Wednesday, January 11, 2017

Outdated Drugs Displayed in Compounding Case

By Walter F. Roche Jr.

Expired drugs, some nearly a decade old, seized from a drug compounding firm, were entered into the record today in the second degree murder case against Barry Cadden, the former head and part owner of the New England Compounding Center.
U.S. Food and Drug Administration Special Agent Frank Lombardo identified the drugs which he said had been seized from NECC's Framingham, Mass. headquarters in 2012. Most of them were found in so-called clean rooms where sterile drugs are supposed to be compounded.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Lombardo also identified a series of files also seized from NECC  in which fake names had been entered as the patients receiving the drugs. The lists came from orders placed by health providers in Texas and Nebraska.
The names included Burt Backarek, Miles Davis, Donald Trump, Wayne Gretzky, Ja Ja Gabor and Tom Brady.
Emails entered into evidence included one from Barry Cadden in which he warned staffers not to use obviously fake names.
"All names must resemble real names," Cadden wrote, adding, not obviously fake names like Mickey Mouse.
In another email Cadden reported that the company "had run into some issues with hospitals" in Colorado.
Records show that the Colorado Pharmacy Board  eventually barred NECC from operating in the state because of its failure to comply with a requirement for patient  specific prescriptions.
The testimony came on the third day of the trial of Cadden, who has been charged with racketeering and 25 counts of second degree murder. The charges stem from a federal probe of the 2012 national fungal meningitis outbreak blamed on fungus riddled steroids shipped from NECC to health providers across the country.
 Lombardo testified that in addition to a raid on NECC's Framingham offices in October of 2012, additional records were obtained under a subpoena in subsequent visits to the facility after NECC closed down.
The FDA agent also testified about records of an NECC employee working as a pharmacy technician, a job requiring a state license.
Connolly, who also has been charged in the case, had voluntarily surrendered his license following charges that he had violated state regulations.
Lombardo produced a letter seized from NECC, showing that Connolly was fired on Oct. 12, 2012, shortly after the raid.
The expired drugs seized from NECC included methotrexate, a cancer drug, that had expired in 2007 and a formaldehyde solution that expired in 2003.
In cross examination, Bruce Singal, Cadden's attorney, questioned Lombardo about who was in charge of the clean rooms and presented a chart showing that co-defendant Glenn Chin oversaw the clean rooms.
"Glenn Chin, he was in charge of the clean room," Singal said.
Lombardo acknowledged that was the case. Singel also noted that the lists of phony patient names had been submitted by NECC's customers and the verification of those orders had been made by other NECC employees, not Cadden.

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