114. The Fungus (New England Compounding Center)

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This episode of Swindled may contain graphic descriptions or audio recordings of disturbing events which may not be suitable for all audiences.

Listener discretion is advised.

In today's world, many hospital pharmacies are struggling with budget cuts that include personnel, and this makes it very difficult to staff your pharmacy to its full full potential.

Pharmacon Pharmaceuticals offers support by providing unique ready-to-use medications.

This will allow your hospital pharmacy staff to focus on what's important, patient care.

Put patient care first.

Give Pharmacon a call to see how we can improve efficiencies and reduce your hospital pharmacy costs.

Unlike retail pharmacies, which typically dispense one-size-fits-all mass-produced medications, a compounding pharmacy is a specialized pharmacy that that customizes drugs for a patient's individual needs.

For example, if a certain ointment contains a non-essential ingredient to which a patient is allergic, a compounding pharmacy can reformulate that ointment without the allergen.

Or say a child needs a less potent version of a certain medication and has difficulty swallowing pills, a compounding pharmacy can not only tailor the dosage, but also create a liquid form that's otherwise non-commercially available.

In these ways and others, compounding pharmacies provide a critical, almost traditional, service of personalized pharmaceutical care, or at least that was the original intent.

These days, compounding pharmacies often fill gaps during drug shortages or offer quick turnarounds on medications with short shelf lives that hospitals require but cannot produce in-house due to a lack of expensive sterile facilities.

So, the compounding is usually outsourced to a compounding pharmacy, such as Pharmacon Pharmaceuticals.

Pharmacon launched in 2008 in Noblesville, Indiana, with the mission to improve efficiencies and reduce costs for its public, private, and military clients across the United States.

Pharmacon's real-time manufacturing would help manage drug inventories and decrease pharmaceutical waste.

Outsourcing the compounding would also alleviate the hospital's burden of keeping up to date on ever-evolving regulations.

Healthcare facilities could also rely on Pharmacon's modern technology to process and deliver an order within 72 hours.

And of course, safety was Pharmacon's highest priority.

The company's rigorous quality assurance program ensured that each product was tested multiple times in its own quality control lab to confirm its sterility, potency, and stability, most of the time, at least.

Pharmacon

in March 2014, a hospital worker in a neonatal intensive care unit at an Indianapolis hospital noticed that the syringes of midazolam they had purchased from Pharmacon were twice as strong as what the hospital had ordered.

Midazolam is a powerful sedative, often used for anesthesia before surgeries.

It's also the drug of choice for lethal injections in some states, obviously not something for which you want to get sloppy with the labeling.

But Pharmacon had, and as a result, the overly potent midazolam was injected into 13 infants at that Indianapolis hospital before the mistake was discovered.

13 infants that were already on respirators.

Miraculously, all 13 survived.

But this was unacceptable.

The hospital alerted the Food and Drug Administration about the incident, and soon, inspectors from the agency were knocking on Pharmacon's door.

Caprice Bearden, Pharmacon's director of compliance, was surprised to learn that the company had shipped midazolam twice as potent as as its label suggested.

Bearden told FDA investigators that none of the company's recent test results for the drug were out of specification.

Paul J.

Elmer, Pharmacon's owner and chief executive, concurred.

He told the FDA that any concerning results would have been flagged for his review.

After the investigation, Pharmacon voluntarily recalled the drug and received a warning letter from the agency, citing, quote, serious deficiencies with its sterile practices at its lab.

Adhering to its own strict quality assurance and sterility measures, Pharmacon is building on its reputation of meeting and frequently exceeding FDA regulatory standards.

Two years later, in February 2016, the FDA received another incident report pertaining to Pharmacon Pharmaceuticals, again from a hospital in Indianapolis.

Three infants were given an ultra-concentrated dose of morphine that was 25 times more potent than its label indicated.

One 12-month-old child immediately went into respiratory arrest and was medevaced to a nearby children's hospital where it took three doses of Narcan to restore breathing.

Upon inspection, CEO Paul Elmer scrambled to mislead the FDA about Pharmacon's latest egregious compounding error.

He was worried that the actual pharmacist at the facility, Marcus Fields, would speak honestly to inspectors about Pharmacon's recurring production issues.

So, Elmer instructed a different pharmacist, Michelle Bieland, to intercept and lie, but their efforts were unsuccessful.

Marcus Fields was interviewed and divulged what he knew.

Michelle Bieland and Caprice Bearden also eventually came clean.

The truth was disturbing.

According to Pharmacon's own internal test results, between 2014 and 2016, there were at least 70 instances of under- or over-potent drugs being distributed to customers.

In most cases, the company shipped the drugs before the test results were even ready.

According to Pharmacon executives and pharmacists, the company's owner, Paul J.

Elmer, assumed that, quote, the healthcare providers had likely already used the drugs, so there was no reason to warn them, the FDA, or anybody else about the problems, because, quote, notification would lead to the loss of customers and therefore, a loss of profit.

That same motivation likely played a role in why Elmer had instructed instructed Caprice Bearden to lie to FDA inspectors back in 2014.

The Food and Drug Administration issued a public safety alert and referred the case to the Department of Justice for a criminal investigation.

A grand jury convened, and on June 20th, 2017, a 10-count indictment was handed down against 64-year-old PharmaCon CEO Paul J.

Elmer.

and 62-year-old compliance director Caprice R.

Bearden.

The indictment included charges of conspiracy to defraud the FDA and introducing adulterated drugs into interstate commerce.

This is U.S.

Attorney Josh Minkler.

As alleged in this indictment, not one time,

not two times, not even three times, but 70 times, the defendants were told that the drugs they were making were weaker or stronger than what the label on the drug said.

