“NECC’s drugs were sent out to 3,000 hospitals and clinics. These meds were injected into 14,000 patients.” (An NECC drug salesman told ’60 Minutes’)
Key players at New England Compounding Center:
- Barry Cadden, Company President, Doctor of Pharmacy
- Glenn A Chin, Head Pharmacist, Doctor of Pharmacy
- Lisa Cadden Conigliaro, co-founder, Doctor of Pharmacy
- Douglas Conigliaro, MD
- Carla Conigliaro, Registered Nurse
- Gregory Conigliaro, businessman
Want to know a terrific way to sell drugs? Well, if you happen to be in the legal drug biz – hanging out at medical “trade shows” will certainly do the trick. Countless thousands of these gaudy gatherings pop up each year at hotels nationwide. In our own enclave of Palm Springs the resorts clamor over each other for the chance to host these so-called healthcare seminars. Makes ’em feel warm and fuzzy and, well, the sound of the cash registers ringing in the bars is music to the ears.
Our topic today is one particular trade show – one that happened on September 24, 2010, at the Embassy Suites in Franklin, Tennessee. That was the day a particular nurse – Debra Schamberg – took a business card from a particular drug sales fellow – John Notarianni. And that simple handoff of a piece of paper set into motion a domino effect that would torture and kill an appalling number of citizens. The end result was a silent homicide spree spanning states from Tennessee to North Carolina, Michigan and beyond.
The show itself was the Freestanding Ambulatory Surgery Center Association’s annual meeting. Among the countless characters wandering the lobby was Notarianni, a drug rep for a company called the New England Compounding Center. When he bumped into Debra Schamberg, the clinical director of St. Thomas Outpatient Neurosurgery Center in Nashville, he did what competent sales people do: he pitched his company. And because nurse Schamberg’s clinic injected thousands of patients with steroids for back and neck pain, she was immediately interested in Notarianni’s spiel that they had a better product.
Unfortunately, Notarianni’s company was not an honest and ethical drug supplier. Not even close. This seemingly professional outfit in a Massachusetts neighborhood was raking in millions by ignoring the law; faking records and cutting corners. Totally unaware, nurse Schamberg was performing the same scary ritual with a poisonous reptile (not the salesman this time. The Company) that so many other medical professionals do. She had no way of knowing that NECC was in the process of perpetrating one of the more murderous corporate crimes in American history. They were churning out contaminated drug mixtures that would infect many, many people with fungal meningitis. All they needed was a few more, you know, distributors.
(It is important to note that neither John Notarianni nor Debra Schamberg are suspects in any crime whatsoever. Federal investigators believe they are simply unwitting pawns in a rotten, multimillion-dollar drug scam by others)
So when the St. Thomas Outpatient Neurosurgery Center – at the urging of nurse Schamberg – began ordering the injectable drug methylprednisolone acetate for pain management a few months later, the staff at the clinic had no reason to believe that NECC was breaking any laws. “Compounding” companies are not allowed to market drugs in large volumes to anybody; they are merely licensed to fill small, individual prescriptions. NECC was in fact performing drug “manufacturing” while being only casually overseen by regulators as a “pharmacy.” A medical clinic would only know this if they did 30 minutes of internet research on their drug suppliers. Not likely.
So NECC started shipping large volumes of drugs to clinics with no patient prescription documented – a critical requirement that “pharmacies” must do. Knowing they could step into deep governmental doo-doo over this, they advised their client clinics and hospitals to “attach names” to every order. That way, if the snoopy feds decided to audit them at all, every dose would be linked to a patient and appear legit. Pretty cool.
Investigators would eventually find this curious entry, as they dug deeper into the case. The president at NECC was Barry Cadden. And as far back as September, 2010, he sent the following email to his national sales manager, Robert A.Ronzio:
“We must connect patients to the dosage forms at some point in the process to prove that we are not a [manufacturer],” Cadden wrote. “They can follow up each month with a roster of actual patients and we can back-fill.”
Uh, couple of challenges here, Barry. Detailing patient names from clinics after drugs are injected takes more time than the clinic staff happen to have.
And then there’s that pesky little matter of it being totally illegal.
