Before 2012, few knew the first thing about fungal meningitis – even doctors. And compounding pharmacies flew well under most people’s radar. That changed as moldy spinal injections sickened hundreds across the country.
The outbreak first discovered in Nashville has killed 39 people nationwide, 14 in Tennessee. The husband of Joyce Lovelace is believed to be the first fatality.
“He was hollering for me in the kitchen,” she said during testimony to Congress. “He had a horrible look on his face. I’ll never forget that expression. And he said, ‘my legs don’t work.’
The active 78-year-old judge walked three miles a day. He died at Vanderbilt University Medical Center before doctors really knew what they were dealing with.
Like 367 families with a loved one who contracted this obscure infection, Lovelace says she’s bitter.
“We’re angry,” she says. “We are heartbroken. We are devastated.”
Lovelace says her husband was full of life until he went to a pain clinic at Nashville’s Saint Thomas Hospital to get back injections. It’s a procedure not fully proven to be effective but performed at hundreds of clinics, like Dr. Graf Hilgenhurst’s practice in Smyrna.
“First I’m going to numb you up, needle stick, burn,” he tells a woman facedown on an operating table.
X-ray images guide the tip between two vertebrae in her neck. Hilgenhurst draws the milky white steroid into his syringe
“You would think that you would notice if there were dark colored particles in it,” he says. “You would think.”
Tainted medicine found at a compounding pharmacy in Framingham, Massachusetts had visible mold in it, according to the FDA.
‘Like Drinking the Tap Water’
Hilgenhurst’s clinic did not receive any of the bad drugs. But as head of the state’s association of interventional pain physician, he heard from everyone who was frantically checking stockrooms.
A state health official says many didn’t realize they were using compounded meds. And to be fair, says Hilgenhurst, doctors can’t be held responsible for the entire supply chain.
“It’s like drinking the tap water,” he says. “Every day you turn on the tap and you drink a glass of water. You don’t once think where does this water come from? Has it been filtered? Are there people supervising the process? Do we know it’s safe? You just assume it must be good. It’s in my tap.”
The fungal meningitis outbreak has sent chills down the spines of folks in charge of ordering injectable medicines.
“Let’s put it this way. I have lost a lot of sleep,” says Dr. Bill Greene of St. Jude Children’s Hospital.
As the official in charge of managing the hospital pharmacy, Greene says he depends on compounding pharmacies for smaller dosages or preservative-free products.
In a growing number of instances, it’s a matter of national shortages with FDA-approved versions.
“This is a major issue for us right now,” he says. “It’s not only the question of supply but the question of how do we make sure the quality of the supply is sufficient.”
Greene says he’s now thinking even harder before turning to a compounder.
“I feel like a rat in a box and everybody’s taking potshots,” says pharmacist Mark Binkley.
Binkley runs a much smaller-scale facility than the New England Compounding Center, producing batches of 10 doses instead of thousands. But he says clients have asked for proof he’s running a clean ship.
A Rush to Regulate
“Most of the corporate sites have requested documentation from us since this started,” he says.
Lawmakers in Washington have been studying what needs to be done since compounders fall in a gap between state and federal oversight. Binkley says he worries about a rush to regulate, though he sees a need to clearly identify when a medicine has been compounded.
Willie Mae Devine certainly had no idea she was getting a compounded drug. The 71-year-old has now quit her job. She’s walking with a cane and taking a purse-full of anti-fungal medication.
Devine had a fungal infection around her spine but was spared developing full-blown meningitis. Still, her confidence in the health care system is shaken.
“I’m afraid of the doctors now,” she says. “I’m almost afraid of the medication.”
But for now, Devine has little choice but to trust her physicians. Three months after her back injections-gone-bad, she’s still seeing neurologists and infectious disease experts nearly every day.