Fungal and bacterial contamination went unaddressed for months at a now-shuttered National Institute of Health pharmacy, inspection reports show. Drugs untested for safety were released to patients receiving experimental treatments at a highly regarded clinical center.
Six cancer patients may have received drugs contaminated with a fungus in medical experiments in April, the federal biomedical research institutes based in Bethesda, Maryland, reported on Thursday.
Two vials of albumin used in experimental treatments displayed signs of a fungal mat, leading to destruction of that run of the drug made in the NIH pharmacy. But no steps were taken to find the source of the contamination, the inspection found.
After an anonymous complaint about the contaminated drugs, Food and Drug Administration inspectors discovered "serious manufacturing problems and lack of compliance with standard operating procedures" at an NIH pharmaceutical facility in May.
"We are grateful to whoever made the complaint because patient safety is our overriding concern," NIH deputy director Lawrence Taback told BuzzFeed News. The production of sterile materials at this facility has been suspended indefinitely. "I can't say when it will reopen. We want to be as thorough as possible and fix the problem."
"To date, there is no evidence of patient harm," according to a FDA statement. Inspection documents detail a series of serious mistakes at the pharmacy, including the release of suspect Lidocaine shots for patients without retesting for sterility. During the inspections, sodium phosphate injection vials were discovered filled with glass particles. They were discarded, but no one tried to figure out the problem or correct its root cause.
Positive hits for bacterial contamination turned up at least 15 times on personnel or pharmacy drug preparation surfaces dating back to October, the inspection reports say, and pharmacy managers never bothered to figure out why.
"It's troubling that NIH, which has some of the best scientists in the world, sees something like this happen," clinical pharmacologist David Benjamin of Northeastern University in Boston told BuzzFeed News. "The whole system and process was lax and safety and sterility procedures were not employed."
"This is a distressing and unacceptable situation," NIH Director Francis Collins, said in a statement. Collins added that it is "deeply troubling" that patients may have been harmed by the tainted drugs.
Collins announced a four-point plan to address the problems at the pharmacy, starting with a review by outside experts. About 250 patients in 46 clinical trials underway at NIH's clinical trial facilities will have to have drugs sourced from outside NIH as a result. A "small fraction" of patients may have to receive urgently needed drugs from the shuttered facility, Deputy Director Taback said.
This post has been updated to include the fact that the NIH knew about these problems for months, as well as what it knew.
This post has been updated to include that the production of sterile materials at this facility has been suspended indefinitely.