60 Minutes: Lethal Medicine
More than 17,000 vials of drugs were shipped to 23 states in fall 2012. The supposedly sterile drug set off a disaster, killing 48 people and affecting over 700 other patients due to a fungus in the medicine. How did this happen? The answer lies at NECC, the New England Compounding Center, which has been tight-lipped until this 60 Minutes report. Scott Pelley talked to patients and experts about this outbreak.
60 Minutes: Chronic Fungal Infection
Julie Otto is one of more than a dozen patients who spoke to 60 Minutes about their experiences after being injected with a chronic fungal infection. Michigan saw nearly 200 patients at just one hospital being treated because of the tainted medicine.
Patients agreed that treatments for their fungus is “unbearable." This is a type of mold that is breaking down bones and nerves, sometimes leading to meningitis. So far, no infected patient 60 Minutes spoke with had been told their fungus is cured or eradicated.
60 Minutes: New England Compounding Center
The drug in question, Methylprednisolone Acetate, came from the New England Compounding Center, a pharmacy owned by the family of Barry Cadden, which also operates a construction recycling facility in the area.
Compounding pharmacies are barred by law from producing drugs for mass market use. However, states have found a way around that, supposedly by contracting with compounding facilities to produce drugs for individual use. An example would be a liquid form of a pill for a patient who cannot swallow easily.
60 Minutes: FDA Vs NECC
Because of the nature and scope of their work, compounding pharmacies are not under the oversight of the Food and Drug Administration, and they are required to have a prescription for every patient when they produce a drug.
The NECC location was shipping thousands and thousands of vials. In an interview, NECC tech Joe Connolly spoke candidly about what went on at the facility that has led to such a dire outcome for so many patients.
60 Minutes: NECC Prescriptions
Connolly, who started at NECC in 2009, said a pharmaceutical salesman came by in 2011, announcing that he had a lot of prescriptions to bring into the facility. In fact, Connolly said his output increased by “a factor of 1000."
He admitted that they were producing manufacturer-level quantities, without the oversight that is required to produce such mass quantities. He also said that mold had been discovered at least a dozen times in a few years in the room where these drugs were produced.
60 Minutes: NECC Manufacturing Vs Compounding
Joe said that he warned a supervisor about the risks that could be involved. “We weren’t compounding anymore. We were manufacturing," Connolly said. The supervisor shrugged at his concerns.
“Either he didn’t care, or he was powerless to change it," the tech told Scott Pelley.
60 Minutes: Compounding Pharmacies Supervision
In 1998, Congress gave compounding facilities an exemption from FDA oversight. The idea was that drugs being produced individually should not need the same level of supervision as mass production facilities.
The FDA commissioner at the time, David Kessler, fought the exemption at the time, and talked to 60 Minutes about the outcome of that decision. “This should not happen in 2013," he said. “There is no reason why people had to die."
60 Minutes: FDA Vs Compounding
Compounding facilities are a $2 billion industry, but responsibilities for regulation now fall on the states. Dr Margaret Hamburg, the current FDA commissioner, said she does not even know how many compounders are at work.
Dr Hamurg said that compounded prescriptions are not FDA-approved. Patients should be on alert for drugs that are produced in vials.
60 Minutes: Meningitis Outbreak
She also said that this meningitis outbreak woke a lot of doctors and patients up to the unknown factors involved in production of compounded prescriptions.
Massachusetts state records showed that NECC passed a 2011 state inspection. But they did not have any record of how many people the facility was serving.
60 Minutes: Compounding Pharmacy Sales
An NECC salesman who talked with 60 Minutes, but left a year before the meningitis case, said that he helped the company contract with 3000 patients and healthcare clients in various states.
According to this anonymous salesman, clients were complicit in fraudulent production of names and prescriptions. In many cases, the salesman said, prescriptions were ordered under false names.
60 Minutes: NECC Sales Practices
He said that drug buyers knew they could save money by skirting the rules, and were happy to further the scam because it got them great discounts on compounded prescriptions.
Some more scrupulous providers refused to be in business with NECC because of their questionable practices. The salesman said that he was supposed to just move on to the next client.
60 Minutes: NECC Methylprednisolone
The company president, Barry Cadden, would instruct the sales team to stay out of the office during state inspections to avoid further scrutiny.
Methylprednisolone sold to clients in a Michigan pain clinic, where some of the first deaths were reported. So far, 48 patients have died as a result of the fungus, which travels to the brain.
60 Minutes: Walking Zombies
Survivors said that strokes or brain damage came on suddenly in the initial cases, before hospital staff knew what they were seeing or should be looking for in these patients.
One man who lost his wife said that he was also treated at the same facility, and is now infected with the fungus himself. “The staff called us the walking zombies," he said of the drug’s effects on memory and concentration.
60 Minutes: 2012 NECC Inspection
The facility was inspected on September 26 2012, and employees like Joe Connolly were told to clean up as inspectors entered the building. They may not have known what was going on, but their supervisors likely did.
However, the FDA tested and found contamination in 50 vials of the drug in question. The company’s intake ventilation was very close to the nearby recycling plant. Barry Cadden had to answer a Congressional subpoena by invoking his Fifth Amendment rights.
60 Minutes: FDA Compounding Pharmacies
Patients are continuing to struggle with their infections, often making frequent hospital stays. The current FDA commissioner told 60 Minutes that there need to be uniform standards for compounding facilities under the purview of the FDA.
“I’m sad to say that if we do not put in place the comprehensive legislation that really defines roles and responsibilities, we will have other similar problems," Hamburg said.
60 Minutes: NECC Bankruptcy
Cadden declined the show’s interview request and is among company officials who are subject to criminal investigation. NECC has filed for bankruptcy, and court records show that executives took $16 million out of the company, even after patients were starting to die due to the contamination.
Can you imagine this happening to you or a loved one when you think you are getting needed medical care? What do you think is the solution to preventing future cases like this?