Potentially Deadly Bacteria Found in NECC Drugs

By Walter F. Roche Jr.

BOSTON-Microbiologists from the U.S. Food and Drug Administration testified today that they found mold, yeast and bacteria, some of it potentially deadly, in several drugs shipped from a Massachusetts drug compounder.
The FDA scientists, testifying in the trial of one-time supervising pharmacist Glenn Chin, said that a variety of bacteria were found in multiple drugs shipped by the New England Compounding Center to health facilities from Massachusetts to Florida and Washington.
Chin has been charged with racketeering and second degree murder for his role in the 2012 fungal meningitis outbreak which eventually sickened some 778 patients, killing 76 of them.
Henry Lau, from FDA's San Francisco office, said that his tests of cardioplegia that had been shipped by NECC to Brigham and Women's Hospital in 2012 contained the bacteria brevibacillus choshinensis.
Asked about the possible effects of that bacteria should it be injected in a patient, Lau answered with a single word: "Deadly."
Forty seven bags of the drug used to stop the heart during surgery, had been shipped to the Boston hospital, according to an exhibit displayed for jurors.
The testimony from Lau and other FDA officials showed that contamination at NECC was not limited to the steroid, methylprednisolone acetate, the drug blamed for the deadly fungal meningitis outbreak.
Lau said an NECC steroid, triamcinolone, was found to have three different bacteria, some of them harmful. He said testing of 10 vials of betamethasone shipped to an Indiana clinic showed five had bacteria that would be harmful to patients with a compromised immune system.
Stephen Yarmouth, one of Chin's lawyers, countered by questioning another FDA microbiolgist in the same California office about test results that showed possible contamination in the clean room at the same office.
Jonathan Yenovkian, Lau's colleague, said that growth, indicating the presence of some contamination, was discovered in the FDA's San Francisco clean room, but despite several tests said, the exact identity of the organism could not be determined.
"We did our best," Yenovkian said, adding "It was viable. It grew."
He said there was no evidence it affected the tests performed on NECC drugs.
Yenovkian said that betamethasone NECC had sold to an Orlando outpatient surgery center had two different bacteria and samples of the same steroid shipped to a Kentucky clinic contained potentially harmful bacteria.
Haydee Romero, who works in a New York FDA laboratory, said that she tested 78 vials of the methylprednisolone acetate that had been shipped to the Saint Thomas Outpatient Neurosurgery Center in Nashville.
She said tests showed 48 vials were contaminated, with 28 showing yeast and 19 with mold. She said there was so much mold in one sample that it was growing off the plate used to conduct the test.
She said tests on 25 vials of the same drug sent to another clinic showed all were contaminated.
"It is unusual to get so much growth from a single drop," she said noting only a single drop of a drug is used to conduct the sterility test.
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