Photomicrograph of fungal infection of brain tissue
A federal jury has convicted the supervisory pharmacist of the now-closed New England Compounding Center on numerous charges in connection to a 2012 nationwide fungal meningitis outbreak that federal prosecutors say killed 76 people and made another 750 sick, the Department of Justice announced.
Glenn Chin, 49, of Canton, Massachusetts was found guilty of racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead. The outbreak occurred in 2012, when 753 patients in 20 states were diagnosed with a rare fungal form of meningitis, as well as joint or spinal infections after receiving tainted injections of preservative-free methylprednisolone acetate, which had been manufactured by NECC, according to the DOJ and other published reports.
The CDC reported that 64 patients in nine states died, however according to the Chicago Tribune, in June when the pharmacy's co-founder and president was sentenced to nine years in prison for his role in the deadly fraud, prosecutors said 12 more people had died elevating the death toll to 76.
The deadly outbreak was born when Chin manufactured three lots of the contaminated MPA, which amounted to more than 17,000 vials of medication. Chin ignored NECC's own drug formulation worksheets and standard operating procedures, insufficiently sterilizing the MPA and failing to even verify the sterilization process at all. With full knowledge of his dangerous missteps, Chin directed thousands of vials of the MPA be filled and shipped to customers across the country, the DOJ said.
Chin served as the supervising pharmacist and was supposed to oversee all of NECC's drug compounding operations, but still directed the shipping of drugs before test results confirmed their sterility and also had technicians mislabel drugs to conceal this practice. He also ordered the compounding of drugs using expired ingredients. Those drugs included chemotherapy drugs that expired years ago.
Finally, Chin regularly disregarded mold and bacteria being found in the clean rooms, ordering cleaning logs to be forged and "prioritizing drug production over cleaning." Along with co-conspirators, he also employed a pharmacy technician whose license had been revoked by the Massachusetts Board of Pharmacy to compound highly sensitive cardiac drug solutions. Chin hid the technician's presence inside the clean room from regulators, the DOJ said.
"Mr. Chin ran NECC's clean room operations with depraved disregard for human lives," said Acting U.S. Attorney William D. Weinreb. "As a licensed pharmacist, Mr. Chin took an oath to protect patients, but instead deliberately violated safety regulations, causing the largest public health crisis caused by a pharmaceutical drug in U.S. history. Time and time again, Mr. Chin made dangerous decisions: he decided to cut corners, to improperly sterilize and test drugs, to mislabel drugs, to skip cleanings and ignore contamination in the clean rooms, and to endanger patients' lives."
U.S. District Court Judge Richard G. Stearns scheduled sentencing for Jan. 30, 2018.
The other major figure in the case, pharmacy co-owner and president Barry Cadden, was slapped with a nine-year federal prison sentence in June. He was convicted of fraud and conspiracy, but ducked 25 charges of second-degree murder, the Tribune reported. His lawyer said there was no evidence he knowingly shipped tainted drugs, and instead pointed the finger at Chin.
The contaminated steroids were given mostly to people with back pain, and Indiana, Michigan and Tennessee were the hardest hit states. Prosecutors argued Cadden sent out the steroids despite knowing there was mold present in the room where the steroids were made. They also said he knew he was ignoring industry cleanliness and sterility standards for the sake of ramping up production and increasing profits, according to the Tribune.