Questions We Should Be Asking About the Meningitis Outbreak

As the investigation by the U.S. House of Representatives’ Energy and Commerce Committee into the causes of a recent outbreak of fungal meningitis continues, it seems to be revealing more and more disturbing information about what happened and why.

The investigation began after a Tennessee man was diagnosed with fungal meningitis. Since this type of meningitis is very rare, his doctor investigated further in addition to reporting it to the Tennessee Department of Health. Since the patient had taken a back injection shortly before developing meningitis symptoms, investigators looked at the plant where the injection was manufactured, the New England Compounding Center. They discovered fungus in other vials of medication.

The first question investigators need to ask is how the fungus got into the medication in the first place. It is likely that the NECC didn’t follow standard procedures to ensure a sterile environment. Investigators are looking at NECC’s manufacturing procedures as well as state regulators’ behavior. If state regulators regularly toured the manufacturing facility to ensure it was up to code, how did the contamination occur? Investigators also may want to learn more about how long the fungus takes to develop and how long NECC has been violating procedures if it turns out NECC has done so.

Investigators have also discovered that the FDA had concerns about the safety of NECC’s manufacturing process as far back as 2006. Thus, they want to know why the NECC was able to stay in business for another six years. The investigation is currently looking at state regulators to see whether they complied with FDA directives and state laws.

The most important question the investigation can ask is how to prevent future outbreaks of disease from contaminated medication. ALthough the meningitis outbreak is the worst example of contamination-driven disease in the United States, it’s far from the only one. Some consumer advocates believe that leaving regulation of compounding pharmacies to states rather than to the FDA is a bad idea. The FDA does not oversee these kinds of pharmacies, which increases the likelihood of non-standard and potentially hazardous practices.

The investigation should also look into what the FDA did to follow up on its concerns about NECC. If the FDA can’t take on oversight of all compounding pharmacies, perhaps it can oversee pharmacies that it has grave concerns about.

Over 14,000 people have been exposed to fungal meningitis as a result of the contamination. More than 10 percent of those people have become sick, and of the ones who have gotten meningitis, about 10 percent have died. It’s time to figure out exactly what went wrong and prevent it from happening again.