Each time, Paul Elmer, a licensed pharmacist and the president of Pharmacom, each time Caprice Bearden, the compliance officer, determined it wasn't worth telling the hospitals, it wasn't worth telling the doctors, it wasn't worth telling the patients who purchased the drugs, and it wasn't worth telling the Food and Drug Administration.

Each time they put profit over the safety of their patients, including newborns in the neonatal care unit.

At his trial, Paul Elmer's defense blamed a, quote, rogue employee for the mishaps at Pharmacon, referring to Caprice Bearden, who had pleaded guilty.

It was her responsibility to take action, Elmer's lawyer told the court.

That was her job.

And had Paul Elmer been made aware, he undoubtedly would have taken action.

The prosecution introduced emails to Paul Elmer.

from that time period that suggested otherwise.

There were multiple instances in which Pharmacon's CEO was alerted to out-of-specification test results.

His response?

There was no response.

After an eight-day trial, on April 11, 2019, Paul J.

Elmer was convicted on nine of 10 counts.

He sobbed at his sentencing hearing.

I'm truly thankful no one was severely injured or died, Elmer told the judge.

I put many at risk.

including patients and employees, and I am sorry.

Paul J.

Elmer was sentenced to 33 months in prison.

Caprice Bearden was sentenced to five months.

The Pharmacon case was just the latest disturbing example of compounding pharmacies gone wild and regulators' inability to prevent a public danger.

Just months before Paul Elmer was indicted, another pharmacist was on trial for similar crimes, but with much more widespread and devastating results.

Dozens of people died, hundreds more sickened.

Why?

Greed, of course.

A contaminated medication leads to the worst public health crisis caused by a pharmaceutical drug in U.S.

history.

On this episode of Swindled.

They bribed government officials to find accounting.

Clear violations of

ethnic groups.

They have tens of millions of dollars.

Now we've got the books and records to highlight.

Support for Swindled comes from Simply Safe.

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The next morning,

of course, he had been up, and when I got up, he was hollering for me in the kitchen.

He had a horrible look on his face.

I'll never forget that expression.

And he said, my legs don't work.

He said, I've been out twice to get my paper, and I've fallen twice.

One morning in September 2012, Joyce Lovelace woke up to her husband to Eddie, yelling from the kitchen.

He told her he had fallen while retrieving the newspaper.

There was terror in his eyes.

Eddie Lovelace was 78 years old, a healthy 78.

He'd walk up to six miles a day sometimes.

Eddie had allergies and kidney stones, but that was as sick as he had ever been until recently.

Now, his mind and body seemed to be failing him every day.

Eddie Lovelace had fallen while leaving work at the courthouse a few days earlier.

He'd been a circuit court judge for numerous Kentucky counties since 1992.

There were a couple of years left in his term, but after that, Eddie planned to hang up the robe.

The Lovelaces had a granddaughter entering the law practice.

Eddie was going to join her and show her the ropes.

But that wouldn't happen.

Eddie Lovelace's health rapidly deteriorated.

On September 11th, 2012, he said his fingers were numb, then his whole fist.

Another granddaughter said she had difficulty understanding what he was trying to say.

Finally, after his latest falls in which he couldn't feel his legs, Eddie Lovelace agreed to go to the emergency room.

He was stumbling.

He was losing his balance.

He fell often.

He began to have headaches, which he never had before.

And I was really concerned by his appearance.

He had the look of someone who might have cancer.

Eddie Lovelace did not have cancer.

In fact, doctors weren't sure what was wrong.

A CT scan revealed nothing.

Eddie was transferred to Vanderbilt Hospital in Nashville, Tennessee, where the medical mystery continued.

They admitted him to Vanderbilt on the 12th.

He immediately,

just within a day or two, started

declining fast.

I mean rapidly.

His speech became slurred.

He lost the use.

He had no grip in his left hand.

He could not move his left foot.

He had no eye-hand coordination.

He could not feed himself.

The best guess was that Eddie Lovelace was suffering from some kind of atypical atypical stroke, but even that made little sense.

The treatments had little effect, and Eddie Lovelace died in the hospital days later.

He passed away on September the 17th, and we went ahead with the funeral services and everything, thinking that he had a stroke because that was their diagnosis.

On the 3rd of October, I believe it was,

we began to hear about the contamination from these injections.

Health alert, the CDC warning about a growing outbreak of meningitis.

At least five people have now died, 35 cases across six states, some patients suffering from stroke, stroke-like symptoms.

The cause, apparently, tainted steroid shots for back pain.

Down the hall from Eddie Lovelace at Vanderbilt Hospital was a 55-year-old father of three named Thomas Rybinski.

Thomas was admitted to the hospital with headaches and neck pain.

I feel like my head is going to explode, he had told his wife.

Doctors treated him for presumed community-acquired bacterial meningitis, even though Thomas Rybinsky would not be qualified as high-risk.

But even that diagnosis seemed misguided.

Thomas wasn't responding to the antibiotics at all.

as his condition worsened.

His face started to droop on one side.

He would stare at the wall.

Thomas, quote, abruptly became unresponsive with rhythmic shaking of the head that was consistent with seizure activity.

The hospital put him on a ventilator.

The scans showed that his brain was bleeding.

Within days he had suffered multiple strokes.

Thomas Rybinsky's family took him off life support 22 days after being admitted, but he had left health professionals a lead.

Doctors found that Thomas's cerebrospinal fluid was contaminated with a fungus, Aspergillus fumigatus, which had impeded the flow of blood to his brain.

