Shortly before hundreds of people became sick with a rare strain of fungal meningitis tied to its drugs, the New England Compounding Center (NECC) was sending customers copies of a “Quality Assurance Report Card” that touted the cleanliness of its labs.  Unfortunately, it’s since become clear that NECC’s report card did not accurately reflect the conditions of those labs, as the pharmacy’s own internal tests had repeatedly turned up widespread contamination problems at the facility.

An epidural steroid injection supplied by Massachusetts-based NECC has been linked to an outbreak of fungal infections in 19 states.  According to the latest update from the U.S. Centers for Disease Control (CDC), 356 cases of meningitis, including 28 deaths, have been reported in people who received NECC   injections to treat back pain.  Seven peripheral joint infections have also been reported in patients who received steroid injections in their knees, hips, shoulders or other joints.   Earlier this month, NECC recalled all of its products and voluntarily surrendered its license to operate to Massachusetts health authorities.

According to a new report from The Boston Globe, a report card sent by NECC to its customers in the first half of 2012 purported to show that surfaces in the company’s “clean rooms,” where drugs are prepared, had no instances of contamination exceeding the accepted standard.    The document also boasted that the company’s “extensive” testing of finished products for sterility and microbial contaminants had a 100 percent success rate from January through June 2012.

“The results of our internal review . . . demonstrate that NECC meets and is in continued compliance with all applicable requirements and standards,” said the report, signed by Barry Cadden, a co-owner of the company and its former lead pharmacist.

However, NECC’s own tests from the same period told a different story, with 33 surface samples from the clean rooms exhibiting bacteria or mold at levels requiring corrective action.  Consultants who examined the NECC report cards for the Globe maintained they lacked important scientific data, and described it as a promotional brochure rather than a true technical report.

“Their marketing material is baloney. They are just saying what they want to say,” said Stephen Runge, president of nanoCLEAN Decontamination Services.

In the wake of the outbreak, a U.S. Food & Drug Administration (FDA) inspection of NECC’s Framingham, Massachusetts facility uncovered a host of potentially unsanitary conditions in and around its clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler, and  vials of visibly contaminated steroids. The FDA inspection also revealed four dozen internal reports stretching back to January of possible contamination in NECC’s clean rooms.  What the FDA did not find, however, was any evidence that NECC took measures to correct those problems.

“The entire pharmacy was an incubator of bacteria and fungus,” Sarah Sellers, a former FDA officer, told the Associated Press. “

Published October 31, 2012 by