineered to accumulate in the area of the body being studied and to emit low-level radiation detectable by a scanner.
The compounds are considered very safe. But because they degrade quickly, many laboratories produce them themselves, under protocols agreed upon with the F.D.A.
The agency regulates the allowable radiation levels and the purity of the drugs. If a drug contains too many impurities — unknown chemicals that may or may not be related to the tracer itself — then its effects in the body are unpredictable.
“There could be a patient safety issue, for one,” said Dr. Barry Siegel, chairman of the radioactive drug research committee at Washington University in St. Louis. “And there could be a scientific validity issue. If you’re exposing people to radiation and getting garbage data, then that becomes an ethical problem.”
Read entire article: http://www.nytimes.com/2010/07/17/health/17columbia.html
For other recent expose’s on psychiatric brain imaging – see this article:
Anti-Psychotic Drugs are Likely to Cause Brain Damage, According to a New Study—
“The results challenge the widely-held view that schizophrenia itself causes brain structural changes, such as less brain grey matter, bigger ventricles and larger cerebrospinal fluid (CSF) spaces, claim researchers. The results are published in an edition earlier this year of the Psychological Medicine Journal.”