Forty-eight people have died, 720 are being treated for persistent fungal infections.
It’s the result of one of the worst pharmaceutical disasters in decades.
The company — New England Compounding Center (NECC).
In the fall of 2012, NECC shipped 17,000 vials of a steroid to clinics and hospitals in 23 states.
The drug had to be sterile because patients would have it injected into their joints or their spines to relieve chronic pain.
But the steroid was contaminated with fungus.
And last night, NECC and it’s owner — the family of Barry Cadden — were caught in the crosshairs of the CBS News Program 60 Minutes.
The steroid, methylprednisolone acetate, made by New England Compounding Center, known as NECC, came from an industrial park near Boston which houses the pharmacy and an outfit that recycles construction debris — both owned by the family of Cadden, a pharmacist, and president of NECC.
Cadden’s New England Compounding Center was a compounding pharmacy.
By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market.
States license compounding pharmacies to make drugs for individuals, 60 Minutes correspondent Scott Pelley explained.
“For example, a doctor might order a liquid form of a medication for a patient who can’t swallow a pill,” Pelley said. “Compounding pharmacies are bound by one rule: they must have a prescription for each individual patient.”
But NECC was shipping tens of thousands of vials from its lab called Clean Room One.
Last night, a NECC whistleblower went public on 60 Minutes.
His name — Joe Connolly.
Connolly worked at the company’s so called “Clean Room One” starting in 2009.
“The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened,” Connolly said.
Connolly remembers, in 2011, a salesman came by with a boast and a warning.
“He was walking through and says — Oh, I got– I got a bunch of stuff coming for you guys. You guys are gonna be busy. You’re gonna– I’m gonna keep you guys movin’. And that just meant compound it, process it, get it out the door.”
Connolly says, over months, the lab was overwhelmed with orders.
Output of drugs that he made increased by a factor of 1,000.
“We became a manufacturer overnight,” Connolly told 60 Minutes. “So we were basically trying to have the best of both worlds. It was trying to manufacture without the oversight of a manufacturer. And it was just, we all got overtaxed and everything.”
“Which made it harder, he says, to follow the strict procedures that kept drug preparation sterile.”
“They would occasionally find mold in the clean room?” Pelley asked Connolly.
“Occasionally, yes,” Connolly said. “I would say maybe a dozen times in three years we would find it.”
Connolly says a month before the first steroid death, he warned his supervisor.
“Something’s going to happen. Something’s going to get missed. And we’re going to get shut down.”
Scott Pelley: What did you mean by that?
Joe Connolly: We were going to hurt a patient. We were just thinking– hurt a patient. We weren’t compounding anymore, we were manufacturing.
Scott Pelley: When you went to your supervisor and told him that, he said what?
Joe Connolly: That’s verbatim. He shrugged. That was his response for a lot of our questions or comments or concerns, was a shrug.
Scott Pelley: Meaning?
Joe Connolly: Just do it. He’d– either he didn’t care, or he was powerless to change it.
In 1998, Congress exempted the compounding industry from Food and Drug Administration (FDA) oversight. The exemption law passed over strong objections from then FDA Commissioner David Kessler.
Kessler told Pelley that he warned Congress at the time that “if you’re not going to have oversight, one day people are going to die.”
“This should not happen in 2013,” Kessler told Pelley “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.”
There is now an open criminal investigation into the NECC deaths and injuries.
And Connolly last night added fuel to the fire.
On September 26th, after patients started dying, state officials came to inspect NECC.
Pelley asked Connolly — “What happened that day?”
Joe Connolly: We were told that we’re being inspected, so, “Everybody stop what you’re doing, start cleaning.”
Scott Pelley: So you started cleaning the clean room?
Joe Connolly: Yeah.
Scott Pelley: Now, at this point, there is a federal investigation underway.
Joe Connolly: I did– we didn’t know that.
Scott Pelley: You didn’t know that, but the company knew that.
Joe Connolly: I would assume, yeah.
Scott Pelley: A prosecutor investigating this case might consider that to be obstruction of justice.
Joe Connolly: I would very much agree.
Scott Pelley: The evidence was getting cleaned up.
Joe Connolly: It seemed like it.
Pelley reported that despite the cleanup, the FDA tested 50 left over vials of methylprednisolone and all were contaminated.
They noted the intake for NECC’s ventilation was 100 feet from the recycling plant, Pelley said.
Barry Cadden is being represented by Bruce Singal, a criminal defense attorney with the firm Donoghue Barrett & Singal in Boston.
Singal released a statement on behalf of Singal.
“No statement on behalf of my client Barry Cadden can possibly provide comfort to the bereaved families of 48 people who lost their lives, and the hundreds of others injured, after being injected with a drug that was compounded at NECC,” Singal said.
“No such statement can adequately convey the profound sense of grief and sadness Barry will carry with him for the rest of his life over these tragic events.”
“But the search for answers must be as fair as it is thorough. What we know at this point is what the CDC (Center for Disease Control and Prevention) has reported. Certain vials of this drug produced at NECC in June and/or August of 2012 became contaminated with fungus.”
“We do not know how the drugs got contaminated. We do not know where the contamination occurred. We do not know why it occurred. And we do not know who – if anyone – engaged in any wrongful conduct causing this contamination.”
“We do know that in May 2011, the Massachusetts Board of Pharmacy conducted a full on-site inspection of NECC. After doing so, the Board found no deficiencies in NECC’s compounding practices or physical plant or equipment, and concluded that the inspection was ‘satisfactory.’”
“It is clear that something terrible happened in June and/or August of 2012 that caused the fungal contamination of certain vials of this drug. But we still do not know how or why this occurred. Until we can answer this question, it is premature and unfair to accuse anybody of causing this contamination.”