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PET material production halted as NIH facilities undergo safety review

by Gail Kalinoski, Contributing Reporter | April 27, 2016
Business Affairs Molecular Imaging Risk Management
Two Maryland NIH facilities
being evaluated for
non-compliance
Concerned with problems uncovered in the sterile manufacturing processes at two facilities that run clinical health trials for the National Institutes of Health — including one producing PET materials — the NIH has shut them down while it conducts a more “rigorous” review.

While there is no evidence that any patients have been harmed, the NIH has halted the research and stopped enrolling new patients in “affected trials until the issues are resolved,” according to a NIH statement.

A report on NPR said the two facilities “manufacture sterile or infused products” and identified the locations as a National Cancer Institute laboratory that performs cell therapy production and a National Institute of Mental Health facility producing positive emission tomography (PET) materials, both in Bethesda, Maryland.

An ongoing investigation by NIH confirmed that it had “identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products,” according to the NIH statement.

The NPR story reported that the cell therapy research is run by Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, and the doctor who treated former President Ronald Reagan’s colon cancer. Rosenberg, who did not respond to NPR’s requests for an interview, is known for pioneering the concept of using the immune system to fight cancer.

The latest shutdowns follow several serious problems that occurred in the NIH Clinical Center Pharmaceutical Development Section, last year, including fungal contamination in two drug vials and inspections of several facilities that found problems like insects in the lights, air-handling system flaws and inadequate staff training.

The NIH put together a task force last year to investigate the center and other safety concerns. That task force recently released its report and called for sweeping reforms to improve patient safety at the center, which it found has “many outdated or inadequate facilities,” according to the Washington Post.

The experts found that there were problems that could “potentially impact patient safety and research outcomes.” The report also called into question issues with the center’s drug production components, stating there “are examples of sustained weaknesses in structure, facilities, practices and compliance.”

While there was no evidence that any patients were harmed, the task force found their safety was occasionally put at risk because of the “inattention to safety,” possibly a byproduct of a “well-intentioned, single-minded focus on research.”

NIH Director Francis S. Collins appointed an outside board, headed by Laura Forese, chief operating officer of New York-Presbyterian, which has six hospitals in the New York City area, to look into the clinical center’s performance, management, finances, quality, leadership needs and ways to improve patient safety, the Post reported.

Collins also said he would hire two outside consulting firms to review all hospital facilities that make “sterile or infused products” given to clinical research patients, The Washington Post added.

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