Most concerningly, there were an increasing number of patients with similar symptoms in the area, including, in retrospect, Judge Eddie Lovelace, who had already been buried.

What all the patients had in common was that they'd received epidural injections of a steroid called methylprednisolone acetate.

Thomas Rybinski had back pain from working at General Motors for 35 years.

Judge Lovelace had injured his lumbar in a recent car accident.

They both received the same shot from the same clinic, St.

Thomas Outpatient Neurosurgical Center in Nashville.

Did fungi kill Judge Lovelace too?

Joyce Lovelace first heard about the possibility when state and federal officials publicly announced the growing outbreak.

She agreed to have his body exhumed to confirm the diagnosis.

Health officials did indeed find a fungus covering the judge's brainstem, which had caused meningitis and ultimately a stroke.

Even stranger, it wasn't Aspergillus fumigatus which was found in Rybinski.

No, the fungi growing in Eddie Lovelace and all the other patients was something unfamiliar.

This is a very unusual type of meningitis.

Most meningitis is caused by bacteria.

Fungal meningitis is very rare.

Usually, if we see fungal meningitis at all, it's in patients whose immune, whose immune systems are severely compromised, such as patients who are undergoing treatment for cancer.

It's unusual to see fungal meningitis in patients with normal immune systems.

Fungal meningitis causes swelling in the membranes that protect the brain and spinal cord.

It is rare and not contagious, but difficult to detect and just as difficult to treat.

All of a sudden, there was a cluster of fungal meningitis cases in Tennessee related to a steroid shot.

State officials contacted the Centers for Disease Control and Prevention and the Food and Drug Administration.

It was too early to tell how widespread the issue might be.

The CDC sent out a nationwide alert on September 26, 2012, as reports from around the country came flooding in.

Their worst fears came true.

Meanwhile, the nationwide outbreak continues to widen.

47 people in seven states have contracted the rare meningitis from the steroid medication.

Five people have died.

So far, 105 people in nine states have been linked to the meningitis outbreak and there have been eight deaths.

A fungal meningitis outbreak keeps growing.

Over 120 people have been diagnosed and 11 have died.

If you or a loved one were diagnosed with meningitis from a contaminated steroid injection, please call 1-800-BAD DRUG.

We've learned another person has died from the rare meningitis, bringing the death toll to 15.

197 people in 13 states are now sick with fungal meningitis.

By mid-October 2012, almost 200 people in 13 states were diagnosed with fungal meningitis.

15 people had died.

The cases were rising dramatically because the CDC and other health officials were getting better at finding them.

Plus, thousands of people who had received epidural steroid shots in recent months had heard the alert and rushed to their doctors.

Also, by mid-October, Beverly Jones, a state lab worker in Virginia, had identified the mysterious fungus, Axerohylum rostratum, a pathogen commonly found feeding on dead plant tissue.

You probably breathe it in all the time.

Typically harmless, unless it is injected directly into a human's central nervous system.

There, it thrives, apparently, multiplying rapidly in the warm, welcoming environment, eating through blood vessels like the mid-rib of a leaf.

Novel.

Doctors had never seen this before.

Exerohylum rostridum, devouring the human body.

What?

There was nothing about this in any of the literature.

Treating the condition would be difficult and experimental.

There are not many antifungal drugs on the market.

They're expensive, hard to find, and usually accompanied by brutal side effects, kidney damage, liver damage, pancreatic damage, plus hallucinations.

Health officials scrambled to control the outbreak, and determining the cause of the infection would help tremendously with doing so.

But the magnitude and complexity of the public health disaster only deepened as they investigated the source.

Well, 23 people are dead and 308 have been sickened by fungal meningitis believed to have started at the New England Compounding Center.

The New England Compounding Center says there is no other indication that any other products are contaminated, but they issued the recall as a precaution.

The contaminated injectable steroid shots were traced back to a compounding pharmacy in Framingham, Massachusetts called the New England Compounding Center.

NECC had produced three lots of potentially contaminated methoprednisolone that summer, a total of 17,675 vials, which had since been voluntarily recalled, but it was much too late.

Those nearly 18,000 vials had been distributed to 75 different hospitals, health health clinics, and doctor's offices in 23 different states.

And between May 21, 2012 and September 24, 2012, nearly 14,000 people had received an injection from one of those vials.

The CDC began the process of contacting each patient individually.

Meanwhile, in late September, after the source of the outbreak had been identified, A Massachusetts state pharmacy inspector arrived at the New England Compounding Center and was greeted with a strong smell of bleach.

Inside, there were too many red flags to list.

Dirty lab equipment, a leaking boiler, the fact that the supposed sterile environment was located 100 feet away from a busy recycling plant.

After a three-hour tour, Massachusetts inspectors realized they needed help.

They called the FDA, which is proper protocol.

Fun fact, compounding pharmacies, since technically they are not manufacturing drugs, are regulated by state pharmacy boards, not the FDA.

The FDA does not review, approve, or inspect any of the products a compounding pharmacy makes.

The agency can only respond reactively after something like this happens.

More on that later.

The FDA inspectors arrived at NECC on October 1st, 2012.

It was obvious that this place was a full-scale manufacturer.

one that had continued to produce even after the first indications of a problem.

Throughout the week, inspectors noted and sampled every trace of grime and muck they encountered.

They observed dirty floor mats, dirty air vents, discolored sterilization equipment.

They also noted that NECC was using non-sterile ingredients to formulate its supposedly sterile acetate, and that the air conditioning in the clean rooms was shut off every night from 8 p.m.

to 5 a.m., fostering a prime breeding ground for fungi.

Speaking of which, the FDA found unopened vials of the injectable steroid that customers had returned to NECC because of the recall.

