NECC Official Told F-Off on Tests

By Walter F. Roche Jr.

BOSTON- The woman who was the sole quality control official at a now defunct drug company said she was told to F-off when she raised questions about the failure to conduct periodic tests on the competency of employees compounding sterile drugs intended for human injection.
Annette Robinson, testifying today at the racketeering and second degree murder trial of Glenn Chin, said it was Chin who sent her an e-mail with that message not once but twice in the weeks and months leading up to a deadly fungal meningitis outbreak caused by drugs produced at the New England Compounding Center.
She said she had emailed Chin, NECC's supervising pharmacist, expressing concerns that the staffers had not even read the mandated procedures for conducting the tests known as media fills.
Another email entered into the record by federal prosecutors was a message Chin sent to an official of a sterilizing device manufacturer showing that he was unsure of how long drugs had to be placed in an autoclave to assure sterility.
The email, sent from Chin's personal computer, was dated Oct. 12, 2012, over a week after the outbreak had become public and even as victim deaths were mounting. Prosecutors have charged that Chin failed to place steroid drugs in an autoclave long enough to kill any contaminants.
Robinson was also a witness against NECC's president and part owner, Barry J. Cadden, who is now serving a nine-year sentence following conviction on racketeering, conspiracy and mail fraud charges. He was acquitted on the 25 second degree murder charges that Chin still faces.
Chin, Cadden and 12 others were indicted in 2014 following a two year federal probe of the deadly fungal meningitis outbreak caused by fungus loaded steroids shipped from NECC to health facilities across the country. The outbreak sickened 778 patients, killing 76 of them.
Robinson, who said she had no formal training or previous experience in environmental monitoring, said she was given the quality control job when another employee left. She said her predecessor described the duties including conducting environmental monitoring in NECC's clean rooms, sending products out for testing and making sure staffers read the Standard Operating Procedures for compounding various drugs.
She said that when her environmental tests showed evidence of fungus or bacteria, nothing was done about it. One hot spot, she said, was in the area where methylprednisolone acetate was being prepared. That drug, federal regulators have concluded, caused the outbreak
Robinson said she also learned that employees were apparently not performing daily and monthly cleaning assignments. In fact she said she found out workers waited till the end of the month and affixed their initials to a cleaning log sheet.
She said she did have a conversation  with Chin because the forms were not being filled out on a daily basis.
"They weren't being done," she said.
She said she saw insects in the clean rooms and other locations in the Framingham, Mass. facility. She also said hair was frequently found in the same two rooms.
When Cadden raised concerns about the hair droppings, Chin replied in an email, "Yes there are a lot of hairy zoo animals in the room."
Robinson said that she only sent out two samples of drug batches for testing at an outside laboratory though she later learned that more samples were required for a valid result. She said that when she raised the issue with Chin, he told her her he didn't want to waste the vials.
She said some drugs were also sent out before sterility test results were received and in some cases the tests were never performed.
As for her relationship with Chin, Robinson said, "Sometimes he was nice" but he also could be hurtful. The hurtful "happened more and more" as NECC raced to an October 2012 shutdown, she said.
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