NIH Clinical Center needs reforms to emphasize patient safety over research, panel says

Safety standards and oversight need to be overhauled at the National Institutes of Health Clinical Center, according to an agency-appointed task force’s report released Thursday.

The panel was asked to examine “structural and cultural issues” after an inspection by the FDA led to the closure of a sterile production unit within the center’s Pharmaceutical Development Section in May 2015.

The report says in some cases, research needs took priority over the safety of patients.

"The emphasis on research is so great, and on trying to save people's lives, that there became a cultural attitude that overshadowed handling some of the details that are important details," said Norman Augustine, chairman of the task force and former CEO of Lockheed Martin, to National Public Radio.

The panel also found concerns about safety and compliance went unreported, safety standards varied in different research programs, and some working in the center weren’t aware of regulations on the hospital’s research and drug manufacturing units.

NIH Director Francis Collins, MD, PhD, said in a statement that while there’s no evidence patients were harmed, he’ll take immediate action on several of the panel’s recommendations to address safety concerns.

“Continuous improvement is an essential part of hospital management, and this is an opportunity to strengthen our patient safety framework,” Collins said.

Among his immediate actions is creating a new external hospital board, and appointing Laura Forese, MD, the current executive vice president and chief operating officer of New York-Presbyterian, as its chairperson. A new compliance office and committee tasked with “continuous surveillance of all clinical activities in the Center” will also be created.

Collins said other recommendations will be implemented over the rest of 2016. Those include a change to the Pharmaceutical Development Section which led to the task force’s creation. The report advises the section’s sterile production unit not be rebuilt within the Clinical Center.

NIH has already acted on one long-term recommendation to allow an external review of facilities producing sterile materials.

Two days before the panel’s report was released, that review led to operations being suspended at two facilities: a National Institutes of Mental Health facility which produces PET materials, and a National Cancer Institute lab engaged in cell production therapy.

NIH said no new patients will be enrolled in affected clinical trials in those facilities until safety issues are resolved.