BOSTON- A microbiolgist from the U.S. Food and Drug Administration said she was surprised to still find nearly a dozen mold growths in the clean room of a drug compounding company even after the facility had undergone two days of cleaning.
Testifying at the racketeetering and second degree murder trial of Glenn Chin, Almaris Alonzo said she found evidence of mold in nearly a dozen locations in her examination of the area where sterile drugs were being compounded. There was "a high level of contamination," she said.
Chin was charged following a two year probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients in 20 states. More than 700 others were sickened after being injected with spinal steroids loaded with fungus.
Chin was a supervising pharmacist at the New England Compounding Center, the company blamed by state and federal regulators for the outbreak. Opening arguments in the case were delivered on Sept. 19 and the case is expected to go to the jury next week.
Alonzo said she saw a evidence of a likely source for mold even before entering the clean room where thousands of vials of methylprednisolone acetate were prepared. Pooled water was found near a boiler and grass was evident on the sticky mats NECC cleanroom workers walked over on their way into the drug preparation area.
"Mold loves to eat grass," Alonzo said, adding that standing water was a perfect place for mold to take hold.
She said some of the grass from the sticky mat was likely dragged into the clean room. She described the general condition of the room and some of its equipment as "very dirty."
She said the goal for her and the other investigators was to isolate the microbes causing a growing number of victims to become ill. She said the original case was a victim from Tennessee who suffered fungal meningitis from an organism called aspergillus fumigatus. He died.
She said some of the grass on the sticky mat likely was dragged into the clean room itself.
Remaining members of the jury - two were absent Tuesday - were shown pictures of Alonzo and other investigators examining the clean room wearing gas masks. Also shown in the pictures was Chin, who was a supervising pharmacist at NECC overseeing the clean rooms.
Alonzo said the on-site inspection took place in early October, just as the growing outbreak was becoming public. Under questioning by Assistant U.S. Attorney George Varghese, the FDA scientist said that the in-house cleaning, while far from thorough, actually made the job of investigators more difficult.
"It would have been a more useful result," she said if the area had been left alone.
She said that when she questioned Annette Robinson, who was in charge of NECC's environmental monitoring, she learned that NECC was using a medium intended to show growth of bacteria but not the medium to best show mold growth.
She said that Robinson also told her that when contamination was found, it was never investigated nor was remedial action taken.
In other testimony, Robert Sheketoff, one of Chin's lawyers, challenged an FDA investigator, Stacey Degarmo, who had testified that NECC was sterilizing drugs for only 15 minutes when 20 minutes was recommended by the manufacturer.
Sheketoff had her read from internal NECC documents that had listed 15 minutes as the standard for some time.
But on redirect by Varghese, Degarmo repeated that 20 minutes in the autoclave at 121 degrees was the minimum necessary to achieve sterility.
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