The human toll on those injected with a fungus-tainted steroid continues to rise. 460 people in 19 states are now sickened and 32 have died from fungal meningitis caused by tainted steroid injections.
Many of those successfully treated for meningitis are now suffering from two new conditions including epidural abscesses on the spine and a much more serious and difficult to treat condition known as arachnoiditis. Epidural abscesses are pus-filled sacs around the spinal column which can be treated with anti-fungal medication or drained and removed surgically if anti-fungal medication is unsuccessful. The more complicated problem of arachnoiditis causes inflammation of the spinal nerve roots causing intense pain, numbness, paralysis and a host of other neurologic problems. Surgery is not an option to treat arachnoiditis and because it is such an unusual condition, the success of drug therapy is uncertain.
Of the 460 sickened, ten patients have peripheral joint infections at the joint site of their steroid injection, and do not suffer from the more severe fungal meningitis suffered by those injected in their back or neck with the tainted steroid.
Federal and state officials believe the tainted steroids were distributed by Massachusetts-based compounding pharmacy, NECC (New England Compounding Center). Officials investigating the fungal meningitis outbreak were repulsed to find the conditions at NECC so unsanitary that mold and bacteria were seen openly growing in the plant.
Criminal charges are now being considered after the Washington Post and FDA reported that NECC knew of contamination problems since January 2012 yet did nothing before the meningitis outbreak to retrieve the tainted steroid vials, or to report the contamination.
A Congressional Oversight and Investigations subcommittee commenced hearings Wednesday, November 14 attempting to get answers about how this deadly outbreak occurred. Unfortunately, NECC owner and director Barry Cadden invoked his Fifth Amendment right against self-incrimination and refused to answer any questions about NECC, their business practices, when NECC knew about the contamination or how the steroids were contaminated in the first place.
Cadden also co-founded another compounding pharmacy, Ameridose, which shut down its facility in October. All products from both NECC and Ameridose have been recalled although to date, no illness or death have been linked to Ameridose products.
Thankfully, Cadden’s pharmaceutical license has been revoked. Furthermore, all NECC pharmacists and pharmacy techs have been ordered to immediately stop working in the pharmacy industry.
Federal officials are also examining whether tighter regulations and oversight should be imposed on compounding pharmacies. Compounding pharmacies are not regulated as strictly as drug manufacturers because they typically mix and alter drug ingredients on a case-by-case basis to meet the specific needs of the individual patient. Drug manufacturers have stricter oversight since they manufacture large quantities of drugs.
Despite holding itself out as a compounding pharmacy, NECC was acting as a drug manufacturer producing multiple drug lots and selling in bulk to medical clinics and institutions, rather than filling individual prescriptions.
Our neighbors to the north and south have suffered tremendously from the meningitis outbreak. In Indiana, 51 people are sickened and four have died from fungal meningitis. Six clinics in Indiana received the tainted steroids. The Indiana Board of Pharmacy voted without objection on Monday to suspend NECC’s operating license in Indiana.
And in Tennessee, 78 people are ill and 13 dead after receiving the contaminated steroids. The first to die in Tennessee was Judge Eddie Lovelace, a Circuit Court Judge from Kentucky whose family is demanding answers about the untimely death of their loved one.
Meningitis is an inflammation of the tissues surrounding the brain and spinal cord. Unlike bacterial meningitis, fungal meningitis is not contagious and doctors are finding it to be much more difficult to successfully treat.