A pharmacist who oversaw the sterile cleanrooms at a Massachusetts compounding pharmacy responsible for a deadly meningitis outbreak was arrested on Sept. 4 as he was about to board a flight for Hong Kong, federal officials say.
Glenn Adam Chin, a former supervisory pharmacist at the New England Compounding Center, didn’t properly sterilize or test equipment and concealed the unsafe practices, federal investigators say.
The pharmacy, which custom-mixed medications in bulk, has been blamed for a 2012 outbreak of fungal meningitis that killed 64 people. About 750 people in 20 states developed meningitis — an inflammation of the lining of the brain and spinal cord — or other infections. Michigan, Tennessee, and Indiana were hit the hardest.
Chin, 46, of Canton, was arrested at Logan International Airport in Boston. He was charged with one count of mail fraud, but federal prosecutors sayit is part of a larger criminal investigation of Chin and others. He is the first person to be charged in the inquiry.
It was not immediately known whether Chin has an attorney. He was expected to appear in federal court Thursday afternoon.
Prosecutors say Chin supervised the cleanrooms and was involved in compounding the contaminated methylprednisolone acetate, or MPA, that caused the outbreak.
An affidavit filed in U.S. District Court alleges that Chin participated in a scheme to fraudulently cause one lot of MPA to be labeled as injectable, meaning that it was sterile and fit for human use. The lot was shipped to Michigan Pain Specialists in Brighton, Mich.
After receiving the drug, Michigan Pain Specialists doctors injected it into patients, believing it to be safe. As a result, 217 patients contracted fungal meningitis, and 15 of them died, according to the affidavit.
In the affidavit, a special agent with the U.S. Food and Drug Administration says Chin used numerous unsafe practices while producing the medication, including improper sterilization and improper testing. Agent Benedict Celso says that Chin, in order to conceal the unsafe practices, “instructed pharmacy technicians to mislabel medication to indicate it was properly sterilized and tested.”
Celso also says the compounding center failed to properly sterilize and maintain its cleanrooms. He says Chin instructed pharmacy technicians to “fraudulently complete cleaning logs” at the end of the month “purporting to show the rooms were properly cleaned and maintained when in fact they had not been.”
He said the pharmacy’s own testing showed the repeated presence of bacteria and mold within its cleanrooms on a weekly basis throughout 2012.
The New England Compounding Center, based in Framingham, just west of Boston, gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits from people who received tainted steroid injections. Attorneys for its creditors late last year announced a preliminary settlement that would set up a victim compensation fund worth more than $100 million.
The contaminated medication was first discovered in the fall of 2012 after people who received steroid injections for back pain became ill.
Inspectors found a host of potential contaminants at the company’s Framingham plant, including standing water, mold, water droplets, and dirty equipment. Fungus was found in more than 50 vials from the pharmacy.
Regulators say the company did not perform enough tests before sending the drugs to hospitals and clinics.
A federal grand jury in Boston has been investigating the center for the last two years. In recent months, FBI agents have interviewed victims and their families.
Release Date: September 4, 2014
Source: The Associated Press
Settlement Seeks $100M Fund for Meningitis Victims: http://www.cemag.us/news/2014/05/settlement-seeks-100m-fund-meningitis-victims
Investigation of Deadly Meningitis Outbreak Moving Forward: http://www.cemag.us/news/2013/11/investigation-deadly-meningitis-outbreak-moving-forward
CDC Update on 2012 Fungal Meningitis Outbreak: http://www.cemag.us/news/2013/10/cdc-update-2012-fungal-meningitis-outbreak
Contaminated Cleanroom Linked to Meningitis Outbreak: http://www.cemag.us/news/2012/10/contaminated-cleanroom-linked-meningitis-outbreak
FDA Reports Conditions at N.E. Compounding Center: http://www.cemag.us/news/2012/10/fda-reports-conditions-ne-compounding-center
Massachusetts Shuts 11 Pharmacies Following Inspections: http://www.cemag.us/news/2013/02/massachusetts-shuts-11-pharmacies-following-inspections
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