Inside of those vials, a quote, greenish-black foreign matter was visible to the naked eye.

The FDA collected those vials for testing and later confirmed the presence of Xerohylum Rostridum.

The Food and Drug Administration tested 50 vials suspected to be a source of contamination in the meningitis outbreak.

They found all 50 were contaminated by bacteria or fungus.

Also, unsurprisingly, many of the environmental samples collected by the FDA tested positive for bacteria or mold.

It was never pinpointed exactly when or how the medication was contaminated, but it's not hard to imagine.

The only surprise was that it hadn't happened sooner.

In response to the FDA and state of Massachusetts investigation, the New England Compounding Center suspended its operations and the Massachusetts Department of Public Health recalled all of NECC's medications.

NECC's larger sister company, Ameridose, also suspended operations and recalled its drugs after an FDA investigation of its facilities found insects and birds inside of a sterile room.

This is Massachusetts Governor Deval Patrick.

Our joint investigation with the FDA continues.

You should also know, if you don't already, that a federal criminal investigation has been launched.

Meanwhile, I want to announce that the Board of Pharmacy has voted permanently to revoke NECC's license to operate in Massachusetts as well as the licenses of the company's three principal pharmacists.

Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again.

By the end of October 2012, there were 363 reported cases of fungal meningitis, including 28 deaths, and the numbers were still growing.

Everyone affected wanted to know why this happened.

How did this happen?

Who is responsible?

Those answers would come soon enough, and it's almost less satisfying than never finding out at all.

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Something's gonna happen, something's gonna get missed, and we're gonna get shut down.

What did you mean by that?

We were gonna hurt a patient.

We were just thinking hurt a patient.

We weren't compounding anymore.

We were manufacturing.

When you went to your supervisor and told him that,

he said what?

That's verbatim.

He shrugged.

That was his response for a lot of our questions or comments or concerns.

It was a shrug.

Meaning, just do it.

Either he didn't care or he was powerless to change it.

The underlying factor is that

the company got greedy and overextended and

we got sloppy and something happened.

Gregory Canigliero made his first fortune in the early 90s by starting a recycling business with nothing more than credit cards and a U-Haul.

Conigliero Industries operated out of an old industrial building and a business center on Waverly Street in Framingham, Massachusetts.

By the end of the decade, Greg Conigliero would own every building in that complex and occupy them all with a different business that he owned.

And there was always room for more.

Greg Canigliero's sister, Lisa, had become a licensed pharmacist in 1990 after graduating from the University of Rhode Island.

Lisa had married an old classmate and son of a pharmacist named Barry Cadden, who had followed in his father's footsteps.

Barry was working as a retail pharmacist at Walgreens in 1996.

when he and his brother-in-law Greg came up with the idea for the New England Compounding Center.

Compounding pharmacies were growing in popularity.

Greg Canigliero would manage the business.

Barry and Lisa could operate the day-to-day, a match made in pharmaceutical heaven.

Plus, they could get Doug involved.

Douglas Conigliero was Greg and Lisa's older brother, an anesthesiologist in Florida who had been disciplined for paralyzing a woman by puncturing her spinal cord while inserting a catheter during surgery.

Doug still had a lot of doctor connections, and he knew how pharmaceutical marketing worked, too.

New England Compounding Center, or NECC, hired more than a dozen sales reps, none of whom had industry experience.

They set up exhibit booths and flooded trade shows with the company's marketing materials.

They cold-called hospitals and physicians with an enticing offer.

Cheaper drugs, rigorously tested, preservative-free, delivered faster, on demand.

The customers took the bait.

If you're in your position, if you're a buyer 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?

You're going to go and get two for the price of one using us?

To establish credibility, NECC often touted its partnerships with large healthcare facilities.

One of those was Massachusetts General, but only because the NECC was paying the hospital's drug buyer tens of thousands of dollars in kickbacks per month to buy from them.

NECC also bragged bragged about its state-of-the-art facilities, testing procedures, and clean room.

Quality assurance was the name of the game.

Even Barry Cadden knew that.

People, the clean rooms, the testing procedures,

our cleaning procedures, it's all that boring stuff.

That's what adds up, and that's what produces a quality product.

NECC made a few million dollars in those early days.

Nothing to sneeze at, but not a fortune after cost and split several ways.

Former employees said business was so slow some days that the technicians would fight over who got to fill the sparse orders.

A few years passed and they looked back at those days longingly.

Thanks to a nationwide drug shortage that spiked in 2012, NECC's production volume increased by 300% almost overnight.

The company simply couldn't keep up, but Barry Cadden had dollar signs in his eyes.

Barry was competitive, especially now.

NECC's sister company, Ameridos, which Barry and Greg Canigliero launched in 2006, had grown exponentially and dwarfed its little brother.

Ameridos was a legitimate licensed drug manufacturer, and Greg, the general manager, basked in its glory.

Barry wanted to seize this new opportunity.

This is Joe Connolly, a former compounding technician at NECC, talking the 60 Minutes.

I think Barry was

he saw with the shortage drugs and the volume that we were putting out on those, I think he saw that there was money to be made.

There was even more money to be made if the New England Compounding Center was willing to cut corners.

And with Barry Cadden as its leader, they most certainly were at every point in the process, basically.

Beginning with the orders, compounding pharmacies are supposed to work like this.

A doctor sees a patient who needs a customized medication.

So a prescription for that customized medication is sent to the compounding pharmacy, which compounds that medication medication on a per individual basis.

Not the case at NECC.

NECC streamlined that process by pre-printing order forms.

These forms contained multiple lines for multiple orders for multiple patients and required only one doctor's signature.

