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Columbia’s Radioactive-Drug Woes Continue

October 11, 2011
Written by: , Filed in: Nuclear Medicine
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Columbia University Medical Center in New York, which was forced to shut down research in a PET lab last year because of impurities in radiotracers, still has problems monitoring radioactive drugs, according to a Food and Drug Administration warning letter.

The FDA sent the letter on September 20 to G. Michael Purdy, PhD, Columbia’s executive vice president for research. It details problems involving the school’s Radioactive Drug Research Committee (RDRC), which oversees research involving radiopharmaceuticals.

After an inspection in May, the letter says, the FDA determined that: “The RDRC failed to assure the necessary conditions so that radioactive drugs used in research under their purview are considered safe and effective.”

The FDA detailed five specific failings, some of them pretty fundamental. For example, the FDA charged that the RDRC failed to ensure that any adverse effects from radioactive drugs in research studies be immediately reported. The letter references David J. Brenner, PhD, director of Columbia’s Center for Radiological Research and chairman of the RDRC:

Dr. Brenner acknowledged that no adverse events had been reported to the RDRC since he became Chairman in January 2007, and that there is no mechanism in place for the RDRC to receive such reports.

No mechanism in place? Seriously? Sure, FDA regulations can be a pain, but when your committee’s job is to make sure that those regulations are followed, shouldn’t you at least make an effort? Especially because, as the letter points out, the point is “to protect the safety and welfare of human subjects, including a potentially vulnerable population (i.e., subjects with psychiatric disorders)”?

The letter 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 the agency found that the center had used impure radioactive drugs on study subjects. (For details, see our post.)

Regarding the latest incident, the FDA letter says the medical center promised changes in RDRC operations. However, the letter says, “this response is inadequate” because Columbia so far has not provided any details nor a completion date.

The letter also notes, “This letter is not intended to be an all-inclusive list of deficiencies related to the RDRC.”

Related seminar: Diagnostic Imaging Review: For Residents, Fellows and Radiologists


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