'Ticking time bomb' - ABC News

How a mysterious case of meningitis in the US led to the unravelling of a national pharmaceutical disaster.

It all started with one patient at a hospital in Tennessee.

This was September 2012, and the man in question had shown up with headaches and neck pain.

He had meningitis — inflammation of the lining around the brain and spinal cord — and after a course of antibiotics, he seemed better and was sent home.

But a week later he was back in the hospital — drowsy and confused, with pain in his lower back.

In the following days, he suffered multiple strokes.

Meningitis is an inflammation of the lining around the brain and spinal cord — a condition that can be life threatening.(

Centers for Disease Control and Prevention/ABC:Teresa Tan


Further tests revealed the culprit for the meningitis — but this raised more questions than it answered.

A species of fungus called aspergillus fumigatus was found in his spinal fluid.

This fungus usually only causes problems in people with compromised immune systems, but this man was otherwise healthy.

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The doctors started an aggressive course of antifungal medications, but the man’s condition continued to deteriorate.

After another week in ICU, his family made the difficult decision to switch off life support.

The email

After doctors identified the fungus, they fired off an email to the Tennessee Department of Health that contained a vital clue to where it might have come from.

A few weeks before he presented to hospital, the man had a series of steroid injections for chronic back pain.

The email landed in Marion Kainer’s inbox.

These days, Dr Kainer is working on the COVID response — informed by her experience in the US.(

Supplied: Marion Kainer


These days, Dr Kainer is head of infectious diseases at Western Health in Melbourne.

But in 2012, she was Director of Healthcare Associated Infections and Antimicrobial Resistance at the Tennessee Department of Health.

“I received this email and it really piqued my interest,” Dr Kainer says.

“First of all, aspergillus meningitis is very rare.

“To have this occur in somebody who has a normal immune system is really unusual.”

The fact that the patient had no risk factors for meningitis, but had undergone a recent procedure, set off alarm bells.

Dr Kainer was concerned the man might have been exposed to the fungus at the clinic where he received the steroid injections.

“In the air sometimes you get fungal spores, and the number of fungal spores can increase dramatically if there is nearby construction or evidence of water damage,” she says.

Aspergillus Fumigatus is a mould commonly found in our environment.(

Centres for Disease Control and Prevention/ABC: Teresa Tan


Dr Kainer quickly launched an investigation.

She needed to find out whether anyone else in the community was at risk.

The outbreak grows

At first, the man’s case appeared to be isolated.

But within days of the email, two other people who’d received injections at the surgical clinic were also admitted to hospital with meningitis, and another with a stroke.

It was difficult to prove the steroids were contaminated.(

Photomicrograph: Centers for Disease Control and Prevention/Illustration: ABC:Teresa Tan


Dr Kainer’s team visited the clinic to look for signs of environmental contamination.

But the inspection turned up nothing: the facilities looked clean.

Their suspicions quickly turned to the steroid injections themselves.

“We have known in the past that steroids can be contaminated,” Dr Kainer says.

The Tennessee Department of Health issued a statewide alert.

But this problem was bigger than Tennessee.

‘Is my doctor poisoning me?’

Dawn says at this point in her life “I was 50, but I felt and looked 30. I prided myself on my fitness”.(

Unsplash: Axel-Lopez


About 700 kilometres north of Nashville, in a small city in Indiana, Dawn Elliot was struggling to get out of bed.

Dawn, who was in her early 50s and in “the best physical shape of [her] life”, had been getting ready to go on a trip to Hawaii when she began to experience back pain.

Not wanting to be out of action, she booked in for a steroid injection to relieve the pain.

Dawn didn’t want to be out of action for her trip to Hawaii, so on the advice of friends, she booked in for a steroid injection.(

Supplied: Dawn Elliot/Unsplash: Mohamed Thasneem


But not long after the procedure, Dawn started to feel unwell.

“All day Friday, Saturday and Sunday, I ended up in bed with a headache, twitching and just terrible, terrible back pain,” Dawn says.

“I ended up calling the clinic and telling them that this injection didn’t take care of the pain.

“So, the doctor basically said that he thought I would be a candidate for a second injection.”

Dawn was reluctant, but took the doctor’s advice. But the next injection only made things worse.

“I was getting sicker and sicker and nobody could figure it out,” she says.

