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The National Institutes of Health has suspended all manufacturing of medical products after finding some were contaminated with fungus.
It has stopped all clinical trials that use products made in its facility while it checks everything and tried to find out just what went wrong. Six patients who got potentially contaminated injections are being watched.
“This is a distressing and unacceptable situation,” said NIH Director Dr. Francis Collins.
“The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”
A Food and Drug Administration inspection has found quality control, training and other problems with the manufacturing process. “The FDA inspection has revealed that we have very serious deficiencies within this facility,” said NIH deputy director Dr. Larry Tabak.
“The FDA inspection has revealed that we have very serious deficiencies within this facility."
The mishap has troubling similarities to the 2012 outbreak of fungal meningitis that killed 64 people and made more than 700 people sick. It was traced to the New England Compounding Center, a Massachusetts based maker of specialty pharmaceuticals.
FDA inspections found widespread contamination of NECC’s products and shut it down. Company officials have been charged with murder and NECC will pay out at least $200 million in compensation to victims.
The case led to strict new U.S. regulations on compounding pharmacies, which mix drugs but had previously been treated with a lighter hand than registered drug manufacturers.
NIH is a much smaller operation. Tabak says it makes drugs and other medical materials for use in clinical trials at the NIH campus outside Washington, D.C.
“In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination,” NIH said in a statement.
“Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated. The six patients have been notified and are being followed closely for any signs of infection. At this time, none has developed signs of infection or illness.”
Tabak says NIH has sent out other products for independent testing and is bringing in outside experts to help find and fix any problems.
He said out of about 1,000 clinical trials going on at NIH, 46 are using drugs made at the NIH facility. “These are medical therapeutics that are used to treat a whole range of different diseases and conditions ranging from rare genetic diseases to autoimmune diseases,” Tabak told NBC News.
“We are trying to find alternative sources for the products.”
He said about 250 patients are affected. If someone has a life-threatening condition and there is no alternative, NIH may consider giving one of the products from the affected facility, anyway.
"The six patients have been notified and are being followed closely for any signs of infection."
It’s not the first hygiene disaster at NIH. An outbreak of drug-resistant Klebsiella pneumoniae killed a dozen patients at NIH in 2011.
And last year NIH workers discovered vials of smallpox virus, some of it still live, forgotten in a storage locker.
Plus it’s yet another embarrassment for the federal government. The Pentagon is trying to track down shipments of anthrax spores after findings some lived through radiation treatments meant to kill them. At last count, 52 labs in 18 states, Australia, South Korea and Canada are known to have received anthrax from batches found to yield live spores.