Tainted steroid injections have sickened at least 138 people throughout the nation with fungal meningitis. At least one dozen people have died, including a 70-year-old Florida man. The injections have been traced to New England Compounding Center (NECC), a Massachusetts company that mixes and combines drugs into custom formulations not commonly available from pharmaceutical manufacturers.
Meningitis is an infection of the membranes surrounding the spinal cord and brain. Symptoms include fever, nausea, and headache. The fungal form of meningitis is not contagious.
NECC has since surrendered its license and recalled its products. In addition, Ameridose LLC, a company owned by the same individuals as NECC, has given up attempts to distance itself from its sister company and the meningitis outbreak. Ameridose has agreed to close down for two weeks while officials investigate the matter.
The outbreak has prompted calls for better oversight of the custom pharmaceutical industry. The process of drug “compounding,” as it is called, is regulated mainly by state governments. The U.S. Food and Drug Administration admits their legal authority to regulate such activity is “complex” and actively opposed by industry leaders.
In 2006, following an inspection of NECC’s facilities, the FDA and the Massachusetts Board of Pharmacy issued a warning letter to the company regarding their operational safeguards. Specifically, they took issue with the company’s practice of opening sterile products and repackaging them without sufficient protection against infection.
The letter also alleged that the company was violating a law forbidding the sale of compounded drugs without receiving a prescription for a specific patient.
“Your firm has reportedly also told physicians’ offices that using a staff member’s name on the prescription would suffice,” the letter said.
Up to 13,000 patients nationwide may have received tainted injections of anti-inflammatory steroids manufactured by NECC for purposes of pain management.
In a Reuters report, Jim McGuire of Tennessee said that his local emergency room was flooded with patients ordered to undergo tests for fungal meningitis.
“It was kind of a chaos in the emergency room,” he said. “The triage for this was incredible. There were beds lined up in the hallway. As soon as one spinal tap was over, they were pushing another one in.”
U.S. Senator Scott Brown of Massachusetts was recently the beneficiary of a fundraiser held by Conigliaro, NECC’s owner, to help his re-election campaign. A spokesperson for the campaign said that Brown would donate the $10,000 contributed by Conigliaro to the Meningitis Foundation of America.
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