Your Health is at Risk: NECC Knew of Contaminants but did Nothing

Continued from Part 1.

The Need for Highly Sterile Conditions in Manufacturing the Drug at the Center of the Meningitis Outbreak

Absolute cleanliness in the manufacture of the drug at the center of the meningitis outbreak is more important than one might think. The steroid medication is manufactured without preservative. This means that contaminants in the drug could grow unchecked. So it’s vital that the steroid drug be made under highly sterile conditions.

Compounding pharmacies are supposed to make their medications in “clean rooms.” Clean rooms, similar to those used in the manufacture of some high tech components such as semiconductors, must maintain temperature and humidity control and filter the air. Workers might wear special garments and hair and shoe coverings in some clean rooms. These special conditions are intended to maintain the room’s highly sterile conditions.

Some of the Unclean Conditions the FDA found at the NECC Compounding Pharmacy:

• Staffers at the NECC turned off the clean room’s air conditioning each night. This could have interfered with the conditions needed to prevent bacterial growth.
• Inspectors found multiple potential contaminants in and around the clean rooms at the NECC. These contaminants included green and yellow residues, water droplets and standing water from a leaking boiler. (If you’ve ever had occasion to look at an ordinary water droplet under a microscope, you might have noticed that it was just “swimming” in bacteria and other microorganisms. Most of these are harmless, but on occasion a water droplet might contain a deadly contaminant.)
• Inspectors also found greenish yellow discoloration inside an autoclave. Autoclaves are machines used to sterilize medicine vials and their stoppers.
• Inspectors found a dark, hair-like discoloration (like a mold or a fungus) along the wall of another room that was supposed to be sterile but apparently was not.
• Additionally, dust from a recycling facility near the NECC appeared to be drifting into the pharmacy’s rooftop air-conditioning system.
• The NECC began shipping vials from the August lot of the steroid medication to its customers on August 17th about two weeks PRIOR TO actually receiving test results from an outside laboratory to confirm that the medication was sterile. It is unclear how the outside lab might have concluded the drug was sterile when tests by FDA scientists of the same lot of the drug this month found contamination in 50 vials. The fungus is said to be slow growing. This is why so many patients who have received injections of the contaminated drug but do not yet have symptoms might still be at risk. The symptoms can take a month or more to appear after the patient has received the drug.

In an Associated Press (AP) news article, Sarah Sellers, a former FDA officer, is quoted as saying, “The entire pharmacy was an incubator of bacteria and fungus…. The pharmacy knew this through monitoring results, and chose to do nothing.” (Source: Matthew Perrone, AP Health Writer, 10/26/12)

In short, the NECC put the health of all patients receiving their drugs at risk. Their disregard of their own internal reports indicating dangerous contamination seems to go beyond simple negligence. The NECC was making drugs without preservatives that would be injected directly into central nervous system tissues, where meningitis takes hold.