The Wall Street Journal published a story this weekend that provides even more insight on the dangers present at the “compounding” pharmacy behind the highly publicized and incredibly destructive meningitis outbreak. Known as a “drug mixing” pharmacy, the New England Compounding Center (NECC) has come under intense scrutiny since the outbreak was traced to contamination of spinal steroid medication from the plant.
Recently the U.S. Food and Drug Administration (FDA) released more information about the state of affairs at the pharmacy which paints a bleak picture of the safety standards at the location. It is a reminder of the hidden dangers faced by all consumers when using products–including medications–where they are forced to rely on the safety steps place by the manufacturers themselves.
According to the story, the FDA conducted a detailed inspection of the plant this month to determine how far reaching the contamination actually was. The results are staggering. About 1/4 of the material examined by investigators had “greenish black foreign matter” visible in the vial to the naked eye. In total, 50 vials were sent for closer testing. Of that group, all fifty came back as contaminated with fungus. Of course, most of us are shocked by the fact that these sorts of sterilization problems could be found anywhere, let alone a pharmaceutical plant where the safety of the products obviously hinge on an ability to ensure no pathogens are present.
The WSJ story explained that the director of the pharmacy explaiend that the NECC “used non-sterile active pharmaceutical ingredients and raw materials” to create the spinal steroid vials that were ultimately contaminated with fungus and sent out to medical clinics in twenty three states–including Illinos. However, there are already signs that there are problems with documentation at the plant, making it difficult to determine for sure exactly what went wrong. FDA investigators explains that the NECC did not have documentation regarding its “steam autoclaves” which are a key component to sterility efforts at the facility.
This latest FDA report comes on the heels of separate state investigations. Those state efforts returned a similar verdict–with obvious signs of sterility problems at the facility. For example, those state inspectors also found that “clean rooms” at the facility were actually not all that clean. These are the loactions where much of the material is made. Internal records from NECC itself revealed problems with bacteria development in those rooms in January, and there is no evidence that anything was done to fix it after that time.
Sadly, these cut corners and sloppy work has wrecked a devastating toll. Hundreds have now been infected with fungal meningitis and at least two dozen have died. In the aftemath of these findings all products made by the NECC near the time of the contamination (beyond just the spinal steroids) have been recalled. In addition, the plant is not currently operating. It is unclear if it will ever re-open and, if so, under what circumstances.
What is known, however, is that all those affected by this outbreak are urged to seek out legal representation. It is entirely unacceptable to be harmed by the misconduct of pharmaceutical companies. If you or someone you know was affected, please call our office to see how we can help.
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The Personal Stories Behind the Meningitis Outbreak