Most of the reports of the infection, known as an epidural abscess, have originated in Michigan, site of 112 meningitis cases during the outbreak.
“This is a significant shift in the presentation of this fungal infection, and quite concerning,” said Dr. Lakshmi K. Halasyamani, chief medical officer at St. Joseph Mercy Hospital in Ann Arbor, Michigan. “An epidural abscess is very serious. It’s not something we expected.”
Nationally, 404 people have been diagnosed with meningitis since late September, after using a contaminated steroid issued by the New England Compounding Center (NECC). The Food and Drug Administration confirmed the company’s link to the outbreak last month when it matched the contaminant involved in the outbreak, Exserohilum rostratum, to a steroid batch the company made in August.
Salon reported on Tuesday that while NECC has been reprimanded several times over the past decade, the company was spared from more serious sanctions by entering into a consent agreement with a state agency, the Massachusetts Board of Registration in Pharmacy.
The company’s president and co-owner, Greg Coniglario, was also revealed to have hosted a fundraiser for Massachusetts Republican Sen. Scott Brown (R-MA), one of 10 senators to sign a letter asking the FDA to loosen regulations on the drug compounding industry.
Coniglario has allegedly contributed thousands of dollars to both Brown’s campaign and former Massachusetts Governor Mitt Romney’s presidential campaign.
About 14,000 people were injected with the steroid, methylprednisolone acetate, after it was initially shipped to hospitals. The drug is mostly used to treat neck and back pain, but some patients reported infections after being injected for arthritic joint pain.
Both NECC and a sister company, Ameridose — also owned by NECC’s owners, Coniglario and Barry Cadden — have been shuttered during the investigation, and their products have been recalled.