The New England Compounding Center (NECC), the compounding pharmacy at the center of a multistate outbreak of fungal meningitis, had been linked to possible meningitis cases back in 2002. According to a report from The Wall Street Journal, inspection records from the U.S. Food & Drug Administration (FDA) indicate that a hospital in Rochester, New York, had reported meningitis-like symptoms in two patients who had received methylprednisolone from NECC. That’s the same steroid linked to the current outbreak.

When the connection was made between NECC steroids and the two cases in New York, the FDA suggested that operations at the NECC facility in Framingham be suspended, but it was prohibited by law from acting. Instead the agency deferred to Massachusetts authorities. In testimony prepared for a hearing today before the House Energy and Commerce Committee, Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, doesn’t say whether state officials ever followed up. According to The Wall Street Journal, Dr. Smith asserts in her testimony that NECC bears the primary responsibility for the safety lapses.

“NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and unlawfully engaged in manufacturing, endangering thousands of lives as a result,” Dr. Smith said in the testimony.

According to the U.S. Centers for Disease Control (CDC), 428 cases of fungal meningitis have been reported in people who received steroid shots prepared by NECC to treat back pain, while 10 peripheral joint infections have been reported in patients who received the injections in knees, hips and other joints. Some meningitis victims have also developed a second infection, epidural abscesses, at the site of their steroid injection, despite being treated with powerful antifungal drugs. At least 32 deaths have been tied to the meningitis outbreak.

The House Energy and Finance Committee has scheduled a hearing on the outbreak today, while the Senate takes up the issue tomorrow. NECC owner Barry Cadden was subpoenaed to testify during today’s hearing, but has invoked his Fifth Amendment rights and declined to answer questions.

According to a report from The Boston Globe, Health and Human Services Secretary Dr. JudyAnn Bigby said she was “disappointed” that Cadden did not respond to questioning, because much remains unanswered about New England Compounding.

“He’s the only one that can answer” some of those questions, she said.

Published November 15, 2012 by