Meningitis Outbreak: Pharmacy Staff Worked in Plain Sight of Health Violations

FDA's latest report confirms that there were visible signs of contaminated work spaces in the lab responsible.
Pain medication from NECC has so far caused hundreds to fall ill and 25 to die from fungal meningitis. (Photo: Erik Von Weber/Getty Images)
Oct 28, 2012· 2 MIN READ
A Bay Area native, Andri Antoniades has previously worked as a fashion industry journalist and a medical writer.

Earlier this month, TakePart reported on a lethal meningitis outbreak stemming from pain medication mixed at one pharmacy in New England. With the death toll increasing and the rate of ill patients rapidly rising, this fungal meningitis resurgence has become one of the country’s worst drug-related health crises in recent years. Worse still, are new reports that staffers at the pharmacy knew of the impending danger and did nothing to stop it.

So far, 338 people have been fallen ill from fungal meningitis, while 25 more have died from it, the Associated Press reports. In all cases, patients received an injection of tainted pain medication made in the New England Compounding Center (NECC) in Framingham, Mass.

Earlier this month, the Food and Drug Administration (FDA) confirmed that a mysterious black fungus found in the vials of the tainted medication was the same fungus responsible for the disease.

This week, the FDA released a preliminary report stating that the pharmacy itself appears contaminated, which could have played a role in corrupting the medicine.

Among the health and safety violations, the agency found abnormalities in and around what should have been sterile work rooms. They included “green and yellow discolorations,” standing water from a leaky boiler, and visible dust filtering through the air conditioning system courtesy of a nearby recycling plant.

Machinery used to sterilize vials was also found to contain a mysterious residue, and against guidelines, staffers routinely turned off the air conditioning at night, rendering the drugs less stable.

The FDA emphasized that the report is based on "initial observations" and that the agency's investigation is ongoing.

Nonetheless, the NECC also made major documented missteps at the distribution and testing levels of its medication. The AP reports that vials of the pain medicine were shipped out to doctors and hospitals two weeks before the pharmacy had even received its standard confirmation that those vials passed inspection.

And according to The New York Times, the one lot tested by the lab came back normal, but when 50 lots were recently tested by the FDA, all came back as contaminated.

Sarah Sellers, a former FDA officer who left amid frustrations the agency wasn’t doing more to increase regulations of pharmacies like NECC, says she’s not surprised by the outbreak at this particular company. She told the AP, "The entire pharmacy was an incubator of bacteria and fungus. The pharmacy knew this through monitoring results, and chose to do nothing."

If that’s true, it’s startling to imagine what must have been an institutionalized kind of apathy. An entire group of people working in tandem to deliver drugs to the masses― drugs that are injected into people’s bloodstreams― every day chose to walk past discolored walls, residue-tainted machinery, moldy patches, and did nothing.

Now about 14,000 more people who were exposed to meningitis through the NECC’s apathy are waiting to see if they develop the disease as well. This may just be one horrific living example of what happens “when good men do nothing.”

If you're concerned that you or someone you know came in contact with any injectable medication made by NECC, visit the FDA's fungal meningitis page to view its lists of patient names and read the agency's latest updates. Symtpoms of the disease include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status.

What do you think caused staffers at NECC to so blatantly disregard health and safety rules? Let us know in the Comments.