Monday, September 25, 2017

Corners Cut, Tests Omitted as Outbreak Loomed


By Walter F. Roche Jr.

BOSTON, Mass. Former employees of the company that caused a deadly 2012 fungal meningitis outbreak testified that as the volume of drugs being compounded jumped by 300 percent, sterility test results were ignored or omitted and corners were cut to meet the demand.
"Orders were getting bigger," Owen Finnegan told the jurors, adding that he and other employees were wondering out loud about how much money the company needed.
Finnegan was testifying as a prosecution witness in the trial of Glenn Chin, who was a supervising pharmacist at the now defunct New England Compounding Center. Chin is facing racketeering and second degree murder charges.
He was one of 14 charged following a two year grand jury probe of the outbreak which sickened 778 patients in 20 states. Seventy six of them died.
Finnegan, who was a pharmacy technician, said that "back when the orders weren't crazy," he and his colleagues followed established procedures, such as waiting for a set period of time after spraying vials with alcohol.
"Wait times had to be reduced. We had to get it done," Finnegan said.
He said the orders for the increase came from Chin, who told NECC workers "the big boss," NECC President Barry Cadden, wanted it that way.
Cadden is already serving a nine-year sentence following his March conviction on racketeering and mail fraud charges. Cadden, however, was acquitted on 25 counts of second degree murder.
Finnegan said that when he first went to work for NECC in 2010, he and other technicians would be fighting over who got to fill the pending orders. But then "it spiked" and production increased drastically, he said.
He said that Chin himself compounded the methylprednisolone acetate that caused the outbreak because he was the only one who knew how to operate the machine.
According to state and federal regulators, thousands of vials of the NECC steroid were contaminated with deadly fungi.
Nicholas Booth, another pharmacy technician, said he first worked for a sister company, Ameridose, but was eventually transferred to NECC where one of his chores was cleaning in the so-called cleanroom where sterile drugs were prepared.
He said that as the volume of orders jumped in 2012 he and other workers were no longer able to perform all of the daily, weekly and monthly cleanings of equipment and work surfaces. As for the logs used to document that the cleaning had been completed, he said those were filled out after the fact whether or not the cleaning had taken place.
"We all knew that stuff was being sent out that hadn't been tested," Booth said.
"It was happening more and more," he added. "The more orders we got, the more corners were cut."
He said that when he questioned why orders were being sent out before test results were received he was told "They have to be sent out."
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