NIH halts experimental drug studies over contamination

WASHINGTON -- The National Institutes of Health is suspending its production of experimental medicines for certain research studies after the discovery of two vials contaminated with fungus and some manufacturing problems.

Six patients who received different doses made from the original batch in the spring show no signs of illness, the NIH said Thursday. The halt in production leaves about 250 people in 46 NIH studies waiting to hear when they will receive other experimental treatments.

"This is a distressing and unacceptable situation," NIH Director Francis Collins said in a statement.

A facility at the NIH's research hospital manufactures modest quantities of experimental drugs and, like at regular drug factories, is supposed to comply with procedures to keep the process sterile.

In April, NIH workers discovered fungal contamination in two vials of albumin, used to administer the drug interleukin. About 600 other vials appeared fine, said NIH Deputy Director Lawrence Tabak. It is not known whether there was any prior contamination, but the six patients who received earlier doses from that albumin batch were notified and closely monitored.

Tabak said there's no evidence of contamination in the facility's other products, although additional testing is underway.

After a complaint to the Food and Drug Administration, inspectors visited the facility late last month and found problems that included flaws in air flow, inadequate quality control and lack of compliance with some standard operating procedures. Thursday, NIH announced that no more products will be made or distributed until the problems are corrected, and that it will appoint outside experts for an extra review.