Bacteria, Fungus Found in NECC Samples

By Walter F. Roche Jr.

Boston - An official from an Oklahoma testing laboratory testified today that increasing numbers of drug samples from a Massachusetts compounding firm were testing positive for bacterial or fungal contamination in the Fall of 2012.
In fact, Tiffany Hyde, a senior microbiologist,from the Analytical Research Laboratories (ARL)in Oklahoma, testified that some samples from the New England Compounding Center (NECC) tested positive for the presence of both bacteria and fungi.
Hyde, was testifying in the criminal case against six former employees of NECC who are facing charges ranging from racketeering to conspiracy. They were indicted following a two year federal grand jury probe of the 2012 fungal meningitis outbreak. Some 76 patients, including 16 from Tennessee, died in the 2012 outbreak.
Hyde said ARL was hired by NECC to perform tests on the drugs the compounding firm was shipping to doctors and health facilities across the country.
Nonetheless, Hyde told jurors, NECC only sent two samples from each lot for testing, an amount far below the numbers mandated under minimum requirements set by the U.S. Pharmacopoeia, the non-profit industry standard setter.
And, she added, only one of the two samples was tested for bacteria. The second was tested for potency.
The alarming test results showing bacterial and fungal contamination came just as the details of the deadly outbreak were becoming public. The outbreak source was eventually traced to fungus laden steroids from NECC. Hyde also testified that the initial tests on the specific three drug lots ultimately tied to the deaths showed no contamination.
But, she said that NECC had only asked her firm to test for bacterial contamination and it was only after the outbreak began to emerge that the Framingham, Mass. company began asking for fungal tests.
They (NECC) had never asked for the fungal tests before, Hyde said, adding that the company also then asked for the first time for fungal tests on vials and stoppers used by the company.
Hyde said the NECC samples tested at the time eventually showed fungi growth she had never seen before. It was so strange, she said she took photographs.
One fungus, she said, was a large cotton-like ball with white filament but it later took on a blackish green color.
"I thought it was interesting," she said under questioning by Assistant U.S. Attorney George Varghese.
Hyde said that on one occasion when she contacted NECC about the contaminated samples, she was instructed not to do any further testing because it would be cheaper for NECC to just throw out the whole lot.
Later she said the company stopped responding to her calls and emails. Ultimately federal investigators advised ARL to stop communicating with NECC.
She said ARL testing showed bacterial growth in NECC antibiotics used to irrigate open surgical wounds. Other NECC drugs cleared preliminary tests, only to show contamination after two weeks, the standard waiting period.
Other witnesses testifying were officials from hospitals in Virginia and New York, who detailed the NECC drugs purchased and the promises by NECC sales representatives that the company complied with all industry sanitary standards.
Under cross examination by defense attorneys, the witnesses acknowledged they never had any direct dealings with any of the six defendants.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Andrew Cordiale, the former drug purchaser at the Glens Falls Hospital, said he was advised that when he made up names of patients when ordering from NECC to make them sound real, otherwise it would be "a red flag."
Prosecutors have charged that NECC sought the patient names to get around state and federal laws requiring a patient specific prescription for every dose of a compounded drug.
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