Tuesday, September 26, 2017

Witness Says Compounding Records Altered


By Walter F. Roche Jr.

BOSTON- A pharmacy technician testified today that his boss ordered him to falsify records to hide the fact that pediatric cancer fighting drugs being shipped to health facilities across the country had passed their effective date years before.
The same witness, testifying in the racketeering and second degree murder trial of Glenn Chin, said records showed that Chin only kept steroids in an autoclave for 15 minutes when 20 minutes was required to assure sterilization.
Some of those same steroids have been blamed for the 2012 fungal meningitis outbreak which took the lives of 76 patients. Chin has been charged in 25 of those deaths. He was one of 14 persons associated with the now defunct New England Compounding Center to be indicted following a two year federal probe of the outbreak.
The witness, Corey Fletcher, whose work station was only inches away from Chin's, detailed his work at NECC including the use of expired drugs. He walked jurors through the process of making and packaging the methylprednisolone acetate. Vials of the drug contaminated with fungus eventually sickened some 778 patients.
He also described how the lot numbers for NECC drugs were altered to make it appear that they had been tested. He said newer batches which hadn't been tested were relabeled with the lot numbers of older drugs that had been tested for sterility.
He said the practice, called "botching the lots" was done at Chin's direction multiple times.
He was shown an Aug. 13, 2012 email in which he asked another NECC employee to send 1,000 new labels to accomplish the botching of an untested lot about to be shipped out.
He was shown another email in which Chin reported that NECC still had a container of methotrexate, a drug used in pediatric cancer,  which had a Jan. 23, 2007 expiration date. The drug was in sudden demand.
Fletcher said that subsequently he was told to create new labels listing an expiration date six months later than the date the orders were filled. He verified a series of new labels listing expiration dates ranging from 2010 to 2015. He said Chin told him to only change the year to make it easier to alter records.
Chin's initials were on related documents indicating he had verified the drug was properly labeled.
He said Chin also ordered him to put a reduced amount of water in the methotrexate powder to make up for the fact that the drug was less than 100 per cent potent.
As prosecutors led Fletcher through a series of related records, U.S. District Judge Richard G. Stearns said that "as mesmerizing" as the testimony was, it was time to send the jurors home.











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