Meningitis Outbreak Traced To Massachusetts Pharmacy
By Phil Williams Chief Investigative Reporter
NASHVILLE, Tenn. -- The tainted steroid drugs that appear to be the culprit in Middle Tennessee's deadly meningitis outbreak were mixed up at a facility just west of Boston.
That facility is the New England Compounding Center (NECC) in Framingham, Massachusetts.
Late Wednesday, the Massachusetts Department of Health said investigators are looking into a possible connection to more than 25 suspected cases of fungal meningitis in five states: Florida, Maryland, North Carolina, Tennessee and Virginia.
According to its website, New England Compounding Center is a compounding-only pharmacy that mixes up medications that are no longer manufactured or, in this case, persistently back-ordered because of production shortages.
The firm had voluntarily recalled three batches of the drug, methylprednisolone acetate, on September 26th, according to a spokesperson for the U.S. Food and Drug Administration.
Still, the North Carolina Board of Pharmacy held an emergency session on Wednesday and immediately suspended the company's permit to provide drugs for that state.
Massachusetts announced that NECC has voluntarily surrendered its license to operate there.
"Our board is concerned based on information that we are receiving that potential contamination problems may range beyond the specific products that were recalled -- and, given the public safety stakes at issue here, the board felt it was appropriate to go ahead and stop NECC's ability to practice pharmacy in North Carolina," the board's executive director, Jay Campbell, told NewsChannel 5 Investigates.
For years now, the U.S. Food and Drug Administration has been trying to regulate such facilities that mix up existing drugs because they don't always meet the same stringent standards as pharmaceutical manufacturers.
In 2006, NECC the company was one of five firms that the FDA warned to stop making high-dose topical anesthetic creams.
The agency cited "serious public health risks."
In addition, our NewsChannel 5 investigation discovered that there may be a good reason that St. Thomas and other clinics turned to this Massachusetts facility.
That's because there's a shortage of methylprednisolone acetate, an injectable steroid drug that's widely used to combat back pain.
One company that makes the drug says it will be next year before it has any new product. The second company does not have any sort of estimate about when its supplies will be back to normal.
While pharmaceutical manufacturers are regulated by the FDA, such compounding pharmacies are overseen by the states.
The FDA has been trying to regulate these compounding pharmacies. But NECC is one of the companies that's been fighting the feds in court.
Here is the statement from NECC:
"New England Compounding Center (NECC) is working closely with the Massachusetts Department of Public Health, the Massachusetts Board of Pharmacy and other regulators to identify the source of infection in patients who received injections of methylprednisolone acetate. Upon notification of incidents of infection, NECC immediately initiated a voluntary recall of this product on September 26. As part of this process, we have voluntarily suspended operations while we assist authorities in their investigation."
Here is the statement from the Massachusetts Department of Public Health:
"The Massachusetts Department of Public Health is collaborating with the CDC, FDA, and other state public health officials to identify the cause of an outbreak of more than 25 suspected cases of aspergillus (fungal) meningitis under investigation in Florida, Maryland, North Carolina, Tennessee and Virginia. The cause for this cluster of cases is not yet known. There are four products common to all of these cases. One medication, Methylprednisolone Acetate, a steroid, was prepared at the New England Compounding Center, Inc (NECC), a pharmacy in Framingham, Massachusetts. It has been recalled and quarantined as a precaution. NECC is voluntarily recalling all similar medications. In addition, at the request of DPH, NECC has agreed to voluntarily surrender their license to operate until this investigation is complete. The form of fungal meningitis in these patients is not transmitted from person to person. There are no known cases in the Commonwealth."