A meningitis outbreak that has killed 11 and infected more than 90 other people is doubly tragic in that it is due to tainted medicine - something that should not happen.
The medicine is a usually reliable injectable steroid, methylprednisolone acetate, often used to treat chronic back pain. Meningitis is an inflammation of the membranes that cover the spinal cord and brain.
The doses in the meningitis cases had been tainted with a fungus. The New England Compounding Center, Framingham, Mass., recalled the products but it is not yet known exactly how many doses were administered between July, when the products were shipped to health care providers in 23 states, and September, when the first cases were detected in nine states. (No cases have been reported in Pennsylvania, even though some of the products were shipped to this state.) The incubation period is about four weeks and a spokesman for the Centers for Disease Control and Prevention said the agency expects more cases to be reported.
"Compounding pharmacies" such as the Massachusetts company are regulated differently than pharmaceutical manufacturers. The U.S. Food and Drug Administration primarily is responsible for regulatory oversight of manufacturers, whereas state pharmacy boards generally are responsible for compounding pharmacies. After the outbreak, the New England Compounding Center surrendered its license to the Massachusetts Board of Pharmacy.
Sen. Richard Blumenthal, a Connecticut Democrat, said "this incident ought to be a clear alarm, a wake-up call that compounding pharmacies pose a potentially dangerous even deadly source of disease if they are not properly regulated." Compounding pharmacies, he said, occupy a "regulatory black hole."
Blumenthal has asked the FDA to assert more oversight over compounding pharmacies.
He should follow up with legislation mandating and funding such uniform federal oversight.
The saving grace of the outbreak is that the meningitis is a rare fungal form, rather than the bacterial and viral firms that are contagious.
But compounding pharmacies produce many types of medicines. They should be regulated with the same level of scrutiny that is applied to pharmaceutical manufacturers.