It was a loophole that was technically legal.

The company's other tactics?

Not so much.

To make the ordering process even more efficient, NECC sales reps often used information from past patients.

That way customers wouldn't have to wait for a new prescription at all.

They could just tell them what medications they needed and the drugs would be backfilled and shipped.

No questions asked.

Other times the NECC sales reps would just use phony names on the prescriptions.

Names like Bud Weiser, Bart Simpson, Tony Tiger, Homer Simpson, Rug Doctor, Mickey Mouse, Chester Cheeto, Baby Jesus.

It was actually Big Baby Jesus, one of old dirty bastards' alter egos, you know, from the Wu-Tang clan.

Anyway, obviously these practices violated state law.

Barry Cadden was aware.

He reminded his employees in an email.

All names must resemble real names.

No obviously false names.

And here he is, avoiding a question about patient names during a sales training.

Is it a one-to-one patient names for the ball bar blocks?

Um

that's something for another time.

Yeah, let's not.

That's we can talk about that.

Those that's actually one of the more difficult things we do.

Let's just talk about the products now.

Okay, this one.

While we're being recorded.

Totally innocuous, right?

It gets worse.

NECC's sterilization process rarely met the minimum requirements, and oftentimes the medications would be shipped to the customer before their own safety tests were completed.

Additionally, the company used third-party analysts that would only send two or three three vials of a 5,000-vial lot, hardly a representative sample.

Even more devious, NECC pharmacists would botch lots, meaning they would combine new batches of a particular medication with an old batch, use the old test results, and call it good.

Were they good?

Probably not, because NECC's facility was filthy.

There was literally oil oozing through the floor because the building was built atop an old train repair depot.

The technicians, who were supposed to scrub in like surgeons before entering the sterile environment, would routinely sign the cleaning log without so much as lifting a broom.

An unlicensed pharmacy tack, oil bubbling up from the floor, a fungal bloom.

The documents also showing Cadden instructed others to relabel old medications.

No need to worry.

The New England Compounding Center had an internal environmental monitoring division.

It was comprised of one employee, Annette Robinson, who had no professional qualifications for the position.

That's not to say that Annette didn't take her role seriously, because she did.

The only problem is that nobody else at the company took her seriously.

Annette was a nuisance.

Every time she registered a hit of mold or bacteria that exceeded actionable levels, which was almost weekly, production would grind to a halt for a cleaning.

or at least it should have.

More often than not, Annette's findings were outright ignored.

Other times, they were met with hostility.

Fuck off, wrote supervising pharmacist Glenn Chin in response to Annette Robinson's reminder that new pharmacists shouldn't be allowed to compound drugs without first having performed competency tests.

46-year-old Glenn Chin was the man responsible for compounding the methoprednisolone that would eventually sicken and kill so many people.

He supervised the technicians who separated the batch and the individual vials.

The FDA discovered NECC's own monitoring repeatedly found mold and bacteria growing on walls and surfaces.

Equipment used to sterilize medicine had, quote, greenish-yellow discoloration, and air ducts were dirty.

According to the FDA, there's no evidence NECC did anything to fix the problem.

Despite NECC's awareness of its own environmental issues, The company sent customers a quality assurance report card showcasing zero instances of contamination during the the first six months of 2012.

In reality, Annette Robinson had recorded 33 samples that should have required corrective action, but nothing was done.

So, where were the regulators?

The Massachusetts Board of Registration and Pharmacy.

In this case, absolutely dropping the ball in every way imaginable.

Just months before the fungal meningitis outbreak, the Colorado Board of Pharmacy complained to the Massachusetts board that the New England Compounding Center was distributing bulk shipments of drugs to hospitals in its state, a violation of its licenses.

Massachusetts Board President James D.

Coffey and Board Attorney Susan Manning received that complaint, but neither took action.

This was just the latest of more than half a dozen complaints aimed at NECC since 2002.

In fact, back in March 2002, A man in New York named William Koch died of bacterial meningitis that was traced to a contaminated anti-inflammatory drug produced by the New England Compounding Center.

Mr.

Koch's family sued, and the company settled.

The FDA also inspected NECC's lab back then and found an open container of supposedly sterile steroids sitting on a shelf for days covered in tinfoil.

NECC apologized, promised to clean up its act, and seemingly fell off the FDA's radar.

But again, compounding pharmacies are not under the FDA's purview unless summoned.

The responsibility of regulating NECC rested with the Massachusetts Pharmacy Board, which was underfunded, understaffed, and quite frankly, uninterested.

Nobody knew that better than Barry Cadden.

Within the state of Massachusetts, the Board of Pharmacy can't even

get around to investigating all the companies of the pharmacies in this state.

How can they come in and inspect me?

They don't even know what they're looking at.

They have no clue.

They go around, they're like, oh, Barry's play look great.

Yeah, I gotta go.

go get a cup of coffee and they go out the door

and ecc's shortcuts to maximizing profits worked as intended the company was on pace to earn 50 million dollars in revenue in 2012 alone everyone involved was getting rich barry and lisa cadden reportedly earned 72 million dollars in the previous five years from their share of ownership in the new england compounding center and ameridose The couple lived in a $1.4 million, 9,000 square foot, 13-room mansion.

They vacationed at their waterfront property in Rhode Island, where they docked their sailboat, plus the cars, the jewelry.

Sounds nice.

Hope they enjoyed it while it lasted.

A nurse's phone call to the New England Compounding Center in early September 2012 was the first sign of a problem.

The company played stupid, but internally, Cadden and company knew there was a good chance that their products were the culprit, and the CC continued shipping orders anyway.

Until the call came from the CDC.

