A former lab technician for the Massachusetts pharmacy tied to the meningitis outbreak that has killed 48 people told 60 Minutes host Scott Pelley that the company ignored safety guidelines as business increased while it skirted federal and state guidelines.
“The underlying factor is that the company got greedy and overextended,” former NCCC lab technician Joe Connolly said in an interview aired on Sunday. “And, we got sloppy. Something happened.”
CBS News reported on March 7 that NECC shipped 17,000 vials of a contaminated steroid to clinics in 23 states last year. The Centers for Disease Control said 707 patients have been infected in the outbreak.
Connolly said the rush of orders made the company operate like a manufacturer, without the benefit of oversight, but that his supervisor literally shrugged when he made his concerns known.
“That’s verbatim. He shrugged,” Connolly said. “That was his response for a lot of our questions or comments or concerns, was a shrug.”
The prescription requirement allowed NECC and other compounding pharmacies to avoid being regulated by the Food and Drug Administration (FDA), an exemption granted by Congress in 1998, despite the objections of then-FDA Commissioner David Kessler. State agencies were entrusted with making sure pharmacies adhered to the one-prescription-per-vial requirement.
“This should not happen in 2013,” he said of the recent outbreak. “Maybe at the turn of the previous century, where we didn’t have institutions like the FDA. There is no reason why people had to die.”
An NECC salesman said clinics resorted to providing obviously fake names when ordering from the company.
“Bart Simpson, Homer Simpson, that we — those ones did raise red flags, and we told to call our client back and say, ‘Hey, give us different names,'” said the salesman for New England Compounding Center (NECC), who refused to identify himself, in an interview that aired Sunday. “The follow-up names would be like a John Doe, Jane Doe, Bill Doe, you know, Jane Smith, Bill Smith, et cetera.”
The NECC salesman, who spoke on camera under a disguise to protect his identity, said the fake names were allegedly a way for the pharmacy to skirt a requirement to provide a prescription for each vial being made, and for clients to save money.
“If you’re in your position, if you’re a buyer, and your job is to save money, and you’re gonna get a brand name for $40, and we’re gonna offer you a $20 vial for the same drug, same size, same everything — what are you gonna do?” the salesman said. “You’re gonna go and get two for the price of one, and using us.”
The company also allegedly escaped sanctions by entering into a consent agreement with the state Board of Registration in Pharmacy. It was revealed in November 2012 that the company’s president and co-owner, Greg Coniglario, hosted a fundraiser for then-Rep. Scott Brown (R-MA). Brown was one of 10 senators who signed a letter asking for less restrictions for the compounding industry.
Margaret Hamburg, the current FDA commissioner, said the meningitis outbreak shows the need for Congress to once again grant her organization monitoring power over pharmacies like NECC.
“We need clear, strong, consistent federal standards that will be applied across the board [in] all 50 states,” she said. “We need to be able to go in and inspect these facilities and get all of the information that we need.”
Watch 60 Minutes’ report on NECC skirting federal oversight, aired Sunday, below.