The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.
What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.
It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.
"The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing," Kauffman told MedPage Today. "The huge morbidity and, for some, mortality, is enormous."The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called "compounding pharmacies."
And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.
The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.
The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: "We're still in the middle of this thing."
Compounding Out of Bounds
The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.
That was problematic in itself: The company was licensed as a compounding pharmacy, meaning in principle it was allowed only to make up small quantities of specialized drugs, after getting a prescription from a doctor for an individual patient.
Instead, it was acting more like a large-scale drug manufacturer, and had been for some years, according to Massachusetts officials, which should have placed it under the FDA's authority.
The manufacturing scale played a key role in what ensued: more than 13,000 people were exposed to the drug when they got injections – mainly into the spine – to control chronic pain.
They were also exposed to a fungal contaminant in the steroid vials, later found to be a black mold called Exserohilum rostratum, which only rarely causes human disease.
Oddly, the index case for the outbreak, reported to health authorities on Sept. 18, was a 56-year-old man in Nashville who had a case of meningitis apparently associated with the fungus Aspergillus fumigatus.
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