Back in October 2012, this blog began covering a fungal meningitis outbreak originating in Massachusetts that eventually killed sixty-four people and injured over 750 more across twenty states. Authorities traced the debilitating outbreak to the New England Compounding Center, a pharmaceutical company that provided personalized medications for medical professionals throughout the country.
In the ensuing two years, we have also discussed matters surrounding the case–the dozens of other potentially unsafe compounding pharmacies in the area, the FDA’s struggle to assert its authority in inspections, and legislative attempts to regulate the compounding pharmacy industry–but today we can report that those responsible for these illnesses and deaths may finally be held accountable.
First, by way of background: many of the affected patients suffer or suffered from chronic back pain, which doctors (often anesthesiologists) most effectively treat with an epidural injection (injection into the cerebrospinal fluid in the spinal canal) of steroids. This method tends to work better than orally administered medication, as its location and exact dosage can be much more finely tuned.
Many patients died from fungal meningitis, which is an infection of the meninges (membranes covering the brain and spinal cord) that occurs when cerebrospinal fluid becomes tainted, as it did in many of these injections. Eventually, fungus begins to grow and spread up and down the spinal cord and eventually to the brain. Symptoms of the condition include: headache, nausea, fever, sensitivity to light, slurred speech, and confusion.
With this terrible illness in mind, it must come as a relief to the families of those affected that, according to the New York Times, fourteen employees of the New England Compounding Center have been charged in connection with the outbreak. This includes four former owners and the former head pharmacist. The charges, which have not yet been disclosed in full, are listed in a 131-count indictment that also includes twenty-five “predicate acts of second-degree murder.” One owner, along with the head pharmacist, faces not only the aforementioned second-degree murder charges (in seven states), but also racketeering.
These criminal charges come after over four hundred individuals have filed civil lawsuits against the compounding pharmacy, which several investigations reveal was operating virtually without oversight from government regulators. This is typical of the compounding pharmaceutical industry as a whole, which is frightening. Such operations are generally small companies that blend and mix doses of medication–usually pain management medication–for individual patients according to their needs, but the number of regulators has not kept up with the number of compounding pharmacies. This has made it impossible to ensure the purity and proper dosage of every vial coming out of such facilities, some of which (according to the FDA) contained “unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in ‘clean rooms’ where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats.”
While legislation has come a long way since the initial infections in 2012, the FDA still lacks the personnel necessary to keep this industry fully in check. Margaret Hamburg, the Commissioner of the FDA, recently wrote a blog post in which she explained that her agency has investigated over 175 compounding pharmacies over the past two years and that risks to patient safety still exist. “Our work on behalf of all patients who want and deserve medicines that do not subject them to undue risk is far from being done,” she wrote, “FDA will continue to work with the states, the Department of Justice and others to enable Americans to have greater confidence in their compounded drugs.”
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