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Brain Imaging Center Faces FDA Woes, Lawsuit

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The Brain Imaging Center at the University of California, Irvine, quietly stopped human experiments in February 2012 after government inspectors discovered tainted drugs, unsecured radioactive materials, and other problems, according to Rex Dalton of Voice of OC, a nonprofit investigative news agency in Orange County, California.

The university and the center’s former director also face a lawsuit from a former researcher at the center who says he was fired in retaliation for trying to address problems there.

The Food and Drug Administration conducted four inspections and issued a report on May 3, 2012, citing 19 areas of concern, Dalton’s story says. He quotes an FDA spokesman:

The inspection team observed some violations of current good manufacturing practice.

According to Dalton, the FDA said the center manufactured radioactive compounds tainted with impurities and used them in at least 168 patients. The FDA spokesman said the agency would not allow the center to resume manufacturing radioactive drugs without an FDA inspection “to verify the adequacy of the facility.”

A report by the Radiologic Health Branch of the California Department of Public Health found that licensed radioactive materials had been stored unsecured for five years until early 2012, Dalton’s story said. It quoted the report as saying the door to the lab that contained radioactive isotopes wasn’t lockable.

In July, the story says, Carl Taswell, MD, PhD, sued UC Irvine and former Brain Imaging Center director Steven G. Potkin, MD, among others. The lawsuit says Dr. Taswell and another researcher were fired after trying to correct problems, including “deplorable” lab conditions. Dalton’s story says Dr. Taswell’s attorney, Louis C. Cohen of Agoura Hills, California, issued a statement saying the following:

Dr. Taswell had the integrity to take action and did not ignore his duties as a physician. He promptly reported these patient, worker, and community safety issues to his supervisors, and when they failed to act, to appropriate government agencies. Within a few weeks, he was fired.

Dalton’s story quoted a university spokesman as saying the center’s radio-chemistry lab was closed in February 2012 because of “irregularities.” The spokesman said some equipment remained available for regular clinical testing of patients. Other university officials declined interview requests.

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