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The number of illnesses linked to the ongoing fungal meningitis outbreak continues to rise with 510 people sickened, to date. According to the U.S. Centers for Disease Control and Prevention (CDC), another 36 people have died in connection with this outbreak. Of those cases, 496 involve central nervous system infection, which usually involves meningitis; 14 […]
The number of illnesses linked to the ongoing fungal meningitis outbreak continues to rise with 510 people sickened, to date. According to the U.S. Centers for Disease Control and Prevention (CDC), another 36 people have died in connection with this outbreak.
Of those cases, 496 involve central nervous system infection, which usually involves meningitis; 14 cases involve peripheral joint infections, according to the Centers. This is the first CDC update since November 19, said MedPage Today.
The outbreak appears to have begun in late September when physicians in Tennessee were treating a man with an unusual form of meningitis that did not appear to have a bacteria or viral cause. Evidence of fungal infection was detected and involved the mold, Aspergillus fumigatus, said MedPage Today. The physicians advised the state’s public health authorities. Soon, injections of a steroid, methylprednisolone acetate, were linked to this first case and to other, subsequent cases. The tainted steroid was injected into patients’ spines or joints for chronic back pain, MedPage Today.
The methylprednisolone acetate was manufactured in large quantities by the New England Compounding Center (NECC) of Framingham, Massachusetts. NECC, a compounding pharmacy, was later discovered to be tainted with a fungus that was not Aspergillus, MedPage noted. A black mold, Exserohilum rostratum, is believed to be the culprit in the outbreak. That mold is one of several organisms that only rarely cause human disease and has been discovered in some vials containing the steroid and in several of those who were sickened; however, the fungus has been challenging to isolate in many of the patients, according to MedPage Today.
As we’ve said, according to a New York Times investigation into NECC, documents released after the newspaper’s Freedom of Information Act request show that the U.S. Food & Drug Administration (FDA) has continuously backed away from asserting any power against the company because it feared a legal struggle as it does not hold the same power over these companies as state regulators. The FDA has known since at least 2002 about possible manufacturing and procedural problems at NECC.
As the agency is seeking more powers that would enable it to regulate companies like NECC and other compounding labs across the country, further details show that the FDA continually delayed releasing or even formulating reports on inspections the agency sponsored or conducted at the NECC in the last decade. In one case, it took the FDA nearly two years to write a report on inspection findings at NECC. When it finally informed company officials of the alleged violations, most were out-dated and not applicable to the company’s current practices. This begs the question: If the FDA were to gain some more regulatory control over compounding labs, would it serve the public’s health interests any more than the current arrangement?
NECC has recalled all shipments of its drugs since earlier this year and has shut its doors, at least temporarily. Investigations launched since the outbreak revealed that conditions inside NECC were far from any industry standards and not up to state or federal codes.
NECC mixed at least 14,000 vials of methylprednisone acetate and shipped it to more than 70 pain management and other health care clinics in 23 states. Testing on sample vials showed that many of them were contaminated with a fungus responsible for the outbreak of the deadly form of meningitis.