November 14, 2012
Patient Illness Risks Noticed At NECC More Than A Decade Ago
Lawrence LeBlond for redOrbit.com - Your Universe Online
As cases of fungal meningitis stemming from tainted steroid injections continue to climb, lawmakers outline the scope of the deadly outbreak that has so far affected more than 438 people and has resulted in 32 deaths, according to CDC data.
In investigations of the government´s response to the outbreak, a US House of Representatives panel has found that the US Food and Drug Administration (FDA) had known more than a decade ago that the New England Compounding Center´s (NECC) drug producing schemes were risky to patient health. According to the House panel, FDA inspection records in 2002 showed that NECC may not have met sterility standards. During that past inspection, the FDA found that conditions at the Framingham, Mass-based compounding facility were similar to a California facility associated with three meningitis deaths in 2001.
The FDA also said in 2002 that a Rochester, NY hospital linked an NECC pain-killing steroid to meningitis-like symptoms in two patients. That steroid, methylprednisolone acetate, is the same drug linked to this year´s outbreak of fungal meningitis. The FDA said it had suggested suspending operations in 2002, yet current laws kept it from acting and was forced to defer action to Massachusetts officials.
In response to the current outbreak, the Energy and Commerce subcommittee on oversight investigations is planning a hearing today to ask FDA Commissioner Margaret Hamburg why the agency didn´t pursue enforcement and how Mass. officials allowed NECC to keep its license. The Senate´s health committee also plans to hold a hearing on November 15.
NECC´s operations were suspended on October 3 after officials determined the company had shipped more than 17,000 vials of contaminated steroid injectables to medical facilities across 23 states. Some 14,000 of the doses had already been used before federal officials were able to step in and close the doors on NECC´s compounding practices.
Inspections of the company´s facility last month showed that NECC knew of elevated levels of mold and bacteria as early as January and further found the company made no efforts to correct the issue, according to a preliminary report citing company documents. The same steroid linked to the current outbreak was also the subject of the 2002 inspection.
Westborough, Mass-based Ameridose LLC, a sister company to NECC, was also shut down and all of its products have been recalled. The FDA said in a separate inspection report that Ameridose failed to investigate microbiological contamination observed at least 53 times during sterility testing of solutions intended for use in its sterile injectables. Ameridose also received 33 complaints that drugs it had made weren´t as potent as they were intended to be and were largely ineffective, according to the FDA report.
Even before 2002, NECC had run into regulation problems. The first complaint was filed against NECC by Massachusetts regulators in 1999–less than a year after it opened its production facility–for providing doctors with blank prescription pads referring to their pharmacy.
More disturbingly, a Colorado complaint that was filed in 2010 against NECC was largely ignored, resulting in last week´s firing of James Coffey, director of the Mass. Board of Pharmacy.
Lauren Smith, interim commissioner of the Mass. Dept. of Public Health, released a statement on Nov. 7 alleging Coffey had known about the complaint for more than two years but failed to act on it. The complaint was over NECC´s actions of selling drugs without patient-specific prescriptions in the state of Colorado. Even after Colorado officials warned NECC of their politics, the company continued to send drugs to the state illegally.
The only good news to surface over the past week is the fact that cases of fungal meningitis are starting to wane, as the 42-day incubation period for the illness was reached last week, after the last possible dose was given on September 26, when doses were recalled. While it is likely cases will continue to trickle in, health officials believe the worst is now behind them.