“I started having all these tremors and tics.”

On the advice of the pain clinic, Dawn went on to have three more steroid injections.

Eventually, she was unable to walk from the pain.

“There were a couple of times I thought to myself, ‘is my doctor poisoning me?'”

‘A mass casualty event’

Back in Tennessee, Dr Kainer’s attention had turned to the company where the steroids were manufactured.

The New England Compounding Center (NECC) was a family-owned pharmaceutical business based in Massachusetts.

After a call from Dr Kainer, the NECC compiled a list of all the clinics and hospitals their steroids had been sent to.

“I found that there were over 17,000 vials … sent out to something like 76 facilities in over 20 states,” Dr Kainer says.

“My heart just sank and I thought, ‘oh my God … this could be a mass casualty event’.”

Facing a potential national health crisis, the CDC notified all state health departments, asking them to check on anyone who’d received a steroid injection.

The evidence against the NECC steroids was mounting, but investigators still didn’t have definitive proof that they were contaminated, or that it was the fungus making people sick.

Then came a breakthrough.

Doctors were finally able to isolate enough spinal fluid from a meningitis patient and grow the fungus in a lab.

“When they looked at it under the microscope, they saw there was a fungus invading across tissue plains,” Dr Kainer says.

Photomicrograph of fungal infection of brain tissue from patients with clinical cases of meningitis.(

Centres for Disease Control and Prevention


The following day, FDA investigators confirmed the NECC steroids were contaminated, and the outbreak began to make national headlines.

It was the first time Dawn learned about what had happened. Suddenly, her pain made sense.

“On my fourth injection, I laid on the table and cried out in pain,” she says.

“The doctor made the comment, ‘Oh, I betcha we just found the spot’.

“But instead, I think it was probably mould going through.”

‘Death wasn’t the worst outcome’

Over the following weeks and months, the scale of the outbreak was laid bare.

Thousands of people across the US had received contaminated injections, and many were becoming very sick.

“Death wasn’t necessarily the worst outcome,” Dr Kainer says.

“We had patients that were locked in — people who were completely aware of their surroundings but could not talk, speak, or make any movements.”

Without treatment, the fungal meningitis was almost certainly fatal.

The pressure was on to track down every single person who’d received one of the 17,000 tainted vials.

NECC began a series of voluntary recalls of Methylprednisolone Acetate (MPA) soon after being investigated by the FDA.(

Centers for Disease Control and Prevention/ABC: Teresa Tan


Making things harder, not all of them showed signs of infection and for some, it took up to nine months for symptoms to appear.

“These people felt like they had a literal ticking time bomb,” Dr Kainer says.

The contact tracing task was enormous and involved knocking on doors, trawling through social media, and bringing in the military.

Some recipients were already sick, others were waiting to get sick, and then there were those who had no idea they were sick — and possibly dying.

“We needed to find them rapidly … before they would have devastating strokes or get really sick,” Dr Kainer says.

“It was really a race against time.”

Lifesaving, but sickening, drugs

Dawn’s illness saw her hospitalised three times.

“[I had] two surgeries to clean out my spine from the fungus, and then I was on the antifungals for nine months,” she says.

Dawn suffered constant drenching sweats, pain, tremors and eye infections.(

Unsplash: Axel-Lopez


Those antifungals that kept the patients alive brought debilitating side effects.

“It was kind of like a chemo that we had to take twice a day. I was pretty much bedridden for nine months,” Dawn says.

And the lifesaving drugs cost $US12,000 every month.

There were times where Dawn didn’t want to live.

“I begged for death because I was in so much pain.

“My family didn’t think I was going to make it. I didn’t think I was going to make it.

“I just figured, if I’m going to die, I might as well just die at home.”

Dawn was bed-ridden for around nine months after her initial infection.(

Unsplash: Axel-Lopez/ABC: Teresa Tan


In the end, more than 100 people died in the outbreak, and almost 800 others became sick.

It’s considered one of the worst pharmaceutical disasters in US history.

How could this have happened?

When investigators visited the NECC, they discovered more than just a few batches of contaminated steroids.

Machines used to sterilise equipment had signs of greenish discolouration, mats used to trap dust and dirt were visibly soiled, and a leaky boiler next to where the drugs were made created an environment that was — according to a Senate report — “susceptible to contaminant growth”.