So evading the dumb prescription requirement got a little goofy among medical professionals nationwide. The parties involved partied on, creating make-believe patient names on the order documents to fake out the auditors. “Hugh Jass” was a favorite. So was “Calvin Klein.” “Big-Baby Jesus” was noted as a patient in Texas. We kind of like it when college-educated health care experts fake medical charts with names like “Coco Puff,” “Squeaky Wheel” and “Filet O’Fish.” Getting rich on other people’s pain is far too serious. Show a little humor, for Godsakes.
While all that fun was going on at trusted medical facilities, back in Massachusetts NECCs head pharmacist, Glenn Adam Chin, age 46, was having a merry time, cooking up some daffy drug mixtures in what drug cartels like to call the “clean room.” Chin was prepping a three-gallon batch of the injectable steroid methylprednisolone acetate, labeled lot number 05212012@68. U.S. sterilization protocol mandated that drug compounds be exposed to high-pressure steam in an autoclave for at least 20 minutes. But cheater-Chin was no dummy: he knew that if he only steamed the drugs for15 minutes, his cartel could churn out 20 more batches a week. More drug sales means more money. Putting patients’ lives at risk was the last thing on his mind.
Now Chin was indeed a highly educated pharmacist. He was well aware that shorting the steaming time was dangerous. Their own air sampling tests had been finding contamination in the “clean room” for months. Ho-hum. While many of America’s clinics were faking patient names, their drug supplier was faking sterile drug reports. Cutting corners in healthcare is nothing if not consistent.
So over a two-month timespan in the summer of 2012, 6,500 vials of injectable steroids were sent out to America’s clinics from Chin’s nifty lab, 500 of which went to St. Thomas Outpatient Neurosurgery Center. Some of those little vials carried a lethal fungus.
One month later Thomas Rybinski, a 56-year-old mechanic, walked into Nashville’s St. Thomas Outpatient Neurosurgery Center. He had chronic low back pain and needed a steroid injection. So a doctor did what he’d done a thousand times: he pushed a needle with a syringe into a small bottle of liquid steroid and then delicately inserted the needle into Rybinski’s back, near his vertebrae. As the doctor slowly pressed down on the plunger, he had no way of knowing that he had just guaranteed the death of his patient, by injecting a microscopic fungus that had been floating unseen inside the bottle.
On September 17, 2012 a patient named Eddie Lovelace died. Unknown to his doctors, he had been killed by fungal meningitis. He would become known as Homicide Victim #1 in the federal case against NECC.
By late September, Tennessee health officials were working with the Centers for Disease Control and Prevention. They now knew of eight patients with meningitis – all had steroid shots at the same clinic. Massachusetts state investigators raided NECC and were stunned by what they discovered: the “laboratory” was filthy. They confiscated every vial of medication and shut down the operation. They would not learn of all the falsified documentation until much later.
Too late: the deadly outbreak was not merely in Tennessee. The North Carolina State Health Department reported that a person at High Point Regional Hospital had the same strain of meningitis too. Their patient, Elwina Shaw, had received a steroid injection a few weeks before at the High Point Surgery Center, another NECC client. And back in Nashville, Thomas Rybinski, the auto mechanic whose case happened first, just died at Vanderbilt Hospital. Godwin Mitchell in Ocala Florida died too.
By September of last year, NECC’s sneaky administrators and pharmacists already knew they were in deep trouble. Company president Cadden was arrested in his living room early one morning. Glenn Chin, the head pharmacist, was placed in handcuffs at Logan Airport in Boston as he tried to flee to China. And in the week before last Christmas, federal investigators arrested a dozen more NECC staff members, including department managers and several owners. Why? Well, it’s like this:
The recklessness of NECC moneymaking scheme had sickened and killed 900 patients in 20 states – 265 patients and 19 dead in Michigan alone. 154 patients in Tennessee with 16 people dead. And now, more than 300 lawsuits are pending against hospitals, clinics, NECC and their staff.
So a monster federal drug scam case is pending; a drug company president and a chief pharmacist are charged with 25 counts of Murder; and Doctor Michelle C. Thomas, a University of Rhode Island pharmacy professor, finds herself in the mix, too.