CBS News program 60 Minutes broadcast a stunning segment Sunday night, exposing dangerous manufacturing practices and fraud inside the compounding pharmacy blamed for a deadly multi-state fungal meningitis outbreak. Whistleblowers inside the company reported unsafe practices in the laboratory where a contaminated steroid compound was made, and falsified prescriptions submitted by medical clinics to obtain the serum.
The New England Compounding Center (NECC), based in Massachusetts, distributed more than 18,000 steroid shots to 23 states between the end of May and the end of September 2012. The steroid, methylprednisolone acetate, was injected into patients to treat back, neck and joint pain. It is believed 14,000 people received shots contaminated with mold, and later developed fungal meningitis as a result.
To date, 48 people have died as a result of fungal meningitis and at least 720 people are suffering from related illnesses including meningitis, spinal infections, strokes and peripheral joint infections. More reports of infections linked to the contaminated shots continue to come into the Centers for Disease Control and Prevention (CDC). 60 Minutes reporter Scott Pelley calls this “the worst pharmaceutical disaster in decades.”
Pelley spoke with Paul Connolly, who worked as a technician at NECC. He said the pharmacy began ramping up production of the steroid as sales skyrocketed. What was supposed to be a “mom and pop” operation producing limited numbers of the injection for individual patients suddenly became a mass production operation, he told Pelley.
Beginning around 2011, Connolly said his production increased by about 1,000 percent, and the lab was overwhelmed. He said he warned his supervisors about one month prior to the first death that operating conditions were dangerous and he was afraid there would be repercussions.
He said he told his supervisor, “Something’s going to happen, something’s going to get missed, and we’re going to get shut down.” When Pelley asks what he meant by that, a visibly shaken Connolly replies, “We were going to hurt a patient. We were just thinking hurt a patient.” Connolly says his supervisor simply shrugged in response.
By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market. In 1998, compounding pharmacies were exempted from U.S. Food and Drug Administration (FDA) oversight by Congress. Compounding pharmacies use drug ingredients that are approved by the FDA to custom-mix drugs for patients based on doctors’ prescriptions, but the drug cocktails these pharmacies manufacture are overseen by state pharmacy boards.
“If you’re not going to have oversight, one day people are going to die,” former FDA Commissioner Dr. David Kessler told 60 Minutes. He objected to the removal of compounding pharmacies from FDA regulation at the time of the decision. “There is no reason why people had to die.”
The compounding pharmacy industry is now a $2 billion industry in the United States.
A whistleblower who requested to remain anonymous also spoke with 60 Minutes. He worked as a sales representative for NECC. He told reporter Pelley that as sales began to skyrocket, clinics were “in on the fraud at the heart of the company’s growth.” They started to provide individual prescriptions with what seemed to be obviously false names attached to them. He said he received prescriptions made out to “Jane Doe, John Doe,” and even cartoon characters like Homer Simpson. He says the clinics that were NECC clients provided these false names in order to order more of the solution at cheaper prices as opposed to other brand name products.
As reports of injuries and deaths linked to the contaminated steroid injection began to surface, NECC recalled all its products. In September 2012, NECC was inspected by the FDA and 50 remaining vials of the compounded steroid injection were tested. All were found to be contaminated with the mold fungus. NECC has since closed its operations and declared bankruptcy.
NECC founder Barry Cadden was called to testify before Congress during the investigation of the clinic, but refused to testify, invoking the Fifth Amendment. He and others associated with NECC are now the subjects of a criminal investigation. Cadden continues to insist he does not know how the drug may have been contaminated.
Because of the 1998 law deregulating compounding pharmacies, the FDA currently has no record of how many compounding pharmacies are in operation, or what products they are making. Dr. Margaret Hamburg, current FDA commissioner, told 60 Minutes the FDA as a result cannot guarantee the safety of drugs in the United States. Often, neither patients nor physicians realize a drug came from a compounding pharmacy not regulated by the FDA.
Dr. Hamburg says she would like to see compounding pharmacies return to FDA supervision. She tells 60 Minutes, “I’m sad to say if we do not put into place the comprehensive legislation that really defines roles and responsibilities we will have other similar problems.”