Again, Cadden expressed confidence when concerns were raised and agreed to a voluntary recall of its methylprednisolone.

Hours later, he received an email from a nurse in Indiana who had found foreign particulates and an unopened vial.

Barry tried to get ahead of the situation.

He started calling every customer who had received an order from that batch.

Hello, this is Barry Cadden.

I'm a pharmacist from New England Compounding Center, your facility's source of methylprednisolone acetate.

We received a complaint from a client late this past evening of potential foreign particulates in a number of vials they received.

We would like you to quarantine this product at this point.

Call us as soon as possible to discuss the situation.

We consider this an emergency, so please, if you get this message, transfer to the individual in charge of medications.

Too little, too late.

The writing was on the wall.

The New England Compounding Center was ruined.

With one last gasp, the company tried to blame its cleaning contractor for any sterility issues.

With one last gasp, Douglas Canigliero and his wife Carla began transferring tens of millions of the company's dollars between bank accounts and withdrawing in cash half a million dollars more.

64 people had died, according to the U.S.

Centers for Disease Control and Prevention's official numbers.

753 others sickened with fungal meningitis.

Most of the victims had received a steroid injection in their spinal area.

The oldest victim was 92 years old.

The youngest was 16.

Librarians, teachers, students, athletes, judges, auto mechanics, just looking for a non-opioid alternative to treat their chronic pain.

They were angry.

Shame on them.

You know, this was all about greed.

This is all about making money.

That's the bottom line.

They were heartbroken.

The doctors kept saying, two more days.

He's going to go home two more days.

And then he was gone.

They were scared.

There's still people dying from this.

I'm scared as hell.

I don't know what's going to happen.

They were hopeless.

I

prayed for death.

I prayed.

for death to relieve my pain.

Many of the victims were financially ruined.

The antifungal treatments alone cost as much as $12,000 a month, and that's probably the baseline.

Victims like J.R.

Mazur had to undergo as many as seven back surgeries and 108 rounds of medication to battle the fungus.

He says his medical bills total approximately $4 million and counting.

Still, there's no relief.

Chronic health problems linger in many.

Some victims have lost their homes to foreclosure.

Others have contemplated suicide.

Yet, perhaps the biggest insult is that their backs still hurt and they can no longer treat it.

Many recovering from the illness suffered secondary infections at the injection site that mimicked the pain from which they had originally sought to escape.

It's like the suffering never ends.

This doesn't happen in America.

I mean, this doesn't, I mean, I know, I hope that doesn't sound, but you're just thinking, this is something

that is not even real.

Oh, but it does, and it is.

I'll allow George Kerry to explain why.

George's 67-year-old wife, Lillian, was one of the first to die during the outbreak.

Our loss and that of others should be a wake-up call to our country.

There are those politicians in state and federal government who want to cut the very programs that protect the American public.

They want to eliminate common sense controls and regulations that hold corporations accountable in many areas that affect us all.

Whoa, whoa, whoa.

Why do you got to make everything so political, bro?

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After a tragedy like this, the first question we all ask, could this have been prevented?

After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S.

Food and Drug Administration, the answer appears to be yes.

On November 14th, 2012, the U.S.

House of Representatives Energy and Commerce Committee held a hearing to further investigate the cause of the fungal meningitis outbreak.

The first panel focused on the impact of the tragedy on the people involved.

Joyce Lovelace was the only victim scheduled to testify.

Joyce reflected on her late husband's life and what ultimately became of it.

She described the nightmare her family had and would continue to endure.

Ms.

Lovelace begged members of the committee to make sure something like this would never happen again.

My family is bitter.

We are angry.

We're heartbroken.

We're devastated.

And I'm just kind of here begging you to do something about the matter.

The second panel that morning focused on the pharmaceutical company's role in the disaster.

New England Compounding Center President Barry Cadden was scheduled to testify.

It went exactly how you'd expect.

Mr.

Cadden,

are you one of the owners of the New England Compounding Center, or NECC, the company that distributed contaminated injectables to medical clinics, doctors' offices, and hospitals across this country?

On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution.

The third and final panel centered on government regulation.

Committee members grilled FDA Commissioner Margaret Hamburg, accusing the agency of failing to prevent the crisis and moving too slowly, despite years of red flags at NECC.

Commissioner Hamburg argued that the FDA's authority over compounding pharmacies was unclear.

NECC might have been operating as a large-scale drug manufacturer, but they were not licensed that way.

Therefore, the regulatory authority rested on the shoulders of the Massachusetts State Pharmaceutical Board, which, honestly, is what the compounding industry preferred.

There had been a legislative effort back in 1997, as part of the Food and Drug Modernization Act, to establish parameters related to the compounding industry that would have enabled direct FDA oversight.

However, part of that reform disallowed compounding pharmacies from from advertising their products, which compounding pharmacies argued was a violation of free speech.

The Supreme Court agreed and overturned sections of the new law that applied to compounding, and the FDA has been hamstrung ever since.

Industry lobbyists and congressional interference have defeated the agency's future attempts to expand its oversight, which has allowed compounding pharmacies to, as Senator Richard Blumenthal described, quote, fall into a regulatory black hole.

Now was the perfect opportunity for Congress to establish clear authority and strengthen standards, Commissioner Hamburg testified.

Give the FDA broader authority to inspect compounding facilities and control the sale of compounded drugs.

The

fact that we have

unclear, limited, and contested authorities and ambiguities in the law and a crazy quilt of legal authority has required us to be very reactive responding to those serious public health threats and selective and of course every effort is resource intensive.