“I was horrified that people could compound medications under those conditions,” Dr Kainer says.

Behind the facilities was a waste management business also run by the NECC’s owners. 

“It was a mattress and recycling sort of centre — a very different sort of cleanliness,” says Kevin Outterson, professor of law and co-director of the Health Law Program at Boston University.

Behind the NECC was a waste management facility owned by the same family.(

Unsplash: Axel-Lopez


It turns out US health regulators had received complaints about the safety of these same NECC steroids years earlier.

In the decade prior, FDA regulators reported over 50 “adverse events” at the company.

Despite issuing warnings to the NECC, federal regulators had never acted on them because they “lacked the authority” to do so, Professor Outterson says.

That’s because the NECC was what’s known as a “compounding pharmacy” — a pharmaceutical business that makes custom medications tailored to the needs of individual patients.

In the US, compounding pharmacies are regulated by the states and don’t have to comply with the same strict quality control standards that commercial drug manufacturers do, because — in theory — they’re making medicines for individuals, not in bulk orders.

A culture plate showing the results of a susceptibility test to the antifungal drug amphotericin B.(

Centres for Disease Control and Prevention: James Gathany/ABC: Teresa Tan


But the NECC was flouting the rules: manufacturing drugs in large quantities, making up patient names, and shipping them around the country.

“[Clinics and hospitals] were using these drugs routinely; not just for patients who had a specific reason, but really for all patients because it was cheaper,” Professor Outterson says.

In the wake of the NECC outbreak, US Congress passed a national law trying to more strictly regulate compounding pharmacies.

But this law only imposed a voluntary set of rules.

“[That] tells you everything you need to know about the political power of compounding pharmacies in the United States,” Professor Outterson says.

In Australia, we don’t have the same huge market for compounding pharmacies, and the ones that sell medicines at a larger scale have to comply with the same strict manufacturing standards as commercial drug makers.

Analysis of cerebrospinal fluid (CSF) was required to give a diagnosis of infection.(

Centers for Disease Control and Prevention/ABC: Teresa Tan


The wash-up

The NECC shut down in October 2012, and later filed for bankruptcy.

A court approved more than $US200 million of its funds to be set aside to compensate victims, and hundreds of lawsuits were launched against the company and pain clinics all around the US.

Dawn received some compensation, but says it didn’t amount to much.

She hasn’t been able to work since she received the injections in 2012.

Two top pharmacists at the NECC were sent to prison and still face further charges, and some other employees were convicted.

“The record of convictions was mixed,” Professor Outterson says.

“For some people, there was clear evidence that they knew something was wrong and they weren’t speaking up.

“For others, it appeared there was reasonable doubt as to whether they knew that corners were being cut.”

‘A prisoner in my own body’

Nine years on, Dawn is still in pain.

“There’s men right now that are sitting in prison because of it,” she says.

“They will be out … but I’m a prisoner in my own body now, so I’ll never get out.”

Dawn struggles with her memory, and can’t stand up for too long.

Dawn loved scuba diving and took a keen interest in sharks.(

Supplied: Dawn Elliot/Unsplash: Silas Baisch


She no longer goes for long runs or dives, or travels with her husband Mike.

“I spend a lot of time laying in between what would be like a 20-minute task,” she says.

“I used to like to be with friends and do social things. Now I rarely leave the house.

“My car battery goes dead because I never drive.

“My life is nothing like what it used to be.”

Stuck inside her home, Dawn has learnt to crochet and quilt, and begun raising monarch butterflies.

She’s raised as many as 250 butterflies in a single year.

“[In my former life] I knew about fish and sharks and all that,” she says.

“But … had this not happened to me, I would have never learnt about monarchs, you know?”

Dawn plants flowers for the monarchs, collects their eggs, and raises the caterpillars indoors until they emerge from their cocoons as butterflies.

The process keeps her busy all summer.

At the end, she stands in her garden and releases them — off into the world that’s no longer hers to explore.

This story comes from Patient Zero, an eight-part series about disease outbreaks. Listen for free wherever you get your podcasts.


Reporter: Olivia Willis

Editor: Annika Blau

Designer and digital producer: Teresa Tan

Researcher: Jane Lee

Executive producer: Joel Werner

Photographs supplied by Dawn Elliot and Dr Marion Kainer