Critical Minutes Lost in Outbreak Probe

By Walter F. Roche Jr.

BOSTON -As critical minutes passed, top state and federal investigators trying to find the source of a deadly and growing fungal meningitis outbreak sat in their cars hiding behind a drug store awaiting a signal they could continue their probe.
That was the testimony Wednesday from an official of the U.S. Food and Drug Administration as federal prosecutors moved toward wrapping up their case against a pharmacist employed by the drug compounding firm blamed for the 2012 outbreak that took the lives of 76 patients..
In a related development U.S. District Judge Richard G. Stearns denied a motion to dismiss filed by three other defendants in the same case.
Stearns ruled the three will have to stand trial at a later date on conspiracy charges.
They were indicted in late 2014 at the same time as Glenn Chin, who was a supervising pharmacist at the New England Compounding Center in Framingham, Mass. He has been charged with racketeering and second degree murder.
In the Chin case FDA micro-biologist Almaris Alonso testified that she and other state and federal investigators sat for an entire day on Oct. 3, 2012 awaiting word on when and if they could continue their investigation inside the New England Compounding Center.
She said that during Oct. 3 U.S. Marshals were in NECC's building apparently executing search warrants. She said both state and federal investigators in her group eventually went back to their offices and did not return to the company until the next day. She said negotiations apparently were also going on over whether NECC would surrender its pharmacy license.
Alonso's revelation came in response to questions posed by Chin's attorney, Stephen Weymouth, who asked why the FDA team only collected a limited number of samples.
"We didn't have enough time," Alonso said. "We had to go. We had to do an inventory."
She said the team, which included investigators from the Massachusetts Pharmacy Board, had only 24 hours to get samples collected at NECC back to FDA testing laboratories.
Asked why she didn't go back on Oct. 5, Alonso said she was under orders to wrap things up by Oct. 4.
Alonso also said that Annette Robinson, who headed NECC's quality control efforts, had no training in micro-biology and didn't follow up when insanitary conditions were found.
In other testimony, Philip Istafanos, another FDA microbiologist, said that samples from NECC, which were delivered in person to his laboratory in New York, were "highly contaminated."
He said the vials of methylprednisolone acetate contained both bacteria and mold. Several also turned up evidence of yeast.
He said he performed the analysis on the very first vials and described how black filaments could be seen in nine vials even without the aid of a microscope.
He described seeing clumps of the black filament bunching together. Describing the initial findings as "very significant," Istafanos said it showed there was excessive mold growth in the samples.
A lab report on one of those initial samples shown to jurors states, "Blackish/whitish mold and yeast like cells detected."
The FDA scientist said that about half of those original vials were kept by the FDA and the rest were sent to the U.S. Centers for Disease Control and Prevention for testing. Two were turned over to the state Pharmacy Board.
Stearns in his ruling on the dismissal motion filed by three of Chin's co-defendants, concluded that the argument raised by the three-- that the charge that they conspired to defraud the FDA was a legal impossibility - was not applicable.
The motion was filed in behalf of Gregory Conigliaro, an NECC officer and stockholder, and Alla Stepanets and Sharon Carter, NECC employees.
"Had the FDA known what the alleged conspirators were up to, it might have imposed more stringent safety standards," Stearns wrote.
"The court has no choice but to put the matter down for trial," Stearns concluded.
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