The Congressional Subcommittee wasn't convinced, noting in its 43-page report, quote, additional authority will not necessarily solve the fundamental issues within FDA that allowed this tragedy to unfold under the agency's nose.

It should be mentioned, as investigative journalist Jason Deerard pointed out in his book, Killshot, that the Republican House reps on the committee investigating the crisis had accepted tens of thousands of dollars in campaign contributions from the International Association of Compounding Pharmacies, the industry's lobbying arm.

In fact, one of those representatives, Morgan Griffith from Virginia, actually introduced legislation in the wake of the tragedy that proposed further eroding the FDA's authority.

Fortunately, that legislation never passed.

But what ultimately did pass wasn't much better, some would argue.

The initial iteration of the Drug Quality and Security Act had granted most of the FDA's wishes, but by the time it was signed into law by President Obama in November 2013, the bill had become a toothless, mercilessly lobbied, bipartisanly compromised turd.

Sure, the FDA was granted the authority to better regulate compounding pharmacies, but only for those compounding pharmacies that voluntarily opted in.

According to the FDA, As of November 27, 2016, which is the most recent reporting that I could find, only 67 compounders are registered with the FDA as outsourcing facilities.

Additional legislation is pending, but currently, that means that thousands of compounding pharmacies are operating under the surveillance of state pharmacy boards that, in many cases, are comprised mostly of local pharmacists and a prime example of regulatory capture in a multi-billion dollar industry.

To its credit, the state of Massachusetts took quick steps to avoid being the birthplace of another compounding pharmacy-induced health crisis.

The state passed laws that allow it to track the volume and distribution of medications made by compounding pharmacies to determine whether they are operating more like a manufacturing facility.

And the Board of Pharmacy was reorganized and professionally diversified to ensure better regulatory practices.

Massachusetts also embarked on a string of surprise inspections of compounding pharmacies within its borders in the immediate wake of the meningitis outbreak.

Several were shut down as a result.

Just four out of 37 pharmacies inspected received a passing grade.

The New England Compounding Center was not among them because the New England Compounding Center was closed, bankrupt.

More than 400 victims had filed civil lawsuits against the company and thousands more would join.

Those cases would eventually be consolidated and the litigation would take years.

As would the unfolding criminal investigation.

A federal grand jury was impaneled in December 2012.

A massive conspiracy charge was being considered.

But then, something happened on September 4th, 2014, that forced the U.S.

attorney's hand.

A former employee of a compounding pharmacy in Framingham that made tainted steroid injections was arrested at Logan International Airport today.

Federal authorities say Glenn Adam Chin was about to board a flight for Hong Kong.

The FBI received a TSA alert that former NECC supervising pharmacist Glenn Chin was boarding a flight from Boston to Hong Kong, where he had family.

Paperwork was expedited to charge him with one count of mail fraud.

The rest of the case wasn't ready yet, but they wanted to make sure he stayed put.

Chin's lawyer, Paul Shaw, said his client was on his way to a wedding that the government had known about for two months, calling the Fed's actions a publicity stunt.

What the government did is they waited, they orchestrated this until Mr.

Chin was at the airport so that they could call you, the media, to say that they apprehended a fugitive four steps away from when he got on the airplane, which was nonsense.

When the FBI had followed him this morning, four agents, all the way from his home in Canton, to the airport to arrest him in front of his wife, six-year-old daughter, two-year-old son, and 66-year-old grandmother.

As far as the allegations that are in this criminal complaint, they are absolute nonsense.

More allegations against Glenn Chin and multiple others at NECC were on the way.

Breaking news this morning we learned just moments ago of arrests in connection with that deadly meningitis compounding outbreak in 2012.

At least 14 people have been taken into custody.

The indictment alleges that the most senior pharmacists and pharmacists working in clean rooms at NECC had knowledge that the drugs that they were making in Massachusetts and dispensing to patients and hospitals across the country were made in a thoroughly contaminated lab.

The cleaning and disinfecting practices in the so-called clean rooms at NECC where the drugs were compounded failed to comply with the most basic health standards.

Production and profit were prioritized over safety.

On December 17th, 2014, Federal prosecutors unsealed a 131-count criminal indictment against 14 former New England Compounding Center executives and staff, including co-owner and president Barry Cadden, supervising pharmacist Glenn Chin, and vice president and co-owner Greg Conigliero.

Douglas and Carla Conigliero, who shared an ownership stake, were also named in the indictment and charged with criminal contempt for their financial maneuvers.

Almost everyone else was facing racketeering and mail fraud charges, except for Barry Cadden and Glenn Chin.

Their quote, depraved indifference for human life earned them a little extra.

25 counts of second-degree murder.

This is Cadden's lawyer, Bruce Single.

He's looking forward to his day in court and welcomes the opportunity to prove his innocence.

Would the charges stick?

We wouldn't find out anytime soon.

Both Cadden and Chin pleaded not guilty.

Their trial date was kicked down the road for a couple of years.

Before then, in May 2015, a financial settlement was approved.

$200 million, made up of cash contributions from the owners and liquidated assets, would be split amongst the NECC's victims and creditors.

A little more than $100 million was ultimately paid out.

The individual amounts were nowhere near life-changing, and it would take another few years before victims ever saw a dime.

But the news spread fast.

Tonight, Suffering Again, a woman who says her life was ruined by a meningitis outbreak, attacked in a brutal home invasion.

Her attackers may have been looking for the settlement money that she was supposed to get for her pain and suffering.

One month after the settlement was approved, 47-year-old Kelly Popaleo was awakened in her Manchester, New Hampshire apartment by a punch to the face.

There were four individuals standing around her, demanding the settlement money.

