The National Institutes of Health has suspended work in two facilities that manufacture products given to people who are enrolled in research studies, saying the facilities haven’t complied with safety standards designed to protect already-sick people from inappropriate risks.
“There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken,” the NIH said in a statement provided to NPR Tuesday. “NIH will not enroll new patients in affected trials until the issues are resolved.”
The NIH says work has been halted in two facilities that manufacture sterile or infused products: a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials.
The cell therapy research is run by a scientific superstar named Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute. He’s spent four decades at the NIH, where he pioneered the idea of using the immune system to fight cancer. He’s also the doctor who treated President Ronald Reagan’s colon cancer.
Rosenberg did not respond to an email and a phone message left at his office. A representative of the company involved with his clinical trials, Kite Pharma, declined to provide information beyond what’s in a press release. Another company, Lion Pharmaceuticals, issued a similar statement saying that its trials were among those suspended.
The shutdowns of these facilities and research studies comes as the NIH is struggling to recover its credibility following embarrassing revelations last year that halted sterile manufacturing operations at a facility that serves the prestigious NIH Clinical Center.
The Clinical Center is a world-famous hospital where the patients are also research subjects. It’s often a place of last resort for desperately ill people who are willing to try unproven medicines.
But in April 2015, fungal contamination was discovered in two vials of the drug albumin that were manufactured by the Clinical Center’s Pharmaceutical Development Service. At least six patients received injections from that batch, but the NIH has said none have suffered any problems.
Shortly after that episode, in May 2015, the Food and Drug Administration received a complaint and conducted an unannounced inspection of the pharmaceutical service facilities. The inspection found worrisome deficiencies, such as insects in the lights of so-called clean rooms, flaws in the air-handling system, and inadequate training of staffers. In June, the NIH announced that sterile operations at the facility were suspended.
Since then, an internal investigation at the NIH revealed that this wasn’t an isolated problem but rather part of a disturbing pattern. “We learned that there was a prior history of contamination events and a systemic failure to adhere to a set of standard safety and compliance principles,” reported an NIH task force. “Instead, priority had been put on producing a high volume of products to meet the requests of intramural investigators.”
That’s why, a few months ago, the NIH put together what it is calling a red team to examine the structural and cultural issues underlying these failures. The team was also tasked with reviewing “other research activities at the Clinical Center that pose a potential risk to research participants,” including other sites at the NIH that make experimental compounds intended for administration into sick people.
The red team is scheduled to brief an advisory committee to the NIH director on Thursday afternoon.