Published on December 20, 2014, at NationofChange.org
Responsible for the deaths of at least 64 people resulting from injections of contaminated medication, the co-owner and supervisory pharmacist of a compounding pharmacy were charged this week with 25 acts of second-degree murder. Sacrificing safety standards for profit, 14 suspects associated with the pharmacy have been charged with 131 counts including conspiracy, mail fraud, racketeering, and violations of the Food, Drug, and Cosmetic Act. Although the International Academy of Compounding Pharmacists (IACP) believes this is an isolated incident, sources assert these crimes occur on a daily basis in compounding pharmacies throughout the nation.
In response to the 2012 nationwide fungal meningitis outbreak, the U.S. Centers for Disease Control and Prevention (CDC) reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections of a contaminated corticosteroid called methylprednisolone acetate. Of those 751 patients, the CDC reported that 64 patients in nine states died. The Justice Department discovered the tainted corticosteroids had been compounded and shipped from the New England Compounding Center (NECC) in Massachusetts.
Co-owner and head pharmacist at NECC, Barry Cadden and his supervisory pharmacist, Glenn Chin, have been charged with 25 counts of second-degree murder for their wanton negligence and complete disregard for safety protocols. Instead of sterilizing their equipment or clean room, the pharmacists allowed bacteria and mold to contaminate the room while falsifying logs claiming they had disinfected the area. Using expired ingredients, Cadden and Chin also failed to test medications for sterility before shipping them to hospitals and pain clinics.
Aware that unsterile medications could kill their patients, Cadden and Chin allegedly ignored basic safety regulations in order to turn a quick profit. With over 750 patients receiving the tainted injections mostly for back pain, roughly half of them contracted a rare fungal form of meningitis. Although the fungal meningitis is not contagious, it caused the deaths of at least 64 people.
Following the meningitis outbreak, NECC declared bankruptcy, and the court ordered the shareholders not to transfer assets. Against the bankruptcy court’s orders, Carla Conigliaro, the majority shareholder of NECC, and her husband Douglas Conigliaro transferred approximately $33.3 million to eight different bank accounts. The pharmacy filed for bankruptcy after receiving hundreds of lawsuits from victims or their families.
Although the Racketeer Influenced and Corrupt Organizations (RICO) Act was originally implemented to target organized crime, prosecutors used RICO to indict 14 individuals connected to NECC with 131 criminal charges. Cadden and Chin are the only pharmacists charged with 25 counts of second-degree murder. Twelve other individuals associated with NECC including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and a spouse have been charged with conspiracy, contempt, mail fraud, racketeering, structuring, and repeatedly violating the Food, Drug, and Cosmetic Act.
“As alleged in the indictment, these employees knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway, with fatal results,” said Attorney General Eric Holder.
“With the indictment and these arrests, the Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in grievous wrongdoing. Actions like the ones alleged in this case display not only a reckless disregard for health and safety regulations, but also an extreme and appalling indifference to human life. American consumers have a right to know that their medications are safe to use, and this case proves that the Department of Justice will always stand resolute to ensure that right, to protect the American people, and to hold wrongdoers accountable to the fullest extent of the law.”
In response to the indictments, IACP’s executive vice president/CEO David Miller stated, “The compounding pharmacy profession takes its work very seriously and always puts patients and their needs first. With the passage of new federal and state legislation, the profession operates in a highly regulated environment and compounding pharmacists adhere to, and even exceed, these regulations every day.”
But according to pharmacy technicians that prefer to remain anonymous, many compounding pharmacies throughout the country conduct business in the same manner. The technicians often mix ingredients in contaminated clean rooms using unsterilized equipment. Ignoring safety regulations, many compounding pharmacists use expired medications and rely on mostly unsupervised pharmacy technicians working unpaid internships. Disinfection logs are often falsified, and pharmacy technicians only wear protective gear during audits or inspections. One source observed an uncertified pharmacy technician wearing open toe shoes and eating her lunch in a clean room where drugs are compounded for AIDS and cancer patients.