According to the Center for Disease Control and Prevention, the death toll
caused by the outbreak of fungal meningitis has risen to 32 individuals
in 19 states, with a reported 438 cases under investigation. The pharmacy
at the center of this tragedy the New England Compounding Center in Framingham,
Massachusetts does not have a good regulatory track record. Beginning
in 2002, when the Food and Drug Administration and Massachusetts state
officials relegated the oversight of the center to a state pharmacy board
even with evidence that two drugs were linked to health problems. One
of the same drugs associated with the risks in 2002 is the same steroid
treatment identified as the source of the current fungal meningitis outbreak.
This multi-state outbreak includes Kentucky and Tennessee, which has been hit the hardest. It is estimated that between 12,000 and 14,000 individuals across the country received injections from the contaminated steroid shots. The Department for Public Health is monitoring the situation closely, and asks that any Kentuckian who has received epidural steroid injections since May 21, 2012 and has the following symptoms to see a doctor as soon as possible:
Fungal Meningitis Symptoms
1) Worsening headache
2) Fever
3) Sensitivity to light
4) Stiff neck
5) New weakness or numbness in any part of the body
6) Slurred speech
Meningitis is an infection of the protective membrane of the brain and spinal cord. This particular outbreak of fungal meningitis is not contagious.
This week The House Energy Commerce Committee and the Senate Health, Education and Labor and Pensions Committee will both hear testimony from FDA Commissioner Margaret Hamburg, interim Massachusetts health commissioner Lauren Smith, and the co-owner of the New England Compounding Center, Barry Cadden. The burning question everyone is asking is how did this happen? And could it have been prevented?
Currently drug compounding pharmacies, unlike drug manufacturers, are not regulated by the FDA, but overseen mainly by state authorities. However, the recent evolution of these compounding pharmacies to produce on a large-scale begs the question, are they moving more towards the activities of a manufacturer, and therefore should be held to the same standards and regulations?
As we have seen by this horrible outbreak of deadly fungal meningitis, the answers to these questions affect us all. We will be watching closely the outcome of the hearings, and keep you posted on the ever-changing and complex case.