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Drug Purity Issues Close Top PET Lab

July 20, 2010
Written by: , Filed in: Medical Ethics, Neuroradiology, Practice Management
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The nation’s leading lab in the use of PET for psychiatric studies, the Kreitchman PET Center in New York, has suspended its research after federal investigators found that it had repeatedly injected mental patients with impure drugs.

The New York Times reported Friday that the center, which is part of Columbia University, had used at least 10 batches of drugs that violated Food and Drug Administration regulations since 2007. Former employees told the Times that the center was under such pressure to produce studies that it cut corners by hiding impurities in drugs despite FDA warnings—even forging at least one document.

“These are not the actions of a rogue, but instead are systematic forgeries condoned and approved by the lab director,” said one employee in a 2009 resignation letter.

Like many laboratories, the Kreitchman Center made its own radiotracers (drugs that emit low-level radiation and are engineered to accumulate in specific areas of the body that are targeted for PET scans) because the compounds degrade quickly. The FDA regulates the allowable radiation levels and the purity of the drugs. Impurities—unknown chemicals created or introduced during the manufacturing process—may or may not harm the patients. (Columbia in fact said it had conducted its own investigation and reported to the FDA on July 6 that it had found no evidence that patients had been harmed.)

However, the impurities might also compromise the research—especially the kind of brain research that the Kreitchman Center has been doing. Impure drugs targeting receptors in the brain could have unpredictable effects on mood or behavior.

“We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping at this lab,” David I. Hirsch, PhD, Columbia’s executive vice president for research, told the Times. “That is why we are fundamentally reorganizing the lab’s management and operations in response to what the FDA told us.”

Neither the FDA nor Columbia publicized the investigations or their consequences. The Times said it learned of them from “doctors who were familiar with the lab’s problems.”

The Kreitchman Center has received millions of dollars over the years from the federal government and pharmaceutical companies to use brain imaging to study patients with such disorders as schizophrenia and severe depression.

Already, law firms are trolling for potential clients among the lab’s research subjects. Here’s just one that is “aggressively investigating potential lawsuits and legal claims relating to research misconduct perpetrated by the Kreitchman Center and Columbia University.”

Dr. Hirsch said that “when manufacturing resumes under new leadership, it will meet the strictest standards and best practices for ensuring the quality” of the drugs the lab makes. He said the clinical (nonresearch) side of the Kreitchman Center was “fully approved and operational” and remained open for patient care.

As for the lab’s reputation and the validity of its research, Barry Siegel, MD, chairman of the Radioactive Drug Research Committee at Washington University in St. Louis, told the Times: “If you’re exposing people to radiation and getting garbage data, then that becomes an ethical problem.”

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One Response to “Drug Purity Issues Close Top PET Lab”

  1. Radiology Daily»AlertArchive » Columbia’s Radioactive-Drug Woes Continue on October 11th, 2011 at 10:01 am

    […] The letter also reminds Columbia that in April 2010, the FDA halted research at the medical center’s Kreitchman PET Center, a leading lab for the use of PET in psychiatric studies, because it found that the center had used impure radioactive drugs on study subjects. (For details, see our post.) […]