NECC Quality Conrtrol Non-Existent

By Walter F. Roche Jr.

Boston- When the head of quality control at a Massachusetts company producing thousands of vials of sterile steroids expressed concern about the refusal of staffers to perform essential safety and sanitary tasks, the supervising pharmacist responded with an expletive.
That was just one of the alarms that sounded in 2012 at the company later blamed for a deadly fungal meningitis outbreak. Testifying today in the criminal trial of six of her former colleagues Annette Robinson testified that she had no experience in quality control when she was given the job and that she was not only the head of the department but also its only employee.
Testifying for the prosecution under a grant of immunity Robinson said safety and sanitation concerns were virtually ignored as the company careened towards a major disaster that ultimately sickened nearly 800 patients, killing 76 of them. Federal prosecutors have called it the worst public health crisis in the country's history caused by a prescription drug
The testimony came in the racketeering and mail fraud case against former employees of the New England Compounding Center, the now defunct firm that shipped steroids laden with a deadly fungus to health providers in 20 states including Tennessee.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said a quality control committee established after her 2010 appointment at first met monthly but in 2011 stopped meeting altogether.
She said her tasks included collecting environmental samples from the clean rooms where sterile drugs, like the methylprednisolone acetate blamed for the outbreak, were prepared. She said that despite findings of bacteria and mold, nothing was done
She said periodic competency tests required of pharmacists were not being performed and the pharmacists should not be allowed to compound drugs till those tests were completed. In fact that was an issues she raised in the Feb. 2. 2012 email to NECC supervising pharmacist Glenn Chin. He responded with two words "F--- Off."
Chin, one of 14 indicted following a two year probe of the outbreak, already is serving an eight year federal prison sentence following his conviction on racketeering and mail fraud charges. Chin's
boss, Barry Cadden, NECC's president and part owner, is serving a nine-year sentence following his conviction on similar charges.
Robinson, who testified at both prior trials, said she had no experience in quality control and her previous jobs at NECC and a sister company included spraying down bags prior to their filling by clean room technicians.
Robinson said she learned from the conversations of fellow employees that the prescriptions purportedly written for NECC products listed patient names like Donald Duck. People joked about it, she said.
She said that notwithstanding the lack of response to her quality control efforts, the only criticism she heard from superiors was that she wasn't working fast enough.
Asked what led to her appointment as the chief of quality control Robinson said she had heard that the then current head was leaving. She applied to Cadden and got the job. Asked if she had any formal training in quality control she said she didn't. She said her predecessor in the job "told me how he did it."
Though she had prior laboratory jobs Robinson said she had no training in microbiolgy and did not even know how beyond-use or expiration dates were determined for chemicals or medications.
Asked specifically about some of the defendants, she testified that pharmacist Sharon Carter, whose job was to check on outgoing orders after they left the clean room, reported to Cadden and she observed them having a lot of "closed door conversations" at NECC's Framingham, Mass. facility.
She said Gene Svirskiy, another clean room supervisor, "just stopped talking to me."
She said she didn't have that much to do with defendant Christopher Leary, who like Svirsiky was a licensed pharmacist.
Shown an NECC sales brochure distributed to potential customers, she said that claims, such as the use of strict standard operating procedures (SOPs) for drug production, were not followed. She said she couldn't even get employees to read the SOPs, never mind follow them.
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