Warning Signs Ignored as Outbreak Approached

By Walter F. Roche Jr.

BOSTON-A sterility expert testified today that a drug compounding company and its supervising pharmacist failed repeatedly to conduct proper tests on its products and ignored industry standards mandated by state boards of pharmacies.
 Answering repeatedly with "Absolutely not" or "No, they did not," Eric Kastango detailed failures by the New England Compounding Center and its supervising pharmacist, Glenn Chin, to adequately prepare and test drugs that would be injected into the bodies of unsuspecting patients.
Hired by federal prosecutors to assist in the investigation leading up to Chin's 2014 indictment, Kastango said NECC shipped drugs without proper tests or with no testing at all. Even when tests showed a need for immediate action, nothing was done.
Kastango said Chin did not properly sterilize hundreds of vials of methylprednisolone acetate that were shipped to health facilities across the country. State and federal regulators have concluded that those vials, loaded with fungus and injected into the spines and joints of patients, caused a nationwide outbreak of fungal meningitis that sickened 778 patients, killing 76 of them.
Kastango said that NECC's own records showed the methylprednisolone acetate was supposed to be placed in an autoclave for 20 minutes, yet NECC's records showed Chin generally removed the steroids after only 15 minutes.
In addition he said Chin failed to use biological indicators needed to ensure the steroids were sterile.
And, Kastango said, Chin should have been adding an additional eight to 11 minutes in each autoclave cycle to ensure that the large volume of liquid had reached the 121 degree mark needed to achieve sterility.
Kastango, who said he was paid about $30,000, for his consulting work for federal prosecutors, said it was critical that the types of drugs Chin was preparing be sterile because they were being injected into patients' bodies.
"Once you inject something, you can't get it back," he said.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango described promotional material from NECC in which the company called its operations "state of the art" and fully compliant with the minimum standards set by the U.S. Pharmacopiea.
"They said they were the best," he said.
Asked by Varghese if indeed NECC was in compliance with those standards, Kastango said, "No they were not."
Kastango testified that while the industry standards did not have the force of law, state pharmacy boards, including Massachusetts, have made compliance mandatory.
Varghese also led Kastango through emails gathered in the investigation including a chain in which Chin described what he did after discovering that a key ingredient was missing from a beaker of a drug. The email showed that instead of discarding the deficient bottle, he mixed it with three other containers of the same drug that had the proper ingredients.
The result, Kastango said, was that all the containers were deficient, including one shipped to a Massachusetts hospital.
Other deficiencies Kastango said included failure to conduct end product testing, using outdated chemicals, falsely labeling drugs and failure to have the proper number of vials sent out for independent testing.
Varghese also introduced emails from Chin's then boss Barry Cadden.
In one Cadden acknowledged required testing was not being done.
"What you are not seeing is what we are not currently doing, but should be doing," Cadden wrote referring to a sterility test.
Cadden is now serving a nine year sentence following his March conviction on racketeering and mail fraud charges. That same email was entered as an exhibit in Cadden's trial.
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