Not believing that she hadn't received the check yet, Kelly said the four assailants kept her captive for what seemed like days, non-stop brutality until she managed to escape.

They beat me till they couldn't beat me anymore.

They kicked my face so hard that my teeth fell off.

What did they want?

Money.

They wanted money.

And they thought you had it.

They thought I had it.

Kelly Populeo required brain surgery after the assault.

Three years later, she took her own life on July 8th, 2018.

At least by then, she'd gotten to see what happened to the man who ruined her life.

At one point, the prosecutor said, evil is not limited to violent crime.

What Barry Cadden did was evil.

Barry Cadden's trial began in early 2017.

It's a story of greed, cutting corners, and fraud, U.S.

Attorney George Varghese told the jury.

64 people died, and more than 700 were sickened by the tainted steroids produced by the New England Compounding Center.

And Barry Cadden was the overseer of it all.

Expired ingredients, falsified cleaning logs, ignored warnings, botched lots, backfilled prescriptions, two months' worth of evidence to witnesses to prove it all.

He knew the injectable drugs that he was making would kill people if they were contaminated, but he kept making them anyway without taking the necessary steps to ensure that they were sterile, Varghese told the jury.

This is a wanton and willful disregard for patients' lives.

That is a depraved indifference for human life, for the lives of 25 people who trusted that the drugs he was making were safe.

Defense Attorney Bruce Single proposed that the second-degree murder charges were overzealous.

His client, Barry Cadden, did not work in the clean rooms.

If anyone was at fault, it was Glenn Chin.

There was no argument that NECC's products hadn't caused death and injury, because they had.

But Cadden is not a murderer, Single told the court.

and he is not responsible for their deaths.

There was no evidence to suggest that he is, according to the

After all, how the contamination occurred had never been solved.

The jury had a lot to consider.

Deliberations took place over three days in March 2017.

Barry Cadden was found guilty of 27 counts of racketeering and mail fraud.

He was found not guilty of the twenty-five counts of murder.

The jury had been split.

Nine of the twelve wanted to convict.

The three holdouts wouldn't budge.

So, misunderstanding that they had to be in unanimous agreement, the foreman wrote not guilty on the verdict slip and turned it in, but included the vote totals.

But look at the final verdict form.

It revealed the jury was split on multiple charges, including the more serious acts of second-degree murder.

Typically, if that was the case, a judge would have sent them back for more deliberations.

Instead, the judge ruled Cadden was not guilty of second-degree murder.

There could have and should have been a hung jury and potentially a a second trial.

Instead, U.S.

District Court Judge Richard G.

Stearns read the not guilty verdict as written.

The opportunity was lost.

This is Cadden's attorney, Bruce Single.

It is a disgrace that he was charged with murder.

It was unprovable, unwarranted, and unjustified.

And we are deeply grateful that the jury saw it that way and vindicated Mr.

Cadden on all 25 of the murder charges.

I am so sorry for your extraordinary loss, Barry Cadden said through tears at his sentencing hearing in June 2017.

I'm sorry for the whole range of suffering that resulted from my company's drugs.

50-year-old Barry Cadden was sentenced to nine years in prison and a forfeiture of $7.5 million.

Cadden's victims were less than enthused.

You didn't get enough time.

I'm a prisoner of my own body for the rest of my life.

I think we should take them

and set them up with a doctor and inject them with their own medicine.

Wouldn't that be wonderful?

What's your message to them?

That's my message to them, to, you know,

take an injection for us.

You know, let us do to you what you did to us.

What have they done to you?

They've stripped me of my quality of life.

Unsurprisingly, Glenn Chin also dodged the murder charges at his trial a few months later.

The 49-year-old former supervising pharmacist was convicted of racketeering and mail fraud and sentenced to eight years in prison.

Barry Cadden and Glenn Chin were both re-sentenced two years later after the sentencing guidelines were re-examined.

Cadden's sentence was increased by five and a half years and Chin's by two and a half.

The state of Michigan, one of the most affected by the meningitis outbreak, had also filed 11 second-degree murder charges against the duo.

Cadden pleaded guilty to 11 counts of manslaughter on March 5th, 2024.

He was sentenced to 10 to 15 years to be served concurrently with his federal time.

Glenn Chin's hearing is scheduled for November 4th, 2024.

It is expected that he will receive a similar deal.

This case was a national tragedy.

The tainted drugs distributed on Mr.

Cadden's watch caused the largest public health crisis in this country ever by a pharmaceutical drug.

Douglas and Carla Canigliero, as well as many of the pharmacists and lower-level employees charged in the indictment, pleaded guilty and received probation for their cooperation.

Others were convicted at trial and sentenced to short prison stints.

However, the vice president and general manager of NECC, Greg Conigliero, had his conviction of conspiracy to defraud the FDA overturned.

The judge ruled that Conigliero and another employee, quote, could not have defrauded the FDA by interfering with the relevant functions because there were none to speak of.

In a December 2018 press release, the U.S.

Justice Department updated the total number of deaths related to the 2012 fungal meningitis outbreak to quote more than 100.

It was another sad milestone for the victims of the tragedy who were let down at every turn.

He killed my mother.

12 years later, What more is there to say?

I was told 12 years ago that you cannot harm someone more than killing them.

I've come to disagree.

You can harm them more when justice fails them.

Swindled is written, researched, produced, and hosted by me, a concerned citizen, with original music by Trevor Howard, aka Deformer, aka Rug Doctor.

For more information about Swindled, you can visit swindledpodcast.com and follow us on Instagram, Facebook, Twitter, and TikTok at SwindledPodcast.

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That's it.

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Please trust me when I tell you all health care is a joke.

Do your best not to get sick.

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