Fungal Meningitis: Anatomy of an Outbreak

Nov. 8, 2012 — -- The fungal meningitis outbreak that sickened 414 people this fall was unprecedented -- first, because only people who received a tainted steroid injection were at risk; and, second, because the fungus wasn't known for making people sick, let alone causing a deadly inflammatory disease that's killed 31 people so far.

Health officials on the local, state and federal levels had to work together to trace the cause of the outbreak and get the word out to at-risk patients and their doctors.

"All of that coordination -- the right hand knowing what the left was doing -- has made a big difference in how quick we could come to an understanding of what was going on," said Dr. David Reagan, the chief medical officer in Tennessee, adding that the tainted drugs were recalled eight days after Tennessee physician Dr. April Pettit contacted the state health department about a patient with a suspicious illness.

Here is a timeline of how the outbreak played out:

Early September: The first fungal meningitis patients arrived in emergency rooms around the country in early September, but it took a clinician in Tennessee, Dr. April Pettit, to realize her patient with a mysterious illness was the beginning of a public health crisis. Reagan said she found fungus in the patient's spinal fluid.

Sept. 18: Pettit contacted the Tennessee Department of Health, including Dr. Marion Kainer, looking for similar patients. Her call set the investigation into motion, and she noted that the patient had recently received an epidural steroid injection.

Sept. 20: Two days later, the state health department called the CDC to report a fungal infection, noting that the patient had received an epidural steroid injection at the Saint Thomas Outpatient Clinic in August. Although the CDC had not heard about similar cases, it suggested Kainer visit the clinic. The same day, the clinic voluntarily closed. It has not reopened.

Sept. 21: The Tennessee Department of Health narrowed its list of possible causes to tainted steroid injectables from the New England Compounding Center (NECC) in Framingham, Mass., environmental contamination, or mishandling of equipment.

Sept. 24: Several other meningitis cases had been reported, and the Tennessee Department of Health reached out to Massachusetts's Department of health to learn more about NECC.

Sept. 25: FDA became involved.

Sept. 26: NECC recalled three tainted lots of steroid injections the next day. The three lots amounted to 17,000 vials that were injected into as many as 1,400 patients, as early as May 21. Since this was the last day patients could have received steroid injections from NECC, it became day one of the 42-day risk period the CDC began talking about.

The same day, the Massachusetts Department of Public Health began its on-site investigation of NECC.

Oct. 6: There were 64 reported cases of fungal meningitis, and NECC voluntarily recalled all of its products and shut down, pending an FDA investigation.

Oct. 24: The state health department released preliminary findings from its NECC investigation. Inspectors wrote about dirty floors and a leaky boiler. Floor mats near sterile drug-mixing areas were "visibly soiled with assorted debris," and a leak from a nearby boiler created an "environment susceptible to contaminant growth," according to the report.

Oct. 26: The FDA released an investigation document, revealing that a quarter of the steroid vials in an NECC bin contained "greenish black foreign matter." The FDA went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

Nov. 6: NECC president Barry Cadden was subpoenaed to appear before Congress about outbreak.

Nov. 7: The 42-day risk period designated by the CDC ended, but five new cases were reported, bringing the total case count to 424, including 10 joint infections. Of those, 31 patients died.

The same day, the Massachusetts pharmacy board director was fired.

Nov. 14: A congressional hearing on the outbreak is set to take place. "The [New England Compounding Center] has a history of problems, some of which were documented in an FDA warning letter in 2006," the House subcommittee on Oversight and Investigation said in a statement announcing the hearing. "We want to know what went wrong at this facility, the views and actions of its regulators, and that steps can be taken to ensure such an outbreak never happens again."