Cj Gunther / EPA
A Food and Drug Administration agent enters the offices of New England Compounding Center, a pharmaceutical company in Framingham, Mass., on Oct. 16. The company made steroids blamed for killing 31 people and making 424 sick.
Massachusetts officials have fired the director of the state’s pharmacy board and suspended its attorney for failing to alert them that the company at the center of an outbreak of fungal meningitis was making and distributing drugs in mass quantities even though it wasn’t licensed to do so, the Boston Globe reported Wednesday.
Federal health officials say the outbreak of fungal meningitis traced to contaminated pain injections from the pharmacy has killed 31 people. They said 424 people have been confirmed sick in 19 states, including 10 who don’t have meningitis but who have infections in the ankle, shoulder or other joints.
Two congressional committees have scheduled hearings into the outbreak for next week, and will forcibly bring in the chief pharmacist at the Massachusetts pharmacy at the center of the outbreak. Meanwhile, officials have given details of the outbreak in Tennessee, where the infections were first noticed and where the alert first went out.
The Globe cited sources close to the investigation as saying James Coffey, director of the state’s pharmacy board, was fired and Susan Manning, attorney for the board, was on administrative leave. It said the Colorado Board of Pharmacy told both Coffey and the U.S Food and Drug Administration that the New England Compounding Center was distributing drugs in bulk. Compounding pharmacies like NECC are only supposed to custom mix drugs to order for specific prescriptions.
NECC has closed and recalled all its drugs. Both the FDA and the Massachusetts health officials say they didn’t have full authority to stop NECC. The FDA doesn’t regulate compounding pharmacies but it can inspect them for cleanliness. Legislation to give the FDA more authority over them foundered more than a decade ago after the U.S. Supreme Court found part of it unconstitutional.
The two committees, one in the House and one in the Senate, will look at the issue of regulation and whether the FDA did enough to control NECC. House Energy and Commerce Committee Chairman Fred Upton, a Michigan Republican, said he issued a subpoena for NECC’s co-owner and managing pharmacist Barry Cadden to appear at his committee’s Nov. 14 hearing.
“With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak. Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena,” Upton said in a statement.
The next day the Senate Health, Education, Labor and Pensions committee will hold its own hearing, with the same panels as well as the Centers for Disease Control and Prevention's Dr. Beth Bell and interim Massachusetts health commissioner Dr. Lauren Smith; David Miller of the International Academy of Compounding Pharmacy and Kasey Thompson of the American Society of Health-System Pharmacists.
The committee also has asked the FDA for any documents from its previous investigations of NECC and other compounding pharmacies.
“Please include whether states were notified, any enforcement actions taken, including all inspections, warning letters, injunctions or seizures executed against compounding pharmacies and how such actions were coordinated with state regulatory authorities,” it asked.
The new statistics from the CDC suggest the outbreak is still related to three contaminated batches of methylprednisolone steroid distributed by the New England Compounding Center in Massachusetts between May and September. Inspections of NECC have turned up dirty conditions and more contaminated drugs, but so far, no infections have been linked to them.
And the report from Tennessee suggests that one of the batches was more contaminated than the others, because people who got injections from that lot were much more likely to become infected than people who got steroid from the other two batches.
“We found a strong association between the age of the methylprednisolone vials and the rate of infection in one clinic,” Dr. Marion Kainer of the Tennessee Department of Health and colleagues wrote in a letter to the New England Journal of Medicine. “One possible explanation for this observation is that the level of contamination in the vials may have increased over time, with subsequent higher fungal burdens present in older vials.”
The more doses of steroid a patient got, the more likely he or she was to become infected, the report found. “Patients who had multiple procedures had an increased risk of a fungal infection,” they wrote. More than 14 percent of patients who got four injections were infected, compared to 5 percent of patients who got just one. So far eight patients, or 12 percent of those infected, have died. Quick treatment seems to save lives they said.
Patients will have to undergo weeks or months of treatment with antifungal drugs, doctors say.