Science News: Meningitis Outbreak

It all started with a common fungus called Aspergillus, which is found in the air we breathe each day. Next came Exserohilum rostratum, another relatively innocuous fungus that lives on plants and in dirt. When these fungi (and probably more like them) found their way into the New England Compounding Center (NECC) in Framingham, Mass., they got cozy and started doing what fungi do—grow—and set off a chain of events which, by the end of November 2012, had sickened more than 500 people and killed 36.

Sterile No More

Causing inflammation of the spine and brain, the first case of fungal meningitis was discovered on Sept. 18, 2012, in Tennessee. Within weeks, it was an outbreak, traced back to three fungal-infested lots of preservative-free methylprednisolone acetate, an injectable steroid medication (usually used to treat back or joint pain), which had been shipped to 23 states for injection into 14,000 patients since May 21, 2012.

When state health investigators and the FDA inspected the NECC beginning in late September, they found a facility that produced and multiplied not only prescriptions, but also bacteria and mold. The reports called out unsanitary conditions such as "visibly soiled" floor mats and a leaky boiler with standing water and inadequate sterilization procedures. An inspection of recalled vials revealed visible "black particulant."

Implications

The NECC is a pharmacy that was licensed to compound sterile injectable products and subject to the Massachusetts board of registration in pharmacy. According to the Massachusetts Department of Health (MDH), "medication compounding involves the practice of taking commercially available products and modifying them to meet the needs of an individual patient pursuant to a prescription from a licensed provider." By producing the injectable steroids in mass quantities, the pharmacy was in violation of their license.

The NECC issued a voluntary recall on Sept. 26 and suspended operations shortly thereafter. This, of course, is not enough. For the thousands affected and millions watching, it is an unacceptable situation: when the medicine we trust to alleviate our suffering holds the potential to kill.