Gov. Expert: NECC Skipped Key Tests

By Walter F. Roche Jr.

Boston-An expert witness testified that the Massachusetts company that caused a deadly outbreak was not even bothering to conduct some critical tests for sterility on its products and even when it did send samples for testing, it did not test a sufficient number to assure a valid result.
The expert, who also has served as a consultant to federal prosecutors, said the company also failed to comply with national standards mandated by the Massachusetts Board of Pharmacy. The testimony came in the trial of six former employees of the New England Compounding Center who are charged with racketeering and mail fraud.
The six on trial in U.S. District Court were among 14 indicted following a two year federal probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients and sickened hundreds more. Closing arguments in the case are expected early next week.
"You can't wing it," said Eric Kastango, who was paid $36,354 for his consulting work for federal prosecutors.
Citing the high risk sterile drug compounding taking place at NECC in 2012, Kastango said NECC pharmacists were removing drugs from an autoclave after only a fraction of the time needed to assure sterility. Shown NECC records, Kastango said one batch of drugs was autoclaved for only 10 minutes when as much as 40 minutes could be required.
In addition he said the Framingham, Mass. company was not using biologic indicators, another method to assure sterility.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango said that although NECC did do some limited end product testing, the number of samples sent to a private testing laboratory was far below that required under the U.S. Pharmacopeia, which sets industry standards
Kastango said NECC was not in compliance with two chapters of the U.S. Pharmacopeia, even though it was required by the Mass. Pharmacy Board, the agency that licensed NECC.
Varghese displayed an email sent to one of the defendants, Alla Stepanets, by NECC President Barry Cadden in which he said NECC should have been doing more testing all along. Cadden already was convicted of racketeering and mail fraud and is serving a nine-year prison sentence.
Kastango said NECC was not even complying with the requirements of its own Standard Operating Procedures on product testing.
Also testifying Thursday was William Frisch, an employee of the Mass. Pharmacy Board, who said he had conducted an inspection at NECC in 2011 after the company opened a new clean room where sterile drugs were to be compounded.
He said he found everything to be satisfactory, though he never actually went into the clean room. A year later he said he was assigned to investigate a complaint that drugs shipped by NECC to a Boston hospital did not have a sufficient amount of a numbing agent. The drug was supposed to numb the eye during surgical procedures.
He said that investigation never concluded because of the meningitis outbreak which put NECC out of business.
Sarah Walsh, attorney for defendant Christopher Leary, questioned Frisch about letters from the state Pharmacy Board to the four pharmacists on trial including Leary, informing them that an investigation by the agency initiated after the outbreak had been closed without any disciplinary action.
Asked if the state board would allow a pharmacist to continue to practice if he or she was a threat to the public, Frisch said, "No."
Court records show that the four are under an order barring them from engaging in any drug compounding but allowing them to dispense drugs.
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