The CBS Evening News has been airing clips from the “60 Minutes” probe into specialty pharmacies, including the New England Compounding Center, which was linked to the meningitis outbreak last fall. Below is a compilation of the CBS segments as well as video clips of the interviews on “60 Minutes,” including one of FDA Commissioner Dr. Margaret Hamburg discussing the need for stronger compounding-industry oversight.
Lab tech, salesperson discuss compounding practices at NECC. The CBS Evening News reported, “A ’60 Minutes’ investigation has discovered how a pharmacy not supervised by the FDA came to ship toxic drugs across the country to unsuspecting patients,” hundreds of whom became ill with bacterial meningitis, with many not surviving the ordeal. “The drug was produced by the New England Compounding Center. … Joe Connolly, a lab technician there, is the first to speak out about what happened.” Connolly was shown saying, “The company got greedy and over-extended, and we got sloppy.” Pelley noted: “Congress exempted” compounding pharmacies “from FDA oversight because by law, they’re allowed to make custom drugs just one patient at a time. But Connolly says…quantities of drugs increased by a factor of 1,000.” Connolly: “We became a manufacturer overnight.” Pelley added: “The state of Massachusetts examined NECC’s lab in 2011 and found it satisfactory, but tomorrow on this broadcast, another company insider will tell us how NECC concealed its true operations from inspectors.”
The CBS Evening News added, “As part of a ’60 Minutes’ investigation, another company insider explains” how the New England Compounding Center “mass produced drugs.” Pelley noted: “NECC was exempt from FDA oversight because it was a so-called compounding pharmacy, limited by law to making specialty drugs…one prescription at a time.” But this former NECC salesperson “told us the company sent drugs nationwide to 3,000 hospitals and clinics.” An unidentified speaker explained: “If you’re a buyer and your job is to save money and you’re going to get a brand name for $40 and we offer you a $20 vial for the same drug, same size, same everything, what are you going to do? … So, most of them knew” that it wasn’t above board. Pelley added: “The salesman asked us to disguise him and not reveal his name because a connection with NECC would ruin his career.”
Probe highlights compounders’ disregard for state, Federal laws. The CBS Evening News reported, “Last night on ’60 Minutes’ we went inside the drug maker New England Compounding Center. … Tonight, Jim Axelrod continues our investigation.” CBS (Axelrod) added, “When the FDA raided the New England Compounding Center last October, inspectors found major violations including visible specks of black fungus in drug vials.” International Academy of Compounding Pharmacists CEO David Miller was shown saying, “That is indeed unusual in the profession of pharmacy to see such blatant disregard for human life and for the professional standards that we hold dear.” Axelrod continued, “In January, Massachusetts finished conducting 40 unannounced inspections of different sterile compounding pharmacies, only four passed and all or part of 11 of those pharmacies were shut down.” Sarah Sellers, a former FDA safety officer was shown saying, “This is an industry that absolutely escapes and avoids regulation at both the state and Federal levels.” Axelrod agreed, citing as an example, “The case of Paul Franck’s pharmacy” which was reprimanded with a fine in 2009, after “21 horses died” then, just “three years later, 27 human patients contracted a fungal eye infection from the same pharmacy. Franck voluntarily closed the pharmacy last July, but three days later he registered a new compounding pharmacy. Currently, in state records there is no mention of his past problems.”
CBS News on its website adds, “Eight years ago, Paul Franck was honored by the IACP and cited for upholding the highest standards of ethics in the profession. Asked what Franck’s being named an IACP fellow says about the safety of the industry, Miller says, ‘An individual pharmacist, the best pharmacist, a fellow, someone recognized for their outstanding contributions to science, research, advancement of a profession, can make mistakes.'” Meanwhile, when “we contacted the Florida Department of Health about Paul Franck, they told us his past disciplinary cases are on file, but you can only find them if you search by his name. Searching his new company shows no prior problems.”
The CBS Evening News reported, “Last night on ’60 Minutes’ we went inside the drug maker New England Compounding Center. … Today, we asked the Commissioner of the FDA, Margaret Hamburg if a patient goes into a clinic and the doctor or the nurse pulls out a vial of something,” does that patient have a “way to know whether that drug has been approved by the FDA?” Dr. Hamburg was shown saying, “Well, I think that’s right under the current system and what I think emerged in the meningitis outbreak was that many patients and their healthcare providers didn’t realize that they, in fact, were using a compounded product.” Pelley asked, “As Commissioner of the FDA, then, you can’t tell us sitting here now that every drug being used in the United States is safe and effective?” Hamburg: “No, I – I really cannot.” Pelley continued, “Compounding pharmacies are supposed to make drugs for individuals by prescription, but NECC shipped 17,000 vials of toxic steroid to 17 states. Dr. Hamburg is now asking Congress to return oversight of the compounding industry to the FDA.”
Group pushes back on call for stronger compounder regs. The Hill “RegWatch” blog reports that a “trade group for pharmacies is pushing back on calls for more federal regulations after a ’60 Minutes’ report on a deadly fungal meningitis outbreak. The National Community Pharmacists Association (NCPA) on Monday said there are already ‘adequate’ regulations in place to protect consumers who visit small-batch pharmacies that mix custom prescriptions.” The Hill notes that FDA Commissioner Dr. Margaret Hamburg “told ’60 Minutes'” that a “lack of federal oversight will ultimately result in more deaths in the future.” In contrast, the “‘FDA and the Massachusetts Board of Pharmacy had adequate authority to take action against NECC. They could have acted to mitigate or potentially even prevent patient suffering,’ said NCPA Chief Executive B. Douglas Hoey.”
From the American Association for Justice news release.